FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/02/97ISR Number: 100000053Report Type:Expedited (15-DaCompany Report #DE97093301A Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Apnoea Foreign Zyprexa PS 10.00 MG Hospitalization - Circulatory Collapse Health Diazepam C 20.00 MG Initial or Prolonged Professional Date:11/03/97ISR Number: 100000061Report Type:Expedited (15-DaCompany Report #US97105236A Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Zyprexa PS ORAL PO Professional Zolpidem C Lorazepam C Thioridazine C Date:11/03/97ISR Number: 100000061Report Type:Expedited (15-DaCompany Report #US97104963A Age:6 WK Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Zyprexa PS TRANSPLACENTAL UNK 28 WK Cardiac Murmur Professional Maternal Drugs Affecting Foetus Date:11/03/97ISR Number: 100000061Report Type:Expedited (15-DaCompany Report #US97105197A Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pulmonary Fibrosis Health Zyprexa PS 20.00 MG Professional DAILY Haloperidol C Benadryl C Zoloft C Cogentin C Klonopin C Pravachol C Tenormin C Nitroglycerin C Date:11/03/97ISR Number: 100000062Report Type:Expedited (15-DaCompany Report #GB97103619A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa PS ORAL PO Health Professional Company Representative 24-Jun-2005 12:19 PM Page: 1 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 100000062Report Type:Expedited (15-DaCompany Report #DE97104120A Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zyprexa PS ORAL 10.00 MG; PO Health Professional Date:11/03/97ISR Number: 100000062Report Type:Expedited (15-DaCompany Report #GB97103925A Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatine Foreign Zyprexa PS ORAL 15.00 MG; PO Hospitalization - Phosphokinase Increased Health Levodopa/Benserazide C ORAL 62.50 MG Initial or Prolonged Immobile Professional ;004/DAY; PO Joint Stiffness Other Fluoxetine C ORAL 20.00 MG PO Neuroleptic Malignant Thioridazine C ORAL 30.00 MG PO Syndrome Lisinopril C ORAL 5.00 MG PO Pneumonia Bisacodyl C ORAL 5.00 MG PO Date:11/03/97ISR Number: 100000062Report Type:Expedited (15-DaCompany Report #IT97103688A Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Musculoskeletal Stiffness Foreign Zyprexa PS ORAL 10.00 MG Initial or Prolonged Pneumonia Health DAILY PO Pyrexia Professional Depakine C ORAL 400.00 MG; Stupor 3/DAY; PO Tavor C ORAL 5.00MG; PO Micoren C ORAL 20. MN 1/DAY; ORAL Tavor C INTRAVENOUS 4.00MG; 1/DAY; IV Date:11/03/97ISR Number: 100000076Report Type:Expedited (15-DaCompany Report #CL97075797A Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Foreign Zyprexa PS ORAL 10.00 MG Initial or Prolonged Dyspnoea Consumer DAILY PO Echolalia Health Prozac C ORAL 80.00 MG Increased Appetite Professional DAILY; ORAL Mania Company Weight Increased Representative Other Date:11/03/97ISR Number: 100000076Report Type:Expedited (15-DaCompany Report #US97070292A Age:72 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Renal Failure Consumer Zyprexa PS ORAL 10.00 MG Initial or Prolonged Rhabdomyolysis Health DAILY; PO Other Professional Acetaminophen C 24-Jun-2005 12:19 PM Page: 2 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 100000076Report Type:Expedited (15-DaCompany Report #DE97090310A Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Foreign Zyprexa PS ORAL 5.00 MG DAILY Initial or Prolonged Alanine Aminotransferase Health PO Increased Professional Fluanxol C Aspartate Aminotransferase Increased Blood Alkaline Phosphatase Increased Blood Bilirubin Increased Gamma-Glutamyltransferase Increased Hepatic Function Abnormal Hepatocellular Damage Hepatomegaly Hypersensitivity Jaundice Oedema Pyrexia Splenomegaly Date:11/03/97ISR Number: 3005364-1Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Murmur Olanzapine PS Lilly Congenital Anomaly Complications Of Maternal Exposure To Therapeutic Drugs Sudden Infant Death Syndrome Date:11/03/97ISR Number: 3011590-8Report Type:Periodic Company Report #US97074846A Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Asthenia Health Zyprexa PS ORAL 10 MG DAILY Chest Pain Professional PO Dehydration Calcium Carbonate C Pyrexia Osteoarthritis C Rhabdomyolysis Sedation Date:11/03/97ISR Number: 3011594-5Report Type:Periodic Company Report #US97080142A Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Study Zyprexa PS ORAL 5.00 MG DAILY Initial or Prolonged Condition Aggravated Health PO Delusion Professional Hydrochlorothiazide C Drug Ineffective Synthroid C K-Dur C Metoprolol C Lorazepam C 24-Jun-2005 12:19 PM Page: 3 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3011595-7Report Type:Periodic Company Report #US97080964A Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Respiratory Health Zyprexa PS ORAL 5.00 MF DAILY Initial or Prolonged Distress Syndrome Professional Provenil C Blood Pressure Increased Atrovent C Coma Convulsion Tachycardia Date:11/03/97ISR Number: 3011598-2Report Type:Periodic Company Report #US97081306A Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Insomnia Study Zyprexa PS ORAL 10.00 MG Initial or Prolonged Irritability Health DAILY PO Mania Professional Date:11/03/97ISR Number: 3011600-8Report Type:Periodic Company Report #US97082461A Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Insomnia Study Zyprexa PS ORAL 10 MG DAILY Initial or Prolonged Paranoia Health Refusal Of Treatment By Professional Patient Date:11/03/97ISR Number: 3011604-5Report Type:Periodic Company Report #US97082704A Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Study Zyprexa PS ORAL 5MG DAILY PO Initial or Prolonged Eye Injury Health Calcium Carbonate C Eye Penetration Professional Colace C Pred-Forte C Timoptic C Ecotrin C Phospholine-Iodide C Dulcolax C Date:11/03/97ISR Number: 3011607-0Report Type:Periodic Company Report #US97084039A Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Study Zyprexa PS ORAL 20 MG DAILY Initial or Prolonged Health Lithium Carbonate C Professional Risperdal C Ativan C Date:11/03/97ISR Number: 3011612-4Report Type:Periodic Company Report #US97084498A Age:87 YR Gender:Female I/FU:I Outcome PT Hospitalization - Cellulitis Initial or Prolonged Delirium Fall 24-Jun-2005 12:19 PM Page: 4 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Oedema Peripheral Pain In Extremity Periorbital Haematoma Report Source Product Role Manufacturer Route Dose Duration Pyrexia Study Zyprexa PS ORAL 10.00 MG Rash Erythematous Health DAILY PO Professional Multivitamins C Nutrition C Peri-Colace C Dulcolax C Lactulose C Date:11/03/97ISR Number: 3011617-3Report Type:Periodic Company Report #US97085023A Age:91 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Bradycardia Study Zyprexa PS ORAL 5.00 MG Other Coma Health DAILY PO Hypotension Professional Cipro C Pain Ferrous Sulfate C Prilosec C Peri-Colace C Albuterol C Alprazolam C Date:11/03/97ISR Number: 3011621-5Report Type:Periodic Company Report #US97085167A Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cellulitis Study Zyprexa PS ORAL 10 MG DAILY Initial or Prolonged Condition Aggravated Health PO Drug Ineffective Professional Vitamin B12 C Oedema Peripheral K-Dur C Artificial Tears C Milk Of Magnesia C Date:11/03/97ISR Number: 3011623-9Report Type:Periodic Company Report #US97090373A Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Study Zyprexa PS ORAL 20 MG DAILY Initial or Prolonged Anger Health PO Hostility Professional Mania Paranoia Psychotic Disorder Date:11/03/97ISR Number: 3011625-2Report Type:Periodic Company Report #US97092296A Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Study Zyprexa PS ORAL 10 MG DAILY Initial or Prolonged Delusion Health PO Drug Withdrawal Syndrome Professional 24-Jun-2005 12:19 PM Page: 5 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3011627-6Report Type:Periodic Company Report #US97092452A Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Study Zyprexa PS ORAL 20 MG DAILY Initial or Prolonged Health Valium C Professional Prozac C Salsalate C Benazepril Hydrochloride C Date:11/03/97ISR Number: 3011628-8Report Type:Periodic Company Report #US97092461A Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Abuser Study Zyprexa PS ORAL 20 MG DAILY Initial or Prolonged Suicidal Ideation Health Valium C Professional Date:11/03/97ISR Number: 3011630-6Report Type:Periodic Company Report #US97092806A Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Study Zyprexa PS ORAL 10 MG DAILY Initial or Prolonged Suicide Attempt Health Salsalate C Other Professional Ativan C Lithium C Lasix C Coumadin C Date:11/03/97ISR Number: 3011632-XReport Type:Periodic Company Report #US97070766A Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Liver Function Test Health Zyprexa PS ORAL 25 MJG DAILY Abnormal Professional PO Nausea Valproic Acid C Vomiting Date:11/03/97ISR Number: 3011633-1Report Type:Periodic Company Report #US97070775A Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Consumer Zyprexa PS ORAL 20.00 MG Initial or Prolonged Drooling Health DAILY PO Ear Infection Professional Trilafon C Eye Movement Disorder Trazodone C Parkinsonism Urinary Retention Date:11/03/97ISR Number: 3011635-5Report Type:Periodic Company Report #US97071180A Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Other Neuroleptic Malignant Health Syndrome Professional Company 24-Jun-2005 12:19 PM Page: 6 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Representative Product Role Manufacturer Route Dose Duration Zyprexa PS Date:11/03/97ISR Number: 3011637-9Report Type:Periodic Company Report #US97072128A Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Consumer Zyprexa PS Initial or Prolonged Feeling Cold Health Lithium C Oedema Peripheral Professional Social Avoidant Behaviour Other Stress Date:11/03/97ISR Number: 3011640-9Report Type:Periodic Company Report #US97072134A Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Zyprexa PS ORAL 10.00 MG Initial or Prolonged Phosphokinase Increased Professional DAILY PO Cognitive Disorder Company Haldol C Depressed Level Of Representative Haldol Decanoate C Consciousness Charcoal, Activated C Dyskinesia Dysphagia Joint Stiffness Muscle Rigidity Neuroleptic Malignant Syndrome Parkinsonian Gait Pyrexia Syncope Tongue Oedema Vomiting Date:11/03/97ISR Number: 3011644-6Report Type:Periodic Company Report #US97072320A Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Choking Health Zyprexa PS 15.00MG DAILY Dysphagia Professional PO Respiratory Disorder Depakote C Prozac C Date:11/03/97ISR Number: 3011647-1Report Type:Periodic Company Report #US97072476A Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Consumer Zyprexa PS ORAL 20.00 MG Initial or Prolonged Hypertension Health DAILY Other Hypomania Professional Diltiazem C Clonazepam C Lisinopril C Aspirin C Lipitor C Estrogens C 24-Jun-2005 12:19 PM Page: 7 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lithium C Valproate Sodium C Date:11/03/97ISR Number: 3011651-3Report Type:Periodic Company Report #US97072785A Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dysphagia Health Zyprexa PS ORAL 2.50 MG 2/DAY Initial or Prolonged Extrapyramidal Disorder Professional Other Pneumonia Aspiration Other Date:11/03/97ISR Number: 3011654-9Report Type:Periodic Company Report #US97072791A Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperhidrosis Other Zyprexa PS ORAL 10.00 MG Initial or Prolonged Lack Of Spontaneous DAILY PO Speech Muscle Rigidity Tremor Date:11/03/97ISR Number: 3011656-2Report Type:Periodic Company Report #US97072797A Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Increased Appetite Health Zyprexa PS ORAL 15 MG DAILY 6 MON Initial or Prolonged Oedema Professional Depakote C Polydipsia Other Lasix C Polyuria Amoxicillin C Vomiting Weight Increased Date:11/03/97ISR Number: 3011659-8Report Type:Periodic Company Report #US97072800A Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Postural Health Zyprexa PS ORAL 2.5 MG DAILY Initial or Prolonged Myocardial Infarction Professional PO Syncope Other Date:11/03/97ISR Number: 3011662-8Report Type:Periodic Company Report #US97072812A Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Liver Function Test Health Zyprexa PS 2.50MG DAILY Abnormal Professional PO Tongue Oedema Ativan C Cardizem Cd C Bactrim Ds C Axid C Effexor C 24-Jun-2005 12:19 PM Page: 8 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3011665-3Report Type:Periodic Company Report #US97072998A Age:46 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebrovascular Accident Health Zyprexa PS Professional Date:11/03/97ISR Number: 3011669-0Report Type:Periodic Company Report #US97073046A Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Health Zyprexa PS ORAL 50.00 MG UNK Professional PO Zoloft C Date:11/03/97ISR Number: 3011671-9Report Type:Periodic Company Report #US97073247A Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Zyprexa PS ORAL 20.00 MG Initial or Prolonged Phosphokinase Increased Professional DAILY PO 3 MON Myalgia Myoglobinuria Rhabdomyolysis Date:11/03/97ISR Number: 3011674-4Report Type:Periodic Company Report #US97073268A Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dysphagia Health Zyprexa PS ORAL 10 MG DAILY Dyspnoea Professional PO Macroglossia Company Cogentin C Representative Ibuprofen C Date:11/03/97ISR Number: 3011677-XReport Type:Periodic Company Report #US97073934A Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Health Zyprexa PS ORAL 30.00 MG Inhibition Professional DAILY PO 5 Oedema Peripheral Other WEEKS Ativan C Premarin C Provera C Prazosin C Elavil C K-Dur C Robaxin C Zoloft C Ibuprofen C Lasix C Lotensin C Magnesium Oxide C Norvasc C Risperdal C Albuterol C 24-Jun-2005 12:19 PM Page: 9 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3011678-1Report Type:Periodic Company Report #US97073961A Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Consumer Prozac PS ORAL 10.00 MG Initial or Prolonged Movement Disorder Health DAILY PO Pyrexia Professional Zyprexa SS ORAL 5.00 MG Tremor DAILY PO Tylenol C Lithium C Inderal C Fosamax C Calcium Carbonate C Date:11/03/97ISR Number: 3011682-3Report Type:Periodic Company Report #US97074255A Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Health Zyprexa PS ORAL 5.00 MG Initial or Prolonged Fall Professional 2/DAY PO Feeling Hot Other Lethargy Neuroleptic Malignant Syndrome Pyrexia Urine Analysis Abnormal Date:11/03/97ISR Number: 3011683-5Report Type:Periodic Company Report #US97074300A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Health Zyprexa PS UNK Professional Date:11/03/97ISR Number: 3011684-7Report Type:Periodic Company Report #US97074306A Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Apnoea Health Zyprexa PS ORAL 15.00 MG Initial or Prolonged Blood Sodium Decreased Professional DAILY PO 1 WK Hyponatraemia Other Clonazepam C Miosis Albuterol C Sedation Metformin C Vasotec C Lasix C Tegretol C Date:11/03/97ISR Number: 3011687-2Report Type:Periodic Company Report #US97074690A Age:64 YR Gender:Male I/FU:I Outcome PT Other Blood Creatine Phosphokinase Increased Drooling Dyskinesia Dysphagia Hypertension Lethargy 24-Jun-2005 12:19 PM Page: 10 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Leukocytosis Mental Impairment Muscle Rigidity Report Source Product Role Manufacturer Route Dose Duration Neuroleptic Malignant Health Zyprexa PS ORAL 10.00 MG Syndrome Professional DAILY PO Parkinsonian Gait Other Navane C Pneumonia Pyrexia Salivary Hypersecretion Sedation Tachycardia Upper Respiratory Tract Infection Date:11/03/97ISR Number: 3011691-4Report Type:Periodic Company Report #US97074819A Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Health Zyprexa PS ORAL 30.00 MG Initial or Prolonged Blood Creatine Professional DAILY PO Other Phosphokinase Increased Paxil C Delirium Synthroid C Disorientation Drug Level Above Therapeutic Hyperhidrosis Hypertension Restlessness Serotonin Syndrome Tachycardia Urinary Incontinence Date:11/03/97ISR Number: 3011694-XReport Type:Periodic Company Report #US97080403A Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Asthenia Health Zyprexa PS Intervention to Blood Creatine Professional Prevent Permanent Phosphokinase Increased Company Impairment/Damage Dysphagia Representative Hypertonia Hyperventilation Leukocytosis Liver Function Test Abnormal Neuroleptic Malignant Syndrome Pyrexia Tachycardia Tremor Date:11/03/97ISR Number: 3011695-1Report Type:Periodic Company Report #US97081750A Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cellulitis Health Zyprexa PS ORAL 20.00 MG Initial or Prolonged Renal Failure Professional DAILY PO 4 MON Urine Flow Decreased Nafcillin C 24-Jun-2005 12:19 PM Page: 11 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Vancomycin C Prozac C Klonopin C Date:11/03/97ISR Number: 3011698-7Report Type:Periodic Company Report #US97082602A Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agitation Health Zyprexa PS ORAL 5.00 MG Hospitalization - Dyspnoea Professional 2/DAY PO Initial or Prolonged Heart Rate Increased Company Clonazepam C Herpangina Representative Herpes Virus Infection Hypersensitivity Laryngeal Oedema Lung Disorder Pneumonia Aspiration Pyrexia Respiratory Distress Respiratory Failure Respiratory Rate Increased Date:11/03/97ISR Number: 3011701-4Report Type:Periodic Company Report #US97082614A Age:12 MON Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accidental Overdose Health Zyprexa PS Agitation Professional Heart Rate Increased Lethargy Sedation Tachypnoea Date:11/03/97ISR Number: 3011704-XReport Type:Periodic Company Report #US97082809A Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Clonic Convulsion Health Zyprexa PS ORAL 10MG DAILY PO 10 DAY Initial or Prolonged Convulsion Professional Cogentin C Synthroid C Date:11/03/97ISR Number: 3011706-3Report Type:Periodic Company Report #US97083556A Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Apnoea Health Zyprexa PS ORAL 5.00 MG Initial or Prolonged Catatonia Professional DAILY PO Coma Vitamin E C Eye Movement Disorder Benztropine C Face Oedema Haemorrhagic Stroke Hypoaesthesia Oral Tongue Oedema 24-Jun-2005 12:19 PM Page: 12 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3011710-5Report Type:Periodic Company Report #US97083568A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Clonic Convulsion Health Zyprexa PS ORAL 25.00 MG Condition Aggravated Professional DAILY PO Muscle Twitching Benadryl C Date:11/03/97ISR Number: 3011713-0Report Type:Periodic Company Report #US97083577A Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depression Health Zyprexa PS 30.00 MG UNK Hallucination, Auditory Professional UNK Company Representative Date:11/03/97ISR Number: 3011715-4Report Type:Periodic Company Report #US97083601A Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Health Zyprexa PS 15.00 MG Initial or Prolonged Gait Disturbance Professional Paxil C Company Clonapin C Representative Buspar C Date:11/03/97ISR Number: 3011719-1Report Type:Periodic Company Report #US97083793A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypersomnia Health Zyprexa PS ORAL PO 6 MON Initial or Prolonged Narcolepsy Professional Dilantin C Company Representative Date:11/03/97ISR Number: 3011724-5Report Type:Periodic Company Report #US97084135A Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Zyprexa PS 25.00MG DAILY Initial or Prolonged Hyperglycaemia Professional PO Other Ketoacidosis Depakote C Polydipsia Polyuria Thirst Date:11/03/97ISR Number: 3011727-0Report Type:Periodic Company Report #US97084261A Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accidental Overdose Health Zyprexa PS ORAL 140MG PO Coordination Abnormal Professional Lithium C Dysarthria Klonopin C Sedation Synthroid C 24-Jun-2005 12:19 PM Page: 13 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3011731-2Report Type:Periodic Company Report #US97084792A Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination Health Zyprexa PS Initial or Prolonged Suicidal Ideation Professional Company Representative Date:11/03/97ISR Number: 3011733-6Report Type:Periodic Company Report #US97085020A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Consumer Zyprexa PS ORAL 25.00 MG Aggression Health DAILY PO Anxiety Professional Lorazepam C Hypervigilance Psychotic Disorder Date:11/03/97ISR Number: 3011737-3Report Type:Periodic Company Report #US97085128A Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Health Zyprexa PS ORAL 5.00 MG DAILY Initial or Prolonged Blood Creatine Professional PO 4 DAY Phosphokinase Increased Depakote C Confusional State Sinemet C Depressed Level Of Consciousness Drug Interaction Dyskinesia Dysphagia Extrapyramidal Disorder Heart Rate Increased Hyperhidrosis Hypotension Muscle Rigidity Neuroleptic Malignant Syndrome Posturing Salivary Hypersecretion Tremor Date:11/03/97ISR Number: 3011740-3Report Type:Periodic Company Report #US97090457A Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Zyprexa PS 5.00 Initial or Prolonged Parkinsonism Professional Clozaril C Date:11/03/97ISR Number: 3011745-2Report Type:Periodic Company Report #US97090832A Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Zyprexa PS ORAL 2.5 MG DAILY Initial or Prolonged Confusional State Professional Paranoia Sedation 24-Jun-2005 12:19 PM Page: 14 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3011749-XReport Type:Periodic Company Report #US97091057A Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Clonic Convulsion Health Zyprexa PS 25.00MG UNK Professional UNK Company Representative Date:11/03/97ISR Number: 3011753-1Report Type:Periodic Company Report #US97091084A Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Zyprexa PS 1 WEEKS Initial or Prolonged Phosphokinase Increased Professional Haldol C Joint Stiffness Company Mental Disorder Representative Pyrexia White Blood Cell Count Increased Date:11/03/97ISR Number: 3011754-3Report Type:Periodic Company Report #US97091330A Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Zyprexa PS Initial or Prolonged Hyperglycaemia Professional Polydipsia Company Representative Date:11/03/97ISR Number: 3011759-2Report Type:Periodic Company Report #US97092005A Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Consumer Zyprexa PS ORAL 30 MG DAILY Tegretol C Lithium C Date:11/03/97ISR Number: 3011762-2Report Type:Periodic Company Report #US97092314A Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Health Zyprexa PS ORAL 2.50 MG DAILY Initial or Prolonged Sedation Professional PO/ 3 WEEKS 3 WK Date:11/03/97ISR Number: 3011768-3Report Type:Periodic Company Report #US97092821A Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Consumer Zyprexa PS ORAL 5 MG DAILY Initial or Prolonged Health Lotensin C Professional 24-Jun-2005 12:19 PM Page: 15 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3011772-5Report Type:Periodic Company Report #US97093190A Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abortion Spontaneous Consumer Zyprexa PS ORAL 5.00 MG DAILY Initial or Prolonged Complications Of Maternal PO/3 MONTH 3 MON Exposure To Therapeutic Klonopin C Drugs Vaginal Haemorrhage Date:11/03/97ISR Number: 3011777-4Report Type:Periodic Company Report #US97093442A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dysphagia Consumer Zyprexa PS ORAL 40MG DAILY PO Health Elavil C Professional Klonopin C Date:11/03/97ISR Number: 3011780-4Report Type:Periodic Company Report #US97093487A Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Muscle Twitching Health Zyprexa PS ORAL 30.00 MG Professional DAILY PO Zoloft C Date:11/03/97ISR Number: 3011784-1Report Type:Periodic Company Report #US97093700A Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Consumer Zyprexa PS ORAL 5.00 MG DAILY Initial or Prolonged Hypertension PO Oedema Mouth Clonazepam C Speech Disorder Tongue Oedema Date:11/03/97ISR Number: 3011787-7Report Type:Periodic Company Report #US97074024A Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Epistaxis Health Zyprexa PS ORAL 10.00 MG Hyperglycaemia Professional DAILY PO Sertraline C Date:11/03/97ISR Number: 3011790-7Report Type:Periodic Company Report #US97074051A Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Discomfort Health Zyprexa PS ORAL 10.00 MG Fatigue Professional DAILY PO Sedation Methocarbamol C 24-Jun-2005 12:19 PM Page: 16 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3011794-4Report Type:Periodic Company Report #US97074246A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Condition Aggravated Health Zyprexa PS 20.00 MG Leukopenia Professional DAILY UNK Neutrophilia Company Representative Date:11/03/97ISR Number: 3011798-1Report Type:Periodic Company Report #US97074288A Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysgraphia Health Zyprexa PS 5.00 MG 2/DAY Movement Disorder Professional PO Tremor Date:11/03/97ISR Number: 3011802-0Report Type:Periodic Company Report #US97074294A Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Health Zyprexa PS ORAL 5.00 MG 2/DAY Movement Disorder Professional PO Date:11/03/97ISR Number: 3011805-6Report Type:Periodic Company Report #US97074303A Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Movement Disorder Health Zyprexa PS ORAL 5MG DAILY PO 1 WK Tremor Professional Date:11/03/97ISR Number: 3011807-XReport Type:Periodic Company Report #US97074315A Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Consumer Zyprexa PS ORAL 10MG DAILY PO Weight Increased Date:11/03/97ISR Number: 3011810-XReport Type:Periodic Company Report #US97074321A Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration No Adverse Drug Effect Consumer Zyprexa PS ORAL PO 4 MON Health Artane C Professional Prozac C Date:11/03/97ISR Number: 3011813-5Report Type:Periodic Company Report #US97074357A Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Health Zyprexa PS ORAL 5MG DAILY PO 1 MON Professional Lasix C Company Synthroid C Representative Procardia C Coumadin C Potassium C 24-Jun-2005 12:19 PM Page: 17 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Premarin C Date:11/03/97ISR Number: 3011816-0Report Type:Periodic Company Report #US97074360A Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Uric Acid Increased Health Zyprexa PS ORAL 5MG DAILY PO Professional Lithium C Date:11/03/97ISR Number: 3011818-4Report Type:Periodic Company Report #US97074363A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration No Adverse Drug Effect Health Prozac PS ORAL 20.00MG DAILY Professional PO Zyprexa SS ORAL 20MG DAILY PO Ferrous Sulfate C Folic Acid C Oral Contraceptive Nos C Date:11/03/97ISR Number: 3011822-6Report Type:Periodic Company Report #US97074369A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Health Zyprexa PS ORAL 10 MG DAILY Professional Company Representative Date:11/03/97ISR Number: 3011824-XReport Type:Periodic Company Report #US97074372A Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Health Zyprexa PS ORAL 5 MG DAILY Professional Depakote C Lopid C Synthroid C Date:11/03/97ISR Number: 3011828-7Report Type:Periodic Company Report #US97074375A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eating Disorder Consumer Zyprexa PS Hallucination, Auditory Date:11/03/97ISR Number: 3011832-9Report Type:Periodic Company Report #US97074378A Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Health Zyprexa PS ORAL 10 MG DAILY Professional Amitriptyline C Trazodone C Loxitane C 24-Jun-2005 12:19 PM Page: 18 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3011834-2Report Type:Periodic Company Report #US97074390A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Health Zyprexa PS ORAL 10.00 MG Extrapyramidal Disorder Professional DAILY PO Mania Valproic Acid C Muscle Rigidity Restlessness Tongue Disorder Date:11/03/97ISR Number: 3011837-8Report Type:Periodic Company Report #US97074519A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Delusion Health Zyprexa PS ORAL PO 9 MON Paranoia Professional Date:11/03/97ISR Number: 3011839-1Report Type:Periodic Company Report #US97074525A Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Aggression Health Zyprexa PS ORAL 10MG DAILY PO Bruxism Professional Lithium C Date:11/03/97ISR Number: 3011840-8Report Type:Periodic Company Report #US97074528A Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dermatitis Consumer Zyprexa PS ORAL 20MG DAILY PO Grunting Prozac C Insomnia Tegretol C Date:11/03/97ISR Number: 3011842-1Report Type:Periodic Company Report #US97074534A Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Rash Vesicular Health Zyprexa PS ORAL 5MG DAILY PO 3 WK Professional Trazodone C Zoloft C Ativan C Verapamil C Imitrex C Meclomen C Date:11/03/97ISR Number: 3011845-7Report Type:Periodic Company Report #US97074540A Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Vision Blurred Health Zyprexa PS ORAL 20MG DAILY PO 3 MON Professional Klonopin C 24-Jun-2005 12:19 PM Page: 19 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3011848-2Report Type:Periodic Company Report #US97074555A Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Uric Acid Increased Health Zyprexa PS ORAL 20MG DAILY PO Professional Lithobid C Synthroid C Effexor C Diazepam C Date:11/03/97ISR Number: 3011850-0Report Type:Periodic Company Report #US97074558A Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Face Oedema Health Zyprexa PS ORAL 10MG DAILY PO 3 WK Oedema Peripheral Professional Paxil C Date:11/03/97ISR Number: 3011852-4Report Type:Periodic Company Report #US97074588A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Health Zyprexa PS ORAL 15MG DAILY PO Professional Lamictal C Date:11/03/97ISR Number: 3011854-8Report Type:Periodic Company Report #US97074612A Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Pressure Health Zyprexa PS ORAL 20 MG DAILY Fluctuation Professional Other Date:11/03/97ISR Number: 3011856-1Report Type:Periodic Company Report #US97074615A Age:55 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Pressure Health Zyprexa PS ORAL 20MG DAILY PO Fluctuation Professional Enalapril C Trifluoperazine C Chlorthalidone C Valproic Acid C Date:11/03/97ISR Number: 3011858-5Report Type:Periodic Company Report #US97074621A Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperhidrosis Health Zyprexa PS ORAL 5 MG DAILY Syncope Professional Depakote C Tachycardia Other Date:11/03/97ISR Number: 3011860-3Report Type:Periodic Company Report #US97074624A Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Coordination Abnormal Health Road Traffic Accident Professional 24-Jun-2005 12:19 PM Page: 20 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Zyprexa PS Clonazepam C Lithium C Date:11/03/97ISR Number: 3011862-7Report Type:Periodic Company Report #US97074630A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Chest Pain Health Zyprexa PS ORAL 10 MG DAILY Dermatitis Professional Tylenol C Other Date:11/03/97ISR Number: 3011864-0Report Type:Periodic Company Report #US97074645A Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Level Above Health Zyprexa PS ORAL 20 MG DAILY Therapeutic Professional Lithium C Fatigue Other Date:11/03/97ISR Number: 3011867-6Report Type:Periodic Company Report #US97074651A Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Health Zyprexa PS ORAL 10MG PO Muscle Twitching Professional Haloperidol C Tremor Other Date:11/03/97ISR Number: 3011871-8Report Type:Periodic Company Report #US97074669A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dermatitis Health Zyprexa PS 7.50 MG DAILY Professional Lithium C Other Date:11/03/97ISR Number: 3011873-1Report Type:Periodic Company Report #US97074693A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pigmentation Disorder Health Zyprexa PS 10.00 MG Rash Papular Professional 2/DAY Other Date:11/03/97ISR Number: 3011877-9Report Type:Periodic Company Report #US97074978A Age:71 YR Gender:Male I/FU:I Outcome PT Asthenia Dyskinesia Lethargy Therapeutic Agent 24-Jun-2005 12:19 PM Page: 21 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Toxicity Report Source Product Role Manufacturer Route Dose Duration Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO Other Lithium C Date:11/03/97ISR Number: 3011879-2Report Type:Periodic Company Report #US97074993A Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Constipation Health Zyprexa PS ORAL 10MG DAILY PO 1 WK Oedema Peripheral Professional Amoxil C Depakote C Date:11/03/97ISR Number: 3011883-4Report Type:Periodic Company Report #US97074999A Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Arthralgia Health Zyprexa PS ORAL 10MG DAILY PO Dermatitis Professional Zoloft C Pyrexia Risperdal C Klonopin C Date:11/03/97ISR Number: 3011885-8Report Type:Periodic Company Report #US97075005A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Distension Health Zyprexa PS ORAL 5MG DAILY PO Abdominal Pain Professional Benztropine C Constipation Glyburide C Urinary Retention Docusate Sodium C Date:11/03/97ISR Number: 3011887-1Report Type:Periodic Company Report #US97075008A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysphagia Health Zyprexa PS ORAL 5MG DAILY PO Professional Date:11/03/97ISR Number: 3011891-3Report Type:Periodic Company Report #US97075011A Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Aphasia Health Zyprexa PS 10.MG DAILY Dysphagia Professional Humabid L.A. C Salivary Hypersecretion Ativan C Date:11/03/97ISR Number: 3011893-7Report Type:Periodic Company Report #US97075014A Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Face Oedema Health Zyprexa PS ORAL 20MG DAILY PO Oedema Peripheral Professional Risperdal C Weight Increased Other Cogentin C 24-Jun-2005 12:19 PM Page: 22 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Zestril C Depakote C Theo-Dur C Ventolin C Vistaril C Lasix C Date:11/03/97ISR Number: 3011895-0Report Type:Periodic Company Report #US97075023A Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cardiac Disorder Health Zyprexa PS ORAL 5MG 2/DAY PO Dermatitis Professional Sertraline C Sedation Other Acetaminophen C Date:11/03/97ISR Number: 3011897-4Report Type:Periodic Company Report #US97075026A Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Asthenia Health Zyprexa PS ORAL 10 MG DAILY Dizziness Professional Trazodone C Extrapyramidal Disorder Other Date:11/03/97ISR Number: 3011900-1Report Type:Periodic Company Report #US97075032A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Health Zyprexa PS Professional Company Representative Date:11/03/97ISR Number: 3011903-7Report Type:Periodic Company Report #US97075044A Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Health Zyprexa PS ORAL 15.00 MG Potentiation Professional DAILY PO Drug Level Above Other Clozaril C Therapeutic Procardia Xl C Depakote C Date:11/03/97ISR Number: 3011905-0Report Type:Periodic Company Report #US97075047A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Mania Zyprexa PS ORAL 10 MG DAILY Paraphilia Multivitamins C Psychomotor Hyperactivity Restlessness 24-Jun-2005 12:19 PM Page: 23 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3011908-6Report Type:Periodic Company Report #US97075050A Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS ORAL 20 MG DAILY 2 MON Professional Date:11/03/97ISR Number: 3011910-4Report Type:Periodic Company Report #US97075056A Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Breast Fibrosis Health Zyprexa PS ORAL PO Professional Date:11/03/97ISR Number: 3011912-8Report Type:Periodic Company Report #US97075071A Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Lethargy Health Zyprexa PS ORAL 10MG DAILY PO Tardive Dyskinesia Professional Other Date:11/03/97ISR Number: 3011916-5Report Type:Periodic Company Report #US97075074A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyspnoea Health Zyprexa PS 10.00 MG Oedema Peripheral Professional DAILY Weight Increased Other Prozac C Diazepam C Depakote C Pepcid C Hydrocortisone C Date:11/03/97ISR Number: 3011919-0Report Type:Periodic Company Report #US97075077A Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Ecchymosis Health Zyprexa PS ORAL 5.00 MG Injury Professional 3/DAY PO Oedema Peripheral Other Lovothyroxine C Ibuprofen C Plaquenil C Date:11/03/97ISR Number: 3011921-9Report Type:Periodic Company Report #US97075083A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hostility Health Zyprexa PS Professional Company Representative 24-Jun-2005 12:19 PM Page: 24 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3011923-2Report Type:Periodic Company Report #US97075089A Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Fatigue Health Zyprexa PS ORAL 5 MG DAILY PO Loss Of Control Of Legs Professional Maxzide C Carbidopa C Levodopa C Date:11/03/97ISR Number: 3011925-6Report Type:Periodic Company Report #US97075092A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Condition Aggravated Health Zyprexa PS Delusion Professional Schizophrenia Company Representative Date:11/03/97ISR Number: 3011929-3Report Type:Periodic Company Report #US97075098A Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Distension Health Zyprexa PS ORAL 10MG DAILY PO Weight Decreased Professional Vitamin E C Depakote C Buspar C Date:11/03/97ISR Number: 3011932-3Report Type:Periodic Company Report #US97075104A Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Bipolar Disorder Health Zyprexa PS ORAL 10 MG DAILY Drug Interaction Professional PO Inhibition Other Depakote C Date:11/03/97ISR Number: 3011934-7Report Type:Periodic Company Report #US97075107A Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Coordination Abnormal Health Zyprexa PS ORAL 5MG DAILY PO Dizziness Professional Valproate Sodium C Hypotension Other Pallor Sedation Date:11/03/97ISR Number: 3011938-4Report Type:Periodic Company Report #US97075125A Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dermatitis Consumer Zyprexa PS ORAL 15 MG DAILY 2 MON Seborrhoea Prolixin C 24-Jun-2005 12:19 PM Page: 25 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3011941-4Report Type:Periodic Company Report #US97075134A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS Professional Serzone C Date:11/03/97ISR Number: 3011942-6Report Type:Periodic Company Report #US97075158A Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Convulsion Health Zyprexa PS ORAL 20.00 MG Hallucination, Auditory Professional DAILY PO Intentional Self-Injury Vitamin E C Paxil C Haldol C Xanax C Dalmane C Date:11/03/97ISR Number: 3011945-1Report Type:Periodic Company Report #US97075164A Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Convulsion Health Zyprexa PS ORAL 20 MG DAILY Hallucination, Auditory Professional PO Klonopin C Date:11/03/97ISR Number: 3011948-7Report Type:Periodic Company Report #US97075173A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Health Zyprexa PS ORAL 15 MG DAILY Professional PO Company Representative Date:11/03/97ISR Number: 3011950-5Report Type:Periodic Company Report #US97075188A Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysarthria Consumer Zyprexa PS ORAL 10 MG DAILY Face Oedema PO Date:11/03/97ISR Number: 3011954-2Report Type:Periodic Company Report #US97075197A Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Asthenia Consumer Zyprexa PS ORAL 10.00 MG Dehydration Health 2/DAY PO Depression Professional Desipramine C Dizziness Ativan C Polydipsia Artane C Restlessness Serzone C Temperature Intolerance 24-Jun-2005 12:19 PM Page: 26 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3011958-XReport Type:Periodic Company Report #US97075284A Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Joint Stiffness Health Zyprexa PS ORAL 15MG DAILY PO Professional Tegretol C Klonopin C Cogentin C Prozac C Date:11/03/97ISR Number: 3011960-8Report Type:Periodic Company Report #US97075335A Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Arthralgia Consumer Zyprexa PS ORAL 10 MG DAILY Joint Stiffness PO Pain Carbamazepine C Fluoxetine C Clonazepam C Benztropine C Date:11/03/97ISR Number: 3011963-3Report Type:Periodic Company Report #US97075389A Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Movement Disorder Health Zyprexa PS ORAL 10 MD DAILY Professional PO 5 MON Zithromax C Date:11/03/97ISR Number: 3011965-7Report Type:Periodic Company Report #US97075416A Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Fatigue Consumer Zyprexa PS ORAL 7.5 MG DAILY Sedation PO Serzone C Klonopin C Date:11/03/97ISR Number: 3011967-0Report Type:Periodic Company Report #US97075425A Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Depression Consumer Zyprexa PS ORAL 5 MG DAILY PO 2 MON Sedation Date:11/03/97ISR Number: 3011968-2Report Type:Periodic Company Report #US97075473A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Amenorrhoea Health Zyprexa PS ORAL 5 MG 2/DAY Professional PO 8 MON Artane C Vitamin E C 24-Jun-2005 12:19 PM Page: 27 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3011982-7Report Type:Periodic Company Report #US97075437A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Condition Aggravated Other Zyprexa PS ORAL 17.5 MG DAILY Fatigue PO Illusion Nefazodone C Date:11/03/97ISR Number: 3011983-9Report Type:Periodic Company Report #US97075479A Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Health Zyprexa PS ORAL 10 MG DAILY Professional PO 2 MON Date:11/03/97ISR Number: 3011986-4Report Type:Periodic Company Report #US97075485A Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Faecal Incontinence Consumer Zyprexa PS ORAL 5 MG DAILY PO 2 WK Weight Increased Date:11/03/97ISR Number: 3011988-8Report Type:Periodic Company Report #US97075494A Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS ORAL 10 MG DAILY Professional PO 1 MON Paxil C Date:11/03/97ISR Number: 3011989-XReport Type:Periodic Company Report #US97075506A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Consumer Zyprexa PS ORAL 20MG DAILY PO 6 WK Health Anafranil C Professional Date:11/03/97ISR Number: 3011991-8Report Type:Periodic Company Report #US97075509A Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Health Zyprexa PS ORAL 15MG DAILY PO Potentiation Professional Vistaril C Hallucination Date:11/03/97ISR Number: 3012015-9Report Type:Periodic Company Report #US97092953A Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS UNKNOWN Professional Company Representative 24-Jun-2005 12:19 PM Page: 28 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3012016-0Report Type:Periodic Company Report #US97092959A Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO Prozac C Date:11/03/97ISR Number: 3012017-2Report Type:Periodic Company Report #US97092962A Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS UNK Professional Company Representative Date:11/03/97ISR Number: 3012018-4Report Type:Periodic Company Report #US97092965A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Liver Function Test Health Zyprexa PS ORAL UNK;DAILY; PO 1 MON Abnormal Professional Tegretol C Ativan C Date:11/03/97ISR Number: 3012021-4Report Type:Periodic Company Report #US97093184A Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Complications Of Maternal Health Zyprexa PS 20.00MG DAILY Exposure To Therapeutic Professional PO Drugs Folic Acid C Nutritional Supplements C Date:11/03/97ISR Number: 3012023-8Report Type:Periodic Company Report #US97093196A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Health Zyprexa PS UNK Professional Luvox C Date:11/03/97ISR Number: 3012025-1Report Type:Periodic Company Report #US97093199A Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Distractibility Health Zyprexa PS ORAL 10.00 MG Flight Of Ideas Professional DAILY PO 1 WK Sedation Valproic Acid C Suspiciousness Weight Increased 24-Jun-2005 12:19 PM Page: 29 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3012028-7Report Type:Periodic Company Report #US97093244A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Health Zyprexa PS UNK Professional Luvox C Date:11/03/97ISR Number: 3012030-5Report Type:Periodic Company Report #US97093274A Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cognitive Disorder Health Zyprexa PS ORAL 2.5MG DAILY Professional PO Date:11/03/97ISR Number: 3012032-9Report Type:Periodic Company Report #US97093388A Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abnormal Behaviour Health Zyprexa PS ORAL 15.00 MG Aggression Professional DAILY PO Irritability Clonazepam C Obsessive Thoughts Lamotrigine C Nefazodone C Cytomel C Date:11/03/97ISR Number: 3012035-4Report Type:Periodic Company Report #US97093400A Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hostility Health Zyprexa PS ORAL 10.00 MG Irritability Professional DAILY PO/ 1 Logorrhoea WEEKS 1 WK Mania Lorazepam C Paranoia Valproic C Sedation Suspiciousness Date:11/03/97ISR Number: 3012037-8Report Type:Periodic Company Report #US97093481A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Health Zyprexa PS ORAL 40MG PO Professional Navane C Doxepin C Depakote C Date:11/03/97ISR Number: 3012039-1Report Type:Periodic Company Report #US97093496A Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Delirium Health Zyprexa PS ORAL 7.50 MG DAILY Delusion Professional PO 24-Jun-2005 12:19 PM Page: 30 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3012041-XReport Type:Periodic Company Report #US97093529A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Lethargy Consumer Zyprexa PS Date:11/03/97ISR Number: 3012044-5Report Type:Periodic Company Report #US97093532A Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Pain Upper Health Zyprexa PS ORAL 7.50 MG DAILY Professional PO Date:11/03/97ISR Number: 3012047-0Report Type:Periodic Company Report #US97092926A Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pollakiuria Health Zyprexa PS ORAL 5.00 MG DAILY Urinary Incontinence Professional PO Prozac SS UNK Date:11/03/97ISR Number: 3012049-4Report Type:Periodic Company Report #US97092929A Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration No Adverse Drug Effect Consumer Zyprexa PS ORAL 20.00 MG 2/DAY PO Zoloft C Zestril C Date:11/03/97ISR Number: 3012052-4Report Type:Periodic Company Report #US97092932A Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Convulsion Health Zyprexa PS ORAL 20MG DAILY PO Professional Clozaril C Company Depakote C Representative Date:11/03/97ISR Number: 3012054-8Report Type:Periodic Company Report #US97092935A Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Urinary Incontinence Health Zyprexa PS ORAL 5.00 MG DAILY Professional PO Prozac C Date:11/03/97ISR Number: 3012058-5Report Type:Periodic Company Report #US97092938A Age:52 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Urinary Incontinence Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO Prozac SS ORAL 20.00 MG DAILY PO Valium C 24-Jun-2005 12:19 PM Page: 31 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3012062-7Report Type:Periodic Company Report #US97092944A Age:40 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Diarrhoea Health Zyprexa PS ORAL 20.00 MG Faecal Incontinence Professional DAILY PO Urinary Incontinence Prozac SS ORAL 10.00 MG DAILY PO Lithium C Levothyroxine C Date:11/03/97ISR Number: 3012067-6Report Type:Periodic Company Report #US97092947A Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS UNK Retroperitoneal Oedema Professional Company Representative Date:11/03/97ISR Number: 3012076-7Report Type:Periodic Company Report #US97092869A Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Delirium Consumer Zyprexa PS ORAL 30.00 MG Drug Ineffective DAILY PO 3 MON Medication Error Paxil C Date:11/03/97ISR Number: 3012079-2Report Type:Periodic Company Report #US97092872A Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Triglycerides Health Zyprexa PS ORAL 10.00 MG Increased Professional DAILY PO Liver Function Test Clonidine C Abnormal Claritin C Thorazine C Date:11/03/97ISR Number: 3012084-6Report Type:Periodic Company Report #US97092875A Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypersomnia Consumer Zyprexa PS SUBCUTANEOUS 7.50MG DAILY Paranoia Health SC 3 MON Sedation Professional Date:11/03/97ISR Number: 3012087-1Report Type:Periodic Company Report #US97092893A Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Psychotic Disorder Health Zyprexa PS 20.00 MG Professional Company Representative 24-Jun-2005 12:19 PM Page: 32 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3012089-5Report Type:Periodic Company Report #US97092896A Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Health Zyprexa PS 25.00MG DAILY Hallucination Professional Serzone C Ativan C Date:11/03/97ISR Number: 3012093-7Report Type:Periodic Company Report #US97092899A Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS ORAL 10 MG DAILY Professional PO Vitamin E C Lorazepam C Date:11/03/97ISR Number: 3012113-XReport Type:Periodic Company Report #US97092917A Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperbilirubinaemia Health Zyprexa PS ORAL 15 MG DAILY Professional PO Cogentin C Klonopin C Amantadine C Date:11/03/97ISR Number: 3012117-7Report Type:Periodic Company Report #US97092923A Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS Professional Company Representative Date:11/03/97ISR Number: 3012121-9Report Type:Periodic Company Report #US97092455A Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Creatine Health Zyprexa PS ORAL 15 MG DAILY Phosphokinase Increased Professional PO Sertraline C Lasix C Librium C Insulin C Prevacid C Imdur C Synthroid C Date:11/03/97ISR Number: 3012124-4Report Type:Periodic Company Report #US97092491A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Breast Discharge Other Zyprexa PS UNK 24-Jun-2005 12:19 PM Page: 33 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3012141-4Report Type:Periodic Company Report #US97092506A Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Consumer Zyprexa PS ORAL 15.00 MG Weight Increased DAILY PO 3 MON Prozac C Date:11/03/97ISR Number: 3012142-6Report Type:Periodic Company Report #US97092851A Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS ORAL 15..00 MG Professional DAILY PO Cogentin C Depakote C Ativan C Ativan C Date:11/03/97ISR Number: 3012146-3Report Type:Periodic Company Report #US97092854A Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Liver Function Test Health Zyprexa PS ORAL 20.00 MG Abnormal Professional DAILY PO Risperdal C Date:11/03/97ISR Number: 3012149-9Report Type:Periodic Company Report #US97092863A Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Antepartum Haemorrhage Consumer Zyprexa PS ORAL 10MG DAILY PO Date:11/03/97ISR Number: 3012153-0Report Type:Periodic Company Report #US97092866A Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Consumer Zyprexa PS 5.00MG/DAILY/ PO Klonopin C Trazodone C Depakote C Date:11/03/97ISR Number: 3012155-4Report Type:Periodic Company Report #US97092080A Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Consumer Zyprexa PS ORAL 5.00MG/DAILY/ Sleep Disorder PO Weight Increased 24-Jun-2005 12:19 PM Page: 34 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3012159-1Report Type:Periodic Company Report #US97092083A Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS ORAL 20.00MG/DAILY Professional /PO 6 MON Prozac C Date:11/03/97ISR Number: 3012161-XReport Type:Periodic Company Report #US97092086A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Electrocardiogram Qt Health Zyprexa PS Prolonged Professional Oedema Company Representative Date:11/03/97ISR Number: 3012162-1Report Type:Periodic Company Report #US97092089A Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akinesia Health Zyprexa PS ORAL 10.00MG/DAILY Hypoaesthesia Oral Professional /PO Weight Increased Paxil C Date:11/03/97ISR Number: 3012165-7Report Type:Periodic Company Report #US97092098A Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anxiety Consumer Zyprexa PS ORAL 10.00MG Chest Discomfort 3/WEEK PO Lithium C Date:11/03/97ISR Number: 3012168-2Report Type:Periodic Company Report #US97092104A Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Movement Disorder Health Zyprexa PS 15 MG Professional Company Representative Date:11/03/97ISR Number: 3012171-2Report Type:Periodic Company Report #US97092107A Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anger Health Zyprexa PS ORAL 15 MG DAILY Delusion Professional PO Hallucination, Auditory Date:11/03/97ISR Number: 3012173-6Report Type:Periodic Company Report #US97092110A Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Health Zyprexa PS ORAL 7.5 DAILY PO Professional Depakote C 24-Jun-2005 12:19 PM Page: 35 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3012176-1Report Type:Periodic Company Report #US97092122A Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyspnoea Consumer Zyprexa PS ORAL 10 MG DAILY Hyperhidrosis Health PO 2 MON Weight Increased Professional Risperdal C Date:11/03/97ISR Number: 3012178-5Report Type:Periodic Company Report #US97092332A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Erectile Dysfunction Health Zyprexa PS Professional Company Representative Date:11/03/97ISR Number: 3012211-0Report Type:Periodic Company Report #US97092446A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS UNK Weight Increased Professional Date:11/03/97ISR Number: 3025923-XReport Type:Periodic Company Report #US97092008A Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperglycaemia Health Zyprexa PS ORAL 20.00 MG Professional DAILY PO 2 MON Date:11/03/97ISR Number: 3025926-5Report Type:Periodic Company Report #US97092017A Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cytomegalovirus Infection Other Zyprexa PS ORAL 15.00 MG Hepatic Function Abnormal DAILY PO 3 DAY Lithium C Lorazepam C Date:11/03/97ISR Number: 3025930-7Report Type:Periodic Company Report #US97092023A Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Breast Oedema Health Zyprexa PS ORAL 15.00 MG Face Oedema Professional DAILY PO 1 MON Oedema Peripheral Lorazepam C Prozac C Date:11/03/97ISR Number: 3025933-2Report Type:Periodic Company Report #US97092029A Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration No Adverse Drug Effect Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO 9 MON Klonopin C 24-Jun-2005 12:19 PM Page: 36 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3025937-XReport Type:Periodic Company Report #US97092041A Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dry Mouth Health Zyprexa PS ORAL 20.00 MG Restlessness Professional DAILY PO 2 MON Company Representative Date:11/03/97ISR Number: 3025940-XReport Type:Periodic Company Report #US97092074A Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Movement Disorder Health Zyprexa PS 10.00 MG Professional Depakote C Company Representative Date:11/03/97ISR Number: 3025942-3Report Type:Periodic Company Report #US97091435A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Consumer Zyprexa PS ORAL 20.00 MG DAILY PO 8 WK Ativan C Zoloft C Date:11/03/97ISR Number: 3025945-9Report Type:Periodic Company Report #US97091438A Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Urinary Incontinence Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO Serzone C Klonopin C Wellbutrin C Neurontin C Date:11/03/97ISR Number: 3025948-4Report Type:Periodic Company Report #US97091444A Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Irritability Health Zyprexa PS ORAL 20.00 MG Professional DAILY PO 3 MON Tegretal C Date:11/03/97ISR Number: 3025949-6Report Type:Periodic Company Report #US97091450A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Formication Consumer Zyprexa PS ORAL 15.00 MG Nausea DAILY PO 2 MON Pruritus Cogentin C Vomiting Navane C 24-Jun-2005 12:19 PM Page: 37 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3025954-XReport Type:Periodic Company Report #US97091486A Age:88 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Health Zyprexa PS ORAL 10.00 MG Extrapyramidal Disorder Professional DAILY PO Tremor Company Clozaril C Representative Date:11/03/97ISR Number: 3025957-5Report Type:Periodic Company Report #US97091954A Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO 6 MON Company Representative Date:11/03/97ISR Number: 3025960-5Report Type:Periodic Company Report #US97091417A Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Musculoskeletal Stiffness Health Zyprexa PS ORAL 15.00 MG Throat Tightness Professional DAILY PO Effexor C Buspar C Date:11/03/97ISR Number: 3025965-4Report Type:Periodic Company Report #US97091411A Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Irritability Health Zyrexa PS ORAL 10.00 MG Professional DAILY PO Lithium C Depakote C Date:11/03/97ISR Number: 3025966-6Report Type:Periodic Company Report #US97091402A Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Muscle Tightness Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO Effexor C Cogentin C Date:11/03/97ISR Number: 3025967-8Report Type:Periodic Company Report #US970191405A Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Polydipsia Health Zyprexa PS ORAL 20.00 MG Thirst Professional DAILY PO 2 MON Glucotrol C Prinivil C Nortriptyline C 24-Jun-2005 12:19 PM Page: 38 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3025970-8Report Type:Periodic Company Report #US97090868A Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Condition Aggravated Health Zyprexa PS ORAL 2.50 MG PO Parkinson'S Disease Professional Date:11/03/97ISR Number: 3025973-3Report Type:Periodic Company Report #US97090871A Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Parkinson'S Disease Health Zyprexa PS 2.50 35 DAY Professional L-Dopa C Pergolide C Clozaril C Date:11/03/97ISR Number: 3025975-7Report Type:Periodic Company Report #US97090874A Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Parkinson'S Disease Health Zyprexa PS 5.00 22 DAY Professional L-Dopa C Clozaril C Date:11/03/97ISR Number: 3025979-4Report Type:Periodic Company Report #US97091069A Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drooling Health Zyprexa PS ORAL 10.00 MG Dyskinesia Professional DAILY PO Other Dexedrine C Date:11/03/97ISR Number: 3025982-4Report Type:Periodic Company Report #US97091072A Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypersomnia Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO Other Date:11/03/97ISR Number: 3025984-8Report Type:Periodic Company Report #US97091075A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Health Zyprexa PS Professional Desipramine C Company Representative Date:11/03/97ISR Number: 3025986-1Report Type:Periodic Company Report #US97091078A Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypomania Health Prozac PS Professional Zyprexa SS 24-Jun-2005 12:19 PM Page: 39 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3025989-7Report Type:Periodic Company Report #US97091111A Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypersomnia Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO Date:11/03/97ISR Number: 3025990-3Report Type:Periodic Company Report #US97091204A Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dry Mouth Consumer Zyprexa PS ORAL 5.00 MG DAILY Dysphonia Health PO Throat Irritation Professional Lithium C Ativan C Date:11/03/97ISR Number: 3025994-0Report Type:Periodic Company Report #US97090859A Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Parkinson'S Disease Health Zyprexa PS ORAL 2.50 MG PO 36 DAY Professional L-Dopa C Clozaril C Date:11/03/97ISR Number: 3025996-4Report Type:Periodic Company Report #US97090862A Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Parkinson'S Disease Health Zyprexa PS ORAL 2.50 MG PO 14 DAY Professional L-Dopa C Pergolide C Clozaril C Date:11/03/97ISR Number: 3025998-8Report Type:Periodic Company Report #US97090865A Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Parkinson'S Disease Health Zyprexa PS 2.50 24 DAY Professional L-Dopa C Amantadine C Clozaril C Date:11/03/97ISR Number: 3026002-8Report Type:Periodic Company Report #US97090847A Age:85 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Health Zyprexa PS ORAL 2.50 PO Insomnia Professional Date:11/03/97ISR Number: 3026003-XReport Type:Periodic Company Report #US97090850A Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Parkinson'S Disease Health Zyprexa PS Professional 24-Jun-2005 12:19 PM Page: 40 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3026004-1Report Type:Periodic Company Report #US97090853A Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Parkinson'S Disease Health Zyprexa PS ORAL 2.5 MG PO Professional Date:11/03/97ISR Number: 3026006-5Report Type:Periodic Company Report #US97090856A Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Parkinson'S Disease Health Zyprexa PS 2.5 MG 6 DAY Professional L-Dopa C Amantadine C Clozaril C Date:11/03/97ISR Number: 3026007-7Report Type:Periodic Company Report #US97084879A Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Condition Aggravated Consumer Zyprexa PS ORAL 2.5 MG DAILY Panic Attack Health PO 6 WK Professional Xanax C Date:11/03/97ISR Number: 3026008-9Report Type:Periodic Company Report #US97084888A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Photopsia Health Zyprexa PS ORAL PO Professional Other Date:11/03/97ISR Number: 3026011-9Report Type:Periodic Company Report #US97084858A Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Convulsion Health Zyprexa PS Professional Other Date:11/03/97ISR Number: 3026013-2Report Type:Periodic Company Report #US97084801A Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Libido Increased Health Zyprexa PS ORAL 5.00 MG DAILY Professional PO 1 MON Haldol C N/A C Date:11/03/97ISR Number: 3026014-4Report Type:Periodic Company Report #US97084816A Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Fluid Retention Health Influenza Like Illness Professional Company 24-Jun-2005 12:19 PM Page: 41 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Representative Product Role Manufacturer Route Dose Duration Zyprexa PS 10 MG Lithium C Date:11/03/97ISR Number: 3026017-XReport Type:Periodic Company Report #US97084855A Age:10 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hiccups Health Zyprexa PS Tic Professional Clonidine C Tourette'S Disorder Date:11/03/97ISR Number: 3026019-3Report Type:Periodic Company Report #US97084783A Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Amnesia Consumer Zyprexa PS ORAL 10 MG DAILY Drug Level Above Health PO 5 MON Therapeutic Professional Zocor C Zoloft C Synthroid C Prilosec C Premarin C Naproxen C Date:11/03/97ISR Number: 3026021-1Report Type:Periodic Company Report #US97084753A Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Asthenia Consumer Zyprexa PS UNK 2 WK Back Pain Risperdal C Date:11/03/97ISR Number: 3026022-3Report Type:Periodic Company Report #US97084780A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Convulsion Health Zyprexa PS Professional Company Representative Date:11/03/97ISR Number: 3026024-7Report Type:Periodic Company Report #US97084579A Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS UNK Professional Depakote C Company Zoloft C Representative 24-Jun-2005 12:19 PM Page: 42 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3026025-9Report Type:Periodic Company Report #US97084570A Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS UNK Professional Depakote C Company Paxil C Representative Date:11/03/97ISR Number: 3026027-2Report Type:Periodic Company Report #US97084564A Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS Professional Lithium C Company Serzone C Representative Date:11/03/97ISR Number: 3026028-4Report Type:Periodic Company Report #US97084339A Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS Professional Company Representative Date:11/03/97ISR Number: 3026029-6Report Type:Periodic Company Report #US97084534A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Feeling Hot Consumer Zyprexa PS ORAL PO Flushing Oedema Peripheral Date:11/03/97ISR Number: 3026031-4Report Type:Periodic Company Report #US97084231A Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Diplopia Health Zyprexa PS ORAL 10 MG DAILY Professional PO Lithium C Date:11/03/97ISR Number: 3026033-8Report Type:Periodic Company Report #US97084267A Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dry Mouth Consumer Zyprexa PS ORAL 5 MG DAILY PO 2 WK Fatigue Health Clonazepam C Professional Neurontin C Hydrochlorothiazide C Potassium C 24-Jun-2005 12:19 PM Page: 43 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3026036-3Report Type:Periodic Company Report #US97084309A Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperhidrosis Consumer Zyprexa PS ORAL 2.5 MG DAILY Restlessness Health PO 2 WK Sedation Professional Ativan C Premarin C Progesterone C Ginkobiloba C Date:11/03/97ISR Number: 3026039-9Report Type:Periodic Company Report #US97084108A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Hypersensitivity Health Zyprexa PS Pruritus Professional Company Representative Date:11/03/97ISR Number: 3026041-7Report Type:Periodic Company Report #US97084117A Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thrombocythaemia Health Zyprexa PS ORAL 15 MG DAILY Professional PO Lithium C Lorazepam C Date:11/03/97ISR Number: 3026043-0Report Type:Periodic Company Report #US97084123A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration No Adverse Drug Effect Health Zyprexa PS ORAL 5 MG DAILY PO 2 MON Professional Lithium C Date:11/03/97ISR Number: 3026047-8Report Type:Periodic Company Report #US97084138A Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperglycaemia Health Zyprexa PS ORAL 5 MG DAILY PO 2 WK Professional Company Representative Date:11/03/97ISR Number: 3026048-XReport Type:Periodic Company Report #US97084228A Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Fluid Retention Health Zyprexa PS ORAL 10 MG DAILY Oedema Professional PO Weight Increased 24-Jun-2005 12:19 PM Page: 44 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3026051-XReport Type:Periodic Company Report #US97083883A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Health Zyprexa PS 20 MG UNK Professional Company Representative Date:11/03/97ISR Number: 3026053-3Report Type:Periodic Company Report #US97083886A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Deafness Health Zyprexa PS Professional Risperdal C Company Representative Date:11/03/97ISR Number: 3026056-9Report Type:Periodic Company Report #US97083892A Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Consumer Zyprexa PS ORAL 10 MG DAILY Tremor Health PO Professional Date:11/03/97ISR Number: 3026057-0Report Type:Periodic Company Report #US97084057A Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Health Zyprexa PS ORAL 5 MG DAILY PO Drug Level Above Professional Depakote C Therapeutic Ativan C Date:11/03/97ISR Number: 3026059-4Report Type:Periodic Company Report #US97083877A Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Bone Pain Health Zyprexa PS 5 MG UNK 2 MON Pyrexia Professional Company Representative Date:11/03/97ISR Number: 3026060-0Report Type:Periodic Company Report #US97083880A Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Health Zyprexa PS ORAL 10 MG PO 1 MON Weight Increased Professional Company Representative 24-Jun-2005 12:19 PM Page: 45 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3027333-8Report Type:Periodic Company Report #US97081042A Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Consumer Zyprexa PS ORAL 5.00 MG DAILY Health PO Professional Date:11/03/97ISR Number: 3027335-1Report Type:Periodic Company Report #US97081045A Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dermatitis Health Prozac PS 3 MON Professional Zyprexa SS 3 MON Date:11/03/97ISR Number: 3027336-3Report Type:Periodic Company Report #US97081156A Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Arthralgia Health Zyprexa PS 1 YR Professional Paxil C Cogentin C Haldol C Benadryl C Zantac C Depo-Provera C Date:11/03/97ISR Number: 3027338-7Report Type:Periodic Company Report #US97081180A Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pyrexia Health Zyprexa PS ORAL 2.5 MG DAILY Professional PO 1 WK Lithium C Date:11/03/97ISR Number: 3027339-9Report Type:Periodic Company Report #US97081186A Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS ORAL 10.00 MG Sedation Professional DAILY PO 1 MON Weight Increased Lasix C Effexor C Date:11/03/97ISR Number: 3027340-5Report Type:Periodic Company Report #US97081318A Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Health Zyprexa PS ORAL 15.00 MG Hostility Professional DAILY PO Sedation 24-Jun-2005 12:19 PM Page: 46 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3027341-7Report Type:Periodic Company Report #US97081510A Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO 6 WK Company Maxzide C Representative Date:11/03/97ISR Number: 3027342-9Report Type:Periodic Company Report #US97080988A Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Face Oedema Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO 1 MON Lithium C Tegretol C Date:11/03/97ISR Number: 3027343-0Report Type:Periodic Company Report #US97081012A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Emotional Disorder Consumer Zyprexa PS ORAL 10.00 MG Feeling Abnormal DAILY PO 1 WK Loxapine C Date:11/03/97ISR Number: 3027344-2Report Type:Periodic Company Report #US97081015A Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO Company Serzone C Representative Zoloft C Date:11/03/97ISR Number: 3027345-4Report Type:Periodic Company Report #US97081018A Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Musculoskeletal Stiffness Health Zyprexa PS ORAL 15.00 MG Professional DAILY PO 1 MON Benztropine C Date:11/03/97ISR Number: 3027346-6Report Type:Periodic Company Report #US97081024A Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO Company Zoloft C Representative 24-Jun-2005 12:19 PM Page: 47 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3027347-8Report Type:Periodic Company Report #US97081030A Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO Company Desyrl C Representative Date:11/03/97ISR Number: 3027348-XReport Type:Periodic Company Report #US97081033A Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tremor Health Zyprexa PS Professional Depakote C Company Representative Date:11/03/97ISR Number: 3027349-1Report Type:Periodic Company Report #US97081036A Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO 1 WK Company Depakote C Representative Navane C Date:11/03/97ISR Number: 3027350-8Report Type:Periodic Company Report #US97080229A Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agoraphobia Consumer Zyprexa PS ORAL 12.5 MG DAILY PO 7 WK Inderal C Date:11/03/97ISR Number: 3027351-XReport Type:Periodic Company Report #US97080238A Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Consumer Zyprexa PS ORAL 10.00 MG DAILY PO 3 WK Pamelor C Tranxene C Date:11/03/97ISR Number: 3027352-1Report Type:Periodic Company Report #US97080295A Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blepharitis Health Zyprexa PS Professional Company Representative 24-Jun-2005 12:19 PM Page: 48 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3027353-3Report Type:Periodic Company Report #US97080301A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Libido Increased Health Zyprexa PS ORAL 1.25 MG DAILY Professional PO 1 WK Valproic C Date:11/03/97ISR Number: 3027354-5Report Type:Periodic Company Report #US97080517A Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO Risperdal C Date:11/03/97ISR Number: 3027355-7Report Type:Periodic Company Report #US97080526A Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Asthenia Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO Haldol C Klonopin C Date:11/03/97ISR Number: 3027356-9Report Type:Periodic Company Report #US97080856A Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eyelid Disorder Health Zyprexa PS Professional Zyprexa C Company A C Representative Zyprexa I Date:11/03/97ISR Number: 3027357-0Report Type:Periodic Company Report #US97080985A Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Consumer Zyprexa PS ORAL Other Depakote C Artane C Date:11/03/97ISR Number: 3027359-4Report Type:Periodic Company Report #US97075668A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration White Blood Cell Count Health Zyprexa PS ORAL 15.00 MG Decreased Professional DAILY PO Company Risperdal C Representative 24-Jun-2005 12:19 PM Page: 49 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3027360-0Report Type:Periodic Company Report #US97075728A Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cataract Consumer Prozac PS 2 YR Sedation Zyprexa SS ORAL 10.00 MG Vision Blurred DAILY PO Weight Increased Haldol C Benadryl C Date:11/03/97ISR Number: 3027361-2Report Type:Periodic Company Report #US97075887A Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Health Zyprexa PS Professional Date:11/03/97ISR Number: 3027362-4Report Type:Periodic Company Report #US97075908A Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Convulsion Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO 1 DAY Risperdal C Prozac C Wellbutrin C Ativan C Buspar C Date:11/03/97ISR Number: 3027363-6Report Type:Periodic Company Report #US97075917A Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Amenorrhoea Health Zyprexa PS ORAL 30.00 MG Constipation Professional DAILY PO 3 MON Faecaloma Date:11/03/97ISR Number: 3027364-8Report Type:Periodic Company Report #US97075923A Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Feeling Abnormal Consumer Zyprexa PS ORAL 15.00 MG DAILY PO Depakote C Serenil C Date:11/03/97ISR Number: 3027365-XReport Type:Periodic Company Report #US97075926A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Ecchymosis Health Zyprexa PS ORAL 5.00 MG DAILY Professional PO Company Lasix C Representative 24-Jun-2005 12:19 PM Page: 50 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3027366-1Report Type:Periodic Company Report #US97075932A Age:9 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tachycardia Consumer Zyprexa PS ORAL 5.00 MG DAILY Weight Increased PO Ritalin C Date:11/03/97ISR Number: 3027367-3Report Type:Periodic Company Report #US97076055A Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pruritus Consumer Zyprexa PS Date:11/03/97ISR Number: 3027368-5Report Type:Periodic Company Report #US97076103A Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Health Zyprexa PS ORAL 5.00 MG PO Hallucination Professional Vasotec C Muscle Rigidity Other Paxil C Tremor Asa C Date:11/03/97ISR Number: 3027369-7Report Type:Periodic Company Report #US97076154A Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tremor Health Zyprexa PS ORAL 5.00 MG 2/DAY Professional PO 2 MON Depakote C Benztropine C Date:11/03/97ISR Number: 3027370-3Report Type:Periodic Company Report #US97076157A Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Memory Impairment Consumer Zyprexa PS ORAL 5.00 MG DAILY Vision Blurred PO 6 DAY Effexor C Ery-Tab C Dihistine C Date:11/03/97ISR Number: 3027371-5Report Type:Periodic Company Report #US97076199A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eye Pain Health Zyprexa PS 5.00 MG Photophobia Professional Company Representative 24-Jun-2005 12:19 PM Page: 51 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3027372-7Report Type:Periodic Company Report #US97076202A Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Condition Aggravated Consumer Zyprexa PS ORAL 10.00 MG Paranoid Personality DAILY PO Disorder Date:11/03/97ISR Number: 3027373-9Report Type:Periodic Company Report #US97076208A Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Face Oedema Health Zyprexa PS ORAL 20.00 MG Livedo Reticularis Professional DAILY PO Purpura Haldol C Prozac C Lorazepam C Artane C Date:11/03/97ISR Number: 3027374-0Report Type:Periodic Company Report #US97076211A Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Facial Palsy Health Zyprexa PS Professional Date:11/03/97ISR Number: 3027375-2Report Type:Periodic Company Report #US97076217A Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Health Zyprexa PS Professional Company Representative Date:11/03/97ISR Number: 3027376-4Report Type:Periodic Company Report #US97076226A Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Increased Appetite Consumer Zyprexa PS ORAL 20.00 MG DAILY PO 4 WK Date:11/03/97ISR Number: 3027377-6Report Type:Periodic Company Report #US97076238A Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Paraesthesia Health Zyprexa PS ORAL 1 MON Professional Prolixin C Naprosyn C Cogentin C Prozac C 24-Jun-2005 12:19 PM Page: 52 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3027378-8Report Type:Periodic Company Report #US97076250A Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Consumer Zyprexa PS ORAL 10.00 MG Health DAILY PO Professional Date:11/03/97ISR Number: 3027379-XReport Type:Periodic Company Report #US97076253A Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dizziness Health Zyprexa PS ORAL 10.00 MG Dyspnoea Professional DAILY PO Heart Rate Increased Date:11/03/97ISR Number: 3027442-3Report Type:Periodic Company Report #US97076259A Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Convulsion Health Zyprexa PS ORAL 30.00 MG Professional DAILY PO Paxil C Loxitane C Dilantin C Remeron C Tegretol C Date:11/03/97ISR Number: 3027445-9Report Type:Periodic Company Report #US97076262A Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hiv Test Positive Health Zyprexa PS ORAL 20.00 MG White Blood Cell Count Professional DAILY PO 3 WK Decreased Haldol C Date:11/03/97ISR Number: 3027450-2Report Type:Periodic Company Report #US97080145A Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thrombocytopenia Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO Zoloft C Reglan C Date:11/03/97ISR Number: 3027453-8Report Type:Periodic Company Report #US97080148A Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Bilirubin Increased Consumer Zyprexa PS ORAL 10.00 MGDAILY Cholelithiasis Health PO Liver Function Test Professional Depakote C Abnormal Tylenol C 24-Jun-2005 12:19 PM Page: 53 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3027924-4Report Type:Periodic Company Report #US97093754A Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Zyprexa PS ORAL 10.00 MG Initial or Prolonged Glucose Tolerance Professional DAILY PO Decreased Company Haldol C Hyperlipidaemia Representative Paxil C Oesophagitis Weight Increased Date:11/03/97ISR Number: 3027927-XReport Type:Periodic Company Report #US97093775A Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eosinophil Count Health Zyprexa PS ORAL 40.00 MG Increased Professional DAILY PO Date:11/03/97ISR Number: 3027929-3Report Type:Periodic Company Report #US97094222A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Health Zyprexa PS ORAL 10.00 MG Initial or Prolonged Mental Impairment Professional DAILY PO Synthroid C Haloperidol C Date:11/03/97ISR Number: 3027932-3Report Type:Periodic Company Report #US97094585A Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Zyprexa PS ORAL 20.00 MG Initial or Prolonged Phosphokinase Increased Professional DAILY PO 4 MON Coma Company Delirium Representative Hyponatraemia Neuroleptic Malignant Syndrome Polydipsia Psychogenic Pyrexia Date:11/03/97ISR Number: 3027935-9Report Type:Periodic Company Report #US97094795A Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Zyprexa PS ORAL 600.00 MG PO Initial or Prolonged Hypotension Professional Zoloft C Other Overdose Depakote C Coumadin C Date:11/03/97ISR Number: 3027938-4Report Type:Periodic Company Report #US97095449A Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Overdose Health Zyprexa PS 150.00 MG Sedation Professional Venlafaxine C Tachycardia 24-Jun-2005 12:19 PM Page: 54 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3027940-2Report Type:Periodic Company Report #US97095674A Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dysarthria Health Zyprexa PS ORAL 40.00 MG Initial or Prolonged Loss Of Control Of Legs Professional DAILY PO Other Company Trazodone C Representative Glipizide C Date:11/03/97ISR Number: 3027943-8Report Type:Periodic Company Report #US97100151A Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Zyprexa PS ORAL 5.00 MG DAILY Initial or Prolonged Pyrexia Professional PO 2 DAY Sleep Talking Company Trazodone C Tremor Representative Tegretol C Xanax C Date:11/03/97ISR Number: 3027946-3Report Type:Periodic Company Report #US97072011A Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Unevaluable Event Study Zyprexa PS ORAL 10.00 MG Health DAILY PO Professional Date:11/03/97ISR Number: 3027949-9Report Type:Periodic Company Report #US97071243A Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Consumer Zyprexa PS ORAL 10.00 MG Akathisia Health DAILY PO Nervousness Professional Risperdal C Sedation Date:11/03/97ISR Number: 3027951-7Report Type:Periodic Company Report #US97071261A Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hallucination Consumer Zyprexa PS ORAL 5.00 MG DAILY Hypersomnia PO Urinary Incontinence Synthroid C Date:11/03/97ISR Number: 3027954-2Report Type:Periodic Company Report #US97071264A Age:12 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Aggression Health Zyprexa PS ORAL 5.00 MG DAILY Feeling Abnormal Professional PO Increased Appetite Depakote C Sedation Tegretol C Paxil C 24-Jun-2005 12:19 PM Page: 55 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3027955-4Report Type:Periodic Company Report #US97071285A Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Liver Function Test Health Zyprexa PS ORAL 5.00 MG DAILY Abnormal Professional PO 3 MON Pyrexia Company Representative Date:11/03/97ISR Number: 3027958-XReport Type:Periodic Company Report #US97071291A Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Consumer Zyprexa PS ORAL 7.5 MG DAILY Health PO Professional Prozac C Date:11/03/97ISR Number: 3027960-8Report Type:Periodic Company Report #US97071312A Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eye Disorder Consumer Zyprexa PS ORAL 5.00 MG DAILY Vision Blurred PO 1 MON Claritin-D C Date:11/03/97ISR Number: 3027963-3Report Type:Periodic Company Report #US97071315A Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Consumer Zyprexa PS ORAL 10.00 MG DAILY PO Valium C Restoril C Date:11/03/97ISR Number: 3027967-0Report Type:Periodic Company Report #US97071318A Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Health Zyprexa PS ORAL 5.00 MG DAILY Professional PO 3 MON Clozaril C Cogentin C Depakote C Ativan C Date:11/03/97ISR Number: 3027970-0Report Type:Periodic Company Report #US97071321A Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Ecchymosis Consumer Zyprexa PS ORAL 2.5 MG DAILY Epistaxis PO 3 WK Hyperhidrosis Effexor C Klonopin C .25 MG 1/D Klonopin C 1.00 MG 1/D 24-Jun-2005 12:19 PM Page: 56 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3027973-6Report Type:Periodic Company Report #US97071324A Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Health Zyprexa PS 5.00 MG DAILY Professional Date:11/03/97ISR Number: 3027976-1Report Type:Periodic Company Report #US97071339A Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Headache Health Zyprexa PS ORAL 20.00 MG Pyrexia Professional DAILY PO Prozac SS 40.00 MG Trazodone C Demadex C Centrum C Relafen C Date:11/03/97ISR Number: 3027978-5Report Type:Periodic Company Report #US97071483A Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS Professional Date:11/03/97ISR Number: 3027982-7Report Type:Periodic Company Report #US97071498A Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hallucination Health Zyprexa PS ORAL 30.00 MG Professional DAILY PO Other Date:11/03/97ISR Number: 3027984-0Report Type:Periodic Company Report #US97071531A Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS Professional Date:11/03/97ISR Number: 3027987-6Report Type:Periodic Company Report #US97071534A Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS Professional Date:11/03/97ISR Number: 3027991-8Report Type:Periodic Company Report #US97071543A Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hallucination Health Zyprexa PS ORAL 30.00 MG Professional DAILY PO Other 24-Jun-2005 12:19 PM Page: 57 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3027994-3Report Type:Periodic Company Report #US97071564A Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Health Zyprexa PS ORAL 25.00 MG Professional DAILY PO Other Haldol C Inderal C Date:11/03/97ISR Number: 3028004-4Report Type:Periodic Company Report #US97071576A Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Confusional State Health Zyprexa PS ORAL 5.00 MG DAILY Dysarthria Professional PO 3 MON Lethargy Carbamazepine C Tremor Calcium Carbonate C Lorazepam C Levothyroxine C Date:11/03/97ISR Number: 3028005-6Report Type:Periodic Company Report #US97071789A Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dizziness Health Zyprexa PS 20.00 MG 1/ Dystonia Professional Heroin C Date:11/03/97ISR Number: 3028007-XReport Type:Periodic Company Report #UA97071816A Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Muscle Twitching Health Zyprexa PS ORAL 5.00 MG DAILY Professional PO Paxil C Artane C Monopril C Date:11/03/97ISR Number: 3028010-XReport Type:Periodic Company Report #US97071828A Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Breast Discharge Health Zyprexa PS ORAL 5.00 MG 2/DAY Professional PO 2 MON Zoloft C Date:11/03/97ISR Number: 3028012-3Report Type:Periodic Company Report #US97071831A Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration No Adverse Drug Effect Health Zyprexa PS ORAL 40.00 TA PO Overdose Professional Company Representative 24-Jun-2005 12:19 PM Page: 58 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3028014-7Report Type:Periodic Company Report #US97071837A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration White Blood Cell Count Health Zyprexa PS ORAL 5.00 MG Decreased Professional DAILY PO 11 DAY Company Clozaril C Representative Depakote C Date:11/03/97ISR Number: 3028016-0Report Type:Periodic Company Report #US97071840A Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tooth Discolouration Consumer Zyprexa PS ORAL 10.00 MG Health DAILY PO Professional Benadryl C Zantac C Klonopin C Date:11/03/97ISR Number: 3028019-6Report Type:Periodic Company Report #US97071846A Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Glucose Increased Health Zyprexa PS ORAL 10.00 MG Lethargy Professional DAILY PO 3 MON Sedation Humalog C Humulin U C Date:11/03/97ISR Number: 3028021-4Report Type:Periodic Company Report #UA97071861A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drooling Health Zyprexa PS ORAL 5.00 MG DAILY Professional PO 6 WK Trazodone C Clonazepam C Buspar C Date:11/03/97ISR Number: 3028023-8Report Type:Periodic Company Report #US97071864A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Health Zyprexa PS Professional Company Representative Date:11/03/97ISR Number: 3028025-1Report Type:Periodic Company Report #US97072005A Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Priapism Health Zyprexa PS ORAL 20.00 MG Professional DAILY PO Haldol C Ativan C Diazepam C Apap C 24-Jun-2005 12:19 PM Page: 59 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Maalox C Milk Of Magnesia C Date:11/03/97ISR Number: 3028027-5Report Type:Periodic Company Report #US97072020A Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alanine Aminotransferase Health Zyprexa PS ORAL 10.00 MG Increased Professional DAILY PO Date:11/03/97ISR Number: 3028030-5Report Type:Periodic Company Report #US97072044A Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hallucination, Visual Health Zyprexa PS ORAL 5.00 MG DAILY Professional PO 10 DAY Klonopin C Trazodone C Date:11/03/97ISR Number: 3028032-9Report Type:Periodic Company Report #US97072047A Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Consumer Zyprexa PS ORAL 10.00 MG DAILY PO Date:11/03/97ISR Number: 3028033-0Report Type:Periodic Company Report #US97072050A Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blister Consumer Zyprexa PS ORAL 5.00 MG DAILY Dermatitis PO Xanax C Date:11/03/97ISR Number: 3028034-2Report Type:Periodic Company Report #US97072053A Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dizziness Health Zyprexa PS ORAL 2.5 MG DAILY Syncope Professional PO Date:11/03/97ISR Number: 3028036-6Report Type:Periodic Company Report #US9702056A Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Consumer Zyprexa PS ORAL 5.00 MG DAILY PO Claritin C 24-Jun-2005 12:19 PM Page: 60 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3028038-XReport Type:Periodic Company Report #US97072059A Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tremor Consumer Zyprexa PS 4 MON Cogentin C Lithium C Date:11/03/97ISR Number: 3028040-8Report Type:Periodic Company Report #US97072062A Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO Depakote C Klonopin C Micro-K C Thiazides C Diuretic C Date:11/03/97ISR Number: 3028041-XReport Type:Periodic Company Report #US97072068A Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hallucination Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO Cephalexin C Date:11/03/97ISR Number: 3028043-3Report Type:Periodic Company Report #US97072080A Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Apnoea Health Zyprexa PS ORAL 5.00 MG 2/DAY Professional PO Iron C Atrovent C Vasotec C Valproic Acid C Date:11/03/97ISR Number: 3028045-7Report Type:Periodic Company Report #US97072089A Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anger Consumer Zyprexa PS ORAL 20.00 MG Delusional Perception Health DAILY PO 3 WK Professional Date:11/03/97ISR Number: 3028046-9Report Type:Periodic Company Report #US97072098A Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dry Mouth Consumer Zyprexa PS ORAL 10.00 MG Pharyngolaryngeal Pain DAILY PO 6 WK Lithium C Lamictal C 24-Jun-2005 12:19 PM Page: 61 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3028048-2Report Type:Periodic Company Report #US97072104A Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Fatigue Consumer Zyprexa PS ORAL 10.00 MG DAILY PO Date:11/03/97ISR Number: 3028050-0Report Type:Periodic Company Report #US97072116A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysarthria Health Zyprexa PS Lethargy Professional Date:11/03/97ISR Number: 3028051-2Report Type:Periodic Company Report #US97072119A Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hallucination Consumer Zyprexa PS ORAL 10.00 MG Health DAILY PO Professional Prolixin C Paxil C Voltaren C Progesterone C Hydrodiuril C Date:11/03/97ISR Number: 3028053-6Report Type:Periodic Company Report #US97072308A Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cataplexy Health Zyprexa PS ORAL 10.00 MG Hallucination Professional DAILY PO Rapid Eye Movements Sleep Abnormal Date:11/03/97ISR Number: 3028054-8Report Type:Periodic Company Report #US97072311A Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Amnesia Consumer Zyprexa PS ORAL 10.00 MG Apathy Health DAILY PO Sedation Professional Inderal C Weight Increased Date:11/03/97ISR Number: 3028055-XReport Type:Periodic Company Report #US97072317A Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Consumer Zyprexa PS ORAL 2.5 MG DAILY PO Ritalin C Depakene C 24-Jun-2005 12:19 PM Page: 62 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3028057-3Report Type:Periodic Company Report #US97072350A Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Angioneurotic Oedema Health Zyprexa PS ORAL 5.00 MG DAILY Face Oedema Professional PO 1 DAY Tongue Oedema Biaxin C Asa C Trihexyphenidyl C Atrovent C Norvasc C Insulin C Zoloft C Date:11/03/97ISR Number: 3028059-7Report Type:Periodic Company Report #US97072773A Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Health Zyprexa PS ORAL 15.00 MG Professional DAILY PO Other Depakote C Lasix C Potassium C Aspirin C Ambien C Amiodarone C Dilantin C Date:11/03/97ISR Number: 3028061-5Report Type:Periodic Company Report #US97072803A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pain Health Zyprexa PS ORAL 15.00 MG Tachyarrhythmia Professional DAILY PO Other Cogentin C Benadryl C Navane C Date:11/03/97ISR Number: 3028064-0Report Type:Periodic Company Report #US97072815A Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Other Zyprexa PS ORAL 10.00 MG Therapeutic Response DAILY PO Unexpected Ativan C Xanax C Lopressor C Date:11/03/97ISR Number: 3028065-2Report Type:Periodic Company Report #US97072950A Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Coma Health Zyprexa PS ORAL 2.50 MG DAILY Lethargy Professional PO Muscle Rigidity Other Lotrel C Muscle Twitching Aspirin C Xalatan C Bromocriptine C 24-Jun-2005 12:19 PM Page: 63 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3028068-8Report Type:Periodic Company Report #US97073034A Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Face Oedema Health Zyprexa PS 5.00 MG DAILY Oedema Professional Valproate Sodium C Weight Increased Company Phenelzine C Representative Date:11/03/97ISR Number: 3028073-1Report Type:Periodic Company Report #US97073037A Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration No Adverse Drug Effect Health Zyprexa PS ORAL 20.00 MG Professional DAILY PO Depakote C Paxil C Date:11/03/97ISR Number: 3028076-7Report Type:Periodic Company Report #US97073061A Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration No Adverse Drug Effect Health Zyprexa PS ORAL 5.00 MG DAILY Professional PO Date:11/03/97ISR Number: 3028080-9Report Type:Periodic Company Report #US97073082A Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Arthropathy Health Zyprexa PS 5.00 MG DAILY Carpal Tunnel Syndrome Professional Valproate Sodium C Hypoaesthesia Company Alprazolam C Oedema Representative Fluoxetine C Paraesthesia Weight Increased Date:11/03/97ISR Number: 3028084-6Report Type:Periodic Company Report #US97073127A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pregnancy Health Zyprexa PS Professional Date:11/03/97ISR Number: 3028087-1Report Type:Periodic Company Report #US97073277A Age:45 YR Gender:Female I/FU:I Outcome PT Blood Creatine Phosphokinase Increased Confusional State Coordination Abnormal Hyperhidrosis Muscle Rigidity Musculoskeletal Stiffness Neuroleptic Malignant Syndrome Posture Abnormal 24-Jun-2005 12:19 PM Page: 64 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pyrexia Tachycardia Report Source Product Role Manufacturer Route Dose Duration Health Zyprexa PS ORAL 25.00 MG Professional DAILY PO Prozac C Cogentin C Lorazepam C Date:11/03/97ISR Number: 3028090-1Report Type:Periodic Company Report #US97073295A Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Buccoglossal Syndrome Consumer Zyprexa PS ORAL 20.00 MG DAILY PO Benztropine C Date:11/03/97ISR Number: 3028093-7Report Type:Periodic Company Report #US97073307A Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Attention Health Zyprexa PS ORAL 20.00 MG Deficit/Hyperactivity Professional DAILY PO 1 WK Disorder Haldol C Symmetrel C Date:11/03/97ISR Number: 3028096-2Report Type:Periodic Company Report #US97073313A Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dermatitis Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO Company Prolixin C Representative Ativan C Benadryl C Date:11/03/97ISR Number: 3028098-6Report Type:Periodic Company Report #US97073316A Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cognitive Disorder Health Zyprexa PS ORAL 5.00 MG DAILY Visual Disturbance Professional PO Sertraline C Estradiol C Date:11/03/97ISR Number: 3028100-1Report Type:Periodic Company Report #US97073322A Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Consumer Zyprexa PS ORAL 20.00 MG Health DAILY PO Professional Haloperidol Company Decanoate C Representative Cogentin C Klonopin C Inderal C 24-Jun-2005 12:19 PM Page: 65 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3028102-5Report Type:Periodic Company Report #US97073328A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neuroleptic Malignant Health Zyprexa PS ORAL 12.5 MG DAILY Syndrome Professional PO Pyrexia Sepsis Urinary Tract Infection Date:11/03/97ISR Number: 3028104-9Report Type:Periodic Company Report #US97073331A Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Consumer Zyprexa PS ORAL 12.50 MG DAILY PO Risperdal C Ativan C Date:11/03/97ISR Number: 3028105-0Report Type:Periodic Company Report #US97073337A Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypersomnia Consumer Zyprexa PS ORAL 10.00 MG Medication Error DAILY PO Speech Disorder Levothroid C Thinking Abnormal Chlorthalidone C Potassium C Lopressor C Date:11/03/97ISR Number: 3028107-4Report Type:Periodic Company Report #US97073346A Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Asperger'S Disorder Health Zyprexa PS ORAL 10.00 MG Fatigue Professional DAILY PO 14 WK Hyperhidrosis Guanfacine C Hypersomnia Increased Appetite Weight Increased Date:11/03/97ISR Number: 3028109-8Report Type:Periodic Company Report #US97073355A Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Alkaline Health Zyprexa PS ORAL 15.00 MG Phosphatase Increased Professional DAILY PO Blood Lactate Glyburide C Dehydrogenase Increased Gamma-Glutamyltransferase Increased 24-Jun-2005 12:19 PM Page: 66 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3028110-4Report Type:Periodic Company Report #US97073394A Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Confusional State Consumer Zyprexa PS ORAL 10.00 MG Hallucination Health 2/DAY PO 5 MON Weight Decreased Professional Antibiotics C Weight Increased Sertraline C Doxazosin C Date:11/03/97ISR Number: 3028114-1Report Type:Periodic Company Report #US97073547A Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Fatigue Consumer Zyprexa PS ORAL 15.00 MG Mood Swings Health DAILY PO Professional Serzone C Date:11/03/97ISR Number: 3028116-5Report Type:Periodic Company Report #US97073577A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eye Pain Consumer Zyprexa PS ORAL 10.00 MG DAILY PO 1 WK Clozaril C Date:11/03/97ISR Number: 3028119-0Report Type:Periodic Company Report #US97073583A Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Consumer Zyprexa PS ORAL 10.00 MG DAILY PO 2 MON Paxil C Date:11/03/97ISR Number: 3028121-9Report Type:Periodic Company Report #US97073601A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypoaesthesia Health Zyprexa PS Professional Date:11/03/97ISR Number: 3028124-4Report Type:Periodic Company Report #US97073604A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Difficulty In Walking Company Zyprexa PS ORAL 5.00 MG DAILY Sedation Representative PO 3 WK Urinary Retention Synthroid C Date:11/03/97ISR Number: 3028127-XReport Type:Periodic Company Report #US97073613A Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Health Zyprexa PS ORAL PO 1 MON Condition Aggravated Professional Prozac C 24-Jun-2005 12:19 PM Page: 67 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3028129-3Report Type:Periodic Company Report #US97073814A Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Liver Function Test Health Zyprexa PS ORAL 5.00 MG DAILY Abnormal Professional PO 2 WK Weight Increased Lithium C Date:11/03/97ISR Number: 3028131-1Report Type:Periodic Company Report #US97073820A Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS ORAL 20.00 MG Professional DAILY PO 1 MON Valproate Sodium C Fluvoxamine C Clonazepam C Diphenhydramine C Lorazepam C Ibuprofen C Chlorpromazine C Date:11/03/97ISR Number: 3028134-7Report Type:Periodic Company Report #US97073823A Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Joint Stiffness Consumer Zyprexa PS ORAL 10.00 MG Nervousness Health DAILY PO Professional Date:11/03/97ISR Number: 3028137-2Report Type:Periodic Company Report #US97074009A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Feeling Abnormal Consumer Zyprexa PS ORAL 10.00 MG Skin Striae DAILY PO 2 MON Weight Increased Date:11/03/97ISR Number: 3028140-2Report Type:Periodic Company Report #US97074015A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Difficulty In Walking Consumer Zyprexa PS Date:11/03/97ISR Number: 3028142-6Report Type:Periodic Company Report #US97074021A Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukocytosis Consumer Zyprexa PS ORAL 10.00 MG Health DAILY PO Professional Oxycodone And Acetaminofen C 24-Jun-2005 12:19 PM Page: 68 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3028613-2Report Type:Periodic Company Report #US970838353A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Condition Aggravated Consumer Zyprexa PS ORAL 2.5 MG DAILY PO Xanax C Date:11/03/97ISR Number: 3028616-8Report Type:Periodic Company Report #US97083859A Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Unevaluable Event Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO Klonopin C Date:11/03/97ISR Number: 3028618-1Report Type:Periodic Company Report #US97083871A Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hallucination, Auditory Health Zyprexa PS ORAL 10.00 MG Tardive Dyskinesia Professional DAILY PO Artane C Paxil C Vitamin E C Date:11/03/97ISR Number: 3028620-XReport Type:Periodic Company Report #US97083850A Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Glucose Increased Health Zyprexa PS ORAL 20.00 MG Glycosuria Professional DAILY PO Haematuria Date:11/03/97ISR Number: 3028621-1Report Type:Periodic Company Report #US97083679A Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Arthralgia Health Zyprexa PS ORAL 5.00 MG DAILY Fatigue Professional PO Lung Infiltration Prozac SS Pyrexia Date:11/03/97ISR Number: 3028623-5Report Type:Periodic Company Report #US97083808A Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dermatitis Health Zyprexa PS Dyskinesia Professional Cardura C Restlessness Company Representative 24-Jun-2005 12:19 PM Page: 69 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3028625-9Report Type:Periodic Company Report #US97083823A Age:91 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Health Zyprexa PS ORAL 20.00 MG Paranoia Professional DALIY PO Thioridazine C Date:11/03/97ISR Number: 3028627-2Report Type:Periodic Company Report #US97083829A Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Consumer Zyprexa PS ORAL 10.00 MG Pain Of Skin DAILY PO 1 WK Synthroid C Date:11/03/97ISR Number: 3028628-4Report Type:Periodic Company Report #US97083847A Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Consumer Zyprexa PS ORAL 12.50 MG DAILY PO Klonopin C Date:11/03/97ISR Number: 3028629-6Report Type:Periodic Company Report #US97083619A Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Myalgia Consumer Zyprexa PS ORAL 5.00 MG DAILY PO 6 WK Depakote C Xanax C Synthroid C Date:11/03/97ISR Number: 3028632-6Report Type:Periodic Company Report #US97083622A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dry Mouth Consumer Zyprexa PS ORAL 10.00 MG Health DAILY PO 2 WK Professional Prozac SS ORAL 80.00 MG DAILY PO Dalmane C Xanax C Date:11/03/97ISR Number: 3028634-XReport Type:Periodic Company Report #US97083508A Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Consumer Zyprexa PS ORAL 10.00 MG Dysphagia Health DAILY PO Muscle Rigidity Professional 24-Jun-2005 12:19 PM Page: 70 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3028637-5Report Type:Periodic Company Report #US97083490A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Arthralgia Health Zyprexa PS 2 MON Oedema Peripheral Professional Date:11/03/97ISR Number: 3028640-5Report Type:Periodic Company Report #US97083232A Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Consumer Zyprexa PS ORAL 20.00 MG Weight Increased DAILY PO Date:11/03/97ISR Number: 3028642-9Report Type:Periodic Company Report #US97083247A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Health Zyprexa PS ORAL 10.00 MG Weight Increased Professional DAILY Date:11/03/97ISR Number: 3028645-4Report Type:Periodic Company Report #US97083253A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO Company Klonopin C Representative Depakote C Levoxyl C Date:11/03/97ISR Number: 3028648-XReport Type:Periodic Company Report #US97083478A Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Urticaria Health Zyprexa PS ORAL 20.00 MG Professional DAILY PO 5 WK Stelazine C Klonopin C Date:11/03/97ISR Number: 3028650-8Report Type:Periodic Company Report #US97082890A Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Apraxia Consumer Zyprexa PS ORAL 2.5 MG DAILY Muscle Rigidity PO Kemadrin C Rigidity C Sinemet C Date:11/03/97ISR Number: 3028652-1Report Type:Periodic Company Report #US97082893A Age:5 YR Gender:Male I/FU:I Outcome PT Accidental Exposure Agitation 24-Jun-2005 12:19 PM Page: 71 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Insomnia Report Source Product Role Manufacturer Route Dose Duration Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO 14 DAY Zyrtec C Flovent C Date:11/03/97ISR Number: 3028655-7Report Type:Periodic Company Report #US97082896A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Confusional State Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO 2 WK Depakote C Date:11/03/97ISR Number: 3028658-2Report Type:Periodic Company Report #US97083109A Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Platelet Count Decreased Health Zyprexa PS ORAL 20.00 MG Professional DAILY PO Company Representative Date:11/03/97ISR Number: 3028661-2Report Type:Periodic Company Report #US97083148A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Pressure Decreased Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO Company Representative Date:11/03/97ISR Number: 3028664-8Report Type:Periodic Company Report #US97082779A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration International Normalised Health Zyprexa PS Ratio Increased Professional Prozac SS 100.00 MG DAILY Coumadin C 2.5 MG DAILY 6 DAY Coumadin C 5.00 MG 1/D 1 DAY Date:11/03/97ISR Number: 3028667-3Report Type:Periodic Company Report #US97082869A Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Therapeutic Response Health Zyprexa PS ORAL 10.00 MG Unexpected Professional DAILY PO 6 WK Paxil C 24-Jun-2005 12:19 PM Page: 72 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3028669-7Report Type:Periodic Company Report #US97082887A Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Muscle Rigidity Consumer Zyprexa PS ORAL 2.5 MG DAILY PO Date:11/03/97ISR Number: 3028672-7Report Type:Periodic Company Report #US97082581A Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Health Zyprexa PS 5.00 MG 30 DAY Professional Risperdal C Company Benadryl C Representative Date:11/03/97ISR Number: 3028676-4Report Type:Periodic Company Report #US97082623A Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Lactation Disorder Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO 6 WK Company Representative Date:11/03/97ISR Number: 3028677-6Report Type:Periodic Company Report #US97082575A Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Health Zyprexa PS ORAL 12.5 MG DAILY Professional PO 2 MON Klonopin C Luvox C Date:11/03/97ISR Number: 3028679-XReport Type:Periodic Company Report #US97082578A Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperhidrosis Health Zyprexa PS Professional Company Representative Date:11/03/97ISR Number: 3028680-6Report Type:Periodic Company Report #US97082563A Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Health Zyprexa PS ORAL 15.00 MG Professional DAILY PO 2 WK Trilafon C Ssri C Ativan C 24-Jun-2005 12:19 PM Page: 73 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3028681-8Report Type:Periodic Company Report #US97082569A Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Health Zyprexa PS 5.00 MG DAILY Professional Trilafon C Prozac C Cogentin C Clonidine C Date:11/03/97ISR Number: 3028683-1Report Type:Periodic Company Report #US97082572A Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Urinary Incontinence Health Zyprexa PS ORAL 5.00 MG DAILY Professional PO 3 MON Synthroid C Multivitamin C Date:11/03/97ISR Number: 3028685-5Report Type:Periodic Company Report #US97082560A Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Health Zyprexa PS ORAL 15.00 MG Professional DAILY PO 2 WK Depakote C Date:11/03/97ISR Number: 3028687-9Report Type:Periodic Company Report #US97082335A Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disorientation Consumer Zyprexa PS ORAL 5.00 MG DAILY Fatigue Health PO Flashback Professional Synthroid C Hepatic Function Abnormal Depakote C Liver Function Test Abnormal Date:11/03/97ISR Number: 3028689-2Report Type:Periodic Company Report #US97082446A Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyspnoea Health Zyprexa PS ORAL 20.00 MG Sedation Professional DAILY PO Weight Increased Date:11/03/97ISR Number: 3028691-0Report Type:Periodic Company Report #US97082449A Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperthermia Malignant Health Zyprexa PS ORAL 12.5 MG DAILY Professional PO Cardizem C Lasix C Sinemet C Eldepryl C Parlodel C 24-Jun-2005 12:19 PM Page: 74 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ditropan C Date:11/03/97ISR Number: 3028693-4Report Type:Periodic Company Report #US97082455A Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Migraine Consumer Zyprexa PS ORAL 10.00 MG Paraesthesia DAILY PO 2 MON Weight Increased Prozac C Clonidine C Date:11/03/97ISR Number: 3028696-XReport Type:Periodic Company Report #US97082458A Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Posture Abnormal Consumer Zyprexa PS ORAL 2.5 MG DAILY Sedation PO 2 WK Paxil C Sinemet C Amantadine C Date:11/03/97ISR Number: 3028697-1Report Type:Periodic Company Report #US97082476A Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperkalaemia Health Zyprexa PS ORAL 15.00 MG PO Hyponatraemia Professional Klonopin C Inappropriate Company Depakote C Antidiuretic Hormone Representative Secretion Date:11/03/97ISR Number: 3028699-5Report Type:Periodic Company Report #US97082059A Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anxiety Consumer Zyprexa PS ORAL 10.00 MG Depression DAILY PO Muscle Rigidity Antibiotic C Tremor L-Dopa C Paxil C Date:11/03/97ISR Number: 3028700-9Report Type:Periodic Company Report #US97082071A Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS Weight Increased Professional Date:11/03/97ISR Number: 3028703-4Report Type:Periodic Company Report #US97082074A Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Consumer Zyprexa PS ORAL 5.00 MG DAILY PO 24-Jun-2005 12:19 PM Page: 75 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3028705-8Report Type:Periodic Company Report #US97082077A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Consumer Zyprexa PS ORAL 10.00 MG DAILY PO 4 MON Demulen C Xanax C Spironolactone C Date:11/03/97ISR Number: 3028707-1Report Type:Periodic Company Report #US97082083A Age:85 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Health Zyprexa PS ORAL 5.00 MG DAILY Professional PO Sinemet C Date:11/03/97ISR Number: 3028708-3Report Type:Periodic Company Report #US97082119A Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anxiety Consumer Prozac PS ORAL 20.00 MG Syncope DAILY PO Zyprexa SS ORAL 10.00 MG DAILY PO 5 MON Lithium C Date:11/03/97ISR Number: 3028710-1Report Type:Periodic Company Report #US97082272A Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Convulsion Health Zyprexa PS Professional Anafranil C Date:11/03/97ISR Number: 3028712-5Report Type:Periodic Company Report #US97082278A Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Parotid Gland Enlargement Health Zyprexa PS 10.00 MG Professional DAILY Octreotide C Insulin C Albuterol C Sertraline C Levothyroxine C Lansoprazole C Date:11/03/97ISR Number: 3028713-7Report Type:Periodic Company Report #US97082284A Age:11 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Antinuclear Antibody Health Zyprexa PS 6 WK Positive Professional Buspar C Arthritis 24-Jun-2005 12:19 PM Page: 76 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3028715-0Report Type:Periodic Company Report #US97082299A Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Overdose Health Zyprexa PS ORAL PO Professional Gentamicin C Vancomycin C Serax C Date:11/03/97ISR Number: 3028717-4Report Type:Periodic Company Report #US97081849A Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pre-Existing Condition Health Zyprexa PS ORAL 5.00 MG DAILY Improved Professional PO 1 MON Therapeutic Response Prozac C Unexpected Date:11/03/97ISR Number: 3028719-8Report Type:Periodic Company Report #US97081855A Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperkalaemia Health Zyprexa PS ORAL 7.50 MG DAILY Professional PO 3 WK Lithium C Lorazepam C Date:11/03/97ISR Number: 3028721-6Report Type:Periodic Company Report #US97081858A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Health Zyprexa PS 10 DAY Nervousness Professional Tylenol C Date:11/03/97ISR Number: 3028724-1Report Type:Periodic Company Report #US97081861A Age:13 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Health Zyprexa PS ORAL 5.00 MG DAILY Sedation Professional PO Date:11/03/97ISR Number: 3028726-5Report Type:Periodic Company Report #US97081522A Age:12 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Arthralgia Other Zyprexa PS Arthritis Buspirone C Weight Increased Date:11/03/97ISR Number: 3028728-9Report Type:Periodic Company Report #US97081588A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Lethargy Consumer Zyprexa PS ORAL 10.00 MG Tinnitus DAILY PO 2 WK Tremor Remerom C 24-Jun-2005 12:19 PM Page: 77 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Premarin C Florinef C Bentyl C Date:11/03/97ISR Number: 3028730-7Report Type:Periodic Company Report #US97081594A Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hepatomegaly Health Zyprexa PS ORAL 10.00 MG Oedema Peripheral Professional DAILY PO Weight Increased Impramine C Date:11/03/97ISR Number: 3028732-0Report Type:Periodic Company Report #US97081597A Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dizziness Consumer Zyprexa PS 15.00 MG Parkinsonian Gait Health DAILY Vertigo Professional Prozac SS Klonopin C Premarin C Date:11/03/97ISR Number: 3028734-4Report Type:Periodic Company Report #US97081657A Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Malaise Consumer Zyprexa PS ORAL 10.00 MG Medication Error DAILY PO 10 DAY Date:11/03/97ISR Number: 3028736-8Report Type:Periodic Company Report #US97081660A Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Parotid Gland Enlargement Health Zyprexa PS Professional Date:11/03/97ISR Number: 3028740-XReport Type:Periodic Company Report #US97081822A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thrombocytopenia Health Zyprexa PS ORAL 7.50 MG DAILY Professional PO Cogentin C Date:11/03/97ISR Number: 3033612-0Report Type:Periodic Company Report #US97095110A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Health Zyprexa PS Professional 24-Jun-2005 12:19 PM Page: 78 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3033615-6Report Type:Periodic Company Report #US97095113A Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Health Zyprexa PS ORAL 10.00 MG Skin Disorder Professional DAILY Weight Increased Lithium C Date:11/03/97ISR Number: 3033616-8Report Type:Periodic Company Report #US97095119A Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Health Zyprexa PS ORAL 10.00 MG Skin Disorder Professional DAILY PO Weight Increased Lithium C Bentyl C Date:11/03/97ISR Number: 3033618-1Report Type:Periodic Company Report #US97095137A Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Back Pain Consumer Zyprexa PS ORAL 10.00 MG DAILY PO 6 WK Sinemet C Sinequan C Levsinex C Acupril C Inderal La C Permax C Propulsid C Ambien C Date:11/03/97ISR Number: 3033620-XReport Type:Periodic Company Report #US97095170A Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Health Zyprexa PS ORAL 20.00 MG White Blood Cell Count Professional DAILY PO Decreased Date:11/03/97ISR Number: 3033622-3Report Type:Periodic Company Report #US97095173A Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Health Zyprexa PS ORAL 15.00 MG Professional DAILY PO Acetaminophen C Naprosyn C Klonopin C Entex La C Vancenase C Benadryl C Depakote C Triple Antibiotic Ointment C 24-Jun-2005 12:19 PM Page: 79 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3033623-5Report Type:Periodic Company Report #US97095182A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Health Zyprexa PS Professional Date:11/03/97ISR Number: 3033624-7Report Type:Periodic Company Report #US97095413A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Health Zyprexa PS Professional Date:11/03/97ISR Number: 3033626-0Report Type:Periodic Company Report #US97095422A Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pain In Extremity Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO 1 MON Date:11/03/97ISR Number: 3033627-2Report Type:Periodic Company Report #US97095431A Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Accidental Overdose Health Zyprexa PS ORAL 10.00 MG Hypotension Professional DAILY PO Medication Error Date:11/03/97ISR Number: 3033629-6Report Type:Periodic Company Report #US97095440A Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Gastrointestinal Pain Health Zyprexa PS ORAL 5.00 MG Nausea Professional DAILY PO Date:11/03/97ISR Number: 3033630-2Report Type:Periodic Company Report #US97095452A Age:7 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Health Zyprexa PS ORAL 10.00 MG PO Professional Date:11/03/97ISR Number: 3033632-6Report Type:Periodic Company Report #US97095689A Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Consumer Zyprexa PS ORAL 7.50 MG Libido Decreased Health DAILY PO Sedation Professional Neurontin C Weight Increased Sunthroid C 24-Jun-2005 12:19 PM Page: 80 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3033634-XReport Type:Periodic Company Report #US97095698A Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Consumer Zyprexa PS ORAL 5.00 MG Skin Discolouration DAILY PO Neurontin C Tegretol C Effexor C Nortriptyline C Date:11/03/97ISR Number: 3033635-1Report Type:Periodic Company Report #US97095701A Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Consumer Zyprexa PS ORAL 10.00 MG DAILY PO 3 MON Depakote C Date:11/03/97ISR Number: 3033637-5Report Type:Periodic Company Report #US97095731A Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Health Zyprexa PS ORAL 10.00 MG Muscle Rigidity Professional DAILY PO 1 MON Tachycardia Sertraline C Tetany Synthroid C Torticollis Tremor Date:11/03/97ISR Number: 3033638-7Report Type:Periodic Company Report #US97095737A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Coordination Abnormal Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO 2 WK Date:11/03/97ISR Number: 3033640-5Report Type:Periodic Company Report #US97095755A Age:85 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Fall Health Zyprexa PS ORAL 2.5 MG DAILY Professional PO 1 WK Date:11/03/97ISR Number: 3033641-7Report Type:Periodic Company Report #US97100175A Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Feeling Hot Health Zyprexa PS ORAL 7.5 MG DAILY Hyperhidrosis Professional PO 24-Jun-2005 12:19 PM Page: 81 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3033643-0Report Type:Periodic Company Report #US97100181A Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Creatinine Consumer Zyprexa PS ORAL 2.5 MG DAILY Increased PO Vasotec C Depakote C Date:11/03/97ISR Number: 3033644-2Report Type:Periodic Company Report #US97100205A Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Memory Impairment Consumer Zyprexa PS ORAL 10.MG DAILY Retinal Oedema Health PO 3 MON Professional Date:11/03/97ISR Number: 3033646-6Report Type:Periodic Company Report #US97100214A Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Condition Aggravated Company Zyprexa PS ORAL 7.5 MG DAILY Hypersomnia Representative PO 4 MON Date:11/03/97ISR Number: 3033647-8Report Type:Periodic Company Report #US97100217A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neck Pain Consumer Zyprexa PS ORAL 20.00 MG DAILY; PO Date:11/03/97ISR Number: 3033649-1Report Type:Periodic Company Report #US97100223A Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Health Zyprexa PS ORAL 7.5 MG DAILY Sedation Professional PO Weight Increased Date:11/03/97ISR Number: 3033650-8Report Type:Periodic Company Report #US97100232A Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Electrocardiogram T Wave Health Zyprexa PS ORAL 10.MG DAILY Inversion Professional PO Tachycardia Date:11/03/97ISR Number: 3033652-1Report Type:Periodic Company Report #US97100466A Age:7 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Asthenia Health Zyprexa PS ORAL 5.0MG DAILY Chills Professional PO Sedation Luvox C 50.MG 002/DAY Vomiting Benztropine C 1.00 MG 2/D Risperdal C 1.00 MG 3/D 24-Jun-2005 12:19 PM Page: 82 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3033653-3Report Type:Periodic Company Report #US97100514A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Mania Consumer Zyprexa PS ORAL 5.00 MG DAILY PO 9 MON Lithium C Depakote C Date:11/03/97ISR Number: 3033655-7Report Type:Periodic Company Report #US97100538A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Scoliosis Consumer Zyprexa PS 5 MON Vision Blurred Date:11/03/97ISR Number: 3033656-9Report Type:Periodic Company Report #US97100562A Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyporeflexia Health Zyprexa PS ORAL 15.00 MG Professional DAILY; PO Company Paxil C Representative Ativan C Cogentin C Date:11/03/97ISR Number: 3033658-2Report Type:Periodic Company Report #US97100721A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Condition Aggravated Health Zyprexa PS Galactorrhoea Professional Company Representative Date:11/03/97ISR Number: 3033659-4Report Type:Periodic Company Report #US97100733A Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Depression Consumer Zyprexa PS 2 MON Nasopharyngitis Health Lithium C Pallor Professional Date:11/03/97ISR Number: 3033661-2Report Type:Periodic Company Report #US97100736A Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Intermittent Claudication Health Zyprexa PS ORAL 10.00MG DAILY Pain In Extremity Professional PO Ativan C 24-Jun-2005 12:19 PM Page: 83 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3033662-4Report Type:Periodic Company Report #US97100745A Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS ORAL 5.00 MG Professional DAILY;PO 4 DAY Company Trilafon C Representative Date:11/03/97ISR Number: 3033664-8Report Type:Periodic Company Report #US97100760A Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anger Health Zyprexa PS Dysphoria Professional Prolixin C Sedation Date:11/03/97ISR Number: 3033665-XReport Type:Periodic Company Report #US97100763A Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Difficulty In Walking Health Zyprexa PS ORAL 10.00MG Hypoaesthesia Professional DAILY; PO Company Representative Date:11/03/97ISR Number: 3033667-3Report Type:Periodic Company Report #US97100919A Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Amnesia Consumer Zyprexa PS ORAL 2.50 MG Weight Decreased DAILY; PO Zoloft C Date:11/03/97ISR Number: 3033668-5Report Type:Periodic Company Report #US97100967A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Erectile Dysfunction Consumer Zyprexa PS ORAL PO 3 MON Date:11/03/97ISR Number: 3033670-3Report Type:Periodic Company Report #US97100982A Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thrombocytopenia Health Zyprexa PS ORAL 25.00 MG Professional DAILY;PO 2 MON Paxil C Date:11/03/97ISR Number: 3033672-7Report Type:Periodic Company Report #US97100994A Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Laryngospasm Health Zyprexa PS SUBCUTANEOUS 20.00 MG Professional DAILY SC Cogentin C Ativan C 24-Jun-2005 12:19 PM Page: 84 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3033674-0Report Type:Periodic Company Report #US97101000A Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Pain Upper Health Zyprexa PS ORAL 15.00MG DAILY Liver Function Test Professional PO Abnormal Anafranil C Vomiting Prozac C Date:11/03/97ISR Number: 3033675-2Report Type:Periodic Company Report #US97101012A Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Convulsion Health Zyprexa PS ORAL 5.00 MG 2/DAY 2 MON Professional Date:11/03/97ISR Number: 3033676-4Report Type:Periodic Company Report #US97101018A Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tachycardia Health Zyprexa PS ORAL 2.50 MG DAILY Professional PO Date:11/03/97ISR Number: 3033678-8Report Type:Periodic Company Report #US97101021A Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Rigidity Consumer Zyprexa PS ORAL 10.00 MG Back Pain DAILY PO Blepharospasm Muscle Rigidity Muscle Spasms Tongue Spasm Date:11/03/97ISR Number: 3033680-6Report Type:Periodic Company Report #US97101048A Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thrombocytopenia Health Zyprexa PS ORAL 20.00 MG Professional DAILY PO 3 MON Insulin C Cogentin C Date:11/03/97ISR Number: 3033681-8Report Type:Periodic Company Report #US97101051A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS 20.00 MG Professional Date:11/03/97ISR Number: 3033682-XReport Type:Periodic Company Report #US97101060A Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Akathisia Health Professional 24-Jun-2005 12:19 PM Page: 85 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company Representative Product Role Manufacturer Route Dose Duration Zyprexa PS ORAL 10.00 MG DAILY PO 1 YR Prozac SS 40.00 MG DAILY Remeron C Date:11/03/97ISR Number: 3033684-3Report Type:Periodic Company Report #US95010928A Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyspnoea Study Zyprexa PS ORAL 20.00 MG Pneumonia Health DAILY PO Productive Cough Professional Vitamin C C Pyrexia Dietary Supplement C Vitamin B C Date:11/03/97ISR Number: 3033686-7Report Type:Periodic Company Report #US97032416A Age:74 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accident Study Zyprexa PS ORAL 10 MG DAILY Initial or Prolonged Hip Fracture Health PO Disability Professional Bumex C Risperdal C Hydrocortisone C Milk Of Magnesia C Tylenol C Ibuprofen C Aspirin C Zestril C Date:11/03/97ISR Number: 3033687-9Report Type:Periodic Company Report #US97042017A Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Study Zyprexa PS ORAL 10 MG DAILY Initial or Prolonged Depressed Mood Health PO Depression Professional Prozac C Hallucination, Auditory Ativan C Stress Suicidal Ideation Date:11/03/97ISR Number: 3033689-2Report Type:Periodic Company Report #US97054300A Age:89 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Unevaluable Event Study Zyprexa PS ORAL 10 MG DAILY Initial or Prolonged Health PO Professional Asa C Vitamn B 12 C Folic Acid C Lactulose C Surfak C 24-Jun-2005 12:19 PM Page: 86 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3033690-9Report Type:Periodic Company Report #US97064384A Age:17 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Nervousness Study Zyprexa PS Initial or Prolonged Overdose Health Congentin C Professional Extrapyramidal Syndrome C Date:11/03/97ISR Number: 3033692-2Report Type:Periodic Company Report #US97065605A Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Study Zyprexa PS ORAL 10 MG DAILY Initial or Prolonged Fall Health PO Sleep Disorder Professional Ativan C Date:11/03/97ISR Number: 3033693-4Report Type:Periodic Company Report #US97070175A Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anhedonia Study Zyprexa PS ORAL 10 MG DAILY Initial or Prolonged Depression Health PO Professional Date:11/03/97ISR Number: 3033695-8Report Type:Periodic Company Report #US96123358A Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutrophil Count Health Zyprexa PS ORAL 20 MG DAILY Decreased Professional PO 2 WK Depakote C Oxybutynin C Docusate C Date:11/03/97ISR Number: 3033697-1Report Type:Periodic Company Report #US97022707A Age:12 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Zyprexa PS 10 MG DAILY 2 WK Pyrexia Professional Depakote C Viral Infection Company Representative Date:11/03/97ISR Number: 3033698-3Report Type:Periodic Company Report #US97031054A Age:65 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haematocrit Decreased Health Zyprexa PS ORAL 10 MG 3/DAY Haemoglobin Decreased Professional PO Hyperglycaemia Trilafon C Hypokalaemia Novolin 70/30 C Humulin R C 24-Jun-2005 12:19 PM Page: 87 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3033700-9Report Type:Periodic Company Report #US97033847A Age:21 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Rectal Haemorrhage Health Zyprexa PS ORAL 15 MG DAILY Professional PO Depakote C Wellbutrin C Dynacin C Date:11/03/97ISR Number: 3033701-0Report Type:Periodic Company Report #US97040622A Age:13 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Health Zyprexa PS ORAL 7.5 MG DAILY Initial or Prolonged Headache Professional PO Hepatic Function Abnormal Hepatitis Pyrexia Vomiting Date:11/03/97ISR Number: 3033702-2Report Type:Periodic Company Report #US97043202A Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Health Zyprexa PS ORAL 5 MG DAILY PO 4 DAY Professional Company Representative Date:11/03/97ISR Number: 3033704-6Report Type:Periodic Company Report #US97043208A Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accidental Overdose Health Zyprexa PS ORAL 30 MG DAILY Coordination Abnormal Professional PO Drug Interaction Company Benadryl C Sedation Representative Depakote C Navane C Luvox C Eskalith Cr C Ativan C Date:11/03/97ISR Number: 3033705-8Report Type:Periodic Company Report #US97045965A Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lethargy Health Zyprexa PS ORAL 100 MG 1 PO Initial or Prolonged Overdose Professional Other Date:11/03/97ISR Number: 3033707-1Report Type:Periodic Company Report #US97054504A Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other No Adverse Drug Effect Health Zyprexa PS ORAL 50 MG DAILY Professional PO 24-Jun-2005 12:19 PM Page: 88 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Haldol C Risperdal C Luvox C Lithium C Date:11/03/97ISR Number: 3033709-5Report Type:Periodic Company Report #US97054936A Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcohol Interaction Health Prozac PS 20 MG Initial or Prolonged Depressed Level Of Professional Zyprexa SS 10 MG Other Consciousness Required Overdose Intervention to Prevent Permanent Impairment/Damage Date:11/03/97ISR Number: 3033710-1Report Type:Periodic Company Report #US97062497A Age:16 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperglycaemia Health Zyprexa PS ORAL 10 MG DAILY Initial or Prolonged Professional PO Other Carbamazepine C Sertraline C Date:11/03/97ISR Number: 3033712-5Report Type:Periodic Company Report #US97064000A Age:81 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Culture Positive Health Zyprexa PS ORAL 10 MG 2/DAY Initial or Prolonged Pyrexia Professional PO Lorazepam C Date:11/03/97ISR Number: 3033832-5Report Type:Periodic Company Report #US97093655A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tic Health Zyprexa PS ORAL 500 MG DAILY Professional PO Date:11/03/97ISR Number: 3033834-9Report Type:Periodic Company Report #US97093670A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tic Health Zyprexa PS ORAL 5.00 MG DAILY Professional PO Company Representative 24-Jun-2005 12:19 PM Page: 89 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3033909-4Report Type:Periodic Company Report #US97093814A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Unevaluable Event Health Zyprexa PS Professional Depakote C Date:11/03/97ISR Number: 3033911-2Report Type:Periodic Company Report #US97094000A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypersomnia Consumer Zyprexa PS ORAL 5.00 MG DAILY PO Effexor C Date:11/03/97ISR Number: 3033914-8Report Type:Periodic Company Report #US97094009A Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Headache Consumer Zyprexa PS ORAL 2.5 MG DAILY Weight Increased PO Zoloft C Date:11/03/97ISR Number: 3033917-3Report Type:Periodic Company Report #US97094012A Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Consumer Zyprexa PS ORAL 10.00 MG Anger DAILY PO Euphoric Mood Hypotension Date:11/03/97ISR Number: 3033920-3Report Type:Periodic Company Report #US97094024A Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Liver Function Test Health Zyprexa PS ORAL 20.00 MG Abnormal Professional DAILY PO Date:11/03/97ISR Number: 3033923-9Report Type:Periodic Company Report #US97094036A Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Unevaluable Event Health Zyprexa PS ORAL PO 2 MON Professional Date:11/03/97ISR Number: 3033927-6Report Type:Periodic Company Report #US97094072A Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Fatigue Consumer Zyprexa PS ORAL 20.00 MG Health DAILY PO Professional 24-Jun-2005 12:19 PM Page: 90 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3033930-6Report Type:Periodic Company Report #US97094078A Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Feeling Abnormal Health Zyprexa PS ORAL 10.00 MG PO Sedation Professional 2/DAY PO 6 MON Date:11/03/97ISR Number: 3033933-1Report Type:Periodic Company Report #US97094081A Age:65 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Health Zyprexa PS Dysphagia Professional Company Representative Date:11/03/97ISR Number: 3033935-5Report Type:Periodic Company Report #US97094084A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cor Pulmonale Health Zyprexa PS 6 WK Pulmonary Hypertension Professional Clozaril C Sleep Apnoea Syndrome Company Representative Date:11/03/97ISR Number: 3033938-0Report Type:Periodic Company Report #US97094252A Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Consumer Zyprexa PS ORAL 10.00 MG Health DAILY PO Professional Cogentin C Date:11/03/97ISR Number: 3033941-0Report Type:Periodic Company Report #US97094258A Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Enzyme Abnormality Health Zyprexa PS ORAL 12.50 MG Haematemesis Professional DAILY PO Zoloft C Asa C Date:11/03/97ISR Number: 3033943-4Report Type:Periodic Company Report #US97094264A Age:83 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Condition Aggravated Health Zyprexa PS ORAL 5.00 MG DAILY Dysphagia Professional PO Klonopin C Date:11/03/97ISR Number: 3033947-1Report Type:Periodic Company Report #US97094321A Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pain In Extremity Health Zyprexa PS ORAL 5.00 MG DAILY Paraesthesia Professional PO 24-Jun-2005 12:19 PM Page: 91 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Klonopin C Norvasc C Date:11/03/97ISR Number: 3033951-3Report Type:Periodic Company Report #US97094324A Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Muscle Spasms Health Zyprexa PS ORAL 10.00 MG Muscle Twitching Professional DAILY PO 4 MON Company Representative Date:11/03/97ISR Number: 3033953-7Report Type:Periodic Company Report #US97094327A Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blepharospasm Health Zyprexa PS ORAL 10.00 MG PO Professional DAILY 3 MON Company Representative Date:11/03/97ISR Number: 3033957-4Report Type:Periodic Company Report #US97094330A Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Condition Aggravated Health Zyprexa PS ORAL 10.00 MG Hallucination, Auditory Professional DAILY PO Tegretol C Synthroid C Klonopin C Zoloft C Date:11/03/97ISR Number: 3033960-4Report Type:Periodic Company Report #US97094336A Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Decreased Appetite Consumer Zyprexa PS ORAL 10.00 MG Hypersomnia DAILY PO 2 MON Sedation Paxil C Vomiting Oxazepam C Date:11/03/97ISR Number: 3033964-1Report Type:Periodic Company Report #US97094540A Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Feeling Abnormal Consumer Zyprexa PS ORAL 15.00 MG Jaw Disorder DAILY PO Neurosis Palpitations Restless Legs Syndrome Tongue Oedema 24-Jun-2005 12:19 PM Page: 92 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3033967-7Report Type:Periodic Company Report #US97094564A Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Conjunctival Hyperaemia Health Zyprexa PS ORAL 5.00 MG DAILY Vision Blurred Professional PO Date:11/03/97ISR Number: 3033970-7Report Type:Periodic Company Report #US97094597A Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO Cogentin C Sorbitol C Norvasc C Asa C Depakote C Flagyl C Klonopin C Ativan C Tylenol C Augmentin C Cardura C Duragesic C Humulin R C Date:11/03/97ISR Number: 3033972-0Report Type:Periodic Company Report #US97094726A Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pyrexia Health Zyprexa PS Professional Date:11/03/97ISR Number: 3033975-6Report Type:Periodic Company Report #US97094765A Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperglycaemia Health Zyprexa PS ORAL 15.00 MG Professional DAILY PO Depakote C Effexor C Date:11/03/97ISR Number: 3033978-1Report Type:Periodic Company Report #US97094774A Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperglycaemia Health Zyprexa PS ORAL 7.5 MG DAILY Professional PO Depakote C Cogentin C Lorazepam C Haldol Depot C 24-Jun-2005 12:19 PM Page: 93 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3033980-XReport Type:Periodic Company Report #US97094846A Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperglycaemia Health Zyprexa PS ORAL 15.00 MG Professional DAILY PO Haldol C Prozac C Depakote C Benadryl C Date:11/03/97ISR Number: 3033984-7Report Type:Periodic Company Report #US97094852A Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperglycaemia Health Zyprexa PS ORAL 15.00 MG Liver Function Test Professional DAILY PO Abnormal Amitriptyline C Hydrochlorothiazide With Triamterene C Premarin C Date:11/03/97ISR Number: 3033987-2Report Type:Periodic Company Report #US97094864A Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Health Zyprexa PS Professional Date:11/03/97ISR Number: 3033989-6Report Type:Periodic Company Report #US97094870A Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Complications Of Maternal Health Zyprexa PS ORAL 10.00 MG Exposure To Therapeutic Professional DAILYPO 2 MON Drugs Depakote C No Adverse Drug Effect Zoloft C Cogentin C Date:11/03/97ISR Number: 3033992-6Report Type:Periodic Company Report #US97094873A Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Chromaturia Health Zyprexa PS Pyrexia Professional Company Representative Date:11/03/97ISR Number: 3033995-1Report Type:Periodic Company Report #US97094882A Age:38 YR Gender:Male I/FU:I Outcome PT Delusional Disorder, Unspecified Type Drug Ineffective Hallucination Hypomania 24-Jun-2005 12:19 PM Page: 94 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Paranoia Report Source Product Role Manufacturer Route Dose Duration Health Zyprexa PS ORAL 10.00 MG Professional 2/DAY PO Prolixin Decanoate C Prolixin C Klonopin C Date:11/03/97ISR Number: 3033998-7Report Type:Periodic Company Report #US97094894A Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Health Zyprexa PS ORAL 10.00 MG Pre-Existing Condition Professional DAILY PO 5 MON Improved Luvox C Weight Increased Tenex C Seldane C Propulsid C Prosom C Xanax C Anticholinergics C Date:11/03/97ISR Number: 3034001-5Report Type:Periodic Company Report #US97094900A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS Psychiatric Symptom Professional Depakote C Date:11/03/97ISR Number: 3034003-9Report Type:Periodic Company Report #US97094906A Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Unevaluable Event Health Zyprexa PS Professional Date:11/03/97ISR Number: 3034006-4Report Type:Periodic Company Report #US97095074A Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Health Zyprexa PS Professional Date:11/03/97ISR Number: 3034010-6Report Type:Periodic Company Report #US97095077A Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Health Zyprexa PS Professional 24-Jun-2005 12:19 PM Page: 95 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3034012-XReport Type:Periodic Company Report #US97095080A Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Feeling Of Relaxation Health Zyprexa PS ORAL 5.00 MG DAILY Professional PO Zestril C Aspirin C Date:11/03/97ISR Number: 3034014-3Report Type:Periodic Company Report #US97095083A Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Health Zyprexa PS Professional Date:11/03/97ISR Number: 3034016-7Report Type:Periodic Company Report #US97095101A Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Health Zyprexa PS Professional Date:11/03/97ISR Number: 3034017-9Report Type:Periodic Company Report #US97095104A Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Health Zyprexa PS Professional Date:11/03/97ISR Number: 3034019-2Report Type:Periodic Company Report #US97095107A Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Health Zyprexa PS Professional Date:11/03/97ISR Number: 3034098-2Report Type:Periodic Company Report #US97084921A Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Health Zyprexa PS ORAL 10.00 MG PO 6 MON Professional Trazodone C Company Prozac C Representative Date:11/03/97ISR Number: 3034099-4Report Type:Periodic Company Report #US97084924A Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS 10.00 MG Professional Stelazine C Company Representative 24-Jun-2005 12:19 PM Page: 96 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3034100-8Report Type:Periodic Company Report #US97084936A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Consumer Zyprexa PS ORAL 10.00 MG Weight Increased DAILY PO 1 MON Zoloft C Ativan C Date:11/03/97ISR Number: 3034101-XReport Type:Periodic Company Report #US97084939A Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hallucination Consumer Zyprexa PS ORAL 15.00 MG Hallucination, Auditory Health DAILY PO Professional Mellaril C Cogentin C Larazepam C Date:11/03/97ISR Number: 3034102-1Report Type:Periodic Company Report #US97084945A Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Health Zyprexa PS ORAL 15.00 MG Professional DAILY PO 2 WK Zoloft C Cogentin C Depakote C Date:11/03/97ISR Number: 3034103-3Report Type:Periodic Company Report #US97084993A Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Influenza Like Illness Health Zyprexa PS ORAL 10.00 MG Malaise Professional DAILY PO Nausea Company Depakote C Representative Date:11/03/97ISR Number: 3034104-5Report Type:Periodic Company Report #US97085014A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Asthenia Health Zyprexa PS Professional Company Representative Date:11/03/97ISR Number: 3034105-7Report Type:Periodic Company Report #US97085017A Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Convulsion Health Zyprexa PS ORAL 15.00 MG Professional DAILY PO Cogentin C 24-Jun-2005 12:19 PM Page: 97 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3034106-9Report Type:Periodic Company Report #US97085029A Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Arthralgia Consumer Zyprexa PS ORAL 10.00 MG Myalgia Health DAILY PO Pain Professional Nadolol C Weight Increased Estrogen C Medroxyprogesterone C Trihexyphenidyl C Fluoxetine C Date:11/03/97ISR Number: 3034107-0Report Type:Periodic Company Report #US97085041A Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Health Zyprexa PS ORAL 15.00 MG Swelling Professional DAILY PO Trilafon C Propranolol C Artane C Prozac C Ativan C Date:11/03/97ISR Number: 3034108-2Report Type:Periodic Company Report #US97085104A Age:12 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Enuresis Health Zyprexa PS ORAL 5.00 MG DAILY Professional PO Ativan C Date:11/03/97ISR Number: 3034109-4Report Type:Periodic Company Report #US97085113A Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Enuresis Other Zyprexa PS ORAL 10.00 MG DAILY PO Paxil C Depakote C Doxepin C Klonopin C Thyroid C Date:11/03/97ISR Number: 3034110-0Report Type:Periodic Company Report #US97085116A Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Pressure Decreased Health Zyprexa PS ORAL 5.00 MG Drug Interaction Professional DAILY PO 4 DAY Extrapyramidal Disorder Sinemet C Fall Depakote C Gait Disturbance Haldol C Hypotension 24-Jun-2005 12:19 PM Page: 98 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3034112-4Report Type:Periodic Company Report #US97085122A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Health Zyprexa PS Professional Company Representative Date:11/03/97ISR Number: 3034113-6Report Type:Periodic Company Report #US97085125A Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Confusional State Health Zyprexa PS ORAL 10.00 MG Mydriasis Professional 2/DAY PO Paxil C Cogentin C Advil C Date:11/03/97ISR Number: 3034114-8Report Type:Periodic Company Report #US97085134A Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Liver Function Test Health Zyprexa PS ORAL 10.00 MG Abnormal Professional DAILY PO Metamucil C Cleocin T C Retin A C Date:11/03/97ISR Number: 3034115-XReport Type:Periodic Company Report #US97085137A Age:70 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Health Zyprexa PS Drug Ineffective Professional Pyrexia Sweating Fever Tremor Date:11/03/97ISR Number: 3034116-1Report Type:Periodic Company Report #US97085143A Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hepatic Function Abnormal Health Zyprexa PS ORAL 10.00 MG Professional DAILY PO Date:11/03/97ISR Number: 3034117-3Report Type:Periodic Company Report #US97085152A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blister Consumer Zyprexa PS ORAL 5.00 MG DAILY Dermatitis Health PO Eye Irritation Professional Xanax C Headache Malaise Rhinorrhoea 24-Jun-2005 12:19 PM Page: 99 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3034119-7Report Type:Periodic Company Report #US97085161A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Health Zyprexa PS ORAL 20.00 MG Oedema Peripheral Professional DAILY PO Depakote C Diazepam C Date:11/03/97ISR Number: 3034120-3Report Type:Periodic Company Report #US97085191A Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS ORAL 15.00 MG Professional DAILY PO Date:11/03/97ISR Number: 3034122-7Report Type:Periodic Company Report #US97085197A Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS ORAL 15.00 MG Professional DAILY PO Date:11/03/97ISR Number: 3034124-0Report Type:Periodic Company Report #US97085200A Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS ORAL 15.00 MG Professional DAILY PO Date:11/03/97ISR Number: 3034126-4Report Type:Periodic Company Report #US97085203A Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Health Zyprexa PS ORAL 15.00 MG Professional DAILY PO Date:11/03/97ISR Number: 3034129-XReport Type:Periodic Company Report #US97085287A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Consumer Zyprexa PS ORAL 7.50 MG DAILY PO 2 MON Date:11/03/97ISR Number: 3034131-8Report Type:Periodic Company Report #US97085293A Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Arthralgia Health Zyprexa PS ORAL 10.00 MG Oedema Peripheral Professional DAILY PO Depakote C Klonopin C 24-Jun-2005 12:19 PM Page: 100 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3034133-1Report Type:Periodic Company Report #US97085299A Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disturbance In Attention Consumer Zyprexa PS ORAL 5.00 MG DAILY Posture Abnormal Health PO 1 WK Professional Sinemet C Date:11/03/97ISR Number: 3034134-3Report Type:Periodic Company Report #US97085305A Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Back Pain Consumer Zyprexa PS ORAL 10.00 MG Health DAILY PO 1 MON Professional Date:11/03/97ISR Number: 3034136-7Report Type:Periodic Company Report #US97085311A Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Health Zyprexa PS 10.00 MG UNK 1 MON Tardive Dyskinesia Professional Company Representative Date:11/03/97ISR Number: 3034138-0Report Type:Periodic Company Report #US97085314A Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Mania Health Zyprexa PS 10.00 MG UNK 2 MON Professional Company Representative Date:11/03/97ISR Number: 3034140-9Report Type:Periodic Company Report #US97090229A Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eyelid Function Disorder Consumer Zyprexa PS ORAL 15.00 MG Movement Disorder Health DAILY PO Nasal Discomfort Professional Date:11/03/97ISR Number: 3034142-2Report Type:Periodic Company Report #US97090466A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Health Zyprexa PS 2 WK Professional Depakote C Company Zoloft C Representative 24-Jun-2005 12:19 PM Page: 101 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 3034144-6Report Type:Periodic Company Report #US97090637A Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Malaise Health Zyprexa PS ORAL 5.00 MG UNK Medication Error Professional PO Date:11/03/97ISR Number: 3034147-1Report Type:Periodic Company Report #US97090826A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Parkinsonism Health Zyprexa PS 5.00 UNK Professional Date:11/03/97ISR Number: 3034149-5Report Type:Periodic Company Report #US97090835A Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Parkinsonism Health Zyprexa PS 5.00 UNK Professional Date:11/03/97ISR Number: 3034151-3Report Type:Periodic Company Report #US97090838A Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration