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Zyprexa. Real Zyprexa side effects. Zyprexa lawsuits are starting. Zyprexa drug information and Zyprexa adverse effects. Zyprexa lawsuits are starting, do you have a Zyprexa claim, find out.

Zyprexa

A systematic review of cardiovascular effects after atypical antipsychotic medication overdose.

Tan HH, Hoppe J, Heard K.

Am J Emerg Med. 2009 Jun;27(5):607-616.

Zyprexa: 19497468 [Zyprexa - as supplied by publisher]

Medication nonadherence and treatment outcome in patients with schizophrenia or schizoaffective disorder with suboptimal prior response.

Lindenmayer JP, Liu-Seifert H, Kulkarni PM, Kinon BJ, Stauffer V, Edwards SE, Chen L, Adams DH, Ascher-Svanum H, Buckley PF, Citrome L, Volavka J.

J Clin Psychiatry. 2009 Jun 2. [Epub ahead of print]

Zyprexa: 19497244 [Zyprexa - as supplied by publisher]

Dopamine D(2/3) receptor binding potential and occupancy in midbrain and temporal cortex by haloperidol, olanzapine and clozapine.

Tuppurainen H, Kuikka JT, Viinamäki H, Husso M, Tiihonen J.

Psychiatry Clin Neurosci. 2009 May 19. [Epub ahead of print]

Zyprexa: 19496999 [Zyprexa - as supplied by publisher]

Risk of lipid abnormality with haloperidol, olanzapine, quetiapine, and risperidone in a Veterans Affairs population.

Duncan EJ, Woolson SL, Hamer RM, Dunlop BW.

Int Clin Psychopharmacol. 2009 Jun 2. [Epub ahead of print]

Zyprexa: 19494785 [Zyprexa - as supplied by publisher]

Does electroconvulsive therapy afford protection against olanzapine-induced parkinsonism? A case report.

Dastgheib SA, Ghanizadeh A, Mowla A, Khajeian AM.

J ECT. 2009 Jun;25(2):146. No abstract available.

Zyprexa: 19494739 [Zyprexa - in process]

Delusion Symptoms and Response to Antipsychotic Treatment are Associated with the 5-HT2A Receptor Polymorphism (102T/C) in Alzheimer's Disease: A 3-Year Follow-up Longitudinal Study.

Angelucci F, Bernardini S, Gravina P, Bellincampi L, Trequattrini A, Di Iulio F, Vanni D, Federici G, Caltagirone C, Bossù P, Spalletta G.

J Alzheimers Dis. 2009 May;17(1):203-11.

Zyprexa: 19494443 [Zyprexa - in process]

Differential effects of M1 and 5-HT1A receptors on atypical antipsychotic drug-induced dopamine efflux in the medial prefrontal cortex.

Li Z, Prus AJ, Dai J, Meltzer HY.

J Pharmacol Exp Ther. 2009 Jun 2. [Epub ahead of print]

Zyprexa: 19491322 [Zyprexa - as supplied by publisher]

A review of smoking cessation: potentially risky effects on prescribed medications.

Schaffer SD, Yoon S, Zadezensky I.

J Clin Nurs. 2009 Jun;18(11):1533-40.

Zyprexa: 19490292 [Zyprexa - in process]

Comparison of treatment completion rates for olanzapine pamoate and risperidone microspheres.

Akhras KS, Singh J, Gopal S, Schadrack J, Palumbo JM.

Int J Clin Pract. 2009 Jun;63(6):962-3; author reply 963. No abstract available.

Zyprexa: 19490204 [Zyprexa - in process]

The effect of antipsychotics on the high-affinity state of D2 and D3 receptors: a positron emission tomography study With [11C]-(+)-PHNO.

Graff-Guerrero A, Mamo D, Shammi CM, Mizrahi R, Marcon H, Barsoum P, Rusjan P, Houle S, Wilson AA, Kapur S.

Arch Gen Psychiatry. 2009 Jun;66(6):606-15.

Zyprexa: 19487625 [Zyprexa - in process]

Effects of 4-week Treatment with Lithium and Olanzapine on Levels of Brain-derived Neurotrophic Factor, B-Cell CLL/Lymphoma 2 and Phosphorylated Cyclic Adenosine Monophosphate Response Element-binding Protein in the Sub-regions of the Hippocampus.

Hammonds MD, Shim SS.

Basic Clin Pharmacol Toxicol. 2009 Apr 17. [Epub ahead of print]

Zyprexa: 19486334 [Zyprexa - as supplied by publisher]

The promotion of olanzapine in primary care: An examination of internal industry documents.

Spielmans GI.

Soc Sci Med. 2009 May 27. [Epub ahead of print]

Zyprexa: 19481322 [Zyprexa - as supplied by publisher]

Neuroleptic malignant syndrome associated with atypical antipsychotic drugs.

Trollor JN, Chen X, Sachdev PS.

CNS Drugs. 2009;23(6):477-92. doi: 10.2165/00023210-200923060-00003.

Zyprexa: 19480467 [Zyprexa - in process]

[Atypical antipsychotic efficacy and safety in managing delirium: A systematic review and critical analysis.]

Pelland C, Trudel JF.

Psychol Neuropsychiatr Vieil. 2009 Jun;7(2):109-19. French.

Zyprexa: 19473954 [Zyprexa - in process]

Chinese slimming capsules containing sibutramine sold over the internet: a case series.

Müller D, Weinmann W, Hermanns-Clausen M.

Dtsch Arztebl Int. 2009 Mar;106(13):218-22. Epub 2009 Mar 27.

Zyprexa: 19471631 [Zyprexa - in process]

Zyprexa side effects
Dry Mouth - The usual amount to moisture in the mouth is noticeably less.

Zyprexa side effects
Sweating Increased - A large quantity of perspiration that is medically caused.

Zyprexa side effects
Cardiovascular (Involving the heart and the blood vessels)

Zyprexa side effects
Palpitation - Unusual and not normal heartbeat, that is sometimes irregular, but rapid and forceful thumping or fluttering. It can be brought on by shock, excitement, exertion, or medical stimulants. A person is normally unaware of his/her heartbeat.

Zyprexa side effects
Hypertension - is high blood pressure, which is a symptom of disease in the blood vessels leading away from the heart. Hypertension is known as the “silent killer”. The symptoms are usually not obvious, however it can lead to damage to the heart, brain, kidneys and eye, and even to stroke and kidney failure. Treatment includes dietary and lifestyle changes.

Zyprexa side effects
Bradycardia - The heart rate is slowed from 72 beats per minute, which is normal, to below 60 beats per minute in an adult.

Zyprexa side effects
Tachycardia - The heart rate is speeded up to above 100 beats per minute in an adult. Normal adult heart rate is 72 beats per minute.

Zyprexa side effects
ECG Abnormal - A test called an electrocardiogram (ECG) that records the activity of the heart. It measures heartbeats as will as the position and size of the heart’s four chambers. It also measures if there is damage to the heart and the effects of drugs or mechanical devices like a pacemaker on the heart. When the test is abnormal this means that one or more of the following are present: heart disease, defects, beating too fast or too slow, disease of the blood vessels leading from the heart or of the heart valves, and/or a past or about to occur heart attack.

Zyprexa side effects
Flushing - The skin all over the body turns red.

Zyprexa side effects
Varicose Vein - Unusually swollen veins near the surface of the skin that sometimes appear twisted and knotted, but always enlarged. They are called hemorrhoids when they appear around the rectum. The cause is attributed to hereditary weakness in the veins aggravated by obesity, pregnancy, pressure from standing, aging, etc. Severe cases may develop swelling in the legs, ankles and feet, eczema and/or ulcers in the affected areas.

Zyprexa side effects
Gastrointestinal (Involving the stomach and the intestines)

Zyprexa side effects
Abdominal Cramp/Pain - Sudden, severe, uncontrollable and painful shortening and thickening of the muscles in the belly. The belly includes the stomach as well as the intestines, liver, kidneys, pancreas, spleen, gall bladder, and urinary bladder.

Zyprexa side effects
Belching - Noisy release of gas from the stomach through the mouth; a burp.

Zyprexa side effects
Bloating - Swelling of the belly caused by excessive intestinal gas.

Zyprexa side effects
Constipation - Difficulty in having a bowel movement where the material in the bowels is hard due to a lack of exercise, fluid intake, and roughage in the diet, or due to certain drugs.

Zyprexa side effects
Diarrhea - Unusually frequent and excessive, runny bowel movements that may result in severe dehydration and shock.

Zyprexa side effects
Dyspepsia - Indigestion. This is the discomfort you experience after eating. It can be heartburn, gas, nausea, a bellyache or bloating.

Zyprexa side effects
Flatulence - More gas than normal in the digestive organs.

Zyprexa side effects
Gagging - Involuntary choking and/or involuntary throwing up.

Zyprexa side effects
Gastritis - A severe irritation of the mucus lining of the stomach either short in duration or lasting for a long period of time.

Zyprexa side effects
Gastroenteritis - A condition where the membranes of the stomach and intestines are irritated.

Zyprexa side effects
Gastroesophageal Reflux - A continuous state where stomach juices flow back into the throat causing acid indigestion and heartburn and possibly injury to the throat.

Zyprexa side effects
Heartburn - A burning pain in the area of the breastbone caused by stomach juices flowing back up into the throat.

Zyprexa side effects
Hemorrhoids - Small rounded purplish swollen veins that either bleed, itch or are painful and appear around the anus.

Zyprexa side effects
Increased Stool frequency - Diarrhea.

Zyprexa side effects
Indigestion - Unable to properly consume and absorb food in the digestive tract causing constipation, nausea, stomach ache, gas, swollen belly, pain and general discomfort or sickness.

Zyprexa side effects
Nausea - Stomach irritation with a queasy sensation similar to motion sickness and a feeling that one is going to vomit.

Zyprexa side effects
Polyposis Gastric - Tumors that grow on stems in the lining of the stomach, which usually become cancerous.

Zyprexa side effects
Swallowing Difficulty - A feeling that food is stuck in the throat or upper chest area and won’t go down, making it difficult to swallow.

Zyprexa side effects
Toothache - Pain in a tooth above and below the gum line.

Zyprexa side effects
Vomiting - Involuntarily throwing up the contents of the stomach and usually getting a nauseated, sick feeling just prior to doing so.

Zyprexa side effects
General

Zyprexa side effects
Allergy - The extreme sensitivity of body tissues triggered by substances in the air, drugs, or foods causing a reaction like sneezing, itching, asthma, hay fever, skin rashes, nausea and/or vomiting.

Zyprexa side effects
Anaphylaxis - A violent, sudden, and severe drop in blood pressure caused by a re-exposure to a foreign protein or a second dosage of a drug that may be fatal unless emergency treatment is given right away.

Zyprexa side effects
Asthenia - A physically weak condition.

Zyprexa side effects
Chest Pains - Severe discomfort in the chest caused by not enough oxygen going to the heart because of narrowing of the blood vessels or spasms.

Zyprexa side effects
Chills - Appearing pale while cold and shivering; sometimes with a fever.

Zyprexa side effects
Edema of Extremities - Abnormal swelling of the body’s tissue caused by the collection of fluid.

Zyprexa side effects
Fall - To suddenly lose your normal standing upright position as if you were shot.

Zyprexa side effects
Fatigue - Loss of normal strength so as to not be able to do the usual physical and mental activities.

Zyprexa side effects
Fever - Abnormally high body temperature, the normal being 98 degrees Fahrenheit or 37 degrees Centigrade in humans, which is a symptom of disease or disorder in the body. The body is affected by feeling hot, chilled, sweaty, weak and exhausted. If the fever goes too high, death can result.

Zyprexa side effects
Hot Flashes - Brief, abnormal enlargement of the blood vessels that causes a sudden heat sensation over the entire body. Women in menopause will sometimes experience this.

Zyprexa side effects
Influenza-like Symptoms - Demonstrating irritation of the respiratory tract (organs of breathing) such as a cold, sudden fever, aches and pains, as well as feeling weak and seeking bed rest, which is similar to having the flu.

Zyprexa side effects
Leg Pain - A hurtful sensation in the legs that is caused by excessive stimulation of the nerve endings in the legs and results in extreme discomfort.

Zyprexa side effects
Malaise - The somewhat unclear feeling of discomfort you get when you start to feel sick.

Zyprexa side effects
Pain in Limb - Sudden, sharp and uncontrolled leg discomfort.

Zyprexa side effects
Syncope - A short period of light headedness or unconsciousness (black-out) also know as fainting caused by lack of oxygen to the brain because of an interruption in blood flowing to the brain.

Zyprexa side effects
Tightness of Chest - Mild or sharp discomfort, tightness or pressure in the chest area (anywhere between the throat and belly). The causes can be mild or seriously life-threatening because they include the heart, lungs and surrounding muscles.

Zyprexa side effects
Hemic and Lymphatic Disorders (Involving the blood and the clear fluids in the tissues that contain white blood cells)

Zyprexa side effects
Bruise - Damage to the skin resulting in a purple-green-yellow skin coloration that’s caused by breaking the blood vessels in the area without breaking the surface of the skin.

Zyprexa side effects
Anemia - A condition where the blood is no longer carrying enough oxygen, so the person looks pale and easily gets dizzy, weak and tired. More severely, a person can end up with an abnormal heart, as well as breathing and digestive difficulties. The causes of anemia are not enough protein in the red blood cells, or missing and chemically destroyed red blood cells, as well as diseased or destroyed bone marrow.

Zyprexa side effects
Nosebleed - Blood lost from the part of the face that has the organs of smell and is where the body takes in oxygen.

Zyprexa side effects
Hematoma - Broken blood vessels that cause a swelling in an area on the body.

Zyprexa side effects
Lymphadenopathy Cervical - The lymph nodes in the neck, which are part of the body’s immune system get swollen and enlarge by reacting to the presence of a drug. The swelling is the result of the white blood cells multiplying in order to fight the invasion of the drug.

Zyprexa side effects
Metabolic and Nutritional Disorders (Energy and health)

Zyprexa side effects
Arthralgia - Sudden sharp nerve pain in one or more joints.

Zyprexa side effects
Arthropathy - Having joint disease or abnormal joints.

Zyprexa side effects
Arthritis - Painfully inflamed and swollen joints. The reddened and swollen condition is brought on by a serious injury or shock to the body either from physical or emotional causes.

Zyprexa side effects
Back Discomfort - Severe physical distress in the area from the neck to the pelvis along the backbone.

Zyprexa side effects
Bilirubin Increased - Bilirubin is a waste product of the breakdown of old blood cells. Bilirubin is sent to the liver to be made water-soluble so it can be eliminated from the body through emptying the bladder. A drug can interfere with or damage this normal liver function creating liver disease.

Zyprexa side effects
Decreased Weight - Uncontrolled and measured loss of heaviness or weight.

Zyprexa side effects
Gout - A severe arthritis condition that is caused by the dumping of a waste product called uric acid in the tissues and joints. It can become worse and cause the body to develop a deformity after going through stages of pain, inflammation, severe tenderness, and stiffness.

Zyprexa side effects
Hepatic Enzymes Increased - An increase in the amount of paired liver proteins that regulate liver processes causing a condition where the liver functions abnormally.

Zyprexa side effects
Hypercholesterolemia - Too much cholesterol in the blood cells.

Zyprexa side effects
Hyperglycemia - An unhealthy amount of sugar in the blood.

Zyprexa side effects
Increased Weight - A concentration and storage of fat in the body accumulating over a period of time caused by unhealthy eating patterns, that can predispose the body to many disorders and diseases.

Zyprexa side effects
Jaw Pain - The pain due to irritation and swelling of the nerves associated with the mouth area where it opens and closes just in front of the ear. Some of the symptoms are pain when chewing, head aches, losing your balance, stuffy ears or ringing in the ears, and teeth grinding.

Zyprexa side effects
Jaw Stiffness - The result of squeezing and grinding the teeth while asleep that can cause your teeth to deteriorate as well as the muscles and joints of the jaw.

Zyprexa side effects
Joint Stiffness - A loss of free motion and easy flexibility where any two bones come together.

Zyprexa side effects
Muscle Cramp - When muscles contract uncontrollably without warning and do not relax. The muscles of any of the body’s organs can cramp.

Zyprexa side effects
Muscle Stiffness - Tightening of muscles making it difficult to bend.

Zyprexa side effects
Muscle Weakness - Loss of physical strength.

Zyprexa side effects
Myalgia - A general widespread pain and tenderness of the muscles.

Zyprexa side effects
Thirst - A strong, unnatural craving for moisture/water in the mouth and throat.

Zyprexa side effects
Nervous System (Sensory channels)

Zyprexa side effects
Carpal Tunnel Syndrome - A pinched nerve in the wrist that causes pain, tingling, and numbing.

Zyprexa side effects
Coordination Abnormal - A lack of normal, harmonious interaction of the parts of the body when it is in motion.

Zyprexa side effects
Dizziness - Losing one’s balance while feeling unsteady and lightheaded which may lead to fainting.

Zyprexa side effects
Disequilibrium - Lack of mental and emotional balance.

Zyprexa side effects
Faintness - A temporary condition where one is likely to go unconscious and fall.

Zyprexa side effects
Headache - A sharp or dull persistent pain in the head

Zyprexa side effects
Hyperreflexia - A not normal and involuntary increased response in the tissues connecting the bones to the muscles.

Zyprexa side effects
Light-headed Feeling – Uncontrolled and usually brief loss of consciousness caused by lack of oxygen to the brain.

Zyprexa side effects
Migraine - Reoccurring severe head pain usually with nausea, vomiting, dizziness, flashes or spots before the eyes, and ringing in the ears

Zyprexa side effects
Muscle Contractions Involuntary - Spontaneous and uncontrollable tightening reaction of the muscles caused by electrical impulses from the nervous system.

Zyprexa side effects
Muscular Tone Increased - Uncontrolled and exaggeration muscle tension. Muscles are normally partially tensed and this is what gives us muscle tone.

Zyprexa side effects
Paresthesia - Burning, prickly, itchy, or tingling skin with no obvious or understood physical cause.

Zyprexa side effects
Restless Legs - A need to move the legs without any apparent reason. Sometimes there is pain, twitching, jerking, cramping, burning, or a creepy-crawly sensation associated with the movements. It worsens when a person is inactive and can interrupt one’s sleep so one feels the need to move to gain some relief.

Zyprexa side effects
Shaking - Uncontrolled quivering and trembling as if one is cold and chilled.

Zyprexa side effects
Sluggishness - Lack of alertness and energy, as well as being slow to respond or perform in life.

Zyprexa side effects
Tics - A contraction of a muscle causing a repeated movement not under the control of the person usually on the face or limbs.

Zyprexa side effects
Tremor - A nervous and involuntary vibrating or quivering of the body.

Zyprexa side effects
Twitching - Sharp, jerky and spastic motion sometimes with a sharp sudden pain.

Zyprexa side effects
Vertigo - A sensation of dizziness with disorientation and confusion.

Zyprexa side effects
Psychiatric Disorders (Mental and emotional)

Zyprexa side effects
Aggravated Nervousness - A progressively worsening, irritated and troubled state of mind.

Zyprexa side effects
Agitation - Suddenly violent and forceful, emotionally disturbed state of mind.

Zyprexa side effects
Amnesia - Long term or short term, partial or full memory loss created by emotional or physical shock, severe illness, or a blow to the head where the person was caused pain and became unconsciousness.

Zyprexa side effects
Anxiety Attack - Sudden and intense feelings of fear, terror, and dread physically creating shortness of breath, sweating, trembling and heart palpitations.

Zyprexa side effects
Apathy - Complete lack of concern or interest for things that ordinarily would be regarded as important or would normally cause concern.

Zyprexa side effects
Appetite Decreased - Having a lack of appetite despite the ordinary caloric demands of living with a resulting unintentional loss of weight.

Zyprexa side effects
Appetite Increased - An unusual hunger causing one to overeat.

Zyprexa side effects
Auditory Hallucination - Hearing things without the voices or noises being present.

Zyprexa side effects
Bruxism - Grinding and clenching of teeth while sleeping.

Zyprexa side effects
Carbohydrate Craving - A drive and craving to eat foods rich in sugar and starches (sweets, snacks and junk foods) that intensifies as the diet becomes more and more unbalanced due to the unbalancing of the proper nutritional requirements of the body.

Zyprexa side effects
Concentration Impaired - Unable to easily focus your attention for long periods of time.

Zyprexa side effects
Confusion - Not able to think clearly and understand in order to make a logical decision.

Zyprexa side effects
Crying Abnormal - Unusual and not normal fits of weeping for short or long periods of time for no apparent reason.

Zyprexa side effects
Depersonalization - A condition where one has lost a normal sense of personal identity.

Zyprexa side effects
Depression - A hopeless feeling of failure, loss and sadness that can deteriorate into thoughts of death.

Zyprexa side effects
Disorientation - A loss of sense of direction, place, time or surroundings as well as mental confusion on personal identity.

Zyprexa side effects
Dreaming Abnormal - Dreaming that leaves a very clear, detailed picture and impression when awake that can last for a long period of time and sometimes be unpleasant.

Zyprexa side effects
Emotional Lability - Suddenly breaking out in laughter or crying or doing both without being able to control the outburst of emotion. These episodes are unstable as they are caused by things that normally would not have this effect on an individual.

Zyprexa side effects
Excitability - Uncontrollably responding to stimuli.

Zyprexa side effects
Feeling Unreal - The awareness that one has an undesirable emotion like fear but can’t seem to shake off the irrational feeling. For example, feeling like one is going crazy but rationally knowing that it is not true. The quality of this side effect resembles being in a bad dream and not being able to wake up.

Zyprexa side effects
Forgetfulness - Unable to remember what one ordinarily would remember.

Zyprexa side effects
Insomnia - Sleeplessness caused by physical stress, mental stress or stimulants such as coffee or medications; it is a condition of being abnormally awake when one would ordinarily be able to fall and remain asleep.

Zyprexa side effects
Irritability - Abnormally annoyed in response to a stimulus.

Zyprexa side effects
Jitteriness - Nervous fidgeting without an apparent cause.

Zyprexa side effects
Lethargy - Mental and physical sluggishness and apathy that can deteriorate into an unconscious state resembling deep sleep. A numbed state of mind.

Zyprexa side effects
Libido Decreased - An abnormal loss of sexual energy or desire.

Zyprexa side effects
Panic Reaction - A sudden, overpowering, chaotic and confused mental state of terror resulting in being doubt ridden often accompanied with hyperventilation, and extreme anxiety.

Zyprexa side effects
Restlessness Aggravated - A constantly worsening troubled state of mind characterized by the person being increasingly nervous, unable to relax, and easily angered.

Zyprexa side effects
Somnolence - Feeling sleepy all the time or having a condition of semi-consciousness.

Zyprexa side effects
Suicide Attempt - An unsuccessful deliberate attack on one’s own life with the intention of ending it.

Zyprexa side effects
Suicidal Tendency - Most likely will attempt to kill oneself.

Zyprexa side effects
Tremulousness Nervous - Very jumpy, shaky, and uneasy while feeling fearful and timid. The condition is characterized by thoughts of dreading the future, involuntary quivering, trembling, and feeling distressed and suddenly upset.

Zyprexa side effects
Yawning - involuntary opening of the mouth with deep inhalation of air.

Zyprexa side effects
Reproductive Disorder Female

Zyprexa side effects
Breast Neoplasm - A tumor or cancer, of either of the two milk-secreting organs on the chest of a woman.

Zyprexa side effects
Menorrhagia - Abnormally heavy menstrual period or a menstrual flow that has continued for an unusually long period of time.

Zyprexa side effects
Menstrual Cramps - Painful, involuntary uterus contractions that women experience around the time of their menstrual period, sometimes causing pain in the lower back and thighs.

Zyprexa side effects
Menstrual Disorder - A disturbance or derangement in the normal function of a woman’s menstrual period.

Zyprexa side effects
Pelvic Inflammation - The reaction of the body to infectious, allergic, or chemical irritation, which in turn causes tissue irritation, injury, or bacterial infection characterized by pain, redness, swelling, and sometimes loss of function. The reaction usually begins in the uterus and spreads to the fallopian tubes, ovaries, and other areas in the hipbone region of the body.

Zyprexa side effects
Premenstrual Syndrome - Various physical and mental symptoms commonly experienced by women of childbearing age usually 2 to 7 days before the start of their monthly period. There are over 150 symptoms including eating binges, behavioral changes, moodiness, irritability, fatigue, fluid retention, breast tenderness, headaches, bloating, anxiety, and depression. The symptoms cease shortly after the period begins, and disappear with menopause.

Zyprexa side effects
Spotting Between Menses - Abnormal bleeding between periods. Unusual spotting between menstrual cycles.

Zyprexa side effects
RESPIRATORY SYSTEM (Organs involved in breathing)

Zyprexa side effects
Asthma - A disease of the breathing system initiated by and allergic reaction or a chemical with repeated attacks of coughing, sticky mucus, wheezing, shortness of breath, and a tight feeling in the chest. The disease can reach a state where it stops a person from exhaling, leading to unconsciousness and death.

Zyprexa side effects
Breath Shortness - Unnatural breathing using a lot off effort resulting in not enough air taken in by the body.

Zyprexa side effects
Bronchitis - Inflammation of the two main breathing tubes leading from the windpipe to the lungs. The disease is marked with coughing, a low-grade fever, chest pains, and hoarseness, caused by an allergic reaction.

Zyprexa side effects
Coughing - A cough is the response to an irritation, such as mucus, that causes the muscles controlling the breathing process to expel air from the lungs suddenly and noisily to keep the air passages free from the irritating material.

Zyprexa side effects
Laryngitis - Inflammation of the voice box characterized by hoarseness, sore throat, and coughing. It can be cause by straining the voice or exposure to infectious, allergic or chemical irritation.

Zyprexa side effects
Nasal Congestion - The presence of an abnormal amount of fluid in the nose.

Zyprexa side effects
Pneumonia Tracheitis - Bacterial infection of the air passageways and lungs that causes redness, swelling and pain in the windpipe. Other symptoms are high fever, chills, pain in the chest, difficulty in breathing, and coughing with mucus discharge.

Zyprexa side effects
Rhinitis - Chemical irritation causing pain, redness and swelling in the mucus membranes of the nose.

Zyprexa side effects
Sinus Congestion - The mucus-lined areas of the bones in the face that are thought to help warm and moisten air to the nose. These areas become clogged with excess fluid or infected.

Zyprexa side effects
Sinus Headache - The abnormal amount of fluid in the hollows of the face bone area especially around the nose. This excess fluid creates pressure, causing pain in the head.

Zyprexa side effects
Sinusitis - The body reacting to chemical irritation causing redness, swelling and pain in the area of the hollows in the facial bones especially around the nose.

Zyprexa side effects
SKELETAL

Zyprexa side effects
Neck/Shoulder Pain - Hurtful sensations of the nerve endings caused by damage to the tissues in the neck and shoulder signaling danger of disease.

Zyprexa side effects
SKIN and APPENDAGES DISORDERS (Skin, legs and arms)

Zyprexa side effects
Acne - Eruptions of the oils glands of the skin, especially on the face, marked by pimples, blackheads, whiteheads, bumps, and more severely, by cysts and scarring.

Zyprexa side effects
Alopecia - The loss of hair or baldness.

Zyprexa side effects
Eczema - A severe or continuing skin disease marked by redness, crusting and scaling with watery blisters and itching. It is often difficult to treat and will sometimes go away only to reappear again.

Zyprexa side effects
Dermatitis - Generally irritated skin that can be caused by any of a number of irritating things such as parasites, fungus, bacteria, or foreign substances causing an allergic reaction. It is a general inflammation of the skin.

Zyprexa side effects
Dry Lips - The lack of normal moisture in the fleshy folds that surround the mouth.

Zyprexa side effects
Dry Skin - The lack of normal moisture/oils in the surface layer of the body. The skin is the body’s largest organ.

Zyprexa side effects
Folliculitis - Inflammation of a follicle (small body sac) especially a hair follicle. A hair follicle contains the root of a hair.

Zyprexa side effects
Furunculosis - Skin boils that show up repeatedly.

Zyprexa side effects
Lipoma - A tumor of mostly fat cells that is not health endangering.

Zyprexa side effects
Pruritus - Extreme itching of often-undamaged skin.

Zyprexa side effects
Rash - A skin eruption or discoloration that may or may not be itching, tingling, burning, or painful. It may be caused by an allergy, an skin irritation, a skin disease.

Zyprexa side effects
Skin Nodule - A bulge, knob, swelling or outgrowth in the skin that is a mass of tissue or cells.

Zyprexa side effects
SPECIAL SENSES

Zyprexa side effects
Conjunctivitis - Infection of the membrane that covers the eyeball and lines the eyelid, caused by a virus, allergic reaction, or an irritating chemical. It is characterized by redness, a discharge of fluid and itching.

Zyprexa side effects
Dry Eyes - Not enough moisture in the eyes.

Zyprexa side effects
Earache - Pain in the ear.

Zyprexa side effects
Eye Infection - The invasion of the eye tissue by a bacteria, virus, fungus, etc, causing damage to the tissue, with toxicity. Infection spreading in the body progresses into disease.

Zyprexa side effects
Eye Irritation - An inflammation of the eye.

Zyprexa side effects
Metallic Taste - A range of taste impairment from distorted taste to a complete loss of taste.

Zyprexa side effects
Pupils Dilated - Abnormal expansion of the blace circular opening in the center of the eye.

Zyprexa side effects
Taste alteration - Abnormal flavor detection in food.

Zyprexa side effects
Tinnitus - A buzzing, ringing, or whistling sound in one or both ears occurring from the internal use of certain drugs.

Zyprexa side effects
Vision Abnormal - Normal images are seen differently by the viewer.

Zyprexa side effects
Vision Blurred - Eyesight is dim or indistinct and hazy in outline or appearance.

Zyprexa side effects
Visual Disturbance - Eyesight is interfered with or interrupted. Some disturbances are light sensitivity and the inability to easily distinguish colors.

Zyprexa side effects
URINARY SYSTEM DISORDER

Zyprexa side effects
Blood in Urine - Blood is present when one empties liquid waste product of the kidneys through the bladder by urinating in the toilet turning the water pink to bright red. Or you could see pots of blood in the water after urinating.

Zyprexa side effects
Dysuria - Difficult or painful urination.

Zyprexa side effects
Kidney Stone - Small hard masses of salt deposits that the kidney forms.

Zyprexa side effects
Urinary Frequency - Having to urinate more often than usual or between unusually short time periods.

Zyprexa side effects
Urinary Tract Infection - An invasion of bacteria, viruses, fungi, etc., of the system in the body that starts with the kidneys and eliminates urine from the body. If the invasion goes unchecked it can injure tissue and progress into disease.

Zyprexa side effects
Urinary Urgency - A sudden compelling urge to urinate, accompanied by discomfort in the bladder.

Zyprexa side effects
UROGENITAL (Urinary tract and genital structures or functions)

Zyprexa side effects
Anorgasmia - Failure to experience an orgasm.

Zyprexa side effects
Ejaculation Disorder - Dysfunction of the discharge of semen during orgasm.

Zyprexa side effects
Menstrual Disorder - Dysfunction of the discharge during the monthly menstrual cycle.

Zyprexa side effects
Acute Renal Failure - The kidneys stop functioning properly to excrete wastes.

Zyprexa side effects
Angioedema - Intensely itching and swelling welts on the skin called hives caused by an allergic reaction to internal or external agents. The reaction is common to a food or a drug. Chronic cases can last for a long period of time.

Zyprexa side effects
Toxic Epidermal Necrolysis - An abnormal condition where a large portion of skin becomes intensely red and peels off like a second-degree burn. Often the symptoms include blistering.

Zyprexa side effects
Gastrointestinal Hemorrhage - Stomach and intestinal excessive internal bleeding.

Zyprexa side effects
Grand Mal Seizures (or Convulsions) - A recurring sudden violent and involuntary attack of muscle spasms with a loss of consciousness.

Zyprexa side effects
Neuroleptic Malignant Syndrome - A life threatening, rare reaction to an anti-psychotic drug marked by fever, muscular rigidity, changed mental status, and dysfunction of the autonomic nervous system.

Zyprexa side effects
Pancreatitis - Chemical irritation with redness, swelling, and pain in the pancreas where digestive enzymes and hormones are secreted.

Zyprexa side effects
QT Prolongation - A very fast heart rhythm disturbance that is too fast for the heart to beat effectively so the blood to the brain falls causing a sudden loss of consciousness and may cause sudden cardiac death.

Zyprexa side effects
Rhabdomyolysis - The breakdown of muscle fibers that releases the fibers into the circulatory system. Some of the fibers are poisonous to the kidney and frequently result in kidney damage.

Zyprexa side effects
Serotonin Syndrome - A disorder brought on by excessive levels of serotonin caused by drugs and can be fatal as death from this side effect can come very rapidly.

Zyprexa side effects
Thrombocytopenia - An abnormal decrease in the number of blood platelets in the circulatory system. A decrease in platelets would cause a decrease in the ability of the blood to clot when necessary.

Zyprexa side effects
Torsades de Pointes - Unusual rapid heart rhythm starting in the lower heart chambers. If the short bursts of rapid heart rhythm continue for a prolonged period it can degenerate into a more rapid rhythm and can be fatal.

Zyprexa Side Effects

Zyprexa and it's effectiveness for longer-term use, that is, for more than 4 weeks treatment of an acute episode, and for prophylactic use in mania, has not been systematically evaluated in controlled clinical trials.

Neuroleptic Malignant Syndrome (NMS) - A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with administration of antipsychotic drugs, including Zyprexa. Manifestations of (NMS) are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmia), and acute renal failure.

Tardive Dyskinesia - A syndrome of potentially irreversible, involuntary, dyskinetic movements may develop in patients treated with Zyprexa. The risk of developing tardive dyskinesia and the likelihood that it will become irreversible are believed to increase as the duration of treatment and the total cumulative dose of Zyprexa increases.

There are no known treatments for tardive dyskinesia.

Orthostatic Hypotension (Lowered blood pressure when a person changes from a setting to an erect position) - Zyprexa may induce orthostatic hypotension associated with dizziness, tachycardia, and in some patients, syncope, especially during the initial dose-titration period. Zyprexa should be used with particular caution in patients with known cardiovascular disease, cerebrovascular disease, and conditions which would predispose patients to hypotension.

Seizures - Seizures during premarketing test showed 22 of 2500 people developed seizures.

Potential for Cognitive and Motor Impairment - Sleepiness, unnatural drowsiness, was a commonly reported adverse event associated with Zyprexa treatment, occurring at an incidence of 26%. Since Zyprexa has the potential to impair judgment, thinking, or motor skills, patients should be cautioned about operating hazardous machinery, including automobiles.

"On May 3, 2002, Britain's Medicines Control Agency warned that several patients taking Eli Lilly's top selling drug Zyprexa (used to treat schizophrenia) had developed diabetes-related complications. In the Medicine Control Agency's Current Problems newsletter, the regulatory body said that the antipsychotic drug "can adversely affect blood glucose."
"Forty reports "of hyperglycemia (elevated blood sugar), diabetes mellitus, or exacerbation of diabetes have been received in the UK. Four were associated with ketoacidosis and/or coma including one with a fatal outcome," according to the newsletter. "The precise mechanism of this suspected adverse drug reaction has not yet been elucidated and is currently being investigated further."
"This follows an emergency report issued in April 2002 by the Japanese Health and Welfare Ministry to Eli Lilly Japan KK concerning side effects of Zyprexa after the deaths of two diabetic users of the drug. It said seven other patients had lost consciousness or become comatose after taking the drugs in the last 10 months. The Japanese Ministry said no new diabetes patients should be treated with the drug and ordered Eli Lilly to warn doctors to closely monitor diabetics already on the medication."
"A paper written in late 2001 in the Journal of Clinical Psychiatry reports the FDA has been alerted 19 case reports of diabetes associated with the use of Zyprexa. Of the 19 patients seven had newly diagnosed hyperglycemia. The sugar disorder developed within a week of taking Zyprexa in two patients and within six months for eight others. One patient ultimately died of necrotizing pancreatitis, a condition in which cells in the pancreas die.
"Personal injury attorneys are expected to file up to 10 lawsuits this month against Eli Lilly alleging the drugmaker failed to adequately disclose “serious side effects” associated with its schizophrenia and acute bipolar mania drug Zyprexa (olanzapine), plaintiffs’ lawyers announced last week. The San Francisco-based firm Hersh & Hersh recently filed two lawsuits over the drug and is filing 30 more on behalf of individuals who claim the drug led to such illnesses as diabetes, hyperglycemia and pancreatitis."

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Source: National Institute of Mental Health

"Researchers and clinical psychopharmacologists do not fully know what causes schizophrenia. Side effects of Zyprexa include slowing of voluntary movement, expressionless face, rigidity and tremor of arms and head, abnormal toxicity of muscle tissues, and restlessness."

Zyprexa Can Cause Diabetes -
Eli Lilly is now trying to get the FDA to approve diabetes medication

Could this be the scam of the century? Bring out Prozac, which has a diabetes side effect, then Zyprexa with the same side effect, they get approved a medication to treat the disease you created for millions?

If you or I did this we would be thrown in jail.

New Drug Application for Exenatide Submitted to FDA for Type 2 Diabetes

June 30, 2004

Amylin Pharmaceuticals, Inc., (Nasdaq: AMLN) and Eli Lilly and Company (NYSE: LLY) today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for regulatory approval of exenatide. Exenatide is the first in a new class of medicines known as incretin mimetics under investigation for the treatment of type 2 diabetes. In clinical trials, exenatide has demonstrated reductions in blood sugar and improvements in markers of beta cell function. Patients in exenatide studies also lost weight.

"The submission of the exenatide NDA is a significant milestone both for Amylin Pharmaceuticals and for our collaboration with Eli Lilly and Company," said Ginger Graham, president and CEO, Amylin Pharmaceuticals. "This NDA includes data on more than 1,800 subjects treated with exenatide. We believe the application provides the FDA with the necessary information to evaluate exenatide for use as a new therapeutic option for people living with type 2 diabetes."

"The rapid increase in the prevalence of diabetes and the need for innovative new treatments has never been more critical than it is today," said John C. Lechleiter, Ph.D., executive vice president of pharmaceutical operations, Eli Lilly and Company. "Many patients with type 2 diabetes are struggling to control their blood sugar and, even with current oral therapies, find that they cannot reach their treatment goals. If approved, we believe exenatide could offer an important and novel treatment option for people with type 2 diabetes."

The exenatide NDA is made up of three major components; chemistry and manufacturing, preclinical and clinical. The clinical component of the submission is based largely on 30-week data from three blinded pivotal trials of exenatide involving more than 1,400 patients who were unable to control their blood sugar on common oral therapies including metformin, sulfonylurea or a combination of both. The submission also includes 52-week open-label data from the extensions of these pivotal studies and from an additional open-label study. In the pivotal studies, exenatide demonstrated statistically significant, sustained reductions in average blood sugar levels as measured by hemoglobin A1c (A1C). Patients in these studies also demonstrated progressive reductions in weight, a secondary endpoint of the studies. The open-label studies demonstrated that the reductions in A1C were sustained through 52 weeks of treatment with average reductions of approximately 1.1 percent. Reductions in weight were also sustained through 52 weeks of treatment with average reductions of approximately eight pounds. In addition, the exenatide data showed improvements in beta cell function, as measured by HOMA-B and proinsulin to insulin ratios, and the restoration of first-phase insulin response, a fundamental response lost early in the development of type 2 diabetes. Exenatide was generally well tolerated across the pivotal trials. The most common adverse event reported was mild to moderate nausea, which occurred primarily at initiation of therapy.

Exenatide is formulated as a sterile, injectable product that, if approved, will be delivered by a pen delivery system.

About Diabetes Diabetes affects an estimated 194 million adults worldwide¹ and more than 18 million in the United States.² Approximately 90-95 percent of those affected have type 2 diabetes, a disease in which the body does not produce enough insulin and the cells in the body do not respond normally to the insulin. According to the U.S. Center for Disease Control and Prevention’s National Health and Nutrition Examination Survey, approximately 60 percent of diabetes patients do not achieve target A1C levels with their current treatment regimen. According to the American Diabetes Association, patients with A1Cs above target are more likely to develop diabetes-related complications, such as kidney disease, blindness and heart disease.³

ZYPREXA

Olanzapine Tablets

ZYPREXA ZYDIS

Olanzapine Orally Disintegrating Tablets

ZYPREXA IntraMuscular

Olanzapine for Injection

DESCRIPTION

CONTRADICTIONS

ZYPREXA is contraindicated in patients with a known hypersensitivity to the product. For specific information about the contraindications of lithium or valproate, refer to the CONTRAINDICATIONS section of the package inserts for these other products.

WARNINGS

Hyperglycemia and Diabetes Mellitus – Hyperglycemia, in some cases extreme and associated with ketpacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics including ZYPRXA, Assessment of the relationship between atypical antipsychotic use and glucose abnormalities is complicated by the possibility of an increased background risk of diabetes mellitus in patients with schizophrenia and the increasing incidence of diabetes mellitus in the general population. Given these confounders the relationship between atypical antipsychotic use and hyperglycemia-related adverse events in not completely understood. However, epidemiological studies suggest an increased risk of treatment-emergent hyperglycemia-related adverse events in patients treated with the atypical antipsychotics. Precise risk estimates for hyperglycemia-related adverse events in patients treated with atypical antipsychotics are not available.

Patients with an established diagnosis of diabetes mellitus who are started on atypical antipsychotics should be monitored regularly for worsening of glucose control. Patients with risk factors for diabetes mellitus (e.g., obesity, family history of diabetes) who are starting treatment with atypical antipsychotics should undergo fasting blood glucose testing at the beginning of treatment and periodically during treatment. Any patient treated with atypical antipsychotics should be monitored for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. Patients who develop symptoms of hyperglycemia during treatment with atypical antipsychotics should undergo fasting blood glucose testing. In some cases, hyperglycemia has resolved when the atypical antipsychotic was discontinued; however, some patients required continuation of anti-diabetic treatment despite discontinuation of the suspect drug.

Safety Experience in Elderly Patients with Dementia-Related Psychosis – In placebo-controlled clinical trials of elderly patients with dementia-related psychosis, the incidence of death in ZYPRXA-treated patients was significantly greater than placebo-treated patients (3.5% vs 1.5%, respectively). Risk factors that may predispose this patient population ot increased mortality when treated with ZYPRXA include age >80 years, sedation, concomitant use of benzodiazepines or presence of pulmonary conditions (e.g., pneumonia, with or without aspiration). ZYPRXA is not approved for the treatment of patients with dementia-related psychosis.

Cerebrovascula Adverse Events, Including Stroke, in Elderly Patients with Dementia -Cerebrovascular adverse events (e.g., stroke, transient ischemic attack), including fatalities, were reported in patients in trials of ZYPREXA in elderly patients with dementia-related psychosis. In placebo-controlled trials, there was a significantly higher incidence of cerebrovascular adverse events in patients treated with ZYPREXA compared to patients treated with placebo. ZYPREXA is not approved for the treatment of patients with dementia-related psychosis.

Neuroleptic Malignant Syndrome (NMS) – A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with administration of antipsychotic drugs, including ZYPREXA. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmia). Additional signs may include elevated creatinine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure.

The diagnostic evaluation of patients with this syndrome is complicated. In arriving at a diagnosis, it is important to exclude cases where the clinical presentation includes bot serious medical illness (e.g., pneumonia, systemic infection, etc.) and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever, and primary central nervous system pathology.

The management of NMS should include: 1) immediate discontinuation of antipsychotic drugs and other drugs not essential to concurrent therapy; 2) intensive symptomatic treatment and medical monitoring; and 3) treatment of any concomitant serious medical problems for which specific treatments are available. There is no general agreement about specific pharmacological treatment regimens for NMS.

If a patient requires antipsychotic drug treatment after recovery from NMS, the potential reintroduction of drug therapy should be carefully considered. The patient should be carefully monitored, since recurrences of NMS have been reported.

Tardive Dyskinesia – A syndrome of potentially irreversible, involuntary, dyskinetic movements may develop in patients treated with antipsychotic drugs. Although the prevalence of the syndrome appears to be highest among the elderly, especially elderly women, it is impossible to rely upon prevalence estimates to predict, at the inception of antipsychotic treatment, which patients are likely to develop the syndrome. Whether antipsychotic drug products differ in their potential to cause Tardive dyskinesia is unknown.

The risk of developing Tardive dyskinesia and the likelihood that it will become irreversible are believed to increase as the duration of treatment and the total cumulative dose of antipsychotic drugs administered to the patient increase. However, the syndrome can develop, although much less commonly, after relatively brief treatment periods at low doses.

There is no known treatment for established cases of Tardive dyskinesia, although the syndrome may remit, partially or completely, if antipsychotic treatment is withdrawn. Antipsychotic treatment, itself, however, may suppress (or partially suppress) the signs and symptoms of syndrome and thereby may possibly mask the underlying process. The effect that symptomatic suppression has upon the long-term course of the syndrome is unknown.

Given these considerations, ZYPREXA should be prescribed in a manner that is most likely to minimize the occurrence of Tardive dyskinesia. Chronic antipsychotic treatment should generally be reserved for patients (1) who suffer from a chronic illness that is known to respond to antipsychotic drugs, and (2) for whom alternative, equally effective, but potentially less harmful treatments are not available or appropriate. In patients who do require chronic treatment, the smallest dose and the shortest duration of treatment producing a satisfactory clinical response should be sought. The need for continued treatment should be reassessed periodically.

If signs and symptoms of Tardive dyskinesia appear in a patient on ZYPREXA, drug discontinuation should be considered. However, some patients may require treatment with ZYPREXA despite the presence of the syndrome.

For specific information about the warnings of lithium or valproate, refer to the WARNINGS section of the package inserts for these other products.

PRECAUTIONS

General

Hemodynamic Effects – ZYPREXA may induce orthostatic hypotension associated with sizziness, tachycardia, and in some patients, syncope, especially during the initial dose-titration period, probably reflecting its α-adrenergic antagonistic properties. Hypotension, bradycardia with or without hypotension, tachycardia, and syncope were also reported during the clinical trials with intramuscular ZYPREXA for injection. In an open-label clinical pharmacology study in non-agitated patients with schizophrenia in which the safety and tolerability of intramuscular ZYPREXA were evaluated under a maximal dosing regimen (three 10 mg doses administered 4 hours apart), approximately one-third of these patients experienced a significant orthostatic decrease in systolic blood pressure (i.e., decrease ≥30 mmHg) (see DOSAGE AND ADMINISTRATION). Syncope was reported in 0.6% (15/2500) of ZYPREXA-treated patients in phase 2-3 oral ZYPREXA studies and in 0.3% (2/722) of ZYPREXA-treated patients with agitation in the intramuscular ZYPREXA for injection studies. Three normal volunteers in phase 1 studies with intramuscular ZYPREXA experienced hypotension, bradycardia, and sinus pauses of up to 6 seconds that spontaneously resolved (in 2 cases the events occurred on intramuscular olanzapine, and in 1 case, on oral ZYPREXA). The risk for this sequence of hypotension, bradycardia, and sinus pause may be greater in nonpsychiatric patients compared to psychiatric patients who are possibly more adapted to certain effects of psychotropic drugs.

For oral ZYPREZA therapy, the risk of orthostatic hypotension and syncope may be minimized by initiating therapy with 5 mg QD ( see DOSAGE AND ADMINISTRATION). A more gradual titration to the target dose should be considered if hypotension occurs.

For intramuscular ZYPREXA for injection therapy, patients should remain recumbent if drowsy or dizzy after injection until examination has indicated that they are not experiencing postural hypotension and/or bradycardia.

ZYPREXA should be used with particular caution in patients with known cardiovascular disease (history of myocardial infarction or ischemia, heart failure, or conduction abnormalities), cerebrovascular disease, and conditions which would predispose patients to hypotension dehydration, hypovolemia, and treatment with antihypertensive medications) where the occurrence of syncope, or hypotension and/or bradycardia might put the patient at increased medical risk.

Seizures – During premarketing testing, seizures occurred in 0.9% (22/2500) of ZYPREXA-treated patients. There were confounding factors that may have contributed to the occurrence of seizures in many of these cases. ZYPREXA should be used cautiously in patients with a history of seizures or with conditions that potentially lower the seizure threshold, e.g., Alzheimer’s dementia. Conditions that lower the seizure threshold may be more prevalent in a population of 65 years or older.

Hyperprolactinemia - As with other drugs that antagonize dopamine D² receptors, ZYPREXA elevates prolactin levels, and a modest elevation persist during chronic administration. Tissue culture experiments indicate that approximately one=-third of human breast cancers are prolactin dependent in vitro, a factor of potential importance if the prescription of these drugs is contemplated in a patient with previously detected breast cancer of this type. Although disturbances such as galactorrhea, amenorrhea, gynecomastia, and impotence have been reported with prolactin-evaluation compounds, the clinical significance of elevated serum prolactin levels is unknown for most patients, As is common with compounds which increase prolactin release, an increase in mammary gland neoplasia was observed in the ZYPREXA carcinogenicity studies conducted n mice and rats (see Carcinogenesis). However, neither clinical studies nor epidemiologic studies have shown an association between chronic administration of this class of drugs and tumorigenesis in humans; the available evidence is considered too limited to be conclusive.

Transaminase Elevations – In placebo-controlled studies, clinically significant ALT (SGPT) elevation (≥3 times the upper limit of the normal range) were observed in 2% (6/243) of patients exposed to ZYPREXA compared to none (0/115) of the placebo patients. None of these patients experienced jaundice. In two of these patients, liver enzymes decreased toward normal despite continued treatment and in two others, enzymes decreased upon discontinuation of ZYPREXA. In the remaining two patients, one, seropositive for hepatitis C, and persistent enzyme elevation for four months after discontinuation, and the other had insufficient follow-up to determine if enzymes normalized.

Within the larger premarketing database of about 2400 patients with baseline SGPT ≤90 IU/L, the incidence of SGPT elevation to >200 IU/L was 2% (50/2381). Again, none of these patients experienced jaundice or other symptoms attributable to live impairment and most had transient changes that tended to normalize while ZYPREXA treatment was continued.

Among 2500 patients in oral ZYPREXA clinical trials, about 1% (23/2500) discontinued treatment due to transaminase increases.

Caution should be exercised inpatients with signs and symptoms of hepatic impairment, in patients with pre-existing conditions associated with limited hepatic functional reserve, and in patients who are being treated with potentially hepatotoxic drugs. Periodic assessment of transaminases is recommended in patients with significant hepatic desease (see Laboratory Tests).

Potential for Cognitive and Motor Impairment – Somnolence was a commonly reported adverse event associated with ZYPREXA treatment, occurring at an incidence of 26% in ZYPREXA patients compared to 15% in placebo patients. This adverse event was also dose related. Somnolence led to discontinuation in 0.4% (9/2500) of patients in the premarketing database.

Since ZYPREXA has the potential to impair judgment, thinking, or motor skills, patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that ZYPREXA therapy does not affect them adversely.

Body Temperature Regulation – Disruption of the body’s ability to reduce core body temperature has been attributed to antipsychotic agents. Appropriate care is advised when prescribing ZYPREXA for patients who will be experiencing conditions which may contribute to an elevation in core body temperature, e.g., exercising strenuously, exposure to extreme heat, receiving concomitant medication with anticholinergic activity, or being subject to dehydration.

Dysphagia – Esophageal dysmotility and aspiration have been associated with antipsychotic drug use. Aspiration pneumonia is a common cause of morbidity and mortality in patients with advance Alzheimer’s disease. ZYPREXA and other antipsychotic drugs should be used cautiously in patients at risk for aspiration pneumonia.

Suicide – The possibility of a suicide attempt is inherent in schizophrenia and in bipolar disorder, and close supervision of high-risk patients should accompany drug therapy. Prescriptions for ZYPREXA should be written for the smallest quantity of tablets consistent with good patient management, in order to reduce the risk of overdose.

Use in Patients with Concomitant Illness – Clinical experience with ZYPREXA in patients with certain concomitant systemic illnesses (see Renal Impairment and Hepatic Impairment under CLINICAL PHARMACOLOGY, Special Populations) is limited.

ZYPREXA exhibits in vitro muscarinic receptor affinity. In premarketing clinical trials with ZYPREXA, ZYPREXA was associated with constipation, dry mouth, and tachycardia, all adverse events possibly related to cholinergic antagonism. Such adverse events were not often the basis for discontinuations from ZYPREXA, but ZYPREXA should be used with caution in patients with clinically significant prostatic hypertrophy, narrow angle glaucoma, or a history of paralytic ileus.

In five placebo-controlled studies of XYPREXA in elderly patients with dementia-related psychosis (n=1184), the following treatment-emergent adverse events were reported in ZYPREXA-treated patients at an incidence of at least 2% and significantly greater than placebo-treated patients: falls, somnolence, peripheral edema, abnormal gait, urinary incontinence, lethargy, increased weight, asthenia, pyrexia, pneumonia, dry mouth and visual hallucinations. The rate of discontinuation due to adverse events was significantly greater with ZYPREXA than placebo (13% vs. 7%). As with other CNS-active drugs, ZYPREXA should be used with caution in elderly patients with dementia. ZYPREXA is not approved for the treatment of patients with dementia-related psychosis. If the prescriber elects to treat elderly patients with dementia-related psychosis, vigilance should be exercised (see WARNINGS).

ZYPREXA has not been evaluated or used to any appreciable extent in patients with a recent history of myocardial infarction or unstable heart disease. Patients with these diagnoses were excluded from premarketing clinical studies. Because of the risk of orthostatic hypotension with ZYPREXA, caution should be observed in cardiac patients (see Hemodynamic Effects).

For specific information about the precautions of lithium or valproate, refer to PRECAUTIONS section of the package inserts for these other products.

Information of Patients

Physicians are advised to discuss the following issues with patients for whom they prescribe ZYPREXA:

Orthostatic Hypotension – Patients should be advised of the risk of orthostatic hypotension, especially during the period of initial dose titration and in association with the use of concomitant drugs that may potentiate the orthostatic effect of ZYPREXA, e.g., diazepam or alcohol (see Drug Interactions).

Interference with Cognitive and Motor Performance – Because ZYPREXA has the potential to impair judgment, thinking, or motor skills, patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that ZYPREXA therapy does not affect them adversely.

Pregnancy – Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during therapy with ZYPREXA.

Nursing – Patients should be advised not to breast-feed an infant if they are taking ZYPREXA.

Concomitant Medication – Patients should be advised to inform their physicians if they are taking, or plan to take, any prescription or over-the-counter drugs, since there is a potential for interactions.

Alcohol – Patients should be advised to avoid alcohol while taking ZYPREXA.

Heat Exposure and Dehydration – Patients should be advised regarding appropriate care in avoiding overheating and dehydration.

Phenylketonurics – ZYPREXA ZYDIS (Olanzapine orally disintegrating tablets) contains phenylalanine (0.34, 0.45,0.67, or 1.90 mg per 5, 10, 15, or 20 mg tablet, respectively).

Laboratory Tests

Periodic assessment of transaminases is recommended in patients with significant hepatic disease (see Transaminase Elevations).

Drug Interactions

The risks of using ZYPREXA in combination with other drugs have not been extensively evaluated in systematic studies. Given the primary CNS effects of ZYPREXA, caution should be used when ZYPREXA is taken in comination with other centrally acting drugs and alcohol.

Because of its potential for inducing hypotension, ZYPREXA, may enhance the effects of certain antihypertensive agents.

ZYPREXA may antagonize the effects of levadopa and dopamine agonists.

The Effect of Other Drugs on ZYPREXA – Agents that induce CYP1A2 or glucuronyl transferase enzymes, such as omeprazole and rifamipin, may cause an increase in ZYPREXA clearance. Inhibitors of CYP1A2 could potentially inhibit ZYPREXA clearance. Although ZYPREXA is metabolized by multiple enzyme systems, induction or inhibition of a single enzyme may appreciably alter ZYPREXCA clearance. Therefore, a dosage increase (for induction) or a dosage decrease (for inhibition) may need to be considered with specific drugs.

Charcoal – The admini9stration of activated charcoal (1g) reduced the Cmax and AUC of oral ZYPREXA by about 60%. A peak ZYPREXA levels are not typically obtained until about 6 hours after dosing, Charcoal may be a useful treatment for ZYPREXA overdose.

Cimetidine and Antacids – Single doses of cimetidine (800 mg) or aluminum- and magnesium-containing antacids did not affect the oral bioavailability of ZYPREXA.

Carbamazepine – Carbamazepine therapy (200 mg bid) causes an approximately 50% increase in the clearance of ZYPREXA. This increase is likely due to the fact that carbamazepine is a potent inducer of CYP1A2 activity. Higher daily doses of carbamazepine may cause an even greater increase in ZYPREXA clearance.

Ethanol – Ethanol (45 mg/70 kg single dose) did not have an effect on ZYPREXA pharmacokinetics.

Fluoxetine – Fluoxetine (60 mg single dose of 60 mg daily for 8 days) causes a small (mean 16%) increase in the maximum concentration of ZYPREXA and a small (mean 16%) decrease in ZYPREXA clearance. The magnitude of the impact of this factor is small in comparison to the overall variability between individuals, and therefore dose modification is not routinely recommended.

FZyprexaamine – FZyprexaamine, a CYP1A2 inhibitor, decreases the clearance of ZYPREXA. This results in a mean increase in ZYPREXA Cmax following fZyprexaamine of 54% in female nonsmokers and 77% in male smokers. The mean increase in ZYPREXAAUC is 52% and 108%, respectively. Lower doses of ZYPREXA should be considered in patients receiving concomitant treatment with fZyprexaamine.

Warfin – Warfin (20 mg single dose) did not affect ZYPREXA pharmacokinetics.

Effect of ZYPREXA on Other Drugs – In vitro studies utilizing human liver microsomes suggest that ZYPREXA has little potential to inhibit CYP1A2, CYP2C9, CYP2C19, CYP2D6, and CYP3A. Thus, ZYPREXA is unlikely to cause clinically important drug interactions mediated by these enzymes.

Lithium – Multiple doses of ZYPREXA (10 mg for 8 days) did not influence the kinetics of lithium. Therefore, concomitant ZYPREXA administration does not require dosage adjustment of lithium.

Valproate – Studies in vitro using human liver microsomes determined that ZYPREXA has little potential to inhibit the major metabolic pathway, glucuronidation, of valproate. Further valproate has little effect on the metabolism of ZYPREXA in vitro. In vivo administration of ZYPREXA (10 mg daily for 2 weeks) did not affect the steady state plasma concentrations of valproate. Therefore, concomitant ZYPREXA administration does not require dosage adjustment of valproate.

Single doses of ZYPREXA did not affect the pharmacokinetics of imipramine or its active metabolite desipramine, and warfarin. Multiple doses of ZYPREXA did not influence the kinetics of diazepam and its active metabolite N-desmethyldiazepam, ethanol, or biperiden. However, the co-administration of either diazepam or ethanol with ZYPREXA potentiated the orthostatic hypotension observed with ZYPREXA. Multiple doses of ZYPREXA did not affect the pharmacokinetics of theophylline or its metabolites.

Lorazepam – Administration of intramuscular lorazepam (2 mg) 1 hour after intramuscular ZYPREXA for injection (5 mg) did not significantly affect the pharmacokinetics of ZEPRXA, unconjugated lorazepam, or total lorazepam. However, this co-administration of intramuscular lorazepam and intramuscular ZYPREXA for infection added to the somnolence observed with either drug alone.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis – Oral carcinogenicity studies were conducted in mice and rats. ZYPREXA was administered to mice in tow 78-week studies at doses of 3, 10, 30/20 mg/kg/day (equivalent to 0.8-5 times the maximum recommended human daily oral dose on a mg/m² basis) and 0.25, 2, 8 mg/kg/day (equivalent to 0.06-2 times the maximum recommended human daily oral dose on a (mg/m² basis). Rats were dosed for 2 years at doses of 0.25, 1, 2.5, 4 mg/kg/day (males) and 0.25, 1, 4, 8 mg/kg/day (females)(equivalent to 0.13-2 and 0.13-4 times the maximum recommended human daily oral dose on a mg/m² basis, respectively). The incidence of liver hemangiomas and hemangiosarcomas was significantly increased in one mouse study in female mice dosed at 8mg/kg/day (2 times the maximum recommended human daily oral dose on a mg/m² basis).

These tumors were not increased in another mouse study in females dosed at 10 or 30/20 mg/kg/day (2-5 times the maximum recommended human daily oral dose on a mg/m² basis); in this study, there was a high incidence of early mortalities in males of the 30/20 mg/kg/day group. The incidence of mammary gland adenomas and adenocarcinomas was significantly increased in female mice dosed at ≥2 mg/kg/day and in female rats dosed at ≥4 mg/kg/day (0.5 and 2 times the maximum recommended human daily oral dose on a mg/m² basis, respectively). Antipsychotic drugs have been shown to chronically elebate prolactin levels in rodents. Serum prolactin levels were not measured during the ZYPREXA cacinogenicty studies; however, measurements during subchronic toxicity studies showed that ZYPREXA elevated serum prolactin levels up to 4-fold in rats at the same doses used in the carcinogenicity study. An increase in mammary gland neoplasms has been found in rodents after chronic administration of other antipsychotic drugs and is considered to be prolactin mediated. The relevance for human risk of the finding of prolactin mediated endocrine tumors in rodents is unknown (see Hyperprelactinemia under PRECAUTIONS, General).

Mutagenesis – No evidence of mutagenic potential for ZYPREXA was found in the Ames reverse mutation test, in vivo micronucleus test in mice, the chromosomal aberration test in Chinese hamster ovary cells, unscheduled DNA synthesis test in rat hepatocytes, induction of forward mutation test in mouse lymphoma cells, or in vivo sister chromatid exchange test in bone marrow if Chinese hamsters.

Impairment of Fertility – In an oral fertility and reproductive performance study in rats, male mating performance, but not fertility, was impaired at a dose of 22.34 mg/kg/day and female fertility was decreased at a dose of 3 mg/kg/day (11 and 1.5 times the maximum recommended human daily oral dose on a mg/m² basis, respectively). Discontinuance of ZYPREXA treatment reversed the effects on male mating performance. In female rats, the precoital period was increased and the mating index reduced at 5 mg/kg/day (2.5 times the maximum recommended human daily oral dose on a mg/m² basis). Diestrous was prolonged and estrous delayed at 1.1 mg/kg/day (0.6 times the maximum recommended human daily oral dose on a mg/m² basis); therefore ZYPREXA may produce a delay in ovulation.

Pregnancy

Pregnancy Category C – In oral reproduction studies in rats at doses up to 18 mg/kg/day and in rabbits at doses up to 30 mg/kg/day (9 and 30 times the maximum recommended human daily oral dose on a mg/m² basis, respectively) no evidence of teratogenicity was observed. In an oral rat teratology study, early resorptions and increased numbers of nonviable fetuses were observed at a dose of 18 mg/kg/day (9 times the maximum recommended human daily oral dose on a mg/m² basis). Gestation was prolonged at 10 mg/kg/day (5 times the maximum recommended human daily oral dose on a mg/m² basis). In an oral rabbit teratology study, fetal toxicity (manifested as increased resorptions and decreased fetal weight) occurred at a maternally toxic dose of 30 mg/kg/day (30 times the maximum recommended human daily oral dose on a mg/m² basis).

Placental transfer of ZYPREXA occurs in rat pups.

There are no adequate and well-controlled trials with ZYPREXA in pregnant females. Seven pregnancies were observed during clinical trials with ZYPREXA, including 2 resulting in normal births, 1 resulting in neonatal death due to a cardiovascular defect, 3 therapeutic abortions, and 1 spontaneous abortion. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Labor and Delivery

Parturition in rats was not affected by ZYPREXA. The effect of ZYPREXA on labor and delivery in humans is unknown.

Nursing Mothers

ZYPREXA was excreted in milk of treated rats during lactation. It is not known if ZYPREXA is excreted in human milk. It is recommended that women receiving ZYPREXA should not breast-feed.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Of the 2500 patients in premarketing clinical studies with oral ZYPREXA, 11% (263) were 65 years of age or over. In patients with schizophrenia, there was no indication of any different tolerability of ZYPREXA in the elderly compared to younger patients. Studies in elderly patients with dementia-related psychosis have suggested that there may be a different tolerability profile in this population compared to younger patients with schizophrenia. As with other CNS-active drugs, ZYPREXA should be used with caution in elderly patients with dementia. ZYPREXA is not approved for the treatment of patients with dementia-related psychosis. If the prescriber elects to treat elderly patients with dementia-related psychosis, vigilance should be exercised. Also, the presence of factors that might decrease paharmacokinetic clearance or increase the pharmacodynamic response to ZYPREXA should lead to consideration of a lower starting dose for any geriatric patient (see WARNINGS, PRECAUTIONS, AND DOSAGE AND ADMINISTRATION).

ADVERSE REACTIONS

The information below is derived from a clinical trial database for ZYPREXA consisting of 8661 patients with approximately 4165 patient-years of exposure to oral ZYPREXA and 722 patients with exposure to intramuscular ZYPREXA for injection. This database includes: (1) 2500 patients who participated in multiple-dose oral ZYPREXA premarketing trials in schizophrenia and Alzheimer’s disease representing approximately 1122 patient-years of exposure as of February 14, 1995; (2) 182 patients who participated in oral ZYPREXA premarketing bipolar mania trials representing approximately 66 patient-years of exposure; (3) 191 patients who participated in an oral ZYPREXA trial of patients having various psychiatric symptoms in association with Alzheimer’s disease representing approximately 29 patient-years of exposures; (4) 5788 patients form 88 additional oral ZYPREXA clinical trials as of December 31, 2001; and (5) 722 patients who participated in intramuscular ZYPREXA for injection premarketing trials in agitated patients with schizophrenia, Bipolar I Disorder (manic or mixed episodes), or dementia. In addition, information from the premarketing 6-week clinical study database for ZYPREXA in combination with lithium or valproate, consisting of 224 patients who participated in bipolar mania trials with approximately 22 patient-years of exposure, is included below.

The conditions and duration of treatment with ZYPREXA varied greatly and included (in overlapping categories) open-label and double-blind phases of studies, inpatients and outpatients, fixed-dose and dose-titration studies, and short-term or longer-term exposure. Adverse reactions were assessed by collecting adverse events, results of physical examinations, vital signs, weights, laboratory analytes, ECGs. Chest x-rays, and results of ophthalmologic examinations.

Certain portions of the discussion below relating to objective or numeric safety parameters, namely, dose-dependent adverse events, vital sign changes, weight gain, laboratory changes, and ECG changes are derived from studies in patients with schizophrenia and have not been duplicated for bipolar mania or agitation. However, this information is also generally applicable to bipolar mania and agitation.

Adverse events during exposure were obtained by spontaneous report and recorded by clinical investigators using terminaology of their won choosing. Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse event without first grouping similar types of events into a smaller number of standardized event categories. In the tables and tabulations that follow, standard COSTART dictionary terminology has been used initially to classify reported adverse events.

The stated frequencies of adverse events represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse event of the type listed. An event was considered treatment emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation. The reported events do not include those event terms that were so general as to be uninformative. Events listed elsewhere in labeling may not be repeated below. It is important to emphasize that, although the events occurred during treatment with ZYPREXA, they were not necessarily caused by it. The entire label should be read to gain a complete understanding of the safety profile of ZYPREXA.

The prescriber should be aware that the figures in the tables and tabulations cannot be used to predict the incidence of side effects in the course of usual medical practice where patient characteristics and other factors differ from those that prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators, The cited figures, however, do provide the prescribing physician with some basis for estimating the relative contribution of drug and nondrug factors to the adverse event incidence in the population studied.

Incidence of Adverse Events in Short-Term, Placebo-Controlled and Combination Trials

The following findings are based on premarketing trials of (1) oral ZYPREXA for schizophrenia, bipolar mania, a subsequent trial of patients having various psychiatric symptoms in association with Alzheimer’s disease, and premarketing combination trials, and (2) intramuscular ZYPREXA for injection in agitated patients with schizophrenia or bipolar mania.

Adverse Events Associated with Discontinuation of Treatment in Short-Term, Placebo-Controlled Trials

Schizophrenia – Overall, there was no difference in the incidence of discontinuation due to adverse events (5% for oral ZYPREXA vs. 6% for placebo). However, discontinuations due to increased in SGPT were considered to be drug related (2% for oral ZYPREXA vs. 0% for placebo) (see PRECAUTIONS).

Bipolar Mania Monotherapy – Overall, there was no difference in the incidence of discontinuation due to adverse events (2% for oral ZYPREXA vs. 2% for placebo).

Agitation – Overall, there was no difference in the incidence of discontinuation due to adverse events (0.4% for intramuscular ZYPREXA for injection vs. 0% for placebo).

Adverse Events Associated with Discontinuation of Treatment in Short-Term Combination Trials

Bipolar Mania Combination Therapy – In a study of patients who were already tolerating either lithium or valproate as monotherapy, discontinuation rates due to adverse events were 11% for the combination of oral ZYPREXA with lituium or valproate compared to 2% for patients who remained on lithium or valproate monotherapy. Discontinuations with the combination of oral ZYPREXA and lithium or valproate that occurred in more than 1 patient were: somnolence (3%), weight gain (1%), and peripheral edema (1%).

Commonly Observed Adverse Events in Short-Term, Placebo-Controlled Trials

The most commonly observed adverse events associated with the use of oral ZYPREXA (incidence of 5% or greater) and not observed at an equivalent incidence among placebo-treated patients (ZYPREXA incidence at least twice that for placebo) were:

Common Treatment-Emergent Adverse Events Associated with the Use of Oral ZYPREXA in 6- Week Trials - SCHIZOPHRENIA

Percentage of Patients Reporting Event

Adverse Event ZYPREXA Placebo

(N=248) (N=118)

Postural hypotension 5 2

Constipation 9 3

Weight gain 6 1

Dizziness 11 4

Personality disorder¹ 8 4

Akathisia 5 1

¹Personality disorder is the COSTART term for designation non-aggressive objectionable behavior

Common Treatment-Emergent Adverse Events Associated with the Use of Oral ZYPREXA in 3- Week and 4- Week Trials – BIPOLAR MANIA

Percentage of Patients Reporting Event

Adverse Event ZYPREXA Placebo

(N=125) (N=129)

Asthenia 15 6

Dry Mouth 22 7

Constipation 11 5

Dyspepsia 11 5

Increased appetite 6 3

Somnolence 35 13

Dizziness 18 6

Tremor 6 3

There was one adverse event (somnolence) observed at an incidence of 5% or greater among intramuscular ZYPREXA for injection-treated patients and not observed at an equivalent incidence among placebo-treated patients (ZYPREXA incidence at least twice that for placebo) during the placebo-controlled premarketing studies. The incidence of somnolence during the 24 hour IM treatment period in clinical trials in agitated patients with schizophrenia or bipolar mania was 6% for intramuscular ZYPREXA for injection and 3% for placebo.

Adverse Events Occurring at an Incidence of 2% or More Among Oral ZYPREXA Treated Patients in Short-Term, Placebo-Controlled Trials

Table 1 enumerates the incidence, rounded to the nearest percent, of treatment-emergent adverse events that occurred in 2% or more of patients treated with oral ZYPREXA (doses ≥2.5 mg/day) and with incidence greater than placebo who participated in the acute phase of placebo-controlled trials.

Table 1

Treatment-Emergent Adverse Events:

Incidence in Short-Term, Placebo-Controlled Clinical Trials¹

With Oral ZYPREXA

Percentage of Patients Reporting Event

ZYPREXA Placebo

Body System/Adverse Event (N=532) (N=294)___

Body as a Whole

Accidental Injury 12 8

Asthenia 10 9

Fever 6 2

Back Pain 5 2

Chest Pain 3 1_________

Cardiovascular System

Postural Hypotension 3 1

Tachycardia 3 1

Hypertension 2 1_________

Digestive System

Dry Mouth 9 5

Constipation 9 4

Dyspepsia 7 5

Vomiting 4 3

Increased appetite 3 2_________

Hemic and Lymphatic System

Ecchymosis 5 3_________

Metabolic and Nutritional Disorders

Weight gain 5 3

Peripheral edema 3 1_________

Musculoskeletal System

Extremity pain (other than joint 5 3

Joint pain 5 3_________

Nervous System

Somnolence 29 13

Insomnia 12 11

Dizziness 11 4

Abnormal gait 6 1

Tremor 4 3

Akathisia 3 2

Hypertonia 3 2

Articulation impairment 2 1_________

Respiratory System

Rhinitis 7 6

Cough increased 6 3

Pharyngitis 4 3_________

Special Senses

Amblyopia 3 2_________

Urogenital System

Urinary Incontinence 2 1

Urinary tract infection 2 1_________

¹ Events reported by at least 2% of patients treated with ZYPREXA, except the following events which had an incidence equal to or less than placebo: abdominal pain, agitation anorexia, anxiety, apathy, confusion, depression, diarrhea, dysmenorrhea², hallucinations, headache, hostility, hyperkinesias, myalgia, nausea, nervousness, paranoid reaction, personality disorder³, rash, thinking abnormal, weight loss.

²Denominator used was for females only (ZYPREXA, N=201; placebo, N=114).

³Personality disorder is the COSTART term for designating non-aggressive objectionable behavior.

Commonly Observed Adverse Events in Short-Term Combination Trials

In the bipolar mania combination placebo-controlled trials, the most commonly observed adverse events associated with the combination of ZYPREXA and lithium or valproate (incidence of ≥5% and at least twice placebo) were:

Common Treatment-Emergent Adverse Events Associated with the

Use of Oral ZYPREXA in 6- Week combination Trials – BIPOLAR MANIA

Percentage of Patients Reporting Event

Adverse Event ZYPREXA with Placebo with

Lithium or valproate Lithium or valproate

(N=229) (N=115)

Dry Mouth 32 9

Weight Gain 26 7

Increased appetite 24 8

Dizziness 14 7

Back Pain 8 4

Constipation 8 4

Speech disorder 7 1

Increased Salivation 6 2

Amnesia 5 2

Paresthesia 5 2

Adverse Events Occurring at an Incidence of 2% or More Among ZYPREXA-Treated Patients in Short-Term Combination Trials

Table 2 enumerates the incidence, rounded to the nearest percent, of treatment-emergent adverse events that occurred in 2% or more of patients treated with the combination of ZYPREXA (dosed ≥5% mg/day) and lithium or valproate and with incidence greater than lithium or valproate alone who participated in the acute phase of placebo-controlled combination trials.

Table 2

Treatment-Emergent Adverse Events:

Incidence in Short-Term, Placebo-Controlled Combination Clinical Trials

With Oral ZYPREXA

Percentage of Patients Reporting Event

ZYPREXA with Placebo with

lithium or valproate lithium or valproate

Body System/Adverse Event (N=229) (N=115)

Body as a Whole

Asthenia 18 13

Back Pain 8 4

Accidental injury 4 2

Chest pain 3 2___________

Cardiovascular System

Hypertension 2 1___________

Digestive System

Dry Mouth 32 9

Increased appetite 24 8

Thirst 10 6

Constipation 8 4

Increased salivation 6 2___________

Metabolic and Nutritional Disorders

Weight gain 26 7

Peripheral edema 6 4

Edema 2 1___________

Nervous System

Somnolence 52 27

Tremor 23 13

Depression 18 17

Dizziness 14 7

Speech Disorder 7 1

Amnesia 5 2

Paresthesia 5 2

Apathy 4 3

Confusion 4 1

Euphoria 3 2

Incoordination 2 0__________

Respiratory System

Pharyngitis 4 1

Dyspnea 3 1__________

Skin Appendages

Sweating 3 1

Acne 2 0

Dry Skin 2 0__________

Special Senses

Amblyopia 9 5

Abnormal vision 2 0__________

Urogential System

Dysmenorrhea² 2 0

Vaginitis² 2 0__________

¹Events reported by at least 2% of patients treated with ZYPREXA, except the following events which had an incidence equal to or less than placebo: abdominal pain, abnormal dreams, abnormal ejaculation, agitation, adathisia, anorexia, anxiety, arthralgia, cough increased, diarrhea, dyspepsia, emotional lability, fever, flatulence, flu syndrome, headache, hostilitym, insomnia, libido decreased, libido increased, menstrual disorder², myalgia, nausea, nervousness, pain, paranoid reaction, personality disorder, rash, rhinitis, sleep disorder, thinking abnormal, vomiting.

²Denominator used was for females only (ZYPREXA, N=128; placebo, N=51)

For specific information about the adverse reactions observed with lithium or valproate, refer to the ADVERSE REACTIONS section of the package inserts for these other products.

Adverse Events Occurring at an Incidence of 1% or More Among Intramuscular ZYPREXA for Injection - Treated Patient s in Short-Term, Placebo-Controlled Trials

Table 3 enumerates the incidence, rounded to the nearest percent, of treatment-emergent adverse events that occurred in 1% or more of patients treated with intramuscular ZYPREXA for injection (dose range of 2.5-10.0 mg/injection) and with incidence greater than placebo who participated in the short-term, placebo-controlled trials in agitated patients with schizophrenia or bipolar mania.

Table 3

Treatment-Emergent Adverse Events:

Incidence in Short-term (24 Hour), Placebo-Controlled Clinical Trials

With Intramuscular ZYPREXA for Injection

In Agitated Patients with Schizophrenia or Bipolar Mania¹

Percentage of Patients Reporting Event

ZYPREXA Placebo

Body System/Adverse Event (N=415) (N=150)____

Body as a whole

Asthenia 2 1________________

Cardiovascular System

Hypotension 2 0

Postural Hypotension 1 0________________

Nervous System

Somnolence 6 3

Dizziness 4 2

Tremor 1 0________________

¹ Events reported by at least 1% of patients treated with ZYPREXA for injection, except the following events which had an incidence equal to or less than placebo: agitation, anxiety, dry mouth, headache, hypertension, insomnia, nervousness.

Additional Findings Observed in Clinical Trials

The following findings are based on clinical trials.

Dose Dependency of Adverse Events in Short-Term, Placebo-Controlled Trials

Extrapyramidal Symptoms – The following table enumerates the percentage of patients with treatment-emergent extrapyramidal symptoms as assessed by categorical analyses of formal rating scales during acute therapy in a controlled clinical trial comparing oral ZYPREXA at 3 fixed doses with placebo in the treatment of schizophrenia.

TREATMENT-EMERGENT EXTRAPYRAMIDAL SYMPTOMS ASSESSED BY RATING SCALES INCIDENCE IN A FIXED DOSAGE RANGE, PLACEBO-CONTROLLED CLINICAL TRIAL OF ORAL ZYPREXA IN SCHIZOPHRENIA – ACUTE PHASE*

Percentage of Patients Reporting event

ZYPREXA ZYPREXA ZYPREXA

Placebo 5±2.5 mg/day 10±2.5 mg/day 15±2.5 mg/day

Parkinson 15 14 12 14

Akathisia² 23 16 19 27

* No statistically significant differences.

¹ Percentage of patients with a Simpson-Angus Scale total score >3.

² Percentage of patients with a Barnes Akathisia Scale global score ≥2.

The following table enumerates the percentage of patients with treatement-emergent extrapyramidal symptoms as assessed by spontaneously reported adverse events during acute therapy in the same controlled clinical trial comparing ZYPREXA at 3 fixed doses with placebo in the treatment of schizophrenia.

TREATMENT-EMERGENT EXTRAPYRAMIDAL SYMPTOMS ASSESSED BY ADVERSE EVENTS INCIDENCE IN A FIXED DOSAGE RANGE, PLACEBO-CONTROLLED CLINICAL TRIAL OF ORAL ZYPREXA IN SCHIZOPHRENIA – ACUTE PHASE

Percentage of Patients Reporting Event

ZYPREXA ZYPREXA ZYPREXA

Placebo 5±2.5 mg/day 10±2.5 mg/day 15±2.5 mg/day

(N=68) (N=65) (N=64) (N=69)

Dystonic events¹ 1 3 2 3

Parkinsonism events² 10 8 14 20

Akathisia events³ 1 5 11* 10*

Dykinetic events4 4 0 2 1

Residual events5 1 2 5 1

Any extrapyramidal event 16 15 25 32*

* Statistically significantly different from placebo.

¹ Patients with the following COSTART terms were counted in this category: dystonia, generalized spasm, neck rigidity, oculogyric crisis, opisthotonos, toricollis.

² Patients with the following COSTART terms were counted in this category: akinesia, cogwheel rigidity, extrapyramidal syndrome, hypertonia, hypokinesia, masked facies, tremor.

³ Patients with the following COSTART terms were counted in this category: akathisia, hyperkinesias.

4 Patients with the following COSTART terms were counted in this category: buccoglossal syndrome, choreoathetosis, dyskinesia, tardive dyskinesia.

5 Patients with the following COSTART terms were counted in this category: movement disorder, myoclonus, twitching.

The following table enumerates the percentage of patients with treatment-emergent extrapyramidal symptoms as assessed by categorical analyses of formal rating scales during controlled clinical trials comparing fixed doses of intramuscular ZYPREXA for injection with placebo in agitation. Patients in each dose group could receive up to three injections during the trials (see CLINICAL PHARMACOLOGY). Patient assessments were conducted during the 24 hours following the initial dose of intramuscular ZYPREXA for injection. There were no statistically significant differences from placebo.

TREATMENT-EMERGENT EXTRAPYRAMIDAL SYMPTOMS ASSESSED BY RATING SCALES INCIDENCE IN A FIXED DOSE, PLACEBO-CONTROLLED CLINICAL TRIAL OF INTRAMUSCULAR ZYPREXA FOR INJECTION IN AGITATED PATIENTS WITH SCHIZOPHRENIA*

Percentage of Patients Reporting Event

ZYPREXA ZYPREXA ZYPREXA ZYPREXA

IM IM IM IM

Placebo 2.5 mg 5 mg 7.5 mg 10 mg

Parkinsonism¹ 0 0 0 0 3

Akathisia² 0 0 5 0 0

* No statistically significant differences.

¹ Percentage of patients with a Simpson-Angus total score >3

² Percentage of patients with a Barnes Akathisia Scale global score ≥2.

The following table enumerates the percentage of patients with treatment-emergent extrapyramidal symptoms as assessed by spontaneously reported adverse events in the same controlled clinical trial comparing fixed doses of intramuscular ZYPREXA fro injection with placebo in agitated patients with schizophrenia. There were no statistically significant differences from placebo.

TREATEMENT-EMERGENT EXTRAPYRAMYDAL SYMPTOMS ASSESSED BY ADVERSE EVETNS INCIDENCE IN A FIXED DOSE, PLACEBO-CONTROLLED CLINICAL TRIAL OF INTRAMUSCULAR ZYPREXA FOR INFECTION IN AGITATED PATIENTS WITH SCHIZOPHRENIA*

Percentage of Patients Reporting Event

ZYPREXA ZYPREXA ZYPERXA ZYPREXA

IM IM IM IM

Placebo 2.5 mg 5 mg 7.5 mg 10 mg

(N=45) (N=48) (N=45) (N=46) (N=46)

Dystonic events¹ 0 0 0 0 0

Parkinsonism events² 0 4 2 0 0

Akathisia events³ 0 2 0 0 0

Dyskinetic events4 0 0 0 0 0

Residual events5 0 0 0 0 0

Any extrapyramidal 0 4 2 0 0

* No statistically significant differences.

¹ Patients with the following COSTART terms were counted in this category: dystonia, generalized spasm, neck rigidity, oculogyric crisis, opisthotonos, toricollis.

² Patients with the following COSTART terms were counted in this category: akinesia, cogwheel rigidity, extrapyramidal syndrome, hypertonia, hypokinesia, masked facies, tremor.

³ Patients with the following COSTART terms were counted in this category: akathisia, hyperkinesias.

4 Patients with the following COSTART terms were counted in this category: buccoglossal syndrome, choreoathetosis, dyskinesia, tardive dyskinesia.

5 Patients with the following COSTART terms were counted in this category: movement disorder, myoclonus, twitching.

Other Adverse Events - The following table addresses dose relatedness for other adverse events using data from a schizophrenia trial involving fixed dosage ranges of oral ZYPREXA. It enumerates the percentage of patients with treatment-emergent adverse events for the three fixed-dose range groups and placebo. The data were analyzed using the Cochran-Armitage test, excluding the placebo group, and the table includes only those adverse events for which there was a statistically significant trend.

Percentage of Patients Reporting Event

ZYPREXA ZYPREXA ZYPREXA

Adverse Event Placebo 5±2.5 mg/day 10±2.5 mg/day 15±2.5 mg/day

(N=68) (N=65) (N=64) (N=69)

Asthenia 15 8 9 20

Dry Mouth 4 3 5 13

Nausea 9 0 2 9

Somnolence 16 20 30 39

Tremor 3 0 5 7

Vital Sign Changes – Oral ZYPREXA was associated with orthostatic hypotension and tachycardia in clinical trials. Intramuscular ZYPREXA for injection was associated with bradycardia, hypotension, and tachycardia in clinical trials (see PRECAUTIONS).

Weight Gain – In placebo-controlled, 6-week studies, weight gain was reported in 5.6% of ZYREXA patients compared to 0.8% of placebo patients. ZYPREXA patients gained an average of 2.8 kg, compared to an average 0.4 kg weight loss in placebo patients: 29% of ZYPREXA patients gained greater than 7% of their baseline weight, compared to 3% of placebo patients. A categorization of patients at baseline on the basis of body mass index (BMI) revealed a significantly greater effect in patients with low BMI compared to normal or overweight patients; nevertheless, weight gain was greater in all 3 ZYPREXA groups compared to the placebo group. During long-term continuation therapy with ZYPREXA (238 median days of exposure), 56% of ZYPREXA patients met the criterion for having gained greater than 7% of their baseline weight. Average weight gain during long-term therapy was 5.4 kg.

Laboratory Changes – An assessment of the premarketing experience for ZYPREXA revealed an association with asymptomatic increases in SGPT, SGOT, and GGT (see PRECAUTIONS). ZYPREXA administration was also associated with increases in serum prolactin (see PRECAUTIONS), with an asymptomatic elevation of the eosinophil count in 0.3% of patients, and with an increase in CPK.

Given the concern about neutropenia associated with other psychotropic compounds and the finding of leukopenia associated with the administration of ZYPREXA in several animal models (see ANIMAL TOXICOLOGY), careful attention was given to examination of hematologic parameters in premarketing studies with ZYPREXA. There was no indication of a risk of clinically significant neutropenia associated with ZYPREXA treatment in the premarketing database for this drug.

ECG Changes – Between-group comparisons for pooled placebo-controlled trials revealed no statistically significant ZYPREXA/placebo differences in the proportions of patients experiencing potentially important changes in ECG parameters, including QT, QTc, and PR intervals. ZYPREXA use was associated with a mean increase in heart rate of 2.4 beats per minute compared to no change among placebo patients. This slight tendency to tachycardia may be related to ZYPREXA’s potential for inducing orthostatic changes (see PRECAUTIONS).

Other Adverse Events Observed During the Clinical Trial Evaluation of ZYPREXA

Following is a list of terms that reflect treatment-emergent adverse events reported by patients treated with oral ZYPREXA (at multiple doses ≥1 mg/day) in clinical trials (8661 patients, 4165 patient-years of exposure). This listing may not include those events already listed in previous tables or elsewhere in labeling, those events for which a drug cause was remote, those event terms which were so general as to be uninformative, and those events reported only once or twice which did not have a substantial probability of being acutely life-threatening.

Events are further categorized by body system and listed in order of decreasing frequency according to the following definitions: frequent adverse events are those occurring in at least 1/100 patients (only those not already listed in the tabulated results for placebo-controlled trials appear in this listing): infrequent adverse events are those occurring in 1/100 to 1/1000 patients; rare events are those occurring in fewer than 1/1000 patients.

Body as a Whole – Frequent: dental pain and flu syndrome; Infrequent: abdomen enlarged, chills, face edema, intentional injury, malaise, moniliasis , neck pain, neck rigidity, pelvic pain, photosensitivity reaction, and suicide attempt; Rare: chills and fever, hangover effect, and sudden death.

Cardiovascular System – Frequent: hypotension; Infrequent: atrial fibrillation, bradycardia, cerebrovascular accident, congestive heart failure, heart arrest, hemorrhage, migraine, pallor, palpitation, vasocilatation, and ventricular extrasystoles; Rare: arteritis, heart failure, and pulmonary embolus.

Digestive System – Frequent: flatulence, increased salivation, and thirst; Infrequent: dysphagia, esophagitis, fecal impaction, fecal incontinence, gastritis, gastroenteritis,gingivitis, hepatitis, melena, mouth ulceration, nausea and vomiting, oral moniliasis, periodontal abscess, rectal hemorrhage, stomatitis, toungue edema, and tooth caries; Rare: aphthous stomatitis, enteritis, eructation, esophageal ulcer, glossitis, ileus, intestinal obstruction, liver fatty deposit, and tongue discoloration.

Endocrine System – Infrequent: diabetes mellitus; Rare: diabetic acidosis and goiter.

Hemic and Lymphatic System – Infrequent: anemia, cyanosis, leukocytosis, seukopenia, lymphadenopathy, and thrombocytopenia; Rare: normocytic anemia and thrombocythemia.

Metobolic and Nutrional Disorders – Infrequent: acidosis, alkaline phosphatase increased, bilirubinemia, dehydration, hypercholesteremia, hyperglycemia, hyperlipemia, hyperuricemia, hypoglycemia, hypokalemia, hyponatremia, lower extremity edema, and upper extremity edema; Rare: gout, hyperkalemia, hypernatremia, hypoproteinemia, ketosis, and water intoxication.

Musculoskeletal System – Frequent: joint stiffness and twitching; Infrequent: arthritis, arthrosis, leg cramps, and myasthenia; Rare: bone pain, bursitis, myopathy, osteoporosis, and rheumatoid arthritis.

Nervous System – Frequent: abnormal dreams, amnesia, delusions, emotional libility, euphoria, manic reaction, paresthesia, and schizophrenic reaction; Infrequent: akinesia, alcohol misuse, antisocial reaction, ataxia, CNS stimulation, cogwheel rigidity, delirium, dementia, depersonalization, dysarthria, facial paralysis, hypesthesia, hypokinesia, hypotonia, incoordination, libido decreased, libido increased, obsessive conpulsive symptoms, phobias, somatization, stimulant misuse, stupor, stuttering, Tardive dyskinesia, vertigo, and withdrawal syndrom; Rare: circumoral paresthesia, coma, encephalopathy, neuralgia, neuropathy nystagmus, paralysis, subarachnoid hemorrhage, and tobacco misuse.

Respiratory System – Frequent: dyspnea; Infrequent: apnea, asthma, epistazis, hemoptysis, hyperventilation, hypoxia, laryngitis, and voice alteration; Rare: atelectasis, hiccup, hypoventilation, lung edema, and stridor.

Skin Appendages – Frequent: sweating; Infrequent: alopecia, contact dermatitis, dry skin, ecxema, maculopapular rash, pruritus, seborrhea, skin discoloration, skin sulcer, urticaria, and vesiculobullous rash; Rare: hirsutism and pustular rash.

Special Senses – Frequent: conjunctiveitis; Infrequent: abnormality of accommodation, blepharitis, cataract, deafness, diplia, dry eyes, ear pain, eye hemorrhage, eye inflammation, eye pain, ocular muscle abnormality, taste perversion, and tinnitus; Rare: corneal lesion, glaucoma, keratoconjunctiveitis, macular hypopigmentation, miosis, mydriasis, and pigment deposits lens.

Urogenital System – Frequent: vaginitis*; Infrequent: abnormal ejaculation*, amenorrhea*, Breast pain, cystitis, decreased menstruation*, dysuria, female lactation*, glycosuria, gynecomastia, hematuria, impotence*, increased menstruation*, menorrhagia*, metrorrhagia*, polyuria, premenstrual syndrome*, pyuria, urinary frequency, urinary retention, urinary urgency, urination impaired, uterine fibroids enlarged*, and vaginal hemorrhage*; Rare: albuminuria, breast enlargement, mastitis, and oliguria.

*Adjusted for gender.

Following is a list of terms that reflect treatment-emergent adverse events reported by patients treated with intramuscular ZYPREXA for injection (at one or more doses ≥2.5 mg/injection) in clinical trials (722 patients). This listing may not include those events already listed in previous tables or elsewhere in labeling, those events for which a drug cause was remote, those event terms which were so general as to be uninformative, and those events reported only once which did not have a substantial probability o being acutely life-threatening.

Events are further categorized by body system and listed in order of decreasing frequency according to the following definitions: frequent adverse events are those occurring in at least 1/100 patients (only those not already listed in the tabulated results from placebo-controlled trials appear in this listing); infrequent adverse events are those occurring in 1/100 to 1/1000 patients.

Body as a Whole – Frequent: injection site pain; Infrequent: abdominal pain and fever.

Cardiovascular System – Infrequent: AV block, heart block, and syncope.

Digestive System - Infrequent: diarrhea and nausea.

Hemic and Lymphatic System – Infrequent: anemia.

Metabolic and Nutritional Disorders – Infrequent: creatine phosphokinase increased, dehydration, and hyperkalemia.

Musculoskeletal System – Infrequent: twitching.

Nervous System – Infrequent: abnormal gait, akathisia, articulation impairment, confusion, and emotional lability.

Skin and Appendages – Infrequent: sweating.

Postintroduction Reports

Adverse events reported since market introduction that were temporally (but not necessarily causally) related to ZYPREXA therapy include the following: Allergic reaction (e.g., anaphylactoid reaction, angiodema, pruritus or uritcaria), diabetic coma, pancreatitis, priapism, rhabdomyolysis, and venous tromboembolic events (including pulmonary embolism and deep venous thrombosis).

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Zyprexa

Zyprexa side effects Body

Zyprexa side effects Dry Mouth - The usual amount to moisture in the mouth is noticeably less.

Zyprexa side effects Sweating Increased - A large quantity of perspiration that is medically caused.

Zyprexa side effects Cardiovascular (Involving the heart and the blood vessels)

Zyprexa side effects Palpitation - Unusual and not normal heartbeat, that is sometimes irregular, but rapid and forceful thumping or fluttering. It can be brought on by shock, excitement, exertion, or medical stimulants. A person is normally unaware of his/her heartbeat.

Zyprexa side effects Bradycardia - The heart rate is slowed from 72 beats per minute, which is normal, to below 60 beats per minute in an adult.

Zyprexa side effects Gastrointestinal (Involving the stomach and the intestines)

Zyprexa side effects General

Zyprexa side effects Allergy - The extreme sensitivity of body tissues triggered by substances in the air, drugs, or foods causing a reaction like sneezing, itching, asthma, hay fever, skin rashes, nausea and/or vomiting.

Zyprexa side effects Anaphylaxis - A violent, sudden, and severe drop in blood pressure caused by a re-exposure to a foreign protein or a second dosage of a drug that may be fatal unless emergency treatment is given right away.

Zyprexa side effects Asthenia - A physically weak condition.

Zyprexa side effects Chest Pains - Severe discomfort in the chest caused by not enough oxygen going to the heart because of narrowing of the blood vessels or spasms.

Zyprexa side effects Chills - Appearing pale while cold and shivering; sometimes with a fever.

Zyprexa side effects Edema of Extremities - Abnormal swelling of the body’s tissue caused by the collection of fluid.

Zyprexa side effects Fall - To suddenly lose your normal standing upright position as if you were shot.

Zyprexa side effects Fatigue - Loss of normal strength so as to not be able to do the usual physical and mental activities.

Zyprexa side effects Hot Flashes - Brief, abnormal enlargement of the blood vessels that causes a sudden heat sensation over the entire body. Women in menopause will sometimes experience this.

Zyprexa side effects Influenza-like Symptoms - Demonstrating irritation of the respiratory tract (organs of breathing) such as a cold, sudden fever, aches and pains, as well as feeling weak and seeking bed rest, which is similar to having the flu.

Zyprexa side effects Leg Pain - A hurtful sensation in the legs that is caused by excessive stimulation of the nerve endings in the legs and results in extreme discomfort.

Zyprexa side effects Malaise - The somewhat unclear feeling of discomfort you get when you start to feel sick.

Zyprexa side effects Pain in Limb - Sudden, sharp and uncontrolled leg discomfort.

Zyprexa side effects Syncope - A short period of light headedness or unconsciousness (black-out) also know as fainting caused by lack of oxygen to the brain because of an interruption in blood flowing to the brain.

Zyprexa side effects Tightness of Chest - Mild or sharp discomfort, tightness or pressure in the chest area (anywhere between the throat and belly). The causes can be mild or seriously life-threatening because they include the heart, lungs and surrounding muscles.

Zyprexa side effects Hemic and Lymphatic Disorders (Involving the blood and the clear fluids in the tissues that contain white blood cells)

Zyprexa side effects Bruise - Damage to the skin resulting in a purple-green-yellow skin coloration that’s caused by breaking the blood vessels in the area without breaking the surface of the skin.

Zyprexa side effects Nosebleed - Blood lost from the part of the face that has the organs of smell and is where the body takes in oxygen.

Zyprexa side effects Hematoma - Broken blood vessels that cause a swelling in an area on the body.

Zyprexa side effects Lymphadenopathy Cervical - The lymph nodes in the neck, which are part of the body’s immune system get swollen and enlarge by reacting to the presence of a drug. The swelling is the result of the white blood cells multiplying in order to fight the invasion of the drug.

Zyprexa side effects Metabolic and Nutritional Disorders (Energy and health)

Zyprexa side effects Arthralgia - Sudden sharp nerve pain in one or more joints.

Zyprexa side effects Arthropathy - Having joint disease or abnormal joints.

Zyprexa side effects Arthritis - Painfully inflamed and swollen joints. The reddened and swollen condition is brought on by a serious injury or shock to the body either from physical or emotional causes.

Zyprexa side effects Thirst - A strong, unnatural craving for moisture/water in the mouth and throat.

Zyprexa side effects Nervous System (Sensory channels)

Zyprexa side effects Psychiatric Disorders (Mental and emotional)

Zyprexa side effects Reproductive Disorder Female

Zyprexa side effects Breast Neoplasm - A tumor or cancer, of either of the two milk-secreting organs on the chest of a woman.

Zyprexa side effects Menorrhagia - Abnormally heavy menstrual period or a menstrual flow that has continued for an unusually long period of time.

Zyprexa side effects Menstrual Cramps - Painful, involuntary uterus contractions that women experience around the time of their menstrual period, sometimes causing pain in the lower back and thighs.

Zyprexa side effects Menstrual Disorder - A disturbance or derangement in the normal function of a woman’s menstrual period.

Zyprexa side effects Spotting Between Menses - Abnormal bleeding between periods. Unusual spotting between menstrual cycles.

Zyprexa side effects RESPIRATORY SYSTEM (Organs involved in breathing)

Zyprexa side effects Breath Shortness - Unnatural breathing using a lot off effort resulting in not enough air taken in by the body.

Zyprexa side effects Bronchitis - Inflammation of the two main breathing tubes leading from the windpipe to the lungs. The disease is marked with coughing, a low-grade fever, chest pains, and hoarseness, caused by an allergic reaction.

Zyprexa side effects Coughing - A cough is the response to an irritation, such as mucus, that causes the muscles controlling the breathing process to expel air from the lungs suddenly and noisily to keep the air passages free from the irritating material.

Zyprexa side effects Laryngitis - Inflammation of the voice box characterized by hoarseness, sore throat, and coughing. It can be cause by straining the voice or exposure to infectious, allergic or chemical irritation.

Zyprexa side effects Nasal Congestion - The presence of an abnormal amount of fluid in the nose.

Zyprexa side effects Pneumonia Tracheitis - Bacterial infection of the air passageways and lungs that causes redness, swelling and pain in the windpipe. Other symptoms are high fever, chills, pain in the chest, difficulty in breathing, and coughing with mucus discharge.

Zyprexa side effects Rhinitis - Chemical irritation causing pain, redness and swelling in the mucus membranes of the nose.

Zyprexa side effects Sinus Congestion - The mucus-lined areas of the bones in the face that are thought to help warm and moisten air to the nose. These areas become clogged with excess fluid or infected.

Zyprexa side effects Sinus Headache - The abnormal amount of fluid in the hollows of the face bone area especially around the nose. This excess fluid creates pressure, causing pain in the head.

Zyprexa side effects Sinusitis - The body reacting to chemical irritation causing redness, swelling and pain in the area of the hollows in the facial bones especially around the nose.

Zyprexa side effects SKELETAL

Zyprexa side effects SKIN and APPENDAGES DISORDERS (Skin, legs and arms)

Zyprexa side effects Acne - Eruptions of the oils glands of the skin, especially on the face, marked by pimples, blackheads, whiteheads, bumps, and more severely, by cysts and scarring.

Zyprexa side effects Eczema - A severe or continuing skin disease marked by redness, crusting and scaling with watery blisters and itching. It is often difficult to treat and will sometimes go away only to reappear again.

Zyprexa side effects Dermatitis - Generally irritated skin that can be caused by any of a number of irritating things such as parasites, fungus, bacteria, or foreign substances causing an allergic reaction. It is a general inflammation of the skin.

Zyprexa side effects Dry Lips - The lack of normal moisture in the fleshy folds that surround the mouth.

Zyprexa side effects URINARY SYSTEM DISORDER

Zyprexa side effects Blood in Urine - Blood is present when one empties liquid waste product of the kidneys through the bladder by urinating in the toilet turning the water pink to bright red. Or you could see pots of blood in the water after urinating.

Zyprexa side effects Dysuria - Difficult or painful urination.

Zyprexa side effects Kidney Stone - Small hard masses of salt deposits that the kidney forms.

Zyprexa side effects Urinary Frequency - Having to urinate more often than usual or between unusually short time periods.

Zyprexa side effects Urinary Tract Infection - An invasion of bacteria, viruses, fungi, etc., of the system in the body that starts with the kidneys and eliminates urine from the body. If the invasion goes unchecked it can injure tissue and progress into disease.

Zyprexa side effects Urinary Urgency - A sudden compelling urge to urinate, accompanied by discomfort in the bladder.

Zyprexa side effects UROGENITAL (Urinary tract and genital structures or functions)

Zyprexa side effects Anorgasmia - Failure to experience an orgasm.

Zyprexa side effects Ejaculation Disorder - Dysfunction of the discharge of semen during orgasm.

Zyprexa side effects Menstrual Disorder - Dysfunction of the discharge during the monthly menstrual cycle.

Zyprexa side effects Toxic Epidermal Necrolysis - An abnormal condition where a large portion of skin becomes intensely red and peels off like a second-degree burn. Often the symptoms include blistering.

Zyprexa side effects Gastrointestinal Hemorrhage - Stomach and intestinal excessive internal bleeding.

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DESCRIPTION

CONTRADICTIONS

WARNINGS

PRECAUTIONS

General

Information of Patients

Zyprexa side effects
Body

Zyprexa side effects
Dry Mouth - The usual amount to moisture in the mouth is noticeably less.

Zyprexa side effects
Sweating Increased - A large quantity of perspiration that is medically caused.

Zyprexa side effects
Cardiovascular (Involving the heart and the blood vessels)

Zyprexa side effects
Palpitation - Unusual and not normal heartbeat, that is sometimes irregular, but rapid and forceful thumping or fluttering. It can be brought on by shock, excitement, exertion, or medical stimulants. A person is normally unaware of his/her heartbeat.

Zyprexa side effects
Bradycardia - The heart rate is slowed from 72 beats per minute, which is normal, to below 60 beats per minute in an adult.

Zyprexa side effects
Gastrointestinal (Involving the stomach and the intestines)

Zyprexa side effects
General

Zyprexa side effects
Allergy - The extreme sensitivity of body tissues triggered by substances in the air, drugs, or foods causing a reaction like sneezing, itching, asthma, hay fever, skin rashes, nausea and/or vomiting.

Zyprexa side effects
Anaphylaxis - A violent, sudden, and severe drop in blood pressure caused by a re-exposure to a foreign protein or a second dosage of a drug that may be fatal unless emergency treatment is given right away.

Zyprexa side effects
Asthenia - A physically weak condition.

Zyprexa side effects
Chest Pains - Severe discomfort in the chest caused by not enough oxygen going to the heart because of narrowing of the blood vessels or spasms.

Zyprexa side effects
Chills - Appearing pale while cold and shivering; sometimes with a fever.

Zyprexa side effects
Edema of Extremities - Abnormal swelling of the body’s tissue caused by the collection of fluid.

Zyprexa side effects
Fall - To suddenly lose your normal standing upright position as if you were shot.

Zyprexa side effects
Fatigue - Loss of normal strength so as to not be able to do the usual physical and mental activities.

Zyprexa side effects
Hot Flashes - Brief, abnormal enlargement of the blood vessels that causes a sudden heat sensation over the entire body. Women in menopause will sometimes experience this.

Zyprexa side effects
Influenza-like Symptoms - Demonstrating irritation of the respiratory tract (organs of breathing) such as a cold, sudden fever, aches and pains, as well as feeling weak and seeking bed rest, which is similar to having the flu.

Zyprexa side effects
Leg Pain - A hurtful sensation in the legs that is caused by excessive stimulation of the nerve endings in the legs and results in extreme discomfort.

Zyprexa side effects
Malaise - The somewhat unclear feeling of discomfort you get when you start to feel sick.

Zyprexa side effects
Pain in Limb - Sudden, sharp and uncontrolled leg discomfort.

Zyprexa side effects
Syncope - A short period of light headedness or unconsciousness (black-out) also know as fainting caused by lack of oxygen to the brain because of an interruption in blood flowing to the brain.

Zyprexa side effects
Tightness of Chest - Mild or sharp discomfort, tightness or pressure in the chest area (anywhere between the throat and belly). The causes can be mild or seriously life-threatening because they include the heart, lungs and surrounding muscles.

Zyprexa side effects
Hemic and Lymphatic Disorders (Involving the blood and the clear fluids in the tissues that contain white blood cells)

Zyprexa side effects
Bruise - Damage to the skin resulting in a purple-green-yellow skin coloration that’s caused by breaking the blood vessels in the area without breaking the surface of the skin.

Zyprexa side effects
Nosebleed - Blood lost from the part of the face that has the organs of smell and is where the body takes in oxygen.

Zyprexa side effects
Hematoma - Broken blood vessels that cause a swelling in an area on the body.

Zyprexa side effects
Lymphadenopathy Cervical - The lymph nodes in the neck, which are part of the body’s immune system get swollen and enlarge by reacting to the presence of a drug. The swelling is the result of the white blood cells multiplying in order to fight the invasion of the drug.

Zyprexa side effects
Metabolic and Nutritional Disorders (Energy and health)

Zyprexa side effects
Arthralgia - Sudden sharp nerve pain in one or more joints.

Zyprexa side effects
Arthropathy - Having joint disease or abnormal joints.

Zyprexa side effects
Arthritis - Painfully inflamed and swollen joints. The reddened and swollen condition is brought on by a serious injury or shock to the body either from physical or emotional causes.

Zyprexa side effects
Thirst - A strong, unnatural craving for moisture/water in the mouth and throat.

Zyprexa side effects
Nervous System (Sensory channels)

Zyprexa side effects
Psychiatric Disorders (Mental and emotional)

Zyprexa side effects
Reproductive Disorder Female

Zyprexa side effects
Breast Neoplasm - A tumor or cancer, of either of the two milk-secreting organs on the chest of a woman.

Zyprexa side effects
Menorrhagia - Abnormally heavy menstrual period or a menstrual flow that has continued for an unusually long period of time.

Zyprexa side effects
Menstrual Cramps - Painful, involuntary uterus contractions that women experience around the time of their menstrual period, sometimes causing pain in the lower back and thighs.

Zyprexa side effects
Menstrual Disorder - A disturbance or derangement in the normal function of a woman’s menstrual period.

Zyprexa side effects
Spotting Between Menses - Abnormal bleeding between periods. Unusual spotting between menstrual cycles.

Zyprexa side effects
RESPIRATORY SYSTEM (Organs involved in breathing)

Zyprexa side effects
Breath Shortness - Unnatural breathing using a lot off effort resulting in not enough air taken in by the body.

Zyprexa side effects
Bronchitis - Inflammation of the two main breathing tubes leading from the windpipe to the lungs. The disease is marked with coughing, a low-grade fever, chest pains, and hoarseness, caused by an allergic reaction.

Zyprexa side effects
Coughing - A cough is the response to an irritation, such as mucus, that causes the muscles controlling the breathing process to expel air from the lungs suddenly and noisily to keep the air passages free from the irritating material.

Zyprexa side effects
Laryngitis - Inflammation of the voice box characterized by hoarseness, sore throat, and coughing. It can be cause by straining the voice or exposure to infectious, allergic or chemical irritation.

Zyprexa side effects
Nasal Congestion - The presence of an abnormal amount of fluid in the nose.

Zyprexa side effects
Pneumonia Tracheitis - Bacterial infection of the air passageways and lungs that causes redness, swelling and pain in the windpipe. Other symptoms are high fever, chills, pain in the chest, difficulty in breathing, and coughing with mucus discharge.

Zyprexa side effects
Rhinitis - Chemical irritation causing pain, redness and swelling in the mucus membranes of the nose.

Zyprexa side effects
Sinus Congestion - The mucus-lined areas of the bones in the face that are thought to help warm and moisten air to the nose. These areas become clogged with excess fluid or infected.

Zyprexa side effects
Sinus Headache - The abnormal amount of fluid in the hollows of the face bone area especially around the nose. This excess fluid creates pressure, causing pain in the head.

Zyprexa side effects
Sinusitis - The body reacting to chemical irritation causing redness, swelling and pain in the area of the hollows in the facial bones especially around the nose.

Zyprexa side effects
SKELETAL

Zyprexa side effects
SKIN and APPENDAGES DISORDERS (Skin, legs and arms)

Zyprexa side effects
Acne - Eruptions of the oils glands of the skin, especially on the face, marked by pimples, blackheads, whiteheads, bumps, and more severely, by cysts and scarring.

Zyprexa side effects
Eczema - A severe or continuing skin disease marked by redness, crusting and scaling with watery blisters and itching. It is often difficult to treat and will sometimes go away only to reappear again.

Zyprexa side effects
Dermatitis - Generally irritated skin that can be caused by any of a number of irritating things such as parasites, fungus, bacteria, or foreign substances causing an allergic reaction. It is a general inflammation of the skin.

Zyprexa side effects
Dry Lips - The lack of normal moisture in the fleshy folds that surround the mouth.

Zyprexa side effects
URINARY SYSTEM DISORDER

Zyprexa side effects
Blood in Urine - Blood is present when one empties liquid waste product of the kidneys through the bladder by urinating in the toilet turning the water pink to bright red. Or you could see pots of blood in the water after urinating.

Zyprexa side effects
Dysuria - Difficult or painful urination.

Zyprexa side effects
Kidney Stone - Small hard masses of salt deposits that the kidney forms.

Zyprexa side effects
Urinary Frequency - Having to urinate more often than usual or between unusually short time periods.

Zyprexa side effects
Urinary Tract Infection - An invasion of bacteria, viruses, fungi, etc., of the system in the body that starts with the kidneys and eliminates urine from the body. If the invasion goes unchecked it can injure tissue and progress into disease.

Zyprexa side effects
Urinary Urgency - A sudden compelling urge to urinate, accompanied by discomfort in the bladder.

Zyprexa side effects
UROGENITAL (Urinary tract and genital structures or functions)

Zyprexa side effects
Anorgasmia - Failure to experience an orgasm.

Zyprexa side effects
Ejaculation Disorder - Dysfunction of the discharge of semen during orgasm.

Zyprexa side effects
Menstrual Disorder - Dysfunction of the discharge during the monthly menstrual cycle.

Zyprexa side effects
Toxic Epidermal Necrolysis - An abnormal condition where a large portion of skin becomes intensely red and peels off like a second-degree burn. Often the symptoms include blistering.

Zyprexa side effects
Gastrointestinal Hemorrhage - Stomach and intestinal excessive internal bleeding.