FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/01ISR Number: 3671177-0Report Type:Expedited (15-DaCompany Report #A102354 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Liver Function Test Foreign Zeldox PS Pfizer Medicinal Initial or Prolonged Abnormal Health Product Research And Pyrexia Professional Development ORAL 40.00 MG Respiratory Failure TOTAL:BID:ORA Viral Infection L Date:03/05/01ISR Number: 3674499-2Report Type:Expedited (15-DaCompany Report #A103693 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Zeldox PS Pfizer Medicinal Health Product Research And Professional Development ORAL ORAL Company Representative Date:03/06/01ISR Number: 3675422-7Report Type:Expedited (15-DaCompany Report #A100973 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cholelithiasis Foreign Zeldox PS Pfizer Medicinal Completed Suicide Health Product Research And Decreased Appetite Professional Development ORAL 40.00 MG Depression TOTAL: BID: Fatigue ORAL Therapeutic Agent Fluoxetin SS Toxicity Propiomazin SS Uterine Leiomyoma Lithionit C Weight Decreased Bevitotal Comp C Alvedon C Losec Mups C Imovane C Apodorm C Date:03/06/01ISR Number: 3675430-6Report Type:Expedited (15-DaCompany Report #A104078 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Zeldox PS Pfizer Medicinal Health Product Research And Professional Development Company Representative Date:03/09/01ISR Number: 3678302-6Report Type:Expedited (15-DaCompany Report #A103833 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicide Attempt Foreign Zeldox PS Pfizer Medicinal Initial or Prolonged Health Product Research And Professional Development ORAL 80.00 MG 22-Feb-2006 08:32 AM Page: 1 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report TOTAL:BID:ORA L Date:03/12/01ISR Number: 3680366-0Report Type:Expedited (15-DaCompany Report #A100973 Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cholecystitis Foreign Zeldox PS Pfizer Medicinal Cholelithiasis Health Product Research And Completed Suicide Professional Development ORAL 40:00 MG Decreased Appetite TOTAL:BID:ORA Depression L Fatigue Fluoxetin SS Intentional Overdose Propiomazin SS Uterine Leiomyoma Lithionit C Weight Decreased Bevitotal Comp C Alvedon C Losec Mups C Imovane C Apodorm C Date:03/12/01ISR Number: 3680847-XReport Type:Expedited (15-DaCompany Report #A103833 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicide Attempt Foreign Zeldox PS Pfizer Medicinal Initial or Prolonged Health Product Research And Professional Development ORAL 80.00 MG TOTAL:BID:ORA L Date:03/19/01ISR Number: 3684501-XReport Type:Expedited (15-DaCompany Report #A103833 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicide Attempt Foreign Zeldox PS Pfizer Medicinal Initial or Prolonged Health Product Research And Professional Development ORAL 160.00 MG TOTAL:BID:ORA L Hibernal C Fluanxol C Date:04/04/01ISR Number: 3696950-4Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Geodon (Ziprazodone) Dyspnoea 40mg-Pfizer PS Pfizer ORAL 40MG PO BID Fatigue Lithium Heart Rate Increased Carbonate(Eskalith Syncope Cr) C Tremor 22-Feb-2006 08:32 AM Page: 2 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/05/01ISR Number: 3699931-XReport Type:Direct Company Report # Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Geodon / 20mg / Corrected Interval Pfizer Roerig PS Pfizer Roerig ORAL 20 MG BID Prolonged ORAL Electrocardiogram Qt Zyprexa C Prolonged Depakote C Artane C Lipitor C Captopril C Verapamil C Hct C Klor Conc C Asa C Date:04/09/01ISR Number: 3701761-7Report Type:Expedited (15-DaCompany Report #A106621 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Liver Function Test Consumer Zeldox PS Pfizer Medicinal Intervention to Abnormal Product Research And Prevent Permanent Development ORAL 80.00 MG Impairment/Damage TOTAL: BID: ORAL Haldol SS Zyprexa C Depakote C Serevent C Topamax C Zoloft C Prevacid C Flovent C Date:04/11/01ISR Number: 3702490-6Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Ziprasidone 80 Mg Initial or Prolonged Consciousness Pfizer PS ORAL 80 MG QD ORAL Medication Error Date:04/18/01ISR Number: 3707782-2Report Type:Expedited (15-DaCompany Report #A107567 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bladder Disorder Foreign Ziprasidone PS Pfizer Medicinal Initial or Prolonged Constipation Consumer Product Research And Faecal Incontinence Development ORAL 40.00 MG Gastrointestinal Disorder TOTAL: BID: Urinary Incontinence ORAL Uterine Disorder 22-Feb-2006 08:32 AM Page: 3 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/19/01ISR Number: 3707346-0Report Type:Direct Company Report # Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Atrioventricular Block Geodon 40 Mg Po Bid PS Pfizer ORAL 40MG PO BID Intervention to First Degree Lanoxin C Prevent Permanent Furosemide C Impairment/Damage Norvasc C Synthroid C Toprol C Buspar C Date:04/24/01ISR Number: 3710641-2Report Type:Expedited (15-DaCompany Report #A107567 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Foreign Zeldox PS Pfizer Central Initial or Prolonged Blood Glucose Increased Consumer Research ORAL 40.00 MG Constipation TOTAL: BID: Diarrhoea ORAL Faecal Incontinence Insomnia Oedema Peripheral Urinary Incontinence Urinary Retention Uterine Enlargement Uterine Injury Uterine Leiomyoma Date:04/25/01ISR Number: 3711157-XReport Type:Expedited (15-DaCompany Report #10801926 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Health Serzone PS Bristol Myers Squibb Initial or Prolonged Dizziness Professional Co Pharmaceutical Drug Interaction Research Institute ORAL 300 Nausea MILLIGRAM, 1 Palpitations DAY ORAL Panic Attack Geodon (Ziprasidone) SS 40 MILLIGRAM, Vomiting 1 DAY Xanax C Seroquel C Date:04/26/01ISR Number: 3711912-6Report Type:Expedited (15-DaCompany Report #A107661 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Agitation Health Geodon PS Pfizer Central Intervention to Anxiety Professional Research ORAL 40.00 MG Prevent Permanent Bundle Branch Block Right TOTAL BID Impairment/Damage Constipation ORAL Electrocardiogram Risperidone SS Abnormal Thorazine C Electrocardiogram Qt Asa C Prolonged Lorazepam C Insomnia Vitamin B12 C Pain Neutra-Phos C Lithium C Tylenol C 22-Feb-2006 08:32 AM Page: 4 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Cogentin C Chloral Hydrate C Mom With Cascara C Fleet Enema C Hydrocortisone C Sebulex C Olanzepine C Mevacor C Imodium C Phenolated Resorcinol C Terbinafine C Date:04/27/01ISR Number: 3713052-9Report Type:Direct Company Report # Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coronary Artery Disease Geodon (Ziprasidone) PS 2 WK Sudden Death Mellaril C Date:04/30/01ISR Number: 3714067-7Report Type:Expedited (15-DaCompany Report #A108439 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Health Geodon PS Pfizer Central Initial or Prolonged Professional Research ORAL 80.00 MG Company TOTAL:BID:ORA Representative L Depakote (Divalproex Sodium) C Seroquel (Quetiapine Fumarate) C Topamax (Topiramate) C Date:04/30/01ISR Number: 3714230-5Report Type:Direct Company Report # Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Agitation Geodon PS ORAL 40MG PO BID Intervention to Arthralgia Haldol C Prevent Permanent Blood Creatine Zyprexa C Impairment/Damage Phosphokinase Increased Seroquel C Leukocytosis Diazepam C Muscle Rigidity Pyrexia Sedation Tachycardia Tremor Date:05/01/01ISR Number: 3714709-6Report Type:Expedited (15-DaCompany Report #A108439 Age:20 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Geodon PS Pfizer Central Initial or Prolonged Hallucination Professional Research ORAL 80.00 MG Mania Company TOTAL:BID:ORA Sedation Representative L 22-Feb-2006 08:32 AM Page: 5 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Depakote (Divalproex Sodium) C Seroquel (Quetiapine Fumarate) C Topamax (Topiramate) C Date:05/04/01ISR Number: 3717506-0Report Type:Direct Company Report # Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyskinesia Ziprasidone PS ORAL 20 MG PO BID Muscle Twitching Date:05/04/01ISR Number: 3718396-2Report Type:Expedited (15-DaCompany Report #A109034 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Decreased Appetite Consumer Geodon PS Pfizer Central Initial or Prolonged Delusion Research ORAL 40.00 MG Drug Ineffective TOTAL: BID: Insomnia ORAL Zoloft C Date:05/04/01ISR Number: 3718403-7Report Type:Expedited (15-DaCompany Report #A109036 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Health Geodon PS Pfizer Central Initial or Prolonged Professional Research 80.00 MG TOTAL: BID Risperdal C Date:05/04/01ISR Number: 3733604-XReport Type:Periodic Company Report #A109516 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyspepsia Health Geodon PS Pfizer Central Nausea Professional Research Company Representative Date:05/07/01ISR Number: 3718074-XReport Type:Direct Company Report # Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Ziprasidone Convulsion (Geodon)-Roerig Loss Of Consciousness Division Of Pfizer PS Roering Division Of Vomiting Pfizer ORAL 20MG PO 1 CAPSULE PER DAY Clonidine C 22-Feb-2006 08:32 AM Page: 6 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/07/01ISR Number: 3718896-5Report Type:Expedited (15-DaCompany Report #A109100 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Papilloedema Health Geodon PS Pfizer Central Intervention to Professional Research ORAL 240.00 MG Prevent Permanent TOTAL:BID:ORA Impairment/Damage L Zyprexa C Zoloft C Aspirin C Date:05/07/01ISR Number: 3718898-9Report Type:Expedited (15-DaCompany Report #A109437 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anticholinergic Syndrome Health Geodon PS Pfizer Central Initial or Prolonged Cerebrovascular Accident Professional Research 40.00 MG Movement Disorder Company TOTAL:BID Tongue Disorder Representative Perphenazine SS Amoxapine C Ativan C Klonopin C Zyprexa C Date:05/07/01ISR Number: 3718920-XReport Type:Expedited (15-DaCompany Report #A109110 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Consumer Geodon PS Pfizer Central Initial or Prolonged Crying Research ORAL 40.00 MG Fear TOTAL: BID: Hallucination ORAL Hallucination, Auditory Paxil C Hyperhidrosis Wellbutrin C Lithium C Zyrtec C Date:05/07/01ISR Number: 3718937-5Report Type:Expedited (15-DaCompany Report #A109368 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Discomfort Health Geodon PS Pfizer Central Initial or Prolonged Chest Pain Professional Research Company Representative Date:05/07/01ISR Number: 3718938-7Report Type:Expedited (15-DaCompany Report #A109401 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Insomnia Health Geodon PS Pfizer Central Hospitalization - Myocardial Infarction Professional Research ORAL 80.00 MG Initial or Prolonged Sudden Death TOTAL: BID; ORAL Serentil SS Depakote C Neurontin C 22-Feb-2006 08:32 AM Page: 7 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/07/01ISR Number: 3719135-1Report Type:Expedited (15-DaCompany Report #A109319 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dyskinesia Consumer Geodon PS Pfizer Central Intervention to Fall Research ORAL 140.00 MG Prevent Permanent Headache TOTAL:DAILY:O Impairment/Damage Muscle Spasms RAL Neck Pain Cogentin SS ORAL 1.50 MG TOTAL:TID:ORA L Aspirin C Date:05/08/01ISR Number: 3720196-4Report Type:Expedited (15-DaCompany Report #A109435 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Health Geodon PS Pfizer Central Initial or Prolonged Asthenia Professional Research ORAL 40.00 MG Decreased Activity TOTAL BID Drug Interaction ORAL Dysarthria Effexor SS ORAL 300.00 MG Gait Disturbance TOTAL DAILY Headache ORAL Hyperhidrosis Aldactone C Insomnia Risperidone C Nausea Restlessness Stress Suicidal Ideation Date:05/08/01ISR Number: 3720198-8Report Type:Expedited (15-DaCompany Report #A108646 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Irritability Consumer Geodon PS Pfizer Central Initial or Prolonged Mania Research ORAL 80.00 MG TOTAL BID ORAL Seroquel SS ORAL 300.00 MG TOTAL DAILY ORAL Depakote C Neurontin C Clonazepam C Date:05/08/01ISR Number: 3720200-3Report Type:Expedited (15-DaCompany Report #A109539 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Geodon PS Pfizer Central Initial or Prolonged Coma Professional Research 40.00 MG Electrocardiogram Company TOTAL BID Abnormal Representative B12 Injection C Hypotension 22-Feb-2006 08:32 AM Page: 8 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/10/01ISR Number: 3720681-5Report Type:Direct Company Report # Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Serotonin Syndrome Geodon 20mg PS ORAL 2TT QD PO Initial or Prolonged Luvox 100mg SS ORAL 2TT QD PO Prinivil C Cogentin C Dextrol C Singular C Date:05/10/01ISR Number: 3720706-7Report Type:Expedited (15-DaCompany Report #A109107 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Consumer Geodon PS Pfizer Central Initial or Prolonged Abdominal Pain Upper Health Research INTRAVENOUS Required Anhedonia Professional Trazodone SS Intervention to Anxiety Venlafaxine SS ORAL ORAL Prevent Permanent Cough Lorazepam SS ORAL ORAL Impairment/Damage Decreased Appetite Aleve C Depression Welbutrin C Diarrhoea Zyprexa C Diplopia Humid C Disturbance In Attention Ascorbic Acid C Electrocardiogram Qt Demadex C Corrected Interval Glucotrol Xl C Prolonged Insulin C Fatigue Indocin C Feelings Of Worthlessness Albuterol C Flat Affect Simvastatin C Hallucination, Auditory Cetirizine C Hallucination, Tactile Dobutamine C Headache Guaifenesin C Intentional Overdose Lansoprazole C Lethargy Potassium Chloride C Nausea Sodium Chloride C Nightmare Torsemide C Psychomotor Retardation Dopamine C Sedation Propofol C Self Mutilation Bisacodyl C Social Avoidant Behaviour Gentamycin C Suicidal Ideation Fluconazole C Vision Blurred Metoclopramide C Triamterene C Acetaminophen C Cisapride C Zinc Sulfate C Platelet C Fentanyl C Morepinephrine C Leukocyte Poor Prbcs C Acetazolamide C Propoxyphene/Acetami nophen C Magnesium Sulfate C Sodium Bicarbonate C Nitroglycerine C Milrinone C Packed Rbcs C Aztreonam C 22-Feb-2006 08:32 AM Page: 9 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Furosemide C Hetastarch C Isorbide Mononitrate C Vancomycin C Lactated Ringers C Calcium Chloride C Cetacaine C Clindamycin C Fresh Frozen Plasma C Isoflurane C Date:05/11/01ISR Number: 3721890-1Report Type:Expedited (15-DaCompany Report #A109802 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Health Geodon PS Pfizer Central Initial or Prolonged Fall Professional Research ORAL ORAL Hallucination, Auditory Seroquel C Muscle Rigidity Klonopin C Muscle Twitching Propranolol C Tongue Discolouration Paxil C Tongue Disorder Nortriptyline C Tremor Lithium C Date:05/11/01ISR Number: 3721901-3Report Type:Expedited (15-DaCompany Report #A109905 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Neuroleptic Malignant Health Geodon PS Pfizer Central Intervention to Syndrome Professional Research Prevent Permanent Company Impairment/Damage Representative Date:05/11/01ISR Number: 3721903-7Report Type:Expedited (15-DaCompany Report #A109864 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Geodon PS Pfizer Central Required Convulsion Professional Research ORAL 20.00 MG Intervention to Nausea TOTAL:DAILY:O Prevent Permanent RAL Impairment/Damage Clonidine C Date:05/14/01ISR Number: 3723774-1Report Type:Expedited (15-DaCompany Report #A110024 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Geodon PS Pfizer Central Initial or Prolonged Impulsive Behaviour Professional Research ORAL 80.00 MG Sexual Dysfunction Company TOTAL; DAILY; Representative ORAL 22-Feb-2006 08:32 AM Page: 10 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/15/01ISR Number: 3723521-3Report Type:Expedited (15-DaCompany Report #A109401 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Insomnia Health Geodon PS Pfizer Central Hospitalization - Myocardial Infarction Professional Research ORAL 80.00 MG Initial or Prolonged Sudden Death Company TOTAL:BID:ORA Representative L Serentil SS Depakote C Neurontin C Date:05/15/01ISR Number: 3723528-6Report Type:Expedited (15-DaCompany Report #A110170 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Geodon PS Pfizer Central Initial or Prolonged Drug Ineffective Professional Research 80.00 MG Required Erythema TOTAL; BID Intervention to Grand Mal Convulsion Haldol C Prevent Permanent Hyperhidrosis Zantac C Impairment/Damage Hypertension Nausea Oxygen Saturation Decreased Tachycardia Vomiting Date:05/15/01ISR Number: 3723712-1Report Type:Expedited (15-DaCompany Report #A109107 Age:42 YR Gender:Female I/FU:F Outcome PT Hospitalization - Abdominal Pain Initial or Prolonged Abdominal Pain Upper Required Abdominal Tenderness Intervention to Anhedonia Prevent Permanent Anxiety Impairment/Damage Cough Decreased Activity Dependent Personality Disorder Diarrhoea Diplopia Disturbance In Attention Dizziness Drug Level Above Therapeutic Dyspepsia Dysphoria Electrocardiogram Abnormal Faecal Incontinence Feelings Of Worthlessness Flat Affect Hallucination, Auditory Hallucination, Synaesthetic Headache Insomnia Intentional Overdose 22-Feb-2006 08:32 AM Page: 11 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lethargy Nausea Neglect Of Personal Report Source Product Role Manufacturer Route Dose Duration Appearance Consumer Geodon PS Pfizer Central Nightmare Health Research Sedation Professional Trazodone SS Social Avoidant Behaviour Venlafaxine SS ORAL ORAL Urinary Incontinence Lorazepam SS ORAL ORAL Vision Blurred Aleve C Welbutrin C Zyprexa C Date:05/15/01ISR Number: 3723713-3Report Type:Expedited (15-DaCompany Report #A109539 Age:84 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Geodon PS Pfizer Central Initial or Prolonged Hypotension Professional Research ORAL 40.00 MG Pulse Pressure Decreased TOTAL:BID:ORA L Vitamin B12 Injection C Date:05/16/01ISR Number: 3724893-6Report Type:Expedited (15-DaCompany Report #A109850 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Geodon PS Pfizer Central Professional Research Date:05/16/01ISR Number: 3724896-1Report Type:Expedited (15-DaCompany Report #A109961 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Neuroleptic Malignant Health Geodon PS Pfizer Central Intervention to Syndrome Professional Research Prevent Permanent Company Impairment/Damage Representative Date:05/16/01ISR Number: 3725030-4Report Type:Expedited (15-DaCompany Report #A110322 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Geodon PS Pfizer Central Professional Research Mellaril SS Date:05/16/01ISR Number: 3725031-6Report Type:Expedited (15-DaCompany Report #A109882 Age:18 YR Gender:Female I/FU:I Outcome PT Required Arthralgia Intervention to Blood Creatine Prevent Permanent Phosphokinase Increased Impairment/Damage Neuroleptic Malignant Syndrome 22-Feb-2006 08:32 AM Page: 12 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sedation Tachycardia Report Source Product Role Manufacturer Route Dose Duration Health Geodon PS Pfizer Central Professional Research Haldol C Zyprexa C Seroquel C Diazepam C Date:05/17/01ISR Number: 3724693-7Report Type:Expedited (15-DaCompany Report #A109850 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Geodon PS Pfizer Central Professional Research Date:05/18/01ISR Number: 3725577-0Report Type:Expedited (15-DaCompany Report #A109401 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Glucose Increased Consumer Geodon PS Pfizer Central Hospitalization - Hypertension Health Research ORAL 20.00 MG Initial or Prolonged Insomnia Professional TOTAL:BID:ORA Insulin Resistance Company L Obesity Representative Serentil SS Osteoarthritis Depakote C Seborrhoea Neurontin C Sudden Death Atorvastatin C Remeron C Klonepin C Date:05/21/01ISR Number: 3726385-7Report Type:Expedited (15-DaCompany Report #A109377 Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Health Geodon PS Pfizer Central Initial or Prolonged Corrected Interval Professional Research ORAL 60.00 MG Required Prolonged TOTAL:BID:ORA Intervention to Electrocardiogram Qt L Prevent Permanent Prolonged ... C Impairment/Damage Mental Impairment Sedation Date:05/22/01ISR Number: 3727194-5Report Type:Expedited (15-DaCompany Report #001-0981-M0103661 Age:47 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Unevaluable Event Health Lipitor PS Pfizer Inc ORAL 10 MG (BID), Initial or Prolonged Professional PER ORAL (Gabapentin) SS ORAL 1200 MG (EVERY AM)'600 MG (EVERY NOON); 1200 MG (Geodon) SS ORAL 40 MG (DAILY);4O MG 22-Feb-2006 08:32 AM Page: 13 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (BID);40 MG (DAILY); 20 MG (DAILY), (Acetylsalicylic Acid) SS ORAL 325 MG (DAILY), PER ORAL (Chlorpromazine) SS ORAL 100 MG (EVERY 4 HOURS PRN), PER ORAL (Clonazepam) SS ORAL 2 MG (AT BEDTIME), PER ORAL (Lorazepam) SS ORAL 2 MG (EVERY 6 HOURS); 2 MG (EVERY 4 HR PRN), PER ORAL (Mesoridazine) SS ORAL 50 MG (DAILY);75 MG (BID);75 MG (TID); 50 MG (EVERY 4 (Mirtazapine) SS ORAL 15 MG (AT BEDTIME), PER ORAL Date:05/22/01ISR Number: 3727618-3Report Type:Direct Company Report # Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Agitation Geodon 20mg Pfizer PS Pfizer ORAL ONE CAPSU AT Intervention to Anxiety BED TIME ORAL Prevent Permanent Chest Pain Impairment/Damage Hyperhidrosis Date:05/23/01ISR Number: 3727876-5Report Type:Expedited (15-DaCompany Report #A110764 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Health Geodon PS Pfizer Central Initial or Prolonged Drug Effect Decreased Professional Research UNKNOWN 40.00 MG TOTAL:BID:UNK NOWN Prolixin (Fluphenazine) C Prozac (Fluoxetine) C Serevent (Salmeterol) C Tegretol (Carbamazepine) C Calcium Supplement C Verapamil C Valproic Acid C 22-Feb-2006 08:32 AM Page: 14 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/23/01ISR Number: 3727877-7Report Type:Expedited (15-DaCompany Report #A110761 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Health Geodon PS Pfizer Central Initial or Prolonged Liver Function Test Professional Research ORAL 80.00 MG Abnormal TOTAL:BID:ORA L Pravachol C Anafranil (Clomipramine) C Clonazepam C Effexor (Venlafaxine) C Risperidone C Os-Cal 500 C Date:05/23/01ISR Number: 3727880-7Report Type:Expedited (15-DaCompany Report #A110766 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Consumer Geodon PS Pfizer Central Initial or Prolonged Disorientation Research 80.00 MG Malaise TOTAL BID Atenolol C Date:05/23/01ISR Number: 3727886-8Report Type:Expedited (15-DaCompany Report #A109864 Age:17 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Geodon PS Pfizer Central Required Convulsion Professional Research ORAL 20.00 MG Intervention to Nausea TOTAL DAILY Prevent Permanent ORAL Impairment/Damage Clonidine C Date:05/23/01ISR Number: 3727887-XReport Type:Expedited (15-DaCompany Report #A108646 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Consumer Geodon PS Pfizer Central Initial or Prolonged Medication Error Health Research ORAL ORAL Schizophrenia Professional Seroquel SS ORAL 300.00 MG TOTAL DAILY ORAL Neurontin (Gabapentin) SS 3600.00 MG TOTAL TID Beer SS ORAL ORAL Depakote C Clonazepam C Date:05/25/01ISR Number: 3728889-XReport Type:Expedited (15-DaCompany Report #A109850 Age:80 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Geodon PS Pfizer Central Life-Threatening Professional Research ORAL 80.00 MG 22-Feb-2006 08:32 AM Page: 15 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report TOTAL:BID:ORA L Lasix C Potassium C Vitamin C Folic Acid C Date:05/25/01ISR Number: 3728891-8Report Type:Expedited (15-DaCompany Report #A109401 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Insomnia Consumer Geodon PS Pfizer Central Hospitalization - Sudden Death Health Research ORAL 20.00 MG Initial or Prolonged Professional TOTAL:DAILY:O RAL Serentil SS ORAL 225.00 MG TOTAL:TID:ORA L Neurontin C Atorvastatin C Remeron C Klonopin C Aspirin C Thorazine C Lorazepam C Cogentin C Depakote C Prinivil C Moban C Zyprexa C Seroquel C Prozac C Date:05/25/01ISR Number: 3730495-8Report Type:Expedited (15-DaCompany Report #A109107 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Consumer Geodon PS Pfizer Central Initial or Prolonged Abdominal Tenderness Health Research 4360.00 MG Required Anhedonia Professional TOTAL Intervention to Anxiety Trazodone SS 800.00 MG Prevent Permanent Body Temperature TOTAL Impairment/Damage Decreased Venlafaxine SS ORAL 2400.00 MG Condition Aggravated TOTAL:ORAL Depression Lorazepam SS ORAL ORAL Diplopia Aleve C Disturbance In Attention Wellbutrin C Electrocardiogram Qt Zyprexa C Corrected Interval Prolonged Hallucination, Auditory Insomnia Intentional Overdose Intentional Self-Injury Laceration Lethargy Oral Intake Reduced Sedation Social Avoidant Behaviour Suicidal Ideation 22-Feb-2006 08:32 AM Page: 16 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/29/01ISR Number: 3729944-0Report Type:Expedited (15-DaCompany Report #A110766 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Consumer Geodon PS Pfizer Central Initial or Prolonged Disorientation Research 60.00 MG Malaise TOTAL; BID Restlessness Atenolol C Date:05/29/01ISR Number: 3729980-4Report Type:Expedited (15-DaCompany Report #A110980 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abdominal Distension Consumer Geodon PS Pfizer Central Anxiety Research ORAL 40.00 MG Arrhythmia TOTAL BID Blood Pressure Increased ORAL Cardiac Arrest Synthroid C Dizziness Estratest C Electrocardiogram Qt Effexor C Prolonged Prevacid C Electrocardiogram T Wave Inversion Extrasystoles Heart Rate Increased Loss Of Consciousness Palpitations Syncope Ventricular Tachycardia Date:05/29/01ISR Number: 3730076-6Report Type:Expedited (15-DaCompany Report #A110982 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Health Geodon PS Pfizer Central Initial or Prolonged Professional Research UNKNOWN UNKNOWN; UNKNOWN Date:05/30/01ISR Number: 3729693-9Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Geodon Ziprasidone Initial or Prolonged 20mg Pfizer PS Pfizer ORAL 20MG BID ORAL Required Intervention to Prevent Permanent Impairment/Damage Date:05/30/01ISR Number: 3730633-7Report Type:Expedited (15-DaCompany Report #A111153 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Inappropriate Foreign Geodon PS Pfizer Central Initial or Prolonged Antidiuretic Hormone Health Research ORAL ORAL Secretion Professional Tegretol SS ORAL ORAL Zopliclone SS Nitrazepam SS 22-Feb-2006 08:32 AM Page: 17 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Stesolid C Date:05/30/01ISR Number: 3730936-6Report Type:Expedited (15-DaCompany Report #A111003 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Consumer Geodon PS Pfizer Central Initial or Prolonged Increased Research BID Required Aspartate Ritalin Sr C Intervention to Aminotransferase Seroquel C Prevent Permanent Increased Aleve C Impairment/Damage Convulsion Dysphagia Headache Infectious Mononucleosis Lymphocyte Count Increased Muscle Rigidity Myalgia Oxygen Saturation Decreased Pharyngolaryngeal Pain Pyrexia Date:05/30/01ISR Number: 3730937-8Report Type:Expedited (15-DaCompany Report #A111431 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arrhythmia Health Geodon PS Pfizer Central Electrocardiogram Qt Professional Research Corrected Interval Company Ativan (Lorazepam) C Prolonged Representative Date:05/30/01ISR Number: 3730953-6Report Type:Expedited (15-DaCompany Report #A108295 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Health Geodon PS Pfizer Central Initial or Prolonged Chest Pain Professional Research Required Heart Rate Increased Risperidone SS Intervention to Panic Attack Prevent Permanent Impairment/Damage Date:05/30/01ISR Number: 3731169-XReport Type:Expedited (15-DaCompany Report #A109850 Age:80 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Health Geodon PS Pfizer Central Life-Threatening Confusional State Professional Research ORAL 80.00 MG Dementia Alzheimer'S Type TOTAL:BID:ORA Sudden Death L Tremor Lasix C Potassium C Vitamin C Folic Acid C 22-Feb-2006 08:32 AM Page: 18 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/30/01ISR Number: 3731172-XReport Type:Expedited (15-DaCompany Report #A109401 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Consumer Geodon PS Pfizer Central Hospitalization - Blood Glucose Increased Health Research ORAL 80.00 MG Initial or Prolonged Insomnia Professional TOTAL:DAILY:O Psychotic Disorder Company RAL Sudden Death Representative Serentil SS ORAL 225.00 MG TOTAL:TID:ORA L Neurontin C Atorvastatin C Remeron C Klonopin C Aspirin C Thorazine C Lorazepam C Cogentin C Depakote C Prinivil C Moban C Zyprexa C Seroquel C Prozac C Date:06/01/01ISR Number: 3732124-6Report Type:Expedited (15-DaCompany Report #A111635 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Geodon PS Pfizer Central Loss Of Consciousness Professional Research ORAL ORAL Medication Error Company Unspecified Overdose Representative Medications SS Suicide Attempt Luvox C Date:06/01/01ISR Number: 3732126-XReport Type:Expedited (15-DaCompany Report #A111562 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Consumer Geodon PS Pfizer Central Initial or Prolonged Research ORAL 120.00 MG TOTAL; BID; ORAL Neurontin (Gabapentin) C Date:06/01/01ISR Number: 3732128-3Report Type:Expedited (15-DaCompany Report #A111507 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypotension Health Geodon PS Pfizer Central Syncope Professional Research ORAL UNKNOWN; ORAL Company Representative 22-Feb-2006 08:32 AM Page: 19 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/01/01ISR Number: 3732136-2Report Type:Expedited (15-DaCompany Report #A110764 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Health Geodon PS Pfizer Central Initial or Prolonged Drug Effect Decreased Professional Research ORAL PO Electrocardiogram Prolixin Abnormal (Fluphenazine) C Prozac (Fluoxetine) C Serevent (Salmeterol) C Tegretol (Carbamazepine) C Calcium Supplement C Verapamil C Valproic Acid C Date:06/01/01ISR Number: 3732141-6Report Type:Expedited (15-DaCompany Report #A111396 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Grand Mal Convulsion Health Geodon PS Pfizer Central Intervention to Professional Research Prevent Permanent Lithium C Impairment/Damage Paxil C Unknown Blood Pressure Medication C Date:06/04/01ISR Number: 3733045-5Report Type:Expedited (15-DaCompany Report #A111507 Age: Gender:Unknown I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Orthostatic Hypotension Health Geodon PS Pfizer Central Syncope Professional Research ORAL ORAL Company Representative Date:06/04/01ISR Number: 3733424-6Report Type:Periodic Company Report #A109385 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Insomnia Health Geodon PS Pfizer Central Mania Professional Research 20.00 MG Sedation Company TOTAL:DAILY Representative Date:06/04/01ISR Number: 3733425-8Report Type:Periodic Company Report #A109386 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chest Pain Health Geodon PS Pfizer Central Dyspnoea Professional Research Company Representative 22-Feb-2006 08:32 AM Page: 20 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/04/01ISR Number: 3733426-XReport Type:Periodic Company Report #A109387 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperhidrosis Health Geodon PS Pfizer Central Nausea Professional Research 60.00 MG Sedation Company TOTAL:BID Representative Date:06/04/01ISR Number: 3733427-1Report Type:Periodic Company Report #A109388 Age:11 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Health Geodon PS Pfizer Central Dyskinesia Professional Research 80.00 MG Company TOTAL:BID Representative Date:06/04/01ISR Number: 3733428-3Report Type:Periodic Company Report #A109389 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Extrapyramidal Disorder Health Geodon PS Pfizer Central Professional Research Company Representative Date:06/04/01ISR Number: 3733429-5Report Type:Periodic Company Report #A109415 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depression Consumer Geodon PS Pfizer Central Research ORAL 20.00 MG TOTAL:DAILY:O RAL Premarin C Prilosec C Date:06/04/01ISR Number: 3733430-1Report Type:Periodic Company Report #A109425 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Headache Health Geodon PS Pfizer Central Nausea Professional Research ORAL 40.00 MG Company TOTAL:BID:ORA Representative L Topamax C Lithium C Date:06/04/01ISR Number: 3733431-3Report Type:Periodic Company Report #A109439 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Health Geodon PS Pfizer Central Visual Disturbance Professional Research ORAL 20.00 MG Company TOTAL:DAILY:O Representative RAL 22-Feb-2006 08:32 AM Page: 21 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Seroquel C Effexor C Risperdal C Date:06/04/01ISR Number: 3733432-5Report Type:Periodic Company Report #A109441 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Consumer Geodon PS Pfizer Central Research 80.00 MG TOTAL:DAILY Accutane C Zoloft C Risperdal C Date:06/04/01ISR Number: 3733433-7Report Type:Periodic Company Report #A109443 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dermatitis Health Geodon PS Pfizer Central Professional Research 80.00 MG TOTAL:BID Depakote C Wellbutrin C Klonopin C Date:06/04/01ISR Number: 3733434-9Report Type:Periodic Company Report #A108437 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diarrhoea Health Geodon PS Pfizer Central Palpitations Professional Research Company Representative Date:06/04/01ISR Number: 3733435-0Report Type:Periodic Company Report #A108440 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Mania Health Geodon PS Pfizer Central Professional Research ORAL 100.00 MG Company TOTAL:BID:ORA Representative L Depakote (Divalproex Sodium) C Zyprexa (Olanzapine) C Date:06/04/01ISR Number: 3733436-2Report Type:Periodic Company Report #A108458 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bradycardia Health Geodon PS Pfizer Central Professional Research 22-Feb-2006 08:32 AM Page: 22 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/04/01ISR Number: 3733437-4Report Type:Periodic Company Report #A108467 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amnesia Consumer Geodon PS Pfizer Central Coordination Abnormal Research ORAL 40.00 MG Depression TOTAL: Dizziness DAILY:ORAL Personality Disorder Effexor C Sedation Synthroid C Thinking Abnormal Cytomel C Progesterone C Ativan C Vitamins C Trazodone C Cozaar C Klonopin C Date:06/04/01ISR Number: 3733438-6Report Type:Periodic Company Report #A108470 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bipolar I Disorder Consumer Geodon PS Pfizer Central Research 40.00 MG TOTAL:BID Risperdal C Depakote C Lithium C Wellbutrin C Date:06/04/01ISR Number: 3733439-8Report Type:Periodic Company Report #A108484 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypersensitivity Consumer Geodon PS Pfizer Central Research ORAL ORAL Date:06/04/01ISR Number: 3733440-4Report Type:Periodic Company Report #A108538 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tremor Health Geodon PS Pfizer Central Professional Research Company Representative Date:06/04/01ISR Number: 3733441-6Report Type:Periodic Company Report #A108577 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypocalcaemia Health Geodon PS Pfizer Central Professional Research Calcium C 22-Feb-2006 08:32 AM Page: 23 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/04/01ISR Number: 3733442-8Report Type:Periodic Company Report #A108581 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Health Geodon PS Pfizer Central Drug Interaction Professional Research ORAL 150.00 MG TOTAL:BID:ORA L Wellbutrin SS ORAL 250.00 MG TOTAL:BID:ORA L Date:06/04/01ISR Number: 3733443-XReport Type:Periodic Company Report #A108585 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyspnoea Consumer Geodon PS Pfizer Central Research ORAL 120.00 MG TOTAL:ORAL Wellbutrin C Seroquel C Topamax C Klonopin C Temazepam C Date:06/04/01ISR Number: 3733444-1Report Type:Periodic Company Report #A108233 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Apathy Consumer Geodon PS Pfizer Central Psychotic Disorder Research ORAL 40.00 MG Sedation TOTAL:BID:ORA L Seroquel SS Date:06/04/01ISR Number: 3733445-3Report Type:Periodic Company Report #A108234 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diarrhoea Health Geodon PS Pfizer Central Palpitations Professional Research Company Seroquel Representative (Quetiapine) C Serzone (Nefazodone) C Xanax (Alprazolam) C Date:06/04/01ISR Number: 3733446-5Report Type:Periodic Company Report #A108309 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dermatitis Health Geodon PS Pfizer Central Folliculitis Professional Research ORAL 20.00 MG Photosensitivity Reaction TOTAL:DAILY:O RAL 22-Feb-2006 08:32 AM Page: 24 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/04/01ISR Number: 3733447-7Report Type:Periodic Company Report #A108367 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thinking Abnormal Health Geodon PS Pfizer Central Professional Research 40.00 MG Company TOTAL Representative Date:06/04/01ISR Number: 3733448-9Report Type:Periodic Company Report #A108382 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Malaise Health Geodon PS Pfizer Central Professional Research 40.00 MG TOTAL:BID Zoloft C Zyprexa C Date:06/04/01ISR Number: 3733449-0Report Type:Periodic Company Report #A108392 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accidental Overdose Company Geodon PS Pfizer Central Medication Error Representative Research ORAL 400.00 MG Sedation TOTAL BID/ORAL Lithobid C Trazodone C Levothyroxine C Loratadine C Docusate C Date:06/04/01ISR Number: 3733450-7Report Type:Periodic Company Report #A108393 Age:22 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accidental Overdose Health Geodon PS Pfizer Central Bundle Branch Block Professional Research ORAL 400.00 MG Encephalopathy Company TOTAL BID, Medication Error Representative ORAL Sedation Carbamazepine C Lithobid C Olanzapine C Valproic Acid C Klonipin C Date:06/04/01ISR Number: 3733451-9Report Type:Periodic Company Report #A108399 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pain Health Geodon PS Pfizer Central Professional Research ORAL 40.00 MG TOTAL BID, OROAL 22-Feb-2006 08:32 AM Page: 25 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/04/01ISR Number: 3733452-0Report Type:Periodic Company Report #A108410 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrioventricular Block Health Geodon PS Pfizer Central First Degree Professional Research ORAL 80.00 MG Electrocardiogram Company TOTAL BID Abnormal Representative ORAL Seroquel C Risperdal C Lanoxin C Cyanocobalamin C Furosemide C Norvasc C Synthroid C Toporol Xl C Buspar C Unspecified Stool Softener C Vitamin E C Haldol C Citrucel C Tylenol C Aricept C Diovan C Potassium Chloride C Colace C Lasix C Date:06/04/01ISR Number: 3733453-2Report Type:Periodic Company Report #A108435 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Delirium Consumer Geodon PS Pfizer Central Research 40.00 MG TOTAL BID Seroquel C Depakote C Paxil C Citomel C Metoprolol C Celebrex C Zocor C Date:06/04/01ISR Number: 3733458-1Report Type:Periodic Company Report #A107893 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Headache Health Geodon PS Pfizer Central Professional Research 40.00 MG TOTAL BID Seroquel C Depakote C 22-Feb-2006 08:32 AM Page: 26 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/04/01ISR Number: 3733460-XReport Type:Periodic Company Report #A108026 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Headache Health Geodon PS Pfizer Central Professional Research Company Representative Date:06/04/01ISR Number: 3733462-3Report Type:Periodic Company Report #A108059 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Liver Function Test Health Geodon PS Pfizer Central Abnormal Professional Research ORAL 120.00 MG TOTAL BID ORAL Prevacid C Avandia C Glucotrol Xl C Zyprexa C Lasix C Plavix C Lopressor C Lanoxin C Sular C Date:06/04/01ISR Number: 3733464-7Report Type:Periodic Company Report #A108074 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Nausea Consumer Geodon PS Pfizer Central Tremor Research ORAL 20.00 MG TOTAL DAILY ORAL Risperdal (Risperidone) C Propranolol C Alprazolam C Hydrochlorothiazide C Birth Control Pills C Date:06/04/01ISR Number: 3733465-9Report Type:Periodic Company Report #A108078 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Unevaluable Event Consumer Geodon PS Pfizer Central Weight Increased Research ORAL ORAL Date:06/04/01ISR Number: 3733467-2Report Type:Periodic Company Report #A108087 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Flatulence Health Geodon PS Pfizer Central Professional Research ORAL 40.00 MG TOTAL BID ORAL 22-Feb-2006 08:32 AM Page: 27 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/04/01ISR Number: 3733468-4Report Type:Periodic Company Report #A108106 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Consumer Geodon PS Pfizer Central Feeling Abnormal Research 20.00 MG Headache TOTAL DAILY Hypertension Thyroid Medication C Palpitations Date:06/04/01ISR Number: 3733470-2Report Type:Periodic Company Report #A108108 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Health Geodon PS Pfizer Central Professional Research Company Representative Date:06/04/01ISR Number: 3733471-4Report Type:Periodic Company Report #A108134 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyspepsia Consumer Geodon PS Pfizer Central Tremor Research Date:06/04/01ISR Number: 3733473-8Report Type:Periodic Company Report #A108170 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Insomnia Consumer Geodon PS Pfizer Central Sedation Research ORAL ORAL Tranxene (Clorazepate) C Seroquel (Quetiapine) C Date:06/04/01ISR Number: 3733476-3Report Type:Periodic Company Report #A107777 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diplopia Health Geodon PS Pfizer Central Nausea Professional Research ORAL 40.00 MG Visual Disturbance TOTAL:BID:ORA Vomiting L Pimozide C Trileptal (Oxcarbazepine) C Date:06/04/01ISR Number: 3733477-5Report Type:Periodic Company Report #A107789 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Geodon PS Pfizer Central Professional Research ORAL ORAL Company Depakote (Valproate) C Representative Trileptal 22-Feb-2006 08:32 AM Page: 28 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Oxacarbazepine) C Date:06/04/01ISR Number: 3733478-7Report Type:Periodic Company Report #A107803 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Insomnia Health Geodon PS Pfizer Central Professional Research 80.00 MG Company TOTAL:BID Representative Olanzapine C Date:06/04/01ISR Number: 3733480-5Report Type:Periodic Company Report #A107822 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anorexia Consumer Geodon PS Pfizer Central Arrhythmia Research ORAL 40.00 MG Breast Pain TOTAL:DAILY:O Dermatitis RAL Dizziness Zyprexa (Olanzapine) C Erection Increased Haldol (Haloperidol) C Muscle Twitching Aspirin C Palpitations Sedation Vasodilatation Weight Decreased Date:06/04/01ISR Number: 3733482-9Report Type:Periodic Company Report #A107852 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Consumer Geodon PS Pfizer Central Dermatitis Bullous Research Dizziness Headache Sedation Date:06/04/01ISR Number: 3733483-0Report Type:Periodic Company Report #A107875 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyspepsia Consumer Geodon PS Pfizer Central Research ORAL 20.00 MG TOTAL:DAILY:O RAL Klonopin C Date:06/04/01ISR Number: 3733485-4Report Type:Periodic Company Report #A107876 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hangover Consumer Geodon PS Pfizer Central Insomnia Research ORAL 80.00 MG TOTAL:BID:ORA L Diazepam SS UNKNOWN UNKNOWN 22-Feb-2006 08:32 AM Page: 29 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/04/01ISR Number: 3733487-8Report Type:Periodic Company Report #A107881 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chest Pain Consumer Geodon PS Pfizer Central Gastrointestinal Disorder Research ORAL 40.00 MG Headache TOTAL:BID:ORA Insomnia L Thiothixene SS ORAL 10.00 MG TOTAL:DAILY:O RAL Zyprexa C Klonopin C Glucosamine Sulfate C Date:06/04/01ISR Number: 3733489-1Report Type:Periodic Company Report #A107884 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diarrhoea Health Geodon PS Pfizer Central Vomiting Professional Research ORAL 20.00 MG TOTAL:DAILY:O RAL Trileptal C Date:06/04/01ISR Number: 3733490-8Report Type:Periodic Company Report #A107886 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Health Geodon PS Pfizer Central Prolonged Professional Research ORAL 160.00 MG Hypernatraemia Company TOTAL:BID:ORA Representative L Effexor C Hydroxyzine C Luvox C Provera C Ativan C Date:06/04/01ISR Number: 3733493-3Report Type:Periodic Company Report #A107571 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Health Geodon PS Pfizer Central Professional Research ORAL 80.00 MG TOTAL:BID:ORA L Date:06/04/01ISR Number: 3733494-5Report Type:Periodic Company Report #A107576 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Personality Disorder Health Geodon PS Pfizer Central Professional Research 22-Feb-2006 08:32 AM Page: 30 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/04/01ISR Number: 3733495-7Report Type:Periodic Company Report #A107643 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Health Geodon PS Pfizer Central Orthostatic Hypotension Professional Research 40.00 MG TOTAL:DAILY Neurontin SS Clonidine SS Date:06/04/01ISR Number: 3733496-9Report Type:Periodic Company Report #A107658 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Health Geodon PS Pfizer Central Professional Research ORAL 40.00 MG Company TOTAL:BID:ORA Representative L Date:06/04/01ISR Number: 3733498-2Report Type:Periodic Company Report #A107659 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Health Geodon PS Pfizer Central Stomatitis Professional Research ORAL 40.00 MG Tongue Disorder Company TOTAL:BID:ORA Representative L Date:06/04/01ISR Number: 3733500-8Report Type:Periodic Company Report #A108695 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Urinary Incontinence Health Geodon PS Pfizer Central Professional Research UNKNOWN UNKNOWN Company Representative Date:06/04/01ISR Number: 3733501-XReport Type:Periodic Company Report #A108697 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Urinary Incontinence Health Geodon PS Pfizer Central Professional Research Company Representative Date:06/04/01ISR Number: 3733502-1Report Type:Periodic Company Report #A108699 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Urinary Incontinence Health Geodon PS Pfizer Central Professional Research UNKNOWN UNKNOWN Company Representative 22-Feb-2006 08:32 AM Page: 31 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/04/01ISR Number: 3733503-3Report Type:Periodic Company Report #A107686 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chest Pain Health Geodon PS Pfizer Central Tachycardia Professional Research Company Representative Date:06/04/01ISR Number: 3733504-5Report Type:Periodic Company Report #A108700 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Urinary Incontinence Health Geodon PS Pfizer Central Professional Research UNKNOWN UNKNOWN Company Representative Date:06/04/01ISR Number: 3733505-7Report Type:Periodic Company Report #A108702 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Urinary Incontinence Health Geodon PS Pfizer Central Professional Research UNKNOWN UNKNOWN Company Representative Date:06/04/01ISR Number: 3733506-9Report Type:Periodic Company Report #A107687 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chest Pain Health Geodon PS Pfizer Central Weight Increased Professional Research Company Representative Date:06/04/01ISR Number: 3733507-0Report Type:Periodic Company Report #A108712 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Clonic Convulsion Health Geodon PS Pfizer Central Muscle Spasms Professional Research 40.00 MG TOTAL Gabitril C Anafranil C Date:06/04/01ISR Number: 3733508-2Report Type:Periodic Company Report #A107695 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Health Geodon PS Pfizer Central Dementia Professional Research ORAL 20.00 MG TOTAL:DAILY:O RAL Zyprexa C 22-Feb-2006 08:32 AM Page: 32 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/04/01ISR Number: 3733509-4Report Type:Periodic Company Report #A107697 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Health Geodon PS Pfizer Central Professional Research 40.00 MG TOTAL:BID Date:06/04/01ISR Number: 3733510-0Report Type:Periodic Company Report #A108714 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Consumer Geodon PS Pfizer Central Anorexia Research ORAL 40.00 MG Apathy TOTAL; BID; Dyskinesia ORAL Euphoric Mood Zyprexa SS ORAL ORAL Insomnia Tegretol C Nervousness Vitamin E C Psychotic Disorder Triphasal C Schizophreniform Disorder Inderal C Multi-Vitamin C Date:06/04/01ISR Number: 3733511-2Report Type:Periodic Company Report #A107758 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Consumer Geodon PS Pfizer Central Confusional State Research ORAL 120.00 MG Hyperhidrosis TOTAL:BID:ORA Neurosis L Tachycardia Klonopin C Luvox C Mellaril C Date:06/04/01ISR Number: 3733512-4Report Type:Periodic Company Report #A108718 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Dreams Consumer Geodon PS Pfizer Central Chills Research 40.00 MG Depression TOTAL BID Emotional Disorder Depakote (Valproate) C Date:06/04/01ISR Number: 3733513-6Report Type:Periodic Company Report #A108729 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Health Geodon PS Pfizer Central Fall Professional Research ORAL 20.00 MG Myasthenic Syndrome TOTAL; DAILY; Sedation ORAL Klonopin C Xanax C 22-Feb-2006 08:32 AM Page: 33 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/04/01ISR Number: 3733514-8Report Type:Periodic Company Report #A107317 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Consumer Geodon PS Pfizer Central Palpitations Research 80.00 MG Speech Disorder TOTAL:BID Prozac C Benadryl C Xanax C Trilafon C Date:06/04/01ISR Number: 3733515-XReport Type:Periodic Company Report #A108847 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Palpitations Health Geodon PS Pfizer Central Professional Research Company Representative Date:06/04/01ISR Number: 3733516-1Report Type:Periodic Company Report #A107319 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Health Geodon PS Pfizer Central Abnormal Professional Research Tachycardia Date:06/04/01ISR Number: 3733517-3Report Type:Periodic Company Report #A107321 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Insomnia Consumer Geodon PS Pfizer Central Libido Decreased Research 40.00 MG TOTAL:DAILY Multiple Unspecified Drugs C Date:06/04/01ISR Number: 3733518-5Report Type:Periodic Company Report #A107325 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anorexia Consumer Geodon PS Pfizer Central Arrhythmia Health Research ORAL 40.00 MG Chest Pain Professional TOTAL:DIALY:O Delusion RAL Dizziness Aspirin And Caffeine Vasodilatation Pain Reliever C Vitamin C C Zyprexa C Haldol C 22-Feb-2006 08:32 AM Page: 34 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/04/01ISR Number: 3733520-3Report Type:Periodic Company Report #A107348 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hallucination Consumer Geodon PS Pfizer Central Research Date:06/04/01ISR Number: 3733522-7Report Type:Periodic Company Report #A107402 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dysgeusia Health Geodon PS Pfizer Central Professional Research Company Representative Date:06/04/01ISR Number: 3733524-0Report Type:Periodic Company Report #A107409 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pruritus Health Geodon PS Pfizer Central Vasodilatation Professional Research 20.00 MG TOTAL:DAILY Date:06/04/01ISR Number: 3733525-2Report Type:Periodic Company Report #A107422 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Respiratory Disorder Health Geodon PS Pfizer Central Professional Research 40.00 MG TOTAL:BID Lithium C Klonopin C Date:06/04/01ISR Number: 3733526-4Report Type:Periodic Company Report #A107446 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Health Geodon PS Pfizer Central Chills Professional Research ORAL 40.00 MG Headache TOTAL:BID:ORA Sedation L Levoxyl C Clonidine C Ambien C Paxil C Date:06/04/01ISR Number: 3733527-6Report Type:Periodic Company Report #A107550 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Health Geodon PS Pfizer Central Apathy Professional Research 40.00 MG Nervousness TOTAL:DAILY Schizophreniform Disorder Depakote C Unevaluable Event Ativan C 22-Feb-2006 08:32 AM Page: 35 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/04/01ISR Number: 3733529-XReport Type:Periodic Company Report #A107152 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chest Pain Health Geodon PS Pfizer Central Hypertension Professional Research ORAL ORAL Date:06/04/01ISR Number: 3733530-6Report Type:Periodic Company Report #A107193 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Palpitations Consumer Geodon PS Pfizer Central Rhinitis Research 40.00 MG TOTAL:BID Sertraline C Lorazepam C Unspecified Vitamins C Gabapentin C Levothyroxine C Date:06/04/01ISR Number: 3733532-XReport Type:Periodic Company Report #A107201 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arrhythmia Health Geodon PS Pfizer Central Professional Research ORAL 80.00 MG TOTAL:BID:ORA L Date:06/04/01ISR Number: 3733533-1Report Type:Periodic Company Report #A107242 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Visual Disturbance Consumer Geodon PS Pfizer Central Research ORAL 40.00 MG TOTAL:BID:ORA L Claritin C Beconase Aq C Celexa C Eskalith Cr C Prevacid C Seroquel C Albuterol Inhaler C Date:06/04/01ISR Number: 3733536-7Report Type:Periodic Company Report #A107244 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Health Geodon PS Pfizer Central Professional Research 20.00 MG TOTAL:DAILY Methyphenidate SS 5.00 MG TOTAL Clonidine C 22-Feb-2006 08:32 AM Page: 36 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/04/01ISR Number: 3733537-9Report Type:Periodic Company Report #A107309 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dermatitis Health Geodon PS Pfizer Central Professional Research 80.00 MG Company TOTAL:BID Representative Date:06/04/01ISR Number: 3733539-2Report Type:Periodic Company Report #A107311 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anorexia Consumer Geodon PS Pfizer Central Dizziness Research ORAL 20.00 MG Increased Appetite TOTAL:DAILY:O RAL Olanzapine SS Haloperidol C Vitamin C C Unspecified Pain Reliever C Date:06/04/01ISR Number: 3733540-9Report Type:Periodic Company Report #A107313 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Health Geodon PS Pfizer Central Professional Research 40.00 MG TOTAL:DAILY Date:06/04/01ISR Number: 3733542-2Report Type:Periodic Company Report #A107314 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Level Above Health Geodon PS Pfizer Central Therapeutic Professional Research 40.00 MG Company TOTAL:BID Representative Lithium C Eskalith C Date:06/04/01ISR Number: 3733544-6Report Type:Periodic Company Report #A107315 Age:13 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Consumer Geodon PS Pfizer Central Research ORAL 20.00 MG TOTAL:DAILY:O RAL Date:06/04/01ISR Number: 3733546-XReport Type:Periodic Company Report #A109874 Age:23 YR Gender:Female I/FU:I Outcome PT Other Bipolar I Disorder Dyskinesia Salivary Hypersecretion 22-Feb-2006 08:32 AM Page: 37 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Speech Disorder Report Source Product Role Manufacturer Route Dose Duration Health Geodon PS Pfizer Central Professional Research ORAL 40.00 MG TOTAL; BID; ORAL Lithium C Cytomel C Neurontin C Trazodone C Date:06/04/01ISR Number: 3733548-3Report Type:Periodic Company Report #A109878 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Health Geodon PS Pfizer Central Extrapyramidal Disorder Professional Research Company Representative Date:06/04/01ISR Number: 3733549-5Report Type:Periodic Company Report #A109896 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Insomnia Consumer Geodon PS Pfizer Central Research Celexa C Wellbutrin C Lithium C Klonipin C Date:06/04/01ISR Number: 3733551-3Report Type:Periodic Company Report #A109907 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Herpes Zoster Health Geodon PS Pfizer Central Unevaluable Event Professional Research ORAL 40.00 MG TOTAL; BID; ORAL Date:06/04/01ISR Number: 3733552-5Report Type:Periodic Company Report #A109911 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Health Geodon PS Pfizer Central Abnormal Professional Research ORAL 80.00 MG Company TOTAL; BID; Representative ORAL Date:06/04/01ISR Number: 3733553-7Report Type:Periodic Company Report #A109912 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Other Electrocardiogram Health Abnormal Professional 22-Feb-2006 08:32 AM Page: 38 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company Representative Product Role Manufacturer Route Dose Duration Geodon PS Pfizer Central Research ORAL 80.00 MG TOTAL; BID; ORAL Clozaril C Date:06/04/01ISR Number: 3733555-0Report Type:Periodic Company Report #A109946 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperhidrosis Health Geodon PS Pfizer Central Professional Research Company Representative Date:06/04/01ISR Number: 3733556-2Report Type:Periodic Company Report #A109949 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accidental Overdose Health Geodon PS Pfizer Central Mydriasis Professional Research Company Risperdal SS Representative Luvox SS Date:06/04/01ISR Number: 3733559-8Report Type:Periodic Company Report #A109950 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dermatitis Health Geodon PS Pfizer Central Urticaria Professional Research ORAL 80.00 MG TOTAL; BID; ORAL Depakote C Klonopin C Lithium C Ativan C Artificial Tears C Date:06/04/01ISR Number: 3733560-4Report Type:Periodic Company Report #A110167 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depression Health Geodon PS Pfizer Central Professional Research 15.00 MG Company TOTAL Representative Date:06/04/01ISR Number: 3733579-3Report Type:Periodic Company Report #A109644 Age:45 YR Gender:Female I/FU:I Outcome PT Other Malaise Paraesthesia 22-Feb-2006 08:32 AM Page: 39 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tremor Report Source Product Role Manufacturer Route Dose Duration Consumer Geodon PS Pfizer Central Research ORAL 20.00 MG TOTAL DAILY ORAL Warfarin C Celebrex C Seroquel C Date:06/04/01ISR Number: 3733580-XReport Type:Periodic Company Report #A109697 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diarrhoea Consumer Geodon PS Breon Laboratories Dizziness Inc Sub Sterling Headache Drug Inc Date:06/04/01ISR Number: 3733582-3Report Type:Periodic Company Report #A109700 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Nausea Health Geodon PS Pfizer Central Professional Research ORAL 40.00 MG Company TOTAL; BID Representative Date:06/04/01ISR Number: 3733584-7Report Type:Periodic Company Report #A109701 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Nausea Health Geodon PS Pfizer Central Professional Research ORAL 40.00 MG Company TOTAL; BID Representative Date:06/04/01ISR Number: 3733586-0Report Type:Periodic Company Report #A109702 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertension Health Geodon PS Pfizer Central Tachycardia Professional Research ORAL 40.00 MG Company TOTAL; BID Representative Date:06/04/01ISR Number: 3733587-2Report Type:Periodic Company Report #A109737 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hostility Health Geodon PS Pfizer Central Hypokinesia Professional Research ORAL 120.00 MG Pyrexia TOTAL; TID; Urinary Tract Infection ORAL Depakote C Lithium C 22-Feb-2006 08:32 AM Page: 40 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Xanax C Levothyroxine C Date:06/04/01ISR Number: 3733588-4Report Type:Periodic Company Report #A109744 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Insomnia Health Geodon PS Pfizer Central Professional Research Company Unknown Representative Antidepressant C Date:06/04/01ISR Number: 3733589-6Report Type:Periodic Company Report #A019816 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arrhythmia Health Geodon PS Pfizer Central Pruritus Professional Research ORAL 20.00 TOTAL; Tachycardia DAILY; ORAL Tenoretic C Prempro C Sonata C Effexor C Date:06/04/01ISR Number: 3733590-2Report Type:Periodic Company Report #A109866 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Health Geodon PS Pfizer Central Drug Tolerance Decreased Professional Research 80.00 MG Company TOTAL BID Representative Buspar C Zoloft C Date:06/04/01ISR Number: 3733591-4Report Type:Periodic Company Report #A109871 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hostility Health Geodon PS Pfizer Central Neurosis Professional Research ORAL 80.00 MG Company TOTAL; BID; Representative ORAL Date:06/04/01ISR Number: 3733598-7Report Type:Periodic Company Report #A109461 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Urticaria Health Geodon PS Pfizer Central Professional Research Company Representative 22-Feb-2006 08:32 AM Page: 41 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/04/01ISR Number: 3733600-2Report Type:Periodic Company Report #A109488 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pollakiuria Health Geodon PS Pfizer Central Professional Research 60.00 MG TOTAL:BID Seroquel SS ORAL 300.00 MG TOTAL:DAILY:O RAL Anafranil C Effexor C Seroquel C Date:06/04/01ISR Number: 3733601-4Report Type:Periodic Company Report #A109490 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Consumer Geodon PS Pfizer Central Asthenia Research 20.00 MG Drug Withdrawal Syndrome TOTAL:DAILY Nausea Trileptal C Valium C Ambien C Amitriptyline C Date:06/04/01ISR Number: 3733603-8Report Type:Periodic Company Report #A109511 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thinking Abnormal Health Geodon PS Pfizer Central Professional Research ORAL 80.00 MG TOTAL:BID:ORA L Date:06/04/01ISR Number: 3733606-3Report Type:Periodic Company Report #A109550 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hallucination Health Geodon PS Pfizer Central Nausea Professional Research ORAL 80.00 MG Vomiting TOTAL:DAILY:O RAL Prevacid C Effexor Xr C Depakote C Verapamil C Date:06/04/01ISR Number: 3733607-5Report Type:Periodic Company Report #A109552 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arthralgia Consumer Geodon PS Pfizer Central Headache Research ORAL 20.00 MG Hostility TOTAL:DAILY:O Hypertonia RAL Muscle Twitching Halcion C Visual Disturbance Ativan C 22-Feb-2006 08:32 AM Page: 42 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/04/01ISR Number: 3733609-9Report Type:Periodic Company Report #A109563 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bipolar I Disorder Consumer Geodon PS Pfizer Central Research 20.00 MG TOTAL:DAILY Klonipin C Buspar C Leucovorin Calcium C Seroquel C Date:06/04/01ISR Number: 3733610-5Report Type:Periodic Company Report #A109564 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Personality Disorder Consumer Geodon PS Pfizer Central Research ORAL 120.00 MG TOTAL:BID:ORA L Date:06/04/01ISR Number: 3733611-7Report Type:Periodic Company Report #A109642 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Consumer Geodon PS Pfizer Central Coordination Abnormal Research ORAL 40.00 MG Migraine TOTAL:BID:ORA Sedation L Speech Disorder Synthroid C Cytomel C Cozaar C Trazodone C Folic Acid C Date:06/04/01ISR Number: 3733625-7Report Type:Periodic Company Report #A105709 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Extrapyramidal Disorder Health Geodon PS Pfizer Central Professional Research 80.00 MG Company TOTAL:BID Representative Clozaril C Date:06/04/01ISR Number: 3733626-9Report Type:Periodic Company Report #A105921 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Consumer Geodon PS Pfizer Central Drug Ineffective Research Date:06/04/01ISR Number: 3733627-0Report Type:Periodic Company Report #A105994 Age: Gender:Male I/FU:I Outcome PT Other Cough Dyspnoea 22-Feb-2006 08:32 AM Page: 43 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hypersensitivity Pharyngitis Report Source Product Role Manufacturer Route Dose Duration Health Geodon PS Pfizer Central Professional Research Company Representative Date:06/04/01ISR Number: 3733628-2Report Type:Periodic Company Report #A105996 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cough Geodon PS Pfizer Central Dyspnoea Research Hypersensitivity Pharyngitis Date:06/04/01ISR Number: 3733629-4Report Type:Periodic Company Report #A105999 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chest Pain Consumer Geodon PS Pfizer Central Flatulence Research ORAL 40.00 MG Thinking Abnormal TOTAL :BID:ORAL Risperidone C Date:06/04/01ISR Number: 3733630-0Report Type:Periodic Company Report #A106053 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tachycardia Consumer Geodon PS Pfizer Central Vasodilatation Research Date:06/04/01ISR Number: 3733631-2Report Type:Periodic Company Report #A106054 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tachycardia Consumer Geodon PS Pfizer Central Research Date:06/04/01ISR Number: 3733632-4Report Type:Periodic Company Report #A106183 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Health Geodon PS Pfizer Central Chest Pain Professional Research Dermatitis Company Dyspnoea Representative 22-Feb-2006 08:32 AM Page: 44 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/04/01ISR Number: 3733633-6Report Type:Periodic Company Report #A106198 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dermatitis Consumer Geodon PS Pfizer Central Tachycardia Research Vasodilatation Olanzapine C Lithium C Fluoxetine C Multivitamins C Essential Oils C Date:06/04/01ISR Number: 3733634-8Report Type:Periodic Company Report #A106336 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Extrapyramidal Disorder Health Geodon PS Pfizer Central Professional Research ORAL 40.00 MG TOTAL:ORAL Date:06/04/01ISR Number: 3733635-XReport Type:Periodic Company Report #A107218 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Consumer Geodon PS Pfizer Central Initial or Prolonged Constipation Research 80.00 MG Hypertension TOTAL DAILY Cogentin C Antidiarrheal Medicine C Lithium C Milk Of Magnesia C Date:06/04/01ISR Number: 3733636-1Report Type:Periodic Company Report #A107310 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Health Geodon PS Pfizer Central Initial or Prolonged Diarrhoea Professional Research ORAL 40.00 MG Nausea Company TOTAL DAILY Representative ORAL Quetiapine C Date:06/04/01ISR Number: 3733637-3Report Type:Periodic Company Report #A107814 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Tachycardia Health Geodon PS Pfizer Central Initial or Prolonged Professional Research Required Company Exelon C Intervention to Representative Prevent Permanent Impairment/Damage 22-Feb-2006 08:32 AM Page: 45 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/04/01ISR Number: 3733638-5Report Type:Periodic Company Report #A109380 Age:12 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Health Geodon PS Pfizer Central Initial or Prolonged Professional Research 160.00 MG Company TOTAL BID. Representative Trileptal C Risperidone C Prozac C Date:06/04/01ISR Number: 3733639-7Report Type:Periodic Company Report #A109062 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Health Geodon PS Pfizer Central Initial or Prolonged Movement Disorder Professional Research 40.00 MG Sedation Company TOTAL BID Representative Lithium Carbonate SS 900.00 MG TOTAL Lithium C Date:06/04/01ISR Number: 3733640-3Report Type:Periodic Company Report #A109963 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Health Geodon PS Pfizer Central Initial or Prolonged Sedation Professional Research 40.00 MG Required TOTAL BID Intervention to Lithium Carbonate SS 1500.00 MG Prevent Permanent TOTAL BID Impairment/Damage Clozaril C Date:06/04/01ISR Number: 3733641-5Report Type:Periodic Company Report #A110091 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Tachycardia Health Geodon PS Pfizer Central Initial or Prolonged Professional Research 40.00 MG TOTAL, BID Chlorpromazine C Clonazepam C Zyprexa C Synthroid C Restoril C Date:06/04/01ISR Number: 3733642-7Report Type:Periodic Company Report #A110168 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Geodon PS Pfizer Central Initial or Prolonged Professional Research ORAL 40.00 MG TOTAL BID ORAL Haldol Decanoate C Benadryl C Ativan C Pancrease C 22-Feb-2006 08:32 AM Page: 46 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Insulin C Adalat C Date:06/04/01ISR Number: 3733643-9Report Type:Periodic Company Report #A105389 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Consumer Geodon PS Pfizer Central Drug Ineffective Health Research ORAL 40.00 MG Insomnia Professional TOTAL DAILY Mania ORAL Nausea Lithium Carbonate SS ORAL 4500.00 MG Nervousness TOTAL/ TID Psychotic Disorder ORAL Vomiting Clonazepam C Date:06/04/01ISR Number: 3733644-0Report Type:Periodic Company Report #A105695 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Nausea Consumer Geodon PS Pfizer Central Research Date:06/04/01ISR Number: 3733645-2Report Type:Periodic Company Report #A106353 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oedema Peripheral Health Geodon PS Pfizer Central Professional Research 80.00 MG Company TOTAL BID Representative Zyprexa C Depakote C Cogentin C Prevacid C Date:06/04/01ISR Number: 3733646-4Report Type:Periodic Company Report #A106559 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Delusion Health Geodon PS Pfizer Central Euphoric Mood Professional Research ORAL 120.00 MG Insomnia Company TOTAL DAILY Neurosis Representative ORAL Speech Disorder Date:06/04/01ISR Number: 3733647-6Report Type:Periodic Company Report #A106560 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Delusion Health Geodon PS Pfizer Central Euphoric Mood Professional Research ORAL 120.00 Insomnia Company MGTOTAL DAILY Neurosis Representative ORAL Speech Disorder 22-Feb-2006 08:32 AM Page: 47 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/04/01ISR Number: 3733648-8Report Type:Periodic Company Report #A106562 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Delusion Health Geodon PS Pfizer Central Euphoric Mood Professional Research ORAL 120.00 MG Insomnia Company TOTAL DAILY Neurosis Representative ORAL Speech Disorder Date:06/04/01ISR Number: 3733649-XReport Type:Periodic Company Report #A106610 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Health Geodon PS Pfizer Central Chills Professional Research ORAL 40.00 MG OTAL Dermatitis BID ORAL Diarrhoea Depakote SS Hallucination Xanax C Insomnia Oedema Peripheral Tongue Oedema Tremor Date:06/04/01ISR Number: 3733650-6Report Type:Periodic Company Report #A106617 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anorexia Consumer Geodon PS Pfizer Central Iron Deficiency Anaemia Research ORAL 80.00 MG Vomiting TOTAL BID ORAL Clozaril C Date:06/04/01ISR Number: 3733651-8Report Type:Periodic Company Report #A106631 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Headache Consumer Geodon PS Pfizer Central Hypertension Health Research ORAL 80.00 G TOTAL Nausea Professional BID ORAL Nervousness Actos C Xanax C Tegretol C Lipitor C Prevacid C Vioxx C Synthroid C Paxil C Hu Malog C Humulin C Accupril C 22-Feb-2006 08:32 AM Page: 48 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/04/01ISR Number: 3733652-XReport Type:Periodic Company Report #A106945 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hallucination Health Geodon PS Pfizer Central Hyperhidrosis Professional Research ORAL 20.00 MG TOTAL DAILY ORAL Sertraline C Fluticasone C Omeprazole C Vitamin C C Cetirizine C Albuterol C Echinacea C Albuterol C Fluticasone C Zinc C Calcium C Date:06/04/01ISR Number: 3733653-1Report Type:Periodic Company Report #A107002 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiovascular Disorder Health Geodon PS Pfizer Central Professional Research Date:06/04/01ISR Number: 3733654-3Report Type:Periodic Company Report #A107133 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Constipation Consumer Geodon PS Pfizer Central Nausea Research ORAL 20.00 MG Suicidal Ideation TOTAL DAILY Vomiting ORAL Lithium C Date:06/04/01ISR Number: 3733655-5Report Type:Periodic Company Report #A108911 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dermatitis Health Geodon PS Pfizer Central Professional Research 160.00 MG TOTAL: BID Date:06/04/01ISR Number: 3733656-7Report Type:Periodic Company Report #A108916 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Back Pain Consumer Geodon PS Pfizer Central Hypersensitivity Research ORAL 40.00 MG Influenza Like Illness TOTAL: BID: Lymphadenopathy ORAL Depakote C Paxil C Risperdal C Lithium C Lamictal C 22-Feb-2006 08:32 AM Page: 49 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/04/01ISR Number: 3733657-9Report Type:Periodic Company Report #A108939 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Consumer Geodon PS Pfizer Central Headache Research 20.00 MG Insomnia TOTAL: DAILY Nausea Ativan C Date:06/04/01ISR Number: 3733658-0Report Type:Periodic Company Report #A108946 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Health Geodon PS Pfizer Central Professional Research 120.00 MG TOTAL: BID Ativan (Lorazepam) C Birth Control Pills C Sonata C Date:06/04/01ISR Number: 3733659-2Report Type:Periodic Company Report #A108947 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Dreams Health Geodon PS Pfizer Central Professional Research ORAL ORAL Reglan C Medrol Dose Pack C Cleocin C Hydrocodone/Acetamin ophen C Date:06/04/01ISR Number: 3733660-9Report Type:Periodic Company Report #A108959 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Consumer Geodon PS Pfizer Central Hyperhidrosis Research 160.00 MG TOTAL: BID Tegretol C Inderal C Triphasil C Vitamin E C Multivitamin C Zyprexa C Date:06/04/01ISR Number: 3733661-0Report Type:Periodic Company Report #A108965 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Health Geodon PS Pfizer Central Prolonged Professional Research Company Representative 22-Feb-2006 08:32 AM Page: 50 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/04/01ISR Number: 3733662-2Report Type:Periodic Company Report #A109093 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Health Geodon PS Pfizer Central Anxiety Professional Research ORAL 40.00 MG Drug Interaction TOTAL: BID: Headache ORAL Hyperhidrosis Effexor Xr SS ORAL 150.00 MG Nausea TOTAL: DAILY: ORAL Clozapine C Prozac (Fluoxetine) C Date:06/04/01ISR Number: 3733663-4Report Type:Periodic Company Report #A109121 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Consumer Geodon PS Pfizer Central Malaise Research Date:06/04/01ISR Number: 3733664-6Report Type:Periodic Company Report #A109131 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Insomnia Consumer Geodon PS Pfizer Central Research ORAL 80.00 MG TOTAL: BID: ORAL Seroquel C Date:06/04/01ISR Number: 3733665-8Report Type:Periodic Company Report #A109144 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Insomnia Health Geodon PS Pfizer Central Oedema Peripheral Professional Research ORAL 120.00 MG TOTAL:BID:ORA L Wellbutrin C Ativan C Klonopin C Vitamins C Date:06/04/01ISR Number: 3733666-XReport Type:Periodic Company Report #A109240 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Health Geodon PS Pfizer Central Professional Research ORAL 80.00 MG TOTAL:BID:ORA L Lithium C Haldol C 22-Feb-2006 08:32 AM Page: 51 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/04/01ISR Number: 3733667-1Report Type:Periodic Company Report #A109262 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Nausea Health Geodon PS Pfizer Central Vomiting Professional Research 40.00 MG Company TOTAL:BID Representative Risperidone C Lithium C Date:06/04/01ISR Number: 3733668-3Report Type:Periodic Company Report #A109347 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Acne Health Geodon PS Pfizer Central Dyspnoea Professional Research 40.00 MG Epistaxis TOTAL:BID Hallucination Lithium Carbonate SS Sedation Seroquel C Tachycardia Restoril C Klonopin C Topamax C Wellbutrin Sr C Colace C Antibiotic C Date:06/04/01ISR Number: 3733669-5Report Type:Periodic Company Report #A109355 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Extrapyramidal Disorder Health Geodon PS Pfizer Central Professional Research Date:06/04/01ISR Number: 3733670-1Report Type:Periodic Company Report #A109376 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Psychotic Disorder Health Geodon PS Pfizer Central Professional Research Date:06/04/01ISR Number: 3733671-3Report Type:Periodic Company Report #A109381 Age:7 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Health Geodon PS Pfizer Central Professional Research 60.00 MG Company TOTAL Representative Date:06/04/01ISR Number: 3733672-5Report Type:Periodic Company Report #A109382 Age:4 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Health Geodon PS Pfizer Central Professional Research Company Representative 22-Feb-2006 08:32 AM Page: 52 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/04/01ISR Number: 3733673-7Report Type:Periodic Company Report #A109383 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Health Geodon PS Pfizer Central Drug Ineffective Professional Research 20.00 MG Company TOTAL DAILY Representative Date:06/04/01ISR Number: 3733674-9Report Type:Periodic Company Report #A109384 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Health Geodon PS Pfizer Central Weight Decreased Professional Research 60.00 MG Company TOTAL:BID Representative Risperdal C Date:06/04/01ISR Number: 3733712-3Report Type:Expedited (15-DaCompany Report #A109435 Age:33 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Health Geodon PS Pfizer Central Initial or Prolonged Asthenia Professional Research ORAL 40.00 MG Drug Interaction TOTAL:BID:ORA Gait Disturbance L Headache Effexor Xr SS ORAL 300.00 MG Hyperhidrosis TOTAL:BID:ORA Insomnia L Nausea Aldactone Obesity (Spironolactone) C Polycystic Ovaries Risperidone C Restlessness Cytomel C Speech Disorder Valium C Stress Neurontin C Glucophage C Date:06/04/01ISR Number: 3735394-3Report Type:Periodic Company Report #A110169 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Insomnia Health Geodon PS Pfizer Central Professional Research 80 MG TOTAL Company Representative Date:06/04/01ISR Number: 3735396-7Report Type:Periodic Company Report #A110172 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Conjunctivitis Health Geodon PS Pfizer Central Hypersensitivity Professional Research ORAL BID: ORAL Rhinitis Zoloft C Alprazolam C Topamax C 22-Feb-2006 08:32 AM Page: 53 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/04/01ISR Number: 3735397-9Report Type:Periodic Company Report #A110190 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Rhinitis Health Geodon PS Pfizer Central Professional Research ORAL BID ORAL Cetirizine SS 10.00 MG TOTAL, DAILY Luvox C Efudex Lotion C Lipitor C Risperdal C Klonopin C Date:06/04/01ISR Number: 3735398-0Report Type:Periodic Company Report #A110227 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatic Function Abnormal Health Geodon PS Pfizer Central Hepatitis Professional Research Company Representative Date:06/04/01ISR Number: 3735399-2Report Type:Periodic Company Report #A110257 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Attention Health Geodon PS Pfizer Central Deficit/Hyperactivity Professional Research Disorder Company Representative Date:06/04/01ISR Number: 3735400-6Report Type:Periodic Company Report #A110481 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Health Geodon PS Pfizer Central Prolonged Professional Research Company Anafranil C Representative Date:06/04/01ISR Number: 3736093-4Report Type:Periodic Company Report #A106603 Age:5 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Confusional State Health Geodon PS Pfizer Central Intervention to Convulsion Professional Research 40.00 MG Prevent Permanent Extrapyramidal Disorder TOTAL:BID Impairment/Damage Gait Disturbance Depakote C Hypertonia Dexedrine C Salivary Hypersecretion Sedation Tremor 22-Feb-2006 08:32 AM Page: 54 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/04/01ISR Number: 3736094-6Report Type:Periodic Company Report #A107458 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Confusional State Health Geodon PS Pfizer Central Intervention to Coordination Abnormal Professional Research ORAL 80.00 MG Prevent Permanent Dyspnoea TOTAL:BID:ORA Impairment/Damage Face Oedema L Tongue Oedema Effexor (Venlafaxine) C Wellbutrin Sr C Date:06/05/01ISR Number: 3735044-6Report Type:Expedited (15-DaCompany Report #A109401 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Consumer Geodon PS Pfizer Central Hospitalization - Blood Glucose Increased Health Research ORAL 80.00 MG Initial or Prolonged Hypertension Professional TOTAL;BID; Insomnia Company ORAL Psychotic Disorder Representative Serentil SS ORAL 225.00 MG Seborrhoea TOTAL;TID;ORA Sudden Death L Neurontin C Atorvastatin C Remeron C Klonopin C Aspirin C Thorazine C Lorazepam C Cogentin C Depakote C Prinivil C Moban C Zyprexa C Seroquel C Prozac C Date:06/05/01ISR Number: 3735323-2Report Type:Expedited (15-DaCompany Report #A111985 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Geodon PS Pfizer Central Hallucination Professional Research Date:06/05/01ISR Number: 3735324-4Report Type:Expedited (15-DaCompany Report #A111801 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Geodon PS Pfizer Central Professional Research Date:06/05/01ISR Number: 3735325-6Report Type:Expedited (15-DaCompany Report #A111797 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Geodon PS Pfizer Central Professional Research 22-Feb-2006 08:32 AM Page: 55 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/05/01ISR Number: 3735326-8Report Type:Expedited (15-DaCompany Report #A109962 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Monoparesis Health Geodon PS Pfizer Central Initial or Prolonged Sedation Professional Research 40.00 MG TOTAL:BID Lithium Carbonate SS 900.00 MG TOTAL:DAILY Naltrexone C Date:06/05/01ISR Number: 3735327-XReport Type:Expedited (15-DaCompany Report #A110348 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Clostridium Colitis Consumer Geodon PS Pfizer Central Initial or Prolonged Flatulence Research 20.00 MG Influenza Like Illness TOTAL Vomiting Prolixin C Weight Decreased Klonipin C Desyrel C Prevacid C Celebrex C Periactin C Date:06/05/01ISR Number: 3735362-1Report Type:Expedited (15-DaCompany Report #A111692 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Consumer Geodon PS Pfizer Central Initial or Prolonged Drug Ineffective Research ORAL DAILY:ORAL Hallucination, Auditory Clozaril C Heart Rate Increased Restoril C Schizophrenia Ativan C Date:06/05/01ISR Number: 3735364-5Report Type:Expedited (15-DaCompany Report #A111694 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Geodon PS Pfizer Central Research NOT SPECIFIED Date:06/05/01ISR Number: 3735365-7Report Type:Expedited (15-DaCompany Report #A111567 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Effect Decreased Health Geodon PS Pfizer Central Initial or Prolonged Extrasystoles Professional Research ORAL 120.00 MG TOTAL:BID:ORA L Lopressor C Univasc C Imdur C Lipitor C Beclovent C Ventolin C Glucotrol C Glucophage C 22-Feb-2006 08:32 AM Page: 56 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevacid C Trazadone C Valium C Motrin C Estradiol C Synthroid C Nitrostat C Zyprexa C Date:06/06/01ISR Number: 3734926-9Report Type:Expedited (15-DaCompany Report #A112695 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Geodon PS Pfizer Central Echocardiogram Abnormal Professional Research Company Representative Date:06/06/01ISR Number: 3735792-8Report Type:Expedited (15-DaCompany Report #A109864 Age:17 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Geodon PS Pfizer Central Required Convulsion Professional Research ORAL 20.00 MG Intervention to Loss Of Consciousness TOTAL:DAILY:O Prevent Permanent Nausea RAL Impairment/Damage Vomiting Clonidine C Date:06/06/01ISR Number: 3735805-3Report Type:Expedited (15-DaCompany Report #A111987 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Consumer Geodon PS Pfizer Central Initial or Prolonged Diabetes Mellitus Research ORAL 40.00 MG Dizziness TOTAL BID Electrocardiogram ORAL Abnormal Elavil SS ORAL 100.00 MG Fatigue TOTAL DAILY ORAL Lithium C Date:06/08/01ISR Number: 3736252-0Report Type:Expedited (15-DaCompany Report #A111797 Age: Gender:Unknown I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Geodon PS Pfizer Central Professional Research Date:06/08/01ISR Number: 3736253-2Report Type:Expedited (15-DaCompany Report #A111801 Age: Gender:Unknown I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Geodon PS Pfizer Central Professional Research Doxepin SS 22-Feb-2006 08:32 AM Page: 57 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/08/01ISR Number: 3736274-XReport Type:Expedited (15-DaCompany Report #A110358 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Health Geodon PS Pfizer Central Initial or Prolonged Drug Level Below Professional Research ORAL PO Therapeutic Haldol SS ORAL ORAL Mania Vioxx C Psychotic Disorder Synthroid C Anafranil C Benztropine C Depakote C Ambien C Date:06/08/01ISR Number: 3736275-1Report Type:Expedited (15-DaCompany Report #A112245 Age:13 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Headache Health Geodon PS Pfizer Central Initial or Prolonged Intentional Overdose Professional Research ORAL PO Screaming Date:06/08/01ISR Number: 3736323-9Report Type:Expedited (15-DaCompany Report #A111788 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Geodon PS Pfizer Central Initial or Prolonged Dysuria Professional Research Insomnia Zoloft (Sertraline) SS ORAL 50.00 MG Paranoia TOTAL: DAILY: Vomiting ORAL Weight Increased Seroquel (Quetiapine) C Prinivil (Lisinopril) C Date:06/11/01ISR Number: 3737107-8Report Type:Expedited (15-DaCompany Report #A109401 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Consumer Geodon PS Pfizer Central Hospitalization - Blood Glucose Increased Health Research ORAL 80.00 MG Initial or Prolonged Electrocardiogram Qt Professional TOTAL:BID:ORA Corrected Interval Company L Prolonged Representative Serentil SS ORAL 225.00 MG Hypertension TOTAL:TID:ORA Insomnia L Myocardial Infarction Neurontin C Osteoarthritis Atorvastatin C Psychotic Disorder Remeron C Seborrhoea Klonopin C Sudden Death Aspirin C Toxicologic Test Abnormal Thorazine C Lorazepam C Cogentin C Depakote C Prinivil C Moban C Zyprexa C 22-Feb-2006 08:32 AM Page: 58 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Seroquel C Prozac C Date:06/11/01ISR Number: 3737156-XReport Type:Expedited (15-DaCompany Report #001-0981-M0103661 Age:47 YR Gender:Unknown I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - No Adverse Drug Effect Health Lipitor PS Pfizer Inc ORAL 10 MG (BID), Initial or Prolonged Professional PER ORAL Gabapentin SS ORAL 1200 MG (EVERY AM); 600 MG (EVERY NOON); 1200 MG (EVERY HS. (Geodon) SS ORAL 40 MG (DAILY); 40 MG (BID); 40 MG (DAILY); 20 MG (DAILY) (Acetylsalicylic Acid) SS ORAL 325 MG (DAILY), PER ORAL (Chlorpromazine) SS ORAL 100 MG (EVERY 4 HOURS PRN), PER ORAL (Clonazepam) SS ORAL 2 MG (AT BEDTIME), PER ORAL (Lorazepam) SS ORAL 2 MG (EVERY 6 HOURS); 2 MG (EVERY 8 HOURS AS NEEDED) PER (Mesoridazine) SS ORAL 50 MG (DAILY); 75 MG (BID); 75 MG (TID) PER ORAL; 50 MG (Mirtazapine) SS ORAL 15 MG (AT BEDTIME), PER ORAL ... C .. C ... C ... C ... C ... C ... C ... C ..... C ... C Date:06/11/01ISR Number: 3737840-8Report Type:Expedited (15-DaCompany Report #A112826 Age:15 YR Gender:Female I/FU:I Outcome Required Intervention to 22-Feb-2006 08:32 AM Page: 59 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Hypersensitivity Health Geodon PS Pfizer Central Professional Research 20.00 MG Company TOTAL: DAILY Representative Date:06/11/01ISR Number: 3737899-8Report Type:Expedited (15-DaCompany Report #A112467 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Bone Pain Consumer Geodon PS Pfizer Central Condition Aggravated Research BID Feeling Jittery Thiothixene SS Paranoia Diovan C Inderal C Tegretol C Date:06/11/01ISR Number: 3737901-3Report Type:Expedited (15-DaCompany Report #A111567 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrasystoles Health Geodon PS Pfizer Central Initial or Prolonged Palpitations Professional Research ORAL 120.00 MG TOTAL:BID: ORAL Lopressor C Univasc C Imdur C Lipitor C Beclovent C Ventolin C Glucotrol C Glucophage C Prevacid C Trazadone C Valium C Motrin C Estradiol C Synthroid C Nitrostat C Zyprexa C Date:06/11/01ISR Number: 3737911-6Report Type:Expedited (15-DaCompany Report #A111985 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anxiety Health Geodon PS Pfizer Central Hospitalization - Cardiac Disorder Professional Research ORAL 160.00 MG Initial or Prolonged Hallucination, Visual TOTAL:BID:ORA Mental Impairment L Anti-Arrhythmic Agent C 22-Feb-2006 08:32 AM Page: 60 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/11/01ISR Number: 3738016-0Report Type:Expedited (15-DaCompany Report #A112408 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Geodon PS Pfizer Central Initial or Prolonged Anxiety Professional Research Drug Ineffective Gastrointestinal Disorder Insomnia Date:06/11/01ISR Number: 3738017-2Report Type:Expedited (15-DaCompany Report #A112403 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Geodon PS Pfizer Central Initial or Prolonged Gastrointestinal Disorder Professional Research Insomnia Date:06/12/01ISR Number: 3738393-0Report Type:Expedited (15-DaCompany Report #A109110 Age:15 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Consumer Geodon PS Pfizer Central Initial or Prolonged Bipolar Disorder Health Research ORAL 40.00 MG Confusional State Professional TOTAL: BID: Crying ORAL Fear Zyrtec C Feeling Abnormal Lithium C Hallucination, Auditory Paxil C Hyperhidrosis Wellbutrin C Mania Date:06/12/01ISR Number: 3738482-0Report Type:Expedited (15-DaCompany Report #A109961 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Health Geodon PS Pfizer Central Initial or Prolonged Blood Creatine Professional Research Phosphokinase Increased Lithium SS 1200.00 MG Coordination Abnormal TOTAL: Dystonia Seroquel Extrapyramidal Disorder (Quetiapine) SS 200.00 MG Hyperhidrosis TOTAL Hypomania Propranolol SS 60.00 MG Muscle Rigidity Paxil (Paroxetine) C Muscle Spasms Nortriptyline C Neuroleptic Malignant Syndrome Psychomotor Hyperactivity Pyrexia Restlessness Sleep Talking Tongue Disorder Urinary Incontinence 22-Feb-2006 08:32 AM Page: 61 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/13/01ISR Number: 3738965-3Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Zaprasidone 20 Pfizer PS Pfizer ORAL 20 MG BID ORAL Zaprasidone 40 Pfizer SS Pfizer ORAL 40 MG BID ORAL Date:06/14/01ISR Number: 3739711-XReport Type:Expedited (15-DaCompany Report #A108787 Age:24 MON Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Exposure Consumer Geodon PS Pfizer Central Initial or Prolonged Depressed Level Of Health Research 40.00 MG Consciousness Professional TOTAL Lethargy Sertraline SS Klonopin SS Date:06/14/01ISR Number: 3739735-2Report Type:Expedited (15-DaCompany Report #A112903 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Geodon PS Pfizer Central Research Date:06/14/01ISR Number: 3739756-XReport Type:Expedited (15-DaCompany Report #A111635 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Overdose Health Geodon PS Pfizer Central Initial or Prolonged Loss Of Consciousness Professional Research ORAL ORAL Other Unspecified Medications SS Luvox C Date:06/14/01ISR Number: 3739757-1Report Type:Expedited (15-DaCompany Report #A110358 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Geodon PS Pfizer Central Initial or Prolonged Drug Interaction Professional Research ORAL 120.00 MG Mania TOTAL:BID:ORA Psychotic Disorder L Haldol SS ORAL ORAL Vioxx C Synthroid C Anafranil C Benztropine C Depakote C Ambien C 22-Feb-2006 08:32 AM Page: 62 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/14/01ISR Number: 3739814-XReport Type:Expedited (15-DaCompany Report #A109401 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Insomnia Consumer Geodon PS Pfizer Central Hospitalization - Myocardial Infarction Health Research ORAL 80.00 MG Initial or Prolonged Sudden Death Professional TOTAL: BID: Company ORAL Representative Serentil SS ORAL 225.00 MG TOTAL: TID: ORAL Neurontin C Atorvastatin C Remeron C Klonopin C Aspirin C Thorazine C Lorazepam C Cogentin C Depakote C Prinivil C Moban C Zyprexa C Date:06/18/01ISR Number: 3741689-XReport Type:Expedited (15-DaCompany Report #A110980 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Arrhythmia Consumer Geodon PS Pfizer Central Blood Pressure Increased Health Research ORAL 40.00 MG Dizziness Professional TOTAL:BID:ORA Electrocardiogram Qt Company L Prolonged Representative Synthroid C Electrocardiogram T Wave Estratest C Inversion Effexor C Extrasystoles Prevacid C Heart Rate Increased Loss Of Consciousness Palpitations Syncope Ventricular Tachycardia Date:06/19/01ISR Number: 3742477-0Report Type:Expedited (15-DaCompany Report #A113136 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Creatinine Consumer Geodon PS Pfizer Central Intervention to Increased Research ORAL 120.00 MG Prevent Permanent Blood Urea Increased TOTAL;BID;ORA Impairment/Damage Drug Level Above L Therapeutic Lithium SS ORAL 180.00 MG Muscle Rigidity TOTAL;TID;ORA Tremor L Sinemet C Premarin C Pepcid C Flovent C Levothyroxine C Primidone C Triazolam C 22-Feb-2006 08:32 AM Page: 63 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/19/01ISR Number: 3742479-4Report Type:Expedited (15-DaCompany Report #A111985 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anxiety Health Geodon PS Pfizer Central Hospitalization - Cardiac Disorder Professional Research ORAL 240.00 MG Initial or Prolonged Condition Aggravated TOTAL;TID;ORA Hallucination L Thinking Abnormal Anti-Arrhythmic Agent C Date:06/19/01ISR Number: 3742481-2Report Type:Expedited (15-DaCompany Report #A112467 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Amnesia Consumer Geodon PS Pfizer Central Bone Pain Research 160.00 MG Condition Aggravated TOTAL;BID Drug Ineffective Thiothixene SS Fatigue Trazodone SS Feeling Jittery Diovan C Paranoia Inderal C Rash Papular Tegretol C Date:06/19/01ISR Number: 3743065-2Report Type:Expedited (15-DaCompany Report #A113037 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Urine Analysis Abnormal Health Geodon PS Pfizer Central Initial or Prolonged Professional Research Adderall C Welbutrin C Date:06/19/01ISR Number: 3743224-9Report Type:Expedited (15-DaCompany Report #A113035 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Agitation Health Geodon PS Pfizer Central Intervention to Deep Vein Thrombosis Professional Research 40.00 MG Prevent Permanent Fluid Retention TOTAL: BID Impairment/Damage Water SS Topiramate C Neurontin C Lithium C Ativan C Flovent C Albuterol C Maxair C Serevent C Motrin C Prempro C Clinoril C 22-Feb-2006 08:32 AM Page: 64 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/19/01ISR Number: 3743228-6Report Type:Expedited (15-DaCompany Report #A113027 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Hyperphagia Health Zoloft PS Pfizer Intervention to Impaired Gastric Emptying Professional Pharmaceuticals Inc Prevent Permanent Vomiting Ziprasidone SS Impairment/Damage Weight Decreased Zyprexa SS Weight Increased Date:06/21/01ISR Number: 3744006-4Report Type:Expedited (15-DaCompany Report #A109107 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Tenderness Consumer Geodon PS Pfizer Central Initial or Prolonged Anhedonia Health Research 4360.00 MG Required Discomfort Professional TOTAL Intervention to Disturbance In Attention Trazodone SS 800.00 MG Prevent Permanent Electrocardiogram Qt TOTAL Impairment/Damage Corrected Interval Venlafaxin SS ORAL 2400.00 MG Prolonged TOTAL:ORAL Fatigue Lorazepam SS ORAL ORAL Feelings Of Worthlessness Aleve C Flat Affect Wellbutrin C Hyperphagia Zyprexa C Intentional Overdose Lethargy Mood Altered Psychomotor Retardation Sedation Social Avoidant Behaviour Suicidal Ideation Date:06/22/01ISR Number: 3745496-3Report Type:Expedited (15-DaCompany Report #A111985 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anxiety Health Geodon PS Pfizer Central Hospitalization - Cardiac Disorder Professional Research ORAL 240.00 MG Initial or Prolonged Coma Company TOTAL:TID:ORA Hallucination Representative L Renal Failure Chronic Anti-Arrhythrmic Thinking Abnormal Agent C Date:06/22/01ISR Number: 3745499-9Report Type:Expedited (15-DaCompany Report #A110764 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Health Geodon PS Pfizer Central Initial or Prolonged Confusional State Professional Research ORAL 40.00 MG Dizziness TOTAL; BID; Drug Effect Decreased ORAL Prolixin (Fluphenazine) C Prozac (Fluoxetine) C Serevent (Salmeterol) C Tegretol (Carbamazepine) C 22-Feb-2006 08:32 AM Page: 65 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Calcium Supplement C Verapamil C Valproic Acid C Lanoxin C Prilosec C Prednisone C Klonopin C Date:06/22/01ISR Number: 3745508-7Report Type:Expedited (15-DaCompany Report #A108295 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Health Geodon PS Pfizer Central Initial or Prolonged Chest Pain Professional Research ORAL 60.00 MG Required Condition Aggravated TOTAL:BID:ORA Intervention to Delusion L Prevent Permanent Heart Rate Increased Risperidone SS Impairment/Damage Panic Attack Date:06/22/01ISR Number: 3745509-9Report Type:Expedited (15-DaCompany Report #A109319 Age:16 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dystonia Consumer Geodon PS Pfizer Central Intervention to Fall Research ORAL 140.00 MG Prevent Permanent Headache TOTAL:DAILY:O Impairment/Damage Medication Error RAL Muscle Spasms Cogentin SS ORAL 1.50 MG Neck Pain TOTAL:TID:ORA L Aspirin C Date:06/22/01ISR Number: 3745510-5Report Type:Expedited (15-DaCompany Report #A112695 Age: Gender:Unknown I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Geodon PS Pfizer Central Sudden Death Professional Research Serentil (Mesoridazine) SS Seroquel (Quetiapine) SS Date:06/22/01ISR Number: 3745556-7Report Type:Expedited (15-DaCompany Report #A112903 Age:29 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Consumer Geodon PS Pfizer Central Condition Aggravated Health Research ORAL 20.00 MG Overdose Professional TOTAL:BID:ORA Sedation L Suicidal Ideation Clonazepam C Promethazine C Zestril C Prevacid C Hydrocodone And Acetominophen C 22-Feb-2006 08:32 AM Page: 66 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lorazepam C Albuterol Inhaler C Levora C Celexa C Zyprexa C Triazolam C Ambien C Ibuprophen C Aerobid-M C Daypro C Date:06/25/01ISR Number: 3745001-1Report Type:Direct Company Report # Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haemorrhagic Stroke Geodon (Ziprasidone) PS ORAL 20MG PO BID Initial or Prolonged Medication Error Mental Impairment Vaginal Haemorrhage Date:06/25/01ISR Number: 3746203-0Report Type:Expedited (15-DaCompany Report #A113653 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Geodon PS Pfizer Central Professional Research Company Representative Date:06/25/01ISR Number: 3746385-0Report Type:Expedited (15-DaCompany Report #A111562 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Consumer Geodon PS Pfizer Central Initial or Prolonged Research ORAL 120.00 MG TOTAL BID ORAL Neurontin (Gabapentin) C Date:06/25/01ISR Number: 3746391-6Report Type:Expedited (15-DaCompany Report #A113893 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Geodon PS Pfizer Central Professional Research 160.00 MG Company TOTAL BID Representative Sertraline C Neurontin C Luvox C Remeron C Lasix C Clonidine C Depakote C Clonopin C Synthroid C Thorazine C 22-Feb-2006 08:32 AM Page: 67 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/25/01ISR Number: 3747082-8Report Type:Expedited (15-DaCompany Report #A113975 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Geodon PS Pfizer Central Professional Research Date:06/25/01ISR Number: 3747150-0Report Type:Expedited (15-DaCompany Report #A113549 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Arrhythmia Consumer Geodon PS Pfizer Central Intervention to Bone Pain Research ORAL 20.00 MG Prevent Permanent Coagulation Time TOTAL:DAILY Impairment/Damage Prolonged Lithium C Dislocation Of Vertebra Benadryl C Exostosis Zyprexa C Haemorrhage Relafen C Headache Tylenol C Intervertebral Disc Seroquel C Disorder Siberian Ginseng C Laceration Colloidal Silver C Pain In Extremity Adderal C Road Traffic Accident Flexeril C Valtrex C Dalmane C Klonopin C Xanax C Zinc C Vitamin C C Vitamin A C Dhea C Paxil C Date:06/25/01ISR Number: 3747172-XReport Type:Expedited (15-DaCompany Report #A110980 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Arrhythmia Consumer Geodon PS Pfizer Central Ascites Health Research ORAL 40.00 MG Dizziness Professional TOTAL:BID:ORA Electrocardiogram Qt Company L Prolonged Representative Synthroid C Electrocardiogram T Wave Estratest C Inversion Effexor C Extrasystoles Prevacid C Loss Of Consciousness Palpitations Syncope Ventricular Tachycardia Date:06/25/01ISR Number: 3747255-4Report Type:Expedited (15-DaCompany Report #A113611 Age:55 YR Gender:Male I/FU:I Outcome Hospitalization - Initial or Prolonged Required Intervention to 22-Feb-2006 08:32 AM Page: 68 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Electrocardiogram Qt Health Geodon PS Pfizer Central Prolonged Professional Research 80.00 MG Schizoaffective Disorder TOTAL:BID Lithium C Date:06/25/01ISR Number: 3747294-3Report Type:Expedited (15-DaCompany Report #A114280 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Geodon PS Pfizer Central Required Health Research Intervention to Professional Prevent Permanent Company Impairment/Damage Representative Date:06/26/01ISR Number: 3747387-0Report Type:Direct Company Report # Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Increased Geodon PS 80 MG BID 2 DAY Initial or Prolonged Body Temperature Serzone C Required Increased Celexa C Intervention to Hallucination Eskalith C Prevent Permanent Heart Rate Increased Allegra C Impairment/Damage Mydriasis Respiratory Rate Increased Tremor Date:06/26/01ISR Number: 3748084-8Report Type:Expedited (15-DaCompany Report #A110238 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neuroleptic Malignant Health Geodon PS Pfizer Central Hospitalization - Syndrome Professional Research ORAL BID PO Initial or Prolonged Psychotic Disorder Company Clozapine SS DAILY Required Urinary Tract Infection Representative Lithium SS Intervention to Lipitor C Prevent Permanent Depakote Er C Impairment/Damage Zyprexa C Date:06/26/01ISR Number: 3748086-1Report Type:Expedited (15-DaCompany Report #A111190 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Decreased Health Geodon PS Pfizer Central Initial or Prolonged Depressed Level Of Professional Research ORAL 80.00 Required Consciousness TOTAL:TID:ORA Intervention to Lethargy L Prevent Permanent Overdose Sertraline SS 300.00 MG Impairment/Damage Sedation TOTAL:DAILY Clonazepam SS ORAL 8.00 MG TOTAL:TID:ORA L 22-Feb-2006 08:32 AM Page: 69 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Trileptal C Lamictal C Date:06/27/01ISR Number: 3748618-3Report Type:Expedited (15-DaCompany Report #A110982 Age:16 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Health Geodon PS Pfizer Central Initial or Prolonged Electrocardiogram Qt Professional Research ORAL Prolonged Date:06/28/01ISR Number: 3749494-5Report Type:Expedited (15-DaCompany Report #A114551 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Geodon PS Pfizer Central Professional Research Date:06/28/01ISR Number: 3749496-9Report Type:Expedited (15-DaCompany Report #A114552 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Geodon PS Pfizer Central Professional Research Date:06/28/01ISR Number: 3749535-5Report Type:Expedited (15-DaCompany Report #A114550 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Geodon PS Pfizer Central Professional Research Date:06/28/01ISR Number: 3749835-9Report Type:Expedited (15-DaCompany Report #A114400 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Geodon PS Pfizer Central Professional Research Company Representative Date:06/28/01ISR Number: 3749836-0Report Type:Expedited (15-DaCompany Report #A114393 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Geodon PS Pfizer Central Professional Research ORAL PO Company Representative 22-Feb-2006 08:32 AM Page: 70 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/28/01ISR Number: 3749837-2Report Type:Expedited (15-DaCompany Report #A113544 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Electrocardiogram Consumer Geodon PS Pfizer Central Intervention to Abnormal Health Research ORAL 160.00 MG Prevent Permanent Electrocardiogram Qt Professional TOTAL:BID:ORA Impairment/Damage Prolonged Company L Representative Date:06/29/01ISR Number: 3750216-2Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Diarrhoea Ziprasidone (Geodon) Intervention to Dizziness (Pfizer) PS Pfizer ORAL 20 MG PO BID Prevent Permanent Impairment/Damage Date:06/29/01ISR Number: 3750315-5Report Type:Direct Company Report # Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Geodon-Ziprasidone-4 Initial or Prolonged Anxiety 0mg Pfizer PS Pfizer ORAL 40MG BID ORAL Restlessness Gabapentin C Speech Disorder Clonazepam C Thought Blocking Zolpidem C Zolpidem C Date:06/29/01ISR Number: 3750327-1Report Type:Expedited (15-DaCompany Report #A112903 Age:29 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Consumer Geodon PS Pfizer Central Suicidal Ideation Health Research ORAL 20.00 MG Professional TOTAL:BID:ORA L Clonazepam C Promethazine C Zestril C Prevacid C Hydrocodone And Acetominophen C Lorazepam C Albuterol Inhaler C Levora C Celexa C Zyprexa C Triazolam C Ambien C Ibuprophen C Aerobid-M C Daypro C 22-Feb-2006 08:32 AM Page: 71 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/29/01ISR Number: 3750556-7Report Type:Expedited (15-DaCompany Report #A114790 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Bradycardia Health Geodon PS Pfizer Central Hospitalization - Brain Scan Abnormal Professional Research ORAL 40.00 MG Initial or Prolonged Cerebral Infarction Company TOTAL:BID:ORA Disability Vein Disorder Representative L Required Neurontin C Intervention to Klonopin C Prevent Permanent Eskalith C Impairment/Damage Date:06/29/01ISR Number: 3750557-9Report Type:Expedited (15-DaCompany Report #A109401 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Consumer Geodon PS Pfizer Central Hospitalization - Electrocardiogram Qt Health Research ORAL 80.00 MG Initial or Prolonged Corrected Interval Professional TOTAL:BID:ORA Prolonged Company L Hypertension Representative Serentil SS ORAL 225.00 MG Insomnia TOTAL:TID:ORA Insulin Resistance L Obesity Neurontin C Psychotic Disorder Atorvastatin C Seborrhoea Remeron C Sudden Death Klonopin C Aspirin C Thorazine C Lorazepam C Cogentin C Depakote C Prinivil C Moban C Zyprexa C Seroquel C Prozac C Date:06/29/01ISR Number: 3750669-XReport Type:Expedited (15-DaCompany Report #A114391 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Ziprasidone Po PS Pfizer Central Research Date:06/29/01ISR Number: 3750670-6Report Type:Expedited (15-DaCompany Report #A114516 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Geodon PS Pfizer Central Research 22-Feb-2006 08:32 AM Page: 72 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/29/01ISR Number: 3750671-8Report Type:Expedited (15-DaCompany Report #A114514 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Geodon PS Pfizer Central Research Date:06/29/01ISR Number: 3750679-2Report Type:Expedited (15-DaCompany Report #001-0981-M0103661 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Unevaluable Event Health Lipitor PS Pfizer Inc ORAL 10 MG (BID), Initial or Prolonged Professional PER ORAL Gabapentin SS ORAL SEE IMAGE, PER ORAL Geodon SS ORAL SEE IMAGE Acetylsalicylic Acid SS ORAL 325 MG (DAILY), PER ORAL Chlorpromazine SS ORAL 100 MG (EVERY 4 HOURS PRN), PER ORAL Clonazepam SS ORAL 2 MG (AT BEDTIME), PER ORAL Lorazepam SS ORAL 2 MG (EVERY 6 HOURS), PER ORAL, 2 MG (EVERY 8 HOURS AS Mesoridazine SS SEE IMAGE Date:06/29/01ISR Number: 3754320-4Report Type:Expedited (15-DaCompany Report #A112245 Age:13 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Body Temperature Health Geodon PS Pfizer Central Initial or Prolonged Increased Professional Research ORAL ORAL Headache Heart Rate Increased Intentional Overdose Date:07/02/01ISR Number: 3750844-4Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depressed Level Of Geodon PS SEE IMAGE Consciousness Remeron SS Depakote C Haldol C Cogentin C Date:07/02/01ISR Number: 3751117-6Report Type:Expedited (15-DaCompany Report #A100973 Age:47 YR Gender:Female I/FU:F Outcome PT Death Cholelithiasis Completed Suicide 22-Feb-2006 08:32 AM Page: 73 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Decreased Appetite Drug Level Above Therapeutic Report Source Product Role Manufacturer Route Dose Duration Fatigue Foreign Geodon PS Pfizer Central Therapeutic Agent Health Research ORAL 40.00 MG Toxicity Professional TOTAL:BID:ORA Uterine Leiomyoma Other L Weight Decreased Fluoxetin SS Propiomazin SS Lithionit C Bevitotal Comp C Alvedon C Losec Mups C Imovane C Apodorm C Zyban (Bupropion) C Date:07/02/01ISR Number: 3751424-7Report Type:Expedited (15-DaCompany Report #A114552 Age: Gender:Unknown I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Geodon PS Pfizer Central Professional Research Date:07/02/01ISR Number: 3751426-0Report Type:Expedited (15-DaCompany Report #A114551 Age: Gender:Unknown I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Geodon PS Pfizer Central Professional Research Date:07/02/01ISR Number: 3751428-4Report Type:Expedited (15-DaCompany Report #A114550 Age: Gender:Unknown I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Geodon PS Pfizer Central Professional Research Date:07/02/01ISR Number: 3751430-2Report Type:Expedited (15-DaCompany Report #A111190 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Overdose Health Geodon PS Pfizer Central Initial or Prolonged Lethargy Professional Research ORAL 80.00 MG Required Loss Of Consciousness TOTAL:TID:ORA Intervention to Sedation L Prevent Permanent Sertraline SS 300.00 MG Impairment/Damage TOTAL:DAILY Clonazepam SS ORAL 8.00 MG TOTAL:TID:ORA L Trileptal C Lamictal C 22-Feb-2006 08:32 AM Page: 74 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/02/01ISR Number: 3752118-4Report Type:Expedited (15-DaCompany Report #A113611 Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bundle Branch Block Left Health Geodon PS Pfizer Central Initial or Prolonged Electrocardiogram Qt Professional Research 80.00 MG Required Prolonged TOTAL:BID Intervention to Lithium C Prevent Permanent Impairment/Damage Date:07/02/01ISR Number: 3752119-6Report Type:Expedited (15-DaCompany Report #A111635 Age:57 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Geodon PS Pfizer Central Initial or Prolonged Electroencephalogram Professional Research ORAL 160.00 MG Abnormal TOTAL:BID:ORA Intentional Overdose L Loss Of Consciousness Luvox SS 100.00 MG Oesophageal Stenosis TOTAL:BID Suicide Attempt Prozac SS 20.00 MG TOTAL:DAILY Date:07/03/01ISR Number: 3752620-5Report Type:Direct Company Report # Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neck Pain Geodon (20mg)(Pfizer) PS Pfizer ORAL 20MG BID PO Geodon (40mg) SS ORAL 40MG BID PO Nicotine C Adderall C Effexor-Xr C Trazodone C Date:07/03/01ISR Number: 3752622-9Report Type:Direct Company Report # Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Geodon (40 Mg) Muscle Rigidity Capsules- (Pfizer) PS Pfizer ORAL 20MG BID PO (5 DOSES PRIOR) Geodon (60mg) Capsules-(Pfizer) SS Pfizer 60MG BID (2 DOSES PRIOR) Effexor-Xr C Temazepam C Lorazepam C Date:07/03/01ISR Number: 3752623-0Report Type:Direct Company Report # Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyskinesia Geodon (20 Mg) (Pfizer) PS Pfizer ORAL 20MG BID PO Prozac C 22-Feb-2006 08:32 AM Page: 75 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/04/01ISR Number: 3752023-3Report Type:Expedited (15-DaCompany Report #A114658 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Health Geodon PS Pfizer Central Initial or Prolonged Blood Pressure Systolic Professional Research ORAL 160.00 MG Required Increased TOTAL:BID:ORA Intervention to Circulatory Collapse L Prevent Permanent Coma Accupril (Quinapril) C Impairment/Damage Electrocardiogram Qt Valproic Acid C Corrected Interval Aldomet (Methyldopa) C Prolonged Atenolol C Date:07/04/01ISR Number: 3752218-9Report Type:Expedited (15-DaCompany Report #A114519 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Geodon PS Pfizer Central Pancreatitis Professional Research UNKNOWN 160.00 MG TOTAL:BID: Trazodone C Date:07/04/01ISR Number: 3752238-4Report Type:Expedited (15-DaCompany Report #A114713 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dermatitis Health Geodon PS Pfizer Central Intervention to Dermatitis Bullous Professional Research ORAL 80.00 MG Prevent Permanent Swelling TOTAL:BID:ORA Impairment/Damage Vaginal Disorder L Thiothixine C Depakote (Sodium Valproate) C Cogentin (Benztropine Mesylate) C Prozac (Fluoxetine) C Date:07/04/01ISR Number: 3752264-5Report Type:Expedited (15-DaCompany Report #A107661 Age:65 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Bundle Branch Block Right Health Geodon PS Pfizer Central Intervention to Condition Aggravated Professional Research ORAL 40.00 MG Prevent Permanent Electrocardiogram TOTAL:BID:ORA Impairment/Damage Abnormal L Electrocardiogram Qt Chlorpromazine SS ORAL 200.00 MG Corrected Interval TOTAL:QID:ORA Prolonged L Psychotic Disorder Asa C Lorazepam C Vitamin B12 C Neutra-Phos C Lithium C Tylenol C Cogentin C Chloral Hydrate C Mom With Cascara C Fleet Enema C 22-Feb-2006 08:32 AM Page: 76 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrocortisone C Sebulex C Olanzepine C Mevacor C Imodium C Phenolated Resorcinol C Terbinafine C Date:07/05/01ISR Number: 3752628-XReport Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Geodon 20mg Roerig PS Roerig ORAL 20 MG BID Required Electrocardiogram ORAL Intervention to Abnormal Ativan C Prevent Permanent Heart Rate Decreased Impairment/Damage Myocardial Ischaemia Pulse Pressure Decreased Respiratory Arrest Date:07/05/01ISR Number: 3752837-XReport Type:Expedited (15-DaCompany Report #A113544 Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Electrocardiogram Qt Consumer Geodon PS Pfizer Central Intervention to Corrected Interval Company Research ORAL PO Prevent Permanent Prolonged Representative Depakote C Impairment/Damage Oxazepam C Fluphenazine C Risperdal C Clozapine C Ativan C Date:07/05/01ISR Number: 3752842-3Report Type:Expedited (15-DaCompany Report #A109437 Age:71 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anticholinergic Syndrome Health Geodon PS Pfizer Central Initial or Prolonged Cerebrovascular Accident Professional Research 40.00 MG Movement Disorder TOTAL:BID Parkinsonism Perphenazine SS Amoxapine C Ativan C Klonopin C Zyprexa C Date:07/06/01ISR Number: 3752989-1Report Type:Direct Company Report # Age:48 YR Gender:Female I/FU:I Outcome Life-Threatening Hospitalization - Initial or Prolonged Required Intervention to Prevent Permanent 22-Feb-2006 08:32 AM Page: 77 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Pneumonia Geodon PS ORAL 20MG BID ORAL Pyrexia Zyprexa C Prevacid C Paxil C Levoxyl C Cogentin C Date:07/06/01ISR Number: 3753763-2Report Type:Expedited (15-DaCompany Report #A109401 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Consumer Geodon PS Pfizer Central Hospitalization - Hypertension Health Research ORAL 80.00 MG Initial or Prolonged Psychotic Disorder Professional TOTAL:BID:ORA Company L Representative Serentil SS ORAL 225.00 MG TOTAL:TID:ORA L Neurontin C Atorvastatin C Remeron C Klonopin C Aspirin C Thorazine C Lorazepam C Cogentin C Depakote C Prinivil C Moban C Zyprexa C Seroquel C Prozac C Date:07/06/01ISR Number: 3753786-3Report Type:Expedited (15-DaCompany Report #A114905 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrioventricular Block Health Geodon PS Pfizer Central Initial or Prolonged First Degree Professional Research ORAL 40.00 MG Required Intentional Overdose TOTAL:DAILY:O Intervention to RAL Prevent Permanent Clonazepam SS Impairment/Damage Alcohol SS Ativan C Date:07/06/01ISR Number: 3753790-5Report Type:Expedited (15-DaCompany Report #A110980 Age:45 YR Gender:Female I/FU:F Outcome PT Life-Threatening Arrhythmia Blood Pressure Increased Breath Sounds Abnormal Cardiac Arrest Dizziness Electrocardiogram Qt 22-Feb-2006 08:32 AM Page: 78 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prolonged Electrocardiogram T Wave Inversion Extrasystoles Report Source Product Role Manufacturer Route Dose Duration Loss Of Consciousness Consumer Geodon PS Pfizer Central Musculoskeletal Disorder Health Research ORAL 40.00 MG Pain Professional TOTAL:BID:ORA Palpitations L Syncope Synthroid C Thinking Abnormal Estratest C Ventricular Tachycardia Effexor C Prevacid C Date:07/06/01ISR Number: 3753802-9Report Type:Expedited (15-DaCompany Report #A114920 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Eosinophil Count Health Geodon PS Pfizer Central Intervention to Increased Professional Research ORAL 80.00 MG Prevent Permanent Haemoglobin Decreased Company TOTAL:BID:ORA Impairment/Damage Oedema Representative L Pulmonary Oedema Valproic Acid C Red Blood Cell Count Lorazapam C Decreased Ferrous Sulfate White Blood Cell Count Elixir C Decreased Lithium C White Blood Cell Count Increased Date:07/06/01ISR Number: 3753803-0Report Type:Expedited (15-DaCompany Report #A115209 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Nausea Health Geodon PS Pfizer Central Intervention to Suicide Attempt Professional Research 2800.00 MG Prevent Permanent Company TOTAL Impairment/Damage Representative Date:07/06/01ISR Number: 3753919-9Report Type:Expedited (15-DaCompany Report #A114727 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Health Geodon PS Pfizer Central Initial or Prolonged Hypercapnia Professional Research ORAL 80.00 MG Thinking Abnormal Company TOTAL:BID:ORA Representative L Cogentin SS 2.00 MG TOTAL:BID Risperidone SS 3.00 MG TOTAL Depakote C Date:07/06/01ISR Number: 3753923-0Report Type:Expedited (15-DaCompany Report #A112903 Age:29 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Consumer Geodon PS Pfizer Central Health Research ORAL 20.00 MG Professional TOTAL:BID:ORA 22-Feb-2006 08:32 AM Page: 79 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report L Clonazepam C Promethazine C Zestril C Prevacid C Hydrocodone And Acetaminophen C Lorazepam C Albuterol Inhaler C Levora C Celexa C Zyprexa C Triazolam C Ambien C Ibuprofen C Aerobid-M C Daypro C Date:07/06/01ISR Number: 3754155-2Report Type:Expedited (15-DaCompany Report #A114730 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Geodon PS Pfizer Central Initial or Prolonged Mania Professional Research ORAL 80.00 MG Company TOTAL:BID:ORA Representative L Cogentin SS 2.00 MG TOTAL:BID Risperidone SS 3.00 MG TOTAL Date:07/06/01ISR Number: 3754159-XReport Type:Expedited (15-DaCompany Report #A114728 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Upper Respiratory Tract Health Geodon PS Pfizer Central Initial or Prolonged Infection Professional Research ORAL 40.00 MG Viral Infection Company TOTAL:BID:ORA Representative L Risperidone SS 2.00 MG TOTAL Claritin C Iron Supplement C Date:07/06/01ISR Number: 3754160-6Report Type:Expedited (15-DaCompany Report #A107661 Age:65 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Atrioventricular Block Health Geodon PS Pfizer Central Intervention to Blood Cholesterol Professional Research ORAL 40.00 MG Prevent Permanent Increased TOTAL;BID;ORA Impairment/Damage Bundle Branch Block Right L Condition Aggravated Chlorpromazine SS ORAL 200.00 MG Electrocardiogram Qt TOTAL; QID; Corrected Interval ORAL Prolonged Asa C Hypophosphataemia Lorazepam C Psychotic Disorder Vitamin B12 C Neutra-Phos C Lithium C Tylenol C 22-Feb-2006 08:32 AM Page: 80 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Cogentin C Chloral Hydrate C Mom With Cascara C Fleet Enema C Hydrocortisone C Sebulex C Olanzepine C Mevacor C Imodium C Phenolated Resorcinol C Terbinafine C Date:07/06/01ISR Number: 3754215-6Report Type:Expedited (15-DaCompany Report #A114827 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperhidrosis Health Geodon PS Pfizer Central Initial or Prolonged Insomnia Professional Research ORAL 60.00 MG TOTAL:DAILY:O RAL Depakote C Topiramate C Trazodone C Ativan C Date:07/06/01ISR Number: 3754613-0Report Type:Expedited (15-DaCompany Report #A114853 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dermatitis Foreign Geodon PS Pfizer Central Initial or Prolonged Pruritus Other Research ORAL 120.00 MG TOTAL: DAILY: ORAL Date:07/09/01ISR Number: 3754439-8Report Type:Direct Company Report # Age:5 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Electrocardiogram Qt Ziprasidone PS DENTAL 20 MG ONCE A Prolonged DAY DENTAL Date:07/09/01ISR Number: 3754555-0Report Type:Expedited (15-DaCompany Report #A115435 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Health Geodon PS Pfizer Central Initial or Prolonged Professional Research UNKNOWN UNK; UNK Date:07/09/01ISR Number: 3754568-9Report Type:Expedited (15-DaCompany Report #A115030 Age: Gender:Female I/FU:I Outcome Life-Threatening Required Intervention to 22-Feb-2006 08:32 AM Page: 81 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Haemorrhagic Stroke Health Geodon PS Pfizer Central International Normalised Professional Research Ratio Increased Vaginal Haemorrhage Date:07/09/01ISR Number: 3754683-XReport Type:Expedited (15-DaCompany Report #A115451 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Ventricular Tachycardia Health Geodon PS Pfizer Central Intervention to Professional Research Prevent Permanent Company Antipsychotic Drug Impairment/Damage Representative (Unspecified) C Date:07/09/01ISR Number: 3754821-9Report Type:Expedited (15-DaCompany Report #A112715 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diarrhoea Consumer Geodon PS Pfizer Central Initial or Prolonged Hallucination Health Research ORAL 20.00 MG Psychotic Disorder Professional TOTAL: ORAL Suicidal Ideation Topiramate SS Klonopin C Date:07/09/01ISR Number: 3755092-XReport Type:Expedited (15-DaCompany Report #A113893 Age:32 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Foreign Body Aspiration Health Geodon PS Pfizer Central Respiratory Arrest Professional Research 160.00 MG Company TOTAL: BID Representative Sertraline C Neurontin C Luvox C Remeron C Lasix C Clonidine C Depakote C Clonopin C Synthroid C Thorazine C Date:07/10/01ISR Number: 3756292-5Report Type:Expedited (15-DaCompany Report #A108646 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Consumer Geodon PS Pfizer Central Initial or Prolonged Drug Ineffective Health Research ORAL PO Mania Professional Seroquel SS ORAL 300.00 MG Medication Error TOTAL:DAILY:O Schizophrenia RAL Neurontin (Gabapentin) SS 3600.00 MG TOTAL:TID 22-Feb-2006 08:32 AM Page: 82 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Beer SS ORAL ORAL Depakote C Clonazepam C Date:07/10/01ISR Number: 3756293-7Report Type:Expedited (15-DaCompany Report #A115347 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Health Geodon PS Pfizer Central Initial or Prolonged Blood Creatine Professional Research ORAL 120.00 MG Phosphokinase Increased Company TOTAL:BID:ORA Insomnia Representative L Neuroleptic Malignant Lithium C Syndrome Restlessness Date:07/10/01ISR Number: 3756294-9Report Type:Expedited (15-DaCompany Report #A115349 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Geodon PS Pfizer Central Professional Research Company Zyprexa (Olanzapine) C Representative Date:07/10/01ISR Number: 3756947-2Report Type:Expedited (15-DaCompany Report #A115424 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Consumer Geodon PS Pfizer Central Dyskinesia Research 80.00 MG Joint Dislocation TOTAL:QID: Muscle Spasms Nightmare Sleep Disorder Tardive Dyskinesia Tremor Trismus Date:07/12/01ISR Number: 3757018-1Report Type:Expedited (15-DaCompany Report #A115451 Age:58 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Health Geodon PS Pfizer Central Initial or Prolonged Dyspnoea Professional Research ORAL 80.00 MG Palpitations TOTAL:BID:ORA Ventricular Tachycardia L Fluvoxamine Maleate C Lorazepam C Antipsychotic Drug (Unspecified) C 22-Feb-2006 08:32 AM Page: 83 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/12/01ISR Number: 3757042-9Report Type:Expedited (15-DaCompany Report #A115656 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Effect Decreased Health Geodon PS Pfizer Central Initial or Prolonged Professional Research Seroquel C Date:07/12/01ISR Number: 3757049-1Report Type:Expedited (15-DaCompany Report #A114514 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Geodon PS Pfizer Central Professional Research ORAL PO Date:07/12/01ISR Number: 3757050-8Report Type:Expedited (15-DaCompany Report #A109802 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Geodon PS Pfizer Central Initial or Prolonged Condition Aggravated Professional Research ORAL BID:ORAL Dysphagia Seroquel Fall (Quetiapine) C Hallucination, Auditory Propranolol C Insomnia Paxil (Paroxetine) C Logorrhoea Nortriptyline C Muscle Rigidity Lithium Carbonate C Muscle Twitching Thiamine C Tongue Discolouration Folic Acid C Tongue Oedema Clonazepam C Tremor Date:07/12/01ISR Number: 3757052-1Report Type:Expedited (15-DaCompany Report #A114516 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Geodon PS Pfizer Central Health Research ORAL PO Professional Date:07/12/01ISR Number: 3757150-2Report Type:Expedited (15-DaCompany Report #A115452 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyspnoea Consumer Geodon PS Pfizer Central Initial or Prolonged Respiratory Depression Research Diphenhydramine C Amoxapine C Ativan (Lorazepam) C Date:07/13/01ISR Number: 3758806-8Report Type:Expedited (15-DaCompany Report #A114391 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Health Geodon PS Pfizer Central Professional Research 22-Feb-2006 08:32 AM Page: 84 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/13/01ISR Number: 3758808-1Report Type:Expedited (15-DaCompany Report #A115906 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dermatitis Health Geodon PS Pfizer Central Initial or Prolonged Mania Professional Research 160.00 MG Company TOTAL:BID Representative Date:07/16/01ISR Number: 3758394-6Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hallucination Haloperidol PS ORAL 0.5 MG PO QHS Hospitalization - Neuroleptic Malignant Geodon SS ORAL 80 MG PO BID Initial or Prolonged Syndrome Required Intervention to Prevent Permanent Impairment/Damage Date:07/16/01ISR Number: 3759279-1Report Type:Expedited (15-DaCompany Report #A116341 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Aspartate Health Geodon PS Pfizer Central Intervention to Aminotransferase Professional Research Prevent Permanent Increased Company Impairment/Damage Representative Date:07/16/01ISR Number: 3759448-0Report Type:Expedited (15-DaCompany Report #A115349 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Health Geodon PS Pfizer Central Professional Research ORAL 80.00 MG TOTAL: BID: ORAL Zyprexa (Olanzapine) C Date:07/17/01ISR Number: 3759765-4Report Type:Direct Company Report # Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Geodon Initial or Prolonged (20mg)(Pfizer) PS Pfizer ORAL 20MG PO Q AM, 80 MG PO QHS Date:07/17/01ISR Number: 3759990-2Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Electrocardiogram Qt Geodon PS Pfizer ORAL 40 MG/ BID/ Prolonged ORAL Geodon SS Pfizer ORAL 60 MG/ BID/ ORAL Carbamazepine C 22-Feb-2006 08:32 AM Page: 85 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tiazac C Depakote C Docusate C Levothyroxine C Multivitamin C Theophylline C Haloperidol C Decanoate C Quetiapine C Date:07/17/01ISR Number: 3759995-1Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Confusional State Geodon 20 Mg Pfizer PS Pfizer ORAL 20 MG/ AM/ ORAL Citalopram C Benztropine C Cyclopentolate C Glyburide C Haloperidol C Decanoate C Lansoprazole C Metformin C Date:07/17/01ISR Number: 3760827-6Report Type:Expedited (15-DaCompany Report #A113544 Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Aggression Consumer Geodon PS Pfizer Central Intervention to Agitation Company Research ORAL ORAL Prevent Permanent Anaemia Macrocytic Representative Depakote C Impairment/Damage Anxiety Oxazepam C Blood Potassium Increased Fluphenazine C Blood Sodium Increased Risperdal C Blood Urea Increased Clozapine C Breast Discharge Ativan C Constipation Sonata C Delusion Cogentin C Electrocardiogram Qt Vistraril C Corrected Interval Vitamin E C Prolonged Colace C Gastrooesophageal Reflux Disease Hallucination, Auditory Hiatus Hernia Hostility Loose Associations Mood Altered Pain Protein Total Decreased Speech Disorder Thinking Abnormal White Blood Cell Count Increased 22-Feb-2006 08:32 AM Page: 86 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/19/01ISR Number: 3760976-2Report Type:Direct Company Report # Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Geodon-Use? PS GEODON 20 Hallucination, Tactile INCREASED TO Obsessive-Compulsive 80 Disorder Seroquel Withdrawal SS SEROQUEL 800 DECREASED 0 Klonopin C Prozac C Wellbutrin Sr C Topamax C Date:07/19/01ISR Number: 3761813-2Report Type:Expedited (15-DaCompany Report #A109401 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Consumer Geodon PS Pfizer Central Hospitalization - Blood Glucose Increased Health Research ORAL 80.00 MG Initial or Prolonged Drug Toxicity Professional TOTAL:BID:ORA Hypertension Company L Insomnia Representative Serentil SS ORAL 225.00 MG Psychotic Disorder TOTAL:TID:ORA Seborrhoea L Sudden Death Thioridazine SS Fluoxetine SS 20.00 MG TOTAL:DAILY Remeron C Atorvastatin C Neurontin C Klonopin C Aspirin C Thorazine C Lorazepam C Cogentin C Depakote C Prinivil C Moban C Zyprexa C Seroquel C Prozac C Date:07/19/01ISR Number: 3762365-3Report Type:Expedited (15-DaCompany Report #A116058 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arrhythmia Health Geodon PS Pfizer Central Initial or Prolonged Overdose Professional Research Paroxetine SS Alcohol SS Cocaine SS Date:07/19/01ISR Number: 3762376-8Report Type:Expedited (15-DaCompany Report #A114658 Age:53 YR Gender:Male I/FU:F Outcome Hospitalization - Initial or Prolonged 22-Feb-2006 08:32 AM Page: 87 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Required Intervention to Prevent Permanent PT Report Source Product Role Manufacturer Route Dose Duration Impairment/Damage Asthenia Health Geodon PS Pfizer Central Circulatory Collapse Professional Research ORAL 160.00 MG Coma TOTAL:BID:ORA Delusion L Electrocardiogram Qt Accupril (Quinapril) C Corrected Interval Valproic Acid C Prolonged Aldomet (Methyldopa) C Hallucination Atenolol C Oedema Peripheral Asa C Sinus Bradycardia Depakote C Ventricular Extrasystoles Unspecified Beta Blocker C Date:07/19/01ISR Number: 3762423-3Report Type:Expedited (15-DaCompany Report #A115349 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Health Geodon PS Pfizer Central Professional Research ORAL 80.00 MG TOTAL:BID:ORA L Zyprexa (Olanzapine) C Date:07/19/01ISR Number: 3762727-4Report Type:Expedited (15-DaCompany Report #A114393 Age: Gender:Unknown I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Geodon PS Pfizer Central Professional Research Date:07/19/01ISR Number: 3762728-6Report Type:Expedited (15-DaCompany Report #A114400 Age: Gender:Unknown I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Geodon PS Pfizer Central Professional Research Date:07/19/01ISR Number: 3762733-XReport Type:Expedited (15-DaCompany Report #A111003 Age:18 YR Gender:Female I/FU:F Outcome PT Hospitalization - Alanine Aminotransferase Initial or Prolonged Increased Required Convulsion Intervention to Dysphagia Prevent Permanent Headache Impairment/Damage Lymphocyte Count Increased Monocyte Count Increased Muscle Rigidity Myalgia Oxygen Saturation Decreased Pharyngolaryngeal Pain 22-Feb-2006 08:32 AM Page: 88 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pyrexia Report Source Product Role Manufacturer Route Dose Duration Consumer Geodon PS Pfizer Central Health Research BID Professional Ritalin Sr C Seroquel C Aleve C Date:07/20/01ISR Number: 3762868-1Report Type:Expedited (15-DaCompany Report #A116732 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Geodon PS Pfizer Central Professional Research Company Representative Date:07/20/01ISR Number: 3762939-XReport Type:Expedited (15-DaCompany Report #A112903 Age:29 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Consumer Geodon PS Pfizer Central Overdose Health Research ORAL 20.00 MG Professional TOTAL:BID:ORA L Clonazepam C Promethazine C Zestril C Prevacid C Hydrocodone And Acetaminophen C Lorazepam C Albuterol Inhaler C Levora C Celexa C Zyprexa C Triazolam C Ambien C Ibuprofen C Aerobid-M C Daypro C Date:07/23/01ISR Number: 3763477-0Report Type:Expedited (15-DaCompany Report #A117086 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Hyperthermia Malignant Health Geodon PS Pfizer Central Intervention to Professional Research Prevent Permanent Company Effexor C Impairment/Damage Representative Topamax C Remeron C Neurontin C 22-Feb-2006 08:32 AM Page: 89 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/23/01ISR Number: 3763602-1Report Type:Expedited (15-DaCompany Report #A115451 Age:58 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Health Geodon PS Pfizer Central Initial or Prolonged Chronic Obstructive Professional Research ORAL 80.00 MG Pulmonary Disease TOTAL:BID:ORA Dyspnoea L Palpitations Fluvoxamine Maleate C Sinus Tachycardia Lorazepam C Ventricular Tachycardia Antipsychotic Drug (Unspecified) C Date:07/23/01ISR Number: 3763743-9Report Type:Expedited (15-DaCompany Report #A116862 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Consumer Ziprasidone PS Pfizer Central Required Drug Dependence Research ORAL 40:00MG Intervention to Mania TOTAL:BID:ORA Prevent Permanent Panic Attack L Impairment/Damage Social Avoidant Behaviour Lithium C Date:07/23/01ISR Number: 3763880-9Report Type:Expedited (15-DaCompany Report #A114790 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Arrhythmia Health Geodon PS Pfizer Central Hospitalization - Asthenia Professional Research ORAL 40.00 MG Initial or Prolonged Blood Potassium Decreased TOTAL:BID:ORA Required Blood Pressure Decreased L Intervention to Bradycardia Neurontin C Prevent Permanent Dizziness Klonopin C Impairment/Damage Hyperhidrosis Eskalith C Nausea Premarin C Weight Decreased Synthroid C Date:07/26/01ISR Number: 3765852-7Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Drug Eruption Geodon 80 Mg PS ORAL T PO BID Intervention to Skin Ulcer Propanolol C Prevent Permanent Topamax C Impairment/Damage Loestrin C Neurontin C Dexedrine C Date:07/26/01ISR Number: 3766176-4Report Type:Expedited (15-DaCompany Report #A117130 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Amnesia Consumer Geodon PS Pfizer Central Initial or Prolonged Difficulty In Walking Research ORAL 120.00 MG Drug Interaction TOTAL: Drug Level Above BIID:ORAL Therapeutic Lithium SS ORAL 1600.00 MG Hallucination TOTAL: DAILY: 22-Feb-2006 08:32 AM Page: 90 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Zyprexa (Olanzapine) SS ORAL 30.00 MG TOTAL: DAILY:ORAL Tegretol (Carbamazepine) SS ORAL ORAL Sleeping Medication C Blood Pressure Medication C Date:07/26/01ISR Number: 3766180-6Report Type:Expedited (15-DaCompany Report #A117132 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coordination Abnormal Consumer Geodon PS Pfizer Central Initial or Prolonged Drug Interaction Research Drug Level Above Lithium SS Therapeutic Dysarthria Date:07/26/01ISR Number: 3766234-4Report Type:Expedited (15-DaCompany Report #A117290 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blindness Unilateral Health Geodon PS Pfizer Central Intervention to Vision Blurred Professional Research 12.00 MG Prevent Permanent Company TOTAL:BID Impairment/Damage Representative Clozapine SS 700.00 MG TOTAL:BID Remeron SS Celexa SS Klonopin C Date:07/26/01ISR Number: 3766636-6Report Type:Expedited (15-DaCompany Report #A116732 Age:17 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Circulatory Collapse Health Geodon PS Pfizer Central Mania Professional Research Depakote C Ativan C Date:07/27/01ISR Number: 3767121-8Report Type:Expedited (15-DaCompany Report #A117094 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Health Geodon PS Pfizer Central Initial or Prolonged Prolonged Professional Research 160.00 MG Required TOTAL;BID Intervention to Prevent Permanent Impairment/Damage 22-Feb-2006 08:32 AM Page: 91 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/27/01ISR Number: 3767156-5Report Type:Expedited (15-DaCompany Report #A117360 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Electrocardiogram Qt Health Geodon (Ziprasidone Intervention to Corrected Interval Professional Po) PS Pfizer Central Prevent Permanent Prolonged Company Research BID Impairment/Damage Electrocardiogram Qt Representative Prolonged Myocardial Infarction Sinus Bradycardia Date:07/30/01ISR Number: 3767722-7Report Type:Expedited (15-DaCompany Report #A117359 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Bundle Branch Block Right Health Geodon PS Pfizer Central Intervention to Condition Aggravated Professional Research BID Prevent Permanent Electrocardiogram Company Impairment/Damage Abnormal Representative Electrocardiogram Qt Corrected Interval Prolonged Palpitations Psychotic Disorder Date:07/30/01ISR Number: 3767723-9Report Type:Expedited (15-DaCompany Report #A116341 Age: Gender:Unknown I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Aspartate Health Geodon PS Pfizer Central Intervention to Aminotransferase Professional Research Prevent Permanent Increased Impairment/Damage Date:07/30/01ISR Number: 3767737-9Report Type:Expedited (15-DaCompany Report #A115451 Age:59 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Health Geodon PS Pfizer Central Initial or Prolonged Asthenia Professional Research ORAL 80.00 MG Chronic Obstructive TOTAL:BID:ORA Pulmonary Disease L Dizziness Fluvoxamine Maleate C Palpitations Lorazepam C Pulse Pressure Decreased Antipsychotic Drug Sinus Tachycardia (Unspecified) C Date:07/30/01ISR Number: 3767742-2Report Type:Expedited (15-DaCompany Report #A116860 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aortic Dissection Consumer Norvasc PS Pfizer Agricultural Hospitalization - Dizziness Div ORAL ORAL Initial or Prolonged Drug Ineffective Geodon SS ORAL ORAL Myocardial Infarction Paxil SS Palpitations Catapress C Ventricular Extrasystoles Zestril C 22-Feb-2006 08:32 AM Page: 92 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Roxicodone C Toprol Xl C Hydrochlorothiazide C Date:07/30/01ISR Number: 3768869-1Report Type:Expedited (15-DaCompany Report #A110764 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Health Geodon PS Pfizer Central Initial or Prolonged Confusional State Professional Research ORAL 40.00 MG Dizziness TOTAL BID Drug Effect Decreased ORAL Tachycardia Prolixin (Fluphenazine) C Prozac (Fluoxetine) C Serevent (Salmeterol) C Tegretol (Carbamazepine) C Calcium Supplement C Verapamil C Valproic Acid C Lanoxin C Prilosec C Prednisone C Klonopin C Date:07/30/01ISR Number: 3768881-2Report Type:Expedited (15-DaCompany Report #A115349 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alcohol Poisoning Health Geodon PS Pfizer Central Coma Professional Research ORAL 80.00 MG TOTAL:BID:ORA L Zyprexa (Olanzapine) C Date:07/30/01ISR Number: 3769186-6Report Type:Expedited (15-DaCompany Report #A114604 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Consumer Geodon PS Pfizer Central Initial or Prolonged Eructation Research ORAL 80.00 MG Feeling Abnormal TOTAL:BID:ORA Hallucination, Auditory L Joint Stiffness Ativan (Lorazepam) C Muscle Rigidity Zyprexa (Olanzapine) C Date:08/01/01ISR Number: 3768395-XReport Type:Direct Company Report # Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Ziprasidone (Geodon) PS ORAL 60 MG PO BID Corrected Interval Prolonged Electrocardiogram Qt Prolonged 22-Feb-2006 08:32 AM Page: 93 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/02/01ISR Number: 3770089-1Report Type:Expedited (15-DaCompany Report #A117678 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Catatonia Health Geodon PS Pfizer Central Intervention to Professional Research Prevent Permanent Company Impairment/Damage Representative Date:08/02/01ISR Number: 3770091-XReport Type:Expedited (15-DaCompany Report #A117765 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Health Geodon PS Pfizer Central Initial or Prolonged Convulsion Professional Research Electrocardiogram Trazadone SS Abnormal Prozac SS Electrocardiogram Qrs Wellbutrin C Complex Prolonged Overdose Sedation Tachycardia Date:08/02/01ISR Number: 3770093-3Report Type:Expedited (15-DaCompany Report #A115030 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Haemorrhagic Stroke Health Geodon PS Pfizer Central Required International Normalised Professional Research 40.00 BID Intervention to Ratio Increased TOTAL:BID Prevent Permanent Poisoning Deliberate Rat Poison SS Impairment/Damage Vaginal Haemorrhage Date:08/02/01ISR Number: 3770105-7Report Type:Expedited (15-DaCompany Report #A117652 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyponatraemia Consumer Geodon PS Pfizer Central Initial or Prolonged Neuroleptic Malignant Health Research ORAL ORAL Syndrome Professional Haldol C Water Intoxication Company Psychotropic Drug Representative (Not Specified) C Date:08/02/01ISR Number: 3770162-8Report Type:Expedited (15-DaCompany Report #A109961 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ecchymosis Health Geodon PS Pfizer Central Initial or Prolonged Fall Professional Research ORAL 40.00 Neuroleptic Malignant TOTAL:ORAL Syndrome Lithium SS 1200.00 MG TOTAL Seroquel (Quetiapine) SS 200.00 MG TOTAL Propranolol SS 60.00 MG TOTAL Paxil (Paroxetine) C 22-Feb-2006 08:32 AM Page: 94 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Nortriptyline C Date:08/02/01ISR Number: 3770164-1Report Type:Expedited (15-DaCompany Report #A113035 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Agitation Health Geodon PS Pfizer Central Intervention to Deep Vein Thrombosis Professional Research 40.00MG Prevent Permanent Fluid Retention TOTAL:BID Impairment/Damage Water SS Topiramate C Neurontin C Lithium C Ativan C Flovent C Albuterol C Maxair C Serevent C Motrin C Prempro C Clinoril C Date:08/03/01ISR Number: 3770909-0Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Geodon 80 Mg. Pfizer PS Pfizer ORAL 80 MG/BID/ORAL Normodyne C Cardizem C Catapres C Asa C Chronulac C Pericolace C Zithromax C Atrovent C Multiple Vitamins C Glyburide C Ativan C Ditropan Xl C Golytely C Date:08/03/01ISR Number: 3771062-XReport Type:Expedited (15-DaCompany Report #A116341 Age:80 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gastrointestinal Health Geodon PS Pfizer Central Initial or Prolonged Haemorrhage Professional Research Required Hepatitis Lamotrigine SS Intervention to Flonase C Prevent Permanent Effexor C Impairment/Damage 22-Feb-2006 08:32 AM Page: 95 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/03/01ISR Number: 3771069-2Report Type:Expedited (15-DaCompany Report #A117780 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Heat Stroke Health Zoloft PS Pfizer Professional Pharmaceuticals Inc Company Geodon SS 240.00 MG Representative TOTAL:BID Depakote C Date:08/07/01ISR Number: 3771790-6Report Type:Expedited (15-DaCompany Report #A117872 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Health Geodon PS Pfizer Central Syndrome Professional Research Company Paxil (Paroxetine) SS Representative Date:08/08/01ISR Number: 3773053-1Report Type:Direct Company Report # Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Geodon 20mg Pfizer PS Pfizer ORAL 20MG BID ORAL Metoprolol C Vasotec C Clonidine C Hydrochlorothiazide C Prilosec C Oxycontin C Oxycodone C Sporanox C Date:08/08/01ISR Number: 3773056-7Report Type:Expedited (15-DaCompany Report #A114920 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Eosinophil Count Health Geodon PS Pfizer Central Intervention to Increased Professional Research ORAL 80.00 MG Prevent Permanent Haemoglobin Decreased TOTAL: BID: Impairment/Damage Oedema ORAL Pulmonary Oedema Valproic Acid C Red Blood Cell Count Lorazapam C Decreased Ferrous Sulfate White Blood Cell Count Elixir C Increased Lithium C Date:08/08/01ISR Number: 3773061-0Report Type:Expedited (15-DaCompany Report #A117982 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cardiac Failure Health Geodon PS Pfizer Central Intervention to Congestive Professional Research ORAL 160.00 MG Prevent Permanent Oedema TOTAL BID Impairment/Damage Pulmonary Oedema ORAL Respiratory Distress Zyprexa C Celexa C Xanax C 22-Feb-2006 08:32 AM Page: 96 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/08/01ISR Number: 3773488-7Report Type:Expedited (15-DaCompany Report #A118109 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyskinesia Consumer Zoloft PS Pfizer Initial or Prolonged Insomnia Health Pharmaceuticals Inc ORAL 75.00 Required Restlessness Professional TOTAL:ORAL Intervention to Company Ziprasidone SS ORAL 120.00 MG Prevent Permanent Representative TOTAL:ORAL Impairment/Damage Zyprexa (Olanzapine) C Date:08/08/01ISR Number: 3782672-8Report Type:Direct Company Report # Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Medication Error Geodon (80 Mg) PS 80MG BID Hospitalization - Overdose Initial or Prolonged Date:08/09/01ISR Number: 3773868-XReport Type:Direct Company Report # Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Geodon (40mg) PS 40MG 1T CAP Jaw Disorder TID Date:08/09/01ISR Number: 3774552-9Report Type:Expedited (15-DaCompany Report #A113544 Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Affective Disorder Consumer Geodon PS Pfizer Central Intervention to Anxiety Health Research ORAL ORAL Prevent Permanent Asthenia Professional Depakote C Impairment/Damage Circadian Rhythm Sleep Company Oxazepam C Disorder Representative Fluphenazine C Condition Aggravated Risperdal C Delusion Clozapine C Electrocardiogram Qt Ativan C Prolonged Sonata C Hostility Cogentin C Thinking Abnormal Vistaril C Weight Decreased Vitamin E C White Blood Cell Count Colace C Increased Date:08/09/01ISR Number: 3774563-3Report Type:Expedited (15-DaCompany Report #A111585 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Geodon PS Pfizer Central Initial or Prolonged Dizziness Professional Research BID Drug Tolerance Decreased Risperdal SS Gastrointestinal Disorder Hallucination Paranoia Sedation 22-Feb-2006 08:32 AM Page: 97 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/09/01ISR Number: 3774564-5Report Type:Expedited (15-DaCompany Report #A112403 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Geodon PS Pfizer Central Initial or Prolonged Dehydration Professional Research ORAL 60.00 MG Gastrointestinal Disorder TOTAL:BID:ORA Insomnia L Nausea Vomiting Date:08/09/01ISR Number: 3774567-0Report Type:Expedited (15-DaCompany Report #A118097 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebral Artery Health Geodon PS Pfizer Central Initial or Prolonged Thrombosis Professional Research ORAL 80.00 MG Cerebrovascular Accident TOTAL:BID:ORA Diarrhoea L Dizziness Wellbustrin C Fall Synthroid C Lithium C (Topiramate) C Haldol C Alupent C Ativan C Tylenol C Rosperdol C Klonopin C Date:08/09/01ISR Number: 3774650-XReport Type:Expedited (15-DaCompany Report #A107661 Age:65 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Bradycardia Health Geodon PS Pfizer Central Intervention to Bundle Branch Block Professional Research ORAL 40.00 MG Prevent Permanent Bilateral TOTAL:BID:ORA Impairment/Damage Bundle Branch Block Right L Electrocardiogram Qt Chlorpromazine SS ORAL 200.00 MG Prolonged TOTAL:QID:ORA Oedema L Psychotic Disorder Asa C Lorazepam C Vitamin B12 C Neutra-Phos C Lithium C Tylenol C Cogentin C Chloral Hydrate C Mom With Cascara C Fleet Enema C Hydrocortisone C Sebulex C Olanzapine C Mevacor C Imodium C Phenolated Resorcinol C Terbinafine C 22-Feb-2006 08:32 AM Page: 98 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/09/01ISR Number: 3774652-3Report Type:Expedited (15-DaCompany Report #A118556 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Health Geodon PS Pfizer Central Phosphokinase Increased Professional Research Catatonia Lithium Carbonate C Condition Aggravated Klonopin Neuroleptic Malignant (Clonazepam) C Syndrome Date:08/09/01ISR Number: 3774653-5Report Type:Expedited (15-DaCompany Report #A118661 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Consumer Geodon PS Pfizer Central Drug Interaction Research Dysphemia Depakote (Sodium Loss Of Consciousness Valproate) SS 500.00 MG Panic Attack TOTAL:UNKNOWN Tremor Paxil (Paroxetine) SS 10.00 MG TOTAL:DAILY Pepto Bismol (Bismuth Subsalicylate) C Aspirin (Acetylsalicylic Acid) C Date:08/09/01ISR Number: 3774884-4Report Type:Expedited (15-DaCompany Report #A109882 Age:18 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arthralgia Health Geodon PS Pfizer Central Initial or Prolonged Neuroleptic Malignant Professional Research ORAL 40.00 MG Required Syndrome TOTAL:BID:ORA Intervention to Tachycardia L Prevent Permanent Haldol Decanoate C Impairment/Damage Haldol C Zyprexa C Seroquel C Diazepam C Date:08/09/01ISR Number: 3774885-6Report Type:Expedited (15-DaCompany Report #A114032 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Decreased Appetite Health Geodon PS Pfizer Central Initial or Prolonged Depression Professional Research ORAL 40.00 MG Drug Ineffective TOTAL: Hallucinations, Mixed BID:ORAL Tic Inderal Weight Decreased (Propranolol) C Ativan (Lorazepam) C Vitamin E C Klonopin (Clonazepam) C Cogetin (Benztropine) C 22-Feb-2006 08:32 AM Page: 99 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Zyprexa C Date:08/09/01ISR Number: 3774892-3Report Type:Expedited (15-DaCompany Report #A116862 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Aggression Consumer Geodon PS Pfizer Central Hospitalization - Drug Dependence Health Research ORAL PO Initial or Prolonged Mania Professional Lithium C Other Panic Disorder Without Required Agoraphobia Intervention to Psychotic Disorder Prevent Permanent Impairment/Damage Date:08/09/01ISR Number: 3775151-5Report Type:Expedited (15-DaCompany Report #A109401 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Consumer Geodon PS Pfizer Central Hospitalization - Blood Glucose Increased Health Research ORAL 60.00 MG Initial or Prolonged Cardiomegaly Professional TOTAL:DAILY:O Coronary Artery Disease Company RAL Drug Toxicity Representative Serentil SS ORAL 25MG TOTAL Hypertension TID: ORAL Insomnia Remeron C Psychotic Disorder Atorvastatin C Seborrhoea Neurontin C Sudden Death Klonopin C Aspirin C Thorazine C Lorazepam C Cogentin C Depakote C Prinivil C Moban C Zyprexa C Seroquel C Prozac C Fluoxetine C Thioridazine C Date:08/09/01ISR Number: 3775192-8Report Type:Expedited (15-DaCompany Report #A118538 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Health Geodon PS Pfizer Central Initial or Prolonged Professional Research Required Intervention to Prevent Permanent Impairment/Damage 22-Feb-2006 08:32 AM Page: 100 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/09/01ISR Number: 3775390-3Report Type:Expedited (15-DaCompany Report #A110763 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Geodon PS Pfizer Central Initial or Prolonged Delusion Professional Research ORAL 40.00 MG Psychotic Disorder TOTAL: BID: Sedation ORAL Risperidone SS ORAL 3.00 MG TOTAL:DAILY:O RAL Date:08/13/01ISR Number: 3776042-6Report Type:Expedited (15-DaCompany Report #A114905 Age:36 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Pr Health Geodon PS Pfizer Central Initial or Prolonged Shortened Professional Research ORAL 40.00 MG Required Intentional Overdose TOTAL: DAILY: Intervention to ORAL Prevent Permanent Clonazepam SS Impairment/Damage Alcohol SS Ativan C K-Dur C Celexa C Benadryl C Magnesium Oxide C Date:08/13/01ISR Number: 3776048-7Report Type:Expedited (15-DaCompany Report #A118400 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Alopecia Health Geodon PS Pfizer Central Intervention to Diabetes Mellitus Professional Research ORAL ORAL Prevent Permanent Paxil (Paroxetine) C Impairment/Damage Depakote (Valproate) C Alprazolam C Bisoprolol C Synthroid (Levothyroxine) C Triamterene/Hydrochl orothiazide C Gemfibrozil C Seroquel C Unspecified Herbs C Unspecified Vitamins C Potassium C Date:08/13/01ISR Number: 3776065-7Report Type:Expedited (15-DaCompany Report #A114391 Age: Gender:Unknown I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Geodon PS Pfizer Central Health Research Professional 22-Feb-2006 08:32 AM Page: 101 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/13/01ISR Number: 3776155-9Report Type:Expedited (15-DaCompany Report #A117094 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Potassium Increased Health Geodon PS Pfizer Central Initial or Prolonged Electrocardiogram Qt Professional Research 160.00 MG Required Prolonged TOTAL:BID Intervention to Seroquel C Prevent Permanent Depakote C Impairment/Damage Date:08/13/01ISR Number: 3776294-2Report Type:Expedited (15-DaCompany Report #A118735 Age:9 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Heart Rate Irregular Consumer Geodon PS Pfizer Central Research ORAL 20.00 MG TOTAL:DAILY:P O Risperdal (Risperidone) C Trileptal (Oxcarbazepine) C Glucophage (Metformin) C Effexor (Venlafaxine) C Date:08/13/01ISR Number: 3776296-6Report Type:Expedited (15-DaCompany Report #A118300 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Parkinsonism Health Geodon PS Pfizer Central Initial or Prolonged Professional Research ORAL 40.00 MG TOTAL:BID:ORA L Fluvoxamine C Prinivil (Lisinopril) C Unspecified Benzodiazepines C Date:08/13/01ISR Number: 3776322-4Report Type:Expedited (15-DaCompany Report #A118737 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Health Geodon PS Pfizer Central Initial or Prolonged Professional Research 40.00 MG TOTAL:BID Date:08/13/01ISR Number: 3776855-0Report Type:Expedited (15-DaCompany Report #A118688 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Disorder Health Geodon PS Pfizer Central Initial or Prolonged Professional Research 160.00 MG TOTAL: BID 22-Feb-2006 08:32 AM Page: 102 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/15/01ISR Number: 3778165-4Report Type:Expedited (15-DaCompany Report #A112903 Age:29 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Consumer Geodon PS Pfizer Central Fear Health Research ORAL 20.00 MG Overdose Professional TOTAL:BID:ORA Renal Disorder L Suicidal Ideation Clonazepam C Toxicologic Test Abnormal Promethazine C Zestril C Prevacid C Hydrocodone And Acetominophen C Lorazepam C Albuterol Inhaler C Levora C Celexa C Zyprexa C Triazolam C Ambien C Ibuprophen C Aerobid-M C Daypro C Date:08/15/01ISR Number: 3778182-4Report Type:Expedited (15-DaCompany Report #A118994 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Insomnia Consumer Geodon PS Pfizer Central Initial or Prolonged Nightmare Research ORAL 60.00 MG Pyrexia TOTAL:TID:ORA Sinusitis L Sleep Disorder Xanax C Acetaminophen C Date:08/15/01ISR Number: 3778187-3Report Type:Expedited (15-DaCompany Report #A118836 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Extrapyramidal Disorder Health Geodon PS Pfizer Central Road Traffic Accident Professional Research ORAL 160.00 MG TOTAL:BID:ORA L Other Unspecified Medications C Date:08/15/01ISR Number: 3778207-6Report Type:Expedited (15-DaCompany Report #A112826 Age:15 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Drug Interaction Health Geodon PS Pfizer Central Intervention to Dyspnoea Professional Research ORAL 20.00 MG Prevent Permanent Flushing TOTAL:DAILY Impairment/Damage Muscular Weakness Paraesthesia Throat Tightness 22-Feb-2006 08:32 AM Page: 103 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/15/01ISR Number: 3778232-5Report Type:Expedited (15-DaCompany Report #A109036 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Health Geodon PS Pfizer Central Initial or Prolonged Professional Research ORAL 80.00 MG TOTAL:BID:ORA L Risperdal C Date:08/16/01ISR Number: 3778677-3Report Type:Expedited (15-DaCompany Report #A118686 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Unevaluable Event Health Geodon PS Pfizer Central Initial or Prolonged Professional Research ORAL Company Representative Date:08/16/01ISR Number: 3778723-7Report Type:Expedited (15-DaCompany Report #A112909 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arrhythmia Health Geodon PS Pfizer Central Arterial Occlusive Professional Research Disease Company Chemotherapy Hypertension Representative Unspecified SS Renal Disorder Date:08/16/01ISR Number: 3778726-2Report Type:Expedited (15-DaCompany Report #A109401 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Glucose Increased Consumer Geodon PS Pfizer Central Hospitalization - Hyperlipidaemia Health Research ORAL 60.00 MG Initial or Prolonged Hypertension Professional TOTAL:DAILY:O Insomnia Company RAL Obesity Representative Serentil SS ORAL 225.00 MG Osteoarthritis TOTAL:TID:ORA Seborrhoea L Sudden Death Remeron C Therapeutic Agent Atorvastatin C Toxicity Neurontin C Klonopin C Aspirin C Thorazine C Lorazepam C Cogentin C Depakote C Prinivil C Moban C Zyprexa C Seroquel C Prozac C Fluoxetine C Thioridazine C 22-Feb-2006 08:32 AM Page: 104 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/16/01ISR Number: 3778900-5Report Type:Expedited (15-DaCompany Report #A116860 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aortic Dissection Consumer Norvasc PS Pfizer Agricultural Hospitalization - Dizziness Health Div ORAL ORAL Initial or Prolonged Drug Ineffective Professional Geodon SS ORAL ORAL Hypertension Paxil SS Myocardial Infarction Catapress C Palpitations Zestril C Ventricular Extrasystoles Roxicodone C Toprol Xl C Hydrochlorothiazide C Date:08/16/01ISR Number: 3779073-5Report Type:Expedited (15-DaCompany Report #A111570 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Health Geodon PS Pfizer Central Initial or Prolonged Dizziness Professional Research 40.00 MG Gastrointestinal Disorder Company TOTAL: BID Paranoia Representative Sedation Date:08/17/01ISR Number: 3780087-XReport Type:Expedited (15-DaCompany Report #A112903 Age:29 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Consumer Geodon PS Pfizer Central Glomerulonephritis Health Research ORAL 20.00 MG Membranoproliferative Professional TOTAL: BID: Suicidal Ideation ORAL Toxicologic Test Abnormal Hydrocodone SS Olanzapine SS Clonazepam C Promethazine C Zestril C Prevacid C Acetominophen C Lorazepam C Albuterol Inhaler C Levora C Celexa C Triazolan C Ambien C Ibuprofen C Aerobid-M C Daypro C Date:08/17/01ISR Number: 3780326-5Report Type:Expedited (15-DaCompany Report #A109905 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Neuroleptic Malignant Health Geodon PS Pfizer Central Intervention to Syndrome Professional Research ORAL ORAL Prevent Permanent Lithium SS Impairment/Damage Nortryptiline C Seroquel C Propanolol C 22-Feb-2006 08:32 AM Page: 105 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Benadryl C Date:08/17/01ISR Number: 3780330-7Report Type:Expedited (15-DaCompany Report #A119144 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Back Pain Consumer Geodon PS Pfizer Central Intervention to Drug Ineffective Research ORAL 80.00 MG Prevent Permanent Prostatitis TOTAL:BID:ORA Impairment/Damage L Trazodone C Date:08/17/01ISR Number: 3780331-9Report Type:Expedited (15-DaCompany Report #A119156 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Vomiting Health Geodon PS Pfizer Central Professional Research ORAL 80.00 MG Company TOTAL:BID:ORA Representative L Risperdal C Neurontin C Trazadone C Ativan C Cogentin C Multivitamin C Date:08/20/01ISR Number: 3779777-4Report Type:Direct Company Report # Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Creatine Geodon 40mg Pfizer PS Pfizer ORAL 40 MG QHS Intervention to Phosphokinase Increased ORAL Prevent Permanent Geodon 80 Mg Pfizer SS Pfizer ORAL 80 MG QAM Impairment/Damage ORAL Risperdal C Haloperidol C Acetaminophen C Bisacodyl C Dilantin C Flomax C Lorazepam C Mom/Cascara C Ceftin C Cipro C Clonazepam C Docusate C Magonate C Date:08/20/01ISR Number: 3780790-1Report Type:Expedited (15-DaCompany Report #A119231 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Pancytopenia Health Geodon PS Pfizer Central Intervention to Professional Research 160.00 MG Prevent Permanent TOTAL:BID Impairment/Damage 22-Feb-2006 08:32 AM Page: 106 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/20/01ISR Number: 3781195-XReport Type:Expedited (15-DaCompany Report #A118977 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Chest Pain Health Geodon PS Pfizer Central Intervention to Drug Effect Decreased Professional Research Prevent Permanent Electrocardiogram Qt Trilafon C Impairment/Damage Prolonged Prozac C Viral Infection Lamictal C Clonazepam C Seroquel C Date:08/22/01ISR Number: 3782098-7Report Type:Expedited (15-DaCompany Report #A117987 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Electrocardiogram Qt Health Ziprasidone Po PS Intervention to Corrected Interval Professional Cordarone C Prevent Permanent Prolonged Melatonin C Impairment/Damage Electrocardiogram Qt Topamax C Prolonged Lasix C Nervous System Disorder Wellbutrin C Date:08/22/01ISR Number: 3782173-7Report Type:Expedited (15-DaCompany Report #A115349 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alcohol Poisoning Health Ziprasidone Po PS ORAL 80.00 MG T Professional OTAL: BID: ORAL Olanzapine C Benztropine Mesylate C Date:08/23/01ISR Number: 3782250-0Report Type:Direct Company Report # Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Geodon (80 Mg Po Tid) PS ORAL 80 MG PO TID Imdur C Allopurinol C Lasix C Zaroxolyn C Prevacid C Arthotec C Cordarone C Date:08/24/01ISR Number: 3783197-6Report Type:Expedited (15-DaCompany Report #A118977 Age:18 YR Gender:Female I/FU:F Outcome PT Required Cardiac Disorder Intervention to Chest Pain Prevent Permanent Conversion Disorder Impairment/Damage Dizziness Electrocardiogram Abnormal Nausea 22-Feb-2006 08:32 AM Page: 107 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Viral Infection Vomiting Report Source Product Role Manufacturer Route Dose Duration Health Ziprasidone Po PS Professional Trilafon C Prozac C Lamictal C Clonazepam C Seroquel C Date:08/24/01ISR Number: 3783201-5Report Type:Expedited (15-DaCompany Report #A114658 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Health Ziprasidone Po PS ORAL 160.00 MG Initial or Prolonged Blood Pressure Increased Professional TOTAL: BID: Required Circulatory Collapse ORAL Intervention to Coma Accupril (Quinapril) C Prevent Permanent Convulsion Valproic Acid C Impairment/Damage Electrocardiogram Qt Aldomet (Methyldopa) C Prolonged Atenolol C Memory Impairment Asa C Myocardial Infarction Depakote C Oedema Unspecified Beta Oedema Peripheral Blocker C Sinus Bradycardia Supraventricular Extrasystoles Syncope Date:08/24/01ISR Number: 3783203-9Report Type:Expedited (15-DaCompany Report #A119552 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancytopenia Health Ziprasidone Po PS Initial or Prolonged Professional Required Intervention to Prevent Permanent Impairment/Damage Date:08/27/01ISR Number: 3783364-1Report Type:Expedited (15-DaCompany Report #A114661 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram T Wave Health Ziprasidone Po PS Initial or Prolonged Inversion Professional Gabapentin SS Overdose Tachycardia Date:08/27/01ISR Number: 3783513-5Report Type:Expedited (15-DaCompany Report #A119591 Age:23 YR Gender:Male I/FU:I Outcome Required Intervention to Prevent Permanent 22-Feb-2006 08:32 AM Page: 108 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Alanine Aminotransferase Health Ziprasidone Po PS ORAL 40.00 MG Increased Professional TOTAL:DAILY:O Blood Cholesterol RAL Increased Prozac C Blood Triglycerides Increased Low Density Lipoprotein Increased Date:08/29/01ISR Number: 3785183-9Report Type:Direct Company Report # Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Pressure Increased Geodon (20mg ) PS ORAL 20MG PO BID 30 DAY Intervention to Electrocardiogram Qt Prevent Permanent Corrected Interval Impairment/Damage Prolonged Heart Rate Increased Date:08/30/01ISR Number: 3785647-8Report Type:Direct Company Report # Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Priapism Geodon 60 Mg PS ORAL 60 MG PO BID Date:08/31/01ISR Number: 3786539-0Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Drug Level Above Geodon 20mg Pfizer PS Pfizer 20MG BID PER Intervention to Therapeutic G-TUBE Prevent Permanent Dilantin 125mg/5ml Impairment/Damage P-D SS P-D 600MG BID PER G-TUBE Date:08/31/01ISR Number: 3787097-7Report Type:Periodic Company Report #A114667 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Consumer Ziprasidone Po PS ORAL 80.00 MG Anxiety Health TOTAL:BID:ORA Chills Professional L Depression Paxil (Paroxetine) C Dyspepsia Wellbutrin Influenza Like Illness (Bupropion) C Insomnia Buspar (Buspirone) C Nausea Multivitamins With Nervousness Mineral Tab C Thinking Abnormal B-Complex C Tremor Vitamin C C Weight Increased Calcium/Magnesium C Fish Oil/Essential Oil Capsules C Klonopin 22-Feb-2006 08:32 AM Page: 109 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Clonazepam0 C Chywanprahs C Zyprexa (Olanzapine) C Date:08/31/01ISR Number: 3787098-9Report Type:Periodic Company Report #A114759 Age:13 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hallucination Consumer Ziprasidone Po PS ORAL 40.00 MG TOTAL:BID:ORA L Klonopin SS ORAL ORAL Celexa C Date:08/31/01ISR Number: 3787099-0Report Type:Periodic Company Report #A114783 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Consumer Ziprasidone Po PS ORAL 40.000 Hypertension TOTAL:BID:ORA Nausea L Rhinitis Zoloft (Sertraline) C Buspar (Buspirone) C Zyprexa (Olanzapine) C Zocor (Simvastatin0 C Diltiazem C Unspecified Ace Inhibitor C Lopressor (Metoprolol) C Date:08/31/01ISR Number: 3787100-4Report Type:Periodic Company Report #A114798 Age:7 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Consumer Ziprasidone Po PS ORAL 20.00 MG Congenital Central TOTAL:DAILY:O Nervous System Anomaly RAL Drug Ineffective Risperidone SS Muscle Twitching Luvox C Sedation Weight Decreased Date:08/31/01ISR Number: 3787101-6Report Type:Periodic Company Report #A114854 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tremor Health Ziprasidone Po PS Professional Date:08/31/01ISR Number: 3787102-8Report Type:Periodic Company Report #A114874 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Health Ziprasidone Po PS ORAL 120.00 MG Visual Disturbance Professional TOTAL:BID:ORA L 22-Feb-2006 08:32 AM Page: 110 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Concerta C Tenex C Ritalin C Date:08/31/01ISR Number: 3787103-XReport Type:Periodic Company Report #A114887 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accidental Overdose Health Ziprasidone Po PS Dermatitis Professional Neurontin (Gabapentin) SS Depakote (Sodium Valproate) SS Date:08/31/01ISR Number: 3787104-1Report Type:Periodic Company Report #A114907 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Health Ziprasidone Po PS 80.00 MG Confusional State Professional TOTAL:BD Insomnia Atropine SS Risperidone SS Clozaril C Cogentin C Date:08/31/01ISR Number: 3787105-3Report Type:Periodic Company Report #A114927 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depersonalisation Health Ziprasidone Po PS Professional Company Representative Date:08/31/01ISR Number: 3787106-5Report Type:Periodic Company Report #A114969 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Palpitations Health Ziprasidone Po PS Tachycardia Professional Company Representative Date:08/31/01ISR Number: 3787160-0Report Type:Periodic Company Report #A116963 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Ziprasidone Po PS Professional 22-Feb-2006 08:32 AM Page: 111 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/31/01ISR Number: 3787161-2Report Type:Periodic Company Report #A116965 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Health Ziprasidone Po PS ORAL 160.00 MG Leukopenia Professional TOTAL:BID:ORA L Clozaril SS ORAL 150.00 MG TOTAL:DAILY:O RAL Loxitane SS Date:08/31/01ISR Number: 3787162-4Report Type:Periodic Company Report #A116971 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Malaise Consumer Ziprasidone Po PS Neurosis Date:08/31/01ISR Number: 3787163-6Report Type:Periodic Company Report #A117061 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Musculoskeletal Disorder Health Ziprasidone Po PS Professional Company Representative Date:08/31/01ISR Number: 3787164-8Report Type:Periodic Company Report #A117097 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Health Ziprasidone Po PS ORAL 40.00 MG Attention Professional TOTAL:DAILY:O Deficit/Hyperactivity RAL Disorder Calcium SS Depression Zinc SS Nausea Vitamin E SS Maxzide C Ambien C Prozac C Xanax C Date:08/31/01ISR Number: 3787165-XReport Type:Periodic Company Report #A111156 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dermatitis Health Ziprasidone Po PS ORAL 40.00 MG Vasodilatation Professional TOTAL: BID: ORAL Unknown Seizure Medication C 22-Feb-2006 08:32 AM Page: 112 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/31/01ISR Number: 3787166-1Report Type:Periodic Company Report #A117100 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Urinary Retention Health Ziprasidone Po PS Professional Cogentin SS Risperdal SS Effexor C Dalmane C Alleve C Date:08/31/01ISR Number: 3787167-3Report Type:Periodic Company Report #A111189 Age:18 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Health Ziprasidone Po PS 160.00 MG Professional TOTAL: DAILY Date:08/31/01ISR Number: 3787168-5Report Type:Periodic Company Report #A117121 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chloasma Consumer Ziprasidone Po PS 120.00 MG Dermatitis Exfoliative TOTAL:BID: Photosensitivity Reaction Zyprexa (Olanzapine) C Pruritus Depakote (Sodium Skin Disorder Valproate) C Vitiligo Date:08/31/01ISR Number: 3787170-3Report Type:Periodic Company Report #A117126 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Facial Palsy Health Ziprasidone Po PS Professional Date:08/31/01ISR Number: 3787171-5Report Type:Periodic Company Report #A111234 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abscess Health Ziprasidone Po PS Chills Professional Celexa C Hyperhidrosis Company Representative Date:08/31/01ISR Number: 3787172-7Report Type:Periodic Company Report #A111235 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Health Ziprasidone Po PS Psychotic Disorder Professional Zyprexa SS Clozaril SS 22-Feb-2006 08:32 AM Page: 113 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/31/01ISR Number: 3787173-9Report Type:Periodic Company Report #A111236 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Health Ziprasidone Po PS Prolonged Professional Company Representative Date:08/31/01ISR Number: 3787174-0Report Type:Periodic Company Report #A111240 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oedema Peripheral Health Ziprasidone Po PS 80.00 MG Professional TOTAL: BID Depakote C Paxil C Trazadone C Date:08/31/01ISR Number: 3787175-2Report Type:Periodic Company Report #A111289 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Health Ziprasidone Po PS 80.00 MG Hypertension Professional TOTAL: BID Insomnia Company Palpitations Representative Date:08/31/01ISR Number: 3787176-4Report Type:Periodic Company Report #A111293 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Consumer Ziprasidone Po PS 40.00 MG Dizziness TOTAL: BID Headache Robaxin C Nausea Zoloft C Paraesthesia Multivitamin With Vitamin B Complex C Serzone C Klonopin C Levbid C Pentasa C Date:08/31/01ISR Number: 3787177-6Report Type:Periodic Company Report #A117144 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Muscle Spasms Health Ziprasidone Po PS Pain Professional Seroquel C Company Representative 22-Feb-2006 08:32 AM Page: 114 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/31/01ISR Number: 3787178-8Report Type:Periodic Company Report #A111304 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dermatitis Health Ziprasidone Po PS Professional Company Representative Date:08/31/01ISR Number: 3787179-XReport Type:Periodic Company Report #A117145 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Paraesthesia Health Ziprasidone Po PS Professional Company Representative Date:08/31/01ISR Number: 3787183-1Report Type:Periodic Company Report #A116690 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Health Ziprasidone Po PS ORAL 120.00 MG Iron Deficiency Anaemia Professional TOTAL: BID: ORAL Effexor C Klonopin C Ambien C Allegra-D C Zomig C Lovenox C Date:08/31/01ISR Number: 3787185-5Report Type:Periodic Company Report #A116715 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Consumer Ziprasidone Po PS 40.00 MG Hostility TOTAL: BID Nervousness Seroquel Paranoia (Quetiapine) C Haldol (Haloperidol) C Cogentin (Benztropine) C Date:08/31/01ISR Number: 3787187-9Report Type:Periodic Company Report #A116718 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Health Ziprasidone Po PS 40.00 MG Muscle Spasms Professional TOTAL: BID Company Representative 22-Feb-2006 08:32 AM Page: 115 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/31/01ISR Number: 3787189-2Report Type:Periodic Company Report #A116719 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Health Ziprasidone Po PS Professional Company Representative Date:08/31/01ISR Number: 3787192-2Report Type:Periodic Company Report #A116720 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Health Ziprasidone Po PS Professional Company Representative Date:08/31/01ISR Number: 3787194-6Report Type:Periodic Company Report #A116864 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Insomnia Consumer Ziprasidone Po PS ORAL 80.00 MG TOTAL: BID: ORAL Date:08/31/01ISR Number: 3787196-XReport Type:Periodic Company Report #A116869 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Visual Disturbance Health Ziprasidone Po PS ORAL 120.00 MG Professional TOTAL: DAILY: ORAL Date:08/31/01ISR Number: 3787198-3Report Type:Periodic Company Report #A116871 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depression Health Ziprasidone Po PS ORAL 40.00 MG Drug Ineffective Professional TOTAL: BID: ORAL Depakote C Date:08/31/01ISR Number: 3787199-5Report Type:Periodic Company Report #A116898 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Insomnia Health Ziprasidone Po PS 80.00 MG Mania Professional TOTAL: BID Date:08/31/01ISR Number: 3787275-7Report Type:Periodic Company Report #A113737 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Liver Function Test Health Ziprasidone Po PS Abnormal Professional 22-Feb-2006 08:32 AM Page: 116 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/31/01ISR Number: 3787276-9Report Type:Periodic Company Report #A113739 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eating Disorder Consumer Ziprasidone Po PS Personality Disorder Date:08/31/01ISR Number: 3787277-0Report Type:Periodic Company Report #A113744 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Surgery Health Ziprasidone Po PS 40.00 MG Professional TOTAL Aprazolam C Propoxyphene C Seroquel C Phentiramine C Clonidine C Date:08/31/01ISR Number: 3787278-2Report Type:Periodic Company Report #A113746 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Unevaluable Event Consumer Ziprasidone Po PS Date:08/31/01ISR Number: 3787279-4Report Type:Periodic Company Report #A113770 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Health Ziprasidone Po PS Professional Zyprexa SS Date:08/31/01ISR Number: 3787281-2Report Type:Periodic Company Report #A113825 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Health Ziprasidone Po PS Professional Date:08/31/01ISR Number: 3787283-6Report Type:Periodic Company Report #A113828 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pruritus Health Ziprasidone Po PS 40.00 MG Visual Disturbance Professional TOTAL:BID Date:08/31/01ISR Number: 3787284-8Report Type:Periodic Company Report #A113831 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pruritus Health Ziprasidone Po PS 40.00 MG Tongue Disorder Professional TOTAL:BID 22-Feb-2006 08:32 AM Page: 117 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/31/01ISR Number: 3787285-XReport Type:Periodic Company Report #A113836 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Flatulence Health Ziprasidone Po PS 400.00 MG Gastrointestinal Disorder Professional TOTAL:BID Intentional Overdose Company Medication Error Representative Date:08/31/01ISR Number: 3787286-1Report Type:Periodic Company Report #A113907 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Health Ziprasidone Po PS 40.00 MG Tremor Professional TOTAL:BID Company Tegretal C Representative Unspecified Drug C Date:08/31/01ISR Number: 3787287-3Report Type:Periodic Company Report #A113235 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Prolactin Increased Health Ziprasidone Po PS Pfizer Regulatory Professional Safety Company Representative Date:08/31/01ISR Number: 3787595-6Report Type:Periodic Company Report #A112523 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Health Ziprasidone PS BID Bronchitis Professional Risperdal SS 1.00 MG Malaise TOTAL:DAILY Respiratory Tract Depakote C Infection Neurontin C Weight Increased Remeron C Klonopin C Date:08/31/01ISR Number: 3787663-9Report Type:Periodic Company Report #A118290 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Erectile Dysfunction Health Ziprasidone Po PS ORAL 80.00 MG Penis Disorder Professional TOTAL:BID:ORA L Celexa (Citalopram) C Prevacid C Glibenclamide / Metformin C Atarax (Hydroxyzine Hydrochloride) C Gel-Kam C 22-Feb-2006 08:32 AM Page: 118 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/31/01ISR Number: 3787667-6Report Type:Periodic Company Report #A118298 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Consumer Ziprasidone Po PS Date:08/31/01ISR Number: 3787679-2Report Type:Periodic Company Report #A118452 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Nausea Health Ziprasidone Po PS Professional Company Representative Date:08/31/01ISR Number: 3787684-6Report Type:Periodic Company Report #A118454 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Health Ziprasidone Po PS Hypoaesthesia Professional Palpitations Company Representative Date:08/31/01ISR Number: 3787688-3Report Type:Periodic Company Report #A118455 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Health Ziprasidone Po PS Hypoaesthesia Professional Palpitations Company Representative Date:08/31/01ISR Number: 3787695-0Report Type:Periodic Company Report #A118560 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arrhythmia Health Ziprasidone Po PS Weight Increased Professional Zyprexa C Antidepressant C Date:08/31/01ISR Number: 3787699-8Report Type:Periodic Company Report #A118563 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thinking Abnormal Consumer Ziprasidone Po PS 10.00 MG Visual Disturbance TOTAL:DAILY Date:08/31/01ISR Number: 3787709-8Report Type:Periodic Company Report #A117459 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Migraine Health Ziprasidone Po PS ORAL 40.00 MG Professional TOTAL:DAILY Wellbutrin C Ambien C 22-Feb-2006 08:32 AM Page: 119 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lorazepam C Date:08/31/01ISR Number: 3787714-1Report Type:Periodic Company Report #A117572 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Syncope Health Ziprasidone Po PS ORAL Professional Company Representative Date:08/31/01ISR Number: 3787720-7Report Type:Periodic Company Report #A117574 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertonia Health Ziprasidone Po PS ORAL 80.00 MG Professional TOTAL:BID Company Depakote C Representative Cogentin C Navane C Date:08/31/01ISR Number: 3787728-1Report Type:Periodic Company Report #A117576 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Mania Health Ziprasidone Po PS Professional Company Representative Date:08/31/01ISR Number: 3787740-2Report Type:Periodic Company Report #A117667 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Health Ziprasidone Po PS 120.00 MG Asthenia Professional TOTAL Diarrhoea Date:08/31/01ISR Number: 3787744-XReport Type:Periodic Company Report #A117680 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Back Pain Consumer Ziprasidone Po PS Date:08/31/01ISR Number: 3787749-9Report Type:Periodic Company Report #A116578 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Health Ziprasidone Po PS ORAL 80.00 MG Initial or Prolonged Professional TOTAL: BID: Required ORAL Intervention to Nicotine Patch C Prevent Permanent Adderall C Impairment/Damage Effexor Xr C Trazodone C 22-Feb-2006 08:32 AM Page: 120 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/31/01ISR Number: 3787750-5Report Type:Periodic Company Report #A117681 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Apathy Consumer Ziprasidone Po PS ORAL 40.00 MG Psychotic Disorder TOTAL Seroquel SS NOT SPECIFIED Lithium C Zoloft C Date:08/31/01ISR Number: 3787752-9Report Type:Periodic Company Report #A116814 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Overdose Consumer Ziprasidone Po PS ORAL Initial or Prolonged Sedation Health Hydroxyzine SS Tachycardia Professional Depakote SS Tremor Vicodin SS Cipro C Ambien C Skelaxin C Date:08/31/01ISR Number: 3787754-2Report Type:Periodic Company Report #A117839 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Health Ziprasidone Po PS ORAL 40.00 MG Hypersensitivity Professional TOTAL:BID:ORA L Effexor C Vioxx C Ranitidine C Cyclobenzeprine C Orthotricycline C Glucophage C Date:08/31/01ISR Number: 3787755-4Report Type:Periodic Company Report #A117660 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Atrioventricular Block Health Ziprasidone Po PS ORAL Intervention to Bradycardia Professional Prevent Permanent Company Impairment/Damage Representative Date:08/31/01ISR Number: 3787756-6Report Type:Periodic Company Report #A117776 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Consumer Ziprasidone Po PS 160.00 MG Initial or Prolonged Intentional Overdose TOTAL: BID Medication Error Glyburide C Avandia C Diovan C 22-Feb-2006 08:32 AM Page: 121 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/31/01ISR Number: 3787759-1Report Type:Periodic Company Report #A117896 Age:19 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Extrapyramidal Disorder Health Ziprasidone Po PS ORAL 40.00 MG Professional TOTAL:BID Company Sertraline SS 200.00 MG Representative TOTAL Date:08/31/01ISR Number: 3787760-8Report Type:Periodic Company Report #A118089 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Atrioventricular Block Health Ziprasidone Po PS ORAL 160.00 MG Intervention to First Degree Professional TOTAL: BID: Prevent Permanent Bradycardia Company ORAL Impairment/Damage Representative Date:08/31/01ISR Number: 3787762-1Report Type:Periodic Company Report #A118096 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Health Ziprasidone Po PS ORAL 80.00 MG Initial or Prolonged Professional TOTAL: BID: Required ORAL Intervention to Haldol C Prevent Permanent Lithium C Impairment/Damage Synthroid C Wellbutrin Sr C Topamax (Topiramate) C Klonopin C Date:08/31/01ISR Number: 3787764-5Report Type:Periodic Company Report #A118145 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Health Ziprasidone Po PS ORAL NOT SPECIFIED Initial or Prolonged Professional Company Representative Date:08/31/01ISR Number: 3787765-7Report Type:Periodic Company Report #A118182 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dyspnoea Health Ziprasidone Po PS ORAL 40.00 MG Intervention to Hypertonia Professional TOTAL:BID:ORA Prevent Permanent Company L Impairment/Damage Representative Date:08/31/01ISR Number: 3787767-0Report Type:Periodic Company Report #A118566 Age:27 YR Gender: I/FU:I Outcome Hospitalization - Initial or Prolonged Required 22-Feb-2006 08:32 AM Page: 122 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Convulsion Health Ziprasidone Po PS ORAL NOT SPECIFIED Electrocardiogram Qt Professional Wellbutrin SS Prolonged Company Prozac SS Intentional Overdose Representative Depakote SS Tachycardia Date:08/31/01ISR Number: 3787768-2Report Type:Periodic Company Report #A118693 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Convulsion Health Ziprasidone Po PS ORAL Intervention to Professional Prevent Permanent Impairment/Damage Date:08/31/01ISR Number: 3787772-4Report Type:Periodic Company Report #A110227 Age:32 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatitis Health Ziprasidone Po PS 120.00 MG Liver Function Test Professional TOTAL: BID Abnormal Urinary Tract Infection Date:08/31/01ISR Number: 3787780-3Report Type:Periodic Company Report #A117663 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Libido Increased Consumer Ziprasidone Po PS ORAL ORAL Gabapentin SS 600.00 MG TOTAL:DAILY Date:08/31/01ISR Number: 3787803-1Report Type:Periodic Company Report #A118629 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Health Ziprasidone Po PS Pfizer Regulatory Abnormal Professional Safety ORAL 80.00 MG Company TOTAL: BID Representative Date:08/31/01ISR Number: 3788329-1Report Type:Periodic Company Report #A108911 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypersensitivity Health Ziprasidone Po PS 160.00 MG Professional TOTAL:BID 22-Feb-2006 08:32 AM Page: 123 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/31/01ISR Number: 3788331-XReport Type:Periodic Company Report #A108916 Age:31 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Back Pain Consumer Ziprasidone Po PS ORAL 40.00 MG Hypersensitivity Health TOTAL:BID:ORA Influenza Like Illness Professional L Lymphadenopathy Paxil SS 10.00 MG Nausea TOTAL:DAILY Pain Depakote C Risperdal C Lithium C Lamictal C Paxil C Date:08/31/01ISR Number: 3788332-1Report Type:Periodic Company Report #A109144 Age:66 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Insomnia Health Ziprasidone Po PS ORAL 120.00 MG Oedema Peripheral Professional TOTAL:BID:ORA L Wellbutrin (Bupropion) C Ativan (Lorazepam) C Klonopin (Clonazepam) C Vitamins C Date:08/31/01ISR Number: 3788333-3Report Type:Periodic Company Report #A109262 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Nausea Health Ziprasidone Po PS ORAL 20.00 MG Vomiting Professional TOTAL:BID:ORA L Lithium Carbonate SS ORAL 1200.00 MG TOTAL:DAILY:O RAL Risperdal SS ORAL 4.00 MG TOTAL:BID:ORA L Date:08/31/01ISR Number: 3788335-7Report Type:Periodic Company Report #A109425 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Health Ziprasidone Po PS ORAL 40.00 MG Headache Professional TOTAL:BID:ORA Nausea Company L Visual Disturbance Representative Topamax C Lithium C Effexor C 22-Feb-2006 08:32 AM Page: 124 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/31/01ISR Number: 3788336-9Report Type:Periodic Company Report #A109488 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pollakiuria Health Ziprasidone Po PS 60.00 MG Professional TOTAL:BID Quetiapine SS ORAL 300.00 MG TOTAL:DAILY:O RAL Anafranil C Affexor C Seroquel C Date:08/31/01ISR Number: 3788338-2Report Type:Periodic Company Report #A109744 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Insomnia Health Ziprasidone Po PS ORAL Professional Unknown Antidepressant C Date:08/31/01ISR Number: 3788339-4Report Type:Periodic Company Report #A109874 Age:23 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Health Ziprasidone Po PS ORAL 40.00 MG Bipolar I Disorder Professional TOTAL:BID:ORA Dyskinesia L Paranoia Lithium C Salivary Hypersecretion Cytomel C Trazodone C Date:08/31/01ISR Number: 3788341-2Report Type:Periodic Company Report #A110167 Age:24 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Health Ziprasidone Po PS ORAL 15.00 MG Chills Professional TOTAL:ORAL Depression Company Seroquel Representative (Quetiapine) C Celexa (Citalopram) C Date:08/31/01ISR Number: 3788343-6Report Type:Periodic Company Report #A110172 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Conjunctivitis Health Ziprasidone Po PS ORAL BID:ORAL Hypersensitivity Professional Zoloft C Rhinitis Alprazolam C Topamax C Date:08/31/01ISR Number: 3790655-7Report Type:Periodic Company Report #A113160 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bradycardia Health Ziprasidone Po PS ORAL 160.00 MG Professional TOTAL:BID:ORA 22-Feb-2006 08:32 AM Page: 125 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report L Zyprexa SS Lithium C Depakote C Date:09/05/01ISR Number: 3788270-4Report Type:Expedited (15-DaCompany Report #A120225 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cardiac Failure Health Ziprasidone PS 120.00 MG Intervention to Congestive Professional TOTAL:BID Prevent Permanent Fluid Retention Company Impairment/Damage Representative Date:09/06/01ISR Number: 3788789-6Report Type:Direct Company Report # Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Nausea Ziprasidone PS ORAL 40 MG QD PO Mirtazapine C Amantadine C Ranitidine C Quetiapine C Date:09/07/01ISR Number: 3789631-XReport Type:Expedited (15-DaCompany Report #A116341 Age:80 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gastrointestinal Health Ziprasidone Po PS Initial or Prolonged Haemorrhage Professional Lamictal Required Hepatitis (Lamotrigine) SS Intervention to Flonase Prevent Permanent (Fluticasone) C Impairment/Damage Effexor (Venlafaxine) C Date:09/07/01ISR Number: 3790335-8Report Type:Expedited (15-DaCompany Report #A120541 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mood Altered Health Ziprasidone Po PS ORAL 120.00 MG Initial or Prolonged Nervousness Professional TOTAL:BID:ORA Suicidal Ideation Company L Representative Depakote C Celexa C Thorazine C Date:09/11/01ISR Number: 3791432-3Report Type:Expedited (15-DaCompany Report #A107661 Age:65 YR Gender:Male I/FU:F Outcome PT Required Atrioventricular Block Intervention to Bundle Branch Block Prevent Permanent Bilateral Impairment/Damage Bundle Branch Block Right Condition Aggravated Conduction Disorder 22-Feb-2006 08:32 AM Page: 126 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Electrocardiogram Qrs Complex Abnormal Electrocardiogram Qt Report Source Product Role Manufacturer Route Dose Duration Corrected Interval Health Ziprasidone Po PS ORAL 40.00 MG Prolonged Professional TOTAL:BID:ORA Oedema Peripheral L Psychotic Disorder Chlorpromazine SS ORAL 200.00 MG TOTAL:QID:ORA L Asa C Lorazepam C Vitamin B12 C Neutra-Phos C Lithium C Tylenol C Cogentin C Chloral Hydrate C Mom With Cascara C Fleet Enema C Hydrocortisone C Sebulex C Olanzepine C Mevacor C Imodium C Phenolated Resorcinol C Terbinafine C Date:09/12/01ISR Number: 3791790-XReport Type:Direct Company Report # Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Geodon PS 60 MG Oral Discomfort Zoloft SS BID Oral Pain Neurontin SS BID Date:09/12/01ISR Number: 3793009-2Report Type:Expedited (15-DaCompany Report #A120955 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Feeling Jittery Health Ziprasidone Po PS ORAL PO Initial or Prolonged Overdose Professional Alcohol SS Company Proloxin SS Representative Date:09/14/01ISR Number: 3794321-3Report Type:Expedited (15-DaCompany Report #A109401 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Consumer Ziprasidone Po PS ORAL 60.00 MG Hospitalization - Cardiomegaly Health TOTAL: DAILY: Initial or Prolonged Coronary Artery Professional ORAL Atherosclerosis Company Serentil SS ORAL 225.00 MG Drug Toxicity Representative TOTAL: TID: Sudden Death ORAL 22-Feb-2006 08:32 AM Page: 127 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/17/01ISR Number: 3794518-2Report Type:Expedited (15-DaCompany Report #A118737 Age:14 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Self-Injury Health Ziprasidone Po PS 160.00 MG Initial or Prolonged Mania Professional TOTAL:DAILY Date:09/20/01ISR Number: 3796131-XReport Type:Direct Company Report # Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Drug Level Above Geodon (Ziprasidone) Intervention to Therapeutic Pfizer PS Pfizer ORAL 60 MG PO BID Prevent Permanent Dysarthria STARTED 8/10 Impairment/Damage Tremor AT 20 MG PO Lithium 300mg Po Bid SS ORAL 300MG PO BID AND THEN INCREASED SLOWLY Trilafon C Haldol C Lamictal C Cogentin C Synthroid C Klonopin C Rocaltrol C Oystcal C Mg Oxide C Date:09/20/01ISR Number: 3796132-1Report Type:Direct Company Report # Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drug Toxicity Geodon PS ORAL 20 MG PO BID Hospitalization - Extrapyramidal Disorder Lithium SS ORAL 600 MG PO BID 1 MON Initial or Prolonged Effexor C Required Wellbutrin Sr C Intervention to Topamax C Prevent Permanent Parlodel C Impairment/Damage Date:09/21/01ISR Number: 3797110-9Report Type:Direct Company Report # Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Electrocardiogram Qt Geodon (40mg) Prolonged (Pfizer) PS Pfizer ORAL 40 MG PO BID Respiratory Arrest Risperidol C Trazodone C Neurontin C Restoril C Protonix C Tylenol C Lorazepam C Congentin C 22-Feb-2006 08:32 AM Page: 128 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/24/01ISR Number: 3797853-7Report Type:Expedited (15-DaCompany Report #A118566 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Decreased Health Ziprasidone Po PS ORAL BID Initial or Prolonged Convulsion Professional Wellbutrin SS Required Electrocardiogram Company Prozac SS BID Intervention to Abnormal Representative Depakote SS Prevent Permanent Electrocardiogram Qt Impairment/Damage Prolonged Myocardial Infarction Overdose Sinus Tachycardia Date:09/24/01ISR Number: 3797856-2Report Type:Expedited (15-DaCompany Report #A112403 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Ziprasidone Po PS ORAL 60.00 MG Initial or Prolonged Dehydration Professional TOTAL:BID:ORA Gastrointestinal Disorder L Insomnia Vomiting Date:09/26/01ISR Number: 3798862-4Report Type:Direct Company Report # Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatine Geodon (Ziprasidone) PS 20MG BID Phosphokinase Increased Risperidone SS 2 MG BID Loss Of Consciousness Diabeta C Muscle Rigidity Motrin C Neuroleptic Malignant Glucophage C Syndrome Paxil C Tachycardia Atarax C Tremor Klonopin C Date:09/27/01ISR Number: 3801793-4Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Ziprasidone (Geodon) PS SEE IMAGE Initial or Prolonged Asthenia Depakote C Dysuria Seroquel C Micturition Urgency Prednisone C Nausea Allegra C Pollakiuria Prilosec C Pyrexia Lasix C Renal Failure Acute Ativan C Salmonellosis Singulair C Vomiting Date:09/28/01ISR Number: 3802154-4Report Type:Expedited (15-DaCompany Report #A122356 Age:40 YR Gender:Female I/FU:I Outcome Death Hospitalization - 22-Feb-2006 08:32 AM Page: 129 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged PT Report Source Product Role Manufacturer Route Dose Duration Cardiac Arrest Consumer Ziprasidone Po PS Pfizer Regulatory Catatonia Safety ORAL 80.00 MG Eye Rolling TOTAL:BID:ORA Hallucination, Auditory L Mitral Valve Prolapse Clozapine C Lamictal (Lamotrigine0 C Ativan (Lorazepam) C Casanthranol/Docusat e Sodium C Metamucil (Psyllium) C Celexa (Citalopram) C Inderal (Propranolol) C Date:10/02/01ISR Number: 3803355-1Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyspnoea Geodon (Ziprasidone) Extrapyramidal Disorder (20mg) PS ORAL 20 MG PO QAMHS Nicotine Patch C Date:10/02/01ISR Number: 3803357-5Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyskinesia Geodon (Ziprasidone) Eyelid Ptosis (40 Mg/20 Mg) Musculoskeletal Stiffness (Phizer) PS Phizer 60 MG PO BID Tongue Paralysis Metronidazole C Date:10/02/01ISR Number: 3803513-6Report Type:Direct Company Report # Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Electrocardiogram Qt Geodon 40mg Pfizer PS Pfizer ORAL 40MG QHS ORAL Intervention to Prolonged Prevent Permanent Impairment/Damage Date:10/03/01ISR Number: 3803295-8Report Type:Direct Company Report # Age:53 YR Gender:Female I/FU:I Outcome PT Bladder Disorder Body Temperature Decreased Coma Communication Disorder Hyperhidrosis Joint Stiffness Muscle Rigidity 22-Feb-2006 08:32 AM Page: 130 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Paranoia Parkinsonian Gait Tremor Report Source Product Role Manufacturer Route Dose Duration Zyprexa (10 Mg) PS 10 MG HS 2 MON Geodon (20 Mg) SS 40 MG BID Lipitor C Date:10/03/01ISR Number: 3804459-XReport Type:Expedited (15-DaCompany Report #A122055 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Ziprasidone Po PS Pfizer Professional Company Representative Date:10/04/01ISR Number: 3803960-2Report Type:Direct Company Report # Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Geodon 40mg Pfizer PS Pfizer ORAL 40MG BID ORAL Initial or Prolonged Consciousness Date:10/05/01ISR Number: 3805486-9Report Type:Direct Company Report #USP 54412 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Geodan PS Pfizer Geodan SS Pfizer Date:10/05/01ISR Number: 3807030-9Report Type:Expedited (15-DaCompany Report #A120989 Age:22 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Convulsion Health Ziprasidone Po PS ORAL ORAL Intervention to Professional Depakote Er SS 1500.00 MG Prevent Permanent TOTAL:DAILY Impairment/Damage Klonopin (Clonazepam) SS Venlafaxine SS 225.00 MG TOTAL:DAILY Date:10/10/01ISR Number: 3807671-9Report Type:Direct Company Report # Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Geodon (80mg) PS 80MG BID Corrected Interval Multivitamin C Prolonged 22-Feb-2006 08:32 AM Page: 131 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/10/01ISR Number: 3809238-5Report Type:Expedited (15-DaCompany Report #A123093 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Ziprasidone Po PS Professional Company Representative Date:10/12/01ISR Number: 3809741-8Report Type:Expedited (15-DaCompany Report #A123176 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Ziprasidone Po PS 160.00 MG Professional TOTAL Company Clozaril SS 250.00 MG Representative TOTAL Date:10/12/01ISR Number: 3809760-1Report Type:Expedited (15-DaCompany Report #A123443 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Health Ziprasidone Po PS Initial or Prolonged Professional Date:10/12/01ISR Number: 3809791-1Report Type:Expedited (15-DaCompany Report #A123290 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Acute Respiratory Health Ziprasidone Po PS ORAL 40.00 MG Hospitalization - Distress Syndrome Professional TOTAL:BID:ORA Initial or Prolonged L Date:10/16/01ISR Number: 3810534-6Report Type:Expedited (15-DaCompany Report #A121742 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arrhythmia Health Ziprasidone Po PS ORAL 80.00 MG Initial or Prolonged Drug Ineffective Professional TOTAL:BID:ORA Required L Intervention to Prevent Permanent Impairment/Damage Date:10/16/01ISR Number: 3810963-0Report Type:Expedited (15-DaCompany Report #A122356 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Catatonia Consumer Ziprasidone Po PS ORAL 120.00 MG Hospitalization - Hallucination, Auditory Health TOTAL:BID:ORA Initial or Prolonged Mitral Valve Prolapse Professional L Orthostatic Hypotension Clozapine C Scar Lamictal Supraventricular (Lamotrigine) C Extrasystoles Ativan (Lorazepam) C Casanthranol/Docusat e Sodium C 22-Feb-2006 08:32 AM Page: 132 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Metamucil (Psyllium) C Celexa (Citalopram) C Inderal (Propranolol) C Date:10/16/01ISR Number: 3810964-2Report Type:Expedited (15-DaCompany Report #A118400 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Alopecia Health Ziprasidone Po PS ORAL 160.00 MG Intervention to Burning Sensation Professional TOTAL:BID:ORA Prevent Permanent Diabetes Mellitus L Impairment/Damage Infection Paxil (Paroxetine) C Pruritus Depakote (Valproate) C Alprazolam C Bisoprolol C Synthroid (Levothyroxine) C Triamterene/Hydrochl orothiazide C Gemfibrozil C Seroquel C Herbs C Vitamins C Potassium C Date:10/18/01ISR Number: 3811630-XReport Type:Expedited (15-DaCompany Report #A123093 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Ventricular Hypertrophy Health Ziprasidone Po PS 80.00 MG Professional TOTAL:BID Prozac C Trazodone C Date:10/18/01ISR Number: 3811631-1Report Type:Expedited (15-DaCompany Report #A119144 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Back Pain Consumer Ziprasidone Po PS ORAL 80.00 MG Intervention to Drug Ineffective Health TOTAL:BID:ORA Prevent Permanent Nephrolithiasis Professional L Impairment/Damage Prostatitis Trazodone C Date:10/18/01ISR Number: 3811777-8Report Type:Expedited (15-DaCompany Report #A122356 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Consumer Ziprasidone Po PS ORAL 120.00 MG Hospitalization - Catatonia Health TOTAL: BID: Initial or Prolonged Condition Aggravated Professional ORAL Endocardial Fibrosis Clozaril SS 400.00 MG Eye Rolling TOTAL: DAILY Hallucination, Auditory Clozapine C Mitral Valve Prolapse Lamictal Orthostatic Hypotension (Lamotrigine) C Sudden Death Ativan (Lorazepam) C 22-Feb-2006 08:32 AM Page: 133 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Casanthranol/Docsuat e Sodium C Metamucil (Psyllium) C Celexa (Citalopram) C Inderal (Propranolol) C Cogentin C Lamictal C Date:10/18/01ISR Number: 3811790-0Report Type:Expedited (15-DaCompany Report #A117982 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Chest X-Ray Abnormal Health Ziprasidone Po PS ORAL 160.00 MG Intervention to Dyspnoea Professional TOTAL:BID:ORA Prevent Permanent Electrocardiogram Qt L Impairment/Damage Corrected Interval Zyprexa (Olanzapine) SS Prolonged Celexa (Citalopram) C Electrocardiogram Qt Xanax (Alprazolam) C Prolonged Fluid Retention Oedema Psychotic Disorder Pulmonary Oedema Respiratory Distress Suicidal Ideation Date:10/18/01ISR Number: 3811813-9Report Type:Expedited (15-DaCompany Report #A117987 Age:87 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Electrocardiogram Qt Health Ziprasidone Po PS ORAL 160.00 MG Intervention to Corrected Interval Professional TOTAL:BID:ORA Prevent Permanent Prolonged L Impairment/Damage Electrocardiogram Qt Cordarone C Prolonged Melatonin C Nervous System Disorder Topamax C Lasix C Wellbutrin Sr C Colace C Depakote C Mobic C Date:10/19/01ISR Number: 3811280-5Report Type:Direct Company Report # Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pyrexia Geodon 40 Mg PS 40 MG BID Date:10/26/01ISR Number: 3816065-1Report Type:Expedited (15-DaCompany Report #A123115 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Health Ziprasidone Po PS ORAL 160.00 MG Initial or Prolonged Lethargy Professional TOTAL;BID;ORA Overdose L Buproprion SS ORAL 100.00 MG 22-Feb-2006 08:32 AM Page: 134 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report TOTAL;DAILY;O RAL Trazodone SS ORAL ORAL Alprazolam SS Date:10/26/01ISR Number: 3816069-9Report Type:Expedited (15-DaCompany Report #A123090 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arrhythmia Health Ziprasidone Po PS ORAL 160.00 MG Initial or Prolonged Condition Aggravated Professional TOTAL;BID;ORA Required Heart Rate Irregular L Intervention to Psychotic Disorder Loxitane C Prevent Permanent Cogentin C Impairment/Damage Date:10/26/01ISR Number: 3816289-3Report Type:Expedited (15-DaCompany Report #A124573 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Stevens-Johnson Syndrome Health Ziprasidone Po PS ORAL 40.00 MG Intervention to Professional TOTAL DAILY: Prevent Permanent Company ORAL Impairment/Damage Representative Lorazepam C Amphetamine/Dextroam phetamine C Venlafaxine C Date:10/26/01ISR Number: 3816452-1Report Type:Direct Company Report # Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Difficulty In Walking Geodon PS Dystonia Extrapyramidal Disorder Date:10/29/01ISR Number: 3816731-8Report Type:Direct Company Report # Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Vith Nerve Paralysis Geodon PS 20MG BID Date:10/30/01ISR Number: 3817348-1Report Type:Direct Company Report # Age:13 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Electrocardiogram Qt Geodon PS 20MG Corrected Interval BID->20MG AM Prolonged 40MG PM Paxil C Topimax C 22-Feb-2006 08:32 AM Page: 135 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/31/01ISR Number: 3818552-9Report Type:Expedited (15-DaCompany Report #A117987 Age:87 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Health Ziprasidone Po PS ORAL 160.00 MG Initial or Prolonged Corrected Interval Professional TOTAL:BID:ORA Required Prolonged L Intervention to Electrocardiogram Qt Cordarone C Prevent Permanent Prolonged Melatonin C Impairment/Damage Topamax C Lasix C Wellbutrin Sr C Colace C Depakote C Mobic C Zaroxolyn C Date:10/31/01ISR Number: 3818598-0Report Type:Expedited (15-DaCompany Report #A124605 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agitation Health Ziprasidone Po PS ORAL 40.00 MG Hospitalization - Neuroleptic Malignant Professional TOTAL; DAILY; Initial or Prolonged Syndrome ORAL Required Renal Impairment Lithium Carbonate SS Intervention to Eskalith SS ORAL ORAL Prevent Permanent Vitamin B6 (Subject Impairment/Damage Drug) SS Paxil SS ORAL ORAL Risperidone C Clonidine (Subject Drug) C Estradiol (Subject Drug) C Ferrous Sequels (Subject Drug) C Trazodone (Subject Drug) C Date:10/31/01ISR Number: 3818638-9Report Type:Expedited (15-DaCompany Report #A122055 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alcoholism Health Ziprasidone Po PS ORAL ORAL Completed Suicide Professional Date:10/31/01ISR Number: 3819127-8Report Type:Expedited (15-DaCompany Report #A123176 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Consumer Ziprasidone Po PS 160.00 MG Psychotic Disorder Health TOTAL:BID Professional Clozaril SS 300.00 MG Company TOTAL:DAILY Representative Lipitor (Atorvastatin) C Ambien (Zolpidem) C Antihypertensive Medication C 22-Feb-2006 08:32 AM Page: 136 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/31/01ISR Number: 3819154-0Report Type:Expedited (15-DaCompany Report #A119156 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Ziprasidone Po PS ORAL 80.00 MG Cardio-Respiratory Arrest Professional TOTAL:BID:ORA Drooling L Gastritis Gabapentin SS ORAL 1200.00 MG Haematemesis TOTAL:BID:ORA Nausea L Vomiting Risperdal C Trazadone C Ativan C Congentin C Multivitamin C Haldol C Tylenol C Protonix C Restoril C Date:11/02/01ISR Number: 3820105-3Report Type:Direct Company Report # Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Geodon PS Hospitalization - Electrocardiogram Seroquel SS Initial or Prolonged Abnormal Tegretal C Pulse Absent Cogentin C Ativan C Glucotrol C Date:11/05/01ISR Number: 3820414-8Report Type:Expedited (15-DaCompany Report #A125357 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dyspnoea Consumer Ziprasidone Po PS ORAL 40.00 MG Intervention to Obstructive Airways TOTAL: BID: Prevent Permanent Disorder ORAL Impairment/Damage Tongue Oedema Proventil C Date:11/05/01ISR Number: 3820445-8Report Type:Expedited (15-DaCompany Report #A120032 Age:83 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Acquired Cardiac Septal Health Ziprasidone Po PS ORAL 100.00 MG Required Defect Professional TOTAL;BID/ORA Intervention to Bundle Branch Block L Prevent Permanent Bilateral Unspecified Impairment/Damage Electrocardiogram Qt Medication C Corrected Interval Pimozide C Prolonged Celexa (Citalopram) C Lorazepam C Ativan C 22-Feb-2006 08:32 AM Page: 137 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/05/01ISR Number: 3820465-3Report Type:Expedited (15-DaCompany Report #A120275 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Disturbance In Social Health Ziprasidone Po PS ORAL BID; ORAL Initial or Prolonged Behaviour Professional Risperdal SS DAILY Disability Nervous System Disorder Wellbutrin Sr C Required Tardive Dyskinesia Temazepam C Intervention to Effexor Xr C Prevent Permanent Synthroid C Impairment/Damage Estrogen C Provera C Coumadin C Date:11/05/01ISR Number: 3820491-4Report Type:Expedited (15-DaCompany Report #A123443 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Health Ziprasidone Po PS ORAL ORAL Initial or Prolonged Overdose Professional Paxil SS Suicidal Ideation Depakote SS Effexor SS Date:11/06/01ISR Number: 3820738-4Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dysphagia Geodon 40mg/20mg Gastrointestinal Disorder (Pfizer) PS Pfizer ORAL 60MG BID PO Joint Contracture 10/14-PM DOSE Muscle Rigidity Date:11/07/01ISR Number: 3822400-0Report Type:Expedited (15-DaCompany Report #A124796 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anger Consumer Ziprasidone Po PS ORAL 20.00 MG Initial or Prolonged Condition Aggravated TOTAL DAILY Difficulty In Walking ORAL Hostility Zyprexa SS Muscle Spasms Benadryl C Speech Disorder Calcium C Stupor Synthroid C Tension Detrol C Depakote C Calcitriol C Lamictal C Risperdal C Date:11/09/01ISR Number: 3824186-2Report Type:Direct Company Report # Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Discomfort Geodon PS ORAL 20MG PO BID 6 WK Initial or Prolonged Drug Toxicity Amiodarone SS ORAL 200MG PO BID Dyspnoea Electrocardiogram Qrs Complex Prolonged 22-Feb-2006 08:32 AM Page: 138 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/12/01ISR Number: 3823582-7Report Type:Expedited (15-DaCompany Report #A125787 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alcoholism Health Ziprasidone Po PS ORAL BID:ORAL Anxiety Professional Citalopram C Cardiovascular Disorder Simvastatin C Condition Aggravated Dyspepsia Headache Hypertension Insomnia Irritability Sudden Death Weight Decreased Date:11/12/01ISR Number: 3824657-9Report Type:Expedited (15-DaCompany Report #A124553 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Ziprasidone Po PS 40.00 MG Periodontitis Professional TOTAL:BID Toxicologic Test Abnormal Depakote (Divalproex Sodium) C Fluvoxamine Maleate C Desyrel (Trazodone) C Remeron (Mirtazapine) C Zyprexa(Olanzapine) C Valium (Diazepam) C Coumadin(Warfarin) C Date:11/14/01ISR Number: 3824182-5Report Type:Direct Company Report # Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gastrooesophageal Reflux Geodon PS ORAL 20 MG PO BID Initial or Prolonged Disease Lopid C Hypoxia Lopressor C Pneumonia Aspiration Cogentin C Serzone C Zyprexa C Actos C Date:11/14/01ISR Number: 3824223-5Report Type:Direct Company Report # Age:32 YR Gender:Male I/FU:I Outcome PT Death Alcoholism Other Anxiety Cardiomegaly Cardiovascular Disorder Condition Aggravated Coronary Artery Atherosclerosis Hallucination Headache Hypertension Insomnia 22-Feb-2006 08:32 AM Page: 139 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Irritability Report Source Product Role Manufacturer Route Dose Duration Ziprasidone (Geodon) By Pfizer 80mg + 60mg + 40mg Caps Various PS Pfizer ORAL 40MG PO BID 80MG PO BID 60MG PO BID 80MG Q AM 60MG Q HS Citalopram C Trazodone C Simvastatin C Lansoprazole C Date:11/14/01ISR Number: 3825341-8Report Type:Expedited (15-DaCompany Report #A122356 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Consumer Ziprasidone Po PS ORAL 120.00 MG Hospitalization - Catatonia Health TOTAL: Initial or Prolonged Scar Professional BID:ORAL Sudden Death Clozaril SS 400.00 MG TOTAL DAILY Lamictal (Lamotrigine) C Ativan (Lorazepam) C Casanthranol /Docusate Sodium C Metamucil (Psyllium) C Celexa (Citalopram) C Inderal (Propanolol) C Cogentin C Date:11/14/01ISR Number: 3825435-7Report Type:Expedited (15-DaCompany Report #001-0945-M0101024 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Neurontin Drooling Professional (Gabapentin) PS ORAL 1200 MG Electrocardiogram Qt (BID), PER Prolonged ORAL Respiratory Arrest Geodon SS ORAL 80 MG (40 MG, Sudden Death BID), PER ORAL Risperidone C Trazodone C Temazepam C Pantoprazole C Paracetamol C Lorazepam C Haloperidol C Benzatropine Mesilate C 22-Feb-2006 08:32 AM Page: 140 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/16/01ISR Number: 3824930-4Report Type:Direct Company Report # Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Priapism Geodon (80 Mg Cap) Initial or Prolonged (Pfizer) PS 80 MG BID Other Valproic Acid C Required Lithium Citrate C Intervention to Clonopin C Prevent Permanent Impairment/Damage Date:11/16/01ISR Number: 3824949-3Report Type:Direct Company Report # Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Geodon (20 Mg Tab) Required Corrected Interval (Pfizer) PS Pfizer ORAL 20MG BID PO Intervention to Prolonged Valproic Acid C Prevent Permanent Pantoprazole C Impairment/Damage Ferrous Sulfate C Benztropine C Date:11/16/01ISR Number: 3827585-8Report Type:Expedited (15-DaCompany Report #EMADSS2001006504 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Haldol (Haloperidol) PS ORAL 30;15; 20 MG, Initial or Prolonged Fall Health DAILY, ORAL Neuroleptic Malignant Professional Zeldox SS ORAL 80;160; MG, Syndrome DAILY, ORAL Parkinson'S Disease Truxal Schizophrenia, Paranoid (Chlorprothixene Type Hydrochloride) C Urinary Retention Dociton Urinary Tract Infection (Propranol-Ol Hydrochloride) C Zopiclone (Zopiclone) C Atosil (Isopremethazine Hydrochloride) C Acc 200 (Acetylcysteine) C Date:11/16/01ISR Number: 3827958-3Report Type:Expedited (15-DaCompany Report #A126158 Age: Gender:Female I/FU:I Outcome PT Hospitalization - Abdominal Distension Initial or Prolonged Agitation Required Anger Intervention to Delirium Prevent Permanent Disorientation Impairment/Damage Dry Skin Feeling Hot Flushing Gastrointestinal Motility Disorder 22-Feb-2006 08:32 AM Page: 141 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hypertension Overdose Tardive Dyskinesia Report Source Product Role Manufacturer Route Dose Duration Toxicologic Test Abnormal Consumer Ziprasidone Po PS ORAL ORAL X-Ray Gastrointestinal Prozac SS Tract Abnormal Benztropine SS Zoloft C Trazodone C Premarin C Date:11/18/01ISR Number: 3825674-5Report Type:Direct Company Report # Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lower Respiratory Tract Geodon PS 20 MICROGRAMS Other Infection QAM & 40 MICROGRAMS QD Clozaril 300 Mg Q Hs SS 300 MG Q HS Paxil C Date:11/20/01ISR Number: 3827396-3Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Ziprasidone (Geodon) PS ORAL 20MG PO BID Syncope Chlorpromazine C Lorazepam C Quetiapine C Trazodone C Sertraline C Date:11/20/01ISR Number: 3827397-5Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyspnoea Ziprasidone(Geodon) PS 40MG BID Throat Tightness Bupropion Sr (Wellbutrin Sr) SS 100MG BID Clozapine C Ddavp C Lamotrigine C Oxcarbezeprine C Date:11/20/01ISR Number: 3827400-2Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dysphagia Ziprasidone(Geodon) PS ORAL 40MG PO BID Other Dyspnoea Bupropion Sr(Wellbutrin Sr) SS ORAL 150MG PO BID Lithium Carbonate C Clozapine C Guanfacine C 22-Feb-2006 08:32 AM Page: 142 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/20/01ISR Number: 3827402-6Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Respiratory Disorder Ziprasidone(Geodon) PS ORAL 40MG PO BID L-Thyroxine C Lithium Carbonate C Quetiapine C Date:11/20/01ISR Number: 3828179-0Report Type:Expedited (15-DaCompany Report #A126571 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Ziprasidone Po PS Company Representative Date:11/20/01ISR Number: 3828234-5Report Type:Expedited (15-DaCompany Report #A125787 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alcoholism Health Ziprasidone Po PS ORAL BID: ORAL Anxiety Professional Citalopram C Cardiovascular Disorder Simvastatin C Condition Aggravated Dyspepsia Headache Hypertension Insomnia Irritability Sudden Death Weight Decreased Date:11/20/01ISR Number: 3828322-3Report Type:Expedited (15-DaCompany Report #A126786 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Abortion Spontaneous Health Ziprasidone Po PS ORAL Intervention to Akathisia Professional Unspecified Oral Prevent Permanent Complications Of Maternal Contraceptive SS ORAL ORAL Impairment/Damage Exposure To Therapeutic Lamictal Drugs (Lamotrigine) C Drug Ineffective Insomnia Pregnancy Tardive Dyskinesia Date:11/20/01ISR Number: 3831580-2Report Type:Periodic Company Report #PHEH2001US04496 Age:48 YR Gender:Female I/FU:I Outcome PT Life-Threatening Amnesia Hospitalization - Anaemia Initial or Prolonged Confusional State Leukopenia Neutropenia Pneumonia Pyrexia 22-Feb-2006 08:32 AM Page: 143 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Urinary Tract Infection Report Source Product Role Manufacturer Route Dose Duration Health Clozaril (Clozapine) Professional Tablet PS ORAL 200 MG, BID, ORAL Ziprasidone Hydrochloride (Ziprasidone Hydrochloride) SS ORAL 20 MG, AM, 40 MG, HS, ORAL Cogentin (Benzatropine Mesilate) C Neurontin (Gabapentin) C Haldol C Lamictal C Date:11/21/01ISR Number: 3829392-9Report Type:Expedited (15-DaCompany Report #US_011176788 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Study Ziprasidone PS Initial or Prolonged Agitation Health Estrogens Conjugated C Condition Aggravated Professional Levothyroxine Sodium C Drug Ineffective Losartan Potassium C Psychotic Disorder Multivitamin C Screaming Calcium Carbonate C Gabapentin C Risperidone C Lorazepam C Lansoprazole C Date:11/23/01ISR Number: 3829268-7Report Type:Expedited (15-DaCompany Report #A126997 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Convulsion Health Ziprasidone Po PS Intervention to Drug Interaction Professional Desipramine SS Prevent Permanent Company Lithium C Impairment/Damage Representative Lorazepam C Synthroid (Levothyroxine) C Wellbutrin (Bupropion) C Date:11/26/01ISR Number: 3828606-9Report Type:Expedited (15-DaCompany Report #301831 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Klonopin PS Roche Initial or Prolonged Mood Swings Zyban I Tobacco Abuse Topamax I Zyprexa I Geodon I Divalproex I 22-Feb-2006 08:32 AM Page: 144 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/27/01ISR Number: 3830660-5Report Type:Expedited (15-DaCompany Report #A125787 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alcoholism Health Ziprasidone Po PS ORAL BID:ORAL Anxiety Professional Citalopram C Cardiomegaly Simvastatin C Cardiovascular Disorder Trazedone C Condition Aggravated Lansoprazole C Coronary Artery Atherosclerosis Hallucination Headache Hypertension Insomnia Irritability Sudden Death Weight Decreased Date:11/27/01ISR Number: 3830661-7Report Type:Expedited (15-DaCompany Report #A126571 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Electrocardiogram Qt Consumer Ziprasidone Po PS Prolonged Company Sudden Death Representative Date:11/27/01ISR Number: 3830909-9Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dysphagia Geodon 80 Mg Feeling Abnormal Pfizer PS Pfizer ORAL 80 MG 2 DAY Salivary Hypersecretion ORAL Sinus Congestion Allegra-D C Date:11/28/01ISR Number: 3831358-XReport Type:Expedited (15-DaCompany Report #301831 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Consumer Klonopin Initial or Prolonged Drug Interaction Other (Clonazepam) PS Mood Swings Zyban (Bupropion Tobacco Abuse Hydrochloride) SS ORAL ORAL Topamax (Topiramate) SS Zyprexa (Olanzapine) SS Geodon (Ziprasidone Hydrochloride) SS Divalproex (Divalproex Sodium) SS Date:11/29/01ISR Number: 3832703-1Report Type:Expedited (15-DaCompany Report #A125210 Age: Gender: I/FU:F Outcome Hospitalization - Initial or Prolonged Required 22-Feb-2006 08:32 AM Page: 145 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Anaphylactic Reaction Health Ziprasidone Po PS ORAL 20.00 MG Professional TOTAL; DAILY; Company ORAL Representative Celexa C Ziac C Date:11/29/01ISR Number: 3832705-5Report Type:Expedited (15-DaCompany Report #A120955 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Feeling Jittery Health Ziprasidone Po PS Initial or Prolonged Overdose Professional Alcohol SS Company Prolixin SS Representative Date:12/04/01ISR Number: 3833080-2Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Wellbutrin Sr 150 Mg PS 150 MG BID Dyspnoea Ziprasidone (Geodon) SS 150 MG BID Bupropion SS SEE IMAGE Albuterol Inhaler C Guanfacine C Date:12/04/01ISR Number: 3834828-3Report Type:Expedited (15-DaCompany Report #A126907 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Consumer Ziprasidone Po PS ORAL ORAL Initial or Prolonged Gynaecomastia Zyprexa SS ORAL ORAL Medication Error Depakote SS Topamax C Date:12/04/01ISR Number: 3834845-3Report Type:Expedited (15-DaCompany Report #A122356 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Consumer Ziprasidone Po PS ORAL 120.00 MG Hospitalization - Arrhythmia Health TOTAL:BID:ORA Initial or Prolonged Cardiomegaly Professional L Catatonia Clozaril SS 400.00 MG Condition Aggravated TOTAL:DAILY Coronary Artery Lamictal Atherosclerosis (Lamotrigine) C Coronary Artery Occlusion Ativan (Lorazepam) C Hallucination Casanthranol/Docusat Mitral Valve Prolapse e Sodium C Scar Metamucil (Psyllium) C Sudden Death Celexa (Citalopram) C Supraventricular Inderal Extrasystoles (Propranolol) C Cogentin C 22-Feb-2006 08:32 AM Page: 146 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/06/01ISR Number: 3837419-3Report Type:Expedited (15-DaCompany Report #A123790 Age:19 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Ziprasidone Po PS ORAL 140.00 MG Initial or Prolonged Mania Professional TOTAL BID Medication Error ORAL Psychomotor Hyperactivity Seroquel(Quetiapine Fumarate) C Eskalith (Lithium Carbonate) C Date:12/07/01ISR Number: 3837507-1Report Type:Expedited (15-DaCompany Report #A125787 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alcoholism Health Ziprasidone Po PS ORAL BID:ORAL Anxiety Professional Celexa (Citalopram) C Cardiomegaly Zocor (Simvastatin) C Condition Aggravated Desyrel (Trazodone) C Coronary Artery Prevacid Atherosclerosis (Lansoprazole) C Drug Effect Decreased Dyspepsia Hallucination Headache Hypertensive Heart Disease Insomnia Irritability Sudden Death Weight Decreased Date:12/07/01ISR Number: 3837730-6Report Type:Expedited (15-DaCompany Report #A118300 Age:59 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Health Ziprasidone Po PS ORAL 40.00 MG Initial or Prolonged Depression Professional TOTAL:BID:ORA Parkinson'S Disease Company L Representative Fluvoxamine C Prinivil (Lisinopril) C Unspecified Benzodiazepines C Date:12/12/01ISR Number: 3839867-4Report Type:Expedited (15-DaCompany Report #A128791 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Aggression Foreign Ziprasidone Po PS ORAL BID:ORAL Intervention to Inappropriate Affect Health Lorazepam C Prevent Permanent Posture Abnormal Professional Impairment/Damage Sedation Company Representative 22-Feb-2006 08:32 AM Page: 147 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/13/01ISR Number: 3839760-7Report Type:Expedited (15-DaCompany Report #A124790 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Health Zipradisone Po PS ORAL 80.00 MG Initial or Prolonged Professional TOTAL; BID; Required ORAL Intervention to Celexa C Prevent Permanent Depakote C Impairment/Damage Benzodiazepine C Date:12/13/01ISR Number: 3839874-1Report Type:Expedited (15-DaCompany Report #A128681 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Alcohol Withdrawal Health Ziprasidone Po PS ORAL 140.00 MG Intervention to Syndrome Professional TOTAL:BID:ORA Prevent Permanent Alcoholism L Impairment/Damage Heart Rate Decreased Alcohol SS Risperdal (Risperidone) C Pravachol (Pravastatin) C Klonopin (Clonazepam) C Vioxx (Rofecoxib) C Depakote (Divalproex) C Date:12/13/01ISR Number: 3840206-3Report Type:Direct Company Report # Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chest Pain Geodon 40mg Bid PS ORAL 40MG BID PO 2 WK Palpitations Depakote C Buspar C Zyprexa C Date:12/14/01ISR Number: 3839500-1Report Type:Expedited (15-DaCompany Report #A126955 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arrhythmia Foreign Ziprasidone Po PS INTRAMUSCULAR BID; Initial or Prolonged Condition Aggravated Health INTRAMUSCULAR Heart Rate Increased Professional Cisordinol Hypotension Company (Zuclopenthixol) SS INTRAVENOUS INTRAVENOUS Pericarditis Representative Psychotic Disorder Date:12/17/01ISR Number: 3840822-9Report Type:Expedited (15-DaCompany Report #A125787 Age:32 YR Gender:Male I/FU:F Outcome PT Death Anxiety Cardiac Disorder Cardiomegaly Cardiovascular Disorder Coronary Artery 22-Feb-2006 08:32 AM Page: 148 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Atherosclerosis Dyspepsia Hallucination Headache Report Source Product Role Manufacturer Route Dose Duration Hepatic Steatosis Health Ziprasidone Po PS ORAL BID; ORAL Hypertension Professional Celexa(Citalopram) C Insomnia Zocor (Simvastatin) C Irritability Desyrel (Trazodone) C Sudden Death Prevacid Weight Decreased (Lansoprazole) C Date:12/17/01ISR Number: 3840823-0Report Type:Expedited (15-DaCompany Report #A128409 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Ziprasidone Po PS Initial or Prolonged Neutropenia Professional Required Intervention to Prevent Permanent Impairment/Damage Date:12/18/01ISR Number: 3841602-0Report Type:Expedited (15-DaCompany Report #A129041 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Stevens-Johnson Syndrome Health Ziprasidone Po PS ORAL 80.00 MG Initial or Prolonged Professional TOTAL:BID:ORA Required L Intervention to Sulfamethoxazole/Tri Prevent Permanent methoprim SS ORAL ORAL Impairment/Damage Paxil (Paroxetine) C Coumadin (Warfarin) C Date:12/18/01ISR Number: 3841610-XReport Type:Direct Company Report # Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cardiovascular Disorder Geodon PS ORAL 60MG Q AM PO Electrocardiogram Qt Geodon 60mg Q Am Po C ORAL 80MG Q HS PO Corrected Interval Prolonged Date:12/26/01ISR Number: 3844617-1Report Type:Expedited (15-DaCompany Report #A129488 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Health Ziprasidone Po PS ORAL 20.00 MG Initial or Prolonged Antinuclear Antibody Professional TOTAL Positive DAILY:ORAL Occult Blood Positive Effexor (Venlafaxine) C Ambien (Zolpidem) C 22-Feb-2006 08:32 AM Page: 149 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/01ISR Number: 3844736-XReport Type:Expedited (15-DaCompany Report #A129480 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Ziprasidone Po PS ORAL DAILY:ORAL Initial or Prolonged Phosphokinase Increased Professional Theodur C Chest Discomfort Chills Dyspnoea Feeling Abnormal Insomnia Date:12/26/01ISR Number: 3844958-8Report Type:Expedited (15-DaCompany Report #A129281 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Pressure Abnormal Foreign Ziprasidone Po PS ORAL 160.00 MG Hospitalization - Burning Sensation Consumer TOTAL:BID:ORA Initial or Prolonged Cardio-Respiratory Arrest L Malaise Lithium Carbonate C Nausea Unspecified Blood Tremor Pressure Medication C Date:12/26/01ISR Number: 3845069-8Report Type:Expedited (15-DaCompany Report #A128110 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cataract Foreign Ziprasidone Po PS ORAL 40.00 MG Intervention to Glaucoma Other TOTAL:BID:ORA Prevent Permanent Muscle Contractions L Impairment/Damage Involuntary Imovane C Stilnoct C Date:12/26/01ISR Number: 3845187-4Report Type:Expedited (15-DaCompany Report #A126513 Age:24 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Face Oedema Consumer Ziprasidone Po PS ORAL 140.00 MG Intervention to Joint Lock Health TOTAL, BID, Prevent Permanent Pain In Jaw Professional ORAL Impairment/Damage Tenosynovitis Throat Tightness Weight Decreased Date:12/28/01ISR Number: 3847359-1Report Type:Expedited (15-DaCompany Report #A129697 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Ziprasidone Po PS Professional Company Representative 22-Feb-2006 08:32 AM Page: 150 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/31/01ISR Number: 3845962-6Report Type:Direct Company Report #CTU 157963 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperhidrosis Geodon PS ORAL 20MG BID PO Initial or Prolonged Vomiting Date:01/03/02ISR Number: 3849262-XReport Type:Expedited (15-DaCompany Report #A130106 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Renal Failure Foreign Ziprasidone Po PS ORAL ORAL Initial or Prolonged Health Professional Company Representative Date:01/07/02ISR Number: 3849158-3Report Type:Direct Company Report #CTU 158433 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abnormal Behaviour Geodon PS Anxiety Crying Nightmare Date:01/08/02ISR Number: 3849883-4Report Type:Expedited (15-DaCompany Report #A200184 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Ziprasidone Po PS ORAL BID:ORAL Initial or Prolonged Hallucination Professional Zoloft SS ORAL ORAL Required Uveitis Seroquel SS ORAL ORAL Intervention to Remeron Prevent Permanent (Mirtazapine) C Impairment/Damage Depakote (Divalproex) C Combivent Inhaler C Ativan (Lorazepam) C Theodur (Theophylline) C Humibid (Guaifenesin) C Date:01/10/02ISR Number: 3851411-4Report Type:Expedited (15-DaCompany Report #A116006 Age:22 YR Gender:Male I/FU:F Outcome PT Hospitalization - Abnormal Behaviour Initial or Prolonged Aggression Anger Crying Drug Interaction Dyskinesia Inappropriate Affect Irritability Malaise Personality Change 22-Feb-2006 08:32 AM Page: 151 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Retching Serum Serotonin Increased Therapeutic Response Report Source Product Role Manufacturer Route Dose Duration Unexpected Consumer Ziprasidone Po PS ORAL 120.00 MG Tremor TOTAL:BID:ORA Weight Decreased L Weight Increased Paxil SS ORAL 20.00 MG TOTAL:DAILY:O RAL Trileptal SS 600.00 MG TOTAL:DAILY Tegretol C Risperidone C Levothyroxine C Date:01/15/02ISR Number: 3853348-3Report Type:Expedited (15-DaCompany Report #A200185 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Psychotic Disorder Health Ziprasidone Po PS 160.00 MG Suicidal Ideation Professional TOTAL:BID Wellbutrin (Bupropion) C Hydrochlorothiazide C Felodipine C Multivitamin C Date:01/15/02ISR Number: 3853349-5Report Type:Expedited (15-DaCompany Report #A200429 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arteriosclerosis Health Ziprasidone Po PS ORAL 160.00 MG Circulatory Collapse Professional TOTAL:BID:ORA Faecal Incontinence L Urinary Incontinence Sudafed C Klonopin C Flomax (Tamsulosin) C Robitussin Dm C Date:01/17/02ISR Number: 3854011-5Report Type:Direct Company Report #CTU 159490 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Ziprasidone PS Initial or Prolonged Corrected Interval Required Prolonged Intervention to Prevent Permanent Impairment/Damage Date:01/23/02ISR Number: 3859533-9Report Type:Expedited (15-DaCompany Report #A200913 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Health Ziprasidone Po PS Professional Haldol (Haloperidol) C Cogentin 22-Feb-2006 08:32 AM Page: 152 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Benztropine) C Date:01/23/02ISR Number: 3859536-4Report Type:Expedited (15-DaCompany Report #A200892 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Body Height Below Normal Consumer Ziprasidone Po PS 40.00 MG Initial or Prolonged Cerebrovascular Accident TOTAL:BID Required Coeliac Disease Aspirin SS Intervention to Cough Procardia Xl Prevent Permanent Depression (Nifedipine) C Impairment/Damage Drooling Risperdal Drug Ineffective (Risperidone) C Dyskinesia Zantac (Ranitidine) C Dysphagia Aspirin C Gastritis Seroquel Hypersomnia (Quetiapine) C Lethargy Rectal Haemorrhage Sneezing Somnolence Weight Decreased Date:01/23/02ISR Number: 3859980-5Report Type:Direct Company Report #CTU 159897 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coronary Artery Geodon 80mg Capsules Atherosclerosis Pfizer PS Pfizer ORAL 1 CAPSU BID ORAL Maltrexone C Celexa C Date:01/23/02ISR Number: 3860014-7Report Type:Direct Company Report #CTU 159871 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Geodon 20 Mg PS ORAL 40MG QAM Dizziness ORAL / 20MG Q Fear 5PM ORAL Heart Rate Increased Synthroid C Insomnia Guaifed Pse C Palpitations Vit E C Centrum Silv C Alprazolam C Ambian C Zocor C Zyprexa C Date:01/24/02ISR Number: 3860018-4Report Type:Expedited (15-DaCompany Report #A200049 Age:52 YR Gender:Female I/FU:I Outcome PT Required Blood Creatinine Intervention to Increased Prevent Permanent Bradycardia Impairment/Damage Electrocardiogram Qt Prolonged 22-Feb-2006 08:32 AM Page: 153 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sinus Arrhythmia Report Source Product Role Manufacturer Route Dose Duration Foreign Ziprasidone Po PS ORAL 160.00 MG Health TOTAL:DAILY:O Professional RAL Nifedipine C Date:01/24/02ISR Number: 3860181-5Report Type:Expedited (15-DaCompany Report #A201159 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Murder Foreign Ziprasidone Po PS ORAL ORAL Intervention to Consumer Beer SS ORAL ORAL Prevent Permanent Impairment/Damage Date:01/25/02ISR Number: 3860698-3Report Type:Expedited (15-DaCompany Report #A200913 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Health Ziprasidone Po PS 60.00 MG Professional TOTAL:DAILY Haldol (Haloperidol) C Cogentin (Benztropine) C Haloperidol Decanoate C Date:01/29/02ISR Number: 3861197-5Report Type:Expedited (15-DaCompany Report #A201159 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Alcohol Interaction Foreign Ziprasidone Po PS ORAL BID:ORAL Intervention to Murder Consumer Beer SS ORAL ORAL Prevent Permanent Impairment/Damage Date:02/01/02ISR Number: 3862734-7Report Type:Direct Company Report #CTU 160537 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Extrapyramidal Disorder Geodon PS ORAL 60MG BID PO Date:02/05/02ISR Number: 3865095-2Report Type:Direct Company Report #CTU 160918 Age:13 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Muscle Spasms Geodon 80mg PS ORAL 80MG TWICE A Initial or Prolonged DAY ORAL 22-Feb-2006 08:32 AM Page: 154 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/07/02ISR Number: 3866633-6Report Type:Expedited (15-DaCompany Report #A200913 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Health Ziprasidone Po PS ORAL 60.00 MG Professional TOTAL:DAILY:O RAL Haldol (Haloperidol) C Cogentin (Benztorpine) C Haloperidol Decanoate C Date:02/08/02ISR Number: 3868157-9Report Type:Expedited (15-DaCompany Report #A201815 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Electrocardiogram Qt Health Ziprasidone Po PS 40.00 MG Intervention to Corrected Interval Professional TOTAL:BID Prevent Permanent Prolonged Clozaril C Impairment/Damage Gastrooesophageal Reflux Dilantin C Disease Estratest C Loss Of Consciousness Valium C Palpitations Zoloft C Rash Neurontin C Date:02/11/02ISR Number: 3869376-8Report Type:Expedited (15-DaCompany Report #A200429 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arteriosclerosis Health Ziprasidone Po PS ORAL 160.00 MG Hospitalization - Blood Chloride Increased Professional TOTAL: BID: Initial or Prolonged Circulatory Collapse ORAL Delusion Sudafed C Delusional Disorder, Klonopin C Persecutory Type Flomax (Tamsulosin) C Diarrhoea Robitussin Dm C Erythema Benadryl C Faecal Incontinence Insomnia Oedema Peripheral Pacing Threshold Increased Skin Warm Urinary Incontinence Date:02/13/02ISR Number: 3870801-7Report Type:Expedited (15-DaCompany Report #A202723 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Health Ziprasidone Po PS ORAL 120.00 MG Initial or Prolonged Catatonia Professional TOTAL:BID:ORA Required Gait Disturbance L Intervention to Movement Disorder Celexa SS ORAL 60.00 MG Prevent Permanent TOTAL:DAILY:O Impairment/Damage RAL Lamictal C Topamax C 22-Feb-2006 08:32 AM Page: 155 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/14/02ISR Number: 3870470-6Report Type:Expedited (15-DaCompany Report #A203015 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Angiopathy Health Ziprasidone Po PS ORAL ORAL Hospitalization - Platelet Count Abnormal Professional Initial or Prolonged Renal Failure Company Stevens-Johnson Syndrome Representative Date:02/14/02ISR Number: 3870488-3Report Type:Expedited (15-DaCompany Report #A126199 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Abnormal Behaviour Consumer Ziprasidone Po PS ORAL PO Intervention to Amnesia Risperdal Prevent Permanent Asthma (Risperidone) SS 12.00 MG Impairment/Damage Bronchitis TOTAL:DAILY Confusional State Flovent Constipation (Fluticasone) SS RESPIRATORY Diabetes Mellitus (INHALATION) 176.00 MCG Drug Interaction TOTAL:BID:INH Hypertension ALATION Insomnia Prozac (Fluoxetine) C Paraesthesia Temazepam C Sedation Allegra Speech Disorder (Fexofenadine) C Weight Increased Diltiazem C Glucophage (Metformin) C Date:02/20/02ISR Number: 3872832-XReport Type:Expedited (15-DaCompany Report #A201815 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Electrocardiogram Qt Health Ziprasidone Po PS 160.00 MG Intervention to Corrected Interval Professional TOTAL:BID Prevent Permanent Prolonged Clozaril C Impairment/Damage Electrocardiogram T Wave Dilantin C Abnormal Estratest C Gastrooesophageal Reflux Valium C Disease Zoloft C Palpitations Neurontin C Rash Syncope Date:02/20/02ISR Number: 3873050-1Report Type:Expedited (15-DaCompany Report #US_020281413 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusional Disorder, Study Ziprasidone PS 160 MG/1 DAY Initial or Prolonged Persecutory Type Health Psychotic Disorder Professional 22-Feb-2006 08:32 AM Page: 156 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/20/02ISR Number: 3873223-8Report Type:Expedited (15-DaCompany Report #US_020179988 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Study Ziprasidone PS Initial or Prolonged Feeling Abnormal Health Restorial Hallucination, Auditory Professional (Temazepam) C Psychotic Disorder Ativan (Lorazepam) C Date:02/20/02ISR Number: 3873895-8Report Type:Expedited (15-DaCompany Report #A202710 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Ziprasidone Po PS ORAL 80.00 MG Initial or Prolonged Gamma-Glutamyltransferase Professional TOTAL: BID: Required Increased ORAL Intervention to Psychiatric Symptom Tegretol SS Prevent Permanent Self-Injurious Ideation Paxil C Impairment/Damage Naltrexone C Date:02/22/02ISR Number: 3874359-8Report Type:Expedited (15-DaCompany Report #A200850 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atherosclerosis Foreign Ziprasidone Po PS ORAL 160.00 MG Hospitalization - Cardiac Arrest Health TOTAL:BID:ORA Initial or Prolonged Coronary Artery Disease Professional L Depression Lactulose C Dizziness Tramadol C Epistaxis Paracetamol C Headache Zopiclone C Indifference Remeron C Influenza Like Illness Nozinan C Malaise Rivotril C Nausea Oxazepam C Sensory Disturbance Sudden Death Suicidal Ideation Visual Disturbance Weight Increased Date:02/22/02ISR Number: 3874778-XReport Type:Expedited (15-DaCompany Report #A203276 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Psychotic Disorder Consumer Ziprasidone Po PS ORAL PO Road Traffic Accident Date:02/25/02ISR Number: 3874322-7Report Type:Expedited (15-DaCompany Report #A200422 Age:49 YR Gender:Female I/FU:I Outcome PT Hospitalization - Cough Initial or Prolonged Dizziness Dyspepsia Insomnia Laryngitis Nasopharyngitis 22-Feb-2006 08:32 AM Page: 157 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Vomiting Report Source Product Role Manufacturer Route Dose Duration Consumer Ziprasidone Po PS ORAL 160.00 MG TOTAL:BID:ORA L Clozaril SS Date:02/25/02ISR Number: 3874328-8Report Type:Expedited (15-DaCompany Report #A123070 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Effect Decreased Consumer Ziprasidone Po PS 40.00 MG Initial or Prolonged Emotional Disorder TOTAL:BID Fear Cogentin C Feeling Abnormal Vistaril C Thinking Abnormal Wellbutrin C Visual Disturbance Date:02/25/02ISR Number: 3874547-0Report Type:Expedited (15-DaCompany Report #A203467 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cerebrovascular Accident Health Ziprasidone Po PS Intervention to Hypertension Professional Prevent Permanent Company Impairment/Damage Representative Date:02/26/02ISR Number: 3876007-XReport Type:Expedited (15-DaCompany Report #A126997 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Ziprasidone Po PS ORAL 120.00 MG Initial or Prolonged Depression Professional TOTAL:DAILY:O Required Drug Interaction RAL Intervention to Drug Level Increased Desipramine SS ORAL 300.00 MG Prevent Permanent Medication Error TOTAL:DAILY:O Impairment/Damage RAL Lithobid SS Lorazepam C Synthroid (Levothyroxine) C Wellbutrin (Bupropion) C Loestrin C Chinese Herbs C Date:02/28/02ISR Number: 3878105-3Report Type:Expedited (15-DaCompany Report #A129041 Age:29 YR Gender:Female I/FU:F Outcome Death Hospitalization - Initial or Prolonged Required Intervention to Prevent Permanent 22-Feb-2006 08:32 AM Page: 158 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Brain Death Consumer Ziprasidone Po PS ORAL BID:ORAL Drug Effect Decreased Health Sulfamethoxazole-Tri Liver Function Test Professional methoprim SS ORAL ORAL Abnormal Paxil (Paroxetine) C Multi-Organ Failure Coumadin (Warfarin) C Oedema Renal Failure Skin Discolouration Stevens-Johnson Syndrome Thrombocytopenia Upper Respiratory Tract Infection Urinary Tract Infection Vasculitis Date:02/28/02ISR Number: 3878548-8Report Type:Expedited (15-DaCompany Report #A202921 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Health Ziprasidone Po PS 80.00 MG Initial or Prolonged Drug Interaction Professional TOTAL:DAILY Required Dyspnoea Seroquel SS ORAL 350.00 MG Intervention to Heart Rate Increased TOTAL:DAILY:O Prevent Permanent Nausea RAL Impairment/Damage Neuroleptic Malignant Ambien (Zolpidem) C Syndrome Tetracycline C Vomiting Date:02/28/02ISR Number: 3889424-9Report Type:Periodic Company Report #001-0945-M0100596 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Neurontin Initial or Prolonged Mania Professional (Gabapentin) PS 3600 MG (TID) Overdose Seroquel SS 900 MG Schizophrenia (DAILY) / SEE IMAGE Geodon SS ORAL 40 MG (BID), PER ORAL / SEE IMAGE Beer SS Date:03/01/02ISR Number: 3878812-2Report Type:Expedited (15-DaCompany Report #A203640 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination Health Ziprasidone Po PS ORAL 120.00 MG Initial or Prolonged Professional TOTAL:BID:ORA L 22-Feb-2006 08:32 AM Page: 159 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/05/02ISR Number: 3879141-3Report Type:Expedited (15-DaCompany Report #A204273 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Health Ziprasidone Po PS Professional Company Representative Date:03/05/02ISR Number: 3879196-6Report Type:Expedited (15-DaCompany Report #A204001 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Ziprasidone Po PS ORAL 600.00 MG Initial or Prolonged Professional TOTAL:BID:ORA Required L Intervention to Prevent Permanent Impairment/Damage Date:03/05/02ISR Number: 3880845-7Report Type:Expedited (15-DaCompany Report #A127624 Age:17 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Conversion Disorder Foreign Ziprasidone Po PS ORAL 40.00 MG Initial or Prolonged Drug Effect Decreased Health TOTAL:BID:ORA Galactorrhoea Professional L Hallucination Cipramil SS ORAL ROAL Nausea Antiepileptic Drugs C Psychotic Disorder Lamictal C Sleep Disorder Weight Increased Date:03/06/02ISR Number: 3890587-XReport Type:Periodic Company Report #A126329 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperkalaemia Health Ziprasidone Po PS ORAL 40.00 MG Initial or Prolonged Professional TOTAL:DAILY:O RAL Septra Ds SS ORAL BID:ORAL Date:03/06/02ISR Number: 3890588-1Report Type:Periodic Company Report #A126954 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Ziprasidone Po PS Initial or Prolonged Professional Company Representative Date:03/06/02ISR Number: 3890589-3Report Type:Periodic Company Report #A127662 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Hospitalization - Electrocardiogram Health Initial or Prolonged Abnormal Professional 22-Feb-2006 08:32 AM Page: 160 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company Representative Product Role Manufacturer Route Dose Duration Ziprasidone Po PS Date:03/06/02ISR Number: 3890590-XReport Type:Periodic Company Report #A128285 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delirium Health Ziprasidone Po PS ORAL 200.00 MG Initial or Prolonged Intentional Overdose Professional TOTAL:BID:ORA Required Medication Error L Intervention to Wellbutrin Sr C Prevent Permanent Celexa C Impairment/Damage Buspar C Date:03/06/02ISR Number: 3890591-1Report Type:Periodic Company Report #A128415 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Overdose Health Ziprasidone Po PS ORAL ORAL Initial or Prolonged Somnolence Professional Required Intervention to Prevent Permanent Impairment/Damage Date:03/06/02ISR Number: 3890592-3Report Type:Periodic Company Report #A200370 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Health Ziprasidone Po PS Initial or Prolonged Professional Date:03/06/02ISR Number: 3890593-5Report Type:Periodic Company Report #A200685 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Health Ziprasidone Po PS ORAL 20.00 MG Initial or Prolonged Increased Professional TOTAL:BID:ORA Amenorrhoea L Hypercholesterolaemia Zyprexa SS Tremor Tegretol Xr C Vomiting Centrum Vit Weight Decreased Supplement C Caltrate C Date:03/06/02ISR Number: 3890594-7Report Type:Periodic Company Report #A124868 Age:61 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Health Ziprasidone Po PS ORAL 40.00 MG Initial or Prolonged Schizophreniform Disorder Professional TOTAL:BID:ORA L 22-Feb-2006 08:32 AM Page: 161 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/07/02ISR Number: 3881067-6Report Type:Expedited (15-DaCompany Report #A204650 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Ziprasidone Po PS Professional Company Representative Date:03/07/02ISR Number: 3881165-7Report Type:Expedited (15-DaCompany Report #A202058 Age:21 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatitis Cholestatic Health Ziprasidone Po PS ORAL 40.00 MG Initial or Prolonged Mental Disorder Professional TOTAL:BID:ORA Required Urinary Retention L Intervention to Luvox C Prevent Permanent Klonopin C Impairment/Damage Minocycline C Wellbutrin C Risperdal C Date:03/08/02ISR Number: 3881737-XReport Type:Expedited (15-DaCompany Report #A204845 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Ziprasidone Po PS ORAL Initial or Prolonged Syndrome Professional Company Representative Date:03/08/02ISR Number: 3882016-7Report Type:Expedited (15-DaCompany Report #A127624 Age:17 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Conversion Disorder Foreign Ziprasidone Po PS ORAL 40.00 MG Initial or Prolonged Galactorrhoea Health TOTAL: BID: Hallucination Professional ORAL Nausea Cipramil SS ORAL ORAL Psychotic Disorder Clozapine SS Sleep Disorder Antiepileptic Drugs C Visual Acuity Reduced Lamictal C Weight Increased Date:03/08/02ISR Number: 3882168-9Report Type:Expedited (15-DaCompany Report #A129041 Age:29 YR Gender:Female I/FU:F Outcome PT Death Haemorrhagic Stroke Hospitalization - Hallucination Initial or Prolonged Hepatic Failure Required Multi-Organ Failure Intervention to Oedema Prevent Permanent Platelet Count Abnormal Impairment/Damage Renal Failure Acute Stevens-Johnson Syndrome Suicidal Ideation Suicide Attempt 22-Feb-2006 08:32 AM Page: 162 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Thrombocytopenia Upper Respiratory Tract Infection Report Source Product Role Manufacturer Route Dose Duration Urinary Tract Infection Consumer Ziprasidone Po PS ORAL 80.00 MG Vasculitis Health TOTAL: BID: White Blood Cell Count Professional ORAL Increased Sulfamethoxazole-Tri methoprim SS ORAL ORAL Coumadin (Warfarin) C Prozac C Date:03/08/02ISR Number: 3882169-0Report Type:Expedited (15-DaCompany Report #A204829 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Antinuclear Antibody Health Ziprasidone Po PS ORAL Intervention to Positive Professional Prednisone SS Prevent Permanent Arteritis Impairment/Damage Asthenia C-Reactive Protein Increased Haemoglobin Decreased Headache Leukaemia Myelocyte Count Increased Pain Red Blood Cell Sedimentation Rate Increased Tenderness Visual Disturbance White Blood Cell Count Increased Date:03/11/02ISR Number: 3881116-5Report Type:Direct Company Report #CTU 163134 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypothermia Geodon 20 Mg Initial or Prolonged (Roerig) PS Roerig ORAL 20MG BID PO Thorazine C Depakote C Date:03/12/02ISR Number: 3882673-5Report Type:Expedited (15-DaCompany Report #A204950 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Serotonin Syndrome Health Ziprasidone Po PS 40.00 MG Intervention to Professional TOTAL:BID Prevent Permanent Venlafaxine SS Impairment/Damage Citalopram SS 22-Feb-2006 08:32 AM Page: 163 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/02ISR Number: 3882839-4Report Type:Expedited (15-DaCompany Report #A201130 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Health Ziprasidone Po PS BID Initial or Prolonged Corrected Interval Professional Prolonged Company Hypokalaemia Representative Date:03/12/02ISR Number: 3882840-0Report Type:Expedited (15-DaCompany Report #A205145 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Prostate Cancer Stage I Consumer Ziprasidone PS ORAL 80.00 MG Intervention to Health TOTAL:QID:ORA Prevent Permanent Professional L Impairment/Damage Unknown Medication C Prozac C Date:03/12/02ISR Number: 3882842-4Report Type:Expedited (15-DaCompany Report #A204652 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Ziprasidone Po PS Professional Date:03/12/02ISR Number: 3882853-9Report Type:Expedited (15-DaCompany Report #A204654 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Ziprasidone Po PS Professional Date:03/12/02ISR Number: 3882854-0Report Type:Expedited (15-DaCompany Report #A204657 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Ziprasidone Po PS Professional Date:03/12/02ISR Number: 3882855-2Report Type:Expedited (15-DaCompany Report #A205147 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Prostate Cancer Consumer Ziprasidone Po PS ORAL 80.00 MG Intervention to TOTAL: QID: Prevent Permanent ORAL Impairment/Damage Unknown Medication SS Prozac C Date:03/12/02ISR Number: 3882857-6Report Type:Expedited (15-DaCompany Report #A205042 Age:12 YR Gender:Female I/FU:I Outcome Required Intervention to 22-Feb-2006 08:32 AM Page: 164 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Health Ziprasidone Po PS ORAL 100.00 MG Electrocardiogram T Wave Professional TOTAL: BID: Inversion ORAL Rash Pruritic Propranolol C Haloperidol C Topiramate C Ddavp (Desmopressin) C Levothyroxine C Lithium Carbonate C Date:03/12/02ISR Number: 3882971-5Report Type:Expedited (15-DaCompany Report #A204574 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Barrett'S Oesophagus Foreign Ziprasidone Po PS ORAL 120.00 MG Initial or Prolonged Cardiac Arrest Health TOTAL:BID:ORA Chronic Obstructive Professional L Pulmonary Disease Company Venlafaxine C Coronary Artery Disease Representative Clonazepam C Gastrointestinal Haemorrhage Hypercholesterolaemia Left Ventricular Failure Lung Infection Myocardial Infarction Nosocomial Infection Thrombocythaemia Ventricular Fibrillation Date:03/13/02ISR Number: 3883236-8Report Type:Expedited (15-DaCompany Report #A204659 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Ziprasidone Po PS Professional Date:03/13/02ISR Number: 3883244-7Report Type:Expedited (15-DaCompany Report #A204655 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Ziprasidone Po PS ORAL Professional Date:03/19/02ISR Number: 3885997-0Report Type:Expedited (15-DaCompany Report #A204692 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Consumer Ziprasidone Po PS 160.00 MG Initial or Prolonged Movement Disorder TOTAL:BID: Muscle Twitching Haldol (Haloperidol) SS INTRAMUSCULAR INTRAMUSCULAR Tongue Disorder Weight Decreased 22-Feb-2006 08:32 AM Page: 165 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/19/02ISR Number: 3885998-2Report Type:Expedited (15-DaCompany Report #A201800 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Condition Aggravated Consumer Ziprasidone Po PS ORAL 40.00 MG Intervention to Dermatitis Health TOTAL:BID:ORA Prevent Permanent Dermatitis Infected Professional L Impairment/Damage Heart Rate Increased Prozac C Tic Risperdal C Tremor Weight Decreased Date:03/19/02ISR Number: 3886014-9Report Type:Expedited (15-DaCompany Report #A205753 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Priapism Health Vistaril Capsules PS Intervention to Professional Ziprasidone SS Prevent Permanent Company Risperdal SS Impairment/Damage Representative Paxil SS Tenormin (Atenolol) C Hydrochlorothiazide C Lescol (Fluvastatin) C Zocor (Simvastatin) C Date:03/19/02ISR Number: 3886051-4Report Type:Expedited (15-DaCompany Report #A205342 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Abnormal Health Ziprasidone Po PS ORAL PO Initial or Prolonged Drug Level Increased Professional Lithium Carbonate SS ORAL 900.00 MG Required Electrocardiogram Qt TOTAL:BID/ORA Intervention to Corrected Interval L Prevent Permanent Prolonged Effexor C Impairment/Damage Glycosylated Haemoglobin Zyprexa C Increased Glucophage C Ambien C Thorazine C Actos C Date:03/19/02ISR Number: 3886120-9Report Type:Expedited (15-DaCompany Report #A205575 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aneurysm Health Ziprasidone Po PS ORAL ORAL Gastrointestinal Professional Zyprexa C Haemorrhage Company Myocardial Infarction Representative Date:03/22/02ISR Number: 3887558-6Report Type:Expedited (15-DaCompany Report #A205753 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Priapism Health Vistaril Capsules PS Intervention to Professional Ziprasidone SS Prevent Permanent Company Risperidal SS Impairment/Damage Representative Paxil SS Tenormin (Atenolol) C 22-Feb-2006 08:32 AM Page: 166 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochlorothiazide C Lescol (Fluvastatin) C Zocor (Simvastatin) C Date:03/27/02ISR Number: 3890966-0Report Type:Expedited (15-DaCompany Report #A206394 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Tardive Dyskinesia Health Ziprasidone Po PS Intervention to Professional Prevent Permanent Company Impairment/Damage Representative Date:03/28/02ISR Number: 3890398-5Report Type:Direct Company Report #USP 54801 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Geodon PS Pfizer Geodon SS Pfizer Date:03/29/02ISR Number: 3892659-2Report Type:Direct Company Report #CTU 164461 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hepatic Failure Geodon - Pfizer PS Pfizer ORAL 80 MG PO BID Stevens-Johnson Syndrome Paxil C Coumadin C Date:03/29/02ISR Number: 3892680-4Report Type:Expedited (15-DaCompany Report #A204845 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Ziprasidone Po PS Initial or Prolonged Syndrome Professional Company Representative Date:03/29/02ISR Number: 3892681-6Report Type:Expedited (15-DaCompany Report #A206681 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Health Ziprasidone Po PS Initial or Prolonged Pyrexia Professional Company Representative Date:03/29/02ISR Number: 3892722-6Report Type:Expedited (15-DaCompany Report #A206561 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Tardive Dyskinesia Health Ziprasidone Po PS ORAL ORAL Intervention to Weight Increased Professional Zyprexa SS Prevent Permanent Company Impairment/Damage Representative 22-Feb-2006 08:32 AM Page: 167 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/29/02ISR Number: 3892819-0Report Type:Expedited (15-DaCompany Report #A204692 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Consumer Ziprasidone Po PS 160.00 MG Initial or Prolonged Drug Hypersensitivity TOTAL:BID:UNK Dyskinesia NOWN Muscle Twitching Haldol (Haloperidol) SS INTRAMUSCULAR INTRAMUSCULAR Refusal Of Treatment By Patient Tongue Disorder Tremor Weight Decreased Date:04/01/02ISR Number: 3892770-6Report Type:Direct Company Report #CTU 164680 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cogwheel Rigidity Geodon 80mg Joint Stiffness (Pfizer) PS Pfizer ORAL 100MG PO BID Geodon 20mg (Pfizer) SS Pfizer Ativan C Tylenol C Mylanta C Date:04/02/02ISR Number: 3893738-6Report Type:Expedited (15-DaCompany Report #A206526 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperhidrosis Health Ziprasidone Po PS ORAL 160.00 MG Initial or Prolonged Pyrexia Professional TOTAL; BID; Tremor ORAL Trazodone C Clonidine C Prozac C Colace C Date:04/02/02ISR Number: 3893739-8Report Type:Expedited (15-DaCompany Report #A206594 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Drug Effect Decreased Consumer Ziprasidone Po PS BID Intervention to Haemoglobin Decreased Olanzepine C Prevent Permanent Myeloproliferative Impairment/Damage Disorder Date:04/02/02ISR Number: 3893876-8Report Type:Expedited (15-DaCompany Report #A205704 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Consumer Ziprasidone Po PS ORAL 160.00 MG Initial or Prolonged Increased Appetite TOTAL: BID: Required Road Traffic Accident ORAL Intervention to Sedation Lithium Prevent Permanent Somnolence (Manufacturer Impairment/Damage Suicidal Ideation Unknown) SS Weight Increased Beer SS 22-Feb-2006 08:32 AM Page: 168 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/02/02ISR Number: 3894323-2Report Type:Expedited (15-DaCompany Report #A206153 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Heart Rate Decreased Foreign Ziprasidone Po PS ORAL 160.00 MG Initial or Prolonged Nausea Study TOTAL:BID: Vertigo Health ORAL Professional Metoprolol C Date:04/02/02ISR Number: 3894764-3Report Type:Expedited (15-DaCompany Report #A038935 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Foreign Ziprasidone Po PS ORAL 160.00 MG Initial or Prolonged Prolonged Health TOTAL:DAILY:O Professional RAL Other Flunitrazepam C Fluoxetine C Diazepam C Propiomazine C Date:04/02/02ISR Number: 3894846-6Report Type:Expedited (15-DaCompany Report #A206369 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Foreign Ziprasidone PS ORAL 160.00 MG Initial or Prolonged Anxiety Consumer TOTAL:DAILY:O Hyperhidrosis RAL Panic Attack Leponex SS ORAL 100.00 MG TOTAL:DAILY:O RAL Haldol (Haloperidol) C Seroxat (Paroxetine) C Theralen C Date:04/05/02ISR Number: 3897046-9Report Type:Expedited (15-DaCompany Report #A129041 Age:29 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Effect Decreased Consumer Ziprasidone Po PS ORAL 80.00 MG Hospitalization - Haemorrhagic Stroke Health TOTAL: BID: Initial or Prolonged Hallucination Professional ORAL Required Multi-Organ Failure Sulfamethoxazole-Tri Intervention to Oedema methoprim SS ORAL ORAL Prevent Permanent Platelet Count Abnormal Coumadin (Warfarin) C Impairment/Damage Rash Generalised Prozac (Fluoxetine) C Skin Discolouration Paxil (Paroxetine) C Stevens-Johnson Syndrome Suicidal Ideation Suicide Attempt Thrombocytopenia Upper Respiratory Tract Infection Urinary Tract Infection Vasculitis 22-Feb-2006 08:32 AM Page: 169 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/05/02ISR Number: 3897075-5Report Type:Expedited (15-DaCompany Report #A204950 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Balance Disorder Health Ziprasidone Po PS 160.00MG Intervention to Disturbance In Attention Professional TOTAL:BID Prevent Permanent Hyperreflexia Venlafaxine SS Impairment/Damage Nystagmus Citalopram SS Paraesthesia Somnolence Speech Disorder Tremor Date:04/09/02ISR Number: 3898841-2Report Type:Direct Company Report #CTU 165360 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Rhinitis Geodon 20 Mg + 40 Mg Sneezing Pfizer PS Pfizer ORAL 40 MG BID P.O. Date:04/10/02ISR Number: 3898378-0Report Type:Expedited (15-DaCompany Report #A205714 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypoxia Health Ziprasidone Po PS ORAL 120:00 MG Initial or Prolonged Pulmonary Fibrosis Professional TOTAL:DAILY:O Tricuspid Valve Company RAL Incompetence Representative Lithium Carbonate C Ventricular Hypertrophy Neurontin C Seroquel C Effexor Xr C Klonopin C Trileptal C Oral Hypoglycemic Drugs C Asthma Inhalers C Date:04/11/02ISR Number: 3899629-9Report Type:Direct Company Report #CTU 165549 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gaze Palsy Ziprasidone Initial or Prolonged Movement Disorder (Geodone) 80mg PS ORAL 80MG PO BID ( Suicidal Ideation RECENT Tremor INCREASED IN DOSE) Date:04/12/02ISR Number: 3900121-3Report Type:Expedited (15-DaCompany Report #A203276 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Confusional State Consumer Ziprasidone Po PS Hyperhidrosis Overdose Road Traffic Accident Staring Tremor 22-Feb-2006 08:32 AM Page: 170 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/16/02ISR Number: 3901200-7Report Type:Direct Company Report #CTU 165797 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arthropod Bite Ziprasidone 40mg PS ORAL 40MG PO BID Face Oedema Hydrochlorthiazide C Oedema Peripheral Enalapril C Urticaria Calcium W Vit D C Date:04/16/02ISR Number: 3901515-2Report Type:Expedited (15-DaCompany Report #A206324 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Automatism Consumer Ziprasidone Po PS ORAL ORAL Intervention to Bruxism Health Fluphenazine SS ORAL ORAL Prevent Permanent Condition Aggravated Professional Prolixin Impairment/Damage Dizziness (Fluphenazine) C Extrapyramidal Disorder Amantadine C Gait Disturbance Celexa (Citalopram) C Grimacing Klonopin Medication Error (Clonazepam) C Oculogyration Date:04/18/02ISR Number: 3902919-4Report Type:Expedited (15-DaCompany Report #A207676 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Foreign Ziprasidone Po PS ORAL 40.00 MG Hospitalization - Electrocardiogram Health TOTAL:DAILY:O Initial or Prolonged Abnormal Professional RAL Insomnia Olanzapine Po SS ORAL ORAL Loss Of Consciousness Fluoxetine SS ORAL ORAL Pericarditis Clonazepam SS ORAL ORAL Sinus Bradycardia Alprazolanum C Somnolence Loratadine C Suicide Attempt Date:04/18/02ISR Number: 3903647-1Report Type:Expedited (15-DaCompany Report #A208082 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Health Ziprasidone Po PS ORAL 80.00 MG Initial or Prolonged Professional TOTAL:BID:ORA Company L Representative Paxil (Paroxetine) C Date:04/18/02ISR Number: 3903649-5Report Type:Expedited (15-DaCompany Report #A208038 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Acidotic Health Ziprasidone Po PS ORAL ORAL Hospitalization - Electrocardiogram Qt Professional Wellbutrin Initial or Prolonged Prolonged (Bupropion) C Intentional Overdose Ativan (Lorazepam) C 22-Feb-2006 08:32 AM Page: 171 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/22/02ISR Number: 3904504-7Report Type:Expedited (15-DaCompany Report #A126992 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Ziprasidone Po PS ORAL 40.00 MG Initial or Prolonged Anxiety Professional TOTAL:BID:ORA Cardiac Enzymes Increased L Chest Pain Trazodone C Condition Aggravated Wellbutrin Depression (Bupropion) C Platelet Count Increased Neurontin Suicidal Ideation (Gabapentin) C Klonopin (Clonazepam) C Vicodin (Hydrochloride-Aceta minophen) C Date:04/22/02ISR Number: 3904634-XReport Type:Expedited (15-DaCompany Report #A208671 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Ziprasidone Po PS Initial or Prolonged Syndrome Professional Clozaril C Required Intervention to Prevent Permanent Impairment/Damage Date:04/22/02ISR Number: 3904738-1Report Type:Expedited (15-DaCompany Report #A208563 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Health Ziprasidone Po PS 160.00 MG Initial or Prolonged Aggression Professional TOTAL:BID Required Depression Company Venlafaxine SS Intervention to Representative Prevent Permanent Impairment/Damage Date:04/22/02ISR Number: 3904971-9Report Type:Expedited (15-DaCompany Report #A200850 Age:30 YR Gender:Male I/FU:F Outcome PT Death Atherosclerosis Hospitalization - Cardiac Arrest Initial or Prolonged Dizziness Drug Toxicity Epistaxis Gastrointestinal Disorder Headache Influenza Like Illness Malaise Nausea Pulmonary Oedema Sensory Disturbance Sensory Loss Sudden Death Suicide Attempt 22-Feb-2006 08:32 AM Page: 172 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Visual Disturbance Vomiting Weight Increased Report Source Product Role Manufacturer Route Dose Duration Foreign Ziprasidone Po PS ORAL 160.00 MG Health TOTAL;BID;ORA Professional L Other Lactulose C Tramadol C Paracetamol C Zopiclone C Remeron C Nozinan C Rivotril C Oxazepam C Date:04/23/02ISR Number: 3905226-9Report Type:Direct Company Report #CTU 166440 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Parkinsonism Geodon (Ziprasidone) PS Pfizer ORAL 80MG DAILY Initial or Prolonged ORAL Required Intervention to Prevent Permanent Impairment/Damage Date:04/23/02ISR Number: 3905641-3Report Type:Expedited (15-DaCompany Report #A208022 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Arrhythmia Literature Ziprasidone Po PS Intervention to Blood Electrolytes Health Amphotericin B C Prevent Permanent Abnormal Professional Lamivudine C Impairment/Damage Electrocardiogram Qt Stavudine C Corrected Interval Efavirenz C Prolonged Piperacillin With Ventricular Extrasystoles Tazobactam C Ranitidine C Metronidazole C Senna C Docusate C Risperidone C Date:04/23/02ISR Number: 3906003-5Report Type:Direct Company Report #CTU 166498 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Body Temperature Geodon 40mg Po Qd PS 40MG 45 YR Initial or Prolonged Increased Depakote C Headache Tylenol C Pruritus 22-Feb-2006 08:32 AM Page: 173 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/26/02ISR Number: 3907418-1Report Type:Direct Company Report #CTU 166719 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Depakote 500mg Initial or Prolonged Difficulty In Walking Abbott PS Abbott ORAL 1000MG QHS Drug Level Above ORAL Therapeutic Geodon 20mg Pfizer SS Pfizer ORAL 20MG TID ORAL Vision Blurred Concerta C Paxil C Date:04/29/02ISR Number: 3909852-2Report Type:Expedited (15-DaCompany Report #A205342 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Ziprasidone Po PS ORAL ORAL Initial or Prolonged Drug Level Below Professional Lithium Carbonate SS ORAL 900.00 MG Required Therapeutic KTOTAL;BID;OR Intervention to Electrocardiogram Qt AL Prevent Permanent Prolonged Venlafaxine SS ORAL 225.00 MG Impairment/Damage Glycosylated Haemoglobin TOTAL;DAILY;O Increased RAL Medication Error Thorazine SS ORAL 100.00 MG TOTAL;DAILY;O RAL Zyprexa C Glucophage C Ambien C Actos C Date:04/29/02ISR Number: 3910008-8Report Type:Expedited (15-DaCompany Report #A208922 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Catatonia Literature Ziprasidone Po PS 120.00 MG Intervention to Homicidal Ideation Health TOTAL: BID Prevent Permanent Neuroleptic Malignant Professional Risperidone SS 6.00 MG Impairment/Damage Syndrome TOTAL:BID Paranoia Clonazepam SS 2.00 MG Suicidal Ideation TOTAL:BID Olanzapine C Date:04/29/02ISR Number: 3910009-XReport Type:Expedited (15-DaCompany Report #A204481 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Irritability Health Ziprasidone Po PS ORAL 120.00 MG Initial or Prolonged Mania Professional TOTAL:BID:ORA L Seroquel C Luvox C Date:04/29/02ISR Number: 3910011-8Report Type:Expedited (15-DaCompany Report #A205753 Age: Gender:Male I/FU:F Outcome Required Intervention to 22-Feb-2006 08:32 AM Page: 174 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Priapism Health Vistaril Capsules PS Professional Ziprasidone SS Company Risperidal SS Representative Paxil SS Hydrochlorothiazide C Lescol(Fluvastatin) C Zocor(Simvastatin) C Tenormin(Atenolol) C Unspecified Medications C Date:05/01/02ISR Number: 3911328-3Report Type:Expedited (15-DaCompany Report #A206153 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Foreign Ziprasidone Po PS ORAL PO Initial or Prolonged Heart Rate Decreased Study Metoprolol C Nausea Health Clozapin C Vertigo Professional Date:05/02/02ISR Number: 3911607-XReport Type:Expedited (15-DaCompany Report #A209704 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Anaemia Health Ziprasidone Po PS ORAL Intervention to Thrombosis Professional Prevent Permanent Company Impairment/Damage Representative Date:05/06/02ISR Number: 3912214-5Report Type:Expedited (15-DaCompany Report #A209320 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Liver Function Test Health Ziprasidone Po PS ORAL ORAL Initial or Prolonged Abnormal Professional Tylenol C Neuroleptic Malignant Depakote C Syndrome Pruritus Date:05/06/02ISR Number: 3912217-0Report Type:Expedited (15-DaCompany Report #A201130 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Health Ziprasidone Po PS BID Initial or Prolonged Corrected Interval Professional Prolonged Hypokalaemia 22-Feb-2006 08:32 AM Page: 175 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/06/02ISR Number: 3912221-2Report Type:Expedited (15-DaCompany Report #A209807 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Nightmare Consumer Zoloft Tablets PS Initial or Prolonged Ziprasidone SS 120.00 MG TOTAL:TID Quetiapine SS Aspirin C Date:05/07/02ISR Number: 3913278-5Report Type:Expedited (15-DaCompany Report #A206561 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Agitation Health Ziprasidone Po PS 40.00 MG Intervention to Akathisia Professional TOTAL BID Prevent Permanent Decreased Appetite Zyprexa SS 20.00 MG Impairment/Damage Dyskinesia TOTAL DAILY Elevated Mood Iron Supplements C Extrapyramidal Disorder Headache Medicine - Fatigue Unspecified C Joint Stiffness Somnolence Tardive Dyskinesia Weight Increased Date:05/09/02ISR Number: 3914390-7Report Type:Direct Company Report #CTU 167733 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Geodone 20mg Po Qd PS ORAL 20MG PO Initial or Prolonged Hyperhidrosis Movement Disorder Paraesthesia Pruritus Date:05/10/02ISR Number: 3914764-4Report Type:Expedited (15-DaCompany Report #A210030 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Insomnia Health Ziprasidone Po PS ORAL 80:00 MG Professional TOTAL:BID:ORA L Paxil (Paraoxetine) C Neurontin (Gabapentin) C Date:05/10/02ISR Number: 3914874-1Report Type:Direct Company Report #CTU 167820 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Geodon (Ziprasidone) Initial or Prolonged Muscle Rigidity Pfizer PS Pfizer ORAL 80MG PO BID Neuroleptic Malignant Prevacid C Syndrome Valium C Elavil C Haldol C 22-Feb-2006 08:32 AM Page: 176 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/13/02ISR Number: 3915995-XReport Type:Expedited (15-DaCompany Report #A210228 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthma Health Ziprasidone Po PS ORAL 20.00 MG Life-Threatening Cardiac Arrest Professional TOTAL:DAILY:O Hospitalization - Circulatory Collapse Company RAL Initial or Prolonged Pulmonary Embolism Representative Trazodone C Required Prozac C Intervention to Depakote C Prevent Permanent Motrin C Impairment/Damage Date:05/15/02ISR Number: 3917223-8Report Type:Expedited (15-DaCompany Report #A210536 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Foreign Ziprasidone Po PS 160.00 MG Initial or Prolonged Blood Pressure Decreased Health TOTAL:BID Difficulty In Walking Professional Hypokalaemia Myalgia Rash Rash Generalised Somnolence Tongue Coated Date:05/15/02ISR Number: 3917251-2Report Type:Direct Company Report #CTU 168151 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Geodon 20mg Pfizer PS Pfizer ORAL 20MG PO BID Date:05/15/02ISR Number: 3917352-9Report Type:Expedited (15-DaCompany Report #A210200 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Effect Decreased Health Ziprasidone Po PS ORAL ORAL Hospitalization - Psychotic Disorder Professional Clozapine SS Initial or Prolonged Date:05/15/02ISR Number: 3917597-8Report Type:Expedited (15-DaCompany Report #A210204 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Tardive Dyskinesia Health Ziprasidone Po PS Intervention to Professional Prevent Permanent Company Impairment/Damage Representative Date:05/17/02ISR Number: 3918821-8Report Type:Expedited (15-DaCompany Report #A210470 Age:51 YR Gender:Female I/FU:I Outcome PT Hospitalization - Diarrhoea Initial or Prolonged Disturbance In Attention Feeling Cold 22-Feb-2006 08:32 AM Page: 177 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hallucinations, Mixed Headache Hypoaesthesia Report Source Product Role Manufacturer Route Dose Duration Insomnia Consumer Ziprasidone Po PS ORAL 80.00 MG Paraesthesia TOTAL, BID, Vomiting ORAL Effexor Xr SS ORAL 22.50 MG TOTAL, ORAL Ativan C Calcium C Date:05/17/02ISR Number: 3918867-XReport Type:Expedited (15-DaCompany Report #A210743 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Consumer Ziprasidone Po PS ORAL 140.00 MG Initial or Prolonged Drug Interaction TOTAL:DAILY:O Electrocardiogram Qt RAL Prolonged Quetiapine SS 500.00 MG Stress TOTAL:DAILY Urinary Tract Infection Neurontin C Buspar C Klonopin (Clonazepam) C Date:05/17/02ISR Number: 3918923-6Report Type:Expedited (15-DaCompany Report #A210352 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Myocardial Infarction Health Ziprasidone Po PS Intervention to Professional Prevent Permanent Company Impairment/Damage Representative Date:05/17/02ISR Number: 3918952-2Report Type:Expedited (15-DaCompany Report #A210373 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia Foreign Ziprasidone Po PS ORAL 160 MG Initial or Prolonged Consumer TOTAL:BID:ORA L Date:05/17/02ISR Number: 3919018-8Report Type:Expedited (15-DaCompany Report #A208704 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Ziprasidone Po PS ORAL 160.00 MG Initial or Prolonged Delirium Health TOTAL;DAILY;O Hallucination Professional RAL Libido Increased Risperidone C 22-Feb-2006 08:32 AM Page: 178 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/20/02ISR Number: 3919658-6Report Type:Expedited (15-DaCompany Report #A210368 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hypersensitivity Health Ziprasidone Po PS Required Obstructive Airways Professional Intervention to Disorder Company Prevent Permanent Representative Impairment/Damage Date:05/21/02ISR Number: 3919303-XReport Type:Direct Company Report #CTU 168482 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Alanine Aminotransferase Luvox 25mg Solvay PS Solvay ORAL 25MG QAM AND Intervention to Increased QHS ORAL Prevent Permanent Aspartate Geodon 60mg Pfizer SS Pfizer ORAL 60MG BID WITH Impairment/Damage Aminotransferase ORAL Increased Lorazepam C Diarrhoea Tylenol C Nausea Cepacol Loz C Vomiting Clotrimazole C Maalox C Milk Of Mag/Cascara C Orajel C Date:05/22/02ISR Number: 3920909-2Report Type:Expedited (15-DaCompany Report #A210725 Age:12 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blindness Transient Health Ziprasidone Po PS ORAL 120.00 MG, Initial or Prolonged Professional TOTAL BID, ORAL Tenex C Date:05/22/02ISR Number: 3920970-5Report Type:Direct Company Report #CTU 168745 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drug Withdrawal Syndrome Geodon 40mg Pfizer PS Pfizer ORAL 40MGS PO Hospitalization - Nervousness ORAL Initial or Prolonged Oedema Mouth Theodur 200 Mgs C Psychomotor Hyperactivity Singulair 10mgs C Sedation Klonopin Up To 2mgs C Tongue Oedema Tremor Date:05/22/02ISR Number: 3922163-4Report Type:Expedited (15-DaCompany Report #A210947 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Health Ziprasidone Po PS ORAL 40.00 MG Initial or Prolonged Depression Professional TOTAL: BID: Parkinsonian Gait ORAL Tremor Lithium SS 300.00 MG TOTAL Haldol SS ORAL 3.00 MG TOTAL: ORAL 22-Feb-2006 08:32 AM Page: 179 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Effexor SS Date:05/22/02ISR Number: 3922259-7Report Type:Expedited (15-DaCompany Report #A211192 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Ziprasidone Po PS Professional Company Representative Date:05/23/02ISR Number: 3920976-6Report Type:Direct Company Report #CTU 168751 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dizziness Geodon PS ORAL 90MG BID ORAL Hospitalization - Electrocardiogram Qt Moban C Initial or Prolonged Corrected Interval Klonopin C Prolonged Celexa C Syncope Ventricular Tachycardia Date:05/23/02ISR Number: 3922250-0Report Type:Expedited (15-DaCompany Report #A203790 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Health Ziprasidone Po PS ORAL 160.00 MG Initial or Prolonged Abnormal Professional TOTAL:BID:ORA Aspartate L Aminotransferase Abnormal Elavil C Blood Alkaline Haldol C Phosphatase Abnormal Valium C Blood Creatinine Prevacid C Increased Ativan C Heart Rate Increased Hyperhidrosis Hypokalaemia Neuroleptic Malignant Syndrome White Blood Cell Count Abnormal Date:05/23/02ISR Number: 3922272-XReport Type:Expedited (15-DaCompany Report #A210707 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Magnesium Decreased Health Ziprasidone Po PS ORAL 40.00 MG Initial or Prolonged Convulsion Professional TOTAL;BID;ORA Neuroleptic Malignant L Syndrome Celexa SS Pneumonia Streptococcal Docusate C Atrovent C 22-Feb-2006 08:32 AM Page: 180 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/28/02ISR Number: 3924289-8Report Type:Expedited (15-DaCompany Report #A206561 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Abnormal Behaviour Health Ziprasidone Po PS 40.00 MG Intervention to Agitation Professional TOTAL:BID Prevent Permanent Akathisia Company Zyprexa SS 20.00 MG Impairment/Damage Athetosis Representative TOTAL:DAILY Bruxism Iron Supplements C Cogwheel Rigidity Headache Medicine C Condition Aggravated Dyskinesia Extrapyramidal Disorder Fatigue Hallucination, Auditory Joint Stiffness Mood Altered Movement Disorder Tardive Dyskinesia Weight Increased Date:05/28/02ISR Number: 3924423-XReport Type:Expedited (15-DaCompany Report #A206394 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Tardive Dyskinesia Health Ziprasidone Po PS ORAL Intervention to Professional Prevent Permanent Impairment/Damage Date:05/28/02ISR Number: 3925881-7Report Type:Periodic Company Report #A116511 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Tremor Health Lithane Tablets PS Initial or Prolonged Professional Ziprasidone SS Ativan (Lorazepam) C Luvox (Fluvoxamine Maleate) C Depakote (Valproate) C Date:05/29/02ISR Number: 3925992-6Report Type:Expedited (15-DaCompany Report #A211183 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Myocardial Infarction Consumer Ziprasidone Po PS ORAL 80.00 MG Initial or Prolonged TOTAL:DAILY:O Required RAL Intervention to Celexa C Prevent Permanent Zyprexa C Impairment/Damage Date:05/29/02ISR Number: 3926436-0Report Type:Direct Company Report #CTU 169196 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Insomnia Geodon 40 Mg Pfizer PS Pfizer ORAL 40 MG BID Thinking Abnormal ORAL 22-Feb-2006 08:32 AM Page: 181 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Asa C Lisinopril C Lovastatin C Metformin C Multivitamin C Perphenazine C Trazodone C Trihexyphenidyl C Date:05/30/02ISR Number: 3927407-0Report Type:Expedited (15-DaCompany Report #A211562 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Ziprasidone Po PS ORAL PO Professional Date:05/30/02ISR Number: 3927408-2Report Type:Expedited (15-DaCompany Report #A211563 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arrhythmia Health Ziprasidone Po PS ORAL ORAL Initial or Prolonged Atherosclerosis Professional Celexa C Required Cardiac Failure Intervention to Myocardial Infarction Prevent Permanent Impairment/Damage Date:05/30/02ISR Number: 3927461-6Report Type:Expedited (15-DaCompany Report #A207489 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Tardive Dyskinesia Health Ziprasidone Po PS ORAL 80.00 MG Intervention to Professional TOTAL:BID:ORA Prevent Permanent L Impairment/Damage Prozac C Topamax C Ativan C Date:05/30/02ISR Number: 3927474-4Report Type:Expedited (15-DaCompany Report #A210352 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Myocardial Infarction Health Ziprasidone Po PS Intervention to Professional Prevent Permanent Impairment/Damage Date:05/30/02ISR Number: 3927477-XReport Type:Expedited (15-DaCompany Report #A208671 Age: Gender: I/FU:F Outcome Hospitalization - Initial or Prolonged Required Intervention to Prevent Permanent 22-Feb-2006 08:32 AM Page: 182 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Neuroleptic Malignant Health Ziprasidone Po PS Syndrome Professional Clozaril C Date:05/30/02ISR Number: 3928028-6Report Type:Expedited (15-DaCompany Report #A206340 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Ziprasidone Po PS ORAL 160.00MG Initial or Prolonged Extrapyramidal Disorder Professional TOTAL: DAILY Required Fatigue Company Intervention to Hypersomnia Representative Prevent Permanent Movement Disorder Impairment/Damage Tardive Dyskinesia Date:05/31/02ISR Number: 3926934-XReport Type:Expedited (15-DaCompany Report #A211941 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Health Ziprasidone Po PS ORAL 120.00 MG Initial or Prolonged Extrapyramidal Disorder Professional TOTAL:BID:ORA Neuroleptic Malignant Company L Syndrome Representative Norvasc C Neurontin C Haldol C Depakote C Combivent C Azmacort C Zyprexa C Nicoderm Patch C Date:06/03/02ISR Number: 3933913-5Report Type:Periodic Company Report #A204446 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Electrocardiogram Qt Health Ziprasidone Po PS Intervention to Prolonged Professional Prevent Permanent Company Impairment/Damage Representative Date:06/03/02ISR Number: 3933914-7Report Type:Periodic Company Report #A0204549 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Health Ziprasidone Po PS ORAL 80.00 MG Initial or Prolonged Professional TOTAL:BID:ORA Required L Intervention to Benadryl SS ORAL ORAL Prevent Permanent Effexor C Impairment/Damage Topamax C 22-Feb-2006 08:32 AM Page: 183 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/03/02ISR Number: 3933915-9Report Type:Periodic Company Report #A206532 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dystonia Health Ziprasidone Po PS ORAL 120.00 MG Intervention to Professional TOTAL:BID:ORA Prevent Permanent L Impairment/Damage Celexa C Adderall C Date:06/03/02ISR Number: 3933916-0Report Type:Periodic Company Report #A207211 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Priapism Health Ziprasidone Po PS ORAL 60.00 Intervention to Professional TOTAL:BID:ORA Prevent Permanent Company L Impairment/Damage Representative Trazodone C Date:06/03/02ISR Number: 3933917-2Report Type:Periodic Company Report #A207274 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Convulsion Health Ziprasidone Po PS ORAL 200.00 Intervention to Intentional Overdose Professional TOTAL:BID:ORA Prevent Permanent Medication Error L Impairment/Damage Date:06/03/02ISR Number: 3933918-4Report Type:Periodic Company Report #A207447 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophreniform Disorder Consumer Ziprasidone Po PS ORAL 80.00 MG Initial or Prolonged Weight Decreased TOTAL:BID:ORA Weight Increased L Date:06/03/02ISR Number: 3933919-6Report Type:Periodic Company Report #A208493 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Health Ziprasidone Po PS ORAL 80.00 MG Initial or Prolonged Hypertonia Professional TOTAL:BID:ORA L Zoloft C Date:06/03/02ISR Number: 3933920-2Report Type:Periodic Company Report #A208953 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Abdominal Pain Health Ziprasidone Po PS ORAL ORAL Intervention to Intentional Overdose Professional Prevent Permanent Impairment/Damage 22-Feb-2006 08:32 AM Page: 184 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/03/02ISR Number: 3933921-4Report Type:Periodic Company Report #A209793 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Choreoathetosis Health Ziprasidone Po PS Intervention to Convulsion Professional Prilosec Prevent Permanent (Omeprazole) C Impairment/Damage Effexor (Venlafaxine) C Clonidine C Depakote (Sodium Valproate) C Keflex (Cephalexin) C Date:06/03/02ISR Number: 3933922-6Report Type:Periodic Company Report #A209916 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Convulsion Health Ziprasidone Po PS ORAL 40.00 MG Intervention to Oedema Peripheral Professional TOTAL:DAILY:O Prevent Permanent RAL Impairment/Damage Celexa (Citalopram) C Loratadine/Pseudoeph edrine C Date:06/03/02ISR Number: 3968401-3Report Type:Periodic Company Report #A209943 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dyspnoea Health Ziprasidone Po PS 80.00 MG Intervention to Electrocardiogram Qt Professional TOTAL:BID: Prevent Permanent Prolonged Dilantin C Impairment/Damage Date:06/03/02ISR Number: 3968404-9Report Type:Periodic Company Report #A210054 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Extrapyramidal Disorder Health Ziprasidone Po PS Intervention to Professional Valproic Acid SS Prevent Permanent Company Impairment/Damage Representative Date:06/03/02ISR Number: 3968408-6Report Type:Periodic Company Report #A200685 Age:15 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Health Ziprasidone Po PS ORAL 20.00 MG Initial or Prolonged Increased Professional TOTAL:BID:ORA Amenorrhoea L Hypercholesterolaemia Zyprexa SS Tremor Tegretol Xr C Vomiting Centrum Vit Weight Decreased Supplement C Caltrate C 22-Feb-2006 08:32 AM Page: 185 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/03/02ISR Number: 3968410-4Report Type:Periodic Company Report #A202642 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Hypokalaemia Health Ziprasidone Po PS ORAL 80.00 MG Intervention to Oedema Professional TOTAL:BID:ORA Prevent Permanent Weight Increased L Impairment/Damage Celebrex C Effexor C Serzone C Buspar C Flexeril C Hydrochlorothiazide C Date:06/04/02ISR Number: 3928297-2Report Type:Expedited (15-DaCompany Report #A211755 Age:84 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Areflexia Foreign Ziprasidone Po PS ORAL 40.00 MG Hospitalization - Cerebrovascular Accident Health TOTAL:DAILY:O Initial or Prolonged Renal Failure Professional RAL Respiratory Failure Company Alprazolam C Representative Mianserine C Clonazepam C Trihexifenidilo C Oxcarbazepine C Date:06/04/02ISR Number: 3929147-0Report Type:Expedited (15-DaCompany Report #A211864 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Depression Consumer Ziprasidone Po PS ORAL 40.00 MG Intervention to Insomnia TOTAL: BID: Prevent Permanent Schizophrenia ORAL Impairment/Damage Somnolence Suicidal Ideation Weight Decreased Date:06/04/02ISR Number: 3929156-1Report Type:Expedited (15-DaCompany Report #A212087 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Hallucination Health Ziprasidone Po PS ORAL 120.00 MG Intervention to Hallucination, Auditory Professional TOTAL: BID: Prevent Permanent Murder Company ORAL Impairment/Damage Representative Motrin C Ativan C Date:06/05/02ISR Number: 3928496-XReport Type:Direct Company Report #CTU 169580 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Geodon 20mg PS ORAL 20MG BID PO, Initial or Prolonged Tunnel Vision 40MG BID PO Vision Blurred Risperdal 1mg Visual Disturbance Janssen SS Janssen ORAL 1MG BID PO Visual Field Defect Wellbutrin C Trazodone C 22-Feb-2006 08:32 AM Page: 186 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lorazepam C Date:06/05/02ISR Number: 3929516-9Report Type:Expedited (15-DaCompany Report #A212012 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Convulsion Health Ziprasidone Po PS Intervention to Drug Withdrawal Syndrome Professional Opiates C Prevent Permanent Benzodiazepine C Impairment/Damage Date:06/05/02ISR Number: 3929517-0Report Type:Expedited (15-DaCompany Report #A211983 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Ziprasidone Po PS Electrocardiogram Qt Professional Corrected Interval Prolonged Date:06/05/02ISR Number: 3929518-2Report Type:Expedited (15-DaCompany Report #A211986 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Ziprasidone Po PS Electrocardiogram Qt Professional Corrected Interval Prolonged Date:06/05/02ISR Number: 3929519-4Report Type:Expedited (15-DaCompany Report #A211993 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Ziprasidone Po PS Electrocardiogram Qt Professional Corrected Interval Prolonged Date:06/05/02ISR Number: 3929520-0Report Type:Expedited (15-DaCompany Report #A211995 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Ziprasidone Po PS Electrocardiogram Qt Professional Corrected Interval Prolonged Date:06/05/02ISR Number: 3929535-2Report Type:Expedited (15-DaCompany Report #A211929 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Health Ziprasidone Po PS Initial or Prolonged Congestive Professional Pneumonia Company Representative 22-Feb-2006 08:32 AM Page: 187 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/06/02ISR Number: 3930712-5Report Type:Expedited (15-DaCompany Report #A211979 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypersensitivity Foreign Ziprasidone Po PS ORAL 80.00 MG Initial or Prolonged Rash Health TOTAL:BID:ORA Professional L Other Seropram (Citalopram) C Date:06/10/02ISR Number: 3931236-1Report Type:Expedited (15-DaCompany Report #A211562 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Ziprasidone Po PS Professional Mellaril C Date:06/10/02ISR Number: 3931503-1Report Type:Expedited (15-DaCompany Report #A200850 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Ziprasidone Po PS ORAL 160.00 MG Hospitalization - Coronary Artery Health TOTAL:BID:ORA Initial or Prolonged Atherosclerosis Professional L Coronary Artery Disease Other Lactulose C Discomfort Tramadol C Dizziness Paracetamol C Drug Toxicity Zopiclone C Epistaxis Remeron C Gastrointestinal Disorder Nozinan C Headache Rivotril C Influenza Oxazepam C Lung Disorder Malaise Nausea Pulmonary Oedema Sensory Disturbance Sudden Death Visual Disturbance Vomiting Weight Decreased Date:06/11/02ISR Number: 3933129-2Report Type:Expedited (15-DaCompany Report #A212658 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Chills Health Ziprasidone Po PS ORAL 40.00 MG Intervention to Dystonia Professional TOTAL: BID: Prevent Permanent Hyperhidrosis ORAL Impairment/Damage Mania Depakote C Multiple Vitamin C Birth Control C 22-Feb-2006 08:32 AM Page: 188 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/11/02ISR Number: 3933133-4Report Type:Expedited (15-DaCompany Report #A212220 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Autoimmune Disorder Health Ziprasidone Po PS Initial or Prolonged Cardiovascular Disorder Professional Deep Vein Thrombosis Haemolytic Anaemia Date:06/11/02ISR Number: 3933136-XReport Type:Expedited (15-DaCompany Report #A211183 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Consumer Ziprasidone Po PS ORAL 80.00 MG Initial or Prolonged Coronary Artery Health TOTAL:DAILY:O Required Atherosclerosis Professional RAL Intervention to Coronary Artery Stenosis Celexa C Prevent Permanent Myocardial Infarction Zyprexa C Impairment/Damage Date:06/11/02ISR Number: 3933167-XReport Type:Expedited (15-DaCompany Report #A210204 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dry Mouth Health Ziprasidone Po PS ORAL 120.00 MG Intervention to Emotional Distress Professional TOTAL:BID:ORA Prevent Permanent Tardive Dyskinesia L Impairment/Damage Effexor Xr C Trazadone C Date:06/17/02ISR Number: 3935450-0Report Type:Expedited (15-DaCompany Report #A213172 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Health Ziprasidone Po PS ORAL 40.00 MG Initial or Prolonged Dizziness Professional TOTAL:BID:ORA Required Dyspnoea L Intervention to Hypoaesthesia Synthroid C Prevent Permanent Paraesthesia Temazepam C Impairment/Damage Lorazepam C Ambien C Prozac C Date:06/17/02ISR Number: 3935597-9Report Type:Expedited (15-DaCompany Report #A212853 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Agitation Literature Ziprasidone Po PS Intervention to Blood Pressure Decreased Health Gabapentin C Prevent Permanent Conduction Disorder Professional Venlafaxine C Impairment/Damage Diarrhoea Metformin C Overdose Rofecoxib C Somnolence Pravastatin C Urinary Retention 22-Feb-2006 08:32 AM Page: 189 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/17/02ISR Number: 3935603-1Report Type:Expedited (15-DaCompany Report #A213244 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Arrhythmia Health Ziprasidone Po PS Intervention to Professional Prevent Permanent Company Impairment/Damage Representative Date:06/17/02ISR Number: 3935604-3Report Type:Expedited (15-DaCompany Report #A213245 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Myocardial Infarction Health Ziprasidone Po PS Intervention to Professional Prevent Permanent Company Impairment/Damage Representative Date:06/18/02ISR Number: 3935681-XReport Type:Expedited (15-DaCompany Report #A212943 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dizziness Health Ziprasidone Po PS 160.00 MG Intervention to Electrocardiogram Qt Professional TOTAL:BID Prevent Permanent Corrected Interval Company Impairment/Damage Prolonged Representative Palpitations Date:06/18/02ISR Number: 3935684-5Report Type:Expedited (15-DaCompany Report #A212019 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Ziprasidone Po PS Initial or Prolonged Mania Professional Depakote C Eskalith C Haldol C Date:06/18/02ISR Number: 3936115-1Report Type:Expedited (15-DaCompany Report #A210352 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cardiac Disorder Health Ziprasidone Po PS Intervention to Myocardial Infarction Professional Prevent Permanent Impairment/Damage Date:06/21/02ISR Number: 3937477-1Report Type:Expedited (15-DaCompany Report #A213355 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiovascular Disorder Health Ziprasidone Po PS Professional Company Representative 22-Feb-2006 08:32 AM Page: 190 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/21/02ISR Number: 3937478-3Report Type:Expedited (15-DaCompany Report #A213257 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Hypertensive Crisis Health Ziprasidone Po PS ORAL 120.00 MG Intervention to Professional TOTAL:BID:ORA Prevent Permanent Company L Impairment/Damage Representative Date:06/21/02ISR Number: 3937501-6Report Type:Expedited (15-DaCompany Report #A213499 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Circulatory Collapse Foreign Ziprasidone Po PS ORAL 40.00 MG Initial or Prolonged Hypotension Health TOTAL:DAILY:O Professional RAL Solian C Date:06/21/02ISR Number: 3937505-3Report Type:Expedited (15-DaCompany Report #A213500 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Ziprasidone Po PS ORAL ORAL Health Risperdal C Professional Date:06/21/02ISR Number: 3937520-XReport Type:Expedited (15-DaCompany Report #A211543 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Urinary Retention Foreign Ziprasidone Po PS ORAL 80.00 MG Initial or Prolonged Health TOTAL:BID:ORA Professional L Date:06/21/02ISR Number: 3937567-3Report Type:Expedited (15-DaCompany Report #A213627 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Ziprasidone Po PS ORAL 160.00 MG Health TOTAL:BID:ORA Professional L Company Representative Date:06/21/02ISR Number: 3937830-6Report Type:Expedited (15-DaCompany Report #A213712 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Health Ziprasidone Po PS ORAL 80.00 MG Initial or Prolonged Electrocardiogram Qt Professional TOTAL, BID Prolonged Luvox SS 25.00 MG TOTAL DAILY 22-Feb-2006 08:32 AM Page: 191 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/21/02ISR Number: 3937873-2Report Type:Expedited (15-DaCompany Report #A210940 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Ventricular Extrasystoles Health Ziprasidone Po PS 160.00 MG Intervention to Professional TOTAL:BID Prevent Permanent Serzone SS ORAL 450.00 MG Impairment/Damage TOTAL:BID:ORA L Date:06/21/02ISR Number: 3937972-5Report Type:Expedited (15-DaCompany Report #A201130 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyponatraemia Health Ziprasidone Po PS BID Initial or Prolonged Professional Date:06/21/02ISR Number: 3937980-4Report Type:Expedited (15-DaCompany Report #A213654 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Health Ziprasidone Po PS ORAL ORAL Initial or Prolonged Abnormal Professional Lorazepam SS ORAL ORAL Electrocardiogram Qrs Company Complex Shortened Representative Electrocardiogram Qt Shortened Myocardial Infarction Overdose Date:06/21/02ISR Number: 3937989-0Report Type:Expedited (15-DaCompany Report #A117982 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Anxiety Health Ziprasidone Po PS ORAL 160.00 MG Intervention to Drug Effect Decreased Professional TOTAL: BID: Prevent Permanent Dyspnoea ORAL Impairment/Damage Fluid Retention Zyprexa (Olanzapine) SS Pulmonary Oedema Celexa (Citalopram) C Respiratory Distress Xanax (Alprazolam) C Date:06/21/02ISR Number: 3938040-9Report Type:Expedited (15-DaCompany Report #A202710 Age:14 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Ziprasidione Po PS ORAL 80.00 MG Initial or Prolonged Gamma-Glutamyltransferase Professional TOTAL:BID:ORA Required Increased L Intervention to Self-Injurious Ideation Tegretol SS 800.00 MG Prevent Permanent TOTAL:BID Impairment/Damage Paxil C Naltrexone C 22-Feb-2006 08:32 AM Page: 192 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/21/02ISR Number: 3938042-2Report Type:Expedited (15-DaCompany Report #A213705 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrioventricular Block Health Ziprasidone Po PS ORAL 20.00 MG Initial or Prolonged Complete Professional TOTAL:DAILY:O Required Bundle Branch Block Left RAL Intervention to Somatoform Disorder Sudafed Prevent Permanent (Pseudoephedrine Impairment/Damage Hydrochloride) SS Multiple Unspecified Medications SS Prozac (Fluoxetine) C Xanax (Alprazolam) C Date:06/21/02ISR Number: 3939288-XReport Type:Expedited (15-DaCompany Report #A200850 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arteriosclerosis Foreign Ziprasidone Po PS ORAL 160.00 MG Hospitalization - Cardiac Arrest Health TOTAL:BID:ORA Initial or Prolonged Completed Suicide Professional L Coronary Artery Disease Other Tramadol SS ORAL ORAL Depression Lactulose C Dizziness Paracetamol C Drug Toxicity Zopiclone C Electrocardiogram Remeron C Abnormal Nozinan C Epistaxis Rivotril C Eye Movement Disorder Oxazepam C Headache Influenza Lung Infiltration Malaise Nausea Pneumonia Pulmonary Oedema Sensory Disturbance Stasis Syndrome Sudden Death Suicidal Ideation Suicide Attempt Visual Disturbance Vomiting Date:06/24/02ISR Number: 3937918-XReport Type:Direct Company Report #CTU 170787 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Geodon PS SEE IMAGE Insomnia Clonazepam C Medication Error Effexor Xr C Sedation Aspirin C 22-Feb-2006 08:32 AM Page: 193 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/24/02ISR Number: 3938788-6Report Type:Expedited (15-DaCompany Report #001-0945-M0200726 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accident Consumer Neurontin Agitation (Gabapentin) PS ORAL PER ORAL Anxiety Sertraline Condition Aggravated Hydrochloride SS ORAL 50 MG Confusional State (DAILY), PER Depression ORAL Diarrhoea Ziprasidone Eating Disorder Symptom Hydrochloride SS ORAL 20 MG Fear (DAILY), PER Feeling Hot And Cold ORAL Headache Topiramate SS ORAL 25 MG Increased Appetite (DAILY), PER Insomnia ORAL Memory Impairment Verapamil C Nervousness Furosemide C Obsessive-Compulsive Estropipate C Disorder Estradiol C Panic Disorder Estradiol C Paraesthesia Clonazepam C Pruritus Psoriasis Tremor Weight Increased Date:06/26/02ISR Number: 3940882-0Report Type:Direct Company Report #CTU 171017 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Frequent Bowel Movements Geodon PS 80MG Disability Grimacing Prozac SS 60MG Other Heart Rate Increased Muscle Rigidity Tic Tremor Date:06/27/02ISR Number: 3943285-8Report Type:Periodic Company Report #A202987 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Drug Ineffective Health Zoloft Tablets PS 200.00 MG Intervention to Thrombocytopenia Professional TOTAL:DAILY Prevent Permanent Geodon SS ORAL 40.00 MG Impairment/Damage TOTAL:BID:ORA L Date:07/01/02ISR Number: 3942932-4Report Type:Expedited (15-DaCompany Report #A213993 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyspnoea Foreign Ziprasidone Initial or Prolonged Eye Movement Disorder Consumer (Ziprasidone) PS ORAL 40 MG Tremor (DAILY), ORAL Clonazepam C Risperidone C 22-Feb-2006 08:32 AM Page: 194 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/01/02ISR Number: 3942941-5Report Type:Expedited (15-DaCompany Report #A208704 Age:23 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Ziprasidone Initial or Prolonged Delirium Health (Ziprasidone ) PS ORAL 160 MG Hallucination Professional (DAILY), ORAL Libido Increased Risperidone (Risperidone) C Date:07/01/02ISR Number: 3942976-2Report Type:Expedited (15-DaCompany Report #A210286 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyspnoea Foreign Ziprasidone Initial or Prolonged Fatigue Health (Ziprasidone) PS 80 MG (BID) Neuroleptic Malignant Professional Syndrome Suffocation Feeling Throat Tightness Date:07/01/02ISR Number: 3943128-2Report Type:Expedited (15-DaCompany Report #2002000709 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Geodon (Ziprasidone) PS ORAL 80 MG (BID), Initial or Prolonged Erectile Dysfunction Professional ORAL Psychotic Disorder Alcohol SS ORAL ORAL Sexual Dysfunction Haldol (Haloperidol) C Date:07/01/02ISR Number: 3943431-6Report Type:Expedited (15-DaCompany Report #A213627 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Foreign Geodon (Ziprasidone) PS ORAL 160 MG (BID) Consumer ORAL Health Professional Company Representative Date:07/03/02ISR Number: 3943578-4Report Type:Direct Company Report #CTU 171593 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Respiratory Geodon 40mg Pfizer PS Pfizer 40MG PID Distress Syndrome Bronchitis Oxygen Saturation Decreased Pneumonia Serum Serotonin Increased Weight Decreased 22-Feb-2006 08:32 AM Page: 195 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/03/02ISR Number: 3944164-2Report Type:Expedited (15-DaCompany Report #A214070 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Consumer Ziprasidone Initial or Prolonged (Ziprasidone) PS Date:07/03/02ISR Number: 3944165-4Report Type:Expedited (15-DaCompany Report #A214071 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Economic Problem Consumer Ziprasidone Initial or Prolonged (Ziprasidone) PS Date:07/03/02ISR Number: 3944168-XReport Type:Expedited (15-DaCompany Report #A214072 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Consumer Ziprasidone Initial or Prolonged (Ziprasidone) PS Date:07/03/02ISR Number: 3944172-1Report Type:Expedited (15-DaCompany Report #A214066 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicide Attempt Consumer Ziprasidone Initial or Prolonged (Ziprasidone) PS Date:07/03/02ISR Number: 3944890-5Report Type:Expedited (15-DaCompany Report #2002000274 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Ziprasidone Initial or Prolonged Syndrome Professional (Ziprasidone) PS ORAL 200 MG (BID), Other ORAL Over The Counter Caffeine Products C Over The Counter Sleeping Pills With Diphenhydramine C Date:07/03/02ISR Number: 3944942-XReport Type:Expedited (15-DaCompany Report #2002000272 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicidal Ideation Consumer Geodon (Ziprasidone) PS ORAL 160 (BID), Initial or Prolonged ORAL Date:07/03/02ISR Number: 3944945-5Report Type:Expedited (15-DaCompany Report #2002000275 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pharyngeal Oedema Health Geodon (Ziprasidone) PS Tongue Oedema Professional Company Representative 22-Feb-2006 08:32 AM Page: 196 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/03/02ISR Number: 3945032-2Report Type:Expedited (15-DaCompany Report #A214068 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arthritis Consumer Ziprasidone Initial or Prolonged Depression (Ziprasidone) PS ORAL ORAL Drug Effect Decreased Tegretol Liver Function Test (Carbamazepine) C Abnormal Corgard (Valproate Osteoporosis Semisodium) C Psychotic Disorder Anafranil (Clomipramine Hydrochloride) C Vistaril (Hydroxyzine Embonate) C Donnatal (Donnatal) C Klonopin (Clonazepam) C Date:07/05/02ISR Number: 3944491-9Report Type:Expedited (15-DaCompany Report #2002000712 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukocytoclastic Foreign Geodon (Ziprasidone) PS Initial or Prolonged Vasculitis Health Professional Date:07/05/02ISR Number: 3945557-XReport Type:Expedited (15-DaCompany Report #A205773 Age:11 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chest Discomfort Health Ziprasidone Dyspnoea Professional (Ziprasidone) PS ORAL 20 MG ORAL Urticaria Company Venlafaxine C Representative Clonazepam C Risperidone C Date:07/05/02ISR Number: 3945884-6Report Type:Expedited (15-DaCompany Report #A210725 Age:12 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Visual Disturbance Consumer Geodon (Ziprasidone) PS ORAL 120 MG (BID), Initial or Prolonged Health ORAL Professional Tenex (Guanfacine Hydrochloride) C Date:07/05/02ISR Number: 3946231-6Report Type:Expedited (15-DaCompany Report #2002000701 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Foreign Ziprasidone Blood Pressure Increased Health (Ziprasidone) PS ORAL 80 MG (BID), Heart Rate Increased Professional ORAL 2 WK Hyperhidrosis Olanzapine C Muscle Rigidity Pyrexia Weight Increased 22-Feb-2006 08:32 AM Page: 197 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/05/02ISR Number: 3946251-1Report Type:Expedited (15-DaCompany Report #2002000762 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Embolism Foreign Ziprasidone Sedation Health (Ziprasidone) PS ORAL BID, ORAL Professional Clozapine C Company Pirenzepine C Representative Acetylsalicylic Acid C Date:07/05/02ISR Number: 3946335-8Report Type:Expedited (15-DaCompany Report #A213993 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Eye Disorder Foreign Ziprasidone Initial or Prolonged Movement Disorder Consumer (Zoprasidone) PS ORAL 40 MG Pneumonia (DAILY), ORAL Clonazepam C Risperidone C Date:07/10/02ISR Number: 3947842-4Report Type:Expedited (15-DaCompany Report #A213355 Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atherosclerosis Health Geodon (Ziprasidone Cardiovascular Disorder Professional Hydrochloride) PS ORAL BID, ORAL Drug Level Increased Company Amitriptyline Representative Hydrochloride C Ssri C Date:07/10/02ISR Number: 3947843-6Report Type:Expedited (15-DaCompany Report #2002000734 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Health Geodon (Ziprasidone) PS Syndrome Professional Risperdal Company (Risperidone) SS Representative Date:07/10/02ISR Number: 3947991-0Report Type:Expedited (15-DaCompany Report #A213500 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zeldox (Ziprasidone) PS ORAL 160 MG Health (DAILY), ORAL Professional Risperdal (Risperidone) C Date:07/11/02ISR Number: 3949020-1Report Type:Expedited (15-DaCompany Report #2002000839 Age:7 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Effect Decreased Consumer Ziprasidone Initial or Prolonged Sedation (Ziprasidone) PS ORAL 20 MG Sluggishness (DAILY), ORAL Paxil (Paroxetine Hydrochloride) C 22-Feb-2006 08:32 AM Page: 198 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/11/02ISR Number: 3949022-5Report Type:Expedited (15-DaCompany Report #A213355 Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiovascular Disorder Health Geodon (Ziprasidone Professional Hydrochloride) PS ORAL 160 MG (BID), Company ORAL Representative Amitriptyline Hydrochloride C Ssri C Date:07/12/02ISR Number: 3948891-2Report Type:Expedited (15-DaCompany Report #A213705 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Atrioventricular Block Health Ziprasidone Hospitalization - Complete Professional (Ziprasidone) PS ORAL 20 MG DAILY Initial or Prolonged ORAL Required Sudafed Intervention to (Pseudoephedrine Prevent Permanent Hydrochloride) Impairment/Damage (Pseudoephedrine) SS Multiple Unspecified Medications (All Other Therapeutic Products) SS Prozac (Fluoxetine) (Fluoxetine Hydrochloride) SS ORAL 80 MG DAILY, ORAL Xanax (Alprazolam) (Alprazolam) C Date:07/12/02ISR Number: 3948948-6Report Type:Expedited (15-DaCompany Report #A210725 Age:12 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blindness Transient Consumer Geodon (Ziprasidone) PS ORAL 120 MG (BID), Initial or Prolonged Health ORAL Professional Tenex (Guanfacine Hydrochloride) C Date:07/12/02ISR Number: 3949037-7Report Type:Expedited (15-DaCompany Report #2002000914 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Electrocardiogram Qt Health Ziprasidone Prolonged Professional (Ziprasidone) PS Company Representative Date:07/16/02ISR Number: 3950033-4Report Type:Expedited (15-DaCompany Report #2002000481 Age: Gender:Male I/FU:I Outcome PT Report Source Hospitalization - Electrocardiogram Qt Health Initial or Prolonged Corrected Interval Professional Other Prolonged Company 22-Feb-2006 08:32 AM Page: 199 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Representative Product Role Manufacturer Route Dose Duration Geodon (Ziprasidone) PS ORAL ORAL Citalopram (Citalopram) C Date:07/16/02ISR Number: 3950143-1Report Type:Expedited (15-DaCompany Report #2002001242 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pharyngeal Oedema Health Geodon (Ziprasidone) PS ORAL 20 MG (DAILY) Professional ORAL Fluoxetine C Trazodone C Zyrtec (Cetirizine Hydrochloride) C Dicyclomine Hydrochloride C Date:07/17/02ISR Number: 3950337-5Report Type:Expedited (15-DaCompany Report #A200850 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arteriosclerosis Foreign Ziprasidone Hospitalization - Atherosclerosis Health (Ziprasidone) PS ORAL 160 MG (BID), Initial or Prolonged Cardiac Arrest Professional ORAL Completed Suicide Tramadol (Tramadol) SS ORAL ORAL Dizziness Lactulose Drug Toxicity (Lactulose) C Epistaxis Paracetamol Gastrointestinal Disorder (Paracetamol) C Headache Zopiclone Hepatic Steatosis (Zopiclone) C Influenza Remeron Malaise (Mirtazapine) C Nausea Nozinan Pneumonia (Levomepromazine) C Pulmonary Oedema Rivotril Sensory Loss (Clonazepam) C Sudden Death Oxazepam (Oxazepam) C Toxicologic Test Abnormal Visual Disturbance Vomiting Date:07/17/02ISR Number: 3950442-3Report Type:Expedited (15-DaCompany Report #2002001644 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Foreign Geodon (Ziprasidone) PS ORAL 160 MG Initial or Prolonged Suicidal Ideation Health (DAILY), ORAL Professional Venlafaxine Hydrochloride C Lorazepam C 22-Feb-2006 08:32 AM Page: 200 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/17/02ISR Number: 3950447-2Report Type:Expedited (15-DaCompany Report #2002001136 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Angioneurotic Oedema Foreign Zeldox(Ziprasidone) PS ORAL 120 Initial or Prolonged Rash Health MG(UNKNOWN), Other Urticaria Professional ORAL Company Edronax(Reboxetine) C Representative Date:07/17/02ISR Number: 3950676-8Report Type:Expedited (15-DaCompany Report #A211562 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death No Adverse Drug Effect Health Ziprasidone Professional (Ziprasidone) PS Mellaril (Thioridazine Hydrochloride) C Date:07/17/02ISR Number: 3950680-XReport Type:Expedited (15-DaCompany Report #A211183 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Consumer Geodon (Ziprasidone) PS ORAL 80 MG Initial or Prolonged Atherosclerosis Health (DAILY), ORAL Required Cardiac Failure Professional Atenolol C Intervention to Coronary Artery Stenosis Hydrochlorothiazide C Prevent Permanent Myocardial Infarction Zyprexa (Olanzapine) C Impairment/Damage Celexa (Citalopram Hydrobromide) C Date:07/17/02ISR Number: 3950699-9Report Type:Expedited (15-DaCompany Report #2002001121 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cognitive Disorder Foreign Geodon (Ziprasidone) PS ORAL 80 MG Initial or Prolonged Condition Aggravated Health (DAILY), ORAL Delusional Disorder, Professional Unspecified Type Date:07/17/02ISR Number: 3950738-5Report Type:Expedited (15-DaCompany Report #2002001133 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia Foreign Ziprasidone Initial or Prolonged Health (Ziprasidone) PS ORAL (DAILY), ORAL Professional Company Representative Date:07/17/02ISR Number: 3950926-8Report Type:Expedited (15-DaCompany Report #2002001123 Age: Gender: I/FU:I Outcome PT Report Source Other Tardive Dyskinesia Health Professional 22-Feb-2006 08:32 AM Page: 201 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company Representative Product Role Manufacturer Route Dose Duration Geodon (Ziprasidone) PS Date:07/17/02ISR Number: 3950927-XReport Type:Expedited (15-DaCompany Report #2002001122 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Health Geodon (Ziprasidone) PS Professional Company Representative Date:07/17/02ISR Number: 3950930-XReport Type:Expedited (15-DaCompany Report #2002001124 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperhidrosis Health Geodon (Ziprasidone) PS Ventricular Tachycardia Professional Company Representative Date:07/18/02ISR Number: 3951100-1Report Type:Expedited (15-DaCompany Report #2002001509 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebral Ischaemia Consumer Ziprasidone (Ziprasidone) PS ORAL 80 MG (TWICE A DAY), ORAL Clonazepam C Date:07/18/02ISR Number: 3951578-3Report Type:Expedited (15-DaCompany Report #2002001403 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gastrooesophageal Reflux Health Geodon (Ziprasidone) PS ORAL ORAL Disease Professional Lithane (Lithium) SS Tardive Dyskinesia Antipsychotics (Antipsychotics) SS Cogentin (Benzatropine Mesilate) C Neuronitn (Gabapentin) C Docusate C Date:07/23/02ISR Number: 3952937-5Report Type:Expedited (15-DaCompany Report #A213627 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Foreign Geodon (Ziprasidone) PS ORAL 160 MG (BID), Health ORAL Professional Clomipramine Company Hydrochloride SS ORAL 150 MG Representative (DAILY), ORAL 22-Feb-2006 08:32 AM Page: 202 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/23/02ISR Number: 3952945-4Report Type:Expedited (15-DaCompany Report #2002001603 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Embolism Foreign Ziprasidone Hospitalization - Respiratory Arrest Health (Ziprasidone) PS ORAL 80 MG (TWICE Initial or Prolonged Professional A DAY), ORAL Clavulin C Olanzapine C Date:07/23/02ISR Number: 3952962-4Report Type:Expedited (15-DaCompany Report #2002000712 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Geodon (Ziprasidone) PS ORAL 120 MG, ORAL Initial or Prolonged Increased Health Blood Cholesterol Professional Increased Blood Triglycerides Increased Gamma-Glutamyltransferase Increased Leukocytoclastic Vasculitis Low Density Lipoprotein Increased Date:07/23/02ISR Number: 3952990-9Report Type:Expedited (15-DaCompany Report #2002000952 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Urticaria Foreign Ziprasidone Initial or Prolonged Study (Ziprasidone) PS ORAL 120 MG (BID), Health ORAL Professional Date:07/23/02ISR Number: 3953017-5Report Type:Expedited (15-DaCompany Report #2002000762 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Conjunctivitis Foreign Zeldox (Ziprasidone) PS ORAL (BID), ORAL Deep Vein Thrombosis Health Leponex (Clozapine) C Exophthalmos Professional Ass (Acetylsalicylic Haematocrit Increased Company Acid) C Pulmonary Embolism Representative Pirenzepine C Sedation Zyprexa (Olanzapine) C Shunt Occlusion Date:07/24/02ISR Number: 3952841-2Report Type:Direct Company Report #CTU 172864 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypoaesthesia Geodon 80mg Caps (Pfizer) PS Pfizer 80MG BY MOUTH AT NIGHT Klonopin C Ees C Gabitril C 22-Feb-2006 08:32 AM Page: 203 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/24/02ISR Number: 3952911-9Report Type:Direct Company Report #CTU 172885 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Affective Disorder Ziprasidone (Geodon) Initial or Prolonged Agitation 40mg PS ORAL 40MG PO BID Akathisia Seroquel C Condition Aggravated Prevacid C Depression Lamictal C Fatigue Synthroid C Insomnia Xanax C Septra Ds C Date:07/24/02ISR Number: 3952916-8Report Type:Direct Company Report #CTU 172887 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Rash Geodon PS 20MG Q AM Initial or Prolonged ,40MG QHS Lamictal SS ORAL 200MG BID PO Date:07/24/02ISR Number: 3955181-0Report Type:Expedited (15-DaCompany Report #2002000914 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Ziprasidone Electrocardiogram Qt Professional (Ziprasidone) PS Prolonged Company Representative Date:07/25/02ISR Number: 3954032-8Report Type:Expedited (15-DaCompany Report #2002001133 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia Foreign Ziprasidone(Ziprasid Initial or Prolonged Health one) PS ORAL 40 MG Professional (DAILY), ORAL Company Representative Date:07/25/02ISR Number: 3954283-2Report Type:Direct Company Report #CTU 172976 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Clozapine (Clozaril) PS ORAL 400MG PO QHS Initial or Prolonged Neuroleptic Malignant PRIOR TO Syndrome ADMIT Psychotic Disorder Ziprasidone (Geodon) SS ORAL 60MG PO BID Pyrexia Valproic Acid (Depakote) C Oxcarbazepine (Trileptal) C Sertraline (Zoloft) C Clomipramine (Nafranil) C Benztropine (Cogentin) C Corgard C 22-Feb-2006 08:32 AM Page: 204 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ditropan C Lisinopril C Synthroid C Phenytoin (Dilantin) C Date:07/25/02ISR Number: 3954335-7Report Type:Expedited (15-DaCompany Report #2002001870 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Coagulopathy Health Geodon (Ziprasidone) PS ORAL ORAL Contusion Professional Neoplasm Malignant Company Representative Date:07/29/02ISR Number: 3955052-XReport Type:Direct Company Report #CTU 173115 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Salivary Hypersecretion Geodon PS ORAL 80MG PO BID Clozaril SS ORAL 225MG PO QAM AND 250MG PO HS Clozaril SS Date:07/30/02ISR Number: 3955535-2Report Type:Direct Company Report #CTU 173176 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Geodon PS 60 MG 2X / Movement Disorder DAY Musculoskeletal Stiffness Accupril C Restlessness Pindolol C Prilosec C Sonata C Date:07/30/02ISR Number: 3955548-0Report Type:Direct Company Report #CTU 173177 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Bradycardia Geodon (Ziprasidone) PS ORAL 20 MG PO BID Hospitalization - Initial or Prolonged Date:07/30/02ISR Number: 3955998-2Report Type:Expedited (15-DaCompany Report #2002002021 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Health Geodon Cardiac Disorder Professional (Ziprasidone) PS ORAL ORAL Cardiac Failure Clozaril (Clozapine) SS ORAL ORAL Congestive Haldol (Haloperidol) C Cardiomegaly Cogentin Dyskinesia (Benztropine) C Dyspnoea Tachycardia Thinking Abnormal 22-Feb-2006 08:32 AM Page: 205 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/30/02ISR Number: 3956510-4Report Type:Expedited (15-DaCompany Report #2002000481 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Health Geodon (Ziprasidone) PS ORAL 80 MG (BID), Initial or Prolonged Corrected Interval Professional ORAL Other Prolonged Company Citalopram Electrocardiogram Qt Representative (Citalopram) C Prolonged Celexia (Citalopram Electrocardiogram T Wave Hydrobromide) C Abnormal Nexium Transient Ischaemic (Esomeprazole) C Attack Norvasc (Amlodipine Ventricular Extrasystoles Besilate) C Lipitor (Atorvastatin) C Atenolol (Atenolol) C Date:07/30/02ISR Number: 3956736-XReport Type:Expedited (15-DaCompany Report #2002000762 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Conjunctivitis Foreign Zeldox (Ziprasidone) PS ORAL 120 MG, Other Deep Vein Thrombosis Health (BID), ORAL Exophthalmos Professional Leponex (Clozapine) C Haematocrit Increased Company Ass (Acetylalicylic Medication Error Representative Acid) C Pulmonary Embolism Pirenzepine C Salivary Hypersecretion Zyprexa (Olanzapine) C Sedation Shunt Occlusion Date:07/30/02ISR Number: 3957135-7Report Type:Expedited (15-DaCompany Report #FLUV00202001320 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Health Luvox (Fluvoxamine Electrocardiogram Qt Professional Maleate) PS ORAL 25 MG QD PO, Prolonged 25 MG BID PO, 75 MG DAILY PO Geodon (Ziprasidone Hcl) SS ORAL 40 MG BID, PO, 40 MG QD PO Date:07/31/02ISR Number: 3957096-0Report Type:Expedited (15-DaCompany Report #2002002029 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Fatigue Foreign Ziprasidone Hospitalization - Muscle Rigidity Health (Ziprasidone) PS ORAL 80 MG (BID), Initial or Prolonged Tongue Disorder Professional ORAL Sertraline C 22-Feb-2006 08:32 AM Page: 206 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/31/02ISR Number: 3957121-7Report Type:Expedited (15-DaCompany Report #2002002139 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Asthenia Foreign Zeldox (Ziprasidone) PS ORAL 160 MG (BID), Hospitalization - Blood Pressure Increased Health ORAL Initial or Prolonged Body Temperature Professional Atorvastatin C Increased Magnesium C Cardiac Arrest Oxazepam C Choking Depressed Level Of Consciousness Drooling Dyskinesia Faecal Incontinence Hallucination Head Injury Loss Of Consciousness Muscle Twitching Paraesthesia Respiratory Failure Urinary Incontinence Vomiting Weight Increased Date:08/01/02ISR Number: 3956848-0Report Type:Direct Company Report #CTU 173381 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Urinary Retention Geodon (Ziprasdone) PS ORAL 80MG PO BID Required Citalopram C Intervention to Rabeprazole C Prevent Permanent Tamsulosin (Glomax) C Impairment/Damage Date:08/01/02ISR Number: 3958249-8Report Type:Expedited (15-DaCompany Report #2002002244 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Murder Health Geodon (Ziprasidone) PS Professional Company Representative Date:08/01/02ISR Number: 3958337-6Report Type:Expedited (15-DaCompany Report #2002002454 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bipolar I Disorder Consumer Ziprasidone Initial or Prolonged Bruxism (Ziprasidone) PS ORAL 80 MG (DAILY) Condition Aggravated ORAL Dyskinesia Lamotrigine C Rhinorrhoea Lithium Carbonate C Clonazepam C Oxcarbazepine C Levothyroxine Sodium C 22-Feb-2006 08:32 AM Page: 207 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/01/02ISR Number: 3958436-9Report Type:Expedited (15-DaCompany Report #A213705 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Atrioventricular Block Health Geodon (Ziprasidone) PS ORAL 20 MG Hospitalization - Complete Professional (DAILY), ORAL Initial or Prolonged Blood Pressure Increased Sudafed Other Bundle Branch Block Left (Pseudoephedrine Required Chest Pain Hydrochloride) SS Intervention to Dyspnoea Multiple Unspecified Prevent Permanent Electrocardiogram Qt Medications (All Impairment/Damage Corrected Interval Other Therapeutic Prolonged Products) SS Fatigue Prozac (Fluoxetine) SS ORAL 80 MG Syncope (DAILY), ORAL Provigil (Modafinil) SS Xanax (Alprazolam) C Date:08/02/02ISR Number: 3957691-9Report Type:Direct Company Report #CTU 173437 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Electrocardiogram Qt Ziprasidone 80 Mg Intervention to Corrected Interval (Pfizer) PS Pfizer ORAL 80 MG PO BID Prevent Permanent Prolonged Impairment/Damage Date:08/06/02ISR Number: 3959145-2Report Type:Expedited (15-DaCompany Report #2002002637 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drug Interaction Foreign Zeldox (Ziprasidone) PS ORAL 80 MG (BID), Hospitalization - Dysarthria Health ORAL Initial or Prolonged Dystonia Professional Seroquel (Quetiapine Opisthotonus Fumarate) SS ORAL 250 MG Respiratory Depression (DAILY), ORAL Tremor Date:08/06/02ISR Number: 3959146-4Report Type:Expedited (15-DaCompany Report #A213993 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anuria Foreign Ziprasidone Hospitalization - Difficulty In Walking Consumer (Ziprasidone) PS ORAL 40 MG Initial or Prolonged Dyspnoea (DAILY), ORAL Eye Movement Disorder Clonazepam C Musculoskeletal Disorder Risperidone C Pneumonia Tremor Date:08/06/02ISR Number: 3959147-6Report Type:Expedited (15-DaCompany Report #2002002489 Age: Gender:Male I/FU:I Outcome PT Report Source Other Suicide Attempt Foreign Health Professional Company 22-Feb-2006 08:32 AM Page: 208 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Representative Product Role Manufacturer Route Dose Duration Ziprasidone (Ziprasidone) PS ORAL ORAL Date:08/06/02ISR Number: 3959332-3Report Type:Expedited (15-DaCompany Report #A213627 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Geodon Health (Ziprasidone) PS ORAL 160 MG (BID), Professional ORAL Company Clomipramine Representative Hydrochloride SS ORAL 150 MG(DAILY), ORAL Date:08/06/02ISR Number: 3959343-8Report Type:Expedited (15-DaCompany Report #2002002496 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Suicide Attempt Foreign Geodon (Ziprasidone) PS ORAL ORAL Health Professional Company Representative Date:08/06/02ISR Number: 3960196-2Report Type:Expedited (15-DaCompany Report #A209943 Age:24 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dyspnoea Health Ziprasidone Intervention to Electrocardiogram Professional (Ziprasidone) PS 80 MG (BID) Prevent Permanent Abnormal Dilantin (Phenytoin Impairment/Damage Electrocardiogram Qt Sodium) C Corrected Interval Prolonged Electrocardiogram T Wave Amplitude Decreased Sinus Arrhythmia Date:08/08/02ISR Number: 3960850-2Report Type:Expedited (15-DaCompany Report #2002001509 Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebral Ischaemia Consumer Geodon (Ziprasidone) PS ORAL 80 MG (TWICE Fatigue Health A DAY), ORAL Hallucination, Auditory Professional Clonazepam C Insomnia Mood Swings Nuclear Magnetic Resonance Imaging Brain Abnormal 22-Feb-2006 08:32 AM Page: 209 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/08/02ISR Number: 3960909-XReport Type:Expedited (15-DaCompany Report #2002000451 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Deep Vein Thrombosis Health Geodon (Ziprasidone) PS ORAL 80 MG (BID) Intervention to Drug Effect Decreased Professional ORAL Prevent Permanent Citalopram Impairment/Damage Hydrobromide C Topiramate C Quetiapine C Unknown Other Medications C Date:08/08/02ISR Number: 3960911-8Report Type:Expedited (15-DaCompany Report #2002002886 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Laryngeal Oedema Health Geodon (Ziprasidone) PS Tongue Oedema Professional Company Representative Date:08/08/02ISR Number: 3961168-4Report Type:Expedited (15-DaCompany Report #2002002581 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Malaise Foreign Geodon (Ziprasidone) PS ORAL 40 MG (BID), Initial or Prolonged Sensation Of Heaviness Health ORAL Somnolence Professional Risperidone C Company Clonazepam C Representative Date:08/08/02ISR Number: 3961316-6Report Type:Expedited (15-DaCompany Report #2002001603 Age:61 YR Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Condition Aggravated Foreign Ziprasidone Hospitalization - Febrile Infection Health (Ziprasidone) PS ORAL 80 MG (TWICE Initial or Prolonged Hallucination, Auditory Professional A DAY), ORAL Hypotension Madopar C Pulmonary Embolism Clavulin C Respiratory Arrest Olanzapine C Nulytely C Haloperidol C Temazepam C Lorazepam C Cabergoline C Date:08/09/02ISR Number: 3960632-1Report Type:Direct Company Report #CTU 173905 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Electrocardiogram Geodon 80 Mg Bid PS 80 MG BID 2 MON Abnormal Tachycardia 22-Feb-2006 08:32 AM Page: 210 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/09/02ISR Number: 3961582-7Report Type:Expedited (15-DaCompany Report #2002001242 Age:14 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Pharyngeal Oedema Health Geodon (Ziprasidone) PS ORAL 20 MG Other Throat Tightness Professional (DAILY), ORAL Vomiting Fluoxetine C Wheezing Trazodone C Zyrtec (Cetirizine Hydrochloride) C Dicyclomine Hydrochloride C Date:08/09/02ISR Number: 3961584-0Report Type:Expedited (15-DaCompany Report #A213654 Age:33 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Health Geodon (Ziprasidone) PS ORAL ORAL Initial or Prolonged Somnolence Professional Lorazepam (Lorazepam) SS ORAL ORAL Date:08/09/02ISR Number: 3962071-6Report Type:Expedited (15-DaCompany Report #2002003066 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Geodon (Ziprasidone) PS 160 MG (BID), Professional Company Representative Date:08/13/02ISR Number: 3963287-5Report Type:Expedited (15-DaCompany Report #2002000669 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Consumer Geodon (Ziprasidone) PS ORAL ORAL Amnesia Health Venlafaxine Anger Professional Hydrochloride C Condition Aggravated Insomnia Intentional Self-Injury Physical Assault Date:08/14/02ISR Number: 3962109-6Report Type:Direct Company Report #CTU 174135 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Muscle Spasms Geodon (Ziprasidone) PS ORAL PO Vomiting Date:08/14/02ISR Number: 3962296-XReport Type:Direct Company Report #CTU 174061 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Geodon PS Initial or Prolonged 22-Feb-2006 08:32 AM Page: 211 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/14/02ISR Number: 3962306-XReport Type:Direct Company Report #CTU 174073 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Ventricular Tachycardia Geodon 20mg Pfizer Intervention to Pharmaceuticals PS Pfizer Prevent Permanent Pharmaceuticals ORAL 40MG BID ORAL Impairment/Damage Date:08/15/02ISR Number: 3962508-2Report Type:Direct Company Report #CTU 174183 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Erection Increased Geodon (Ziprasidone) 40 Mg Bid PS ORAL 40MG PO BID 3 MON Date:08/15/02ISR Number: 3963862-8Report Type:Expedited (15-DaCompany Report #2002003428 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bruxism Health Geodon (Ziprasidone) PS ORAL 80 MG (BID) Initial or Prolonged Professional ORAL Paxil (Paroxetine Hydrochloride) C Lithobid (Lithium Carbonate) C Date:08/15/02ISR Number: 3964230-5Report Type:Expedited (15-DaCompany Report #2002003448 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Zeldox (Ziprasidone) PS ORAL 160 MG, ORAL Weight Increased Health Insulin C Professional Risperidone C Date:08/19/02ISR Number: 3964179-8Report Type:Direct Company Report #CTU 174515 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Muscle Rigidity Geodon Pfizer , Inc PS Pfizer, Inc ORAL 80MG BID Initial or Prolonged ORAL Lithium SS ORAL 600MG BID ORAL Depakote C Klonopin C Cogentin C Propranolol C Amaryl C Levoxyl C Copaxone C Gluophage C 22-Feb-2006 08:32 AM Page: 212 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/19/02ISR Number: 3964684-4Report Type:Expedited (15-DaCompany Report #2002000481 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Health Geodon (Ziprasidone) PS ORAL 80 MG (BID) , Initial or Prolonged Corrected Interval Professional ORAL Other Prolonged Company Citalopram Electrocardiogram Qt Representative (Citalopram) C Prolonged Celexia (Citalopram Electrocardiogram T Wave Hydrobromide) C Abnormal Nexium Transient Ischaemic (Esomeprazole) C Attack Norvasc (Amlodipine Ventricular Extrasystoles Besilate) C Lipitor (Atorvastatin) C Atenolol (Atenolol) C Date:08/19/02ISR Number: 3964686-8Report Type:Expedited (15-DaCompany Report #2002000262 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrioventricular Block Health Geodon (Ziprasidone) PS Initial or Prolonged Cardiac Failure Professional Fluoxetine Other Congestive Company Hydrochloride C Representative Date:08/19/02ISR Number: 3964773-4Report Type:Expedited (15-DaCompany Report #2002003272 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Vomiting Health Geodon (Ziprasidone) PS ORAL ORAL Professional Company Representative Date:08/20/02ISR Number: 3964479-1Report Type:Direct Company Report #CTU 174597 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tongue Disorder Geodon 40 Mg Pfizer PS Pfizer ORAL 40MG BID ORAL Paroxetine C Trazodone C Divalproex C Asa C Isdn C Metoprolol C Ranitidine C Simvastatin C Terazosin C Ntg Sl C Date:08/20/02ISR Number: 3965813-9Report Type:Expedited (15-DaCompany Report #A212234 Age:32 YR Gender:Female I/FU:F Outcome PT Hospitalization - Anal Sphincter Atony Initial or Prolonged Bladder Sphincter Atony 22-Feb-2006 08:32 AM Page: 213 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Muscle Rigidity Neuroleptic Malignant Syndrome Report Source Product Role Manufacturer Route Dose Duration Foreign Geodon (Ziprasidone) PS ORAL 40 MG Consumer (DAILY), ORAL Company Clozapine Representative (Clozapine) C Date:08/21/02ISR Number: 3965296-9Report Type:Direct Company Report #CTU 174717 Age:84 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Urinary Retention Geodon 80mg Pfizer PS Pfizer ORAL 80MG BID PO Intervention to Tylenol C Prevent Permanent Metamucil C Impairment/Damage Lorazepam C Nystatin Swish & Shallow C Remeron C Prevacid C Lactulose C Zoloft C Date:08/23/02ISR Number: 3967179-7Report Type:Expedited (15-DaCompany Report #2002003870 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Akathisia Health Lithium PS ORAL ORAL Professional Ziprasidone SS ORAL 40 MG (BID), ORAL Verapamil C Synthroid (Levothyroxine Sodium) C Date:08/23/02ISR Number: 3967368-1Report Type:Expedited (15-DaCompany Report #2002003545 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Geodon (Ziprasidone) PS ORAL 160 MG (BID), Initial or Prolonged Psychotic Disorder Professional ORAL Depakote (Valproate Semisodium) C Haldol (Haloperidol) C Ativan (Lorazepam) C Cogentin (Benzatropine Mesilate) C Date:08/26/02ISR Number: 3966649-5Report Type:Expedited (15-DaCompany Report #2002003357 Age:26 YR Gender:Male I/FU:I Outcome PT Other Erythema Granulomatous Liver Disease Hypersensitivity 22-Feb-2006 08:32 AM Page: 214 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Oedema Rash Splenomegaly Report Source Product Role Manufacturer Route Dose Duration Tachycardia Foreign Geodon (Ziprasidone) PS ORAL 120 MG Health (DAILY), ORAL Professional Reboxetine C Company Representative Date:08/26/02ISR Number: 3966656-2Report Type:Expedited (15-DaCompany Report #2002003837 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Disturbance In Attention Health Geodon (Ziprasidone) Initial or Prolonged Mental Status Changes Professional Agitation PS ORAL 40 MG (QD), Somnolence ORAL Vision Blurred Paroxetine (Paroxetine) Agitation SS ORAL 10 MG (QD), ORAL Date:08/26/02ISR Number: 3966683-5Report Type:Expedited (15-DaCompany Report #2002000709 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Dependence Health Geodon (Ziprasidone) PS ORAL 80 MG (BID), Erectile Dysfunction Professional ORAL Libido Decreased Alcohol SS ORAL ORAL Psychotic Disorder Haldol (Haloperidol) C Date:08/26/02ISR Number: 3966881-0Report Type:Direct Company Report #CTU 174977 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Paxil 30mg Glaxco PS Glaxco ORAL 30MG ONCE Depression DAILY ORAL Dizziness Geodon 80mg Pfizer SS Pfizer ORAL 80MG ONCE Faeces Hard BEDTIM ORAL Intestinal Obstruction Sinus Arrhythmia Syncope Visual Disturbance Weight Increased Date:08/26/02ISR Number: 3967690-9Report Type:Expedited (15-DaCompany Report #2002003702 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Overdose Foreign Geodon (Ziprasidone) PS ORAL 80 MG (BID), Initial or Prolonged Suicide Attempt Health ORAL Professional Alprazolam C Company Representative 22-Feb-2006 08:32 AM Page: 215 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/26/02ISR Number: 3967790-3Report Type:Expedited (15-DaCompany Report #2002003839 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Health Geodon (Ziprasidone) PS Syndrome Professional Company Representative Date:08/26/02ISR Number: 3967913-6Report Type:Expedited (15-DaCompany Report #2002000709 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Erectile Dysfunction Health Geodon (Ziprasidone) PS ORAL 80 MG (BID), Libido Decreased Professional ORAL Psychotic Disorder Alcohol SS ORAL ORAL Haldol (Haloperidol) C Date:08/27/02ISR Number: 3967666-1Report Type:Direct Company Report #CTU 175184 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Electrocardiogram Qt Geodon (Ziprasidone) Prolonged 20 Mg Capsules And 40 Mg PS ORAL 20 MG BID AND 40 MG HS 12 DAY Celexa C Zyprexa C Adderall C Albuterol Inhaler C Date:08/27/02ISR Number: 3969283-6Report Type:Expedited (15-DaCompany Report #A118994 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alopecia Consumer Ziprasidone(Ziprasid Initial or Prolonged Dry Mouth one) PS ORAL 60 MG (TID), Insomnia ORAL Middle Insomnia Xanax (Alprazolam) C Nightmare Acetaminophen(Parace Sinusitis tamol) C Date:08/27/02ISR Number: 3969284-8Report Type:Expedited (15-DaCompany Report #A210707 Age:16 YR Gender:Male I/FU:F Outcome PT Hospitalization - Abnormal Behaviour Initial or Prolonged Aggression Autism Blood Magnesium Decreased Blood Pressure Increased Convulsion Crying Disturbance In Attention Dyskinesia Excessive Masturbation Mania Mood Altered 22-Feb-2006 08:32 AM Page: 216 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Neuroleptic Malignant Syndrome Obsessive-Compulsive Report Source Product Role Manufacturer Route Dose Duration Disorder Health Geodon (Ziprasidone) PS ORAL 40 MG (BID), Pneumonia Streptococcal Professional ORAL Psychotic Disorder Celexa (Citalopram Streptococcal Infection Hydrobromide) SS 30 MG (QAM) Tachycardia Docusate(Docusate) C Thinking Abnormal Atrovent(Ipratropium Vomiting Bromide) C Date:08/28/02ISR Number: 3968598-5Report Type:Direct Company Report #CTU 175266 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Geodon (Ziprasidone) Prolonged 80 Mg Capsules PS ORAL 80 MG BID 8 DAY Hydroxyzine C Valproic Acid C Date:08/30/02ISR Number: 3969423-9Report Type:Expedited (15-DaCompany Report #2002004459 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Ziprasidone (Ziprasidone) PS Date:08/30/02ISR Number: 3969440-9Report Type:Expedited (15-DaCompany Report #2002003870 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Akathisia Health Lithium PS ORAL ORAL Drug Interaction Professional Ziprasidone SS ORAL 60 MG Dyskinesia (DAILY), ORAL Verapamil C Synthroid (Levothyroxine Sodium) C Date:08/30/02ISR Number: 3970271-4Report Type:Expedited (15-DaCompany Report #2002001221 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Ziprasidone Initial or Prolonged Increased Health (Ziprasidone) PS 80 MG (TWICE Atrial Fibrillation Professional A DAY) Blood Lactate Zuclopenthixol C Dehydrogenase Increased Levomepromazine C Gamma-Glutamyltransferase Oxazepam C Increased Citalopram C 22-Feb-2006 08:32 AM Page: 217 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/02ISR Number: 3970274-XReport Type:Expedited (15-DaCompany Report #2002004011 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Granulocytopenia Foreign Zeldox (Capsules) Initial or Prolonged Health (Ziprasidone) PS ORAL 80 MG Professional (DAILY), ORAL Company Lorazepam C Representative Date:09/03/02ISR Number: 4001977-9Report Type:Periodic Company Report #2002000271 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Rash Health Geodon (Ziprasidone Initial or Prolonged Professional Hydrochloride) PS ORAL 80 MG (BID), Company ORAL Representative Date:09/03/02ISR Number: 4001978-0Report Type:Periodic Company Report #2002000957 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Priapism Health Ziprasidone Professional (Ziprasidone) PS Date:09/03/02ISR Number: 4001979-2Report Type:Periodic Company Report #2002001148 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Somnolence Health Geodon (Ziprasidone Professional Hydrochloride) PS Date:09/03/02ISR Number: 4001980-9Report Type:Periodic Company Report #2002001149 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Somnolence Health Geodon (Ziprasidone Professional Hydrochloride) PS Date:09/03/02ISR Number: 4001983-4Report Type:Periodic Company Report #2002002559 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Overdose Consumer Geodon (Ziprasidone Initial or Prolonged Visual Disturbance Hydrochloride) PS 300 MG All Other Therapeutic Products SS Date:09/03/02ISR Number: 4001984-6Report Type:Periodic Company Report #2002002578 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Urinary Retention Health Geodon (Ziprasidone Professional Hydrochloride) PS ORAL 140 MG (BID), ORAL 22-Feb-2006 08:32 AM Page: 218 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/03/02ISR Number: 4001985-8Report Type:Periodic Company Report #A208953 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Abdominal Pain Health Ziprasidone Intervention to Intentional Overdose Professional (Ziprasidone) PS ORAL ORAL Prevent Permanent Impairment/Damage Date:09/03/02ISR Number: 4001989-5Report Type:Periodic Company Report #A211100 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Gait Disturbance Consumer Geodon (Ziprasidone Intervention to Hypoglycaemia Health Hydrochloride) PS ORAL (BID), ORAL Prevent Permanent Medication Error Professional Prempro Impairment/Damage Somnolence (Provella--14) C Syncope Trazodone C Benzotropine (Benzatropine Mesilate) C Neurontin (Gabapentin) C Lorazepam C Depo-Provera (Medroxyprogesterone Acetate) C Date:09/03/02ISR Number: 4001990-1Report Type:Periodic Company Report #A211557 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Bundle Branch Block Health Ziprasidone Intervention to Weight Decreased Professional (Ziprasidone) PS ORAL 160 MG (BID), Prevent Permanent Company ORAL Impairment/Damage Representative Date:09/03/02ISR Number: 4001991-3Report Type:Periodic Company Report #A212557 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyponatraemia Consumer Ziprasidone Initial or Prolonged Health (Ziprasidone) PS ORAL 80 MG (BID), Professional ORAL Effexor (Venlafaxine) (Venlafaxine Hydrochloride) C Depakote (Sodium Valproate) (Valproate Semisodium) C 22-Feb-2006 08:32 AM Page: 219 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/03/02ISR Number: 4001992-5Report Type:Periodic Company Report #A212722 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oculogyration Health Ziprasidone Professional (Ziprasidone) PS ORAL 80 MG (BID), ORAL Risperidone C Celexa (Citalopram Hydrobromide) C Date:09/03/02ISR Number: 4001993-7Report Type:Periodic Company Report #A213240 Age:5 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Electrocardiogram Qt Health Ziprasidone Intervention to Prolonged Professional (Ziprasidone) PS 80 MG (BID) Prevent Permanent Company Trileptal Impairment/Damage Representative (Oxcarbazepine) C Seroquel (Quetiapine Fumarate) C Date:09/03/02ISR Number: 4001994-9Report Type:Periodic Company Report #A213842 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Health Ziprasidone Prolonged Professional (Ziprasidone) PS Company Representative Date:09/03/02ISR Number: 4001995-0Report Type:Periodic Company Report #A213843 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Health Ziprasidone Prolonged Professional (Ziprasidone) PS Company Representative Date:09/03/02ISR Number: 4001996-2Report Type:Periodic Company Report #A213919 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyspnoea Health Geodon (Ziprasidone Dystonia Professional Hydrochloride) PS Company Representative Date:09/03/02ISR Number: 4001997-4Report Type:Periodic Company Report #A208805 Age: Gender:Unknown I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Health Ziprasidone Initial or Prolonged Prolonged Professional (Ziprasidone) PS Company Representative 22-Feb-2006 08:32 AM Page: 220 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/03/02ISR Number: 4001998-6Report Type:Periodic Company Report #A208807 Age: Gender:Unknown I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Health Ziprasidone Initial or Prolonged Prolonged Professional (Ziprasidone) PS Company Representative Date:09/03/02ISR Number: 4001999-8Report Type:Periodic Company Report #A210054 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Extrapyramidal Disorder Health Ziprasidone Intervention to Professional (Ziprasidone) PS Prevent Permanent Company Valproic Acid Impairment/Damage Representative (Valproic Acid) SS Date:09/04/02ISR Number: 3971179-0Report Type:Expedited (15-DaCompany Report #2002004462 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Foreign Geodon (Ziprasidone) PS ORAL ORAL Respiratory Arrest Health Professional Company Representative Date:09/04/02ISR Number: 3971355-7Report Type:Expedited (15-DaCompany Report #2002004511 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chest Pain Health Geodon (Ziprasidone Electrocardiogram Qt Professional Hydrochloride) PS ORAL 60 MG (QD), Corrected Interval Company ORAL Prolonged Representative Valproate Semisodium C Date:09/04/02ISR Number: 3971450-2Report Type:Expedited (15-DaCompany Report #2002054266 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Health Ziprasidone Initial or Prolonged Emotional Distress Professional (Ziprasidone) PS 40 (TWICE A Mydriasis DAY) Gabapentin C Venlafaxine Hydrochloride C Date:09/04/02ISR Number: 3971611-2Report Type:Expedited (15-DaCompany Report #2002004169 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Consumer Geodon (Ziprasidone Other Hydrochloride) PS ORAL ORAL Haloperidol C Trazdone C 22-Feb-2006 08:32 AM Page: 221 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/05/02ISR Number: 3971298-9Report Type:Direct Company Report #CTU 175735 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Zyprexa PS Initial or Prolonged Non-Insulin-Dependent Geodon SS Disability Hirsutism Required Polycystic Ovaries Intervention to Weight Increased Prevent Permanent Impairment/Damage Date:09/05/02ISR Number: 3972173-6Report Type:Expedited (15-DaCompany Report #2002001644 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Foreign Geodon (Ziprasidone Initial or Prolonged Suicidal Ideation Health Hydrochloride) PS ORAL 180 MG Professional (DAILY), ORAL Company Venlafaxine Representative Hydrochloride C Lorazepam C Date:09/05/02ISR Number: 3972744-7Report Type:Expedited (15-DaCompany Report #2002003870 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Health Lithium PS ORAL ORAL Formication Professional Ziprasidone SS ORAL 120 MG (BID), Insomnia ORAL Lethargy Mellaril (Thioridazine Hydrochloride) SS Zyprexa (Olanzapine) SS Verapamil C Synthroid (Levothyroxine Sodium) C Date:09/06/02ISR Number: 3972453-4Report Type:Expedited (15-DaCompany Report #2002054697 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Intolerance Health Geodon (Ziprasidone) PS Initial or Prolonged Professional Company Representative Date:09/09/02ISR Number: 3973989-2Report Type:Expedited (15-DaCompany Report #HQ4041603SEP2002 Age:32 YR Gender:Male I/FU:I Outcome PT Life-Threatening Alanine Aminotransferase Hospitalization - Increased Initial or Prolonged Aspartate Aminotransferase Increased 22-Feb-2006 08:32 AM Page: 222 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Blood Creatinine Increased Cardiac Failure Report Source Product Role Manufacturer Route Dose Duration Cardiomyopathy Health Efexor Depot Decreased Appetite Professional (Venlafaxine Diarrhoea Other Hydrochloride, Dilatation Ventricular Capsule, Extended Liver Function Test Release) PS ORAL 300 MG 1X Abnormal PER 1 DAY Nausea ORAL Shock Geodon (Ziprasidone, Vomiting ) SS ORAL 120 MG 3X PER 1 DAY ORAL 6 MON Imovane (Zopiclone) C Triatec (Ramipril) C Seloken - Slow Release (Metoprolol Tartrate) C Lanacrist (Digoxin) C Spironolactone "Nm Pharma" (Spironolactone) C Furosemide (Furosemide) C Date:09/11/02ISR Number: 3974668-8Report Type:Expedited (15-DaCompany Report #2002000481 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bundle Branch Block Right Health Geodon (Ziprasidone) PS ORAL 80 MG (BID), Initial or Prolonged Electrocardiogram Qt Professional ORAL Other Corrected Interval Company Celexa (Citalopram Prolonged Representative Hyrdobromide) C Electrocardiogram Qt Nexium Prolonged (Esomeprazole) C Electrocardiogram T Wave Norvasc (Amlodipine Abnormal Besilate) C Transient Ischaemic Lipitor Attack (Atorvastatin) C Ventricular Extrasystoles Atenolol C Date:09/11/02ISR Number: 3974681-0Report Type:Expedited (15-DaCompany Report #2002003428 Age:28 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bruxism Health Geodon (Ziprasidone Initial or Prolonged Suicide Attempt Professional Hydrochloride) PS ORAL 80 MG (BID) , Other ORAL Paxil (Paroxetine Hydrochloride) C Lithobid (Lithium Carbonate) C 22-Feb-2006 08:32 AM Page: 223 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/11/02ISR Number: 3974682-2Report Type:Expedited (15-DaCompany Report #A213499 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Syncope Vasovagal Foreign Zeldox (Ziprasidone) PS ORAL 40 MG, Initial or Prolonged Health (DAILY), ORAL Professional Solian (Amisulpride) C Date:09/11/02ISR Number: 3974684-6Report Type:Expedited (15-DaCompany Report #2002055319 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Unevaluable Event Consumer Geodon (Ziprasidone) PS UNKNOWN Initial or Prolonged Date:09/12/02ISR Number: 3975243-1Report Type:Expedited (15-DaCompany Report #2002003870 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Health Lithium PS ORAL 900 MG Drug Interaction Professional (DAILY), ORAL Feeling Abnormal Geodon (Ziprasidone) SS ORAL 1`20 MG Insomnia (BID), ORAL Lethargy Mellaril (Thiridazine Hydrochloride) SS Zyprexa (Olanzapine) SS Verapamil C Synthroid (Levothyroxine Sodium) C Date:09/12/02ISR Number: 3975453-3Report Type:Expedited (15-DaCompany Report #2002055576 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Consumer Geodon (Ziprasidone) PS ORAL 20 MG Initial or Prolonged Cerebrovascular Accident (DAILY), ORAL Condition Aggravated Clonazepam C Disturbance In Attention Hydroxyzine Embonate C Feeling Abnormal Nadolol C Insomnia Nausea Obsessive-Compulsive Disorder Panic Attack Speech Disorder Vomiting Date:09/12/02ISR Number: 3975710-0Report Type:Expedited (15-DaCompany Report #2002055324 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Angina Pectoris Foreign Ziprasidone Anxiety Health (Ziprasidone) PS ORAL 80 MG (TWICE Dyspnoea Exertional Professional A DAY), ORAL Hallucination Company Nicorandil C Persecutory Delusion Representative Isosorbide 22-Feb-2006 08:32 AM Page: 224 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Mononitrate C Date:09/13/02ISR Number: 3975786-0Report Type:Expedited (15-DaCompany Report #2002055974 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neurogenic Bladder Foreign Zeldox (Ziprasidone) PS ORAL 80 MG (BID), Initial or Prolonged Urinary Retention ORAL Disipal (Orphenadrine Hydrochloride) C Propavan (Propiomazine Maleate) C Oralovite (Parentrovite) C Apodorm (Nitrazepam) C Daonil (Glibenclamide) C Flunitrazepam C Date:09/13/02ISR Number: 3975787-2Report Type:Expedited (15-DaCompany Report #2002056262 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Angioneurotic Oedema Foreign Zeldox (Ziprasidone) PS ORAL 40 MG ORAL Health Cisordinol Professional (Zuclopenthixol) C Risperdal (Risperidone) C Date:09/16/02ISR Number: 3975915-9Report Type:Expedited (15-DaCompany Report #FLUV00202001320 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Health Luvox (Fluvoxamine Electrocardiogram Qt Professional Maleate) PS ORAL 25 MG QD PO, Corrected Interval 25 MG BID PO, Prolonged 75 MG DAILY Electrocardiogram Qt PO, 75 MG BID Prolonged PO Geodon (Ziprasidone Hcl) SS ORAL 40 MG BID PO, 40 MG QD PO Risperdal (Risperdone) SS 3 MG BID Klonopin (Clonazepam) C Colace (Docusate Sodium) C Ditropan (Oxybutynin) C Cogentin (Benzatropine Mesilate) C Depakote (Valproate Semisodium) C 22-Feb-2006 08:32 AM Page: 225 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/16/02ISR Number: 3976363-8Report Type:Expedited (15-DaCompany Report #2002056537 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Fall Health Ziprasidone Parkinsonism Professional (Ziprasidone) PS 160 MG (TWICE Tardive Dyskinesia Company A DAY) Representative Date:09/16/02ISR Number: 3976522-4Report Type:Expedited (15-DaCompany Report #2002055831 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lethargy Health Geodon (Ziprasidone) PS ORAL 60 MG Suicide Attempt Professional (DAILY), ORAL Date:09/16/02ISR Number: 3976524-8Report Type:Expedited (15-DaCompany Report #A118994 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alopecia Consumer Ziprasidone Initial or Prolonged Drug Effect Decreased (Ziprasidone) PS ORAL ORAL Dry Mouth Xanax (Alprazolam) C Insomnia Acetaminophen Nightmare (Paracetamol) C Oral Infection Pyrexia Sinusitis Date:09/16/02ISR Number: 3976548-0Report Type:Expedited (15-DaCompany Report #2002056448 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Balance Disorder Health Geodon (Ziprasidone) PS ORAL ORAL Disorientation Professional Dysphagia Company Dysphoria Representative Date:09/16/02ISR Number: 3976722-3Report Type:Expedited (15-DaCompany Report #2002003110 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Hypersensitivity Foreign Ziprasidone Face Oedema Health (Ziprasidone) PS ORAL 120 MG Joint Swelling Professional (DAILY), ORAL Pruritus Company Zolpidem C Rash Representative Date:09/17/02ISR Number: 3980743-4Report Type:Expedited (15-DaCompany Report #A119156 Age:39 YR Gender:Female I/FU:F Outcome PT Death Agitation Hospitalization - Arrhythmia Initial or Prolonged Drooling Electrocardiogram Qt Prolonged 22-Feb-2006 08:32 AM Page: 226 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Gastritis Haematemesis Respiratory Arrest Report Source Product Role Manufacturer Route Dose Duration Health Ziprasidone Professional (Ziprasidone) PS ORAL 80 MG (BID), ORAL Gabapentin (Gabapentin) SS ORAL 1200 MG (BID), ORAL Risperdal (Risperidone) C Trazadone C Ativan (Lorazepam) C Cogentin (Benzatropine Mesilate) C Multivitamin C Haldol (Haloperidol) C Tylenol (Paracetamol) C Protonix (Pantoprazole) C Restoril (Temazepam) C Date:09/20/02ISR Number: 3979254-1Report Type:Expedited (15-DaCompany Report #2002002496 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Suicide Attempt Foreign Geodon (Ziprasidone Health Hydrochloride) PS ORAL 80 MG (BID), Professional ORAL Company Representative Date:09/20/02ISR Number: 3979518-1Report Type:Expedited (15-DaCompany Report #2002057248 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Health Ziprasidone Professional (Ziprasidone) PS Company Ethanol SS Representative Date:09/23/02ISR Number: 3979700-3Report Type:Expedited (15-DaCompany Report #2002056876 Age: Gender:Female I/FU:I Outcome PT Hospitalization - Asthenia Initial or Prolonged Blood Potassium Decreased Other Blood Pressure Increased Blood Sodium Decreased Body Temperature Decreased Chronic Obstructive Pulmonary Disease Condition Aggravated Confusional State Convulsion 22-Feb-2006 08:32 AM Page: 227 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Cyst Dehydration Disease Recurrence Report Source Product Role Manufacturer Route Dose Duration Dizziness Consumer Ziprasidone Emphysema (Ziprasidone) PS ORAL 20 MG Hepatic Cyst (DAILY), ORAL Keratoconjunctivitis Prozac (Fluoxetine Sicca Hydrochloride) SS ORAL 20 MG Lung Infection (DAILY), ORAL Macular Degeneration Klonopin Pancreatic Atrophy (Clonazepam) SS Pneumonia Levothyroxine Sodium C Pulmonary Oedema Estrogens Conjugated C Somnolence Medroxyprogesterone Tremor Acetate C Date:09/24/02ISR Number: 3981056-7Report Type:Expedited (15-DaCompany Report #A214068 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arthritis Consumer Geodon (Ziprasidone) PS ORAL ORAL Initial or Prolonged Bipolar Disorder Tegretol Body Height (Carbamazepine) C Hepatic Neoplasm Corgard (Nadolol) C Malignant Depakote (Valpraote Liver Function Test Semisodium)) C Abnormal Anafranil Osteoporosis (Clomipramine Physical Examination Hydrochloride) C Abnormal Vistaril Psychotic Disorder (Hydroxyzine Renal Function Test Embonate) C Abnormal Donnatal (Donnatal) C Klonopin (Clonazepam) C Date:09/24/02ISR Number: 3981057-9Report Type:Expedited (15-DaCompany Report #2002057666 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyspnoea Health Geodon (Ziprasidone) PS 40 MG (BID), Dystonia Professional UNKNOWN Pharyngeal Oedema Company Dilantin (Phenytoin Throat Tightness Representative Sodium) C Allegra (Fexofenadine Hydrochloride) C Naprosyn (Naproxen) C Date:09/24/02ISR Number: 3981560-1Report Type:Expedited (15-DaCompany Report #2002057673 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Oedema Foreign Geodon (Ziprasidone) PS ORAL 40 MG Initial or Prolonged Rash Health (DAILY), ORAL Professional Valproate Sodium C 22-Feb-2006 08:32 AM Page: 228 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/24/02ISR Number: 3981815-0Report Type:Expedited (15-DaCompany Report #2002000485 Age:20 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Health Geodon (Ziprasidone) PS ORAL 80 MG (BID), Corrected Interval Professional ORAL Prolonged Effexor (Venlafaxine Malaise Hydrochloride) C Vistaril (Hydroxyzine Embonate) C Date:09/25/02ISR Number: 3982309-9Report Type:Expedited (15-DaCompany Report #B0279668A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Level Decreased Literature Ziprasidone Hcl Initial or Prolonged Haemodialysis Health (Ziprasidone Hcl) Neuroleptic Malignant Professional (Formulation Syndrome Unknown) PS 2 WK Pancreatitis Lithium Salt (Lithium Salt) (Formulation Unknown) SS YR Clozapine (Clozapine) (Formulation Unknown) SS YR Date:09/27/02ISR Number: 3982788-7Report Type:Expedited (15-DaCompany Report #A109401 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Consumer Ziprasidone Hospitalization - Blood Glucose Increased Health (Ziprasidone) PS ORAL 80 MG Initial or Prolonged Hypertension Professional (DAILY), ORAL Insomnia Company Serentil Myocardial Infarction Representative (Mesoridazine) SS ORAL 225 MG (TID), Psychotic Disorder ORAL Seborrhoea Remeron Sudden Death (Mirtazapine) C Toxicologic Test Abnormal Atorvastatin (Atorvastatin) C Neurontin (Gabapentin) C Klonopin (Clonazepam) C Aspirin (Acetylsalicylic Acid) C Thorazine (Chlorpromazine Hydrochloride) C Lorazepam (Lorazepam) C Cogentin (Benzatropine Mesilate) C Depakote (Valproate Semisodium) C 22-Feb-2006 08:32 AM Page: 229 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prinivil (Lisinopril) C Moban (Molindone) C Zyperxa (Olanzapine) C Seroquel (Quetiapine Fumarate) C Prozac (Fluoxetine Hydrochloride) C Fluoxetine (Fluoxetine) C Thioridazine (Thioridazine) C Date:09/27/02ISR Number: 3982839-XReport Type:Expedited (15-DaCompany Report #2002057729 Age:12 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fatigue Health Geodon (Ziprasidone) PS ORAL 40 MG (TWICE Initial or Prolonged Mastoiditis Professional A DAY), ORAL Somnolence Buspirone Hydrochloride C Sertraline Hydrochloride C Melatonin C Pancrelipase C Guaifenesin C Topiramate C Levothyroxine Sodium C Hydrocortisone Acetate C Date:09/27/02ISR Number: 3982841-8Report Type:Expedited (15-DaCompany Report #2002003839 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neuroleptic Malignant Health Geodon (Ziprasidone Hospitalization - Syndrome Professional Hydrochloride) PS Initial or Prolonged Company Risperdal SS 7 MG Representative Paroxetine Hydrochloride C Benzatropine Mesilate C Famotidine C Date:09/27/02ISR Number: 3985799-0Report Type:Expedited (15-DaCompany Report #A109401 Age:47 YR Gender:Male I/FU:F Outcome PT Death Cardiomegaly Hospitalization - Drug Toxicity Initial or Prolonged Electrocardiogram Qt Prolonged Hypertension Insomnia Insulin Resistance Syndrome Seborrhoea Sudden Death 22-Feb-2006 08:32 AM Page: 230 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Toxicologic Test Abnormal Report Source Product Role Manufacturer Route Dose Duration Consumer Ziprasidone Health (Ziprasidone) PS ORAL 80 MG Professional (DAILY), ORAL Company Serentil Representative (Mesoridazine) SS ORAL 225 MG (TID), ORAL Remeron (Mirtazapine) C Atorvastatin (Atorvastatin) C Neurontin (Gabapentin) C Klonopin (Clonazepam) C Aspirin (Acetylsalicylic Acid) C Thorazine (Chlorpromazine Hydrochloride) C Lorazepam (Lorazepam) C Cogentin (Benzatropine Mesilate) C Depakote (Valproate Semisodium) C Prinivil (Lisinopril) C Moban (Molindone) C Zyprexa (Olanzapine) C Seroquel (Quetiapine Fumarate) C Prozac (Fluoxetine Hydrochloride) C Fluoxetine (Fluoxetine) C Thioridazine (Thioridazine) C Date:10/01/02ISR Number: 3983147-3Report Type:Expedited (15-DaCompany Report #2002003448 Age:56 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Zeldox (Ziprasidone Drug Ineffective Health Hyrochloride) PS ORAL 160 MG (BID), Panic Attack Professional ORAL Weight Increased Insulin C Risperidone C Solian (Amisulpride) C 22-Feb-2006 08:32 AM Page: 231 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/01/02ISR Number: 3983148-5Report Type:Expedited (15-DaCompany Report #2002004034 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Zeldox (Ziprasidone Initial or Prolonged Crying Health Hydrochloride) PS ORAL 80 MG, ORAL Eye Oedema Professional Insomnia Company Neurodermatitis Representative Rash Date:10/01/02ISR Number: 3983149-7Report Type:Expedited (15-DaCompany Report #2002055977 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psoriasis Foreign Zeldox (Ziprasidone Initial or Prolonged Health Hydrochloride) PS ORAL 80 MG, ORAL Professional Benperidol-Neuraxpha Company rm (Benperidol) C Representative Stangyl (Trimipramine Maleate) C Tafil (Alprazolam) C Date:10/01/02ISR Number: 3984927-0Report Type:Expedited (15-DaCompany Report #2002055908 Age:58 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Health Geodon (Ziprasidone) PS ORAL 160 MG (TWICE Professional A DAY),ORAL Oxcarbazepine C Clonazepam C Date:10/01/02ISR Number: 3985775-8Report Type:Expedited (15-DaCompany Report #2002002294 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Health Geodon (Ziprasidone Initial or Prolonged Congestive Professional Hydrochloride) PS 160 MG (BID) Other Cardiomyopathy Company Haldol (Haloperidol) SS INTRAMUSCULAR 150 MG (EVERY Condition Aggravated Representative FOUR WEEKS) , Ejection Fraction INTRAMUSCULAR Decreased Cogentin Ventricular Hypertrophy (Benzatropine Mesilate) C Date:10/03/02ISR Number: 3986945-5Report Type:Expedited (15-DaCompany Report #2002055576 Age:44 YR Gender:Male I/FU:F Outcome PT Hospitalization - Anxiety Initial or Prolonged Aphasia Condition Aggravated Disturbance In Attention Feeling Abnormal Insomnia Nausea Obsessive-Compulsive 22-Feb-2006 08:32 AM Page: 232 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Disorder Panic Reaction Vomiting Report Source Product Role Manufacturer Route Dose Duration Consumer Geodon (Ziprasidone) PS ORAL 20 MG Health (DAILY), ORAL Professional Clonazepam C Hydroxyzine Embonate C Nadolol C Date:10/03/02ISR Number: 3987802-0Report Type:Expedited (15-DaCompany Report #A211864 Age:20 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Depression Health Geodon (Ziprasidone) PS ORAL 40 MG (BID), Intervention to Insomnia Professional ORAL Prevent Permanent Somnolence Impairment/Damage Suicidal Ideation Weight Decreased Date:10/03/02ISR Number: 3987974-8Report Type:Expedited (15-DaCompany Report #2002058038 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bundle Branch Block Left Foreign Zeldox Palpitations Health Tachycardia Professional (Ziprasidone) PS ORAL 120 MG (BID), ORAL Perazine C Levomepromazine Maleate C Date:10/03/02ISR Number: 3987975-XReport Type:Expedited (15-DaCompany Report #2002058137 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Completed Suicide Foreign Ziprasidone Initial or Prolonged Health (Ziprasidone) PS ORAL 120 MG (TWICE Professional A DAY), ORAL Company Clotiapine C ORAL Representative Date:10/03/02ISR Number: 3988140-2Report Type:Expedited (15-DaCompany Report #2002053989 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Atorvastatin Initial or Prolonged Phosphokinase Increased Health (Atorvastatin) PS ORAL 5 MG DAILY Drug Effect Decreased Professional ORAL Drug Interaction Ziprasidone Myalgia Hydrochloride SS ORAL 160 MG ORAL Myoglobin Blood Increased Fluspirilene C 22-Feb-2006 08:32 AM Page: 233 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/03/02ISR Number: 3988891-XReport Type:Expedited (15-DaCompany Report #2002059635 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Myocardial Infarction Health Geodon (Ziprasidone) PS ORAL 40 MG Initial or Prolonged Professional (DAILY), ORAL Other Depakote (Valproate Semisodium) C Glucophage (Metformin) C Ranitidine C Premarin (Estrogens Conjugated) C Lopid (Gemfibrozil) C Amaryl (Glimepiride) C Hydrochlorothiazide C Lorazepam C Tylenol #3 (Panadeine Co) C Buspar (Buspirone Hydrochloride) C Date:10/03/02ISR Number: 3988892-1Report Type:Expedited (15-DaCompany Report #2002004511 Age:16 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chest Pain Health Geodon (Ziprasidone Electrocardiogram Qt Professional Hydrochloride) PS ORAL 60 MG (QD), Prolonged Company ORAL Representative Valproate Semisodium C Date:10/03/02ISR Number: 3989054-4Report Type:Expedited (15-DaCompany Report #2002054697 Age:38 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Tardive Dyskinesia Health Geodon (Ziprasidone) PS ORAL 20 MG Initial or Prolonged Professional (DAILY), ORAL Company Topiramate C Representative Clonazepam C Flurazepam Hydrochloride C Date:10/04/02ISR Number: 3985650-9Report Type:Direct Company Report #CTU 177899 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Ziprasidone 60 Mg Initial or Prolonged Capsules PS 60 MG BID Required Intervention to Prevent Permanent Impairment/Damage 22-Feb-2006 08:32 AM Page: 234 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/04/02ISR Number: 3989091-XReport Type:Expedited (15-DaCompany Report #2002055324 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Angina Pectoris Foreign Zeldox (Ziprasidone) PS ORAL 80 MG BID, Anxiety Health ORAL Dyspnoea Exertional Professional Dancor (Nocorandil) C Hallucination Monoket (Isosorbide Mania Mononitrate) C Persecutory Delusion Pravachol (Pravastatin Sodium) C Date:10/04/02ISR Number: 3989094-5Report Type:Expedited (15-DaCompany Report #2002004462 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Zeldox (Ziprasidone Drug Toxicity Health Hydrochloride) PS ORAL 80 MG TWICE Grand Mal Convulsion Professional DAILY, ORAL Mydriasis Company Noritren Overdose Representative (Nortriptyline Rales Hydrochloride) SS ORAL ORAL Respiratory Arrest Risperidone C Toxicologic Test Abnormal Zolpidem Tartrate C Clonazepam C Oxazepam C Orphenadrine Hydrochloride C Chlorprothixene Hydrochloride C Date:10/07/02ISR Number: 3987054-1Report Type:Direct Company Report #CTU 178116 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Akathisia Geodon 80 Mg Pfizer PS Pfizer ORAL 1 BID PO Required Tardive Dyskinesia Intervention to Prevent Permanent Impairment/Damage Date:10/08/02ISR Number: 3989589-4Report Type:Expedited (15-DaCompany Report #2002003819 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Geodon (Ziprasidone) PS ORAL 40 MG (TWICE Initial or Prolonged Electrocardiogram Qt Professional A DAY), ORAL Corrected Interval Trifluoperazine Prolonged Hydrochloride SS 5 MG (DAILY) Quetiapine Fumarate SS Citalopram Hydrobromide C 22-Feb-2006 08:32 AM Page: 235 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/08/02ISR Number: 3989592-4Report Type:Expedited (15-DaCompany Report #2002002294 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Health Geodon (Ziprasidone) PS 160 MG (BID) Initial or Prolonged Congestive Professional Haldol (Haloperidol) SS INTRAMUSCULAR 150 MG (Q4W), Other Cardiomyopathy INTRAMUSCULAR Ventricular Hypertrophy Klonopin (Clonazepam) SS 4 MG (DAILY) Cogentin (Benzatropine Mesilate) C Date:10/08/02ISR Number: 3989594-8Report Type:Expedited (15-DaCompany Report #A211864 Age:20 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Depression Health Geodon (Ziprasidone) PS ORAL 40 MG (BID), Intervention to Drug Effect Decreased Professional ORAL Prevent Permanent Insomnia Impairment/Damage Schizophrenia Somnolence Suicidal Ideation Weight Decreased Date:10/08/02ISR Number: 3989822-9Report Type:Expedited (15-DaCompany Report #2002056537 Age:58 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Parkinsonism Health Geodon (Ziprasidone) PS 160 MG (BID), Other Tardive Dyskinesia Professional Seroquel (Quetiapine Company Fumarate) SS 100 MG (TID), Representative Valium (Diazepam) C Wellbutrin (Bupropion Hydrochloride) C Paxil (Paroxetine Hydrochloride) C Vicodin Es (Vicodin) C Naprosyn (Naproxen) C Date:10/08/02ISR Number: 3989823-0Report Type:Expedited (15-DaCompany Report #2002059583 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Overdose Health Ziprasidone Initial or Prolonged Professional (Ziprasidone) PS Company Representative Date:10/08/02ISR Number: 3990105-1Report Type:Expedited (15-DaCompany Report #2002059718 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Hospitalization - Chills Foreign Initial or Prolonged Cogwheel Rigidity Health Muscle Rigidity Professional Company 22-Feb-2006 08:32 AM Page: 236 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Representative Product Role Manufacturer Route Dose Duration Zeldox (Capsules) (Ziprasidone) PS ORAL 160 MG (DAILY), ORAL Truxal (Chlorprothixene Hydrochloride) C Tavor (Lorazepam) C Date:10/09/02ISR Number: 3987395-8Report Type:Direct Company Report #USP 55307 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Geodon For Injection PS Ben Venue Laboratories Date:10/09/02ISR Number: 3990870-3Report Type:Expedited (15-DaCompany Report #2002001870 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Coagulopathy Consumer Geodon (Ziprasidone Contusion Health Hydrochloride) PS ORAL ORAL Professional Company Representative Date:10/09/02ISR Number: 3991618-9Report Type:Expedited (15-DaCompany Report #2002004511 Age:13 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chest Pain Health Geodon (Ziprasidone) PS ORAL 60 MG(DAILY), Electrocardiogram Qt Professional ORAL Corrected Interval Company Depakote(Valproate Prolonged Representative Semisodium) C Date:10/09/02ISR Number: 3991622-0Report Type:Expedited (15-DaCompany Report #2002059942 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cellulitis Consumer Geodon Initial or Prolonged Cerebrovascular Accident (Ziprasidone) PS 160 MG (TWICE Other Dizziness A DAY) Eye Disorder Gatifloxacin SS INTRAVENOUS INTRAVENOUS Venlafaxine Hydrochloride C Zolpidem Tartrate C Trazodone C Date:10/10/02ISR Number: 3991597-4Report Type:Expedited (15-DaCompany Report #2002004169 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Consumer Geodon (Ziprasidone) PS ORAL ORAL Other Coma Haldol (Haloperidol) C 22-Feb-2006 08:32 AM Page: 237 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Trazodone C Date:10/11/02ISR Number: 3991296-9Report Type:Expedited (15-DaCompany Report #2002056876 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aortic Valve Consumer Geodon (Ziprasidone) PS ORAL 80 MG (BID), Initial or Prolonged Calcification Health ORAL Other Asthenia Professional Prozac (Fluoxetine Blood Cholesterol Hydrochloride) SS ORAL 20 MG Increased (DAILY), ORAL Blood Pressure Klonopin Fluctuation (Clonazepam) SS 1 MG Body Temperature Levothyroxine Sodium C Decreased Estrogens Conjugated C Chronic Obstructive Medroxyprogesterone Pulmonary Disease Acetate C Condition Aggravated Trifluoperazine Confusional State Hydrochloride C Convulsion Dehydration Disorientation Dizziness Drug Effect Decreased Electrolyte Imbalance Emphysema Hepatic Cyst Hypokalaemia Hyponatraemia Keratoconjunctivitis Sicca Lung Infection Macular Degeneration Medication Error Pancreatic Atrophy Pneumonia Somnolence Tremor Date:10/11/02ISR Number: 3992719-1Report Type:Expedited (15-DaCompany Report #2002002667 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Ziprasidone Initial or Prolonged Agitation Study (Ziprasidone) PS ORAL 160 MG (BID), Persecutory Delusion Health ORAL Professional Promethazine C En (Delorazepam) C Haloperidol C Date:10/15/02ISR Number: 3993086-XReport Type:Expedited (15-DaCompany Report #2002061133 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Health Geodon (Ziprasidone) PS Professional Company Representative 22-Feb-2006 08:32 AM Page: 238 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/15/02ISR Number: 3993088-3Report Type:Expedited (15-DaCompany Report #2002004511 Age:13 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chest Pain Health Geodon (Ziprasidone) PS ORAL 120 MG (BID), Electrocardiogram Qt Professional ORAL Corrected Interval Company Depakote (Valproate Prolonged Representative Semisodium) C Electrocardiogram St Segment Abnormal Date:10/15/02ISR Number: 3993144-XReport Type:Expedited (15-DaCompany Report #2002060336 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Foreign Zeldox (Capsules) Health (Ziprasidone) PS Professional Company Representative Date:10/15/02ISR Number: 3993486-8Report Type:Expedited (15-DaCompany Report #2002055024 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Geodon (Ziprasidone) PS ORAL 100 MG (TWICE Medication Error Professional A DAY), ORAL Movement Disorder Citalopram Paralysis Hydrobromide C Paroxetine Hydrochloride C Desipramine C Valproate Semisodium C Clonazepam C Date:10/16/02ISR Number: 3994750-9Report Type:Expedited (15-DaCompany Report #2002002306 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Increased Health Geodon (Ziprasidone Epistaxis Professional Hydrochloride) PS ORAL 80 MG (BID), Company ORAL Representative Wellbutrin Sr (Bupropion Hydrochloride) C Zyprexa (Olanzapine) C Date:10/16/02ISR Number: 3999470-2Report Type:Expedited (15-DaCompany Report #B0282391A Age:26 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Paxil (Formulation Intentional Overdose Health Unknown) (Paroxetine Professional Hydrochloride) PS Aspirin (Formulation Unknown) (Aspirin) SS Ziprasidone Hcl (Formulation 22-Feb-2006 08:32 AM Page: 239 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Unknown) (Ziprasidone Hcl) SS Date:10/16/02ISR Number: 4012485-3Report Type:Periodic Company Report #001-0945-M0200272 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Consumer Neurontin Initial or Prolonged Bipolar I Disorder (Gabapentin) PS ORAL ORAL Diarrhoea Ziprasidone SS ORAL 20 MG, DAILY, Hypotension ORAL Infection Azithromycin SS ORAL DAILY, ORAL Rash Methylphenidate Somnolence Hydrochloride C Syncope Alprazolam C Tachycardia Venlafaxine Tremor Hydrochloride C Weight Increased Citalopram Hydrobromide C Topiramate C Date:10/17/02ISR Number: 3997462-0Report Type:Expedited (15-DaCompany Report #2002060835 Age:17 MON Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Medication Error Health Geodon (Ziprasidone) PS ORAL ORAL Initial or Prolonged Professional Date:10/21/02ISR Number: 3998559-1Report Type:Expedited (15-DaCompany Report #2002003435 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pericarditis Health Geodon (Ziprasidone Initial or Prolonged Professional Hydrochloride) PS ORAL 160 MG (BID), Company ORAL Representative Unspecified Medications C Ranitidine Hydrochloride C Paroxetine Hydrochloride C Hydroxyzine Embonate C Clonazepam C Date:10/21/02ISR Number: 3998636-5Report Type:Expedited (15-DaCompany Report #2002061026 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Embolism Foreign Zeldox (Capsules) Health (Ziprasidone) PS ORAL 80 MG Professional (DAILY), ORAL Company Lisinopril C Representative 22-Feb-2006 08:32 AM Page: 240 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/23/02ISR Number: 3998581-5Report Type:Expedited (15-DaCompany Report #2002061198 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Ineffective Health Geodon (Ziprasidone) PS Hospitalization - Sudden Cardiac Death Professional All Other Initial or Prolonged Therapeutic Products SS Date:10/23/02ISR Number: 3999413-1Report Type:Expedited (15-DaCompany Report #2002061607 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Geodon (Ziprasidone) PS ORAL ORAL Professional Clonazepam C All Other Therapeutic Products C Date:10/23/02ISR Number: 3999415-5Report Type:Expedited (15-DaCompany Report #2002004187 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Hypersensitivity Health Geodon (Ziprasidone) PS ORAL 160 MG (BID), Dyspnoea Professional ORAL Rash Company Citalopram Representative Hydrobromide C Trazodone C Date:10/23/02ISR Number: 3999514-8Report Type:Expedited (15-DaCompany Report #2002061795 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Consumer Geodon (Ziprasidone) PS ORAL 160 MG (BID) Initial or Prolonged Fracture ORAL Other Date:10/24/02ISR Number: 3997495-4Report Type:Direct Company Report #CTU 179406 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Attention Geodon (Ziprasidone) Deficit/Hyperactivity 40 Mg Capsule PS ORAL 40 MG BID 7 DAY Disorder Klonopin C Blood Pressure Increased Prozac C Heart Rate Increased Motrin C Baclofen C Cogentin C Tegretol C Dilantin C Vistaril C Atrovent/Albuterol Nebulization Treatements C 22-Feb-2006 08:32 AM Page: 241 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/25/02ISR Number: 4000536-1Report Type:Expedited (15-DaCompany Report #2002055319 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - No Adverse Drug Effect Consumer Geodon (Ziprasidone) PS Initial or Prolonged Health Professional Date:10/25/02ISR Number: 4000538-5Report Type:Expedited (15-DaCompany Report #2002003742 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Consumer Geodon (Ziprasidone) PS ORAL 80 MG (BID), Initial or Prolonged Dystonia ORAL Feeling Abnormal Venlafaxine Joint Stiffness Hydrochloride C Movement Disorder Clonazepam C Psychotic Disorder Date:10/25/02ISR Number: 4000547-6Report Type:Expedited (15-DaCompany Report #2002062770 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Geodon (Ziprasidone) PS Professional Company Representative Date:10/25/02ISR Number: 4000549-XReport Type:Expedited (15-DaCompany Report #2002061950 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Geodon (Ziprasidone) PS ORAL 20 MG Professional (DAILY), ORAL Company Representative Date:10/25/02ISR Number: 4001321-7Report Type:Expedited (15-DaCompany Report #2002004201 Age:17 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Foreign Zeldox (Ziprasidone Initial or Prolonged Drug Toxicity Health Hydrochloride) PS ORAL 40 MG (BID), Epilepsy Professional ORAL Overdose Carbamazepine SS ORAL ORAL Suicide Attempt Cannabis C Toxicologic Test Abnormal Date:10/28/02ISR Number: 3999360-5Report Type:Direct Company Report #CTU 179727 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dyspnoea Geodon 60 Mg Pfizer PS Pfizer 60 MG TWICE Fall DAILY Skin Discolouration Standard White Capsule C 22-Feb-2006 08:32 AM Page: 242 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/29/02ISR Number: 4002140-8Report Type:Expedited (15-DaCompany Report #2002062680 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypoxia Consumer Geodon (Ziprasidone) PS INTRAMUSCULAR 20 MG (BID), Syncope INTRAMUSCULAR Clonidine C Haloperidol C Chlorpromazine Hydrochloride C Fluphenazine Hydrochloride C Trifluoperazine Hydrochloride C Date:10/31/02ISR Number: 4004969-9Report Type:Expedited (15-DaCompany Report #2002057236 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Paralysis Health Geodon (Ziprasidone) PS ORAL ORAL Initial or Prolonged Professional Other Date:11/04/02ISR Number: 4003513-XReport Type:Direct Company Report #CTU 180266 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Geodon 20 Mg Circadian Rhythm Sleep Capsules Pfizer PS Pfizer 2 X DAILY Disorder Zoloft C Dyspepsia Wellbutrin C Palpitations Alprazolam C Tension Prilosec C Tremor Lipitor C Albuterol C Date:11/06/02ISR Number: 4004537-9Report Type:Direct Company Report #CTU 180437 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Tardive Dyskinesia Ziprasidone 20mg Pfizer PS Pfizer ORAL 20MG BID ORAL Viread C Kaletra C Lithium Carbonate C Temazepam C Benztropine C Date:11/06/02ISR Number: 4007363-XReport Type:Expedited (15-DaCompany Report #2002063394 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Fluid Retention Health Geodon (Im) Swelling Professional (Ziprasidone) PS INTRAMUSCULAR INTRAMUSCULAR Company Representative 22-Feb-2006 08:32 AM Page: 243 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/06/02ISR Number: 4007374-4Report Type:Expedited (15-DaCompany Report #2002064375 Age:83 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aggression Health Geodon (Ziprasidone) PS Other Blood Pressure Decreased Professional All Other Cognitive Disorder Therapeutic Products C Confusional State Chloral Hydrate C Decreased Appetite Depressed Level Of Consciousness Drug Effect Decreased Dysarthria Dysphagia Heart Rate Decreased Insomnia Lethargy Pneumonitis Respiratory Arrest Restlessness Somnolence Date:11/06/02ISR Number: 4007630-XReport Type:Expedited (15-DaCompany Report #2002063957 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ventricular Arrhythmia Health Geodon (Im) Ventricular Tachycardia Professional (Ziprasidone) PS INTRAMUSCULAR INTRAMUSCULAR Company Representative Date:11/06/02ISR Number: 4007788-2Report Type:Expedited (15-DaCompany Report #2002063201 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Geodon (Ziprasidone) PS ORAL 40 MG (BID), Initial or Prolonged Face Oedema Professional ORAL Oedema Peripheral Pravastatin Sodium C Pitting Oedema Clozapine C Psychotic Disorder Quetiapine Fumarate C Rash Venlafaxine Hydrochloride C Date:11/06/02ISR Number: 4008563-5Report Type:Expedited (15-DaCompany Report #2002063839 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Suicide Attempt Foreign Zeldox (Ziprasidone Hospitalization - Health Hydrochloride) PS ORAL ORAL Initial or Prolonged Professional Zopiclone C Other Company Representative 22-Feb-2006 08:32 AM Page: 244 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/07/02ISR Number: 4005856-2Report Type:Direct Company Report #CTU 180540 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aphasia Geodon PS Pfizer INTRAMUSCULAR 20 MG IM Cyanosis Geodon Injection SS Pfizer INTRAMUSCULAR 20MG IM Dyskinesia Extrapyramidal Disorder Muscle Tightness Pallor Tongue Dry Date:11/07/02ISR Number: 4008957-8Report Type:Expedited (15-DaCompany Report #2002064378 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Increased Consumer Geodon (Ziprasidone) PS Other Mesoridazine SS Thioridazine SS Klonopin(Clonazepam) C Date:11/08/02ISR Number: 4012343-4Report Type:Expedited (15-DaCompany Report #2002001221 Age:33 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Ziprasidone Initial or Prolonged Increased Health (Ziprasidone) PS 80 MG (TWICE Atrial Fibrillation Professional A DAY) Blood Lactate Zuclopenthixol C Dehydrogenase Increased Levomepromazine C Electrocardiogram Qt Oxazepam C Prolonged Citalopram C Gamma-Glutamyltransferase Increased Date:11/13/02ISR Number: 4010283-8Report Type:Expedited (15-DaCompany Report #2002064483 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Antinuclear Antibody Health Geodon (Ziprasidone) PS ORAL BID (BID), Initial or Prolonged Positive Professional ORAL Failure To Thrive Company Fluphenazine Intervertebral Disc Representative Hydrochloride C Disorder Fluphenazine Muscular Weakness Enantate C Nuclear Magnetic Tricyclic Resonance Imaging Antidepressants C Abnormal All Other Pain In Extremity Therapeutic Products C Red Blood Cell Sedimentation Rate Increased 22-Feb-2006 08:32 AM Page: 245 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/13/02ISR Number: 4010291-7Report Type:Expedited (15-DaCompany Report #2002004511 Age:13 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chest Pain Health Geodon (Ziprasidone) PS ORAL 120 MG (BID), Electrocardiogram Qt Professional ORAL Corrected Interval Company Depakote (Valproate Prolonged Representative Semisodium) C Electrocardiogram St Segment Abnormal Electrocardiogram T Wave Abnormal Date:11/13/02ISR Number: 4010323-6Report Type:Expedited (15-DaCompany Report #2002060835 Age:17 MON Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Exposure Health Geodon (Ziprasidone) PS ORAL ORAL Initial or Prolonged Blood Pressure Decreased Professional Other Depressed Level Of Consciousness Electrocardiogram Qt Corrected Interval Prolonged Electrocardiogram Qt Prolonged Sinus Tachycardia Date:11/13/02ISR Number: 4010325-XReport Type:Expedited (15-DaCompany Report #2002064480 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Feeling Abnormal Consumer Zoloft (Sertraline) PS ORAL 250 MG Initial or Prolonged Hypertension (DAILY), ORAL Suicidal Ideation Geodon (Ziprasidone) SS 120 MG (BID) Suicide Attempt Zolpidem Tartrate SS Valproate Semisodium SS Buspirone Hydrochloride SS Clonazepam SS Date:11/13/02ISR Number: 4010812-4Report Type:Expedited (15-DaCompany Report #2002003435 Age:34 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Health Geodon (Ziprasidone Initial or Prolonged Dyspnoea Professional Hydrochloride) PS ORAL 160 MG (BID), Pericarditis Company ORAL Representative Unspecified Medications C Ranitidine Hydrochloride C Paroxetine Hydrochloride C Hydroxyzine Embonate C Clonazepam C 22-Feb-2006 08:32 AM Page: 246 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/13/02ISR Number: 4010824-0Report Type:Expedited (15-DaCompany Report #2002064942 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Tardive Dyskinesia Health Geodon (Ziprasidone) PS ORAL 60 MG Initial or Prolonged Professional (DAILY), ORAL Benzatropine Mesilate C Fluoxetine Hydrochloride C Valproate Semisodium C Date:11/13/02ISR Number: 4010855-0Report Type:Expedited (15-DaCompany Report #2002064943 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Zoloft (Sertraline) PS ORAL 50 MG Initial or Prolonged Syndrome Professional (DAILY), ORAL Other Schizoaffective Disorder Geodon (Ziprasidone) SS ORAL 120 MG (TID), ORAL Calcium Carbonate C Disulfiram C Methadone C Alendronate Sodium C Pantoprazole C Buspirone Hydrochloride C Clonazepam C Metoprolol Tartrate C Date:11/13/02ISR Number: 4012046-6Report Type:Expedited (15-DaCompany Report #2002057729 Age:12 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fatigue Health Geodon (Ziprasidone) PS ORAL 40 MG TWICE A Initial or Prolonged Mastoiditis Professional DAY, ORAL Other Somnolence Buspirone Hydrochloride C Sertraline Hydrochloride C Melatonin C Pancrelipase C Guaifenesin C Topiramate C Levothyroxine Sodium C Hydrocortisone Acetate C Date:11/13/02ISR Number: 4012049-1Report Type:Expedited (15-DaCompany Report #2002064939 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Disorder Health Geodon (Ziprasidone) PS ORAL 160 MG TWICE Electrocardiogram Qt Professional A DAY, ORAL Prolonged Company Fluphenazine Representative Hydrochloride C Fluphenazine Decanoate C Quetiapine Fumarate C 22-Feb-2006 08:32 AM Page: 247 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/14/02ISR Number: 4012539-1Report Type:Expedited (15-DaCompany Report #2002065455 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Foreign Geodon (Ziprasidone) PS Health Professional Company Representative Date:11/14/02ISR Number: 4012936-4Report Type:Expedited (15-DaCompany Report #2002065359 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Consumer Geodon (Ziprasidone) PS 40 MG (DAILY) Initial or Prolonged Syndrome Lamotrigine C Other Vomiting Venlafaxine Hydrochloride C Date:11/15/02ISR Number: 4011304-9Report Type:Direct Company Report #CTU 181062 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Geodon PS ORAL 40MG PO QD BID Seroquel C Date:11/18/02ISR Number: 4013466-6Report Type:Expedited (15-DaCompany Report #2002065652 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Health Geodon (Ziprasidone) PS Syndrome Professional Serotonin Syndrome Company Representative Date:11/18/02ISR Number: 4013469-1Report Type:Expedited (15-DaCompany Report #2002066181 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Geodon (Ziprasidone) PS Professional Date:11/18/02ISR Number: 4013568-4Report Type:Expedited (15-DaCompany Report #2002056312 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Geodon (Ziprasidone) PS ORAL 80 MG (BID), Other Condition Aggravated Professional ORAL Fear Company Paroxetine Feeling Of Despair Representative Hydrochloride C Tardive Dyskinesia Bupropion Hydrochloride C Levothyroxine Sodium C 22-Feb-2006 08:32 AM Page: 248 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/18/02ISR Number: 4014891-XReport Type:Expedited (15-DaCompany Report #2002065353 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Foreign Zeldox (Capsules) Initial or Prolonged Health (Ziprasidone) PS ORAL 120 MG (BID), Professional ORAL Company Clozapine C Representative Perazine C Date:11/19/02ISR Number: 4015141-0Report Type:Expedited (15-DaCompany Report #2002066177 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Health Geodon (Ziprasidone) PS 160 MG Chest Pain Professional Olanzapine SS 20 MG Electrocardiogram Qt Company Corrected Interval Representative Prolonged Date:11/20/02ISR Number: 4012643-8Report Type:Direct Company Report #CTU 181410 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Geodon PS ORAL 160MG, 80MG Life-Threatening BID ORAL Disability Divalproex C Required Clonazepam C Intervention to Nicotine Transdermal Prevent Permanent Patch C Impairment/Damage Thiamine C Alum/Magnes/Simethic one C Ranitidine C Acetaminophen C Haloperidol C Date:11/20/02ISR Number: 4016630-5Report Type:Expedited (15-DaCompany Report #2002063957 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Geodon (Im) Initial or Prolonged Blood Pressure Increased Professional (Ziprasidone) PS INTRAMUSCULAR INTRAMUSCULAR Other Ventricular Arrhythmia Company Ventricular Tachycardia Representative Date:11/26/02ISR Number: 4017842-7Report Type:Expedited (15-DaCompany Report #2002066311 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Ziprasidone Initial or Prolonged Homicidal Ideation Health (Ziprasidone) PS ORAL 160 MG (BID), Mania Professional ORAL Company Diazepam C Representative 22-Feb-2006 08:32 AM Page: 249 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/26/02ISR Number: 4018181-0Report Type:Expedited (15-DaCompany Report #2002066651 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accelerated Health Geodon (Ziprasidone) PS 160 MG Initial or Prolonged Idioventricular Rhythm Professional Quetiapine Fumarate C Other Electrocardiogram T Wave Fluphenazine Abnormal Hydrochloride C Lithium C Trihexyphenidyl Hydrochloride C Clonazepam C Oxcarbazepine C Date:11/26/02ISR Number: 4018184-6Report Type:Expedited (15-DaCompany Report #2002066424 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Geodon (Ziprasidone) PS ORAL 160 MG Initial or Prolonged Anger Professional (DAILY), ORAL Other Schizophrenia Company Suicidal Ideation Representative Date:11/27/02ISR Number: 4019009-5Report Type:Expedited (15-DaCompany Report #2002067357 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Unevaluable Event Consumer Geodon (Ziprasidone) PS ORAL ORAL Initial or Prolonged Lithium C Haloperidol C Date:11/27/02ISR Number: 4019035-6Report Type:Expedited (15-DaCompany Report #2002064375 Age:83 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aggression Health Geodon (Ziprasidone) PS Other Agitation Professional All Other Aspiration Therapeutic Products C Blood Pressure Decreased Chloral Hydrate C Cognitive Disorder Confusional State Decreased Appetite Dehydration Delusion Depressed Level Of Consciousness Dysphagia General Physical Health Deterioration Hallucination Heart Rate Decreased Lethargy Oral Intake Reduced Pneumonitis Respiratory Arrest Restlessness Speech Disorder 22-Feb-2006 08:32 AM Page: 250 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/27/02ISR Number: 4019037-XReport Type:Expedited (15-DaCompany Report #2002067242 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hepatic Failure Health Geodon (Ziprasidone) PS Hospitalization - Sepsis Professional Metformin SS Initial or Prolonged Ramipril SS Other Quetiapine Fumarate SS Lithium Carbonate SS Date:11/27/02ISR Number: 4019049-6Report Type:Expedited (15-DaCompany Report #2002064943 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Zoloft (Sertraline) PS ORAL 50 MG Initial or Prolonged Catatonia Professional (DAILY), ORAL Other Delirium Geodon (Ziprasidone) SS ORAL 80 MG (BID), Neuroleptic Malignant ORAL Syndrome Calcium Carbonate C Restlessness Disulfiram C Methadone C Alendronate Sodium C Pantoprazole C Buspirone Hydrochloride C Clonazepam C Metoprolol Tartrate C Date:11/27/02ISR Number: 4019052-6Report Type:Expedited (15-DaCompany Report #2002061133 Age:38 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dry Mouth Health Geodon (Ziprasidone) PS ORAL 60 MG (BID), Tardive Dyskinesia Professional ORAL Company Fluoxetine C Representative Date:11/29/02ISR Number: 4018296-7Report Type:Expedited (15-DaCompany Report #2002062770 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Geodon (Ziprasidone) PS ORAL 240 MG (TID), Cardiac Disorder Professional ORAL Drug Ineffective Company Representative Date:11/29/02ISR Number: 4018297-9Report Type:Expedited (15-DaCompany Report #A118661 Age:28 YR Gender:Male I/FU:F Outcome PT Other Drug Interaction Dysphemia Feeling Cold Hallucination Hyperhidrosis Loss Of Consciousness Panic Reaction Pruritus 22-Feb-2006 08:32 AM Page: 251 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Rash Tremor Report Source Product Role Manufacturer Route Dose Duration Consumer Ziprasidone Health (Ziprasidone) PS 40 MG (BID) Professional Depakote (Sodium Valoproate) (Valproate Semidsodium) SS 750 MG (DAILY) Paxil (Paroxetine) (Paroxetine Hydrochloride) SS 10 MG (DAILY) Pepto Bismol (Bismuth Subsalicylate) (Bismuth Subsalicylate) C Aspirin (Acetylsalicylic Acid) (Acetylsalicylic Acid) C Date:11/29/02ISR Number: 4018839-3Report Type:Expedited (15-DaCompany Report #2002067964 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Central Nervous System Health Geodon (Ziprasidone) PS Initial or Prolonged Infection Professional Sinemet C Other Electrocardiogram Qt Company Bupropion Prolonged Representative Hydrochloride C Extrapyramidal Disorder Alprazolam C Neuroleptic Malignant Lithium C Syndrome Trihexyphenidyl Hydrochloride C Date:11/29/02ISR Number: 4019720-6Report Type:Expedited (15-DaCompany Report #CEL-2002-01441-ROC (0) Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Health Metadate Cd Capsules Blindness Transient Professional 20 Blindness Unilateral Mg(Methylphenidate Hypoaesthesia Hydrochloride) PS 60 MG(60 MG, Muscle Disorder DAILY)/ Vision Blurred SEVERAL MONTHS AGO- Geodon (Ziprasidone Hydrochloride) SS LOW DOSE (DAILY)/ SEVERAL MONTHS AGO- Effexor(Venlafaxine Hydrochloride) C Wellbutrin - Slow Release (Bupropion Hydrochloride) C 22-Feb-2006 08:32 AM Page: 252 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/03/02ISR Number: 4021016-3Report Type:Expedited (15-DaCompany Report #2002068179 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardio-Respiratory Arrest Neurontin Initial or Prolonged Delirium (Gabapentin) PS Other Geodon (Ziprasidone) SS 120 MG BID Clozappine SS Lithium SS Date:12/03/02ISR Number: 4021054-0Report Type:Expedited (15-DaCompany Report #2002066177 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Health Geodon (Ziprasidone) PS 160 MG (TWICE Chest Pain Professional A DAY) Dyspnoea Exertional Company Olanzapine SS 25 MG (DAILY) Electrocardiogram Qt Representative Liothyronine Sodium C Corrected Interval Lorazepam C Prolonged Citalopram Epistaxis Hydrobromide C Nausea Palpitations Vomiting Date:12/03/02ISR Number: 4025890-6Report Type:Periodic Company Report #2002061393 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Health Geodon (Ziprasidone) PS Professional Company Representative Date:12/03/02ISR Number: 4025891-8Report Type:Periodic Company Report #2002061395 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Health Geodon (Ziprasidone) PS Professional Company Representative Date:12/03/02ISR Number: 4025892-XReport Type:Periodic Company Report #2002061396 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Health Geodon (Ziprasidone) PS Professional Company Representative 22-Feb-2006 08:32 AM Page: 253 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/03/02ISR Number: 4025893-1Report Type:Periodic Company Report #2002061397 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Health Geodon (Ziprasidone) PS Professional Company Representative Date:12/03/02ISR Number: 4025894-3Report Type:Periodic Company Report #2002061462 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Geodon (Ziprasidone) PS 40 MG (20 MG, Professional BID) Company Representative Date:12/03/02ISR Number: 4025895-5Report Type:Periodic Company Report #2002061599 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bundle Branch Block Health Geodon (Ziprasidone) PS ORAL 160 MG (BID), Professional ORAL Bupropion Hydrochloride SS ORAL 200 MG (BID), ORAL Lorazepam C Date:12/03/02ISR Number: 4025896-7Report Type:Periodic Company Report #2002061784 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Priapism Health Geodon (Ziprasidone) PS 160 MG (BID) Initial or Prolonged Professional Trazodone C Company Representative Date:12/03/02ISR Number: 4025897-9Report Type:Periodic Company Report #2002062383 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Health Ziprasidone Prolonged Professional (Ziprasidone) PS (BID) Date:12/03/02ISR Number: 4025898-0Report Type:Periodic Company Report #2002062840 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gait Disturbance Consumer Geodon (Ziprasidone) PS ORAL ORAL Initial or Prolonged Hyperhidrosis Atorvastatin C Hyponatraemia Citalopram Schizophreniform Disorder Hydrobromide C Unspecified Blood Pressure Medication (All Other Therapeutic 22-Feb-2006 08:32 AM Page: 254 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Products) C Date:12/03/02ISR Number: 4025899-2Report Type:Periodic Company Report #2002065651 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Liver Function Test Health Geodon (Ziprasidone) PS ORAL 80 MG (TID), Initial or Prolonged Abnormal Professional ORAL Other Neurosis Valproate Semisodium SS ORAL 500 MG (BID), Personality Disorder ORAL Psychotic Disorder Sertraline Weight Increased Hydrochloride C Date:12/03/02ISR Number: 4025900-6Report Type:Periodic Company Report #2002057728 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypoaesthesia Health Geodon (Ziprasidone) PS ORAL 40 MG (BID), Tongue Oedema Professional ORAL Company Representative Date:12/03/02ISR Number: 4025901-8Report Type:Periodic Company Report #2002059209 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bradycardia Health Geodon (Ziprasidone) PS Electrocardiogram Qt Professional Prolonged Company Representative Date:12/03/02ISR Number: 4025902-XReport Type:Periodic Company Report #2002059211 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Health Geodon (Ziprasidone) PS Prolonged Professional Syncope Company Representative Date:12/03/02ISR Number: 4025903-1Report Type:Periodic Company Report #2002059580 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Consumer Geodon (Ziprasidone) PS Initial or Prolonged Confusional State Other Convulsion Depersonalisation Extrapyramidal Disorder Salivary Hypersecretion Visual Disturbance 22-Feb-2006 08:32 AM Page: 255 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/03/02ISR Number: 4025904-3Report Type:Periodic Company Report #2002059585 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Geodon (Ziprasidone) PS Professional Company Representative Date:12/03/02ISR Number: 4025905-5Report Type:Periodic Company Report #2002060577 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Emotional Disorder Consumer Geodon (Ziprasidone) PS ORAL ORAL Initial or Prolonged Insomnia Luvox (Fluvoxamine Oedema Maleate) C Oliguria Adderall (Obetrol) C Pruritus Date:12/03/02ISR Number: 4025906-7Report Type:Periodic Company Report #2002060759 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Health Geodon (Ziprasidone) PS ORAL ORAL Initial or Prolonged Electrocardiogram Qt Professional Salbutamol C Other Prolonged Company Fluticasone C Intentional Overdose Representative Rabeprazole C Zyprexa (Olanzapine) C Date:12/03/02ISR Number: 4025907-9Report Type:Periodic Company Report #2002061212 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bradycardia Health Geodon (Ziprasidone) PS Professional Propanolol(Propranol Company ol) SS Representative Date:12/03/02ISR Number: 4025908-0Report Type:Periodic Company Report #2002061215 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bradycardia Health Geodon (Ziprasidone Professional Hydrochloride) PS Company Propanolol Representative (Propranolol) SS Date:12/03/02ISR Number: 4026019-0Report Type:Periodic Company Report #2002000271 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Rash Health Geodon (Ziprasidone Initial or Prolonged Professional Hydrochloride) PS ORAL 80 MG (BID), ORAL Lithium Carbonate C 22-Feb-2006 08:32 AM Page: 256 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/03/02ISR Number: 4026021-9Report Type:Periodic Company Report #2002001148 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Somnolence Health Geodon (Ziprasidone Professional Hydrochloride) PS Date:12/03/02ISR Number: 4026024-4Report Type:Periodic Company Report #2002002425 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Geodon (Ziprasidone Initial or Prolonged Blood Creatinine Professional Hydrochloride) PS ORAL 120 MG (BID), Increased ORAL Blood Urea Increased Zerit (Stavudine) C Cerebrovascular Disorder Epivir (Lamivudine) C Emotional Disorder Levoxyl Hostility (Levothyroxine Hypertension Sodium) C Insomnia Claritin Laboratory Test Abnormal (Loratadine) C Mania Rescriptor Personality Disorder (Delavirdine Suicidal Ideation Mesylate) C Oxandrin (Oxandrolone) C Wellbutrin (Bupropion Hydrochloride) C Zyprexa (Olanzapine) C Viramune (Nevirapine) C Carbamazepine C Klonopin (Clonazepam) C Date:12/03/02ISR Number: 4026028-1Report Type:Periodic Company Report #2002003352 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Urinary Retention Health Geodon (Ziprasidone Intervention to Professional Hydrochloride) PS ORAL 160 MG (BID), Prevent Permanent ORAL Impairment/Damage Citalopram C Rabeprazole C Date:12/03/02ISR Number: 4026029-3Report Type:Periodic Company Report #2002003392 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pulmonary Embolism Health Geodon (Ziprasidone Professional Hydrochloride) PS Company Representative 22-Feb-2006 08:32 AM Page: 257 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/03/02ISR Number: 4026034-7Report Type:Periodic Company Report #2002003395 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pulmonary Embolism Health Geodon (Ziprasidone Professional Hydrochloride) PS Company Representative Date:12/03/02ISR Number: 4026040-2Report Type:Periodic Company Report #2002056966 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Health Geodon (Ziprasidone) PS ORAL 80 MG (BID), Professional ORAL Company Representative Date:12/03/02ISR Number: 4026042-6Report Type:Periodic Company Report #2002057074 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Extrapyramidal Disorder Health Geodon (Ziprasidone) PS Professional Company Representative Date:12/03/02ISR Number: 4026043-8Report Type:Periodic Company Report #2002057235 Age:12 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Syncope Health Geodon (Ziprasidone) PS ORAL 20 MG Professional (DAILY), ORAL Company Lithium C Representative Paroxetine Hydrochloride C Mercaptopurine C Date:12/03/02ISR Number: 4026044-XReport Type:Periodic Company Report #2002057496 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Catatonia Health Geodon (Ziprasidone) PS 160 MG (BID), Electrocardiogram Qt Professional Prolonged Company Representative Date:12/03/02ISR Number: 4026509-0Report Type:Periodic Company Report #2002000552 Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Syncope Health Geodon (Ziprasidone Initial or Prolonged Professional Hydrochloride) PS 40 MG (BID, Company Valproate Semisodium C Representative Gabapentin C Lorazepam C Citalopram 22-Feb-2006 08:32 AM Page: 258 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrobromide C Date:12/03/02ISR Number: 4026511-9Report Type:Periodic Company Report #2002000957 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Priapism Health Ziprasidone Professional (Ziprasidone) PS Thioridazine Hydrochloride C Date:12/03/02ISR Number: 4026515-6Report Type:Periodic Company Report #2002002578 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Urinary Retention Health Geodon (Ziprasidone Professional Hydrochloride) PS ORAL 160 MG (BID), ORAL Citalopram C Rabeprazole C Date:12/04/02ISR Number: 4020197-5Report Type:Direct Company Report #CTU 182286 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Ziprasidone PS 160MG DAY Initial or Prolonged Blood Thyroid Stimulating Depakoten (Valproate Hormone Increased Semisodium) C Depression Eskalith (Lithium Drug Level Below Carbonate) C Therapeutic Drug Level Increased Hypothyroidism Suicidal Ideation Date:12/04/02ISR Number: 4021550-6Report Type:Expedited (15-DaCompany Report #2002068307 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Consumer Geodon (Ziprasidone) PS ORAL 20 MG Initial or Prolonged Aggression (DAILY), ORAL Agitation Bupropion Bipolar Disorder Hydrochloride C Condition Aggravated Paroxetine Homicidal Ideation Hydrochloride C Mania Obsessive-Compulsive Disorder Restlessness Suicide Attempt Weight Increased 22-Feb-2006 08:32 AM Page: 259 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/04/02ISR Number: 4021938-3Report Type:Expedited (15-DaCompany Report #2002055313 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancreatitis Health Geodon (Ziprasidone) PS Initial or Prolonged Professional Atorvastatin C Other Company Levothyroxine Sodium C Representative Trazodone C Date:12/05/02ISR Number: 4021892-4Report Type:Expedited (15-DaCompany Report #2002060759 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Health Geodon (Ziprasidone) PS ORAL ORAL Initial or Prolonged Prolonged Professional Salbutamol C Other Intentional Overdose Company Fluticasone C Sinus Bradycardia Representative Rabeprazole C Suicide Attempt Olanzapine C Benzatropine Mesilate C Haloperidol C Lorazepam C Date:12/05/02ISR Number: 4022583-6Report Type:Expedited (15-DaCompany Report #2002069157 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Angioneurotic Oedema Foreign Zeldox (Ziprasidone) PS ORAL 80 MG, ORAL Dermatitis Atopic Health Bromperidol C Rash Generalised Professional Biperiden Streptococcal Serology Hydrochloride C Positive Date:12/09/02ISR Number: 4023125-1Report Type:Expedited (15-DaCompany Report #2002062770 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Geodon (Ziprasidone) PS ORAL 240 MG (TID), Cardiac Disorder Professional ORAL Dilatation Ventricular Company Intentional Overdose Representative Medication Error Date:12/09/02ISR Number: 4023127-5Report Type:Expedited (15-DaCompany Report #2002064375 Age:83 YR Gender:Male I/FU:F Outcome PT Death Aggression Other Agitation Aspiration Blood Pressure Decreased Cognitive Disorder Coma Condition Aggravated Confusional State Decreased Appetite Dehydration Dysarthria 22-Feb-2006 08:32 AM Page: 260 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dysphagia Heart Rate Decreased Hypersomnia Report Source Product Role Manufacturer Route Dose Duration Insomnia Health Geodon (Ziprasidone) PS Irritability Professional All Other Lethargy Therapeutic Products C Pneumonitis Chloral Hydrate C Respiratory Arrest Restlessness Somnolence Date:12/09/02ISR Number: 4023192-5Report Type:Expedited (15-DaCompany Report #2002068780 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram St Foreign Geodon (Ziprasidone) PS ORAL 200 MG, ORAL Initial or Prolonged Segment Depression Health Haloperidol C Professional Valproic Acid C Company Levomepromazine C Representative Date:12/09/02ISR Number: 4023194-9Report Type:Expedited (15-DaCompany Report #2002060836 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Petit Mal Epilepsy Foreign Zeldox (Capsules) Initial or Prolonged Vomiting Health (Ziprasidone) PS ORAL 180 MG, ORAL Other Professional Lithium C Carbamazepine C Levomepromazine C Haloperidol C Levothyroxine Sodium C Pantoprazole Sodium C Date:12/09/02ISR Number: 4023270-0Report Type:Expedited (15-DaCompany Report #2002069500 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fatigue Foreign Zeldox (Ziprasidone) PS ORAL 80 MG Initial or Prolonged Respiratory Depression Consumer (DAILY), ORAL Date:12/09/02ISR Number: 4023467-XReport Type:Expedited (15-DaCompany Report #2002069463 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blindness Transient Health Geodon (Ziprasidone) PS DAILY Blindness Unilateral Professional Methylphenidate Multiple Sclerosis Hydrochloride SS 60 MG (DAILY) Vision Blurred Venlafaxine Hydrochloride C Bupropion Hydrochloride C 22-Feb-2006 08:32 AM Page: 261 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/09/02ISR Number: 4023775-2Report Type:Expedited (15-DaCompany Report #2002069503 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bradycardia Foreign Geodon Coma Consumer (Ziprasidone) PS ORAL ORAL Electrocardiogram Abnormal Hypotension Myocardial Ischaemia Respiratory Arrest Date:12/10/02ISR Number: 4024750-4Report Type:Expedited (15-DaCompany Report #2002060759 Age:31 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Consumer Geodon (Ziprasidone) PS ORAL ORAL Initial or Prolonged Electrocardiogram Qt Health Salbutamol C Other Prolonged Professional Fluticasone C Intentional Overdose Company Rabeprazole C Sinus Bradycardia Representative Olanzapine C Suicide Attempt Benzatropine Mesilate C Haloperidol C Lorazepam C Date:12/10/02ISR Number: 4024967-9Report Type:Expedited (15-DaCompany Report #2002065652 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Health Geodon (Ziprasidone) PS ORAL 80 MG Abnormal Professional (DAILY), ORAL Aspartate Company Venlafaxine Aminotransferase Abnormal Representative Hydrochloride SS Blood Alkaline Lansoprazole C Phosphatase Abnormal Zolpidem Tartrate C Blood Creatine Combivent C Phosphokinase Abnormal Glibenclamide C Blood Creatine Phosphokinase Mb Abnormal Blood Pressure Increased Dyspnoea Electrocardiogram Qt Prolonged Heart Rate Increased Hyperhidrosis Muscle Rigidity Muscle Twitching Pyrexia White Blood Cell Count Abnormal Date:12/12/02ISR Number: 4026424-2Report Type:Expedited (15-DaCompany Report #2002059991 Age: Gender:Female I/FU:I Outcome PT Hospitalization - Alanine Aminotransferase Initial or Prolonged Increased Aspartate 22-Feb-2006 08:32 AM Page: 262 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Aminotransferase Increased Bilirubin Conjugated Increased Report Source Product Role Manufacturer Route Dose Duration Blood Alkaline Health Geodon (Ziprasidone) PS 30 MG (DAILY) Phosphatase Increased Professional Celecoxib SS Blood Lactate Company Carbamazepine C Dehydrogenase Increased Representative Lamotrigine C Gamma-Glutamyltransferase Increased Influenza Like Illness Date:12/13/02ISR Number: 4023543-1Report Type:Direct Company Report #CTU 182684 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Electrocardiogram Qt Ziprasadone PS 100MG BID Intervention to Prolonged Quetiapine SS 300 AM 600HS Prevent Permanent Impairment/Damage Date:12/16/02ISR Number: 4027063-XReport Type:Expedited (15-DaCompany Report #2002061950 Age:66 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Health Geodon (Ziprasidone) PS ORAL 20 MG Myocardial Infarction Professional (DAILY), ORAL Company Rofecoxib C Representative Olanzapine C Benazepril Hydrochloride C Pantoprazole C Acetylsalicylic Acid C Warfarin Sodium C Insulin Injection, Isophane C Megestrol Acetate C Metoprolol Tartrate C Docusate Sodium C Cefalexin Monohydrate C Levothyroxine Sodium C Lansoprazole C Bupropion Hydrochloride C Citalopram Bromide C Lorazepam C Valproate Semisodium C Insulin C Date:12/17/02ISR Number: 4027963-0Report Type:Expedited (15-DaCompany Report #2002069819 Age:39 YR Gender:Female I/FU:I Outcome PT Hospitalization - Akathisia Initial or Prolonged Alcoholism Other Depression Insomnia Mania 22-Feb-2006 08:32 AM Page: 263 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Weight Decreased Report Source Product Role Manufacturer Route Dose Duration Health Geodon (Ziprasidone) PS (DAILY) Professional Venlafaxine Hydrochloride SS 300 MG (DAILY) Topiramate C Trazodone C Disulfiram C Date:12/17/02ISR Number: 4028290-8Report Type:Expedited (15-DaCompany Report #2002070058 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hypotension Foreign Ziprasidone Hospitalization - Health (Ziprasidone) PS INTRAMUSCULAR 20 MG(DAILY), Initial or Prolonged Professional INTRAMUSCULAR Company Carbamazepine C Representative Date:12/18/02ISR Number: 4025725-1Report Type:Direct Company Report #CTU 183007 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Movement Disorder Seroquel 300mg Tabs Astra Zeneca PS Astra Zeneca ORAL 600MG PO QHS Geodon 80mg Caps Pfizer SS Pfizer ORAL 80MG PO BID Altace C Valproic Acid C Prevacid C Klonopin C Glucophage C Motrin C Tylenol C Kaopectate C Maalox C Date:12/18/02ISR Number: 4029490-3Report Type:Expedited (15-DaCompany Report #A213712 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Health Geodon (Ziprasidone) PS 40 MG BID Initial or Prolonged Electrocardiogram Qt Professional Luvox (Fluvoxamine Prolonged Maleate) SS 150 MG (BID) Risperidone SS 80 MG (TWICE A DAY) Clonazepam C Docusate C Benzatropine C Valproate Sodium C Oxybutynin C 22-Feb-2006 08:32 AM Page: 264 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/18/02ISR Number: 4029531-3Report Type:Expedited (15-DaCompany Report #2002002454 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bipolar I Disorder Consumer Ziprasidone Initial or Prolonged Bruxism (Ziprasidone) PS ORAL 80 MG Dyskinesia (DAILY), ORAL Rhinorrhoea Lamotrigine C Lithium Carbonate C Clonazepam C Oxcarbazepine C Levothyroxine Sodium C Date:12/19/02ISR Number: 4026344-3Report Type:Direct Company Report #CTU 183045 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Coma Geodon 40mg Roerig PS Roerig ORAL 40 MG BID Drug Level Increased ORAL Movement Disorder Carbamazepine C Sedation Ceftriaxone C Enalapril C Furosemide C Insulin C Levothyroxine C Potassium Chloride C Famotidine C Date:12/20/02ISR Number: 4030873-6Report Type:Expedited (15-DaCompany Report #2002070646 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Failure Health Geodon (Ziprasidone) PS Professional Zoloft (Sertraline) SS Company Wellbutrin Representative (Bupropion Hydrochloride) SS Date:12/20/02ISR Number: 4030876-1Report Type:Expedited (15-DaCompany Report #2002056813 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Health Geodon (Ziprasidone Initial or Prolonged Agitation Professional Hydrochloride) PS 60 MG (BID) Other Anger Risperdal Hostility (Risperidone) SS ORAL 6 MG (DAILY), ORAL Zestril (Lisinopril) SS 10 MG (DAILY) Lorzepam C Date:12/20/02ISR Number: 4031286-3Report Type:Expedited (15-DaCompany Report #2002060577 Age:44 YR Gender:Female I/FU:I Outcome PT Hospitalization - Crying Initial or Prolonged Hypersensitivity Insomnia Mental Disorder 22-Feb-2006 08:32 AM Page: 265 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Oliguria Retching Report Source Product Role Manufacturer Route Dose Duration Consumer Geodon (Ziprasidone) PS ORAL ORAL Luvox (Fluvoxamine Maleate) C Aderall (Obetrol) C Date:12/23/02ISR Number: 4032436-5Report Type:Expedited (15-DaCompany Report #2002071211 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Consumer Geodon(Ziprasidone) PS ORAL 40 MG Initial or Prolonged Agitation (DAILY), ORAL Anger Valproate Semisodium SS Depression Paroxetine Energy Increased Hydrochloride C Homicidal Ideation Hypersomnia Logorrhoea Mania Parosmia Weight Decreased Weight Increased Date:12/23/02ISR Number: 4032821-1Report Type:Expedited (15-DaCompany Report #2002071322 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Disease Recurrence Literature Geodon (Ziprasidone) PS ORAL 40 MG (BID), Initial or Prolonged Hyponatraemia Health ORAL Other Neuroleptic Malignant Professional Gabapentin Syndrome (Gabapentin) SS ORAL 600 MG (BID), Neutrophilia ORAL Polydipsia Psychogenic Venlafaxine Psychotic Disorder Hydrochloride SS ORAL 300 MG (BID), Rhabdomyolysis ORAL Tardive Dyskinesia Lorazepam SS ORAL 1.5 MG White Blood Cell Count (DAILY), ORAL Increased Date:12/23/02ISR Number: 4032847-8Report Type:Expedited (15-DaCompany Report #A209320 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Epstein-Barr Virus Health Geodon (Ziprasidone) PS ORAL 40 MG (ORAL), Initial or Prolonged Antigen Positive Professional ORAL Other Neuroleptic Malignant Tylenol(Paracetamol) C Syndrome Depakote(Valproate Semisodium) C Date:12/23/02ISR Number: 4032866-1Report Type:Expedited (15-DaCompany Report #2002059991 Age: Gender:Female I/FU:F Outcome PT Hospitalization - Alanine Aminotransferase Initial or Prolonged Increased 22-Feb-2006 08:32 AM Page: 266 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Aspartate Aminotransferase Increased Report Source Product Role Manufacturer Route Dose Duration Blood Alkaline Health Geodon (Ziprasidone) PS 30 MG (DAILY) Phosphatase Increased Professional Celecoxib SS Blood Bilirubin Increased Company Carbamazepine C Blood Lactate Representative Lamotrigine C Dehydrogenase Increased Gamma-Glutamyltransferase Increased Influenza Like Illness Date:12/23/02ISR Number: 4032959-9Report Type:Expedited (15-DaCompany Report #2002062680 Age:73 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypoxia Consumer Geodon (Im) Refusal Of Treatment By Health (Ziprasidone) PS INTRAMUSCULAR 20 MG (BID), Patient Professional INTRAMUSCULAR Syncope Clonidine SS TRANSDERMAL TRANSDERMAL Haloperidol C Chlorpromazine Hydrochloride C Fluphenazine Hydrochloride C Trifluoperazine Hydrochloride C Metoprolol Tartrate C Date:12/26/02ISR Number: 4030690-7Report Type:Direct Company Report #CTU 183401 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Rash Geodon 20 Mg PS 1 DOSE Initial or Prolonged Depakote C Ditropan C Haldol C Levothyroid C Norvasc C Protonix C Naldecon C Date:12/26/02ISR Number: 4030706-8Report Type:Direct Company Report #CTU 183354 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dystonia Ziprasidone 80 Mg Intervention to Muscle Rigidity Pfizer PS Pfizer ORAL 80MG BID ORAL Prevent Permanent Impairment/Damage Date:12/26/02ISR Number: 4034745-2Report Type:Expedited (15-DaCompany Report #2002071786 Age: Gender:Male I/FU:I Outcome Hospitalization - Initial or Prolonged 22-Feb-2006 08:32 AM Page: 267 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other PT Report Source Product Role Manufacturer Route Dose Duration Neuroleptic Malignant Health Geodon (Ziprasidone) PS ORAL 160 MG, ORAL Syndrome Professional Bupropion Company Hydrochloride C Representative Date:12/26/02ISR Number: 4035169-4Report Type:Expedited (15-DaCompany Report #2002071918 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Tongue Oedema Health Geodon (Ziprasidone) PS ORAL 40 MG (BID), Initial or Prolonged Professional ORAL Other Company Representative Date:12/26/02ISR Number: 4035176-1Report Type:Expedited (15-DaCompany Report #2002071784 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oedema Health Geodon (Ziprasidone) PS Pituitary Tumour Professional Company Representative Date:12/26/02ISR Number: 4035272-9Report Type:Expedited (15-DaCompany Report #2002069463 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Health Geodon (Ziprasidone) PS ORAL 40 MG (BID), Blindness Transient Professional ORAL Feeling Abnormal Methylphenidate Hypoaesthesia Hydrochloride SS ORAL 60 MG Multiple Sclerosis (DAILY), ORAL Vision Blurred Venlafaxine Hydrochloride C Bupropion Hydrochloride C Date:12/26/02ISR Number: 4035307-3Report Type:Expedited (15-DaCompany Report #2002065455 Age:70 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Foreign Geodon (Ziprasidone) PS 1 MON Health Professional Date:12/27/02ISR Number: 4035112-8Report Type:Expedited (15-DaCompany Report #2002066651 Age:27 YR Gender:Male I/FU:F Outcome PT Hospitalization - Electrocardiogram Qt Initial or Prolonged Corrected Interval Other Prolonged Electrocardiogram Qt 22-Feb-2006 08:32 AM Page: 268 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prolonged Electrocardiogram T Wave Abnormal Nodal Arrhythmia Report Source Product Role Manufacturer Route Dose Duration Sinus Tachycardia Health Geodon (Ziprasidone) PS 120 MG (BID) Professional Quetiapine Fumarate C Fluphenazine Hydrochloride C Lithium C Trihexyphenidyl C Clonazepam C Oxacarbazepine C Date:12/30/02ISR Number: 4032768-0Report Type:Direct Company Report #CTU 183508 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Akathisia Geodon 60mg; Intervention to Dysarthria Pfizer PS Pfizer ORAL 60MG BID PO Prevent Permanent Effexor Xr C Impairment/Damage Date:12/30/02ISR Number: 4036494-3Report Type:Expedited (15-DaCompany Report #2002070646 Age:24 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fall Health Geodon (Ziprasidone) PS ORAL 160 MG, ORAL Respiratory Failure Professional Zoloft (Sertraline) SS ORAL ORAL Toxicologic Test Abnormal Company Wellbutrin Representative (Bupropion Hydrochloride) SS Obetrol C Risperidone C Date:12/31/02ISR Number: 4037901-2Report Type:Expedited (15-DaCompany Report #2002059635 Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Myocardial Infarction Health Geodon (Ziprasidone) PS ORAL 40 MG Initial or Prolonged Professional (DAILY), ORAL Other Depakote (Valproate Semisodium) C Glucophage (Metformin) C Rantidine C Premarin (Estrogens Conjugated) C Lopid (Gemfibrozil) C Amaryl (Glimepiride) C Hydrochlorothiazide C Lorazepam C Tylenol #3 (Panadeine Co) C Buspar (Buspirone Hydrohcloride ) C 22-Feb-2006 08:32 AM Page: 269 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/31/02ISR Number: 4037902-4Report Type:Expedited (15-DaCompany Report #2002059821 Age:15 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Health Geodon (Ziprasidone) PS 40 MG (BID) Initial or Prolonged Extrapyramidal Disorder Professional Paroxetine Torticollis Company Hydrochloride SS 60 MG Tremor Representative Clomipramine Hydrochloride C Date:01/03/03ISR Number: 4035117-7Report Type:Direct Company Report #CTU 183757 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Ziprasidone PS Initial or Prolonged Prolonged Required Hypokalaemia Intervention to Treatment Noncompliance Prevent Permanent Impairment/Damage Date:01/03/03ISR Number: 4035475-3Report Type:Direct Company Report #USP 55434 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Geodon For Inj PS Ben Venue Labs, Inc. Date:01/03/03ISR Number: 4035776-9Report Type:Direct Company Report #USP 55391 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Geodon PS Ben Venue Labs Inc/Distributor: Pfizer/Roerig Date:01/03/03ISR Number: 4038692-1Report Type:Expedited (15-DaCompany Report #2002073086 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Ziprasidone Non-Insulin-Dependent Health (Ziprasidone) PS Professional Date:01/03/03ISR Number: 4039081-6Report Type:Expedited (15-DaCompany Report #2002061054 Age:26 YR Gender:Female I/FU:I Outcome PT Hospitalization - Abdominal Pain Initial or Prolonged Asthenia Other Cerebrovascular Accident Depression Headache Hypokalaemia Nystagmus Paraesthesia Petit Mal Epilepsy Suicidal Ideation 22-Feb-2006 08:32 AM Page: 270 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tremor Vomiting Report Source Product Role Manufacturer Route Dose Duration Health Geodon (Ziprasidone) PS ORAL 40 MG Professional (DAILY), ORAL Lamotrigine SS ORAL 100 MG (BID), ORAL Diphenhydramine Hydrochloride SS 50 MG Excedrin C Date:01/03/03ISR Number: 4039188-3Report Type:Expedited (15-DaCompany Report #2002067076 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Health Geodon (Ziprasidone) PS ORAL 80 MG (BID), Initial or Prolonged Chest Pain Professional ORAL Dizziness Haloperidol Dyspnoea Decanoate C Loss Of Consciousness Citalopram Syncope Hydrobromide C Trazodone C Benzatropine Mesilate C Enalapril C Metoprolol C Lansoprazole C Hydroxyzine C Date:01/03/03ISR Number: 4039196-2Report Type:Expedited (15-DaCompany Report #2002066181 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Circulatory Collapse Health Geodon (Ziprasidone) PS ORAL 60 MG Other Coronary Artery Professional (DAILY), ORAL Atherosclerosis Company Haloperidol Myocardial Ischaemia Representative Decanoate C Date:01/07/03ISR Number: 4039552-2Report Type:Expedited (15-DaCompany Report #2002073360 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Mood Literature Geodon (Ziprasidone) PS ORAL 180 MG (TID), Initial or Prolonged Galactorrhoea Health ORAL Paranoia Professional Sertraline C Suicidal Ideation Olanzapine C Quetiapine C Valproate Semisodium C Date:01/09/03ISR Number: 4039799-5Report Type:Direct Company Report #CTU 184158 Age:17 YR Gender:Male I/FU:I Outcome PT Other Electrocardiogram Repolarisation Abnormality Sinus Arrhythmia 22-Feb-2006 08:32 AM Page: 271 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sinus Bradycardia Report Source Product Role Manufacturer Route Dose Duration Geodon PS 40MG Q AN AND 160 MG QHS Thyrolar C Lamictal C Colace C Topamax C Ddavp C Date:01/09/03ISR Number: 4039812-5Report Type:Direct Company Report #CTU 184146 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Aggression Geodon (Ziprasidone) Agitation 20 Mg Im PS INTRAMUSCULAR 20 MG IM X 1 Anxiety Albuterol C Blood Potassium Decreased Amlodipine C Blood Pressure Increased Aspirin C Heart Rate Decreased Bactrim C Respiratory Failure Centrum C Respiratory Rate Clonidine C Increased Dalteparin C Flumazenil C Famotidine C Furosemide C Gabapentin C Gatifloxacin C Geodon C Plaquenil C Lorazepam C Methadone C Methylprednisolone C Oscal C Pantoprazole C Paroxetine C Prednisone C Rofecoxib C Tizanidine C Zosyn C Date:01/10/03ISR Number: 4040888-XReport Type:Expedited (15-DaCompany Report #2002070102 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drug Ineffective Health Geodon (Ziprasidone) PS 160 MG (BID) Feeling Abnormal Professional Quetiapine Fumarate SS Hallucination, Auditory Company Paroxetine Nausea Representative Hydrochloride C Paranoia Haloperidol C Vomiting 22-Feb-2006 08:32 AM Page: 272 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/10/03ISR Number: 4041186-0Report Type:Expedited (15-DaCompany Report #2002068780 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Foreign Geodon (Ziprasidone) PS ORAL 200 MG, ORAL Initial or Prolonged Chest Pain Health Haloperidol SS ORAL 60 MG, ORAL Dizziness Professional Valproic Acid C Dyspepsia Company Levomepromazine C Electrocardiogram St Representative Amantadine C Segment Depression Date:01/11/03ISR Number: 4072642-7Report Type:Direct Company Report #CTU 188432 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Rash Erythematous Geodon PS ORAL 40MG PO BID Glucophage C Glucotrol C Zestril C Wellbutrin C Date:01/13/03ISR Number: 4041050-7Report Type:Expedited (15-DaCompany Report #A0382645A Age:26 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Health Lamictal PS Glaxo Wellcome ORAL 50MG Twice Depression Professional per day 6 WK Drug Interaction Geodon SS ORAL 40MG Per day 1 DAY Hallucination, Auditory Headache Hypokalaemia Nausea Paraesthesia Tearfulness Tremor Vomiting Date:01/13/03ISR Number: 4042363-5Report Type:Periodic Company Report #2002069560 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oculogyration Health Ziprasidone Professional (Ziprasidone PS INTRAMUSCULAR INTRAMUSCULAR Company Representative Date:01/13/03ISR Number: 4042397-0Report Type:Expedited (15-DaCompany Report #2003000223 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Tardive Dyskinesia Health Geodon (Ziprasidone) PS ORAL 80 MG (BID), Initial or Prolonged Professional ORAL Clozapine C Venlafaxine Hydrochloride C Lorazepam C Lansoprazole C Potassium Chloride C 22-Feb-2006 08:32 AM Page: 273 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Mesalazine C Fludrocortisone Acetate C Date:01/14/03ISR Number: 4042694-9Report Type:Expedited (15-DaCompany Report #2003000371 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Health Geodon (Ziprasidone) PS Syndrome Professional Company Representative Date:01/14/03ISR Number: 4042722-0Report Type:Expedited (15-DaCompany Report #02P-062-0204412-00 Age:21 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delirium Foreign Akineton Retard Initial or Prolonged Health (Biperiden) PS ORAL SEE IMAGE Professional Ziprasidone Hydrochloride SS ORAL SEE IMAGE Olanzapine SS ORAL SEE IMAGE Lorazepam C Date:01/14/03ISR Number: 4043031-6Report Type:Expedited (15-DaCompany Report #2003000349 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Ileus Paralytic Foreign Ziprasidone Hospitalization - Health (Ziprasidone) PS ORAL 160 MG (BID), Initial or Prolonged Professional ORAL Company Clozapine Representative (Clozapine) SS ORAL 600 MG, ORAL Clonazepam C Date:01/16/03ISR Number: 4043650-7Report Type:Expedited (15-DaCompany Report #2003000677 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Health Geodon (Ziprasidone) PS ORAL ORAL Initial or Prolonged Professional Citalopram Hydrobromide C Hyzaar C Date:01/16/03ISR Number: 4044095-6Report Type:Expedited (15-DaCompany Report #2003001011 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Foreign Zeldox (Ziprasidone) PS ORAL 120 MG (TWICE Initial or Prolonged Depression Health A DAY), ORAL Emotional Disorder Professional Hypomania Mood Altered Suicidal Ideation 22-Feb-2006 08:32 AM Page: 274 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/17/03ISR Number: 4044796-XReport Type:Expedited (15-DaCompany Report #2002068357 Age:67 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Stevens-Johnson Syndrome Foreign Zeldox (Capsules) Health (Ziprasidone) PS ORAL 40 MG(TWICE A Professional DAY), ORAL Date:01/21/03ISR Number: 4043970-6Report Type:Direct Company Report #CTU 184834 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Geodon PS ORAL 60MG DAILY Initial or Prolonged ORAL Lithobid SS ORAL DAILY ORAL Date:01/21/03ISR Number: 4044013-0Report Type:Expedited (15-DaCompany Report #2002059991 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Consumer Geodon (Ziprasidone) PS ORAL 30 MG Initial or Prolonged Increased Health (DAILY), ORAL Aspartate Professional Celecoxib SS ORAL ORAL Aminotransferase Company Carbamazepine C Increased Representative Lamotrigine C Blood Alkaline Phosphatase Increased Blood Bilirubin Increased Blood Lactate Dehydrogenase Increased Gamma-Glutamyltransferase Increased Influenza Like Illness Date:01/21/03ISR Number: 4044238-4Report Type:Direct Company Report #CTU 184884 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Ziprasidone PS ORAL 80MG PO BID Initial or Prolonged Syndrome Date:01/21/03ISR Number: 4044959-3Report Type:Expedited (15-DaCompany Report #2003001185 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Consumer Zoloft (Sertraline) PS ORAL 150 MG Initial or Prolonged Coma (DAILY), ORAL Other Convulsion Geodon (Ziprasidone) SS ORAL 20 MG Muscle Twitching (BID),ORAL Panic Disorder Poverty Of Speech Respiratory Disorder Syncope 22-Feb-2006 08:32 AM Page: 275 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/23/03ISR Number: 4047068-2Report Type:Expedited (15-DaCompany Report #2002067242 Age:58 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Autoimmune Hepatitis Health Geodon (Ziprasidone) PS ORAL ORAL Hospitalization - Cholelithiasis Professional Metformin SS ORAL 500 MG Initial or Prolonged General Physical Health (DAILY), ORAL Other Deterioration Ramipril SS Hepatic Failure Quetiapine Fumarate SS 100 MG Ischaemia (DAILY) Pancreatitis Lithium Carbonate SS Sepsis Vitamins C Docusate Sodium C Psyllium C Date:01/23/03ISR Number: 4047074-8Report Type:Expedited (15-DaCompany Report #2002063201 Age:55 YR Gender:Female I/FU:F Outcome PT Hospitalization - Alanine Aminotransferase Initial or Prolonged Increased Other Aspartate Aminotransferase Increased Blood Alkaline Phosphatase Increased Blood Glucose Increased Blood Triglycerides Increased Breast Mass Breast Pain Breathing-Related Sleep Disorder Bundle Branch Block Right Cardiac Failure Cardiomegaly Circadian Rhythm Sleep Disorder Clonic Convulsion Condition Aggravated Cough Difficulty In Walking Dizziness Drug Effect Decreased Dysstasia Electrocardiogram Qt Corrected Interval Shortened Electrocardiogram Qt Prolonged Electrocardiogram St-T Change Face Oedema General Physical Health Deterioration Hypersomnia Ill-Defined Disorder Laboratory Test Abnormal Lung Disorder Neglect Of Personal Appearance 22-Feb-2006 08:32 AM Page: 276 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Oedema Peripheral Pallor Paranoia Report Source Product Role Manufacturer Route Dose Duration Parotid Gland Enlargement Health Geodon (Ziprasidone) PS ORAL 40 MG Pericardial Effusion Professional (DAILY); ORAL Pitting Oedema Mirtazapine SS ORAL 30 MG Psychotic Disorder (DAILY); ORAL Rash Pravastatin Sodium C Schizoaffective Disorder Clozapine C Sinus Arrhythmia Quetiapine Fumarate C Sinus Bradycardia Venlafaxine Sinus Tachycardia Hydrochloride C Somnolence Ventricular Hypertrophy Ventricular Wall Thickening Weight Increased Date:01/23/03ISR Number: 4047179-1Report Type:Expedited (15-DaCompany Report #A108646 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Consumer Geodon(Ziprasidone) PS ORAL ORAL Initial or Prolonged Mania Health Neurontin Medication Error Professional (Gabapentin) SS 3600 MG Schizophrenia (TID); UNKNOWN Quetiapine Fumarate SS ORAL 300 MG (DAILY); ORAL Ethanol SS ORAL (UNKNOWN), ORAL Valproate Semisodium C Clonazepam C Date:01/28/03ISR Number: 4048792-8Report Type:Expedited (15-DaCompany Report #2003001651 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Geodon (Im) Professional (Ziprasidone) PS INTRAMUSCULAR INTRAMUSCULAR Date:01/28/03ISR Number: 4049039-9Report Type:Expedited (15-DaCompany Report #2003001969 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Foreign Geodon(Ziprasidone) PS Health Professional Company Representative Date:01/28/03ISR Number: 4049369-0Report Type:Expedited (15-DaCompany Report #2002065455 Age:70 YR Gender:Male I/FU:F Outcome PT Report Source Death Hypertension Foreign Sudden Death Health 22-Feb-2006 08:32 AM Page: 277 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Company Representative Product Role Manufacturer Route Dose Duration Geodon (Ziprasidone) PS Date:01/29/03ISR Number: 4048906-XReport Type:Direct Company Report #CTU 185501 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Geodon Pfizer PS Pfizer ORAL ONE TIME ORAL Initial or Prolonged Oculogyration Date:01/29/03ISR Number: 4048907-1Report Type:Direct Company Report #CTU 185503 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Geodon 40mg Pfizer PS Pfizer ORAL 40MG BID ORAL Initial or Prolonged Electrocardiogram Qt Lorazepam C Corrected Interval Prolonged Date:01/29/03ISR Number: 4049899-1Report Type:Expedited (15-DaCompany Report #2003001970 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gastritis Foreign Zeldox (Capsules) Initial or Prolonged Consumer (Ziprasidone) PS Date:01/29/03ISR Number: 4049912-1Report Type:Expedited (15-DaCompany Report #2003001709 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Foreign Ziprasidone Initial or Prolonged Syndrome Health (Ziprasidone) PS ORAL 120 MG (BID), Other Schizophrenia Professional ORAL Risperidone C Date:01/29/03ISR Number: 4049914-5Report Type:Expedited (15-DaCompany Report #2003001689 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drug Hypersensitivity Foreign Zeldox (Ziprasidone) PS ORAL 40 MG (BID), Hospitalization - Tremor Health ORAL Initial or Prolonged Professional Sertraline Hydrochloride C Date:01/30/03ISR Number: 4050516-5Report Type:Expedited (15-DaCompany Report #2002063839 Age:21 YR Gender:Male I/FU:F Outcome PT Report Source Life-Threatening Suicide Attempt Foreign Hospitalization - Study Initial or Prolonged Health Other Professional Company 22-Feb-2006 08:32 AM Page: 278 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Representative Product Role Manufacturer Route Dose Duration Zeldox (Ziprasidone Hydrochloride) PS ORAL (BID), ORAL Zopiclone C Date:01/30/03ISR Number: 4050522-0Report Type:Expedited (15-DaCompany Report #2002001970 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Somnolence Foreign Zeldox (Capsules) Initial or Prolonged Consumer (Ziprasidone) PS ORAL 80 MG (BID), Health ORAL Professional Citalopram Hyrdobromide C Date:01/31/03ISR Number: 4051164-3Report Type:Expedited (15-DaCompany Report #CEL-2002-01441-ROC (1) Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Health Metadate Cd Capsules Blindness Transient Professional 20 Mg Hypoaesthesia (Methylphenidate Muscle Disorder Hydrochloride) PS ORAL 60 MG (20 MG, Paraesthesia TID), PO Viral Infection Geodon (Ziprasidone Vision Blurred Hydrochloride) SS LOW DOSE (DAILY) Effexor (Venlafaxine Hydrochloride) C Wellbutrin- Slow Release (Bupropion Hydrochloride) C Date:01/31/03ISR Number: 4051192-8Report Type:Expedited (15-DaCompany Report #2003002350 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Foreign Zeldox (Capsules) Initial or Prolonged Health (Ziprasidone) PS ORAL 80 MG (BID), Professional ORAL Date:02/02/03ISR Number: 4056198-0Report Type:Expedited (15-DaCompany Report #2002067701 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Folliculitis Health Geodon (Ziprasidone) PS ORAL 160 MG (BID), Initial or Prolonged Tinea Infection Professional ORAL Topiramate SS ORAL 100 MG (BID), ORAL 22-Feb-2006 08:32 AM Page: 279 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/03/03ISR Number: 4050770-XReport Type:Direct Company Report #CTU 185832 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Musculoskeletal Stiffness Geodon Cap 60mg Pfizer PS Pfizer ORAL 60MG BID ORAL Geodon Inj 20mg/Ml Pfizer SS Pfizer INTRAMUSCULAR 20MG Q6H PRN IM Hydroxyzine Pamoate C Date:02/04/03ISR Number: 4052331-5Report Type:Direct Company Report #CTU 185934 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Ziprasidone PS 20MG Q AM, Agitation 40MG Q HS Condition Aggravated Zoloft C Incontinence Tegretol C Self Injurious Behaviour Depakote C L-Carnitine C Date:02/04/03ISR Number: 4052698-8Report Type:Expedited (15-DaCompany Report #2002000952 Age:24 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Urticaria Foreign Ziprasidone(Ziprasid Initial or Prolonged Study one) PS ORAL 120 MG (BID), Health ORAL Professional Date:02/04/03ISR Number: 4052878-1Report Type:Expedited (15-DaCompany Report #2003003725 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebral Haemorrhage Health Geodon (Ziprasidone) PS Coma Professional Bactrim SS Dehydration Company All Other Sepsis Representative Therapeutic Products C Stevens-Johnson Syndrome Date:02/04/03ISR Number: 4053025-2Report Type:Expedited (15-DaCompany Report #2003000371 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Geodon (Ziprasidone) PS Syndrome Date:02/06/03ISR Number: 4055390-9Report Type:Expedited (15-DaCompany Report #2003003432 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypokalaemia Health Geodon Initial or Prolonged Myocardial Infarction Professional (Ziprasidone) PS INTRAMUSCULAR INTRAMUSCULAR Company Representative 22-Feb-2006 08:32 AM Page: 280 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/06/03ISR Number: 4055396-XReport Type:Expedited (15-DaCompany Report #2003000848 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Facial Palsy Health Geodon (Ziprasidone) PS 40 MG (BID) Initial or Prolonged Professional Escitalopram C Date:02/06/03ISR Number: 4055397-1Report Type:Expedited (15-DaCompany Report #2002071786 Age:16 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Geodon (Ziprasidone) PS ORAL 160 MG, ORAL Initial or Prolonged Syndrome Professional Bupropion Other Company Hydrochloride C Representative Date:02/07/03ISR Number: 4054021-1Report Type:Expedited (15-DaCompany Report #2003002631 Age:26 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Zeldox (Capsules) Health (Ziprasidone) PS Professional Paroxetine SS Acetylsalicylic Acid SS Date:02/07/03ISR Number: 4054105-8Report Type:Expedited (15-DaCompany Report #2003003276 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyspnoea Foreign Geodon (Ziprasidone) PS ORAL ORAL Initial or Prolonged Gastrointestinal Disorder Health Penicillin Nos C Malaise Professional Clopenthixol Company Hydrochloride C Representative Quetiapine Fumarate C Terbutaline Sulfate C Date:02/07/03ISR Number: 4054860-7Report Type:Direct Company Report #CTU 186193 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Apnoea Geodon ( Cardio-Respiratory Arrest Ziprasidone) PS INTRAMUSCULAR 20MG IM X 1 Coma Pulse Absent Snoring Somnolence Date:02/07/03ISR Number: 4070170-6Report Type:Periodic Company Report #2002136966US Age:47 YR Gender:Female I/FU:I Outcome PT Hospitalization - Alanine Aminotransferase Initial or Prolonged Increased Aspartate Aminotransferase Increased Blood Alkaline 22-Feb-2006 08:32 AM Page: 281 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Phosphatase Increased Blood Bilirubin Increased Gamma-Glutamyltransferase Increased Report Source Product Role Manufacturer Route Dose Duration Hepatic Function Abnormal Health Celebrex (Celecoxib) Influenza Like Illness Professional Capsule PS ORAL 200 MG, ORAL; Nausea 400 MG, ORAL Vomiting Geodon (Ziprasidone) SS ORAL 20 MG, QD, ORAL; 30 MG, QD, ORAL 42 DAY Tegretol C Lamictal (Lamotrigine) C Date:02/10/03ISR Number: 4054709-2Report Type:Expedited (15-DaCompany Report #2003001970 Age:32 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gastritis Foreign Zeldox (Capsules) Initial or Prolonged Consumer (Ziprasidone) PS ORAL 60 MG, ORAL Health Citalopram Professional Hydrobromide C Diazepam C Date:02/10/03ISR Number: 4054921-2Report Type:Expedited (15-DaCompany Report #2002063839 Age:21 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Suicide Attempt Foreign Zeldox (Ziprasidone Hospitalization - Study Hydrochloride) PS ORAL (BID), ORAL Initial or Prolonged Health Zoplicone C Other Professional Company Representative Date:02/10/03ISR Number: 4055071-1Report Type:Expedited (15-DaCompany Report #2002064942 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dysgraphia Health Geodon (Ziprasidone) PS ORAL 60 MG Initial or Prolonged Tardive Dyskinesia Professional (DAILY), ORAL Benzatropine Mesilate C Fluoxetine Hydrochloride C Valproate Semisodium C Mirtazapine C Methylphenidate Hydrochloride C Date:02/10/03ISR Number: 4055086-3Report Type:Expedited (15-DaCompany Report #2003004261 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Geodon (Ziprasidone) PS Initial or Prolonged Drug Interaction Professional Dopamine SS Other 22-Feb-2006 08:32 AM Page: 282 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/12/03ISR Number: 4054716-XReport Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12174017 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Ziprasidone PS ORAL Interrupted/P Initial or Prolonged Disease Recurrence t. stopped Hallucination, Auditory taking Psychotic Disorder drug/unknown Suicidal Ideation date. Lorazepam C Zopiclone C Date:02/12/03ISR Number: 4055584-2Report Type:Direct Company Report #CTU 186477 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Fatigue Geodon PS 60MG BID Feeling Abnormal Effexor C Impulsive Behaviour Zyprexa C Intentional Overdose Lorazepam C Obsessive Thoughts Restlessness Somnolence Tension Weight Increased Date:02/12/03ISR Number: 4056486-8Report Type:Expedited (15-DaCompany Report #2002064375 Age:83 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aggression Health Geodon (Ziprasidone) PS Other Agitation Professional All Other Blood Pressure Decreased Therapeutic Products C Cognitive Disorder Chloral Hydrate C Confusional State Decreased Appetite Delusion Drug Ineffective Dysarthria Dysphagia General Physical Health Deterioration Hallucination Heart Rate Decreased Hypersomnia Insomnia Lethargy Mood Swings Oral Intake Reduced Pneumonitis Respiratory Arrest Restlessness Somnolence Speech Disorder 22-Feb-2006 08:32 AM Page: 283 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/13/03ISR Number: 4057221-XReport Type:Expedited (15-DaCompany Report #2003004928 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Foreign Ziprasidone Initial or Prolonged Rhabdomyolysis Health (Ziprasidone) PS ORAL ORAL Suicidal Ideation Professional Melperone Company Hydrochloride C Representative Date:02/13/03ISR Number: 4058014-XReport Type:Expedited (15-DaCompany Report #2002066424 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Geodon (Ziprasidone) PS ORAL 160 MG Initial or Prolonged Mania Professional (DAILY), ORAL Other Suicidal Ideation Company Representative Date:02/14/03ISR Number: 4056682-XReport Type:Direct Company Report #CTU 186686 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Ziprasidone-Geodon-4 Initial or Prolonged Abnormal 0mg Pfizer PS Pfizer ORAL 80MG AM PM Metabolic Acidosis ORAL Neuroleptic Malignant Quetiapine C Syndrome Venlafaxine Xr C Rhabdomyolysis Haloperidol C Social Avoidant Behaviour Treatment Noncompliance Date:02/14/03ISR Number: 4060199-6Report Type:Expedited (15-DaCompany Report #2003003725 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebral Haemorrhage Health Geodon (Ziprasidone) PS Hospitalization - Coma Professional Bactrim SS Initial or Prolonged Dehydration Company All Other Sepsis Representative Therapeutic Products C Stevens-Johnson Syndrome Date:02/14/03ISR Number: 4060314-4Report Type:Expedited (15-DaCompany Report #2003004477 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Tardive Dyskinesia Health Geodon (Ziprasidone) PS Initial or Prolonged Professional Company Representative Date:02/14/03ISR Number: 4060744-0Report Type:Expedited (15-DaCompany Report #2003005177 Age: Gender:Male I/FU:I Outcome PT Report Source Hospitalization - Status Epilepticus Foreign Initial or Prolonged Health 22-Feb-2006 08:32 AM Page: 284 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Company Representative Product Role Manufacturer Route Dose Duration Ziprasidone (Ziprasidone) PS Date:02/14/03ISR Number: 4060944-XReport Type:Expedited (15-DaCompany Report #2003005735 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Geodon (Ziprasidone) PS Initial or Prolonged Syndrome Professional Antipsychotics SS Other Date:02/14/03ISR Number: 4060945-1Report Type:Expedited (15-DaCompany Report #2003004896 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atherosclerosis Health Geodon (Ziprasidone) PS ORAL 40 MG (BID), Hospitalization - Chest Pain Professional ORAL Initial or Prolonged Pancreatitis Company Antivirals For Representative Systemic Use C Date:02/14/03ISR Number: 4061025-1Report Type:Expedited (15-DaCompany Report #2003005472 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Geodon (Ziprasidone) PS Professional Company Representative Date:02/14/03ISR Number: 4061027-5Report Type:Expedited (15-DaCompany Report #2003005088 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Health Geodon (Ziprasidone) PS ORAL 120 MG Other Neuroleptic Malignant Professional (DAILY), ORAL Syndrome Company Lithium C Representative Erythromycin C Oxcarbazepine C Alprazolam C Date:02/19/03ISR Number: 4059317-5Report Type:Expedited (15-DaCompany Report #2003004961 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Consumer Neurontin Gastric Neoplasm (Gabapentin) PS Syncope Geodon (Ziprasidone) SS ORAL ORAL Lamotrigine SS Antihypertensives C Diuretics C Arpiprazole C 22-Feb-2006 08:32 AM Page: 285 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/19/03ISR Number: 4059323-0Report Type:Expedited (15-DaCompany Report #2003004765 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Ziprasidone Professional (Ziprasidone) PS ORAL ORAL Company Representative Date:02/19/03ISR Number: 4059561-7Report Type:Expedited (15-DaCompany Report #2003005306 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Unevaluable Event Foreign Ziprasidone Initial or Prolonged Consumer (Ziprasidone) PS ORAL 40 MG (DAILY), ORAL Date:02/19/03ISR Number: 4059823-3Report Type:Expedited (15-DaCompany Report #EMADSS2003001171 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arrhythmia Foreign Haldol Decanoate Initial or Prolonged Atrial Fibrillation Health (Injection) Professional (Haloperidol Decanoate) PS INTRAMUSCULAR 75 MG, 1 IN 4 WEEK (S), IM Leponex (Clozapine) SS ORAL SEE IMAGE Glianimon (Benperidol) SS ORAL SEE IMAGE Zeldox SS ORAL SEE IMAGE Ximovan (Zopiclone) C Pantozol (Pantoprazole Sodium) C Date:02/19/03ISR Number: 4060012-7Report Type:Periodic Company Report #HQ2052725APR2002 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Health Effexor (Venlafaxine Dystonia Professional Hydrochloride, Feeling Abnormal Tablet) PS ORAL DOSE UNKNOWN Pain In Extremity INCREASED TO 150 MG DAILY, ORAL 3 MON Geodon (Ziprasidone, ) SS Topamax (Topiramate) C Date:02/19/03ISR Number: 4060305-3Report Type:Expedited (15-DaCompany Report #2003004928 Age:21 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Rhabdomyolysis Foreign Ziprasidone Initial or Prolonged Health (Ziprasidone) PS ORAL ORAL Professional Melperone Company Hydrochloride C Representative Olanzapine C 22-Feb-2006 08:32 AM Page: 286 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/19/03ISR Number: 4060308-9Report Type:Expedited (15-DaCompany Report #2003001969 Age:62 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Calcium Abnormal Foreign Geodon (Ziprasidone) PS ORAL 80 MG (BID), Initial or Prolonged Circulatory Collapse Health ORAL Other Epilepsy Professional Lithium SS ORAL 600 MG Postictal State Company (DAILY), ORAL Representative Date:02/19/03ISR Number: 4060381-8Report Type:Expedited (15-DaCompany Report #2003005263 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chest Pain Foreign Geodon (Ziprasidone) PS ORAL 80 MG Electrocardiogram Health (DAILY), ORAL Abnormal Professional All Other Therpeutic Sinus Bradycardia Products C Date:02/19/03ISR Number: 4060448-4Report Type:Expedited (15-DaCompany Report #NSADSS2003005795 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Study Risperidone Initial or Prolonged Drug Level Increased Health (Unspecified)(Risper Hepatic Encephalopathy Professional idone) PS Ziprasidone SS Olanzapine (Olanzapine) SS Quetiapine (Quetiapine) SS Zoloft (Sertraline Hydrochloride) C Gabitril (Tiagabine Hydrochloride) C Cogentin (Benzatropine Mesilate) C Artane (Trihexyphenidyl Hydrochloride) C Date:02/20/03ISR Number: 4058309-XReport Type:Direct Company Report #CTU 186924 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Ziprasidone 80mg PS ORAL 80MG BID ORAL Prolonged Ziprasidone 120mg SS ORAL 120MG BID ORAL Haloperidol C Clonazepam C Date:02/20/03ISR Number: 4060726-9Report Type:Expedited (15-DaCompany Report #2003006006 Age: Gender:Male I/FU:I Outcome PT Report Source Death Death Health Professional 22-Feb-2006 08:32 AM Page: 287 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company Representative Product Role Manufacturer Route Dose Duration Ziprasidone (Ziprasidone) PS Date:02/20/03ISR Number: 4060732-4Report Type:Expedited (15-DaCompany Report #2002069463 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Consumer Geodon (Ziprasidone) PS ORAL 40 MG (BID), Blindness Transient Health ORAL Blindness Unilateral Professional Methylphenidate Hypoaesthesia Hydrochloride SS ORAL 60 MG (TID), Sensory Disturbance ORAL Vision Blurred Venlafaxine Hydrochloride C Bupropion Hydrochloride C Date:02/20/03ISR Number: 4060900-1Report Type:Expedited (15-DaCompany Report #2003003725 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebral Haemorrhage Consumer Geodon (Ziprasidone) PS Hospitalization - Coma Health Bactrim SS Initial or Prolonged Dehydration Professional All Other Sepsis Company Therapeutic Products C Stevens-Johnson Syndrome Representative Date:02/20/03ISR Number: 4060901-3Report Type:Expedited (15-DaCompany Report #2003004896 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atherosclerosis Health Geodon (Ziprasidone) PS ORAL 40 MG (BID), Cardiomyopathy Professional ORAL Drug Effect Decreased Company Antivirals For Euphoric Mood Representative Systemic Use C Myocardial Infarction Date:02/20/03ISR Number: 4061046-9Report Type:Expedited (15-DaCompany Report #2003005511 Age:94 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pyrexia Health Geodon (Ziprasidone) PS INTRAVENOUS Professional Date:02/20/03ISR Number: 4061137-2Report Type:Expedited (15-DaCompany Report #2003005372 Age:70 YR Gender:Female I/FU:I Outcome PT Life-Threatening Circulatory Collapse Hospitalization - Depression Initial or Prolonged Diabetes Mellitus Dizziness Drug Interaction 22-Feb-2006 08:32 AM Page: 288 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Electrocardiogram Qt Prolonged Hypertension Report Source Product Role Manufacturer Route Dose Duration Respiratory Tract Foreign Zeldox (Capsules) Infection Health (Ziprasidone) PS ORAL 80 MG (BID), Tachycardia Professional ORAL Torsade De Pointes Verapamil Vomiting Hydrochloride SS ORAL 160 MG (BID), ORAL Theophylline C Digitoxin C Zopiclone C Date:02/20/03ISR Number: 4061249-3Report Type:Expedited (15-DaCompany Report #2003005592 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depressed Level Of Foreign Zeldox Consciousness Health (Ziprasidone) PS ORAL 4 GRAM, ORAL Overdose Professional Suicide Attempt Other Date:02/21/03ISR Number: 4059161-9Report Type:Direct Company Report #CTU 187083 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Geodon 80 Mg Pfizer PS Pfizer ORAL 80 MG 14:30 Initial or Prolonged ORAL, 80 MG 15:30 ORAL Date:02/21/03ISR Number: 4059239-XReport Type:Direct Company Report #CTU 187061 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Catatonia Geodon 20mg And 40mg Initial or Prolonged Pfizer PS Pfizer 20MG 3 TIME, Other 40MG UP 40 2 DAY 1 Zyprexa C Depakote Sprinkles C Date:02/24/03ISR Number: 4064755-0Report Type:Expedited (15-DaCompany Report #2003006003 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypotension Health Geodon (Ziprasidone) PS ORAL 120 MG (BID), Initial or Prolonged Professional ORAL Other Geodon (Im) (Ziprasidone) SS 40 MG (BID, AS NEEDED) Captopril C All Other Therapeutic Products C 22-Feb-2006 08:32 AM Page: 289 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/24/03ISR Number: 4064765-3Report Type:Expedited (15-DaCompany Report #2003005472 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Geodon (Im) Professional (Ziprasidone) PS INTRAMUSCULAR 20 MG (ONE Company DOSE), Representative INTRAMUSCULAR Date:02/25/03ISR Number: 4060251-5Report Type:Direct Company Report #CTU 187252 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Geodon 40mg PS ORAL 40MG HS ORAL Initial or Prolonged Polydipsia Multivitamin C Polyuria Date:02/25/03ISR Number: 4061312-7Report Type:Direct Company Report #CTU 187314 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Asthenia Geodon 60mg Pfizer PS Pfizer Disability Asthma Dyspnoea Feeling Abnormal Increased Appetite Memory Impairment Pain Panic Disorder Tremor Weight Increased Date:02/25/03ISR Number: 4065663-1Report Type:Expedited (15-DaCompany Report #2003005336 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Health Geodon (Ziprasidone) PS 40 MG(DAILY) Initial or Prolonged Increased Professional Citalopram Aspartate Hydrobromide SS ORAL 40 MG Aminotransferase (DAILY), ORAL Increased Olanzapine C Risperidone C Lithium C Clonazepam C Benzatropine Mesilate C Ranitidine Hydrochloride C Date:02/25/03ISR Number: 4065798-3Report Type:Expedited (15-DaCompany Report #2003006699 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Health Geodon (Ziprasidone) PS Syndrome Professional Company Representative 22-Feb-2006 08:32 AM Page: 290 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/03ISR Number: 4061423-6Report Type:Direct Company Report #CTU 187437 Age:88 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Gatifloxacin 400 Mg Confusional State Iv / Bms PS Bms INTRAVENOUS 400 MG IV Drug Ineffective Ziprasidone 10 Mg Im Ventricular Tachycardia / Pfizer SS Pfizer INTRAMUSCULAR 10 MG IM Date:02/26/03ISR Number: 4066005-8Report Type:Expedited (15-DaCompany Report #2003006748 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Myocardial Infarction Health Geodon (Ziprasidone) PS 80 MG (BID) Professional Company Representative Date:02/27/03ISR Number: 4066899-6Report Type:Expedited (15-DaCompany Report #2003001970 Age:32 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gastritis Foreign Zeldox (Capsules) Initial or Prolonged Hunger Consumer (Ziprasidone) PS ORAL 60 MG, ORAL Nausea Health Diazepam C Vomiting Professional Citalopram Weight Increased Hydrobromide C Date:02/27/03ISR Number: 4066902-3Report Type:Expedited (15-DaCompany Report #2002001970 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Somnolence Foreign Zeldox (Capsules) Health (Ziprasidone) PS ORAL 80 MG (BID), Professional ORAL Date:02/27/03ISR Number: 4067448-9Report Type:Expedited (15-DaCompany Report #2003002870 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accident Consumer Zoloft (Sertraline) PS ORAL 200 MG Initial or Prolonged Blood Pressure Decreased Health (DAILY), ORAL Other Blood Pressure Increased Professional Risperidone SS ORAL 3 MG (DAILY), Bronchitis ORAL Dry Mouth Quetiapine Fumarate SS ORAL ORAL Fall Ibuprofen SS ORAL ORAL Fear Diphenhydramine Forearm Fracture Hydrochloride SS ORAL ORAL Increased Appetite Geodon (Ziprasidone) SS ORAL ORAL Joint Sprain Fexofenadine Loss Of Consciousness Hydrochloride C Malaise Desloratadine C Menorrhagia Atenolol C Pneumonia Aspiration Somnolence Suicide Attempt Weight Increased 22-Feb-2006 08:32 AM Page: 291 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/03ISR Number: 4065205-0Report Type:Direct Company Report #CTU 187719 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Pain Ziprasidone (Pfizer) PS Pfizer ORAL 60 MG PO BID Date:02/28/03ISR Number: 4065605-9Report Type:Direct Company Report #CTU 187656 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Pain Ziprasidone(Pfizer) PS ORAL 60 MG PO BID Date:02/28/03ISR Number: 4067470-2Report Type:Expedited (15-DaCompany Report #2003000349 Age:27 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death General Physical Health Foreign Ziprasidone Hospitalization - Deterioration Health (Ziprasidone) PS ORAL 160 MG (BID), Initial or Prolonged Ileus Paralytic Professional ORAL Company Clozapine Representative (Clozapine) SS ORAL 600 MG, ORAL Clonazepam C Date:02/28/03ISR Number: 4068112-2Report Type:Expedited (15-DaCompany Report #2003004928 Age:21 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Rhabdomyolysis Foreign Zeldox (Ziprasidone) PS ORAL ORAL Initial or Prolonged Health Melperone Professional Hydrochloride C Company Olanzapine C Representative Date:03/03/03ISR Number: 4069817-XReport Type:Expedited (15-DaCompany Report #2003006941 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyspnoea Consumer Geodon (Ziprasidone) PS ORAL 120 MG (BID), Dystonia ORAL Headache Olanzapine C Oedema Mouth Pain In Jaw Speech Disorder Tongue Oedema Date:03/04/03ISR Number: 4070058-0Report Type:Expedited (15-DaCompany Report #2003007492 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Unevaluable Event Foreign Zeldox (Capsules) Initial or Prolonged Health (Ziprasidone) PS Professional Company Representative 22-Feb-2006 08:32 AM Page: 292 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/04/03ISR Number: 4070060-9Report Type:Expedited (15-DaCompany Report #2003005592 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Depressed Level Of Foreign Zeldox (Capsules) Hospitalization - Consciousness Health (Ziprasidone) PS ORAL 4.2 GRAM, Initial or Prolonged Intentional Overdose Professional ORAL Other Suicide Attempt Date:03/05/03ISR Number: 4067911-0Report Type:Direct Company Report #USP 55517 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Geodon(Ziprasidone Hydrochloride) PS Pfizer Date:03/05/03ISR Number: 4070208-6Report Type:Periodic Company Report #2002062383 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Health Geodon (Ziprasidone) PS 80 MG (BID) Initial or Prolonged Prolonged Professional Clozapine SS Other Nausea Metoclopramide C Urinary Tract Infection Levothyroxine C Vomiting Topiramate C Lansoprazole C Date:03/05/03ISR Number: 4070210-4Report Type:Periodic Company Report #2002068571 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Geodon (Ziprasidone) PS Professional Company Representative Date:03/05/03ISR Number: 4070211-6Report Type:Periodic Company Report #2002069121 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Health Geodon(Ziprasidone) PS Initial or Prolonged Professional Company Representative Date:03/05/03ISR Number: 4070213-XReport Type:Periodic Company Report #2002071669 Age:12 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Geodon (Ziprasidone) PS ORAL 20 MG, ORAL Professional Risperidone C Carbamazepine C Topiramate C Clonidine C 22-Feb-2006 08:32 AM Page: 293 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/05/03ISR Number: 4070215-3Report Type:Periodic Company Report #2002072017 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Consumer Ziprasidone Initial or Prolonged Dizziness (Ziprasidone) PS ORAL 60 MG (BID), Other Hypothyroidism ORAL Schizophreniform Disorder Quetiapine SS ORAL UNK, ORAL Valproate Semisodium SS Vitamins Nos C Docusate Sodium C Date:03/05/03ISR Number: 4070217-7Report Type:Periodic Company Report #2002072626 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrial Fibrillation Consumer Geodon (Ziprasidone) PS ORAL 40 MG (BID), Dementia ORAL Baclofen C Mirtazapine Citalopram Hydrobromide C Risperidone C Clopidogrel Sulfate C Simvastatin C Donepezil Hydrochloride C Ramipril C Esomeprazole C Tocopherol C Acetylsalicylic Acid C Valproate Semisodium C Azithromycin C Boost C Date:03/05/03ISR Number: 4070220-7Report Type:Periodic Company Report #2002072839 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Health Geodon (Ziprasidone) PS ORAL UNK, ORAL Prolonged Professional Company Representative Date:03/05/03ISR Number: 4070224-4Report Type:Periodic Company Report #2003000333 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Health Geodon (Ziprasidone) PS Professional Company Representative 22-Feb-2006 08:32 AM Page: 294 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/05/03ISR Number: 4070226-8Report Type:Periodic Company Report #2003000334 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Priapism Health Geodon (Ziprasidone) PS ORAL 120 MG (BID), Professional ORAL Lithium C Fluphenazine Decanoate C Trihexyphenidyl Hydrochloride C Date:03/05/03ISR Number: 4070228-1Report Type:Periodic Company Report #2003000674 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Delusion Health Geodon (Ziprasidone) PS ORAL 160 MG (BID), Electrocardiogram Qt Professional ORAL Prolonged All Other Hypomagnesaemia Non-Therapeutic Tremor Produts SS UNK Weight Decreased Fexofenadine SS ORAL UNK, ORAL Sertraline C Hydrochlorothiazide C Dyazide C Levothyroxine Sodium C Diltiazem C Lorazepam C Date:03/05/03ISR Number: 4071187-8Report Type:Expedited (15-DaCompany Report #2003007497 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Geodon (Ziprasidone) PS 160 MG (DAILY Professional Venlafaxine Hydrochloride SS 225 MG (DAILY) Quetiapine Fumarate C Date:03/05/03ISR Number: 4072169-2Report Type:Periodic Company Report #2003001478 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Health Geodon(Ziprasidone) PS ORAL 120 MG (BID), Electrocardiogram Qt Professional ORAL Prolonged Haloperidol Decanoate C Benzatropine Mesilate C Ranitidine Hydrochloride C Lansoprazole C 22-Feb-2006 08:32 AM Page: 295 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/05/03ISR Number: 4072170-9Report Type:Periodic Company Report #2003003535 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coordination Abnormal Health Geodon (Ziprasidone) PS INTRAMUSCULAR INTRAMUSCULAR Initial or Prolonged Medication Error Professional Syncope Company Representative Date:03/05/03ISR Number: 4072171-0Report Type:Periodic Company Report #2003004348 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Overdose Health Geodon (Ziprasidone) PS ORAL ORAL Initial or Prolonged Electrocardiogram Qt Professional Bupropion Other Prolonged Hydrochloride C Isoniazid C Date:03/05/03ISR Number: 4072173-4Report Type:Periodic Company Report #2003005856 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Geodon (Ziprasidone) PS ORAL ORAL Initial or Prolonged Professional Bupropion Other Company Hydrochloride SS Representative Olanzapine SS All Other Non-Therapeutic Products SS Date:03/05/03ISR Number: 4072188-6Report Type:Periodic Company Report #2002060528 Age:10 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Health Geodon (Ziprasidone) PS ORAL 40 MG (BID), Professional ORAL Company Methylphenidate Representative Hydrochloride C Date:03/05/03ISR Number: 4072641-5Report Type:Periodic Company Report #2002054572 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Geodon (Ziprasidone) PS ORAL 160 MG (BID), Initial or Prolonged Psychotic Disorder Professional ORAL Company Olanzapine C Representative Clonazepam C Date:03/06/03ISR Number: 4068598-3Report Type:Direct Company Report #CTU 188088 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Geodon 20 Mg PS ORAL 20 MG, BID, Corrected Interval BY MOUTH Prolonged Geodon 40 Mg SS ORAL 40 MG, BID, BY MOUTH Geodon 60 Mg SS ORAL 60 MG, BID, 22-Feb-2006 08:32 AM Page: 296 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report BY MOUTH Geodon 80 Mg SS ORAL 80 MG, BID, BY MOUTH (PO) Atenolol C Vitamin E C Lorazepam (Ativan) C Trazodone C Milk Of Magnesia C Ibuprofen C Haloperidol Tab C Haloperidol Lactate C Acetaminophen C Date:03/06/03ISR Number: 4071766-8Report Type:Expedited (15-DaCompany Report #2003007921 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Calcium Decreased Health Geodon (Ziprasidone) PS GASTROSTOMY Other Hypokalaemia Professional TUBE Medication Error Geodon (Im) (Ziprasidone) SS INTRAVENOUS 5MG, INTRAVENOUS Potassium C Deftriaxone Sodium C Digoxin C Fentanyl C Furosemide C Lansoprazole C Mirtazapine C Neomycin C Glyceryl Trinitrate C Risperidone C Warfarin C Olanzapine C Amlodipine Besilate C Clonidine Hydrochloride C Zinc Sulfate C Ascorbic Acid C Vitamins Nos C Enalapril Maleate C Metoprolol Tartrate C Polymyxin B C Date:03/10/03ISR Number: 4073040-2Report Type:Expedited (15-DaCompany Report #200303-0074 (0) Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Study Benadryl - Initial or Prolonged Respiratory Failure Health Formulation Suicide Attempt Professional Unspecified (Diphenhydramine) PS ORAL PER ORAL Ziprasidone (Nos) SS ORAL 80 MG BID, PER ORAL Trazodone (Trazaodone) C Lexapro (Escitalopram Oxalate) C Vasotec (Enalapril 22-Feb-2006 08:32 AM Page: 297 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Maleate) C Date:03/12/03ISR Number: 4074779-5Report Type:Expedited (15-DaCompany Report #2003008887 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Disease Recurrence Health Geodon (Ziprasidone) PS ORAL 80 MG (BID) Initial or Prolonged Drug Abuser Professional ORAL Other Drug Ineffective Paroxetine Electrocardiogram Hydrochloride C Abnormal Carbamazepine C Laboratory Test Abnormal Myocardial Infarction Treatment Noncompliance Date:03/12/03ISR Number: 4074781-3Report Type:Expedited (15-DaCompany Report #2002071784 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Face Oedema Health Geodon (Ziprasidone) PS ORAL 20 MG (HS) Oedema Professional ORAL Pituitary Tumour Company Bupropion Representative Hydrochloride C Sertraline Hydrochloride C Date:03/12/03ISR Number: 4075419-1Report Type:Expedited (15-DaCompany Report #2003007921 Age:81 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Calcium Decreased Health Geodon (Ziprasidone) PS GASTROSTOMY Other Hypokalaemia Professional TUBE Medication Error Geodon (Im) (Ziprasidone) SS INTRAVENOUS 5 MG, INTRAVENOUS Potassium C Ceftriaxone Sodium C Digoxin C Fentanyl C Furosemide C Lansoprazole C Mirtazapine C Neomycin C Glyceryl Trinitrate C Risperidone C Warfarin C Olanzapine C Amlodipine Besilate C Clonidine Besilate C Zinc Sulfate C Ascorbic Acid C Vitamins Nos C Enalapril Maleate C Metoprolol Tartrate C Polymyxin B C 22-Feb-2006 08:32 AM Page: 298 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/03ISR Number: 4075422-1Report Type:Expedited (15-DaCompany Report #2003009387 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Consumer Geodon (Ziprasidone) PS Initial or Prolonged Health Other Professional Date:03/13/03ISR Number: 4076067-XReport Type:Expedited (15-DaCompany Report #2003006748 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Myocardial Infarction Health Geodon (Ziprasidone) PS 160 MG (BID) Professional Company Representative Date:03/13/03ISR Number: 4076069-3Report Type:Expedited (15-DaCompany Report #2003009152 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Respiratory Disorder Health Geodon (Im) Other Professional (Ziprasidone) PS INTRAMUSCULAR 20 MG, Company INTRAMUSCULAR Representative Geodon (Ziprasidone) SS ORAL 80 MG (BID), ORAL Oxcarbazepine C Date:03/13/03ISR Number: 4076072-3Report Type:Expedited (15-DaCompany Report #2003009143 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Potassium Decreased Health Geodon (Ziprasidone) PS ORAL 240 MG (BID), Initial or Prolonged Drug Level Increased Professional ORAL Other Electrocardiogram Qt Valproate Semisodium SS ORAL 3000 MG Corrected Interval (BID), ORAL Prolonged Diphenhydramine Syncope Hydrochloride C Ventricular Fibrillation Date:03/17/03ISR Number: 4077295-XReport Type:Expedited (15-DaCompany Report #2003009863 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Complications Of Maternal Health Geodon (Ziprasidone) PS 120 MG (BID) Exposure To Therapeutic Professional Bupropion Drugs Company Hydrochloride SS Congenital Anomaly Representative Maternal Drugs Affecting Foetus Pregnancy 22-Feb-2006 08:32 AM Page: 299 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/17/03ISR Number: 4077349-8Report Type:Expedited (15-DaCompany Report #2003003728 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Foreign Ziprasidone Initial or Prolonged Insomnia Study (Ziprasidone) PS ORAL 160 MG Other Nervousness Health (DAILY), ORAL Professional Valproate Sodium C Date:03/17/03ISR Number: 4077351-6Report Type:Expedited (15-DaCompany Report #2003003621 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aspartate Study Geodon (Ziprasidone) PS ORAL 80 MG Initial or Prolonged Aminotransferase Health (DAILY), ORAL Increased Professional Bundle Branch Block Cardiomyopathy Electroencephalogram Abnormal Grand Mal Convulsion Mitral Valve Incompetence Pulmonary Congestion Pulmonary Valve Incompetence Rhabdomyolysis Sinus Bradycardia Tricuspid Valve Incompetence Date:03/17/03ISR Number: 4077438-8Report Type:Expedited (15-DaCompany Report #2003009387 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Consumer Geodon (Ziprasidone) PS Initial or Prolonged Health Other Professional Date:03/17/03ISR Number: 4077440-6Report Type:Expedited (15-DaCompany Report #2003010033 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyspnoea Health Geodon (Ziprasidone) PS ORAL 80 MG (BID), Tongue Disorder Professional ORAL Tongue Spasm Sertraline Torticollis Hydrochloride C Metronidazole C Bactrim C Triamcinolone C Date:03/17/03ISR Number: 4077523-0Report Type:Expedited (15-DaCompany Report #2003004928 Age:21 YR Gender:Male I/FU:F Outcome PT Report Source Hospitalization - Depression Foreign Initial or Prolonged Psychotic Disorder Health Other Rhabdomyolysis Professional Suicidal Ideation Company 22-Feb-2006 08:32 AM Page: 300 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Representative Product Role Manufacturer Route Dose Duration Zeldox (Ziprasidone) PS ORAL 120 MG, ORAL Melperone Hydrochloride SS ORAL ORAL Olanzapine C Date:03/17/03ISR Number: 4077527-8Report Type:Expedited (15-DaCompany Report #2003005306 Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia Foreign Ziprasidone Initial or Prolonged Consumer (Ziprasidone) PS ORAL 40 MG (DAILY), ORAL Date:03/17/03ISR Number: 4077529-1Report Type:Expedited (15-DaCompany Report #2003009435 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Foreign Zeldox (Capsules) Initial or Prolonged Medication Error Health (Ziprasidone) PS ORAL 400 MG Restlessness Professional (DAILY), ORAL Flupentixol C Promethazine C Date:03/17/03ISR Number: 4077535-7Report Type:Expedited (15-DaCompany Report #A200671 Age:32 YR Gender:Male I/FU:F Outcome PT Life-Threatening Alanine Aminotransferase Hospitalization - Increased Initial or Prolonged Aspartate Aminotransferase Increased Asthenia Bacterial Infection Blood Culture Positive Blood Pressure Decreased Cardiac Failure Cardiogenic Shock Cardiomegaly Cardiomyopathy Chest Pain Dehydration Diarrhoea Dilatation Ventricular Electrolyte Imbalance Gamma-Glutamyltransferase Increased Gastroenteritis Hypertension Liver Disorder Mental Disorder Mitral Valve Incompetence Oliguria Renal Failure Sepsis 22-Feb-2006 08:32 AM Page: 301 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Syncope Tachycardia Ventricular Hypokinesia Report Source Product Role Manufacturer Route Dose Duration Viral Infection Foreign Ziprasidone Vomiting Consumer (Ziprasidone) PS ORAL 120 MG (TID), Health ORAL Professional Venlafaxine Hydrochloride SS ORAL 300 MG (DAILY), ORAL Ramipril C Diazepam C Oxazepam C Carvedilol C Spironolactone C Digoxin C Date:03/17/03ISR Number: 4077689-2Report Type:Expedited (15-DaCompany Report #2003009714 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Allergic Oedema Foreign Zeldox (Ziprasidone) PS Initial or Prolonged Respiratory Disorder Health Lorazepam C Professional Company Representative Date:03/18/03ISR Number: 4074960-5Report Type:Direct Company Report #CTU 188962 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Ziprasidone 20 Mg PS INTRAMUSCULAR 20 MG ONE Throat Tightness TIME INTRAMUSCULAR Citalopram C Divalproex C Lorazepam C Mvi C Olanzapine C Thiamine C Date:03/19/03ISR Number: 4078378-0Report Type:Expedited (15-DaCompany Report #2003006006 Age:58 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiomegaly Health Geodon (Ziprasidone) PS ORAL 40 MG Coronary Artery Professional (DAILY), ORAL Atherosclerosis Company Bupropion Mitral Valve Incompetence Representative Hydrochlordie SS ORAL 450 MG (TID), Pulmonary Valve ORAL Incompetence Mirtazapine C Lithium Carbonate C Methadone C Desloratadine C Pseudoephedrine Hydrochloride C Chlorphenamine C 22-Feb-2006 08:32 AM Page: 302 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/19/03ISR Number: 4078439-6Report Type:Expedited (15-DaCompany Report #2003009810 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Caffeine Increased Consumer Geodon (Ziprasidone) PS ORAL ORAL Completed Suicide Buspirone Drug Screen Positive Hydrochloride SS ORAL ORAL Overdose Venlafaxine Hydrochloride SS ORAL ORAL Amitriptyline C Clonazepam C Date:03/19/03ISR Number: 4078454-2Report Type:Expedited (15-DaCompany Report #2003004896 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atherosclerosis Health Geodon (Ziprasidone) PS ORAL 40 MG (BID), Cardiomyopathy Professional ORAL Chest Pain Company Antivirals For Circulatory Collapse Representative Systemic Use C Euphoric Mood Zolpidem Tartrate C Myocardial Infarction Risperidone C Treatment Noncompliance Quetiapine Fumarate C Date:03/20/03ISR Number: 4080118-6Report Type:Expedited (15-DaCompany Report #2003011074 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Foreign Zeldox (Ziprasidone) PS 80 MG (BID) Health Professional Company Representative Date:03/20/03ISR Number: 4080586-XReport Type:Expedited (15-DaCompany Report #2003011202 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Infection Foreign Zeldox (Ziprasidone) PS ORAL 120 MG (BID), Initial or Prolonged Oedema Peripheral Health ORAL Pain In Extremity Professional Date:03/20/03ISR Number: 4080643-8Report Type:Expedited (15-DaCompany Report #2003010437 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Demyelinating Consumer Geodon (Ziprasidone) PS ORAL 180 MG (BID), Initial or Prolonged Polyneuropathy ORAL Other Fall Diltiazem Muscle Spasms Hydrochloride C Thermal Burn Levothyroxine Sodium C Rabeprazole Sodium C Fluoxetine C Benzatropine Mesilate C Metformin Hydrochloride C Lisinopril C 22-Feb-2006 08:32 AM Page: 303 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Clonazepam C Modafinil C Fluphenazine Hydrochloride C Salbutamol C Ipratropium Bromide C Date:03/24/03ISR Number: 4082363-2Report Type:Expedited (15-DaCompany Report #2003010432 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Angioneurotic Oedema Foreign Zeldox (Ziprasidone) PS ORAL 40 MG, ORAL Health Metformin Professional Hydrochloride C Metformin Hydrochloride C Bisoprolol C Date:03/24/03ISR Number: 4082736-8Report Type:Expedited (15-DaCompany Report #2003010421 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Geodon (Ziprasidone) PS ORAL ORAL Torsade De Pointes Professional Company Representative Date:03/25/03ISR Number: 4082996-3Report Type:Expedited (15-DaCompany Report #2002064480 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Consumer Zoloft (Sertraline) PS ORAL (DAILY), ORAL Initial or Prolonged Aggression Geodon (Ziprasidone) SS 12 MG (BID) Disability Akathisia Tylenol SS Other Amnesia Mirtazapine C Blood Pressure Increased Zolpidem Tartrate C Bruxism Valproate Semisodium C Feeling Abnormal Buspirone Homicidal Ideation Hydrochloride C Intentional Overdose Clonazepam C Knee Operation Laceration Loss Of Consciousness Medication Error Memory Impairment Mood Swings Self Mutilation Social Avoidant Behaviour Staring Suicidal Ideation Suicide Attempt 22-Feb-2006 08:32 AM Page: 304 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/26/03ISR Number: 4083482-7Report Type:Expedited (15-DaCompany Report #200303-0074 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Benadryl 25mg Initial or Prolonged Respiratory Failure Professional Tablets Suicide Attempt (Diphenhydramine) PS ORAL UNSPECIFIED TABLETS, PER ORAL Ziprasidone SS ORAL 40 MG BID, PER ORAL Trazodone (Trazodone) C Escitalopram C Enalapril Maleate (Enalapril Maleate) C Date:03/26/03ISR Number: 4083847-3Report Type:Expedited (15-DaCompany Report #2003006699 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Geodon (Ziprasidone) PS 120 MG (BID) Neuroleptic Malignant Professional All Other Syndrome Company Therapeutic Products C Representative Date:03/26/03ISR Number: 4083851-5Report Type:Expedited (15-DaCompany Report #A211192 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Calcium Increased Health Geodon (Ziprasidone) PS ORAL 160 MG (BID), Completed Suicide Professional ORAL Electrocardiogram T Wave Company Effexor Xr Abnormal Representative (Venlafaxine Feeling Guilty Hydrochloride) SS ORAL 225 MG Mood Altered (DAILY), ORAL Protein Total Increased Quetiapine Fumarate C Red Blood Cell Sedimentation Rate Increased Date:03/26/03ISR Number: 4083862-XReport Type:Expedited (15-DaCompany Report #2003011623 Age: Gender:Female I/FU:I Outcome PT Hospitalization - Anger Initial or Prolonged Anorexia Other Arthritis Asthenia Bladder Disorder Blood Cholesterol Blood Pressure Blood Pressure Systolic Cough Dizziness Dyspepsia Fatigue Feeling Abnormal Frequent Bowel Movements 22-Feb-2006 08:32 AM Page: 305 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Gait Disturbance Headache Heart Rate Increased Report Source Product Role Manufacturer Route Dose Duration Incontinence Consumer Navane (Capsule) Increased Appetite (Tiotixene) PS 6 MG (TID) Mental Disorder Geodon (Ziprasidone) SS 20 MG Muscle Spasms (WEEKLY) Pain In Extremity Lithane (Lithium) SS Paranasal Sinus Valdecoxib SS Hypersecretion Celecoxib SS Physical Examination Haloperidol SS Abnormal Calcium Ascorbate C Pollakiuria Cyanocobalamin C Pyrexia Pyridoxine Schizoaffective Disorder Hydrochloride C Screaming Zinc Picolinate C Sleep Disorder Fluphenazine Stress Hydrochloride C Suicidal Ideation Methylphenidate Urinary Retention Hydrochloride C Weight Fluctuation Ketoconazole C Levothyroxine Sodium C Estrogens Conjugated C Clobetasol Propionate C Rofecoxib C Tocopherol C Clarithromycin C Entex C Mesoridazine C Risperidone C Olanzapine C Valproate Semisodium C Omeprazole C Nizatidine C Thiamine Hydrochloride C Date:03/26/03ISR Number: 4083869-2Report Type:Expedited (15-DaCompany Report #2003011347 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Geodon (Ziprasidone) PS ORAL 40 MG (BID), Initial or Prolonged Syndrome Professional ORAL Other Company Representative Date:03/26/03ISR Number: 4083870-9Report Type:Expedited (15-DaCompany Report #2003011342 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Geodon (Ziprasidone) PS ORAL 40 MG (BID) , Initial or Prolonged Syndrome Professional ORAL Other Company Representative 22-Feb-2006 08:32 AM Page: 306 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/26/03ISR Number: 4083871-0Report Type:Expedited (15-DaCompany Report #2003011340 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Geodon (Ziprasidone) PS ORAL 40 MG (BID), Initial or Prolonged Syndrome Professional ORAL Other Company Representative Date:03/26/03ISR Number: 4083928-4Report Type:Expedited (15-DaCompany Report #2003011074 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Foreign Zeldox (Ziprasidone) PS 80 MG (BID) Health Professional Company Representative Date:03/26/03ISR Number: 4084013-8Report Type:Expedited (15-DaCompany Report #2003009143 Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Potassium Health Geodon (Ziprasidone) PS ORAL 240 MG (BID), Initial or Prolonged Drug Level Professional ORAL Other Electrocardiogram Qt Valproate Semisodium SS ORAL 3000 MG(BID), Corrected Interval ORAL Syncope Diphenhydramine Ventricular Fibrillation Hydrochloride C Ventricular Tachycardia Triamterene C Date:03/27/03ISR Number: 4084899-7Report Type:Expedited (15-DaCompany Report #2003011794 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Deep Vein Thrombosis Health Geodon (Ziprasidone) PS Professional Company Representative Date:03/27/03ISR Number: 4084907-3Report Type:Expedited (15-DaCompany Report #2003011793 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Deep Vein Thrombosis Health Geodon (Ziprasidone) PS Professional Company Representative Date:03/27/03ISR Number: 4084909-7Report Type:Expedited (15-DaCompany Report #2003011613 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Torsade De Pointes Health Geodon (Ziprasidone) PS Other Professional All Other Company Therapeutic Products C Representative 22-Feb-2006 08:32 AM Page: 307 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/27/03ISR Number: 4086305-5Report Type:Expedited (15-DaCompany Report #2003011645 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Angioneurotic Oedema Foreign Zeldox (Capsules) Health (Ziprasidone) PS ORAL 80 MG (BID), Professional ORAL Company Representative Date:03/28/03ISR Number: 4084414-8Report Type:Direct Company Report #CTU 189753 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram T Wave Paroxetine PS 20MG Q HS Amplitude Decreased Divalproex Sodium SS 500 MG TID Ziprasidone SS ILLEGIBLE SEE IMAGE Amoxicillin C Risperidone C Calcium Polycarbophil C Date:03/28/03ISR Number: 4087048-4Report Type:Expedited (15-DaCompany Report #2003011613 Age:88 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Ventricular Tachycardia Health Geodon (Ziprasidone) PS Professional Gatifloxacin C Company Metronidazole C Representative Clindamycin C Olanzapine C Date:03/28/03ISR Number: 4087052-6Report Type:Expedited (15-DaCompany Report #2003011678 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypomagnesaemia Consumer Geodon (Ziprasidone) PS Initial or Prolonged Living In Residential Other Institution Date:03/28/03ISR Number: 4087063-0Report Type:Expedited (15-DaCompany Report #2003010421 Age:76 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arrhythmia Health Geodon (Ziprasidone) PS ORAL 40 MG (BID), Torsade De Pointes Professional ORAL Company Geodon (Im) Representative (Ziprasidone) SS INTRAMUSCULAR 20 MG (PRN), INTRAMUSCULAR Amiodarone Hydrochloride SS Acetylsalicylic Acid C Diltiazem Hydrochloride C Heparin-Fraction, Sodium Salt C Furosemide C 22-Feb-2006 08:32 AM Page: 308 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Isosorbide Mononitrate C Pneumococcal Vaccine C Metoprolol Tartrate C Ramipril C Magnesium Oxide C Date:03/28/03ISR Number: 4087639-0Report Type:Expedited (15-DaCompany Report #2003005511 Age:85 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Geodon (Ziprasidone) PS INTRAMUSCULAR 20 MG (PRN) Other Movement Disorder Professional INTRAMUSCULAR Pyrexia Levothyroxine Sodium C Lisinopril C Digoxin C Quetiapine Fumarate C Sertraline Hydrochloride C Heparin C Date:04/01/03ISR Number: 4084951-6Report Type:Direct Company Report #CTU 189953 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Geodon 40mg Capsule Extrapyramidal Disorder Pfizer PS Pfizer ORAL 40MG PO BID Torticollis Date:04/01/03ISR Number: 4085562-9Report Type:Expedited (15-DaCompany Report #2003012518 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Geodon (Ziprasidone) PS INTRAMUSCULAR INTRAMUSCULAR Professional Company Representative Date:04/01/03ISR Number: 4085563-0Report Type:Expedited (15-DaCompany Report #2003012036 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Health Geodon (Im) Other Professional (Ziprasidone) PS INTRAMUSCULAR INTRAMUSCULAR Company Representative Date:04/02/03ISR Number: 4087900-XReport Type:Expedited (15-DaCompany Report #2003011988 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Prolactin Increased Foreign Ziprasidone Initial or Prolonged Galactorrhoea Health (Ziprasidone) PS ORAL (BID), ORAL Psychotic Disorder Professional Lamotrigine C Schizophrenia Company Lorazepam C Representative Benzodiazepine 22-Feb-2006 08:32 AM Page: 309 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Derivatives C Paroxetine C Date:04/02/03ISR Number: 4087902-3Report Type:Expedited (15-DaCompany Report #2003011969 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delirium Foreign Ziprasidone Initial or Prolonged Gait Disturbance Health (Ziprasidone) PS ORAL 160 MG Hypernatraemia Professional (DAILY), ORAL Psychotic Disorder Company Ziprasidone Schizoaffective Disorder Representative (Ziprasidone) SS INTRAMUSCULAR 20 MG (ONCE), INTRAMUSCULAR Lithium C Date:04/02/03ISR Number: 4087969-2Report Type:Expedited (15-DaCompany Report #2003012519 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Geodon (Ziprasidone) PS INTRAMUSCULAR INTRAMUSCULAR Professional Quetiapine Fumarate Company (Quetiapine Representative Fumarate) C Thioridazine Hydrochloride (Thioridazine Hydrochloride) C Date:04/02/03ISR Number: 4088000-5Report Type:Expedited (15-DaCompany Report #2003012530 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Deep Vein Thrombosis Health Ziprasidone Professional (Ziprasidone) PS Company Representative Date:04/02/03ISR Number: 4088005-4Report Type:Expedited (15-DaCompany Report #2003012209 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyspnoea Health Geodon (Ziprasidone) PS ORAL (BID), ORAL Initial or Prolonged Hallucination, Visual Professional Estradiol C Other Medication Error Lisinopril C Screaming Lorazepam C Venlafaxine Hydrochloride C Obetrol (Amfetamine Sulfate, Dexamfetamine Saccharate, Amfetamine C Liothyronine Sodium C Gabapentin C Levothyroxine Sodium C 22-Feb-2006 08:32 AM Page: 310 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/02/03ISR Number: 4088006-6Report Type:Expedited (15-DaCompany Report #2003012529 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Deep Vein Thrombosis Health Ziprasidone Professional (Ziprasidone) PS Company Representative Date:04/03/03ISR Number: 4089356-XReport Type:Expedited (15-DaCompany Report #2003012803 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Geodon (Ziprasidone) PS ORAL 160 MG (BID), Initial or Prolonged Coma Professional ORAL Sepsis Clozapine Vomiting (Clozapine) SS ORAL 400 MG White Blood Cell Count (DAILY), ORAL Increased Benzatropine Mesilate C Date:04/03/03ISR Number: 4089359-5Report Type:Expedited (15-DaCompany Report #2003003621 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bundle Branch Block Right Health Geodon (Ziprasidone) PS ORAL 80 MG Initial or Prolonged Cardiac Failure Professional (DAILY), ORAL Other Congestive Cardiomyopathy Electroencephalogram Abnormal Grand Mal Convulsion Mitral Valve Incompetence Pneumonia Pulmonary Valve Incompetence Rhabdomyolysis Sinus Bradycardia Tricuspid Valve Incompetence Date:04/03/03ISR Number: 4091529-7Report Type:Expedited (15-DaCompany Report #2003003276 Age:23 YR Gender:Female I/FU:F Outcome PT Hospitalization - Abscess Initial or Prolonged Aggression Other Blood Creatine Phosphokinase Increased Coma Disseminated Intravascular Coagulation Infection Intestinal Gangrene Neuroleptic Malignant Syndrome Psychomotor Hyperactivity Pulmonary Embolism Respiratory Failure 22-Feb-2006 08:32 AM Page: 311 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sedation Suicidal Ideation Report Source Product Role Manufacturer Route Dose Duration Foreign Zeldox (Capsules) Health (Ziprasidone) PS ORAL 160 MG (BID), Professional ORAL Company Zoloft (Sertraline) SS ORAL ORAL Representative Quetiapine Fumarate (Quetiapine Fumarate) SS ORAL ORAL Penicillin Nos (Penicillin Nos) C Clopenthixol Hydrochloride (Clopenthixol Hydrochloride) C Terbutaline Sulfate (Terbutaline Sulfate) C Chlorprothixene Hydrochloride (Chlorprothixene Hydrochloride) C Clonazepam (Clonazepam) C Citalopram Hydrobromide (Citalopram Hydrobromide) C Salmeterol Xinafoate (Salmeterol Xinafoate) C Date:04/03/03ISR Number: 4091532-7Report Type:Expedited (15-DaCompany Report #2003007756 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Joint Stiffness Foreign Ziprasidone Muscle Spasms Health (Ziprasidone) PS ORAL (BID), ORAL Restlessness Professional Clozapine C Company All Other Representative Therapeutic Products C Date:04/04/03ISR Number: 4090175-9Report Type:Expedited (15-DaCompany Report #2003011074 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Zeldox (Ziprasidone) PS 80 MG (BID) Health Loperamide Professional (Loperamide) C Company Representative 22-Feb-2006 08:32 AM Page: 312 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/08/03ISR Number: 4086315-8Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12174017 Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Disease Recurrence Ziprasidone PS ORAL Interrupted/P Initial or Prolonged Psychotic Disorder t. stopped Suicidal Ideation taking drug/unknown date. Lorazepam C Zopiclone C Date:04/08/03ISR Number: 4091119-6Report Type:Expedited (15-DaCompany Report #2003009143 Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anxiety Health Geodon (Ziprasidone) PS ORAL 240 MG, BID, Hospitalization - Arrhythmia Professional ORAL Initial or Prolonged Blood Potassium Decreased Valproate Semisodium SS ORAL 3000 MG, BID, Other Blood Sodium Decreased ORAL Blood Urea Increased Diphenhydramine Chronic Obstructive Hydrochloride C Pulmonary Disease Triamterene C Diarrhoea Drug Level Above Therapeutic Electrocardiogram Poor R-Wave Progression Electrocardiogram Pr Shortened Electrocardiogram Qt Corrected Interval Prolonged Electrocardiogram St Segment Depression Electrocardiogram St-T Segment Abnormal Hallucination, Auditory Hypokalaemia Paranoia Pco2 Increased Sinus Bradycardia Speech Disorder Suspiciousness Syncope Tearfulness Tremor Ventricular Fibrillation Ventricular Tachycardia Date:04/08/03ISR Number: 4091121-4Report Type:Expedited (15-DaCompany Report #2003010421 Age:76 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arrhythmia Health Geodon (Ziprasidone) PS ORAL 40 MG, BID, Torsade De Pointes Professional ORAL Company Geodon (Im) Representative (Ziprasidone) SS INTRAMUSCULAR 20 MG, PRN, INTRAMUSCULAR Amiodarone 22-Feb-2006 08:32 AM Page: 313 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride SS Acetylsalicylic Acid C Diltiazem Hydrochloride C Heparin-Fraction, Sodium Salt C Furosemide C Isosorbide Mononitrate C Pneumococcal Vaccine C Metoprolol Tartrate C Ramipril C Magnesium Oxide C Date:04/08/03ISR Number: 4091123-8Report Type:Expedited (15-DaCompany Report #2003013100 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Cholesterol Health Geodon (Ziprasidone) PS ORAL 40 MG (BID), Initial or Prolonged Increased Professional ORAL Other Diabetes Mellitus Lithane (Lithium) SS ORAL 1500 MG Nocturia (DAILY), ORAL Valproate Semisodium (Valproate Semisodium) C Date:04/08/03ISR Number: 4091167-6Report Type:Expedited (15-DaCompany Report #2003007756 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oropharyngeal Spasm Foreign Ziprasidone Restlessness Health (Ziprasidone) PS ORAL UNK (BID); Professional ORAL Company Clozapine C Representative Chlorprothixene Hydrochloride C Date:04/08/03ISR Number: 4091293-1Report Type:Expedited (15-DaCompany Report #2003003725 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebral Haemorrhage Consumer Geodon (Ziprasidone) PS Hospitalization - Coma Health Bactrim SS Initial or Prolonged Dehydration Professional All Other Other Platelet Count Decreased Company Therapeutic Products C Renal Failure Representative All Other Sepsis Therapeutic Products C Stevens-Johnson Syndrome Vasculitis Date:04/08/03ISR Number: 4091589-3Report Type:Expedited (15-DaCompany Report #200303-2071 (0) Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Syncope Health Diphenhydramine Initial or Prolonged Professional Unspecified (Diphenhydramine) PS ORAL 25 MG QD, PER ORAL 22-Feb-2006 08:32 AM Page: 314 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ziprasidone Hydrochloride SS ORAL 60 MG QD, PER ORAL Date:04/08/03ISR Number: 4092105-2Report Type:Expedited (15-DaCompany Report #A213712 Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Literature Geodon (Ziprasidone) PS 80 MG (BID) Initial or Prolonged Electrocardiogram Qt Consumer Luvox (Fluvoxamine Corrected Interval Health Maleate) SS 150 MG (BID) Prolonged Professional Clonazepam Electrocardiogram Qt (Clonazepam) C Prolonged Docusate (Docusate) C Benzatropine (Benzatropine) C Valproate Sodium (Valproate Sodium) C Oxybutynin (Oxybutynin) C Risperidone (Risperidone) C Date:04/08/03ISR Number: 4092107-6Report Type:Expedited (15-DaCompany Report #2003013228 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Geodon (Im) Professional (Ziprasidone) PS INTRAMUSCULAR INTRAMUSCULAR Company Representative Date:04/08/03ISR Number: 4092148-9Report Type:Expedited (15-DaCompany Report #2003010033 Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Health Geodon (Ziprasidone) PS ORAL 80 MG (BID0, Dyspnoea Professional ORAL Motor Dysfunction Sertraline Tongue Disorder Hydrochloride Torticollis (Sertraline Hydrochloride) C Metronidazole (Metronidazole) C Bactrim (Sulfamethoxazole, Trimethoprim) C Triamcinolone (Triamcinolone) C Date:04/09/03ISR Number: 4090320-5Report Type:Direct Company Report #CTU 190563 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypotension Ziprasidone PS 22-Feb-2006 08:32 AM Page: 315 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/09/03ISR Number: 4092982-5Report Type:Expedited (15-DaCompany Report #2003011613 Age:88 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Ventricular Tachycardia Health Geodon (Ziprasidone) PS Professional Gatifloxacin Company (Gastifloxacin) C Representative Metronidazole (Metronidazole) C Clindamycin (Clindamycin) C Olanzapine (Olanzapine) C Date:04/10/03ISR Number: 4091425-5Report Type:Direct Company Report #CTU 190664 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gaze Palsy Geodon PS ORAL 40 PO BID Initial or Prolonged Effexor C Lamictal C Cogentin C Date:04/10/03ISR Number: 4093313-7Report Type:Expedited (15-DaCompany Report #2003007492 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Unevaluable Event Foreign Zeldox (Ziprasidone) PS Initial or Prolonged Health Professional Company Representative Date:04/10/03ISR Number: 4093835-9Report Type:Expedited (15-DaCompany Report #A208038 Age:17 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Acidosis Literature Ziprasidone Hospitalization - Coma Health (Ziprasidone) PS ORAL 2400 MG, ORAL Initial or Prolonged Electrocardiogram Qrs Professional Wellbutrin Required Complex Prolonged (Bupropion) Intervention to Electrocardiogram Qt (Bupropion Prevent Permanent Corrected Interval Hydrohloride) SS ORAL ORAL Impairment/Damage Prolonged Klonopin Electrocardiogram Qt (Clonazepam0 SS ORAL 7.5 MG, ORAL Prolonged Ativan (Lorazepam) Hyperventilation (Lorazepam) SS ORAL 2 MG, ORAL Intentional Overdose Lethargy Somnolence Date:04/11/03ISR Number: 4094051-7Report Type:Expedited (15-DaCompany Report #2002060835 Age:17 MON Gender:Female I/FU:F Outcome PT Hospitalization - Accidental Exposure Initial or Prolonged Blood Pressure Other Electrocardiogram Qt 22-Feb-2006 08:32 AM Page: 316 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Corrected Interval Prolonged Electrocardiogram Qt Interval Report Source Product Role Manufacturer Route Dose Duration Sinus Tachycardia Literature Geodon (Ziprasidone) PS ORAL 400 MG, ORAL Health Professional Date:04/11/03ISR Number: 4094055-4Report Type:Expedited (15-DaCompany Report #2003014035 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Screen Positive Literature Geodon (Ziprasidone) PS 1200 MG Initial or Prolonged Electrocardiogram Health Cocaine (Cocaine) SS Abnormal Professional Diamorphine Miosis (Diamorphine) SS Somnolence Suicide Attempt Date:04/14/03ISR Number: 4092213-6Report Type:Direct Company Report #CTU 190777 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gynaecomastia Geodon, Pfizer PS Pfizer Initial or Prolonged Tremor Date:04/14/03ISR Number: 4092398-1Report Type:Direct Company Report #CTU 190765 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Geodon PS ORAL PO BID Initial or Prolonged Electrocardiogram Qt Corrected Interval Prolonged Date:04/14/03ISR Number: 4094500-4Report Type:Expedited (15-DaCompany Report #2003005372 Age:70 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Pressure Increased Foreign Zeldox (Capsules) Hospitalization - Circulatory Collapse Health (Ziprasidone) PS ORAL 80 MG (BID), Initial or Prolonged Diabetes Mellitus Professional ORAL Dizziness Verapamil Drug Interaction Hydrochloride Paranoia (Verapamil Respiratory Tract Hydrochloride) SS ORAL 160 MG (BID), Infection ORAL Torsade De Pointes Theophylline Vomiting (Theophylline) SS ORAL ORAL Digoxin (Digoxin) SS ORAL ORAL Zopiclone (Zopiclone) SS ORAL ORAL Levofloxacin (Levofloxacin) SS Citalopram Hydrobromide C Donepezil Hydrochloride C 22-Feb-2006 08:32 AM Page: 317 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/14/03ISR Number: 4094520-XReport Type:Expedited (15-DaCompany Report #2003014114 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gastrointestinal Foreign Zeldox (Capsules) Initial or Prolonged Haemorrhage Health (Ziprasidone) PS ORAL 80 MG (BID), Professional ORAL Company Representative Date:04/14/03ISR Number: 4095197-XReport Type:Expedited (15-DaCompany Report #A0403475A Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acidosis Literature Wellbutrin Sr Initial or Prolonged Arrhythmia Health Tablet-Controlled Drug Toxicity Professional Release (Bupropion Electrocardiogram Qrs Hydrochloride) PS ORAL SEE DOSAGE Complex Prolonged TEXT/ORAL Electrocardiogram Qt Ziprasidone Hcl Prolonged (Formulation Lethargy Unknown)(Ziprasidone Overdose Hcl) SS ORAL 2400 MG/ Somnolence SINGLE DOSE/ ORAL Clonazepam (Formulation Unknown) SS ORAL 7.5 MG / SINGLE DOSE / ORAL Lorazepam (Formulation Unknown) (Lorazepam) SS 2 MG / SINGLE DOSE / Date:04/15/03ISR Number: 4095406-7Report Type:Expedited (15-DaCompany Report #2003014486 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Geodon (Ziprazidone) PS ORAL 160 MG (BID), Initial or Prolonged Diabetes Mellitus Professional ORAL Schizoaffective Disorder Perphenazine C Furosemide C Enalapril C Valproate Semisodium C Date:04/15/03ISR Number: 4095439-0Report Type:Expedited (15-DaCompany Report #2003014683 Age:44 YR Gender:Female I/FU:I Outcome PT Hospitalization - Dizziness Initial or Prolonged Drug Hypersensitivity Dyspnoea Fall Fungal Infection Gait Disturbance Hallucination Headache Herpes Simplex 22-Feb-2006 08:32 AM Page: 318 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Speech Disorder Report Source Product Role Manufacturer Route Dose Duration Consumer Geodon (Ziprasidone) PS ORAL ORAL Zoloft (Sertraline) C Celexa (Citalopram Hydrobromide) C Date:04/15/03ISR Number: 4095443-2Report Type:Expedited (15-DaCompany Report #2003011794 Age: Gender:Unknown I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Deep Vein Thrombosis Health Geodon (Ziprasidone) PS Professional Company Representative Date:04/15/03ISR Number: 4095447-XReport Type:Expedited (15-DaCompany Report #2003011793 Age: Gender:Unknown I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Deep Vein Thrombosis Health Geodon (Ziprasidone) PS Professional Company Representative Date:04/15/03ISR Number: 4095637-6Report Type:Expedited (15-DaCompany Report #2003014798 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Apathy Foreign Geodon (Ziprasidone) PS ORAL ORAL Initial or Prolonged Overdose Consumer Sertraline Vomiting (Sertraline) SS Date:04/15/03ISR Number: 4095765-5Report Type:Expedited (15-DaCompany Report #2003014796 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Apathy Foreign Ziprasidone Initial or Prolonged Miosis Consumer (Ziprasidone) PS ORAL 4800 MG Overdose (ONCE), ORAL Alprazolam (Alprazolam) SS ORAL 50 MG (ONCE), ORAL Date:04/15/03ISR Number: 4115343-9Report Type:Periodic Company Report #2002068583 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Health Geodon (Im) Corrected Interval Professional (Ziprasidone) PS INTRAMUSCULAR 40 MG (BID), Prolonged Company INTRAMUSCULAR Representative 22-Feb-2006 08:32 AM Page: 319 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/16/03ISR Number: 4096119-8Report Type:Direct Company Report #CTU 191110 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Geodon 80mg Po Bid Pfeizer PS Pfeizer ORAL 80MG PO BID Date:04/16/03ISR Number: 4097325-9Report Type:Expedited (15-DaCompany Report #2003011969 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delirium Foreign Ziprasidone Initial or Prolonged Difficulty In Walking Health (Ziprasidone) PS ORAL 160 MG Hypernatraemia Professional (DAILY), ORAL Company Ziprasidone Representative (Ziprasidone) SS INTRAMUSCULAR 20 MG (ONCE), INTRAMUSCULAR Lithium (Lithium,) C Date:04/16/03ISR Number: 4097331-4Report Type:Expedited (15-DaCompany Report #2003004961 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Benign Gastric Neoplasm Consumer Neurontin(Gabapentin Bipolar Disorder Health ) PS Drug Ineffective Professional Geodon (Ziprasidone) SS ORAL ORAL Syncope Lamotrigine (Lamotrigine) SS Antihypertensives C Diuretics C Aripiprazole (Aripiprazole) C Date:04/17/03ISR Number: 4098273-0Report Type:Expedited (15-DaCompany Report #2003003725 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebral Haemorrhage Consumer Geodon (Ziprasidone) PS 80 MG (DAILY) Life-Threatening Coma Health Bactrim Hospitalization - Dehydration Professional (Sulfamethoxazole, Initial or Prolonged Multi-Organ Failure Company Trimethoprim) SS Other Renal Failure Representative Sepsis Skin Discolouration Skin Necrosis Stevens-Johnson Syndrome Thrombocytopenia Vasculitis Date:04/17/03ISR Number: 4098275-4Report Type:Expedited (15-DaCompany Report #2003014923 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Geodon (Ziprasidone) PS Life-Threatening Professional Other Company Representative 22-Feb-2006 08:32 AM Page: 320 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/18/03ISR Number: 4098852-0Report Type:Expedited (15-DaCompany Report #2003011613 Age:88 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Geodon (Ziprasidone) PS INTRAMUSCULAR (Q4-6 HOURS, Heart Rate Irregular Professional AS NEEDED), Tachycardia Company INTRAMUSCULAR Ventricular Tachycardia Representative Gatifloxacin (Gatifloxacin) C Metronidazole (Metronidazole) C Clindamycin C Olanzapine (Olanzapine) C Salbutamol (Salbutamol) C Prednisone (Prednisone) C Tamsulosin Hydrochloride (Tamsulosin Hydrochloride) C Nitrofurantoin (Nitrofurantoin) C Acetylsalicylic Acid (Acetylsalicylic Acid) C Calcium (Calcium) C Zinc (Zinc) C Morphine Sulfate (Morphine Sulfate) C Hydrocortisone (Hydrocortisone) C Lorazepam (Lorazepam) C Risperidone (Risperidone) C Fluticasone Propionate (Fluticasone Propionate) C Salmeterol Xinafoate (Salmeterol Xinafoate) C Date:04/18/03ISR Number: 4098880-5Report Type:Expedited (15-DaCompany Report #2003015357 Age:19 YR Gender:Male I/FU:I Outcome PT Death Blood Calcium Decreased Other Blood Magnesium Increased Blood Phosphorus Increased Cardiac Arrest Coma Convulsion Drug Level Below Therapeutic Electrocardiogram St-T Segment Abnormal Heart Rate 22-Feb-2006 08:32 AM Page: 321 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lethargy Treatment Noncompliance Ventricular Hypertrophy Report Source Product Role Manufacturer Route Dose Duration Health Geodon (Ziprasidone) PS 160 MG (BID) Professional Olanzapine C Fluphenazine Hydrochloride C Date:04/18/03ISR Number: 4099028-3Report Type:Expedited (15-DaCompany Report #2003009714 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Hypersensitivity Foreign Zeldox (Ziprasidone) PS ORAL 120 MG, ORAL Dystonia Health Lorazepam Nasopharyngeal Disorder Professional (Lorazepam) C Tongue Disorder Company Representative Date:04/21/03ISR Number: 4099274-9Report Type:Expedited (15-DaCompany Report #2003016012 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Geodon (Ziprasidone) PS 80 MG (BID) Initial or Prolonged Phosphokinase Health Circulatory Collapse Professional Company Representative Date:04/21/03ISR Number: 4099424-4Report Type:Expedited (15-DaCompany Report #2003015276 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Potassium Decreased Consumer Geodon (Ziprasidone) PS ORAL ORAL Initial or Prolonged Cerebrovascular Accident Rofecoxib Other Coma (Rofecoxib) SS ORAL ORAL Electrocardiogram Fluoxetine Abnormal Hydrochloride Electroencephalogram (Fluoxetine Abnormal Hydrochloride) C Tooth Abscess Omeprazole Weight Decreased (Omeprazole) C Diazepam (Diazepam) C Sucralfate (Sucralfate) C Metoclopramide (Metoclopramide) C Phentermine (Phentermine) C Paracetamol (Paracetamol) C Date:04/21/03ISR Number: 4099428-1Report Type:Expedited (15-DaCompany Report #2003015772 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Respiratory Failure Health Geodon (Ziprasidone) PS Professional 22-Feb-2006 08:32 AM Page: 322 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/21/03ISR Number: 4099431-1Report Type:Expedited (15-DaCompany Report #2003014486 Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Geodon (Ziprasidone) PS ORAL 160 MG (BID), Initial or Prolonged Diabetes Mellitus Professional ORAL Schizoaffective Disorder Perphenazine (Perphenazzne) C Furosemide (Furosemide) C Enalapril (Enalapril) C Valproate Semisodium (Valproate Semisodium) C Date:04/22/03ISR Number: 4100280-6Report Type:Expedited (15-DaCompany Report #200303-2071 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Sensation Of Heaviness Health Benadryl Initial or Prolonged Syncope Professional (Diphenhydramine) PS ORAL 25 MG, QD, HS, ORAL Ziprasidone Hydrochloride (Ziprasidone Hydrochloride) SS ORAL 60 MG QD, ORAL Trifluoperazine Hydrochloride (Trifluoperazine Hydrochloride) C Trihexyphenidyl Hydrochloride (Trihexphenidyl Hydrochloride) C Date:04/23/03ISR Number: 4097228-XReport Type:Direct Company Report #USP 55517 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Geodon PS Pfizer Uspg Date:04/23/03ISR Number: 4097620-3Report Type:Direct Company Report #CTU 191516 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Zyprexa-Lilly PS Lilly ORAL 20MG Q DAY PO 4 MON Initial or Prolonged Dehydration Geodon-Pfizer SS Pfizer ORAL 60MG BID PO 4 MON Diabetes Mellitus Depakote C Hyperosmolar State Pancreatitis 22-Feb-2006 08:32 AM Page: 323 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/23/03ISR Number: 4101749-0Report Type:Expedited (15-DaCompany Report #2003015727 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Extrapyramidal Disorder Foreign Geodon (Im) Hypotension Health (Ziprasidone) PS INTRAMUSCULAR 20 MG, Professional INTRAMUSCULAR Company Representative Date:04/23/03ISR Number: 4101755-6Report Type:Expedited (15-DaCompany Report #2003007492 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Palpitations Foreign Zeldox (Ziprasidone) PS ORAL 160 MG (BID), Initial or Prolonged Health ORAL Professional Company Representative Date:04/24/03ISR Number: 4102502-4Report Type:Expedited (15-DaCompany Report #2003016312 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Health Geodon (Ziprasidone) PS ORAL ORAL Other Completed Suicide Professional Oxcarbazepine Company (Oxcarbazepine) SS Representative Date:04/25/03ISR Number: 4102923-XReport Type:Expedited (15-DaCompany Report #2003011202 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Infection Foreign Zeldox (Ziprasidone) PS ORAL 120 MG (BID), Initial or Prolonged Oedema Peripheral Health ORAL Pain In Extremity Professional Date:04/25/03ISR Number: 4103103-4Report Type:Expedited (15-DaCompany Report #2003003590 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthma Health Geodon (Ziprasidone) PS ORAL 20 MG (QD), Decreased Activity Professional ORAL Diarrhoea Company Risperidone Difficulty In Walking Representative (Risperidone) SS Drug Effect Decreased Venlafaxine Gout Hydrochloride Hypoaesthesia (Venlafaxine Influenza Like Illness Hydrochloride) C Joint Stiffness Lamotrigine Movement Disorder (Lamotrigine) C Muscle Rigidity Sinemet (Levodopa, Neuroleptic Malignant Carbidopa) C Syndrome Prqpranolol Oedema Peripheral (Propranolol) C Paraesthesia Theophylline Restless Legs Syndrome (Theophylline) C Sensory Loss Formoterol Fumarate 22-Feb-2006 08:32 AM Page: 324 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Formoterol Fumarate) C Loratadine (Loratadine) C Salbutamol (Salbutamol) C Alprazolam (Alprazolam) C Colchicine (Colchicine) C Date:04/25/03ISR Number: 4103183-6Report Type:Expedited (15-DaCompany Report #2003016607 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Electrocardiogram Qt Health Geodon (Im) Corrected Interval Professional (Ziprasidone) PS INTRAMUSCULAR INTRAMUSCULAR Prolonged Date:04/25/03ISR Number: 4103216-7Report Type:Expedited (15-DaCompany Report #2003013228 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Geodon (Im) Professional (Ziprasidone) PS INTRAMUSCULAR INTRAMUSCULAR Company Representative Date:04/25/03ISR Number: 4103224-6Report Type:Expedited (15-DaCompany Report #2003017132 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Withdrawal Syndrome Health Geodon (Ziprasidone) PS ORAL 240 MG (BID), Tardive Dyskinesia Professional ORAL Date:04/28/03ISR Number: 4103410-5Report Type:Expedited (15-DaCompany Report #2003016995 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Health Geodon (Ziprasidone) PS Syndrome Professional Company Representative Date:04/28/03ISR Number: 4104468-XReport Type:Expedited (15-DaCompany Report #2003015727 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Extrapyramidal Disorder Foreign Geodon (Im) Hypotension Health (Ziprasidone) PS INTRAMUSCULAR 20 MG, Professional INTRAMUSCULAR Company Representative 22-Feb-2006 08:32 AM Page: 325 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/30/03ISR Number: 4105113-XReport Type:Direct Company Report #CTU 192010 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Choreoathetosis Geodon 80 Mg B+ PS ORAL BID W/ FOOD Intervention to Tardive Dyskinesia (PO) Prevent Permanent Tremor Remeron C Impairment/Damage Effexor Xr C Mvi C Ec Asa C Norvasc S C Humubid C Levoxyl C Lipitor C Lopid C Prevacid C Vioxx C Glucophage C Insulin I Date:04/30/03ISR Number: 4105640-5Report Type:Expedited (15-DaCompany Report #2003017201 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Sedation Health Geodon (Ziprasidone) PS INTRAVENOUS INTRAVENOUS Initial or Prolonged Professional Other Date:04/30/03ISR Number: 4105646-6Report Type:Expedited (15-DaCompany Report #2003017081 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Health Geodon (Ziprasidone) PS Syndrome Professional Company Representative Date:04/30/03ISR Number: 4105713-7Report Type:Expedited (15-DaCompany Report #2003017204 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Geodon (Im) Initial or Prolonged Professional (Ziprasidone) PS INTRAMUSCULAR (PRN), Other Company INTRAMUSCULAR Representative Date:04/30/03ISR Number: 4105726-5Report Type:Expedited (15-DaCompany Report #2003017001 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Health Geodon (Ziprasidone) PS 160 MG( BID) Syndrome Professional Fluvoxamine Maleate Company (Fluvoxamine Representative Maleate) SS 22-Feb-2006 08:32 AM Page: 326 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/30/03ISR Number: 4105729-0Report Type:Expedited (15-DaCompany Report #2003017017 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Consumer Geodon (Ziprasidone) PS ORAL ORAL Initial or Prolonged Dyspnoea Exertional Multivitamins Other Gastrointestinal Mucosal (Ergocalciferol, Disorder Ascorbic Acid, Folic Productive Cough Acid, Thiamine Rhinorrhoea Hydrochloride, C Ibuprofen (Ibuprofen) C Metaxalone (Metaxalone) C Date:04/30/03ISR Number: 4105733-2Report Type:Expedited (15-DaCompany Report #2003017031 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Health Geodon (Ziprasidone) PS ORAL 160 MG (BID), Syndrome Professional ORAL Company Geodon (Im) Representative (Ziprasidone) SS INTRAMUSCULAR INTRAMUSCULAR All Other Therapeutic Products SS Fluvoxamine Maleate (Fluvoxamine Maleate) C Lorazepam (Lorazepam) C Date:04/30/03ISR Number: 4105919-7Report Type:Expedited (15-DaCompany Report #2003017008 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatocellular Damage Health Geodon (Ziprasidone) PS Initial or Prolonged Professional All Other Other Company Therapeutic Products C Representative Date:05/01/03ISR Number: 4106731-5Report Type:Expedited (15-DaCompany Report #2002061054 Age:26 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Health Geodon (Ziprasidone) PS ORAL 40 MG Initial or Prolonged Asthenia Professional (DAILY), ORAL Other Blood Potassium Decreased Lamotrigine Convulsion (Lamotrigine) SS ORAL 100 MG (BID), Delusion ORAL Hallucination, Auditory Diphenhydramine Headache Hydrochloride Hemiparesis (Diphenhydramine Nystagmus Hydrochloride) SS 50 MG Paraesthesia Excedrin/Usa/ Suicidal Ideation (Acetylsalicylic Tremor Acid, Caffeine, Vomiting Salicylamide, Paracetamol) C 22-Feb-2006 08:32 AM Page: 327 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/01/03ISR Number: 4106733-9Report Type:Expedited (15-DaCompany Report #2003008887 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Dependence Health Geodon (Ziprasidone) PS ORAL 80 MG (BID), Initial or Prolonged Drug Ineffective Professional ORAL Other Myocardial Infarction Paroxetine Treatment Noncompliance Hydrochloride (Paroxetine Hydrochloride) C Carbamazepine (Carbamazepine) C Date:05/02/03ISR Number: 4105543-6Report Type:Direct Company Report #CTU 192189 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Abilify PS Life-Threatening Geodon 60 Mg Tid SS Hospitalization - Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage Date:05/02/03ISR Number: 4105600-4Report Type:Direct Company Report #CTU 192133 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dystonia Geodon 80 Mg PS 80 MG X 3 Intervention to Trismus DOSES Prevent Permanent Impairment/Damage Date:05/05/03ISR Number: 4107577-4Report Type:Expedited (15-DaCompany Report #2003015276 Age: Gender:Female I/FU:F Outcome PT Hospitalization - Arthropathy Initial or Prolonged Blood Potassium Decreased Disability Blood Pressure Other Fluctuation Body Height Decreased Cerebrovascular Accident Coma Condition Aggravated Dizziness Drug Interaction Feeling Abnormal Hypertension Kidney Infection Laboratory Test Abnormal Migraine Nasopharyngitis Tooth Abscess Tremor Ulcer Uterine Neoplasm 22-Feb-2006 08:32 AM Page: 328 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Weight Decreased Report Source Product Role Manufacturer Route Dose Duration Consumer Geodon (Ziprasidone) PS ORAL (BID), ORAL Erythromycin (Erythromycin) SS Rofecoxib (Rofecoxib) SS ORAL ORAL Oxycocet (Paracetamol, Oxycodone Hydrochloride) SS Temazepam (Temazepam) SS Cyclobenzaprine Hydrochloride SS Fluoxetine Hydrochloride C Omeprazole C Diazepam (Diazepam) C Sucralfate (Sucralfate) C Metclopramide (Metclopramide) C Phentermine (Phentermine) C Paracetamol (Paracetamol) C Antihistamines C Benzeftamine Hydrochloride C Ketorolac Tromethamine C Estrogens Conjugated C Lotrel (Amlodipine, Benazepril Hydrochloride) C Cotylenol (Paracetamol, Chlorphenamine Maleate, Dextromethoprhan C Medinite (Ethanol, Paracetamol, Dextromethorphan Hydrobromide, Ephedrine Sulfate, C All Other Non-Therapeutic Products C Furosemide (Furosemide) C Date:05/05/03ISR Number: 4108430-2Report Type:Expedited (15-DaCompany Report #2003010437 Age:32 YR Gender:Male I/FU:F Outcome PT Hospitalization - Autoimmune Disorder Initial or Prolonged Burning Sensation Other Coordination Abnormal 22-Feb-2006 08:32 AM Page: 329 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Demyelination Fall Hypoaesthesia Report Source Product Role Manufacturer Route Dose Duration Muscle Spasms Consumer Geodon (Ziprasidone) PS ORAL 180 MG (BID), Neuropathy Peripheral Health ORAL Paraesthesia Professional Diltiazem Thermal Burn Hydrochloride (Diltiazem Hydrochloride) C Levothyroxine Sodium (Levothyroxine Sodium) C Rabeprazole Sodium (Rabeprazole Sodium) C Fluoxetine Hydrochloride (Fluoxetine Hydrochloride) C Benzatropine Mesilate (Benzatropine Mesilate) C Metformin Hydrochloride (Metformin Hydrochloride) C Lisinopril (Lisinopril) C Clonazepam (Clonazepam) C Modafinil (Modafinil) C Fluphenazine Hydrochloride (Fluphenazine Hydrochloride) C Salbutamol (Salbutamol) C Ipratropium Bromide (Ipratropium Bromide) C Date:05/06/03ISR Number: 4108947-0Report Type:Expedited (15-DaCompany Report #2003015357 Age:19 YR Gender:Male I/FU:F Outcome PT Death Blood Calcium Decreased Hospitalization - Blood Magnesium Increased Initial or Prolonged Blood Phosphorus Other Increased Cardiac Arrest Coma Convulsion Electrocardiogram St-T Segment Abnormal Heart Rate Increased Hyperhidrosis Lethargy Schizophrenia Treatment Noncompliance 22-Feb-2006 08:32 AM Page: 330 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tremor Ventricular Hypertrophy Report Source Product Role Manufacturer Route Dose Duration Health Geodon (Ziprasidone) PS 160 MG BID Professional Fosphenytoin Sodium SS Olanzapine C Fluphenazine Hydrochloride) C Date:05/06/03ISR Number: 4108948-2Report Type:Expedited (15-DaCompany Report #2003015276 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aphasia Consumer Geodon (Ziprasidone) PS ORAL BID, ORAL Initial or Prolonged Arthropathy Erythromycin SS Disability Blood Potassium Decreased Rofecoxib SS ORAL 50 MG, BID, Other Blood Pressure ORAL Inadequately Controlled Oxycocet Body Height Decreased (Paracetamol, Cerebrovascular Accident Oxycodone Condition Aggravated Hydrochloride) SS ORAL 50 MG, BID, Depression ORAL Hypertension Temazepam SS Hysterectomy Cyclobenzaprine Kidney Infection Hydrochloride SS Laboratory Test Abnormal Fluoxetine Malaise Hydrochloride C Migraine Omeprazole C Post-Traumatic Stress Diazepam C Disorder Sucralfate C Tooth Abscess Metoclopramide C Tremor Phentermine C Ulcer Paracetamol C Weight Decreased Antihistamines C Benzfetamine Hydrohcloride C Ketorolac Tromethamine C Estrogens Conjugated C Lotrel (Amlodipine, Benazepril Hydrochloride) C Cotylenol (Paracetamol, Chropheniramine Maleate, Dextromethorphan C Medinite (Ethanol, Paracetamol, Dextromethorphan Hydrobromide, Ephedrine Sulfate, C All Other Non-Therapeutic Products C Furosemide C Bupropion Hydrochloride C Zolpidem Tartrate C Topiramate C 22-Feb-2006 08:32 AM Page: 331 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Propacet (Paracetamol, Dextropropoxyphene Napsilate) C Oxycodone Hydrochloride C All Other Therapeutic Products C Date:05/07/03ISR Number: 4109240-2Report Type:Expedited (15-DaCompany Report #2003011645 Age:59 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Angioneurotic Oedema Foreign Zeldox (Capsules) Disease Recurrence Health (Ziprasidone) PS ORAL 80 MG (BID), Dyspnoea Professional ORAL Oedema Peripheral Company Isopromethazine Representative Hydrochloride (Isopromethazine Hydrochloride) SS ORAL 75 MG, ORAL Metoprolol Tartrate (Metoprolol Tartrate) C Levothyroxine Sodium (Levothyroxine Sodium) C Date:05/07/03ISR Number: 4109577-7Report Type:Expedited (15-DaCompany Report #2003UW05590 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Respiratory Health Seroquel PS ORAL 12 G ONCE PO Initial or Prolonged Distress Syndrome Professional Seroquel SS ORAL 600 MG PO Infection Geodon SS 3.36 G ONCE Intentional Overdose Geodon SS Lethargy Paralysis Pneumonia Aspiration Pulmonary Oedema Sedation Ventricular Tachycardia Date:05/07/03ISR Number: 4109744-2Report Type:Expedited (15-DaCompany Report #2003018219 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Medication Error Health Geodon (Ziprasidone) PS Psychotic Disorder Professional Date:05/07/03ISR Number: 4109749-1Report Type:Expedited (15-DaCompany Report #2003018220 Age:20 YR Gender:Female I/FU:I Outcome PT Hospitalization - Blood Creatine Initial or Prolonged Phosphokinase Increased Other Hypoxia Intentional Overdose 22-Feb-2006 08:32 AM Page: 332 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ventricular Tachycardia Report Source Product Role Manufacturer Route Dose Duration Health Geodon (Ziprasidone) PS ORAL 3.36 GRAM, Professional ORAL Quetiapine Fumarate (Quetiapine Fumarate) SS 12 GRAM Date:05/08/03ISR Number: 4108234-0Report Type:Direct Company Report #CTU 192534 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Seroquel Astra Initial or Prolonged Blood Glucose Increased Zeneca PS Astra Zeneca ORAL 650MG DAILY Required Fatigue ORAL Intervention to Nausea Geodon Pfizer SS Pfizer Prevent Permanent Polydipsia Zoloft C Impairment/Damage Polyuria Depakote C Vomiting Date:05/08/03ISR Number: 4110114-1Report Type:Expedited (15-DaCompany Report #2003008887 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Dependence Health Geodon (Ziprasidone) PS ORAL 80 MG (BID), Initial or Prolonged Drug Ineffective Professional ORAL Other Myocardial Infarction Paroxetine Hydrochloride (Paroxetine Hydrochloride) C Carbamazepine (Carbamazepine) C Date:05/09/03ISR Number: 4108304-7Report Type:Direct Company Report #CTU 192594 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Ziprasidone PS ORAL 60 BID ORAL Date:05/09/03ISR Number: 4110369-3Report Type:Expedited (15-DaCompany Report #2003018758 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Foreign Ziprasidone Initial or Prolonged Health (Ziprasidone) PS ORAL 40 MG Professional (DAILY), ORAL Company Representative Date:05/09/03ISR Number: 4110549-7Report Type:Expedited (15-DaCompany Report #A210937 Age:73 YR Gender:Female I/FU:I Outcome PT Other Arachnoid Cyst Chest Pain 22-Feb-2006 08:32 AM Page: 333 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Constipation Convulsion Drug Withdrawal Syndrome Report Source Product Role Manufacturer Route Dose Duration Dry Mouth Consumer Geodon (Ziprasidone) PS ORAL 40 MG (BID), Electroencephalogram Health ORAL Abnormal Professional Lithane (Lithium) Heart Rate Irregular (Lithium) SS ORAL ORAL Impaired Driving Ability Levoxyl Insomnia (Levothyroxine) Major Depression (Levothyroxine Malaise Sodium) C Parkinson'S Disease Lipitor Tachycardia (Atorvastatin) Tardive Dyskinesia (Atorvastatin) C Tongue Disorder Triamterene/Hydrochl orothiazide (Hydrochlorothiazide , Triamterene) C Conjugated Estrogens (Estrogens Conjugated) C Multivitamin (Ergocalciferol, Ascorbic Acid, Folic Acid, Thiamine Hydrochloride, C Vitamin E (Tocopherol) C Glucosamine (Glucosamine) C Calcium (Calcium) C Aspirin (Acetylsalicylic Acid) (Acetylsalicylic Acid) C Cenestin (Estrogens Conjugated) C Date:05/12/03ISR Number: 4110854-4Report Type:Expedited (15-DaCompany Report #2003018817 Age: Gender:Female I/FU:I Outcome PT Hospitalization - Abdominal Pain Upper Initial or Prolonged Asthenia Other Balance Disorder Condition Aggravated Decreased Appetite Dizziness Dry Skin Feeling Of Body Temperature Change Fluid Retention Increased Appetite Mental Disorder Micturition Urgency Muscular Weakness Nausea Pyrexia Rash 22-Feb-2006 08:32 AM Page: 334 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sinus Disorder Thyroid Disorder Tourette'S Disorder Report Source Product Role Manufacturer Route Dose Duration Treatment Noncompliance Consumer Geodon (Ziprasidone) PS ORAL ORAL Vomiting Atomoxetine Hydrochloride (Atomoxetine Hydrochloride) SS Obetrol (Dexamefetamine Sulfate, Amfetamine Sulfate,,Dexamefetam ine Saccharate, C Flooxetine Hydrochloride (Fluoxetine Hydrochloride) C Date:05/12/03ISR Number: 4111427-XReport Type:Expedited (15-DaCompany Report #2003005177 Age:24 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Foreign Ziprasidone Initial or Prolonged Status Epilepticus Health (Ziprasidone) PS 60 MG (DAILY) Professional Company Representative Date:05/14/03ISR Number: 4112037-0Report Type:Expedited (15-DaCompany Report #2003019437 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancreatitis Health Geodon (Ziprasidone) PS Initial or Prolonged Professional Company Representative Date:05/16/03ISR Number: 4112439-2Report Type:Expedited (15-DaCompany Report #2003012036 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Health Geodon (Im) Professional (Ziprasidone) PS INTRAMUSCULAR INTRAMUSCULAR Company Representative Date:05/16/03ISR Number: 4112440-9Report Type:Expedited (15-DaCompany Report #2003012803 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Geodon (Ziprasidone) PS ORAL 160 MG (BID) Initial or Prolonged Coma Professional ORAL Sepsis Clozapine Vomiting (Clozapine) SS ORAL 400 MG White Blood Cell Count (DAILY) ORAL Increased Benzatropine Mesilate C 22-Feb-2006 08:32 AM Page: 335 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/16/03ISR Number: 4112717-7Report Type:Expedited (15-DaCompany Report #2003019511 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Paranoia Consumer Geodon (Ziprasidone) PS ORAL ORAL Initial or Prolonged Treatment Noncompliance Lithium Carbonate (Lithium Carbonate) C Gabapentin (Gabapentin) C Bupropion Hydrochloride (Bupropion Hydrochloride) C Date:05/16/03ISR Number: 4114319-5Report Type:Direct Company Report #CTU 193201 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Laryngospasm Geodon 60 Mg Pfizer PS Pfizer ORAL 60 MG BID Hospitalization - ORAL Initial or Prolonged Effexor Xr C Date:05/19/03ISR Number: 4114439-5Report Type:Direct Company Report #CTU 193260 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dermatitis Contact Geodon PS ORAL 60MG BID PO Date:05/19/03ISR Number: 4114752-1Report Type:Expedited (15-DaCompany Report #2003019437 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pancreatitis Health Geodon (Ziprasidone) PS Professional Trazodone Company (Trazodone) C Representative All Other Therapeutic Products C Date:05/19/03ISR Number: 4114887-3Report Type:Expedited (15-DaCompany Report #2003019890 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Alcohol Health Geodon (Ziprasidone) PS ORAL ORAL Overdose Professional Clonazepam Torsade De Pointes Company (Clonazepam) SS Representative Ethanol (Ethanol) SS Date:05/20/03ISR Number: 4114539-XReport Type:Expedited (15-DaCompany Report #2003010432 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dysphagia Foreign Zeldox (Ziprasidone) PS ORAL 40 MG, ORAL Face Oedema Health Metformin Oedema Peripheral Professional Hydrochloride Swollen Tongue (Metformin Hydrochloride) C Bisoprolol 22-Feb-2006 08:32 AM Page: 336 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Bisoprolol) C Date:05/20/03ISR Number: 4114542-XReport Type:Expedited (15-DaCompany Report #2003019825 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Muscle Spasms Foreign Ziprasidone Initial or Prolonged Respiratory Disorder Health (Ziprasidone) PS ORAL 80 MG (BID), Professional ORAL Company Representative Date:05/20/03ISR Number: 4115400-7Report Type:Expedited (15-DaCompany Report #2003020024 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Health Geodon (Ziprasidone) PS ORAL 160 MG (BID), Initial or Prolonged Aspartate Professional ORAL Other Aminotransferase Company Ondansetron Blood Alkaline Representative Hydrochloride Phosphatase (Ondansetron Electroconvulsive Therapy Hydrochloride) C Date:05/20/03ISR Number: 4115414-7Report Type:Expedited (15-DaCompany Report #2003019779 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Health Geodon (Ziprasidone) PS 160 MG (BID) Interval Professional Nefazodone Loss Of Consciousness Company Hydrochloride Representative (Nefazodone Hydrochloride) C Date:05/20/03ISR Number: 4115446-9Report Type:Expedited (15-DaCompany Report #2003008892 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Consumer Geodon (Ziprasidone) PS ORAL 160 MG (BID), Initial or Prolonged Anaemia ORAL Anxiety Zoloft (Sertraline) SS ORAL 25 MG Balance Disorder (DAILY), ORAL Catatonia Lorazepam Coma (Lorazepam) SS ORAL 0.75 MG Condition Aggravated (TID), ORAL Delirium Acetylsalicylic Acid Dementia (Acetylsalicylic Depression Acid) C Disorientation Olanzapine C Dizziness Drug Withdrawal Syndrome Hostility Hypothyroidism Insomnia Nervousness Oral Intake Reduced Psychomotor Hyperactivity Stereotypy Urinary Tract Infection 22-Feb-2006 08:32 AM Page: 337 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/21/03ISR Number: 4115848-0Report Type:Expedited (15-DaCompany Report #2003020171 Age: Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Catatonia Health Geodon (Im) Initial or Prolonged Professional (Ziprasidone) PS INTRAMUSCULAR 20 MG, Other INTRAMUSCULAR Date:05/21/03ISR Number: 4115851-0Report Type:Expedited (15-DaCompany Report #2003012209 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyspnoea Health Geodon (Ziprasidone) PS ORAL BID, ORAL Initial or Prolonged Hallucination, Visual Professional Estradiol C Other Hyperacusis Lisinopril C Hyperaesthesia Lorazepam C Medication Error Venlafaxine Multiple Allergies Hydrochloride C Pruritus Generalised Obetrol (Amfetamine Screaming Sulfate, Self-Injurious Ideation Dexafetamine Wheezing Saccharate, Amefatamine C Liothyronine Sodium C Gabapentin C Levothyroxine Sodium C Date:05/22/03ISR Number: 4116233-8Report Type:Expedited (15-DaCompany Report #2003005848 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthma Consumer Geodon (Ziprasidone) PS ORAL 80 MG (BID), Disturbance In Attention Health ORAL Dysgeusia Professional Modafinil Dyspnoea (Modafinil) SS ORAL ORAL Hallucination Topiramate Hysterectomy (Topiramate) C Insomnia Bupropion Mental Impairment Hydrochloride Psychomotor Hyperactivity (Bupropion Somnolence Hydrochloride) C Visual Disturbance Zonisamide Wheezing (Zonisamide) C Date:05/23/03ISR Number: 4116973-0Report Type:Expedited (15-DaCompany Report #2003020799 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Laryngospasm Foreign Zeldox (Capsules) Tongue Spasm Health (Ziprasidone) PS 80 MG (BID) Professional Company Representative 22-Feb-2006 08:32 AM Page: 338 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/23/03ISR Number: 4117131-6Report Type:Expedited (15-DaCompany Report #2003010437 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accident Consumer Geodon (Ziprasidone) PS ORAL 180 MG (BID), Initial or Prolonged Autoimmune Disorder Health ORAL Other Demyelinating Professional Diltiazem Polyneuropathy Hydrochloride Fall (Diltiazem Hypoaesthesia Hydrochloride) C Muscle Spasms Levothyroxine Sodium Paraesthesia (Levothyroxine Skin Burning Sensation Sodium) C Thermal Burn Rabeprazole Sodium (Rabeprazole Sodium) C Fluoxetine Hydrochloride (Fluoxetine Hydrochloride) C Benzatropine Mesilate (Benzatropine Mesilate) C Metformin Hydrochloride (Metformin Hydrochloride) C Lisinopril (Lisinopril) C Clonazepam (Clonazepam) C Modafinil (Modafinil) C Fluphenazine Hydrochloride (Fluphenazine Hydrochloride) C Salbutamol (Salbutamol) C Ipratropium Bromide (Ipratropium Bromide) C Date:05/23/03ISR Number: 4118173-7Report Type:Direct Company Report #CTU 193861 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Withdrawal Syndrome Geodon PS ORAL 30 MG PO TID Erectile Dysfunction Lorazepam C Heart Rate Decreased Zantac C Heart Rate Increased Omeprazole C Nausea Lanbid C Paraesthesia Tremor 22-Feb-2006 08:32 AM Page: 339 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/27/03ISR Number: 4117422-9Report Type:Direct Company Report #CTU 194042 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bradycardia Geodon 60 Mg Bid Po PS ORAL 120MG/DAY 48 HR Lorazepam C Haldol C Trazodone C Hydroxyzine C Date:05/27/03ISR Number: 4117911-7Report Type:Expedited (15-DaCompany Report #2003005372 Age:70 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Atrial Fibrillation Foreign Zeldox (Capsules) Hospitalization - Blood Pressure Increased Health (Ziprasidone) PS ORAL 80 MG (BID), Initial or Prolonged Bundle Branch Block Left Professional ORAL Other Circulatory Collapse Verapamil Condition Aggravated Hydrochloride Depression (Verapamil Diabetes Mellitus Hydrochloride) SS ORAL 160 MG (BID), Dizziness ORAL Drug Interaction Theophylline Electrocardiogram Qt (Theophylline) SS ORAL ORAL Prolonged Digoxin (Digoxin) SS ORAL ORAL Electrocardiogram St Zopiclone Segment Abnormal (Zopiclone) SS ORAL ORAL Myocardial Infarction Levofloxacin Paranoia (Levofloxacin) SS Respiratory Tract Citalopram Infection Hydrobromide Torsade De Pointes (Citalopram Ventricular Tachycardia Hydrobromide) C Vomiting Donepezil Hydrochloride (Donepezil Hydrochloride) C Date:05/27/03ISR Number: 4118103-8Report Type:Expedited (15-DaCompany Report #2003020608 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Somnolence Health Geodon (Ziprasidone) PS ORAL 1680 MG, ORAL Suicide Attempt Professional Trazodone Company (Trazodone) SS Representative Date:05/27/03ISR Number: 4118227-5Report Type:Expedited (15-DaCompany Report #2003020799 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Laryngospasm Foreign Zeldox (Capsules) Oropharyngeal Spasm Health (Ziprasidone) PS 80 MG (BID) Professional Company Representative 22-Feb-2006 08:32 AM Page: 340 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/27/03ISR Number: 4118389-XReport Type:Expedited (15-DaCompany Report #2003016012 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Geodon (Ziprasidone) PS ORAL 20 MG Initial or Prolonged Increased Health (DAILY), ORAL Aspartate Professional Alprazolam Aminotransferase Company (Alprazolam) C Increased Representative Flurazepam Blood Creatine Hydrochloride Phosphokinase Increased (Flurazepam Circulatory Collapse Hydrochloride) C Cold Sweat Escitalopram Feeling Hot (Escitalopram) C Loss Of Consciousness Muscle Injury Nausea Syncope Vasovagal Date:05/28/03ISR Number: 4119508-1Report Type:Expedited (15-DaCompany Report #2003005592 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Depressed Level Of Foreign Zeldox (Capsules) Hospitalization - Consciousness Health (Ziprasidone) PS ORAL 4200 MG, ORAL Initial or Prolonged Nervousness Professional Other Overdose Suicide Attempt Date:05/30/03ISR Number: 4120679-1Report Type:Expedited (15-DaCompany Report #2003013100 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Health Geodon (Ziprasidone) PS ORAL 40 MG (BID), Initial or Prolonged Blood Cholesterol Professional ORAL Other Increased Lithane (Lithium) SS ORAL 900 MG Blood Glucose Increased (DAILY), ORAL Blood Sodium Decreased Valproae Semisodium Formication (Valproate Irritability Semisodium) C Mood Altered Lithium Carbonate Nocturia (Lithium Carbonate) C Palpitations Clonazepam (Clonazepam) C Levetiracetam (Levetiracetam) C Date:05/30/03ISR Number: 4121368-XReport Type:Expedited (15-DaCompany Report #A211543 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Urinary Retention Foreign Ziprasidone Initial or Prolonged Health (Ziprasidone) PS ORAL 80 MG (BID), Professional ORAL 22-Feb-2006 08:32 AM Page: 341 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/02/03ISR Number: 4121909-2Report Type:Expedited (15-DaCompany Report #2003004928 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Zeldox (Ziprasidone) PS ORAL 120 MG, ORAL Initial or Prolonged Psychotic Disorder Health Melperone Other Rhabdomyolysis Professional Hydrochloride Suicidal Ideation Company (Melperone Representative Hydrochloride) SS ORAL 100 MG (DAILY), ORAL Olanzapine (Olanzapine) C Date:06/02/03ISR Number: 4122321-2Report Type:Expedited (15-DaCompany Report #2003021859 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Health Geodon (Ziprasidone) PS ORAL (BID), ORAL Initial or Prolonged Cyanosis Professional Clonazepam(Clonazepa Dyspnoea m) C Glycosylated Haemoglobin Propranolol Increased (Propranolol) C Hyperhidrosis Liothyronine Sodium Thirst (Liothyronine Sodium) C Warfarin (Warfarin) C Esomeprazole (Esomeprazole) C Poassium (Potassium) C Bumetanide (Bumetanide) C Seretide Mite (Fluticasone Propionate, Sameterol Xionafoate) C Combivent (Ipratropium Bromide, Salbutamol Sulfate) C Pirbuterol Acetate (Pirbuterol Acetate0 C Quetiapine Fumarate (Quetiapine Fumarate) C Gabapentin (Gabapentin) C Date:06/02/03ISR Number: 4122412-6Report Type:Expedited (15-DaCompany Report #2003007921 Age:81 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Calcium Decreased Health Geodon (Ziprasidone) PS ORAL 20 MG, Life-Threatening Cardio-Respiratory Arrest Professional GASTROSTOMY Hospitalization - Hypokalaemia TUBE, ORAL Initial or Prolonged Medication Error Geodone (Im) Other Salivary Hypersecretion (Ziprasidone) SS INTRAVENOUS 5 MG (ONCE), INTRAVENOUS Potassium (Potassium) C 22-Feb-2006 08:32 AM Page: 342 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ceftriaxone Sodium (Ceftriaxone Sodium) C Digoxin (Digoxin) C Fentanyl (Fentanyl) C Furosemide (Furosemide) C Lansoprazole (Lansoprazole) C Mirtazapine (Mirtazapine) C Neomycin (Neomycin) C Gluceryl Trinitrate (Glyceryl Trinitrate) C Risperidone (Risperidone) C Warfarin (Warfarin) C Olanzapine (Olanzapine) C Amlodipine Besilate (Amlodipine Besilate) C Clonidine Hydrochloride (Clonidine Hydrochloride) C Zinc Sulfate (Zinc Sulfate) C Ascorbic Acid (Ascorbic Acid) C Vitamins Nos (Vitamins Nos) C Enalapril Maleate (Enalapril Maleate) C Metoprolol Tartrate (Metoprolol Tartrate) C Polymyxin B (Polymyxin B) C Lorazepam (Lorazepam) C Date:06/02/03ISR Number: 4140892-7Report Type:Periodic Company Report #2003007925 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Geodon (Ziprasidone) PS ORAL 160 MG (BID), Initial or Prolonged Extrapyramidal Disorder Professional ORAL Food Interaction All Other Schizophrenia Non-Therapeutic Products SS Haloperidol (Haloperidol) C Benzatropine Mesilate (Benzatropine Mesilate) C Gabapentin(Gabapenti n) C Lorazepam 22-Feb-2006 08:32 AM Page: 343 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Lorazepam) C Date:06/02/03ISR Number: 4140894-0Report Type:Periodic Company Report #2003007963 Age:67 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Health Geodon (Ziprasidone) PS 40 MG (BID) Corrected Interval Professional All Other Prolonged Company Therapeutic Products C Representative Date:06/02/03ISR Number: 4140896-4Report Type:Periodic Company Report #2003008657 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Health Geodon (Ziprasidone) PS Corrected Interval Professional Prolonged Company Representative Date:06/02/03ISR Number: 4140899-XReport Type:Periodic Company Report #2003008885 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tachycardia Health Geodon (Ziprasidone) PS ORAL ORAL Professional Haloperidol Company Decanoate Representative (Haloperidol Decanoate) C Date:06/02/03ISR Number: 4140901-5Report Type:Periodic Company Report #2003008892 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Consumer Geodon (Ziprasidone) PS ORAL 160 MG Initial or Prolonged Agitation (DAILY), ORAL Anaemia Zoloft (Sertraline) SS ORAL 25 MG Balance Disorder (DAILY), ORAL Delirium Lorazepam Diet Refusal (Lorazepam) SS ORAL 0.75 MG Dizziness (TID), ORAL Drug Withdrawal Syndrome Hostility Insomnia Nervousness Psychomotor Hyperactivity Screaming Date:06/02/03ISR Number: 4140904-0Report Type:Periodic Company Report #2003011718 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Priapism Health Geodon (Ziprasidone) PS Professional Company Representative 22-Feb-2006 08:32 AM Page: 344 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/02/03ISR Number: 4140906-4Report Type:Periodic Company Report #2003013213 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Consumer Geodon (Ziprasidone) PS (DAILY) Corrected Interval Topiramate C Prolonged Date:06/02/03ISR Number: 4140909-XReport Type:Periodic Company Report #2003013575 Age:4 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Grand Mal Convulsion Health Geodon (Ziprasidone) PS 60 MG (DAILY) Professional Oxcarbazepine Company (Oxcarbazepine) C Representative Date:06/02/03ISR Number: 4140911-8Report Type:Periodic Company Report #2003016781 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Health Geodon (Ziprasidone) PS Prolonged Professional All Other Multiple Drug Overdose Company Therapeutic Products SS Representative Date:06/02/03ISR Number: 4140913-1Report Type:Periodic Company Report #2003017379 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Jaundice Cholestatic Health Geodon (Ziprasidone) PS Initial or Prolonged Liver Function Test Professional Bupronion Abnormal Company Hydrochloride Representative (Bupronion Hydrochloride) C Olanzapine (Olanzapine) C Date:06/02/03ISR Number: 4140918-0Report Type:Periodic Company Report #2003018999 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dysarthria Health Geodon (Ziprasidone) PS 6400 MG Initial or Prolonged Electrocardiogram Qt Professional (ONCE) Prolonged Company Diazepam SS Intentional Overdose Representative Medication Error Sedation Date:06/02/03ISR Number: 4140920-9Report Type:Periodic Company Report #2003019239 Age: Gender:Female I/FU:I Outcome PT Other Drooling Grand Mal Convulsion Intentional Overdose Medication Error 22-Feb-2006 08:32 AM Page: 345 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Muscular Weakness Somnolence Report Source Product Role Manufacturer Route Dose Duration Health Geodon (Ziprasidone) PS ORAL 200 MG, ORAL Professional Valproate Semisodium SS Date:06/02/03ISR Number: 4140923-4Report Type:Periodic Company Report #2003019402 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Geodon (Ziprasidone) PS 80 MG BID Professional Chlorpromazine Company Hydrochloride SS Representative Date:06/02/03ISR Number: 4140926-XReport Type:Periodic Company Report #2003019572 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Health Geodon (Ziprasidone) PS ORAL ORAL Initial or Prolonged Professional Labetalol C Other Metformin C Acetylsalicylic Acid C Clopidogrel Sulfate C Date:06/02/03ISR Number: 4140928-3Report Type:Periodic Company Report #2002072418 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Health Geodon (Ziprasidone) PS ORAL 60 MG, DAILY, Initial or Prolonged Insomnia Professional ORAL Syncope All Other Therapeutic Products SS Diphenhydramine SS ORAL 25 MG, DAILY, ORAL Date:06/02/03ISR Number: 4140929-5Report Type:Periodic Company Report #2002072626 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrial Fibrillation Consumer Geodon (Ziprasidone) PS ORAL 40 MG, BID, Dementia Health ORAL Professional Omeprazole C Baclofen C Mirtazapine C Citalopram Hydrobromide C Risperidone C Clopidogrel Sulfate C Simvastatin C Donepezil Hydrochloride C Ramipril C Esomeprazole C Tocopherol C Acetylsalicylic Acid C Valproate Semisodium C 22-Feb-2006 08:32 AM Page: 346 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Azithromycin C Boost (Biotin, Potassium, Sodium, Fats Nos, Vitamins Nos, Minerals Nos, Carbohydrates Nos, C Date:06/02/03ISR Number: 4140930-1Report Type:Periodic Company Report #2003000674 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Magnesium Decreased Health Geodon (Ziprasidone) PS ORAL 160 MG, BID, Delusional Perception Professional ORAL Electrocardiogram Qt All Other Corrected Interval Therapeutic Products SS Prolonged Fexofenadine SS ORAL ORAL Tremor Sertraline C Weight Decreased Hydrochlorothiazide C Dyazide (Hydrochlorothiazide , Triamterene) C Levothyroxine Sodium C Diltiazem C Lorazepam C Date:06/02/03ISR Number: 4140931-3Report Type:Periodic Company Report #2003001478 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Health Geodon (Ziprasidone) PS ORAL 120 MG, BID, Initial or Prolonged Electrocardiogram Qt Professional ORAL Other Prolonged Haloperidol Decanoate C Benzatropine Mesilate C Ranitidine Hydrochloride C Lansoprazole C Date:06/02/03ISR Number: 4140932-5Report Type:Periodic Company Report #2003005856 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Geodon (Ziprasidone) PS ORAL 80 MG, BID, Professional ORAL Company Bupropion Representative Hydrochloride SS 300 MG BID Non-Therapeutic Products SS Alprazolam C Zolpidem Tartrate C 22-Feb-2006 08:32 AM Page: 347 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/03/03ISR Number: 4123202-0Report Type:Expedited (15-DaCompany Report #2003022466 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Geodon (Im) Professional (Ziprasidone) PS INTRAMUSCULAR INTRAMUSCULAR Company Representative Date:06/03/03ISR Number: 4123206-8Report Type:Expedited (15-DaCompany Report #2003022465 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Geodon (Im) Professional (Ziprasidone) PS INTRAMUSCULAR INTRAMUSCULAR Company Representative Date:06/03/03ISR Number: 4123253-6Report Type:Expedited (15-DaCompany Report #2003019511 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Paranoia Consumer Geodon (Ziprasidone) PS ORAL ORAL Initial or Prolonged Treatment Noncompliance Lithium Carbonate (Lithium Carbonate) C Gabapentin (Gabapentin) C Bupropion Hydrochloride (Bupropion Hydrochloride) C Date:06/04/03ISR Number: 4123090-2Report Type:Direct Company Report #CTU 194946 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Electrocardiogram Qt Geodon 50 Mg Pfizer PS Pfizer ORAL 60 MG BID Hospitalization - Corrected Interval ORAL Initial or Prolonged Prolonged Lipitor C Required Mental Status Changes Lasix C Intervention to Ventricular Tachycardia Bextra C Prevent Permanent Impairment/Damage Date:06/04/03ISR Number: 4124307-0Report Type:Expedited (15-DaCompany Report #2003020799 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Abuser Foreign Zeldox (Capsules) Laryngospasm Health (Ziprasidone) PS ORAL 80 MG (BID), Musculoskeletal Stiffness Professional ORAL Salivary Hypersecretion Company Representative 22-Feb-2006 08:32 AM Page: 348 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/04/03ISR Number: 4124393-8Report Type:Expedited (15-DaCompany Report #2003022792 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Geodon (Im) Other Professional (Ziprasidone) PS INTRAMUSCULAR INTRAMUSCULAR Company Representative Date:06/05/03ISR Number: 4124780-8Report Type:Expedited (15-DaCompany Report #2003019890 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Alcohol Increased Health Geodon (Ziprasidone) PS ORAL UNK, ORAL Intentional Overdose Professional Clonazepam Torsade De Pointes Company (Clonazepam) SS UNKNOWN UNK Representative Ethanol (Ethanol) SS UNKNOWN UNK Date:06/05/03ISR Number: 4124949-2Report Type:Expedited (15-DaCompany Report #NSADSS2003024835 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Rhabdomyolysis Health Risperdal Hospitalization - Professional (Unspecified) Initial or Prolonged (Risperidone) PS Other Geodon SS Required Zoloft (Sertraline Intervention to Hydrochloride) C Prevent Permanent Trileptal Impairment/Damage (Oxcarbazepine) C Dulcolax (Bisacodyl) C Desyrel (Trazodone Hydrochloride) C Vistaril (Hydroxyzine Embonate) C Prolixin Decanoate (Fluphenazine Decanoate) C Date:06/05/03ISR Number: 4125461-7Report Type:Expedited (15-DaCompany Report #2003012209 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyspnoea Consumer Geodon (Ziprasidone) PS ORAL (BID), ORAL Initial or Prolonged Hallucination, Visual Health Estradiol Other Hypersensitivity Professional (Estradiol) C Pruritus Lisinopril( Screaming Lisinopril) C Wheezing Lorazepam (Larazepam) C Venlafaxine Hydrochloride (Venlafaxine Hydrochloride) C Obetrol (Amfetamine Sulfate, Dexamfetamine Saccharate, 22-Feb-2006 08:32 AM Page: 349 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Amfetamine C Liothyronine Sodium (Liothyronine Sodium) C Gabapentn (Gabapentin) C Levothyroxine Sodium (Levothyroxine Sodium) C Date:06/05/03ISR Number: 4125568-4Report Type:Expedited (15-DaCompany Report #2003022278 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Amenorrhoea Foreign Zeldox (Capsules) Initial or Prolonged Blood Prolactin Increased Health (Ziprasidone) PS ORAL 120 MG (BID), Extrapyramidal Disorder Professional ORAL Muscle Rigidity Fluoxetine Somnolence (Fluoxetine) C Alprazolam (Alprazolam) C All Other Therapeutic Products C Zuclopenthixol (Zuclopenthixol) C Date:06/05/03ISR Number: 4125571-4Report Type:Expedited (15-DaCompany Report #2003022241 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Deep Vein Thrombosis Foreign Zeldox (Capsules) Other Pulmonary Thrombosis Health (Ziprasidone) PS ORAL 160 MG (BID), Professional ORAL Company Representative Date:06/06/03ISR Number: 4126061-5Report Type:Expedited (15-DaCompany Report #2003012518 Age:69 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Geodon (Im) Professional (Ziprasidone) PS INTRAMUSCULAR 20 MG, Company INTRAMUSCULAR Representative Quetiapine Fumarate (Quetiapine Fumarate) C Risperidone (Risperidone) C Levothyroxine Sodium (Levothyroxine Sodium) C Calcium Carbonate (Calcium Carbonate) C Thioridazine (Thioridazine) C 22-Feb-2006 08:32 AM Page: 350 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/06/03ISR Number: 4140927-1Report Type:Periodic Company Report #2002071669 Age:12 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Geodon (Ziprasidone) PS ORAL 20 MG ORAL Professional Risperidone C Carbamazepine C Topiramate C Clonidine C Date:06/09/03ISR Number: 4125377-6Report Type:Direct Company Report #CTU 195242 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dysarthria Geodon 80mg 2 Oropharyngeal Swelling Capsules PS ORAL 160MG PO QHS Swollen Tongue Allegra C Tongue Disorder Vioxx C Trismus Flonase C Depoprovera C Protonix C Nicotine Patch C Keflex C Ultram C Wellbutrin Sr C Date:06/09/03ISR Number: 4126120-7Report Type:Expedited (15-DaCompany Report #2003022381 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Arrest Health Geodon (Ziprasidone) PS Professional Company Representative Date:06/09/03ISR Number: 4126172-4Report Type:Expedited (15-DaCompany Report #2003022532 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypersensitivity Foreign Zeldox (Capsules) Initial or Prolonged Stevens-Johnson Syndrome Health (Ziprasidone) PS ORAL 20 MG Other Professional (DAILY), ORAL 2 MON Company Clonazepam Representative (Clonazepam) C Mianserin (Mianserin) C Preparations Increasing Uric Acid Excretion C Date:06/09/03ISR Number: 4126456-XReport Type:Expedited (15-DaCompany Report #2003021532 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Disability Akathisia Foreign Muscle Rigidity Health Tardive Dyskinesia Professional Company 22-Feb-2006 08:32 AM Page: 351 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Representative Product Role Manufacturer Route Dose Duration Geodon (Ziprasidone) PS ORAL 80 MG (BID), ORAL Zuclopenthixol Decanoate (Zuclopenthixol Decanoate) SS INTRAMUSCULAR 100 MG (EVERY 2 WEEKS), INTRAMUSCULAR Chlorpromazine Hydrochloride (Chlorpromazine Hydrochloride) SS ORAL 150 MG (TID), ORAL Date:06/10/03ISR Number: 4127853-9Report Type:Expedited (15-DaCompany Report #2003023426 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Consumer Geodon (Ziprasidone) PS ORAL 80 MG Initial or Prolonged Dyspnoea (DAILY), ORAL Other Food Interaction Citrus Paradisi Fruit Juice (Citrus Paradisi Fruit Juice) SS Date:06/12/03ISR Number: 4127648-6Report Type:Direct Company Report #CTU 195652 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Geodon PS ORAL 100MG PO ORAL Initial or Prolonged Clonazepram C Ambien C Ibuprofen C Date:06/12/03ISR Number: 4128524-5Report Type:Expedited (15-DaCompany Report #2003022278 Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Amenorrhoea Foreign Zeldox (Capsules) Initial or Prolonged Blood Prolactin Increased Health (Ziprasidone) PS ORAL 120 MG (BID), Extrapyramidal Disorder Professional ORAL Muscle Rigidity Company Perphenazine Sleep Disorder Representative (Perphenazine) C Somnolence Fluoxetine (Fluoxetine) C Alprazolam (Alprazolam) C All Other Therapeutic Products C Zuclopenthixol (Zuclopenthixol) C 22-Feb-2006 08:32 AM Page: 352 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/12/03ISR Number: 4128532-4Report Type:Expedited (15-DaCompany Report #2003022241 Age:67 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Deep Vein Thrombosis Foreign Zeldox (Capsules) Other Pulmonary Embolism Health (Ziprasidone) PS ORAL 160 MG (BID); Professional ORAL Company Flupentixol Representative Dihydrochloride C Biperiden Hydrochloride C Date:06/12/03ISR Number: 4129284-4Report Type:Expedited (15-DaCompany Report #2003015357 Age:19 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Calcium Decreased Health Gedon (Ziprasidone) PS 160 MG (BID) Hospitalization - Blood Magnesium Increased Professional Cerebyx Initial or Prolonged Blood Phosphorus (Fosphenytoin) Other Increased (Fosphenytoin Cardiac Arrest Sodium) SS Cardio-Respiratory Arrest Olanzapine C Coma Fluphenazine Convulsion Hydrochloride C Drug Level Decreased Electrocardiogram St-T Segment Abnormal Feeling Abnormal Heart Rate Increased Hyperhidrosis Lethargy Loss Of Consciousness Somnolence Treatment Noncompliance Tremor Ventricular Hypertrophy Date:06/12/03ISR Number: 4129336-9Report Type:Expedited (15-DaCompany Report #2003023497 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Health Geodon (Ziprasidone) PS 40 MG (BID) Initial or Prolonged Irritability Professional Clozapine Psychomotor Hyperactivity (Clozapine) SS ORAL 500 MG (DAILY), ORAL Date:06/12/03ISR Number: 4129339-4Report Type:Expedited (15-DaCompany Report #2003024041 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Health Geodon (Ziprasidone) PS ORAL ORAL Hospitalization - Cardiac Arrest Professional Haloperidol Initial or Prolonged Condition Aggravated Company (Haloperidol) C Other Psychotic Disorder Representative Lorazepam Schizophrenia (Lorazepam) C All Other Therapeutic Products C 22-Feb-2006 08:32 AM Page: 353 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/13/03ISR Number: 4128832-8Report Type:Direct Company Report #CTU 195753 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Geodon PS SEE IMAGE Phosphokinase Increased Body Temperature Increased Haemoglobin Decreased Platelet Count Decreased Renal Failure Acute Date:06/13/03ISR Number: 4129769-0Report Type:Expedited (15-DaCompany Report #2003023883 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Angioneurotic Oedema Foreign Ziprasidone Urticaria Health (Ziprasidone) PS ORAL ORAL (2-3 Professional MONTHS) Date:06/13/03ISR Number: 4129770-7Report Type:Expedited (15-DaCompany Report #2003023882 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Angioneurotic Oedema Foreign Ziprasidone Urticaria Health (Ziprasisone) PS ORAL ORAL (2-3 Professional MONTHS) Date:06/16/03ISR Number: 4129403-XReport Type:Direct Company Report #CTU 195808 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Overdose Geodon 60mg Phizer PS Phizer ORAL 60MG ORAL Hospitalization - Ventricular Tachycardia Wellbutrin Sr C Initial or Prolonged Lamictal C Ambien C Klonopin C Date:06/16/03ISR Number: 4130243-6Report Type:Expedited (15-DaCompany Report #2003024345 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Coma Health Geodon (Ziprasidone) PS Overdose Professional Company Representative Date:06/16/03ISR Number: 4130245-XReport Type:Expedited (15-DaCompany Report #2003024825 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cognitive Deterioration Health Geodon (Ziprasidone) PS ORAL 160 MG (BID), Initial or Prolonged Encephalopathy Professional ORAL Neurotoxicity Company Hydroxyzine Representative Hyrdochloride (Hydroxyzine Hydrochloride) C 22-Feb-2006 08:32 AM Page: 354 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Loratadine (Loratidine) C Metformin (Metformin) C Enalapril Maleate (Enalapril Maleate) C Valproate Semisodium (Valproate Semisodium) C Olanzapine (Olanzapine) C Date:06/17/03ISR Number: 4131262-6Report Type:Expedited (15-DaCompany Report #2003024545 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Complications Of Maternal Health Geodon (Ziprasidone) PS Initial or Prolonged Exposure To Therapeutic Professional Bupropion Other Drugs Hydrochloride Congenital Central (Bupropion Nervous System Anomaly Hydrochloride) C Maternal Drugs Affecting Foetus Pregnancy Psychotic Disorder Date:06/17/03ISR Number: 4131528-XReport Type:Expedited (15-DaCompany Report #2003009863 Age: Gender:Unknown I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Complications Of Maternal Health Geodon (Ziprasidone) PS 120 MG (BID) Other Exposure To Therapeutic Professional Bupropion Drugs Company Hydrochloride Congenital Central Representative (Bupropion Nervous System Anomaly Hydrochloride) SS UNKNOWN UNKNOWN Congenital Oesophageal Anomaly Maternal Drugs Affecting Foetus Pregnancy Date:06/17/03ISR Number: 4131601-6Report Type:Expedited (15-DaCompany Report #2003024145 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Medication Error Health Geodon (Ziprasidone) PS Hospitalization - Pyrexia Professional Clozapine Initial or Prolonged Rhabdomyolysis (Clozapine) SS ORAL 400 MG (BID), Other ORAL Quetiapine Fumarate (Quetiapine Fumarate) SS Risperidone (Risperidone) SS Sertraline Hydrochloride (Sertraline Hydrochloride) C 22-Feb-2006 08:32 AM Page: 355 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Oxcarbazepine (Oxcarbazepine) C Bisacodyl (Bisacodyl) C Trazodone Hydrochloride (Trazodone Hydrochloride) C Hydroxyzine Embonate (Hydroxyzine Embonate) C Fluphenazine Decanoate (Fluphenazine Decanoate) C Date:06/18/03ISR Number: 4132529-8Report Type:Expedited (15-DaCompany Report #2003024728 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Recurrent Health Geodon (Ziprasidone) PS Breast Microcalcification Professional Company Representative Date:06/18/03ISR Number: 4132569-9Report Type:Expedited (15-DaCompany Report #2003024765 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Health Geodon (Ziprasidone) PS Syndrome Professional Company Representative Date:06/19/03ISR Number: 4188922-0Report Type:Periodic Company Report #325146 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Klonopin Health (Clonazepam) PS ORAL ORAL Professional Elavil (Amitriptyline Hydrochloride) SS ORAL ORAL Adderall (Amphetamine Aspartate/Amphetamin e Sulfated/Dextroamphe SS ORAL ORAL Vioxx (Rofecoxib) SS ORAL ORAL Topamax(Topiramate) SS ORAL ORAL Geodon (Ziprasidone Hydrochloride) SS ORAL ORAL Remeron (Mirtazapine) SS ORAL ORAL Methadone (Methadone Hydrochloride) SS ORAL ORAL Neurontin (Gabapentin) SS ORAL ORAL 22-Feb-2006 08:32 AM Page: 356 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/20/03ISR Number: 4132414-1Report Type:Expedited (15-DaCompany Report #US-ROCHE-339787 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acidosis Klonopin PS Roche ORAL 15 TABLETS. Initial or Prolonged Arrhythmia Wellbutrin Sr SS ORAL 15-20 Drug Screen Positive TABLETS. Electrocardiogram Qrs Geodon SS ORAL 120 TABLETS. Complex Prolonged Ativan SS ORAL 4 TABLETS. Electrocardiogram Qt Prolonged Hyperventilation Lethargy Multiple Drug Overdose Somnolence Date:06/20/03ISR Number: 4133802-XReport Type:Expedited (15-DaCompany Report #2003025157 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gastric Bypass Health Geodon (Ziprasidone) PS Professional Date:06/23/03ISR Number: 4134493-4Report Type:Expedited (15-DaCompany Report #2003017017 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyspnoea Consumer Geodon (Ziprasidone) PS ORAL 160 MG (BID), Initial or Prolonged Fatigue Health ORAL Other Feeling Abnormal Professional Multivitamins Increased Upper Airway (Ergocalciferol, Secretion Ascorbic Acid, Folic Paranoia Acid, Thiamine Tension Hydrochloride, C Ibuprofen (Ibuprofen) C Metaxalone (Metaxalone) C Date:06/24/03ISR Number: 4134663-5Report Type:Direct Company Report #CTU 196517 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Geodon 20mg, 40mg, Initial or Prolonged Disorientation 60mg= All Pfizer PS Pfizer Required Hyperhidrosis Geodon 20mg, 40mg, Intervention to Insomnia 60mg= All Pfizer SS Prevent Permanent Productive Cough Geodon 20mg, 40mg, Impairment/Damage Self-Injurious Ideation 60mg= All Pfizer SS Suicidal Ideation Vomiting Date:06/24/03ISR Number: 4135755-7Report Type:Expedited (15-DaCompany Report #2003025127 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Health Geodon (Ziprasidone) PS Initial or Prolonged Professional 22-Feb-2006 08:32 AM Page: 357 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/25/03ISR Number: 4136110-6Report Type:Expedited (15-DaCompany Report #2003026458 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Overdose Health Geodon (Ziprasidone) PS ORAL ORAL Initial or Prolonged Suicide Attempt Professional Other Company Representative Date:06/25/03ISR Number: 4136153-2Report Type:Expedited (15-DaCompany Report #2003025507 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyspnoea Foreign Geodon (Im) Pruritus Health (Ziprasidone) PS ORAL SEE IMAGE Rash Professional Diazepam C ORAL Company Representative Date:06/25/03ISR Number: 4136157-XReport Type:Expedited (15-DaCompany Report #2003025850 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zeldox (Capsules) Health (Ziprasidone) PS UNKNOWN 160 MG (BID) Professional UNKNOWN Company Representative Date:06/25/03ISR Number: 4136375-0Report Type:Expedited (15-DaCompany Report #2003025571 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Consumer Geodon (Ziprasidone) PS ORAL 20 MG (DAILY) Blood Pressure Diastolic ORAL Increased Bupropion Chest Discomfort Hydrochloride C Feeling Abnormal Tylenol Sinus Lipoma Medication Lipoma Excision (Paracetamol, Procedural Pain Pseudoephedrine) C Date:06/26/03ISR Number: 4135967-2Report Type:Direct Company Report #CTU 196661 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Electrocardiogram Qrs Geodon Pfizer PS Pfizer ORAL SEE IMAGE Complex Prolonged Electrocardiogram Qt Corrected Interval Prolonged Electrocardiogram T Wave Abnormal Myocardial Ischaemia 22-Feb-2006 08:32 AM Page: 358 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/26/03ISR Number: 4137044-3Report Type:Expedited (15-DaCompany Report #2003025738 Age:46 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Arrest Consumer Geodon (Ziprasidone) PS Initial or Prolonged Treatment Noncompliance Other Date:06/26/03ISR Number: 4137515-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20030601813 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Study Risperidone Initial or Prolonged Aspartate Health (Risperidone) Aminotransferase Professional Unspecified PS Blood Alkaline Perphenazine Phosphatase (Perphenazine) SS Blood Bicarbonate Olanzapine Blood Calcium (Olanzapine) SS Blood Chloride Quetiapine Blood Creatine (Quetiapine) SS Phosphokinase Ziprasidone Blood Creatine (Ziprasidone) SS Phosphokinase Mb Clonazepam () Blood Creatinine Clonazepam C Blood Glucose Mirtazapine () Blood Magnesium Mirtazapine C Blood Ph Increased Catopril () Blood Potassium Captopril C Blood Sodium Glipizide () Dyspnoea Glipizide C Electrocardiogram T Wave Abnormal Glucose Urine Present Haemoglobin Mental Disorder Oxygen Saturation Decreased Pco2 Po2 Protein Total Pulmonary Congestion Pulmonary Vascular Disorder Red Blood Cells Urine Positive Sinus Tachycardia Thirst Urine Ketone Body Present White Blood Cells Urine Positive Date:06/26/03ISR Number: 4137633-6Report Type:Expedited (15-DaCompany Report #2003026289 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Health Geodon (Im) Other Professional (Ziprasidone) PS INTRAVENOUS 20 MG (ONCE), INTRAVENOUS Simvastatin 22-Feb-2006 08:32 AM Page: 359 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Simvastatin) C Probenecid (Probenecid) C Glipizide (Glipizide) C Date:06/27/03ISR Number: 4139091-4Report Type:Expedited (15-DaCompany Report #2003020608 Age:26 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Health Geodon (Ziprasidone) PS ORAL 60 MG, ORAL Initial or Prolonged Somnolence Professional Trazodone Other Suicide Attempt Company (Trazodone) SS Vomiting Representative Date:07/01/03ISR Number: 4140561-3Report Type:Expedited (15-DaCompany Report #2003026481 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrioventricular Block Health Geodon (Ziprasidone) PS ORAL 120 MG BID, Initial or Prolonged Myocardial Infarction Professional ORAL Weight Increased Clopidogrel Sulfate (Clopidogrel Sulfate) C Atorvastatin (Atorvastatin) C Levothyroxine Sodium (Levothyroxine Sodium) C Escitalopram (Escitalopram) C Amitriptyline Hydrochloride (Amitriptyline Hydrochloride) C Valproate Semisodium (Valproate Semisodium) C Pantoprazole (Pantoprazole) C Acetylsalicylic Acid (Acetylsalicylic Acid) C Fexofenadine Hydrochloride (Fexofenadine Hydrochloride) C Multivitamins (Ergocalciferol, Ascorbic Acid, Folic Acid, Thiamine Hydrochloride, C Metformin (Metformin) C Topiramate (Topiramate) C Lisinopril (Lisinopril) C Gemfibrozil (Gemfibrozil) C 22-Feb-2006 08:32 AM Page: 360 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Salbutamol (Salbutamol) C Salmeterol Xinafoate (Salmeterol Xinafoate) C Methotrexate (Methotrexate) C Meclozine (Meclozine) C Date:07/01/03ISR Number: 4140565-0Report Type:Expedited (15-DaCompany Report #2003005088 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Health Geodon (Ziprasidone) PS ORAL 120 MG DAILY, Other Confusional State Professional ORAL Drug Interaction Company Lithium (Lithium) C Infection Representative Erythromycin Neuroleptic Malignant (Erythromycin) C Syndrome Oxcarbazepine Psychotic Disorder (Oxcarbazepine) C Alprazolam (Alprazolam) C Date:07/01/03ISR Number: 4140567-4Report Type:Expedited (15-DaCompany Report #2003026442 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Extrapyramidal Disorder Health Geodon (Ziprasidone) PS ORAL 160 MG DAILY, Professional ORAL Fexofenadine Hydrochloride (Fexofenadine Hydrochloride) C Rofecoxib (Rofecoxib) C Fluticasone Propionate (Fluticasone Propionate) C Medroxyprogesterone Acetate (Medroxyprogesterone Acetate) C Pantoprazole (Pantoprazole) C Nicotine (Nicotine) C Cefalexin Monohydrate (Cefalexin Monohydrate) C Tramadol Hydrochloride (Tramadol Hydrochloride) C Bupropion Hydrochloride (Bupropion Hydrochloride) C 22-Feb-2006 08:32 AM Page: 361 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/02/03ISR Number: 4141707-3Report Type:Expedited (15-DaCompany Report #2003021047 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Catheter Sepsis Health Geodon (Ziprasidone) PS ORAL SEE IMAGE Wheezing Professional Valproate Semisodium (Valproate Semisodium) C Quetiapine Fumarate (Quetiapine Fumarate) C All Other Therapeutic Products C Date:07/02/03ISR Number: 4141744-9Report Type:Direct Company Report #CTU 197193 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Posture Abnormal Geodon Pfizer PS Pfizer ORAL 160MG PO DAILY Date:07/03/03ISR Number: 4142266-1Report Type:Expedited (15-DaCompany Report #2003016824 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Zeldox (Capsules) Initial or Prolonged Erectile Dysfunction Literature (Ziprasidone) PS ORAL 100 MG, ORAL Hypomania Health Venlafaxine Professional Hydrochloride Company (Venlafaxine Representative Hydrochloride) C Valproate Sodium (Valproate Sodium) C Quetiapine Fumarate (Quetiapine Fumarate) C Date:07/03/03ISR Number: 4142289-2Report Type:Expedited (15-DaCompany Report #2003027341 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Foreign Zeldox (Capsules) Initial or Prolonged Gait Disturbance Health (Ziprasidone) PS ORAL 100 MG DAILY Sleep Disorder Professional ORAL Risperidone C Date:07/03/03ISR Number: 4143249-8Report Type:Expedited (15-DaCompany Report #2003027134 Age: Gender:Female I/FU:I Outcome PT Life-Threatening Blood Creatine Hospitalization - Phosphokinase Increased Initial or Prolonged Blood Pressure Increased Other Ear Infection Haematuria Lethargy Myoglobinuria Neuroleptic Malignant 22-Feb-2006 08:32 AM Page: 362 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Syndrome Tachycardia Tremor Report Source Product Role Manufacturer Route Dose Duration Health Geodon (Ziprasidone) PS ORAL 60 MG Professional (DAILY), ORAL Carbamazepine (Carbamazepine) C Topiramate (Topiramate) C Guanfacine (Guanfacine) C Clonidine (Clonidine) C Benzatropine Mesilate (Benzatropine Mesilate) C Cefdinir (Cefdinir) C Date:07/07/03ISR Number: 4142747-0Report Type:Direct Company Report #CTU 197339 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Ziprasidone PS Date:07/07/03ISR Number: 4142972-9Report Type:Direct Company Report #CTU 197312 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Ziprasidone PS Date:07/07/03ISR Number: 4144601-7Report Type:Expedited (15-DaCompany Report #HQWYE509309JUN03 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arrhythmia Literature Ativan (Lorazepam, Initial or Prolonged Cardiotoxicity Tablet) PS ORAL 4 TABLETS OF Depressed Level Of 0.5 MG (2MG) Consciousness OVERDOSE Drug Screen Positive AMOUNT, ORAL 1 DAY Electrocardiogram Qrs Clonazepam Complex Prolonged (Clonazepam) SS ORAL 15 TABLETS OF Electrocardiogram Qt 0.5 MG (7.5 Corrected Interval MG) OVERDOSE Prolonged AMOUNT, ORAL 1 DAY Intentional Overdose Geodon (Ziprasidone) SS ORAL 120 TABLETS Lethargy OF 20 MG Somnolence (2400 MG) OVERDOSE AMOUNT, ORAL 1 DAY Wellbutrin-Slow Release (Amfebutamone Hydrochloride) SS ORAL 15-20 TABLETS OF 150 MG, OVERDOSE AMOUNT, ORAL 1 DAY 22-Feb-2006 08:32 AM Page: 363 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/07/03ISR Number: 4144702-3Report Type:Expedited (15-DaCompany Report #2003027036 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drug Level Increased Foreign Zeldox (Capsules) Suicidal Ideation Health (Ziprasidone) PS ORAL 160 MG, ORAL Therapeutic Response Professional Lorazepam Decreased (Lorazepam) C Biperiden Hydrochloride (Biperiden Hydrochloride) C Pirenzepine Dihydrochloride (Pirenzepine Dihydrochloride) C Date:07/07/03ISR Number: 4144716-3Report Type:Expedited (15-DaCompany Report #2003027200 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Foreign Zeldox (Capsules) Initial or Prolonged Feeling Abnormal Health (Ziprasidone) PS Restlessness Professional Enalapril Maleate Suicidal Ideation (Enalapril Maleate) C Acetylsalicylic Acid (Acetylsalicylic Acid) C Date:07/07/03ISR Number: 4144718-7Report Type:Expedited (15-DaCompany Report #2003027201 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypersensitivity Foreign Zeldox (Capsules) Initial or Prolonged Health (Ziprasidone) PS ORAL 160 MG, ORAL Professional Valproate Sodium (Valproate Sodium) SS ORAL ORAL Amisulpride (Amisulpride) C Date:07/08/03ISR Number: 4145501-9Report Type:Expedited (15-DaCompany Report #2003021047 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Catheter Sepsis Health Geodon (Ziprasidone) PS ORAL 40 MG (BID), Neuroleptic Malignant Professional ORAL Syndrome Valproate Semisodium Wheezing (Valproate Semisodium) C Quetiapine Fumarate (Quetiapine Fumarate) C All Other Therapeutic Products C 22-Feb-2006 08:32 AM Page: 364 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/08/03ISR Number: 4145507-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20030601813 Age:36 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Respiratory Study Risperidone Initial or Prolonged Distress Syndrome Health (Risperidone) Alanine Aminotransferase Professional Unspecified PS Aspartate Perphenazine Aminotransferase (Perphenazine) SS Blood Alkaline Olanzapine Phosphatase (Olanzapine) SS Blood Bicarbonate Quetiapine Blood Calcium (Quetiapine) SS Blood Chloride Ziprasidone Blood Creatine (Ziprasidone) SS Blood Creatine Clonazepam C Phosphokinase Mirtazapine C Blood Creatine Catopril C Phosphokinase Mb Glipizide C Blood Glucose Blood Magnesium Blood Urine Chest X-Ray Abnormal Dyspnoea Electrocardiogram T Wave Abnormal Glucose Urine Present Haematocrit Decreased Haemoglobin Hypokalaemia Hyponatraemia Mental Disorder Pco2 Decreased Po2 Decreased Polydipsia Psychogenic Protein Total Pulmonary Congestion Respiratory Failure Sinus Tachycardia Thirst Troponin White Blood Cells Urine Positive Date:07/08/03ISR Number: 4145522-6Report Type:Expedited (15-DaCompany Report #A120276 Age:26 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Health Geodon (Ziprasidone) PS ORAL 80 MG (BID), Initial or Prolonged Coordination Abnormal Professional ORAL Drug Level Increased Lithium (Lithium) SS ORAL 1200 MG Gastrointestinal Disorder (BID), ORAL Lethargy Effexor Xr Psychotic Disorder (Venlafaxine Hydrochloride) C Wellbutrin (Bupropion Hydrochloride) C Topamax (Topiramate) C Parlodel (Bromocriptine 22-Feb-2006 08:32 AM Page: 365 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Mesilate) C Date:07/09/03ISR Number: 4146513-1Report Type:Expedited (15-DaCompany Report #2002059583 Age:19 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Health Geodon (Ziprasidone) PS Initial or Prolonged Corrected Interval Professional Other Prolonged Company Extrapyramidal Disorder Representative Intentional Overdose Date:07/09/03ISR Number: 4146517-9Report Type:Expedited (15-DaCompany Report #A118994 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alopecia Consumer Geodon (Ziprasidone) PS ORAL 80 MG (BID), Initial or Prolonged Drug Ineffective ORAL Dry Mouth Xanax (Alprazolam) C Headache Acetaminophen Insomnia (Paracetamol) C Nightmare Buspirone Oral Infection (Buspirone) C Paraesthesia Pyrexia Sinusitis Tooth Loss Date:07/09/03ISR Number: 4147733-2Report Type:Expedited (15-DaCompany Report #2003025507 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyspnoea Foreign Geodon (Im) Pruritus Health (Ziprasidone) PS ORAL 120 MG (BID) Rash Professional ORAL, 40 MG Company (BID) Representative INTRAMUSCULAR Other Diazepam (Diazepam) C Date:07/10/03ISR Number: 4144672-8Report Type:Direct Company Report #CTU 197627 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Ziprasidone (Geodon) PS ORAL 60 MG BID PO Dysphagia Haldol C Dystonia Prozac C Psychomotor Hyperactivity Ativan C Klonopin C Seroquel C Date:07/10/03ISR Number: 4144741-2Report Type:Direct Company Report #CTU 197644 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Geodon 40mg Pfizer PS Pfizer ORAL 40MG 6 PM Initial or Prolonged DAILY ORAL 22-Feb-2006 08:32 AM Page: 366 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/10/03ISR Number: 4146402-2Report Type:Expedited (15-DaCompany Report #2003023497 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Insomnia Health Geodon (Ziprasidone) PS ORAL 40 MG (BID), Initial or Prolonged Irritability Professional ORAL Other Psychomotor Hyperactivity Clozapine Psychotic Disorder (Clozapine) SS ORAL 500 MG (BID), Schizophrenia, ORAL Disorganised Type Social Avoidant Behaviour Treatment Noncompliance Date:07/10/03ISR Number: 4146413-7Report Type:Expedited (15-DaCompany Report #2003028413 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Geodon (Ziprasidone) PS Professional Company Representative Date:07/10/03ISR Number: 4146874-3Report Type:Expedited (15-DaCompany Report #2003028086 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Foreign Zeldox (Capsules) Increased Health (Ziprasidone) PS ORAL 80 MG (BID), Aspartate Professional ORAL Aminotransferase Venlafaxine Increased Hydrochloride Gamma-Glutamyltransferase (Venlafaxine Increased Hydrochloride) C Date:07/10/03ISR Number: 4146912-8Report Type:Expedited (15-DaCompany Report #2003027968 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Foreign Zeldox (Capsules) Initial or Prolonged Syndrome Health (Ziprasidone) PS ORAL 120 MG Parkinsonism Professional (DAILY), ORAL Seborrhoea Galantamine (Galantamine) C Date:07/11/03ISR Number: 4147805-2Report Type:Expedited (15-DaCompany Report #2003028133 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Generalised Oedema Foreign Ziprasidone Consumer (Ziprasidone) PS ORAL 40 MG (DAILY), ORAL Ibuprofen (Ibuprofen) C 22-Feb-2006 08:32 AM Page: 367 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/11/03ISR Number: 4147912-4Report Type:Expedited (15-DaCompany Report #2003018758 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Foreign Ziprasidone Initial or Prolonged Somnolence Health (Ziprasidone) PS ORAL 40 MG Professional (DAILY), ORAL Company Digoxin (Digoxin) C Representative Ramipril (Ramipril) C All Other Therapeutic Products C Date:07/14/03ISR Number: 4148338-XReport Type:Expedited (15-DaCompany Report #2003016607 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coronary Artery Disease Consumer Geodon (Im) Electrocardiogram Qt Health (Ziprasidone) PS INTRAMUSCULAR INTRAMUSCULAR Corrected Interval Professional Prolonged Date:07/15/03ISR Number: 4147189-XReport Type:Direct Company Report #CTU 197910 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Geodon 20 Mg Thomson Pdr PS Thomson Pdr ORAL 20 MG AM ORAL Geodon 40 Mg Thomson Pdr SS Thomson Pdr ORAL 40 MG PM ORAL Date:07/15/03ISR Number: 4149128-4Report Type:Expedited (15-DaCompany Report #2003028651 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Health Geodon (Ziprasidone) PS Initial or Prolonged Corrected Interval Professional Other Prolonged Company Representative Date:07/15/03ISR Number: 4149129-6Report Type:Expedited (15-DaCompany Report #2003029195 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Health Geodon (Ziprasidone) PS Weight Decreased Professional Company Representative Date:07/16/03ISR Number: 4148734-0Report Type:Direct Company Report #CTU 197987 Age:70 YR Gender:Male I/FU:I Outcome Life-Threatening Hospitalization - Initial or Prolonged Required Intervention to 22-Feb-2006 08:32 AM Page: 368 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Dizziness Ziprasidone PS 80 MG BID Orthostatic Hypotension Terazosin SS 5 MG QHS Date:07/16/03ISR Number: 4150339-2Report Type:Expedited (15-DaCompany Report #2003029682 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Breast Cancer Foreign Ziprasidone (Caps) Health (Ziprasidone) PS 120 MG (BID) Professional Date:07/17/03ISR Number: 4148651-6Report Type:Direct Company Report #CTU 198093 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Hernia Mellaril PS ORAL ORAL (PO) Other Medication Error 2X/DAY Geodon SS ORAL ORAL (PO) 1X DAY Date:07/17/03ISR Number: 4150945-5Report Type:Expedited (15-DaCompany Report #2003018470 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Health Geodon (Ziprasidone) PS 60 MG Initial or Prolonged Muscle Spasms Professional (DAILY), Other Company Paroxetine Representative Hydrochloride (Paroxetine Hydrochloride) C Clonazepam (Clonazepam) C Date:07/17/03ISR Number: 4150948-0Report Type:Expedited (15-DaCompany Report #2003029590 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardio-Respiratory Arrest Health Geodon (Ziprasidone) PS 160 MG (BID) Hospitalization - Dyspnoea Professional Chlorpromazine Initial or Prolonged Hydrochloride (Chlorpromazine Hydrochloride) C Date:07/17/03ISR Number: 4187071-5Report Type:Periodic Company Report #2003015938 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Health Geodon (Im) Somnolence Professional Ziprasidone) PS INTRAMUSCULAR 20 MG Company INTERMUSCULAR Representative 22-Feb-2006 08:32 AM Page: 369 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/17/03ISR Number: 4187075-2Report Type:Periodic Company Report #2003016901 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Health Geodon (Im) Nuchal Rigidity Professional Ziprasidone) PS INTRAMUSCULAR Company Representative Date:07/17/03ISR Number: 4187077-6Report Type:Periodic Company Report #2003021704 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Health Geodon (Im) Professional Ziprasidone) PS INTRAMUSCULAR INTRAMUSCULAR Date:07/17/03ISR Number: 4187081-8Report Type:Periodic Company Report #2003022337 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Palpitations Health Geodon (Im) Professional Ziprasidone) PS INTRAMUSCULAR INTRAMUSCULAR Company All Other Representative Therapeutic Products C Date:07/17/03ISR Number: 4187084-3Report Type:Periodic Company Report #2003023839 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Injury Health Geodon (Im) Unevaluable Event Professional Ziprasidone) PS INTRAMUSCULAR 40 MG (BID), INTERMUSCULAR Date:07/17/03ISR Number: 4187085-5Report Type:Periodic Company Report #2003026942 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Headache Health Geodon (Im) Nausea Professional Ziprasidone) PS INTRAMUSCULAR INTRAMUSCULAR Overdose Company Ethanol (Ethanol) SS Vomiting Representative All Other Therapeutic Products C Date:07/17/03ISR Number: 4194357-7Report Type:Periodic Company Report #2003013106 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Priapism Health Geodon (Ziprasidone) PS INTRAMUSCULAR INTRAMUSCULAR Professional Date:07/17/03ISR Number: 4194361-9Report Type:Periodic Company Report #2003013108 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Priapism Health Geodon (Ziprasidone) PS INTRAMUSCULAR INTRAMUSCULAR Professional 22-Feb-2006 08:32 AM Page: 370 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/17/03ISR Number: 4194374-7Report Type:Periodic Company Report #2003013111 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Priapism Health Geodon (Ziprasidone) PS INTRAMUSCULAR INTRAMUSCULAR Professional Date:07/17/03ISR Number: 4194375-9Report Type:Periodic Company Report #2003019015 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Health Geodon (Im) Initial or Prolonged Corrected Interval Professional (Ziprasidone) PS Prolonged Company Unevaluable Event Representative Date:07/17/03ISR Number: 4194380-2Report Type:Periodic Company Report #2003011718 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Priapism Health Geodon (Im) Professional (Ziprasidone) PS INTRAMUSCULAR INTRAMUSCULAR Company Representative Date:07/17/03ISR Number: 4194383-8Report Type:Periodic Company Report #2003015933 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyskinesia Health Geodon (Im) Initial or Prolonged Dystonia Professional (Ziprasidone) PS 160 MG (BID), Extrapyramidal Disorder Company INTRAMUSCULAR Oculogyration Representative Diphenhydramine Torticollis (Diphenhydramine) C Benzatropine Mesilate (Benzatropine Mesilate) C Trihexyphenidyl (Trihexyphenidyl) C Lorazepam (Lorazepam) C Date:07/18/03ISR Number: 4150712-2Report Type:Direct Company Report #CTU 198196 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Ziprasidone 20mg/Ml Life-Threatening Dehydration Pfizer PS Pfizer INTRAMUSCULAR 5 MG PRN Hospitalization - Dementia INTRAMUSCULAR Initial or Prolonged Electrolyte Imbalance Quetiapine 100 Mg Required Insomnia Tab Astra Zeneca SS Astra Zeneca ORAL 100 MG TID Intervention to Neuroleptic Malignant ORAL Prevent Permanent Syndrome Lorazepam C Impairment/Damage Renal Failure Acute Acetaminophen C Rhabdomyolysis Haloperidol C White Blood Cell Count Metoprolol C Increased Donepezil C 22-Feb-2006 08:32 AM Page: 371 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/18/03ISR Number: 4152520-5Report Type:Expedited (15-DaCompany Report #2003029191 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Consumer Geodon (Ziprasidone) PS Initial or Prolonged Cough Quetiapine Fumarate Disorientation (Quetiapine Hyperhidrosis Fumarate) C Intentional Self-Injury Sleep Disorder Suicidal Ideation Vomiting Date:07/18/03ISR Number: 4152528-XReport Type:Expedited (15-DaCompany Report #2003028946 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyspnoea Health Geodon (Ziprasidone) PS Throat Tightness Professional Company Representative Date:07/18/03ISR Number: 4152531-XReport Type:Expedited (15-DaCompany Report #2003029186 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Decreased Health Geodon (Ziprasidone) PS 100 MG Professional Citalopram Company Hydrobromide Representative (Citalopram Hydrobromide) SS 20 MG Date:07/21/03ISR Number: 4151165-0Report Type:Direct Company Report #CTU 198290 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Ziprasidone PS ORAL 60MG BID ORAL Initial or Prolonged Date:07/21/03ISR Number: 4151191-1Report Type:Direct Company Report #CTU 198298 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Muscle Disorder Ziprasidone 20mg Geodon PS ORAL 2 TABLE DAY ORAL Date:07/21/03ISR Number: 4152740-XReport Type:Expedited (15-DaCompany Report #2003029612 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Health Geodon (Ziprasidone) PS Corrected Interval Professional Sinequan (Doxepin) SS Prolonged Company Representative 22-Feb-2006 08:32 AM Page: 372 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/21/03ISR Number: 4152906-9Report Type:Expedited (15-DaCompany Report #A120276 Age:26 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Geodon (Ziprasidone) PS ORAL 80 MG (BID), Initial or Prolonged Confusional State Professional ORAL Coordination Abnormal Lithium (Lithium) SS ORAL 1200 M G Drug Level Increased (BID), ORAL Gastrointestinal Disorder Venlafaxine Lethargy Hydrochloride (Venlafaxine Hydrochloride) C Bupropion Hydrochloride (Bupropion Hydrochloride) C Topiramate (Topiramate) C Bromocriptine Mesilate (Bromocriptine Mesilate) C Date:07/21/03ISR Number: 4152916-1Report Type:Expedited (15-DaCompany Report #2003029145 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Geodon (Ziprasidone) PS Other Drug Interaction Professional Propranolol Company Hydrochloride Representative (Propranolol Hydrochloride) SS Date:07/22/03ISR Number: 4152143-8Report Type:Direct Company Report #CTU 198348 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bradycardia Geodon 80 Mg Pfizer PS Pfizer ORAL 80 MG BID Cardiac Arrest ORAL Tachycardia Haldol C Effexor Xr C Gatifloxacin C Date:07/22/03ISR Number: 4153905-3Report Type:Expedited (15-DaCompany Report #2003026348 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcohol Withdrawal Foreign Ziprasidone (Caps) Initial or Prolonged Syndrome Health (Ziprasidone) PS ORAL 120 MG (BID), Condition Aggravated Professional ORAL Dizziness Company Paroxetine Drug Interaction Representative (Paroxetine) SS ORAL 20 MG Hyperhidrosis (DAILY), ORAL Schizophrenia Serotonin Syndrome Social Phobia Tremor 22-Feb-2006 08:32 AM Page: 373 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/22/03ISR Number: 4153965-XReport Type:Expedited (15-DaCompany Report #2003029187 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Foreign Ziprasidone (Caps) Initial or Prolonged Drug Toxicity Health (Ziprasidone) PS ORAL (DAILY), ORAL Other Intentional Overdose Professional Suicide Attempt Date:07/23/03ISR Number: 4155513-7Report Type:Expedited (15-DaCompany Report #2003029784 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Stevens-Johnson Syndrome Foreign Zeldox (Capsules) Hospitalization - Toxic Epidermal Health (Ziprasidone) PS ORAL 80 MG (BID), Initial or Prolonged Necrolysis Professional ORAL Ibuprofen (Ibuprofen) SS ORAL 1600 MG (BID), ORAL Oxazepam (Oxazepam) C Date:07/23/03ISR Number: 4155721-5Report Type:Expedited (15-DaCompany Report #2003021537 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dyskinesia Health Geodon (Ziprasidone) PS ORAL ORAL Myoclonus Professional Treatment Noncompliance Date:07/23/03ISR Number: 4155745-8Report Type:Expedited (15-DaCompany Report #2003029613 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypothermia Health Geodon (Ziprasidone) PS Initial or Prolonged Laboratory Test Abnormal Professional Clozapine Renal Failure Company (Clozapine) SS Unevaluable Event Representative All Other Therapeutic Products SS Date:07/24/03ISR Number: 4153454-2Report Type:Direct Company Report #CTU 198556 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Upper Ziprasidone 20 Mg Initial or Prolonged Diarrhoea Pfizer PS Pfizer ORAL 1 20 MG 1 PERDAY ORAL Prozac C Lovastan C Leventhol C Date:07/25/03ISR Number: 4153840-0Report Type:Direct Company Report #CTU 198669 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Ziprasidone PS ORAL 20 MG QD PO Initial or Prolonged Prozac C Lovastan C 22-Feb-2006 08:32 AM Page: 374 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Leventhol C Date:07/25/03ISR Number: 4156877-0Report Type:Expedited (15-DaCompany Report #2003027341 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Foreign Zeldox Initial or Prolonged Condition Aggravated Health (Capsules)(Ziprasido Dizziness Professional ne) PS ORAL 100 MG, Gait Disturbance (DAILY), ORAL Sleep Disorder Risperidone (Risperidone) C Date:07/25/03ISR Number: 4156878-2Report Type:Expedited (15-DaCompany Report #2003027036 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drug Level Increased Foreign Zeldox Psychotic Disorder Health (Capsules)(Ziprasido Suicidal Ideation Professional ne) PS ORAL 160 MG, ORAL Lorazepam (Lorazepam) C Biperiden Hydrochloride (Biperiden Hydrochloride) C Pirenzepine Dihydrochloride (Pirenzepine Dihydrochloride) C Date:07/25/03ISR Number: 4156881-2Report Type:Expedited (15-DaCompany Report #2003027201 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bronchospasm Foreign Zeldox Initial or Prolonged Hypersensitivity Health (Capsules)(Ziprasido Professional ne) PS ORAL 160 MG(DAILY), ORAL Valproate Sodium (Valproate Sodium) SS ORAL ORAL Amisulpride (Amisulpride) C Date:07/25/03ISR Number: 4157642-0Report Type:Expedited (15-DaCompany Report #2003022466 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Geodon (Im) Professional (Ziprasidone) PS INTRAMUSCULAR INTRAMUSCULAR Company Representative 22-Feb-2006 08:32 AM Page: 375 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/25/03ISR Number: 4157643-2Report Type:Expedited (15-DaCompany Report #2003022465 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Geodon (Im) Professional (Ziprasidone) PS INTRAMUSCULAR INTRAMUSCULAR Company Representative Date:07/25/03ISR Number: 4157690-0Report Type:Expedited (15-DaCompany Report #2003027200 Age:63 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Foreign Zeldox (Capsules) Initial or Prolonged Restlessness Health (Ziprasidone) PS ORAL 120 MG DAILY, Suicidal Ideation Professional ORAL Mirtazapine (Mirtazapine) C Zopiclone (Zopiclone) C Enalapril Maleate (Enalapril Maleate) C Acetylsalicylic Acid (Acetylsalicylic Acid) C Date:07/25/03ISR Number: 4157721-8Report Type:Expedited (15-DaCompany Report #2003030050 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Angioneurotic Oedema Health Geodon (Ziprasidone) PS Professional Company Representative Date:07/29/03ISR Number: 4157504-9Report Type:Direct Company Report #CTU 198890 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Nervous System Disorder Geodon PS Pain Date:07/29/03ISR Number: 4159428-XReport Type:Expedited (15-DaCompany Report #2003030374 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardio-Respiratory Arrest Foreign Zeldox (Capsules) Health (Ziprasidone) PS ORAL 40 MG Professional (DAILY), ORAL Date:07/29/03ISR Number: 4159637-XReport Type:Expedited (15-DaCompany Report #2003022824 Age:29 YR Gender:Male I/FU:I Outcome PT Hospitalization - Abdominal Distension Initial or Prolonged Dry Mouth Other Face Oedema 22-Feb-2006 08:32 AM Page: 376 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hypersomnia Liver Function Test Abnormal Report Source Product Role Manufacturer Route Dose Duration Localised Oedema Consumer Geodon (Ziprasidone) PS ORAL 40 MG (BID), Mania ORAL Rhinorrhoea Citalopram Thirst Hydrobromide (Citalopram Hydrobromide ) SS ORAL 20 MG (DAILY), ORAL Date:07/30/03ISR Number: 4160973-1Report Type:Expedited (15-DaCompany Report #2003028207 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Decreased Health Geodon (Ziprasidone) PS 80 MG (BID) Dizziness Professional Neurontin (Tablets) Dry Mouth Company (Gabapentin) SS 2400 MG (TID) Electrocardiogram Qt Representative Sertraline Corrected Interval Hydrochloride Prolonged (Sertraline Heart Rate Decreased Hydrochloride) C Heart Rate Irregular Pruritus Somnolence Date:07/31/03ISR Number: 4163199-0Report Type:Expedited (15-DaCompany Report #2003019779 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Health Geodon (Ziprasidone) PS 120 MG (TID) Initial or Prolonged Convulsion Professional Nefazodone Other Electrocardiogram Qt Company Hydrochloride Corrected Interval Representative (Nefazodone Prolonged Hydrochloride) C Electrocardiogram Qt Zolpidem Tartrate Prolonged (Zolpidem Tartrate)~ C Loss Of Consciousness Fentanyl (Fentanyl) C Memory Impairment Buspirone Ventricular Tachycardia Hydrochloride (Buspirone Hydrochloride) C Atorvastatin (Atorvastatin) C Date:08/01/03ISR Number: 4162137-4Report Type:Expedited (15-DaCompany Report #2003024982 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diarrhoea Foreign Zeldox (Capsules) Initial or Prolonged Hypertensive Crisis Health (Ziprasidone) PS ORAL 60 MG (BID), Restlessness Professional ORAL Treatment Noncompliance Olanzapine (Olanzapine) SS 5 MG (DAILY) 22-Feb-2006 08:32 AM Page: 377 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/01/03ISR Number: 4162181-7Report Type:Expedited (15-DaCompany Report #2003031047 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cerebrovascular Accident Foreign Ziprasidone (Caps) Hospitalization - Hepatic Failure Health (Ziprasidone) PS ORAL 160 MG (BID), Initial or Prolonged Neuroleptic Malignant Professional ORAL Syndrome Other Dantrolene SS INTRAVENOUS 140 MG Renal Failure Acute (DAILY), INTRAVENOUS Bromocriptine Mesilate (Bromocriptine Mesilate) C Date:08/01/03ISR Number: 4162855-8Report Type:Expedited (15-DaCompany Report #2003031221 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Multiple Drug Overdose Health Geodon (Ziprasidone) PS Initial or Prolonged Professional All Other Other Company Therapeutic Products SS Representative Date:08/01/03ISR Number: 4162857-1Report Type:Expedited (15-DaCompany Report #2003030900 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Geodon (Ziprasidone) PS Health Professional Date:08/01/03ISR Number: 4162860-1Report Type:Expedited (15-DaCompany Report #2003031785 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Embolism Health Geodon (Ziprasidone) PS 240 MG (BID) Other Professional Clozapine Company (Clozapine) C Representative Escitalopram (Escitalopram) C Benzodiazepine Derivatives C Date:08/01/03ISR Number: 4162862-5Report Type:Expedited (15-DaCompany Report #2003029145 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Geodon (Ziprasidone) PS Other Drug Interaction Professional Propranolol Sudden Death Company Hydrochloride Representative (Propranolol Hydrochloride) SS 22-Feb-2006 08:32 AM Page: 378 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/01/03ISR Number: 4162864-9Report Type:Expedited (15-DaCompany Report #2003016781 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Geodon (Ziprasidone) PS Initial or Prolonged Phosphokinase Professional Haloperidol Other Blood Pressure Diastolic Company (Haloperidol) SS Decreased Representative Paroxetine Blood Pressure Systolic Hydrochloride Increased (Paroxetine Body Temperature Hydrochloride) SS Increased Quetiapine Fumarate Electrocardiogram Qt (Quetiapine Prolonged Fumarate) SS Heart Rate Increased Trihexyphenidyl Multiple Drug Overdose Hydrochloride Oxygen Saturation (Trihexyphenidyl Decreased Hydrochloride) SS Suicide Attempt White Blood Cell Count Date:08/04/03ISR Number: 4161016-6Report Type:Direct Company Report #CTU 199133 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abnormal Behaviour Lithium 300-600 PS Affect Lability Clozaril SS 50-100 Distractibility Geodon SS Educational Problem Ddavp SS .6 OR .8 Irritability Strattera SS 60 Obesity Lithium C 300-600 Weight Increased Date:08/04/03ISR Number: 4161093-2Report Type:Direct Company Report #USP 55986 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Geodan PS Pfizer Geodan SS Pfizer Date:08/04/03ISR Number: 4163880-3Report Type:Expedited (15-DaCompany Report #2003031492 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Health Geodon (Ziprasidone) PS ORAL 80 MG (BID), Drug Interaction Professional ORAL Electrocardiogram Qt Doxepin (Caps) Corrected Interval (Doxepin) SS ORAL ORAL Prolonged Dyazide Sinusitis (Hydrochlorothiazide Sleep Apnoea Syndrome , Triamterene) C Somnolence Probucol (Probucol) C 22-Feb-2006 08:32 AM Page: 379 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/04/03ISR Number: 4163883-9Report Type:Expedited (15-DaCompany Report #2003031386 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Geodon (Ziprasidone) PS ORAL ORAL Professional Company Representative Date:08/04/03ISR Number: 4164307-8Report Type:Expedited (15-DaCompany Report #2003012534 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Foreign Ziprasidone (Caps) Hyperpyrexia Health (Ziprasidone) PS ORAL 40 MG Myalgia Professional (DAILY), ORAL Other Lamotrigine (Lamotrigine) C Date:08/04/03ISR Number: 4164308-XReport Type:Expedited (15-DaCompany Report #2003031196 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Palpitations Foreign Zeldox (Capsules) Initial or Prolonged Sinus Tachycardia Health (Ziprasidone) PS ORAL 80 MG (BID), Professional ORAL Quetiapine Fumarate (Quetiapine Fumarate) C Levomepromazine (Levomepromazine) C Clonazepam (Clonazepam) C Salbutamol (Salbutamol) C Date:08/05/03ISR Number: 4165725-4Report Type:Expedited (15-DaCompany Report #2003031563 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Geodon (Ziprasidone) PS ORAL / Other Fall Professional INTRAMUSCULAR Company Representative Date:08/06/03ISR Number: 4166109-5Report Type:Expedited (15-DaCompany Report #2003007927 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Study Geodon (Ziprasidone) PS ORAL 100 MG (BID), Initial or Prolonged Agitation Health ORAL Energy Increased Professional Risperidone Irritability (Risperidone) C Mania Clonazepam Pressure Of Speech (Clonazepam) C 22-Feb-2006 08:32 AM Page: 380 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/07/03ISR Number: 4167233-3Report Type:Expedited (15-DaCompany Report #2003030900 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Geodon (Ziprasidone) PS Hospitalization - Professional Initial or Prolonged Company Representative Date:08/08/03ISR Number: 4166214-3Report Type:Direct Company Report #CTU 199619E Age:23 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Geodon PS Pfizer ORAL 40MG BID Initial or Prolonged Constipation ORAL Dizziness Dysuria Pain Tremor Vision Blurred Vomiting Date:08/11/03ISR Number: 4167523-4Report Type:Expedited (15-DaCompany Report #2003032595 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Zeldox (Capsules) Initial or Prolonged Agitation Health (Ziprasidone) PS ORAL 120 MG Hypomania Professional (DAILY), ORAL Leukocytosis Valproate Sodium Neutrophilia (Valproate Sodium) C Pyrexia Haloperidol Treatment Noncompliance Decanoate (Haloperidol Decanoate) C Date:08/11/03ISR Number: 4167725-7Report Type:Expedited (15-DaCompany Report #A210368 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Choking Health Geodon (Ziprazidone) PS Other Hypersensitivity Professional Required Obstructive Airways Company Intervention to Disorder Representative Prevent Permanent Swollen Tongue Impairment/Damage Date:08/11/03ISR Number: 4168320-6Report Type:Expedited (15-DaCompany Report #2003032593 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Choking Health Geodon (Ziprasidone) PS ORAL 40 MG (BID), Drug Ineffective Professional ORAL Pregnancy Company Swollen Tongue Representative 22-Feb-2006 08:32 AM Page: 381 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/11/03ISR Number: 4168321-8Report Type:Expedited (15-DaCompany Report #2003032460 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Geodon (Ziprasidone) PS ORAL 80 MG Initial or Prolonged Blood Lactate Professional (DAILY), ORAL Other Dehydrogenase Increased Lithium (Lithium) SS ORAL ORAL Dyskinesia Hallucination, Auditory Paranoia Streptococcal Serology Positive Tic Date:08/12/03ISR Number: 4168450-9Report Type:Expedited (15-DaCompany Report #2003003728 Age:28 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Foreign Ziprasidone Initial or Prolonged Insomnia Study (Ziprasidone) PS ORAL 160 MG Other Nervousness Health (DAILY), ORAL Professional Valproate Sodium (Valproate Sodium) C Date:08/12/03ISR Number: 4168461-3Report Type:Expedited (15-DaCompany Report #2003031196 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Foreign Zeldox (Capsules) Initial or Prolonged Heart Rate Increased Health (Ziprasidone) PS ORAL 80 MG (BID), Palpitations Professional ORAL Sinus Tachycardia Quetiapine Fumarate (Quetiapine Fumarate) C Levomepromazine (Levomepromazine) C Clonazepam (Clonazepam) C Salbutamol (Salbutamol) C Date:08/13/03ISR Number: 4169248-8Report Type:Expedited (15-DaCompany Report #2003025127 Age: Gender:Female I/FU:F Outcome PT Hospitalization - Allergy To Arthropod Initial or Prolonged Sting Bronchitis Decreased Appetite Delusion Delusion Of Grandeur Emphysema Hallucination Heart Rate Irregular Insomnia Mania Mental Disorder Mood Swings Restlessness 22-Feb-2006 08:32 AM Page: 382 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sinusitis Treatment Noncompliance Report Source Product Role Manufacturer Route Dose Duration Health Geodon (Ziprasidone) PS 120 MG Professional Prednisone (Prednisone) SS 30 MG Tiagabine Hydrochloride (Tiagabine Hydrochoride) C Clonazepam (Clonazepam) C Quetiapine Fumarate (Quetiapine Fumarate) C Temazepam (Temazepam) C Diphenhydramine Hydrochloride (Diphenhydramine Hydrochloride) C Escitalopram (Escitalopram) C Topiramate (Topiramate) C Salmeterol Xinafoate (Salmeterol Xinafoate) C Salbutamol (Salbutamol) C Fluticasone Propionate (Fluticasone Propionate) C Salbutamol (Salbutamol) C Date:08/13/03ISR Number: 4169911-9Report Type:Expedited (15-DaCompany Report #2003032419 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zeldox (Capsules) Somnolence Health (Ziprasidone) PS ORAL 40 (BID), Professional ORAL Date:08/14/03ISR Number: 4170100-2Report Type:Expedited (15-DaCompany Report #2003031563 Age:81 YR Gender:Female I/FU:F Outcome PT Death Arrhythmia Other Bundle Branch Block Right Cardiac Arrest Circulatory Collapse Electrocardiogram T Wave Abnormal Fall Pulse Absent Sinus Tachycardia Supraventricular 22-Feb-2006 08:32 AM Page: 383 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Extrasystoles Report Source Product Role Manufacturer Route Dose Duration Health Geodon (Ziprasidone) PS ORAL 40 MG (BID), Professional ORAL Company Representative Date:08/14/03ISR Number: 4170382-7Report Type:Expedited (15-DaCompany Report #C2003-1626.01 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozapine PS Mylan ORAL 100MG Q AM Deep Vein Thrombosis Professional AND 200MG Q Pharmaceutical Product Other HS, ORAL Complaint Geodon SS Pfizer Pulmonary Embolism Trazodone C Clonazepam C Furosemide C Metformin C Verapamil C Date:08/15/03ISR Number: 4169081-7Report Type:Direct Company Report #CTU 200028 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depressed Level Of Geodon 20 Mg Thomson Consciousness Pdr PS Thomson Pdr ORAL 20 MG AM Sedation ORAL Geodon 40 Mg Thomson Pdr SS ORAL 40 MG PM ORAL Date:08/15/03ISR Number: 4170313-XReport Type:Expedited (15-DaCompany Report #2003033059 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Geodon (Ziprasidone) PS 160 MG (BID) Other Professional Company Representative Date:08/15/03ISR Number: 4170323-2Report Type:Expedited (15-DaCompany Report #2003033052 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chromatopsia Consumer Geodon (Ziprasidone) PS ORAL ORAL Initial or Prolonged Feeling Abnormal Olanzapine C Hallucination, Auditory Influenza Like Illness Oral Intake Reduced Rash Tremor 22-Feb-2006 08:32 AM Page: 384 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/15/03ISR Number: 4170936-8Report Type:Direct Company Report #USP 56011 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Geodan PS Pfizer CAPSULE Geodan SS Pfizer INJECTABLE Date:08/15/03ISR Number: 4172269-2Report Type:Expedited (15-DaCompany Report #2003029831 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agitation Foreign Geodon (Ziprasidone) PS ORAL 80 MG (BID), Hospitalization - Anxiety Health ORAL Initial or Prolonged Suicidal Ideation Professional Antidepressants C Company Representative Date:08/15/03ISR Number: 4172272-2Report Type:Expedited (15-DaCompany Report #2003033328 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Foreign Zeldox (Capsules) Hip Fracture Health (Ziprasidone) PS Professional Company Representative Date:08/18/03ISR Number: 4172375-2Report Type:Expedited (15-DaCompany Report #2003030900 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Geodon (Ziprasidone) PS Hospitalization - Treatment Noncompliance Professional Initial or Prolonged Company Other Representative Date:08/18/03ISR Number: 4172403-4Report Type:Expedited (15-DaCompany Report #2003021859 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Health Geodon (Ziprasidone) PS ORAL (BID), ORAL Initial or Prolonged Cyanosis Professional Clonazepam Dyspnoea (Clonazepam) C Hyperhidrosis Propranolol Oxygen Saturation (Propranolol) C Decreased Liothyronine Sodium Thirst (Liothyronine Sodium) C Warfarin (Warfarin) C Esomeprazole (Esomeprazole) C Potassium (Potassium) C Bumetanide (Bumetanide) C Seretide Mite (Fluticasone Propionate, 22-Feb-2006 08:32 AM Page: 385 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Salmeterol Xinafoate) C Combivent (Ipratropium Bromide, Salbutamol Sulfate) C Pirbuterol Acetate (Pirbuterol Acetate) C Quetiapine Fumarate (Quetiapine Fumarate) C Gabapentin (Gabapentin) C Date:08/19/03ISR Number: 4172966-9Report Type:Expedited (15-DaCompany Report #2003033453 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Multiple Sclerosis Health Geodon (Ziprasidone) PS ORAL 160 MG (BID), Pregnancy Professional ORAL Gabapentin (Gabapentin) C Oxcarbazepine (Oxcarbazepine) C Escitalopram (Escitalopram) C Date:08/19/03ISR Number: 4173226-2Report Type:Expedited (15-DaCompany Report #2003012036 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Geodon (Im) Cardio-Respiratory Arrest Professional (Ziprasidone) PS INTRAMUSCULAR INTRAMUSCULAR Sudden Death Company Representative Date:08/20/03ISR Number: 4175692-5Report Type:Expedited (15-DaCompany Report #2003033757 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertension Health Geodon (Ziprasidone) PS ORAL 120 MG BID Serotonin Syndrome Professional ORAL Tremor Company Synthroid Representative (Levothyroxine Sodium) C Date:08/20/03ISR Number: 4175694-9Report Type:Expedited (15-DaCompany Report #2003033756 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertension Health Geodon (Ziprasidone) PS Serotonin Syndrome Professional Company Representative 22-Feb-2006 08:32 AM Page: 386 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/20/03ISR Number: 4175695-0Report Type:Expedited (15-DaCompany Report #2003033755 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertension Health Geodon (Ziprasidone) PS Serotonin Syndrome Professional Tremor Company Representative Date:08/21/03ISR Number: 4175683-4Report Type:Expedited (15-DaCompany Report #2003032419 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zeldox (Capsules) Family Stress Health (Ziprasidone) PS ORAL 80 (BID), Medication Error Professional ORAL Somnolence Mirtazapine (Mirtazapine) C Chlorpromazine (Chlorpromazine) C Date:08/21/03ISR Number: 4176441-7Report Type:Expedited (15-DaCompany Report #2003029191 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Consumer Geodon (Ziprasidone) PS Initial or Prolonged Cough Quetiapine Fumarate Disorientation (Quetiapine Hyperhidrosis Fumarate) C Insomnia Suicidal Ideation Vomiting Date:08/22/03ISR Number: 4173273-0Report Type:Direct Company Report #CTU 200489 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Priapism Ziprasidone PS Initial or Prolonged Trazodone Hcl 100 Mg Disability Tab SS Required Intervention to Prevent Permanent Impairment/Damage Date:08/22/03ISR Number: 4176377-1Report Type:Expedited (15-DaCompany Report #2003022466 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Geodon (Im) Professional (Ziprasidone) PS INTRAMUSCULAR UNK; Company INTRAMUSCULAR Representative 22-Feb-2006 08:32 AM Page: 387 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/22/03ISR Number: 4176378-3Report Type:Expedited (15-DaCompany Report #2003022465 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Geodon (Im) Professional (Ziprasidone) PS INTRAMUSCULAR UNK, Company INTRAMUSCULAR Representative Date:08/25/03ISR Number: 4173829-5Report Type:Direct Company Report #CTU 200559 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Geodon 20 Mg PS ORAL 20 MG BID ORAL Geodon 40 Mg SS ORAL 40 MG BID ORAL Date:08/25/03ISR Number: 4177766-1Report Type:Expedited (15-DaCompany Report #2003034278 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Foreign Zeldox (Capsules) Initial or Prolonged Difficulty In Walking Health (Ziprasidone) PS ORAL 240 MG (BID), Fatigue Professional ORAL Musculoskeletal Stiffness Zuclopenthixol (Zuclopenthixol) C Lamotrigine (Lamotrigine) C Mirtazapine (Mirtazapine) C Venlafaxine (Venlafaxine) C Date:08/25/03ISR Number: 4177782-XReport Type:Expedited (15-DaCompany Report #2003034279 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyspnoea Foreign Zeldox (Capsules) Initial Insomnia Health (Ziprasidone) PS ORAL 40 MG (BID), Nausea Professional ORAL Amitriptyline Hydrochloride (Amitriptyline Hydrochloride) C Perphenazine Decanoate (Perphenazine Decanoate) C Simvastatin (Simvastatin) C Glimepiride (Glimepiride) C 22-Feb-2006 08:32 AM Page: 388 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/25/03ISR Number: 4178444-5Report Type:Expedited (15-DaCompany Report #2003034272 Age:7 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Immunoglobulin E Health Geodon (Ziprasidone) PS ORAL UNK, ORAL Increased Professional Insulin (Insulin) C Eosinophilia Valproate Semisodium (Valproate Semisodium) C Olanzapine (Olanzapine) C Dexamfetamine (Dexamfetamine) C Ranitidine Hydrochloride (Ranitidine Hydrochloride) C Omeprazole (Omeprazole) C Date:08/25/03ISR Number: 4178466-4Report Type:Expedited (15-DaCompany Report #2003034238 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcoholism Health Geodon (Ziprasidone) PS 120 MG (BID); Initial or Prolonged Drug Abuser Professional EIGHT MONTHS Other Hepatitis Acute AGO Suicidal Ideation Sertraline Hydrochloride (Sertraline Hydrochloride) C Olanzapine (Olanzapine) C Date:08/26/03ISR Number: 4178792-9Report Type:Expedited (15-DaCompany Report #2003032002 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fall Foreign Geodon (Ziprasidone) PS ORAL 120 MG (BID), Life-Threatening Myocarditis Health ORAL Hospitalization - Pneumonia Professional Initial or Prolonged Pyrexia Company Other Renal Failure Representative Date:08/26/03ISR Number: 4179610-5Report Type:Expedited (15-DaCompany Report #2003034801 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Health Geodon (Ziprasidone) PS 10 MG (DAILY) Professional Company Representative 22-Feb-2006 08:32 AM Page: 389 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/27/03ISR Number: 4180569-5Report Type:Expedited (15-DaCompany Report #2003035165 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Geodon (Ziprasidone) PS ORAL 120 MG Other Professional (DAILY), ORAL Company Benzatropine Representative Mesilate (Benzatropine Mesilate) C Haloperidol Decanoate (Haloperidol Decanoate) C Date:08/27/03ISR Number: 4180591-9Report Type:Expedited (15-DaCompany Report #2003027968 Age:60 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Foreign Zeldox (Capsules) Initial or Prolonged Syndrome Health (Ziprasidone) PS ORAL 120 MG Parkinsonism Professional (DAILY), ORAL Galantamine (Galantamine) C Bromocriptine Mesilate (Bromocriptine Mesilate) C Sinemet (Levodopa, Carbidopa) C Date:08/27/03ISR Number: 4181259-5Report Type:Expedited (15-DaCompany Report #2003034753 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Foreign Geodon (Ziprasidone) PS ORAL 80 MG DAILY Suicide Attempt Health ORAL Professional Reboxetine C Escitalopram C Date:08/28/03ISR Number: 4175186-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12289898 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Geodon SS Date:08/28/03ISR Number: 4175195-8Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12291936 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Abilify Tabs PS Otsuka Pharmaceutical Company, Ltd. ORAL Geodon SS 22-Feb-2006 08:32 AM Page: 390 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/28/03ISR Number: 4181434-XReport Type:Expedited (15-DaCompany Report #2003035329 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Geodon (Ziprasidone) PS Life-Threatening Professional Other Company Representative Date:08/28/03ISR Number: 4181435-1Report Type:Expedited (15-DaCompany Report #2003035153 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Carbon Monoxide Poisoning Consumer Geodon (Ziprasidone) PS ORAL ORAL Life-Threatening Completed Suicide Lithium (Lithium) SS Drug Ineffective Citalopram Lethargy Hydrobromide (Citalopram Hydrobromide) SS ORAL ORAL Lorazepam (Lorazepam) SS ORAL ORAL Olanzapine (Olanzapine) C Date:08/28/03ISR Number: 4181528-9Report Type:Expedited (15-DaCompany Report #2003034678 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bipolar I Disorder Foreign Ziprasidone (Caps) Initial or Prolonged Fatigue Health (Ziprasidone) PS ORAL 80 MG Syncope Professional (DAILY), ORAL Company Oral Contraceptive Representative Nos (Oral Contraceptive Nos) C Date:08/29/03ISR Number: 4182642-4Report Type:Expedited (15-DaCompany Report #2003035576 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Ziprasidone (Caps) Other Health (Ziprasidone) PS ORAL 40 MG (BID), Professional ORAL Atenolol (Atenolol) C Date:09/02/03ISR Number: 4182484-XReport Type:Periodic Company Report #2003018421 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Geodon (Ziprasidone) PS Professional Erythromycin Company (Erythromycin) SS Representative Fluoxetine Hydrochloride (Fluoxetine Hydrochloride) SS 22-Feb-2006 08:32 AM Page: 391 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/02/03ISR Number: 4182487-5Report Type:Periodic Company Report #2003020168 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Geodon (Ziprasidone) PS Professional Company Representative Date:09/02/03ISR Number: 4182490-5Report Type:Periodic Company Report #2003020172 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Geodon (Ziprasidone) PS ORAL 100 MG (BID), Professional ORAL Escitalopram (Escitalopram) C Quetiapine Fumarate (Quetiapine) C Insulin (Insulin) C Atorvastatin (Atorvastatin) C Enalapril (Enalapril) C Levothyroxine Sodium (Levothyroxine Sodium) C Date:09/02/03ISR Number: 4182493-0Report Type:Periodic Company Report #2003020613 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Overdose Consumer Geodon (Ziprasidone) PS 180 MG (TID) Initial or Prolonged Pain Valproate Semisodium Other Priapism (Valproate Semisodium) C Date:09/02/03ISR Number: 4182494-2Report Type:Periodic Company Report #2003023425 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chills Consumer Geodon (Ziprasidone) PS ORAL 160 MG (BID), Initial or Prolonged Hyperhidrosis ORAL Other Infection Benazepril Micturition Urgency Hydrochloride Pyrexia (Benazepril Tremor Hydrochloride) C Urinary Retention Paroxetine Hydrochloride (Paroxetine Hydrochloride) C Metformin Hydrochloride (Metformin Hydrochloride) C 22-Feb-2006 08:32 AM Page: 392 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/02/03ISR Number: 4182495-4Report Type:Periodic Company Report #2003024552 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Health Geodon (Ziprasidone) PS ORAL 160 MD (BID), Initial or Prolonged Professional ORAL Date:09/02/03ISR Number: 4182496-6Report Type:Periodic Company Report #2003026837 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fungal Infection Health Geodon (Ziprasidone) PS ORAL 40 MG Initial or Prolonged Orthostatic Hypotension Professional (DAILY), ORAL Other Company Losartan Potassium Representative (Losartan Potassium) C Levofloxacin (Levofloxacin) C Hydrochlorothiazide (Hydrochlorothiazide ) C Docusate Sodium (Docusate Sodium) C Lansoprazole (Lansoprazole) C Date:09/02/03ISR Number: 4182498-XReport Type:Periodic Company Report #2003027116 Age:17 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Health Geodon (Ziprasidone) PS Corrected Interval Professional Prolonged Date:09/02/03ISR Number: 4182501-7Report Type:Periodic Company Report #2003027128 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delirium Health Geodon (Ziprasidone) PS 160 MG (BID), Initial or Prolonged Extrapyramidal Disorder Professional ORAL Other Platelet Count Increased Company Benzatropine Representative Mesilate (Benzatropine Mesilate) SS ORAL 2 MG (BID), ORAL Citalopram Hydrobromide (Citalopram Hydrobromide) C Oxcarbazepine Oxcarbazepine) C Risperidone (Risperidone) C 22-Feb-2006 08:32 AM Page: 393 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/02/03ISR Number: 4182502-9Report Type:Periodic Company Report #2003027373 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Consumer Geodon (Ziprasidone) PS ORAL 40 MG Initial or Prolonged Nausea (DAILY), ORAL Other Psychotic Disorder Morphine (Morphine) C Vomiting Trazodone (Trazodone) C Date:09/02/03ISR Number: 4183426-3Report Type:Expedited (15-DaCompany Report #2003026481 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Myocardial Infarction Health Geodon (Ziprasidone) PS ORAL 120 MG (BID), Initial or Prolonged Weight Decreased Professional ORAL Weight Increased Amitriptyline Hydrochloride (Amitriptyline Hydrochloride) SS Clopidogrel Sulfate (Clopidogrel Sulfate) C Atorvastatin (Atorvastatin) C Pantoprazole (Pantoprazole) C Fexofenadine Hydrochloride (Fexofenadine Hydrochloride) C Metformin (Metformin) C Lisinopril (Lisinopril) C Salbutamol (Salbutamol) C Cyanocobalamin (Cyanocobalamin) C Meclozine (Meclozine) C Methotrexate (Methotrexate) C Salmeterol Xinafoate (Salmeterol Xinafoate) C Gemfibrozil (Gemfibrozil) C Topiramate (Topiramate) C Multivitamins (Ergocalciferol, Ascorbic Acid, Folic Acid,Thiamine Hydrochloride, C Acetylsalicylic Acid(Acetylsalicylic Acid) C Valproate Semisodium (Valproate Semisodium) C 22-Feb-2006 08:32 AM Page: 394 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Levothyroxine Sodium (Levothyroxine Sodium) C Escitalopram (Escitalopram) C Date:09/02/03ISR Number: 4183968-0Report Type:Expedited (15-DaCompany Report #2002063839 Age:21 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Suicide Attempt Foreign Zeldox (Capsules) Hospitalization - Study (Ziprasidone) PS ORAL Initial or Prolonged Health Zoplicone Other Professional (Zopiclone) C Company Representative Date:09/02/03ISR Number: 4184741-XReport Type:Expedited (15-DaCompany Report #2003029831 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agitation Foreign Geodon (Ziprasidone) PS ORAL 80 MG Hospitalization - Anxiety Health (DAILY), ORAL Initial or Prolonged Suicidal Ideation Professional Antidepressants C Suicide Attempt Company Representative Date:09/02/03ISR Number: 4208241-3Report Type:Periodic Company Report #2003028652 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Health Geodon (Ziprasidone) PS 260 MG Corrected Interval Professional (DIALY) Prolonged Company Intentional Overdose Representative Medication Error Date:09/02/03ISR Number: 4208245-0Report Type:Periodic Company Report #2003032561 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Health Geodon (Ziprasidone) PS ORAL ORAL Corrected Interval Professional Prolonged Company Representative Date:09/02/03ISR Number: 4208248-6Report Type:Periodic Company Report #2003032724 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arrhythmia Health Geodon (Ziprasidone) PS Initial or Prolonged Electrocardiogram Qt Professional Other Prolonged Company Syncope Representative 22-Feb-2006 08:32 AM Page: 395 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/02/03ISR Number: 4208251-6Report Type:Periodic Company Report #2003013575 Age:4 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Health Geodon (Ziprasidone) PS ORAL 120 MG (BID), Communication Disorder Professional ORAL Dystonia Company Oxcarbazepine Hypotension Representative (Oxcardbazepine) C Lethargy Guanfacine Somnolence Hydrochloride (Guanfacine Hydrochloride) C Obetrol (Dexamfetamine Sulfate, Amfestamine Sulfate, Dexamfetamine C Date:09/02/03ISR Number: 4208254-1Report Type:Periodic Company Report #2003016574 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anorexia Consumer Geodon (Ziprasidone) PS ORAL 240 MED Delusion Health (BID), ORAL Depression Professional Trazone (Trazone) C Hepatitis Bupropion Malaise Hydrdorchloride Medication Error (Bupropion Nausea Hydrochloride) C Prescribed Overdose Date:09/03/03ISR Number: 4184533-1Report Type:Expedited (15-DaCompany Report #2003035488 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Difficulty In Walking Consumer Geodon (Ziprasidone) PS ORAL ORAL Initial or Prolonged Discomfort Other Drug Ineffective Oral Intake Reduced Pyrexia Speech Disorder Throat Tightness Tremor Date:09/03/03ISR Number: 4184537-9Report Type:Expedited (15-DaCompany Report #2003032460 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Geodon (Ziprasidone) PS ORAL 80 MG Initial or Prolonged Agitation Professional (DAILY), ORAL Other Blood Lactate Lithium (Lithium) SS ORAL ORAL Dehydrogenase Increased Dyskinesia Hallucination, Auditory Impulsive Behaviour Paranoia Tic 22-Feb-2006 08:32 AM Page: 396 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/03/03ISR Number: 4184828-1Report Type:Expedited (15-DaCompany Report #2003028946 Age:19 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyspnoea Health Geodon (Ziprasidone) PS ORAL ORAL Initial or Prolonged Throat Tightness Professional Other Company Representative Date:09/03/03ISR Number: 4184829-3Report Type:Expedited (15-DaCompany Report #2003026289 Age:73 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Health Geodon (Im) Other Medication Error Professional (Ziprasidone) PS INTRAVENOUS 20 MG (ONCE), INTRAVENOUS Simvastatin (Simvastatin) C Probenecid (Probenecid) C Glipizide (Glipizide) C Date:09/04/03ISR Number: 4179861-XReport Type:Direct Company Report #CTU 201299 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cogwheel Rigidity Geodon PS ORAL 160-200 Intervention to Musculoskeletal Stiffness MG.DAY PO 5 DAY Prevent Permanent Impairment/Damage Date:09/04/03ISR Number: 4179877-3Report Type:Direct Company Report #CTU 201298 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dystonia Ziprasidone (Geodon) PS ORAL 80 MG PO BID Intervention to Swollen Tongue Prevent Permanent Impairment/Damage Date:09/04/03ISR Number: 4183822-4Report Type:Expedited (15-DaCompany Report #2003035968 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zeldox (Capsules) Other Health (Ziprasidone) PS Professional Company Representative Date:09/04/03ISR Number: 4185022-0Report Type:Expedited (15-DaCompany Report #2003035542 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Other Coma Health Professional 22-Feb-2006 08:32 AM Page: 397 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company Representative Product Role Manufacturer Route Dose Duration Geodon (Ziprasidone) PS 160 MG Date:09/05/03ISR Number: 4185374-1Report Type:Expedited (15-DaCompany Report #2003032593 Age:27 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Choking Health Geodon (Ziprasidone) PS ORAL ORAL Drug Ineffective Professional Dysphagia Company Dyspnoea Representative Pregnancy Swollen Tongue Date:09/08/03ISR Number: 4184588-4Report Type:Direct Company Report #CTU 201407 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Geodon 40 Mg Pfizer PS Pfizer PARENTERAL 40 MG BID Initial or Prolonged Consciousness PARENTERAL Dyspnoea Electrocardiogram Qrs Complex Prolonged Electrocardiogram Qt Prolonged Hypoventilation Date:09/08/03ISR Number: 4186102-6Report Type:Expedited (15-DaCompany Report #20030306047 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bradycardia Health Geodon (Ziprasidone) PS 60 MG Other Embolism Professional All Other Sudden Death Company Therapeutic Products C Representative Date:09/08/03ISR Number: 4186111-7Report Type:Expedited (15-DaCompany Report #2003036173 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradyphrenia Consumer Geodon (Ziprasidone) PS ORAL 400 MG, ORAL Initial or Prolonged Disturbance In Attention Fluoxetine Other Dizziness Hydrochloride Headache (Fluoxetine Overdose Hydrochloride) SS Paraesthesia Somnolence Date:09/08/03ISR Number: 4186866-1Report Type:Expedited (15-DaCompany Report #2003033328 Age:59 YR Gender:Female I/FU:F Outcome Hospitalization - Initial or Prolonged 22-Feb-2006 08:32 AM Page: 398 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other PT Report Source Product Role Manufacturer Route Dose Duration Convulsion Foreign Zeldox (Capsules) Fall Health (Ziprasidone) PS ORAL 30 MG, ORAL Hip Fracture Professional Esomeprazole Humerus Fracture Company (Esomeprazole) C Representative Salutec (Hydrochlorothiazide , Ramipril) C Levothyroxine Sodium( Levothyroxine Sodium) C Phenprocoumon (Phenprocoumon) C Date:09/08/03ISR Number: 4186867-3Report Type:Expedited (15-DaCompany Report #2003029682 Age:71 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Breast Cancer Metastatic Foreign Ziprasidone (Caps) Insomnia Health (Ziprasidone) PS ORAL 120 MG (BID), Professional ORAL Temazepam (Temazepam) C Letrozole (Letrozole) C Date:09/09/03ISR Number: 4187949-2Report Type:Expedited (15-DaCompany Report #2003036259 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Serotonin Syndrome Health Geodon (Ziprasidone) PS 40 MG (BID), Professional Oxycodone Company Hydrochloride Representative (Oxycodone Hydrochloride) SS 80 MG (TID), Venlafaxine Hydrochloride (Venlafaxine Hydrochloride) SS 40 MG (DAILY), Date:09/09/03ISR Number: 4188155-8Report Type:Expedited (15-DaCompany Report #2003036349 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Foreign Ziprasidone (Caps) Initial or Prolonged Psychotic Disorder Health (Ziprasidone) PS ORAL 140 MG, ORAL Professional Fluvoxamine Company (Fluvoxamine) C Representative Propranolol (Propranolol) C Biperiden (Biperiden) C 22-Feb-2006 08:32 AM Page: 399 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/10/03ISR Number: 4188603-3Report Type:Expedited (15-DaCompany Report #2003031785 Age:58 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Embolism Health Geodon (Ziprasidone) PS ORAL 240 MG (BID), Other Feeling Abnormal Professional ORAL Company Clozapine Representative (Clozapine) C Escitalopram (Escitalopram) C Benzodiazepine Derivatives C Clonazepam (Clonazepam) C Levothyroxine Sodium (Levothyroxine Sodium) C Pantoprazole (Pantoprazole) C Oxybutynin Hydrochloride (Oxybutynin Hydrochloride) C Desmopressin (Desmopressin) C Date:09/10/03ISR Number: 4188670-7Report Type:Expedited (15-DaCompany Report #2003036539 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Health Geodon (Ziprasidone) PS Other Professional Date:09/10/03ISR Number: 4188852-4Report Type:Expedited (15-DaCompany Report #2003036605 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Foreign Zeldox (Capsules) Initial or Prolonged Loss Of Consciousness Health (Ziprasidone) PS ORAL 160 MG, Pneumonia Professional DAILY, ORAL Company Quetiapine Fumarate C Representative Ssri C Date:09/10/03ISR Number: 4188853-6Report Type:Expedited (15-DaCompany Report #2003032002 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Foreign Geodon (Ziprasidone) PS ORAL 120 MG, BID, Life-Threatening Fall Health ORAL Hospitalization - Myocarditis Professional Initial or Prolonged Nosocomial Infection Company Other Pneumonia Representative Postoperative Infection Pyrexia Renal Failure 22-Feb-2006 08:32 AM Page: 400 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/11/03ISR Number: 4187353-7Report Type:Direct Company Report #CTU 201609 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Geodon 20 Mg PS Geodon 80 Mg SS Date:09/11/03ISR Number: 4189353-XReport Type:Expedited (15-DaCompany Report #2003036699 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Foreign Zeldox (Capsules) Syndrome Health (Ziprasidone) PS ORAL 80 MG (BID), Pyrexia Professional ORAL Company Haloperidol Representative (Haloperidol) C Olanzapine (Olanzapine) C Reboxetine (Reboxetine) C Date:09/11/03ISR Number: 4189363-2Report Type:Expedited (15-DaCompany Report #2003037077 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Foreign Ziprasidone (Caps) Health (Ziprasidone) PS ORAL 120 MG (BID), Professional ORAL Company Representative Date:09/11/03ISR Number: 4189569-2Report Type:Expedited (15-DaCompany Report #2003029191 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Consumer Geodon (Ziprasidone) PS Initial or Prolonged Cough Quetiapine Fumarate Disorientation (Guetiapine Energy Increased Fumarate) C Hyperhidrosis Self-Injurious Ideation Sleep Disorder Suicidal Ideation Vomiting Date:09/11/03ISR Number: 4201528-XReport Type:Expedited (15-DaCompany Report #2003036824 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Geodon Other (Zisprasidone) PS ORAL (PRN) ORAL 22-Feb-2006 08:32 AM Page: 401 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/12/03ISR Number: 4189880-5Report Type:Expedited (15-DaCompany Report #2003031640 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Health Geodon (Ziprasidone) PS ORAL ORAL Initial or Prolonged Delirium Professional Buspirone Dysarthria Hydrochloride C Hallucination, Auditory Nortriptyline C Mania Lansoprazole C Posture Abnormal Polycarbophil Somnolence Calcium C Tremor B-Plex (Thiamine, Vomiting Nicotinic Acid, Pyridoxine, Cyanocobalamin, Riboflavin, C Date:09/12/03ISR Number: 4190066-9Report Type:Expedited (15-DaCompany Report #A129041 Age:29 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Brain Death Consumer Geodon (Ziprasidone) PS ORAL 80 MG Life-Threatening Cerebral Haemorrhage Health (DAILY), ORAL Hospitalization - Coma Professional Sulfamethoxazole-Tri Initial or Prolonged Condition Aggravated Company methoprim Required Dehydration Representative (Sulfamethoxazole, Intervention to Hallucination, Auditory Trimethoprim) SS ORAL ORAL Prevent Permanent Hepatic Failure Coumadin (Warfarin) Impairment/Damage Liver Function Test (Warfarin Sodium) C Abnormal Prozac (Fluoxetine) Multi-Organ Failure (Fluoxetine Renal Failure Hydrochloride) C Sepsis Paxil (Paroxetine) Skin Discolouration (Paroxetine Stevens-Johnson Syndrome Hydrochloride) C Suicide Attempt All Other Thrombocytopenia Therapeutic Products C Upper Respiratory Tract Infection Urinary Tract Infection Vasculitis White Blood Cell Count Increased Date:09/12/03ISR Number: 4190069-4Report Type:Expedited (15-DaCompany Report #2003033318 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Tourette'S Disorder Health Geodon (Ziprasidone) PS ORAL 120 MG, BID, Initial or Prolonged Professional ORAL All Other Therapeutic Products C Escitalopram C 22-Feb-2006 08:32 AM Page: 402 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/12/03ISR Number: 4190234-6Report Type:Expedited (15-DaCompany Report #2003034521 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Acute Myocardial Foreign Zeldox (Capsules) Hospitalization - Infarction Health (Ziprasidone) PS ORAL 160 MG (BID), Initial or Prolonged Chills Professional ORAL Other Cold Sweat Company Lupentixol Confusional State Representative Dihydrochlorie Convulsion (Flupentixol Coronary Artery Stenosis Dihydrochlorde) C Disorientation Biperiden C Drug Withdrawal Syndrome Chlorprothixene Face Injury Hydrochloride Flushing (Chlorprothixene Gastric Ulcer Haemorrhage Hydrochloride) C Gastrooesophagitis General Physical Health Deterioration Hyperhidrosis Inflammation Limb Injury Loss Of Consciousness Neck Injury Neuroleptic Malignant Syndrome Rhabdomyolysis Sinus Tachycardia Somnolence Spinal Haematoma Tremor Upper Gastrointestinal Haemorrhage Urosepsis Date:09/15/03ISR Number: 4189779-4Report Type:Direct Company Report #CTU 201847 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cogwheel Rigidity Geodon 40 Mg PS 40 MG BID Extrapyramidal Disorder Tums C Albuterol C Diphenhydramine C Lorazepam C Tylenol C Date:09/16/03ISR Number: 4190771-4Report Type:Expedited (15-DaCompany Report #2003029219 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Blepharospasm Health Geodon (Ziprasidone) PS ORAL 120 MG (BID), Tardive Dyskinesia Professional ORAL Lithium Carbonate (Lithium Carbonate) C Levothyroxine Sodium C Escitalopram (Escitalopram) C 22-Feb-2006 08:32 AM Page: 403 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/16/03ISR Number: 4192814-0Report Type:Direct Company Report #CTU 201865 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hallucinations, Mixed Geodon 80 Mg Leukocytosis Pfizer PS Pfizer ORAL 80 MG QHS Medication Error ORAL Productive Cough Geodon 20 Mg Pyrexia Pfizer SS Pfizer ORAL 40 MG QAM White Blood Cell Count ORAL Increased Fluphenazine C Depakote C Ativan C Date:09/16/03ISR Number: 4193086-3Report Type:Direct Company Report #CTU 201919 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Extrapyramidal Disorder Geodon 60 Mg Cap PS ORAL 60 MG PO TID Intervention to Throat Tightness Lexapro C Prevent Permanent Seroquel C Impairment/Damage Topamax C Trazodone C Ativan C Vistaril C Date:09/17/03ISR Number: 4191421-3Report Type:Expedited (15-DaCompany Report #2003027968 Age:60 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Foreign Zeldox Initial or Prolonged Depression Health (Ziprasidone) PS ORAL 120 MG (BID), Dysphagia Professional ORAL Gait Disturbance Zoloft Hyperhidrosis (Sertraline) SS Mastication Disorder Galantamine Neuroleptic Malignant (Galantamine) C Syndrome Bromocriptine Parkinsonism Mesilate Seborrhoea (Bromocriptine Urinary Tract Infection Mesilate) C Sinemet (Levodopa, Carbidopa) C Date:09/17/03ISR Number: 4193484-8Report Type:Expedited (15-DaCompany Report #2003025850 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zeldox (Capsules) Drug Effect Decreased Health (Ziprasidone) PS 120 MG Suicidal Ideation Professional (DAILY) Company Lorazepam Representative (Lorazepam) C Carbamazepine (Carbamazepine) C Levomepromazine (Levomepromazine) C 22-Feb-2006 08:32 AM Page: 404 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/22/03ISR Number: 4193763-4Report Type:Expedited (15-DaCompany Report #2003027373 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Consumer Geodon (Ziprasidone) PS ORAL 80 MG (BID), Initial or Prolonged Delusion Health ORAL Other Drug Ineffective Professional Morphine (Morphine) SS ORAL ORAL Feeling Abnormal Trazodone Hallucination, Auditory (Trazodone) C Insomnia Nausea Pain Psychotic Disorder Vomiting Date:09/22/03ISR Number: 4193995-5Report Type:Direct Company Report #CTU 202171E Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Depression Geodon 20 Mg Pfizer PS Pfizer ORAL 20 MG DAILY Hospitalization - Mydriasis ORAL Initial or Prolonged Neuroleptic Malignant Syndrome Date:09/22/03ISR Number: 4194138-4Report Type:Expedited (15-DaCompany Report #2003038089 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Activities Of Daily Health Geodon (Ziprasidone) PS ORAL 40 MG (BID), Initial or Prolonged Living Impaired Professional ORAL Other Cerebrovascular Accident Valproate Semisodium Drug Ineffective (Valproate Nausea Semisodium) C Oral Intake Reduced Zinc (Zinc) C Subdural Haematoma Ascorbic Acid (Ascorbic Acid) C Multivitamins (Ergocalciferol, Ascorbic Acid, Folic Acid, Thiamine Hydrochloride, C Quetiapine Fumarate (Quetiapine Fumarate) C Phenytoin Sodium (Phenytoin Sodium) C Cefalexin Monohydrate (Cefalexin Monohydrate) C Galantamine (Galantamine) C Lisinopril (Lisinopril) C Insulin (Insulin) C Paracetamol (Paracetamol) C 22-Feb-2006 08:32 AM Page: 405 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/22/03ISR Number: 4194758-7Report Type:Expedited (15-DaCompany Report #2003017238 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Activated Partial Health Neurontin Hospitalization - Thromboplastin Time Professional (Gabapentin) PS 1800 MG (600, Initial or Prolonged Prolonged TID) Other Anaemia Geodon (Ziprasidone) SS 160 MG Angioneurotic Oedema Benzatropine Anorexia Mesilate Asthenia (Benzatropine Blood Albumin Decreased Besilate) SS 4 MG Blood Chloride Increased Risperidone Blood Fibrinogen Abnormal (Risperidone) SS 6 MG (3, BID) Blood Iron Decreased Venlafaxine Blood Urea Decreased Hydrochloride Cough (Venlafaxine Drug Toxicity Hydrochloride) SS 75 MG (DAILY) Drug Withdrawal Syndrome Clonazepam Dyspnoea (Clonazepam) C Hallucination Haloperidol Hyperhidrosis (Haloperidol) C Hyperplasia Lamotrigine Hyperpyrexia (Lamotrigine) C Insomnia Lansoprazole Lymphadenopathy (Lansoprazole) C Lymphoma Ranitidine Muscular Weakness Hydrochloride Nausea (Ranitidine Hy Paranoia Drochloride) C Psychomotor Hyperactivity Diphenhydramine Rash Hydrochloride Red Cell Distribution (Diphenhydramine Width Increased Hydrochloride) C Serum Ferritin Decreased Trihexyphenidyl Tachycardia Hydrochloride Thrombocytopenia (Trihexyphenidyl Vomiting Hydrochloride) C Weight Decreased Chlorpromazine White Blood Cell Count Hydrochloride Decreased (Chlorpromazine Hydrochloride) C Olanzapine (Olanzapine) C Lorazepam (Lorazepam) C Temazepam (Temazepam) C Zolpidem Tartrate (Zolpidem Tartrate) C Date:09/22/03ISR Number: 4194965-3Report Type:Expedited (15-DaCompany Report #2003025116 Age: Gender:Male I/FU:I Outcome PT Other Blood Bicarbonate Diabetes Mellitus Glycosylated Haemoglobin Increased Hyperglycaemia Insulin C-Peptide 22-Feb-2006 08:32 AM Page: 406 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Increased Insulin Resistance Report Source Product Role Manufacturer Route Dose Duration Health Geodon (Ziprasidone) PS 160 MG DAILY Professional Sertraline Hydrochloride C Date:09/22/03ISR Number: 4195409-8Report Type:Expedited (15-DaCompany Report #2003038261 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperreflexia Foreign Geodon (Ziprasidone) PS ORAL ORAL Initial or Prolonged Overdose Health Lisinopril(Lisinopri Other Professional l) C Company Drug, Unspecified C Representative Date:09/22/03ISR Number: 4195842-4Report Type:Expedited (15-DaCompany Report #2003025452 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Foreign Ziprasidone (Caps) Hypomania Health (Ziprasidone) PS ORAL 60 MG Partial Seizures Professional (DAILY), ORAL Company Representative Date:09/22/03ISR Number: 4196353-2Report Type:Expedited (15-DaCompany Report #2003028695 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abnormal Behaviour Foreign Zeldox (Capsules) Feeling Abnormal Health (Ziprasidone) PS ORAL 120 MG, ORAL Sleep Walking Professional Haloperidol Company (Haloperidol) C Representative Biperiden Hydrochloride (Biperiden Hydrochloride) C All Other Therapeutic Products C Date:09/23/03ISR Number: 4197215-7Report Type:Expedited (15-DaCompany Report #2003038541 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Consumer Geodon (Ziprasidone) PS ORAL 120 MG (BID), Initial or Prolonged Condition Aggravated ORAL Confusional State Bupropion Depression Hydrochloride Hypertrophy Breast (Bupropion Menstruation Irregular Hydrochloride) C Night Sweats Fluoxetine Hydrochloride (Fluoxetine Hydrochloride) C Venlafaxine 22-Feb-2006 08:32 AM Page: 407 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride (Venlafaxine Hydrochloride) C Date:09/24/03ISR Number: 4198211-6Report Type:Expedited (15-DaCompany Report #2003038491 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Health Geodon (Ziprasidone) PS ORAL 120 MG BID Initial or Prolonged Corrected Interval Professional ORAL Other Prolonged Company Salbutamol Myocardial Infarction Representative (Salbutamol) SS ORAL 200 PUFF(S), ORAL Date:09/24/03ISR Number: 4198214-1Report Type:Expedited (15-DaCompany Report #2003035165 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Geodon (Ziprasidone) PS ORAL 160MG DAILY Other Circulatory Collapse Professional ORAL Dysstasia Company Benzatropine Loss Of Consciousness Representative Mesilate C Myocardial Infarction Haloperidol Urinary Incontinence Decanoate C Ventricular Fibrillation Date:09/24/03ISR Number: 4198274-8Report Type:Expedited (15-DaCompany Report #2003018079 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Conversion Disorder Health Geodon (Ziprasidone) PS Initial or Prolonged Dysphemia Professional Zoloft (Sertraline Fall Company Hydrochloride) Syncope Representative (Sertraline) C Date:09/24/03ISR Number: 4198368-7Report Type:Expedited (15-DaCompany Report #2003038614 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Angioneurotic Oedema Foreign Zeldox (Capsules) Initial or Prolonged Health (Ziprasidone) PS ORAL 80 MG (BID), Professional ORAL Escitalopram C Quetiapine Fumarate C Date:09/24/03ISR Number: 4198369-9Report Type:Expedited (15-DaCompany Report #2003038622 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Foreign Zeldox (Capsules) Initial or Prolonged Condition Aggravated Consumer (Ziprasidone) PS 20 MG (DAILY) 2 YR Other Intervertebral Disc Protrusion 22-Feb-2006 08:32 AM Page: 408 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/24/03ISR Number: 4198394-8Report Type:Expedited (15-DaCompany Report #2003038635 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Geodon (Im) Health (Ziprasidone) PS INTRAMUSCULAR INTRAMUSCULAR Professional All Other Company Therapeutic Products C Representative Date:09/24/03ISR Number: 4198464-4Report Type:Expedited (15-DaCompany Report #2003034521 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Acute Myocardial Foreign Zeldox (Capsules) Hospitalization - Infarction Health (Ziprasidone) PS ORAL 160 MG (BID, Initial or Prolonged Cold Sweat Professional ORAL Other Confusional State Company Flupentixol Convulsion Representative Dihydrochloride Coronary Artery Stenosis (Flupentixol Disorientation Dihydrochloride) C Drug Withdrawal Syndrome Biperiden Extrapyramidal Disorder Hydrochloride Face Injury (Biperiden Flushing Hydrochloride) C Gastrointestinal Chlorprothixene Haemorrhage Hydrochloride General Physical Health (Chlorprothixene Deterioration Hydrochloride) C Haematoma Hyperhidrosis Loss Of Consciousness Mental Disorder Due To A General Medical Condition Neuroleptic Malignant Syndrome Oesophagitis Rhabdomyolysis Sinus Tachycardia Somnolence Tremor Urosepsis Date:09/25/03ISR Number: 4199559-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030904753 Age:39 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Topamax (Topiramate) PS ORAL ORAL Overdose Health Chloral Hydrate Professional (Chloral Hydrate) SS ORAL ORAL Distributor Ziprasidone (Ziprasidone) SS ORAL ORAL Date:09/25/03ISR Number: 4199602-XReport Type:Expedited (15-DaCompany Report #2003036824 Age:84 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Geodon (Ziprasidone) PS ORAL (PRN), ORAL Other 22-Feb-2006 08:32 AM Page: 409 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/25/03ISR Number: 4200373-9Report Type:Expedited (15-DaCompany Report #2003037574 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Lower Foreign Zeldox (Capsules) Initial or Prolonged Asthenia Health (Ziprasidone) PS ORAL 160 MG (BID), C-Reactive Protein Professional ORAL Increased Metformin Infection Hydrochloride Inflammation (Metformin Malaise Hydrochloride) C Pyrexia Glimepiride Tachycardia (Glimepiride) C Viral Infection Pipamperone Vomiting (Pipamperone) C Mirtazapine (Mirtazapine) C Tocopherol (Tocopherol) C Date:09/26/03ISR Number: 4197031-6Report Type:Direct Company Report #CTU 202658 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Geodon 10mg PS INTRAMUSCULAR 10MG Q2H Electrocardiogram Qrs INTRAMUSCULAR Complex Prolonged Levaquin 250mg SS INTRAVENOUS Electrocardiogram Qt DRIP 250MG Q 24H Corrected Interval INTRAVENOUS Prolonged DRIP Electrocardiogram Qt Prolonged Sinus Bradycardia Ventricular Extrasystoles Ventricular Tachycardia Date:09/26/03ISR Number: 4199464-0Report Type:Expedited (15-DaCompany Report #2003039106 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Geodon (Ziprasidone) PS Other Company Chlorpromazine Representative Hydrochloride C Date:09/26/03ISR Number: 4199470-6Report Type:Expedited (15-DaCompany Report #2003039031 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Health Geodon (Ziprasidone) PS ORAL 160 MG (BID), Syndrome Professional ORAL Company Antipsychotics C Representative 22-Feb-2006 08:32 AM Page: 410 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/26/03ISR Number: 4199473-1Report Type:Expedited (15-DaCompany Report #2003039025 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bruxism Consumer Geodon (Ziprasidone) PS ORAL 120 MG (BID), Dementia Alzheimer'S Type ORAL Dyskinesia Atenolol (Atenolol) C Gingival Bleeding Fosinopril Sodium (Fosinopril Sodium) C Date:09/29/03ISR Number: 4197199-1Report Type:Direct Company Report #CTU 202775 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Geodon PS Date:09/29/03ISR Number: 4201720-4Report Type:Expedited (15-DaCompany Report #2003039028 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Discomfort Foreign Zeldox (Capsules) Initial or Prolonged Infarction Health (Ziprasidone) PS ORAL 40 MG ORAL Other Professional Haloperidol (Haloperidol) C Biperiden (Biperiden) C Date:09/29/03ISR Number: 4201729-0Report Type:Expedited (15-DaCompany Report #2003038635 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Geodon (Im) Extrapyramidal Disorder Health (Ziprasidone) PS INTRAMUSCULAR 40 MG (BID), Somnolence Professional INTRAMUSCULAR Company Representative Date:09/30/03ISR Number: 4203016-3Report Type:Expedited (15-DaCompany Report #2003039279 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Geodon (Im) Hospitalization - Professional (Ziprasidone) PS INTRAMUSCULAR INTRAMUSCULAR Initial or Prolonged Date:09/30/03ISR Number: 4203018-7Report Type:Expedited (15-DaCompany Report #2003036047 Age:50 YR Gender:Male I/FU:F Outcome PT Death Arteriosclerosis Life-Threatening Bradycardia Other Cardiomegaly Chest Pain Cyanosis Dilatation Ventricular Dyspnoea Embolism 22-Feb-2006 08:32 AM Page: 411 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Obstruction Pain In Extremity Sudden Death Report Source Product Role Manufacturer Route Dose Duration Health Geodon (Ziprasidone) PS 60 MG (DAILY) Professional All Other Company Therapeutic Products C Representative Alprazolam (Alprazolam) C Bupropion (Bupropion) C Topiramate (Topiramate) C Valproate Semisodium (Valproate Semisodium) C Atorvastatin (Atorvastatin) C Vicodin (Paracetamol, Hydrocodone Bitartrate) C Propanolol (Propranolol) C Nadolol (Nadolol) C Tiagabine Hydrochloride (Tiagabine Hydrochloried) C Date:10/01/03ISR Number: 4204015-8Report Type:Expedited (15-DaCompany Report #2003039988 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Geodon (Ziprasidone) PS ORAL 80 MG Health (DAILY), ORAL Professional Date:10/02/03ISR Number: 4204209-1Report Type:Expedited (15-DaCompany Report #2003039994 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Foreign Zoloft (Sertraline) PS ORAL ORAL Initial or Prolonged Heart Rate Increased Health Zeldox (Im) Hypertension Professional (Ziprasidone) SS INTRAMUSCULAR 20 MG (DAILY) Neuroleptic Malignant INTRAMUSCULAR Syndrome Psychotic Disorder Pyrexia Date:10/02/03ISR Number: 4204278-9Report Type:Expedited (15-DaCompany Report #2003039620 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Foreign Zeldox (Im) Initial or Prolonged Fall Consumer (Ziprasidone) PS INTRAMUSCULAR 40 MG (BID), Other Feeling Abnormal INTRAMUSCULAR Humerus Fracture Flupentixol Dihydrochloride 22-Feb-2006 08:32 AM Page: 412 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Flupentixol Dihydrochloride) C Date:10/03/03ISR Number: 4204584-8Report Type:Expedited (15-DaCompany Report #2003039840 Age:39 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Ziprasidone (Caps) Overdose Health (Ziprasidone) PS ORAL ORAL Professional Topiramate (Topiramate) SS ORAL ORAL Chloral Hydrate (Chloral Hydrate) SS ORAL ORAL All Other Therapeutic Products SS ORAL ORAL Date:10/03/03ISR Number: 4204586-1Report Type:Expedited (15-DaCompany Report #2003039904 Age:47 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Ziprasidone (Caps) Other Completed Suicide Health (Ziprasidone) PS Overdose Professional Fluoxetine (Fluoxetine) SS Clonazepam (Clonazepam) SS Date:10/03/03ISR Number: 4204731-8Report Type:Expedited (15-DaCompany Report #2003040444 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Coma Health Geodon (Ziprasidone) PS ORAL 160 MG, ORAL Neuroleptic Malignant Professional Topiramate Syndrome Company (Topiramate) C Representative Fluoxetine Hydrochloride (Fluoxetine Hydrochloride) C Aripiprazole (Aripiprazole) C Date:10/03/03ISR Number: 4204733-1Report Type:Expedited (15-DaCompany Report #2003036173 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Consumer Geodon (Ziprasidone) PS ORAL 400 MG, ORAL Initial or Prolonged Disturbance In Attention Fluoxetine Other Dizziness Hydrochloride Feeling Abnormal (Fluoxetine Headache Hydrochloride) SS Overdose Paraesthesia Somnolence Thinking Abnormal 22-Feb-2006 08:32 AM Page: 413 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/03/03ISR Number: 4206021-6Report Type:Expedited (15-DaCompany Report #2003039952 Age:24 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Ziprasidone (Caps) Overdose Health (Ziprasidone) PS Professional Amlodipine (Amlodipine) SS Date:10/06/03ISR Number: 4204967-6Report Type:Expedited (15-DaCompany Report #2003033453 Age:36 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Spontaneous Health Geodon (Ziprasidone) PS ORAL 160 MG (BID), Complications Of Maternal Professional ORAL Exposure To Therapeutic Gabapentin Drugs (Gabapentin) C Maternal Drugs Affecting Oxcarbazepine Foetus (Oxcarbazepine) C Unintended Pregnancy Escitalopram (Escitalopram) C Date:10/06/03ISR Number: 4204998-6Report Type:Expedited (15-DaCompany Report #2003039950 Age:31 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Ziprasidone (Caps) Health (Ziprasidone) PS Professional Olanzapine (Olanzapine) SS Acetylsalicylic Acid (Acetylsalicylic Acid) SS Date:10/06/03ISR Number: 4205018-XReport Type:Expedited (15-DaCompany Report #2003039953 Age:38 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Ziprasidone (Caps) Other Completed Suicide Health (Ziprasidone) PS ORAL ORAL Professional Paroxetine (Paroxetine) SS ORAL ORAL Methadone (Methadone) SS ORAL ORAL All Other Therapeutic Products SS ORAL ORAL Date:10/06/03ISR Number: 4205035-XReport Type:Expedited (15-DaCompany Report #2003040340 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Benign Intracranial Health Geodon (Ziprasidone) PS Initial or Prolonged Hypertension Professional Other Company Representative 22-Feb-2006 08:32 AM Page: 414 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/06/03ISR Number: 4205617-5Report Type:Expedited (15-DaCompany Report #2003040562 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukaemia Health Geodon (Ziprasidone) PS ORAL 40 MG White Blood Cell Count Professional (BID),ORAL Decreased Date:10/06/03ISR Number: 4205714-4Report Type:Expedited (15-DaCompany Report #2003039954 Age:42 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Ziprasidone (Caps) Multiple Drug Overdose Health (Ziprasidone) PS Professional Quetiapine (Quetiapine) SS Date:10/06/03ISR Number: 4205715-6Report Type:Expedited (15-DaCompany Report #2003039698 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Amlodipine Overdose Health (Amlodipine) PS ORAL ORAL Professional Ziprasidone (Caps) (Ziprasidone) SS ORAL ORAL Verapamil (Verapamil) SS ORAL ORAL Date:10/06/03ISR Number: 4205717-XReport Type:Expedited (15-DaCompany Report #2003039927 Age:43 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Ziprasidone (Caps) Overdose Health (Ziprasidone) PS Professional Verapamil (Verapamil) SS Clonazepam (Clonazepam) SS All Other Therapeutic Products SS Date:10/07/03ISR Number: 4206708-5Report Type:Expedited (15-DaCompany Report #2003178751US Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Calan (Verapamil) Intentional Overdose Health Tablet PS ORAL ORAL Professional Amlodipine (Amlodipine) Tablet SS ORAL ORAL Ziprasidone (Ziprasidone) SS ORAL ORAL 22-Feb-2006 08:32 AM Page: 415 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/07/03ISR Number: 4206798-XReport Type:Expedited (15-DaCompany Report #2003036047 Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Adrenal Disorder Health Geodon (Ziprasidone) PS ORAL 60 MG, Other Aortic Atherosclerosis Professional (DAILY), ORAL Aortic Occlusion Company Valproate Semisodium Arteriosclerosis Representative (Valproate Blood Pressure Abnormal Semisodium) SS Blood Pressure Decreased All Other Bradycardia Therapeutic Products C Bundle Branch Block Alprazolam Bundle Branch Block Left (Alprazolam) C Cardiac Arrest Vicodin Cardiomegaly (Paracetamol, Chest Pain Hydrocodone Coma Bitartrate) C Coronary Artery Disease Nadolol (Nadolol) C Cyanosis Zaleplon (Zaleplon) C Dyspnoea Tiagabine Embolism Hydrochloride Emphysema (Tiagabine Feeling Cold Hydrochloride) C Heart Rate Irregular Propranolol Hepatic Congestion (Propranolol) C Hyperhidrosis Atorvastatin Lymphadenopathy (Atorvastatin) C Pain In Extremity Bupropion Pancreatic Disorder (Bupropion) C Pulmonary Fibrosis Topiramate Pulse Absent (Topiramate) C Respiratory Distress Respiratory Rate Increased Spleen Congestion Sudden Death Tremor Date:10/07/03ISR Number: 4206886-8Report Type:Expedited (15-DaCompany Report #2003040874 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Death Health Geodon (Im) Professional (Ziprasidone) PS INTRAMUSCULAR 20 MG Company (DAILY), Representative INTRAMUSCULAR Date:10/07/03ISR Number: 4207426-XReport Type:Expedited (15-DaCompany Report #2003178857US Age:43 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Calan (Verapamil) Intentional Overdose Health Tablet PS ORAL ORAL Professional Solfidin (Clonazepam) Tablet SS ORAL ORAL Ziprasidone (Ziprasidone) SS ORAL ORAL 22-Feb-2006 08:32 AM Page: 416 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/08/03ISR Number: 4207745-7Report Type:Expedited (15-DaCompany Report #2003039204 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Decreased Appetite Foreign Ziprasidone (Caps) Initial or Prolonged Delusion Study (Ziprasidone) PS INTRAMUSCULAR 20 MG (BID), Disinhibition Health INTRAMUSCULAR Drug Ineffective Professional Delorazepam C Euphoric Mood Clozapine C Mania Date:10/10/03ISR Number: 4208760-XReport Type:Expedited (15-DaCompany Report #2003041382 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaesthetic Complication Health Geodon (Ziprasidone) PS ORAL 120 MG (BID), Cardiac Arrest Professional ORAL Electrocardiogram Company Sertraline Abnormal Representative Hydrochloride (Sertraline Hydrochloride) C Lorazepam (Lorazepam) C Ranitidine Hydrochloride (Ranitidine Hydrochloride) C Date:10/14/03ISR Number: 4209457-2Report Type:Expedited (15-DaCompany Report #2003031221 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Health Geodon (Ziprasidone) PS ORAL ORAL Initial or Prolonged Professional All Other Other Company Therapeutic Products SS Representative Date:10/14/03ISR Number: 4209461-4Report Type:Expedited (15-DaCompany Report #2003034801 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetic Hyperglycaemic Health Geodon (Ziprasidone) PS ORAL 10 MG Hospitalization - Coma Professional (DAILY), ORAL Initial or Prolonged Company Lithium (Lithium) Representative (Lithium) SS ORAL 900 MG (BID), ORAL Bupropion Hyrochloride (Bupropion Hydrochloride) C Anti-Diabetics C Date:10/14/03ISR Number: 4209462-6Report Type:Expedited (15-DaCompany Report #2003005472 Age:25 YR Gender:Male I/FU:F Outcome PT Death Atrial Septal Defect Acquired 22-Feb-2006 08:32 AM Page: 417 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Cardiac Arrest Report Source Product Role Manufacturer Route Dose Duration Health Geodon (Im) Professional Ziprasidone) PS INTRAMUSCULAR 20 MG (ONE Company DOSE), Representative INTRAMUSCULAR Date:10/14/03ISR Number: 4209464-XReport Type:Expedited (15-DaCompany Report #2003034238 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Geodon (Ziprasidone) PS 120 MG (BID) Initial or Prolonged Hepatitis Acute /EIGHT MONTHS Other Suicidal Ideation Sertraline Hydrochloride (Sertraline Hydrochloride) C Olanzapine (Olanzapine) C Date:10/14/03ISR Number: 4209711-4Report Type:Expedited (15-DaCompany Report #2003041589 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Rash Health Geodon (Ziprasidone) PS ORAL ORAL Initial or Prolonged Professional Company Representative Date:10/14/03ISR Number: 4210140-8Report Type:Expedited (15-DaCompany Report #2003038261 Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Foreign Geodon (Ziprasidone) PS ORAL 140 MG (BID), Initial or Prolonged Hyperreflexia Health ORAL Other Intentional Overdose Professional Lisinopril Company (Lisinopril) C Representative Drug C Zopiclone (Zopiclone) C Date:10/15/03ISR Number: 4210832-0Report Type:Expedited (15-DaCompany Report #2003033020 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cyanopsia Consumer Geodon (Ziprasidone) PS ORAL ORAL Initial or Prolonged Erythema Of Eyelid All Other Hallucination, Auditory Therapeutic Products C Tremor 22-Feb-2006 08:32 AM Page: 418 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/15/03ISR Number: 4211139-8Report Type:Expedited (15-DaCompany Report #2003110101 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Geodon (Ziprasidone) PS Professional Date:10/15/03ISR Number: 4211145-3Report Type:Expedited (15-DaCompany Report #2003035873 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alopecia Consumer Geodon (Ziprasidone) PS ORAL 20 MG Initial or Prolonged Depression Health (DAILY), ORAL Feeling Abnormal Professional Lipitor Insomnia (Atorvastatin) SS ORAL 20 MG Palpitations (DAILY), ORAL Photosensitivity Reaction All Other Temperature Intolerance Therapeutic Products SS Weight Increased Calcitonin, Salmon (Calcitonin, Salmon) C Omeprazole 9omeprazole) C Lorazepam (Lorazepam) C Vitamins C Chloral Hydrate (Chloral Hydrate) C Zolpidem Tartrate (Zolpidem Tartrate) C Date:10/15/03ISR Number: 4211164-7Report Type:Expedited (15-DaCompany Report #2003037011 Age:7 DY Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hypocalcaemia Health Geodon (Ziprasidone) PS ORAL ORAL Hospitalization - Maternal Drugs Affecting Professional Benzatropine Initial or Prolonged Foetus Mesilate Other Neonatal Apnoeic Attack (Benzatropine Neonatal Disorder Mesilate) C Diazepam (Diazepam) C Date:10/15/03ISR Number: 4211633-XReport Type:Expedited (15-DaCompany Report #2003109984 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Congenital Anomaly Foreign Zeldox (Capsules) Drug Exposure During Health (Ziprasidone) PS Pregnancy Professional Company Representative Date:10/15/03ISR Number: 4211749-8Report Type:Expedited (15-DaCompany Report #2003018220 Age:20 YR Gender:Female I/FU:F Outcome PT Hospitalization - Blood Creatine Initial or Prolonged Phosphokinase Increased Other Convulsion 22-Feb-2006 08:32 AM Page: 419 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Drug Interaction Potentiation Electrocardiogram Qrs Report Source Product Role Manufacturer Route Dose Duration Complex Shortened Health Geodon (Ziprasidone) PS ORAL 3.36 GRAM, Hypoxia Professional ORAL Intentional Overdose Quetiapine Fumarate Pneumonia Aspiration (Quetiapine Ventricular Tachycardia Fumarate) SS 12 GRAM Lithium (Lithium) SS Date:10/16/03ISR Number: 4211709-7Report Type:Expedited (15-DaCompany Report #2003110260 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pulmonary Embolism Foreign Geodon (Ziprasidone) PS ORAL 120 MG (TID) Initial or Prolonged Health ORAL Professional Company Representative Date:10/17/03ISR Number: 4210622-9Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0424117A Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Lamictal PS Glaxosmithkline ORAL 150MG Three Flight Of Ideas times per day 52 WK Hypervigilance Geodon SS ORAL 20MG Twice Mania per day Date:10/17/03ISR Number: 4214588-7Report Type:Expedited (15-DaCompany Report #2003036169 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Potassium Decreased Health Geodon (Ziprasidone) PS ORAL 80 MG (BID), Initial or Prolonged Chest Pain Professional ORAL Dizziness Company Furosemide Hallucination Representative (Furosemide) SS Palpitations Tachycardia Date:10/17/03ISR Number: 4217801-5Report Type:Periodic Company Report #2003031425 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tachycardia Health Geodon (Im) Professional (Ziprasidone) PS INTRAMUSCULAR 20 MG, Company INTRAMUSCULAR Representative All Other Therapeutic Products C Date:10/20/03ISR Number: 4214683-2Report Type:Expedited (15-DaCompany Report #2003110348 Age:38 YR Gender:Female I/FU:I Outcome Hospitalization - Initial or Prolonged 22-Feb-2006 08:32 AM Page: 420 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other PT Report Source Product Role Manufacturer Route Dose Duration Chest Pain Consumer Geodon (Ziprasidone) PS ORAL 60 MG (BID), Drug Withdrawal Syndrome ORAL Loss Of Consciousness Hydromorphone Pyrexia Hydrochloride Screaming (Hydromorphone Urinary Tract Infection Hydrochloride) SS (PRN) White Blood Cell Count Clonidine Increased (Clonidine) SS Lorazepam (Lorazepam) C Diazepam (Diazepam) C Clonazepam (Clonazepam) C Lansoprazole (Lansoprazole) C Gabapentin (Gabapentin) C Carisoprodol (Carisoprodol) C Paracetamol (Paracetamol) C Acetylsalicylic Acid (Acetylsalicylic Acid) C Date:10/20/03ISR Number: 4214818-1Report Type:Expedited (15-DaCompany Report #2003030892 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Overdose Foreign Ziprasidone (Caps) Initial or Prolonged Miosis Health (Ziprasidone) PS ORAL 160 MG (BID), Other Mydriasis Professional ORAL Restlessness Zuclopenthixol Suicide Attempt (Zuclopenthixol) C Clonazepam (Clonazepam) C Alprazolam (Alprazolam) C Sertraline (Sertraline) C Date:10/20/03ISR Number: 4214820-XReport Type:Expedited (15-DaCompany Report #2003039620 Age:59 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Foreign Zeldox (Im) Initial or Prolonged Fall Consumer (Ziprasidone) PS INTRAMUSCULAR 40 MG (BID), Other Feeling Abnormal INTRAMUSCULAR Humerus Fracture Flupentixol Dihydrochloride (Flupentixol Dihydrochloride) C 22-Feb-2006 08:32 AM Page: 421 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/21/03ISR Number: 4215515-9Report Type:Direct Company Report #CTU 204244 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dysarthria Geodon PS 20 MG QAM 80 Initial or Prolonged Dysphagia MG QHS Dyspnoea Seroquel SS QHS Muscle Twitching Prevacid C Tongue Disorder Albuterol C Date:10/21/03ISR Number: 4215700-6Report Type:Expedited (15-DaCompany Report #2003005472 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Geodon (Im) Hypertrophic Professional (Ziprasidone) PS INTRAVENOUS 20 MG (ONE Cardiomyopathy Company DOSE), Patient Restraint Representative INTRAVENOUS Date:10/21/03ISR Number: 4215745-6Report Type:Expedited (15-DaCompany Report #2003111189 Age:6 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Wolff-Parkinson-White Health Geodon (Ziprasidone) PS 20 MG (DAILY) Syndrome Professional Valproate Semisodium Company (Valproate Representative Semisodium) C Quetiapine Fumarate (Quetiapine Fumarate) C Guanfacine Hydrochloride (Guanfacine Hydrochloride) C Methylphenidate Hydrochloride (Methylphenidate Hydrochloride) C Date:10/22/03ISR Number: 4216652-5Report Type:Expedited (15-DaCompany Report #2003007927 Age:28 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Study Geodon (Ziprasidone) PS ORAL 100 MG BID Initial or Prolonged Agitation Health ORAL Bipolar Disorder Professional Risperidone C Irritability Clonazepam C Mania Mood Altered Schizoaffective Disorder Schizophrenia Date:10/22/03ISR Number: 4217652-1Report Type:Expedited (15-DaCompany Report #2003111371 Age: Gender:Male I/FU:I Outcome Hospitalization - Initial or Prolonged 22-Feb-2006 08:32 AM Page: 422 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other PT Report Source Product Role Manufacturer Route Dose Duration Suicidal Ideation Health Geodon (Ziprasidone) PS Professional Date:10/22/03ISR Number: 4217654-5Report Type:Expedited (15-DaCompany Report #2003111370 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicidal Ideation Health Geodon (Ziprasidone) PS Initial or Prolonged Professional Other Date:10/22/03ISR Number: 4217656-9Report Type:Expedited (15-DaCompany Report #2003111372 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depression Health Geodon (Ziprasidone) PS (BID) Hallucinations, Mixed Professional Valproate Semisodium Suicide Attempt (Valproate Semisodium) C Escitalopram (Escitalopram) C Date:10/23/03ISR Number: 4216615-XReport Type:Direct Company Report #CTU 204476 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Feeling Jittery Ziprasadone 20 Mg Intervention to Nervousness -Pfizer/Roerig PS Pfizer/Roerig ORAL 20 MG TID PO Prevent Permanent Impairment/Damage Date:10/24/03ISR Number: 4220035-1Report Type:Expedited (15-DaCompany Report #2003112452 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Health Geodon (Ziprasidone) PS Professional Citalopram Company Hydrobromide Representative (Citaloprim Hydrobromide) C Date:10/24/03ISR Number: 4220039-9Report Type:Expedited (15-DaCompany Report #2003111626 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Health Geodon (Ziprasidone) PS ORAL 20 MG Initial or Prolonged Homicidal Ideation Professional (DAILY), ORAL Other Psychotic Disorder Citalopram Treatment Noncompliance Hydrobromide (Citalopram Hydrobromide) C 22-Feb-2006 08:32 AM Page: 423 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/27/03ISR Number: 4221096-6Report Type:Expedited (15-DaCompany Report #2003112449 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Decreased Foreign Ziprasidone (Caps) Somnolence Consumer (Ziprasidone) PS ORAL 40 MG Syncope (DAILY), ORAL Date:10/27/03ISR Number: 4221103-0Report Type:Expedited (15-DaCompany Report #2003111758 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Back Pain Foreign Zeldox (Capsules) Initial or Prolonged Compartment Syndrome Health (Ziprasidone) PS Pain In Extremity Professional Ofloxacin Peroneal Nerve Palsy (Ofloxacin) C Rhabdomyolysis Metamizole Sodium (Metamizole Sodium) C Heparin-Fraction, Sodium Salt (Heparin-Fraction, Sodium) C Date:10/27/03ISR Number: 4221355-7Report Type:Expedited (15-DaCompany Report #2003111630 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Geodon (Ziprasidone) PS Professional Company Representative Date:10/27/03ISR Number: 4221358-2Report Type:Expedited (15-DaCompany Report #2003030763 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypersomnia Consumer Geodon (Ziprasidone) PS Initial or Prolonged Weight Decreased Donepezil Hydrochloride (Donepezil Hydrochloride) SS Date:10/27/03ISR Number: 4221362-4Report Type:Expedited (15-DaCompany Report #2003022824 Age:29 YR Gender:Male I/FU:F Outcome PT Hospitalization - Abdominal Distension Initial or Prolonged Aggression Other Delusion Drug Ineffective Dry Mouth Face Oedema Hostility Hypersomnia Irritability Liver Function Test Abnormal Local Swelling 22-Feb-2006 08:32 AM Page: 424 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Mania Muscle Disorder Rhinorrhoea Report Source Product Role Manufacturer Route Dose Duration Somnolence Consumer Geodon (Ziprasidone) PS ORAL 80 MG (QID), Thirst ORAL Citalopram Hydrobromide (Citalopram Hydrobromide) SS ORAL 20 MG (DAILY), ORAL Ursodeoxycholic Acid (Ursodeoxycholic Acid) C Date:10/28/03ISR Number: 4222944-6Report Type:Expedited (15-DaCompany Report #2003112431 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Disorder Consumer Geodon Chest Pain (Zirasidone) PS INTRAVENOUS INTRAVENOUS Dizziness Olanzapine Feeling Abnormal (Olanzapine) SS ORAL ORAL Medication Error Haloperidol Prostate Cancer (Haloperidol) C Weight Fluctuation Date:10/28/03ISR Number: 4222945-8Report Type:Expedited (15-DaCompany Report #2003040562 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Health Geodon Bone Marrow Disorder Professional (Ziprasidone) PS ORAL 40 MG (BID), Feeling Abnormal ORAL Leukaemia Lorazepam Lymphocyte Count (Lorazepam) C Neoplasm Malignant Bupropion Neutrophil Count Hydrochloride White Blood Cell Count (Bupropion Decreased Hydrochloride) C Obetrol C Olanzapine (Olanzapine) C Date:10/30/03ISR Number: 4224162-4Report Type:Expedited (15-DaCompany Report #2003113913 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Fibrillation Health Geodon (Im) Myopathy Professional (Ziprasidone) PS INTRAMUSCULAR INTRAMUSCULAR Parkinsonism Company Geodon (Ziprasidone) SS ORAL ORAL Representative Olanzapine (Olanzapine) C Diphenhydramine Hydrochloride (Diphenhydramine Hydrochloride) C 22-Feb-2006 08:32 AM Page: 425 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/30/03ISR Number: 4224166-1Report Type:Expedited (15-DaCompany Report #2003029612 Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bipolar Disorder Health Geodon (Ziprasidone) PS ORAL 60 MG (BID), Dizziness Professional ORAL Electrocardiogram Qt Company Sinequan (Doxepin) SS ORAL 275 MG Corrected Interval Representative (DAILY), ORAL Prolonged Venlafaxine Hydrochloride (Venlafaxine Hydrochloride) C Date:10/30/03ISR Number: 4224277-0Report Type:Expedited (15-DaCompany Report #2003113653 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Ziprasidone (Caps) Initial or Prolonged Delirium Health (Ziprasidone) PS ORAL 160 MG Suicide Attempt Professional (DAILY), ORAL Company Representative Date:10/30/03ISR Number: 4224279-4Report Type:Expedited (15-DaCompany Report #2003041536 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypomania Foreign Zeldox (Capsules) Initial or Prolonged Health (Ziprasidone) PS ORAL 40 MG Professional (DAILY), ORAL Company Citalopram Representative Hydrobromide (Citalopram Hydrobromide) C Perazine (Dimaleate (Perazine Dimaleate) C Date:10/31/03ISR Number: 4225429-6Report Type:Expedited (15-DaCompany Report #2003113870 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Akathisia Foreign Zeldox (Capsules) Drug Interaction Health (Ziprasidone) PS ORAL 80 MG, BID, Professional ORAL Clozapine SS ORAL 175 MG, ORAL Citalopram SS ORAL 40 MG, ORAL Date:11/04/03ISR Number: 4227076-9Report Type:Expedited (15-DaCompany Report #2003113977 Age:40 YR Gender:Male I/FU:I Outcome PT Hospitalization - Activated Partial Initial or Prolonged Thromboplastin Time Other Prolonged Atrial Fibrillation Atrial Flutter Constipation Haematochezia 22-Feb-2006 08:32 AM Page: 426 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report International Normalised Ratio Decreased Procedural Complication Report Source Product Role Manufacturer Route Dose Duration Prothrombin Time Health Geodon (Ziprasidone) PS ORAL 200 MG (BID), Prolonged Professional ORAL Allopurinol (Allopurinol) C Quetiapine (Quetiapine) C Fluvoxamine (Fluvoxamine) C Simvastatin (Simvastatin) C Date:11/04/03ISR Number: 4227198-2Report Type:Expedited (15-DaCompany Report #2003039028 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Zeldox (Capsules) Initial or Prolonged Phosphokinase Increased Health (Ziprasidone) PS ORAL 60 MG (BID), Blood Creatine Professional ORAL Phosphokinase Mb All Other Increased Therapeutic Products C C-Reactive Protein Haloperidol Increased (Haloperidol) C Chest Discomfort Biperiden Electrocardiogram Qt (Biperiden) C Prolonged Electrocardiogram St Segment Elevation Laboratory Test Abnormal Myocardial Infarction Troponin I Date:11/05/03ISR Number: 4228756-1Report Type:Expedited (15-DaCompany Report #2003114526 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Myocardial Infarction Foreign Zeldox (Capsules) Health (Ziprasidone) PS ORAL 120 MG (BID), Professional ORAL Venlafaxine Hydrochloride (Venlafaxine Hydrochloride) C Date:11/05/03ISR Number: 4228757-3Report Type:Expedited (15-DaCompany Report #2003039028 Age:37 YR Gender:Male I/FU:F Outcome PT Hospitalization - Blood Creatine Initial or Prolonged Phosphokinase Increased Blood Creatine Phosphokinase Mb Increased C-Reactive Protein Increased Electrocardiogram Q Wave 22-Feb-2006 08:32 AM Page: 427 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Abnormal Electrocardiogram St Segment Elevation Enzyme Abnormality Report Source Product Role Manufacturer Route Dose Duration Myocardial Infarction Foreign Zeldox (Capsules) Health (Ziprasidone) PS ORAL 60 MG (BID), Professional ORAL All Other Therapeutic Products C Haloperidol (Haloperidol) C Biperiden (Biperiden) C Date:11/05/03ISR Number: 4228902-XReport Type:Expedited (15-DaCompany Report #2003039988 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Geodon (Ziprasidone) PS ORAL 80 MG DAILY Other Health ORAL Professional Date:11/05/03ISR Number: 4229015-3Report Type:Expedited (15-DaCompany Report #2003036428 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grandiosity Health Geodon (Ziprasidone) PS ORAL 40 MG (BID), Initial or Prolonged Mania Professional ORAL Pressure Of Speech Company All Other Sleep Disorder Representative Therapeutic Products C Lithium (Lithium) C Haloperidol (Haloperidol) C Clonazepam (Clonazepam) C Date:11/06/03ISR Number: 4230457-0Report Type:Expedited (15-DaCompany Report #2003114592 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cholelithiasis Consumer Geodon (Ziprasidone) PS ORAL 80 MG (DAILY), ORAL Estradiol (Estradiol) C Alprazolam (Alprazolam) C Escitalopram (Escitalopram) C Obetrol (Dexamfetamine Sulfate, Amfetamine Sulfate, Dexamfetamine C 22-Feb-2006 08:32 AM Page: 428 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/07/03ISR Number: 4232041-1Report Type:Expedited (15-DaCompany Report #2003036699 Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatic Enzyme Increased Foreign Zeldox (Capsules) Initial or Prolonged Leukocytosis Health (Ziprasidone) PS ORAL 160 MG (BID), Other Neuroleptic Malignant Professional ORAL Syndrome Company Haloperidol Representative (Haloperidol) C Olanzapine (Olanzapine) C Reboxetine (Reboxetine) C Madopar (Levodopa, Benserazide Hydrochloride) C Date:11/07/03ISR Number: 4232313-0Report Type:Expedited (15-DaCompany Report #2003113977 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Activated Partial Health Geodon (Ziprasidone) PS ORAL 200 MG (BID), Initial or Prolonged Thromboplastin Time Professional ORAL Other Prolonged Allopurinol Atrial Fibrillation (Allopurinol) C Atrial Flutter Bupropion Constipation (Bupropion) C Haematochezia Quetiapine Prothrombin Time (Quetiapine) C Prolonged Fluvoxamine (Fluvoxamine) C Simvastatin (Simvastatin) C Date:11/10/03ISR Number: 4233766-4Report Type:Expedited (15-DaCompany Report #2003114571 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Consumer Geodon (Ziprasidone) PS ORAL ORAL Decreased Activity Depression Drug Withdrawal Syndrome Mental Disorder Visual Acuity Reduced Date:11/10/03ISR Number: 4233816-5Report Type:Expedited (15-DaCompany Report #2003034521 Age:36 YR Gender:Male I/FU:F Outcome PT Life-Threatening Acute Myocardial Hospitalization - Infarction Initial or Prolonged Computerised Tomogram Other Abnormal Confusional State Coronary Artery Stenosis Disorientation Drug Withdrawal Syndrome Electrocardiogram Abnormal 22-Feb-2006 08:32 AM Page: 429 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Electrocardiogram St Segment Elevation Extrapyramidal Disorder Report Source Product Role Manufacturer Route Dose Duration Flushing Foreign Zeldox (Capsules) Gastric Ulcer Haemorrhage Health (Ziprasidone) PS ORAL 160 MG (BID), Haematoma Professional ORAL Injury Company Haloperidol Limb Injury Representative (Haloperidol) SS Loss Of Consciousness Flupentixol Mental Disorder Due To A Dihydrochloride General Medical Condition (Flupentixol Myocardial Ischaemia Dihydrochloride) C Neck Injury Biperiden Neuroleptic Malignant Hydrochloride Syndrome (Biperiden Oesophagitis Hydrochloride) C Rhabdomyolysis Chlorprothixene Sinus Tachycardia Hydrochloride Somnolence (Chlorprothixene Tremor Hydrochloride) C Upper Gastrointestinal Haemorrhage Urosepsis Date:11/10/03ISR Number: 4234185-7Report Type:Expedited (15-DaCompany Report #2003114583 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Geodon (Ziprasidone) PS Professional Paroxetine Company Hydrochloride Representative (Paroxetine Hydrochloride) C Bupropion Hydrochloride (Bupropion Hydrochloride) C Date:11/10/03ISR Number: 4234308-XReport Type:Expedited (15-DaCompany Report #2003114693 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Consumer Geodon (Ziprasidone) PS 80 MG (BID), Initial or Prolonged Syndrome Health Haloperidol Other Professional (Haloperidol) (Haloperidol) SS Morphine (Morphine) SS Labetalol (Labetalol) SS Fluconazole (Fluconazole) C Ceftriaxone Sodium (Ceftriaxone Sodium) C Salbutamol (Salbutamol) C Heparin (Heparin) C Azelastine Hydrochloride (Azelastine 22-Feb-2006 08:32 AM Page: 430 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) C Fluticasone Propionate (Fluticasone Propionate) C Jevity (Potassium Bicarbonate, Potassium Bitartrate, Soya Oil, Corn Oil, C Clonidine Hydrochloride (Clonidine Hydrochloride) C Lansoprazole (Lansoprazole) C Phenytoin Sodium (Phenytoin Sodium) C Chlordiazepoxide (Chlordiazepoxide) C Oxybutynin (Oxybutynin) C Diphenhydramine Hydrochloride (Diphenhydramine Hydrochloride) C Nystatin (Nystatin) C Tetracycline (Tetracycline) C Water (Water) C Date:11/10/03ISR Number: 4234434-5Report Type:Expedited (15-DaCompany Report #2003114986 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Foreign Zeldox (Casules) Initial or Prolonged Fall Health (Ziprasidone) PS ORAL ORAL Gait Disturbance Professional Muscle Strain Company Urinary Incontinence Representative Urinary Tract Disorder Date:11/12/03ISR Number: 4235126-9Report Type:Expedited (15-DaCompany Report #2003115539 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Foreign Zeldox (Capsules) Initial or Prolonged Consciousness Health (Ziprasidone) PS 160 MG (BID) Electroencephalogram Professional Abnormal Company Loss Of Consciousness Representative Psychomotor Retardation Somnolence 22-Feb-2006 08:32 AM Page: 431 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/13/03ISR Number: 4235749-7Report Type:Expedited (15-DaCompany Report #2003112452 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Health Geodon (Ziprasidone) PS ORAL 140 MG (TID), Anger Professional ORAL Delusion Company Valproate Semisodium Hallucination Representative (Valproate Imprisonment Semisodium) SS ORAL 500 MG (DAILY), ORAL Date:11/13/03ISR Number: 4235754-0Report Type:Expedited (15-DaCompany Report #2003031492 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Health Geodon (Ziprasidone) PS ORAL 80 MG (BID), Drug Interaction Professional ORAL Electrocardiogram Qt Doxepin (Caps) Corrected Interval (Doxepin) SS ORAL ORAL Prolonged Dyazide Sinusitis (Hydrochlorothiazide Sleep Apnoea Syndrome , Triamterene) C Somnolence Probucol C Date:11/13/03ISR Number: 4235758-8Report Type:Expedited (15-DaCompany Report #2003116181 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Geodon (Im) Other Professional (Ziprasidone) PS INTRAMUSCULAR INTRAMUSCULAR Company All Other Representative Therapeutic Products C Date:11/13/03ISR Number: 4235975-7Report Type:Expedited (15-DaCompany Report #2003115719 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Polytraumatism Foreign Zeldox (Capsules) Hospitalization - Suicide Attempt Health (Ziprasidone) PS ORAL 240 MG, ORAL Initial or Prolonged Professional Lorazepam Company (Lorazepam) SS 0.5 MG Representative Haloperidol (Haloperidol) C Prothipendyl Hydrochloride(Prothi pendyl Hydrochloride) C Date:11/13/03ISR Number: 4235997-6Report Type:Expedited (15-DaCompany Report #2003111758 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Compartment Syndrome Foreign Zeldox (Capsules) Initial or Prolonged Disease Recurrence Health (Ziprasidone) PS Paresis Professional Ofloxacin Psychotic Disorder Company (Ofloxacin) C Rhabdomyolysis Representative Metamizole Sodium (Metamizole Sodium) C 22-Feb-2006 08:32 AM Page: 432 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Heparin-Fraction, Sodium Salt (Heparin-Fraction, Sodium Salt) C Date:11/14/03ISR Number: 4236215-5Report Type:Expedited (15-DaCompany Report #2003035153 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Carbon Monoxide Poisoning Consumer Geodon (Ziprasidone) PS ORAL ORAL Life-Threatening Completed Suicide Lithium (Lithium) SS Drug Effect Decreased Citalopram Lethargy Hydrobromide (Citalopram Hydrobromide) SS ORAL ORAL Lorazepam (Lorazepam) SS ORAL ORAL Olanzapine (Olanzapine) C Date:11/17/03ISR Number: 4237178-9Report Type:Expedited (15-DaCompany Report #2003116649 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Foreign Zeldox (Capsules) Phosphokinase Increased Health (Ziprasidone) PS 160 MG Blood Lactate Professional Olanzapine Dehydrogenase Increased (Olanzapine) C Hepatic Enzyme Increased Leukocytosis Neuroleptic Malignant Syndrome Date:11/17/03ISR Number: 4237183-2Report Type:Expedited (15-DaCompany Report #2003037077 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Foreign Ziprasidone (Caps) Other Myocardial Infarction Health (Ziprasidone) PS ORAL 120 MG (BID), Sudden Death Professional ORAL Company Representative Date:11/17/03ISR Number: 4237190-XReport Type:Expedited (15-DaCompany Report #2003116678 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Foreign Zeldox (Capsules) Initial or Prolonged Tachycardia Health (Ziprasidone) PS ORAL ORAL Ventricular Extrasystoles Professional 22-Feb-2006 08:32 AM Page: 433 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/17/03ISR Number: 4237248-5Report Type:Expedited (15-DaCompany Report #2003113913 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Fibrillation Health Geodon (Im) Myopathy Professional (Ziprasidone) PS INTRAMUSCULAR INTRAMUSCULAR Parkinsonism Company Geodon (Ziprasidone) SS ORAL ORAL Representative Olanzapine (Olanzapine) C Diphenhydramine Hydrochloride (Diphenhydramine Hydrochloride) C C Date:11/17/03ISR Number: 4237252-7Report Type:Expedited (15-DaCompany Report #2003112981 Age:17 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Consumer Zoloft (Sertaline) PS ORAL 50 MG Initial or Prolonged Anhedonia (DAILY), ORAL Other Anxiety Geodon (Ziprasidone) SS Asthenia Olanzapine Chest Discomfort (Olanzapine) C Depressed Mood Dyspnoea Fear Feeling Abnormal Injury Listless Liver Disorder Memory Impairment Middle Insomnia Panic Attack Schizophrenia Somnolence Suicidal Ideation Tremor Weight Decreased Date:11/17/03ISR Number: 4237275-8Report Type:Expedited (15-DaCompany Report #2003033052 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination, Auditory Consumer Geodon (Ziprasidone) PS ORAL ORAL Initial or Prolonged Influenza Like Illness Health Olanzapine Oral Intake Reduced Professional (Olanzapine) C Rash Self-Injurious Ideation Tremor Visual Disturbance Date:11/18/03ISR Number: 4236839-5Report Type:Direct Company Report #CTU 206319E Age:42 YR Gender: I/FU:I Outcome PT Hospitalization - Blood Creatine Initial or Prolonged Phosphokinase Increased Hypotension Lethargy 22-Feb-2006 08:32 AM Page: 434 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Muscle Rigidity Musculoskeletal Stiffness Neuroleptic Malignant Report Source Product Role Manufacturer Route Dose Duration Syndrome Ziprasidone -Geodon- Pyrexia 80 Mg Pfizer PS Pfizer ORAL 80 MG BID Renal Failure Acute ORAL Renal Impairment Klonopin C Tachycardia Cogentin C Depakote C Lisinopril C Pantoprazole C Bactrim Ds C Date:11/18/03ISR Number: 4237611-2Report Type:Expedited (15-DaCompany Report #2003116749 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Adrenal Adenoma Health Geodon (Ziprasidone) PS ORAL 60 MG Initial or Prolonged Depression Professional (DAILY), ORAL Other Disease Recurrence Zoloft (Sertraline) SS ORAL 200 MG Drug Ineffective (DAILY), ORAL Hepatic Steatosis Clonazepam Pancreatitis (Clonazepam) C Treatment Noncompliance Ezetimibe White Blood Cell Count (Ezetimibe) C Increased Insulin (Insulin) C Insulin Injection, Isophane (Insulin Injection, Isophane) C Captopril (Captopril) C Pantoprazole (Pantoprazole) C Date:11/18/03ISR Number: 4237613-6Report Type:Expedited (15-DaCompany Report #2003117120 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Electrocardiogram Qt Health Geodon (Ziprasidone) PS Hospitalization - Corrected Interval Professional Initial or Prolonged Prolonged Company Other Representative Date:11/19/03ISR Number: 4238673-9Report Type:Expedited (15-DaCompany Report #2003035576 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Ziprasidone (Caps) Other Health (Ziprasidone) PS ORAL 40 MG (BID), Professional ORAL Atenolol (Atenolol) C 22-Feb-2006 08:32 AM Page: 435 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/19/03ISR Number: 4238833-7Report Type:Expedited (15-DaCompany Report #2003-03847 Age:43 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Literature Clonazepam (Watson Health Laboratories)(Clonaz Professional epam) Tablet PS Verapamil (Watson Laboratories) (Verapamil Hydrochloride) Unknown SS Ziprasidone (Ziprasidone) SS Date:11/19/03ISR Number: 4239173-2Report Type:Expedited (15-DaCompany Report #2003005472 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Geodon (Im) Cardiac Disorder Professional (Ziprasidone) PS INTRAMUSCULAR 20 MG (ONE Hypertrophic Obstructive Company DOSE), Cardiomyopathy Representative INTRAMUSCULAR Date:11/19/03ISR Number: 4239196-3Report Type:Expedited (15-DaCompany Report #2003117176 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutrophil Count Health Geodon (Ziprasidone) PS 80 MG (BID) Decreased Professional Date:11/19/03ISR Number: 4239405-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030703153 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Generalised Oedema Health Risperdal Professional (Risperidone) Company Unspecified PS ORAL ORAL Representative Geodon (Ziprasidone Hydrochoride) SS ORAL ORAL Celebrex (Celecoxib) C Hctz (Hydrochlorotiazide) C Effexor (Venlafaxine Hydrochloride) C Serzone (Nefazodone Hydrochloride) C Date:11/19/03ISR Number: 4239433-5Report Type:Expedited (15-DaCompany Report #2003UW14976 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Health Seroquel PS Decreased Professional Geodon SS 22-Feb-2006 08:32 AM Page: 436 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/20/03ISR Number: 4239492-XReport Type:Expedited (15-DaCompany Report #2003-03945 Age:50 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Literature Verapamil (Watson Health Laboratories)(Verapa Professional mil Hydrochloride) Unknown PS Watson Laboratories Amlodipine (Amlodipine) SS Ziprasidone (Ziprasidone) SS Date:11/24/03ISR Number: 4240522-XReport Type:Direct Company Report #CTU 206731 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Sodium Decreased Geodon 80 Mg Tabs Intervention to Pfizer PS Pfizer ORAL 80 MG BID Prevent Permanent ORAL Impairment/Damage Lithobid C Date:11/24/03ISR Number: 4241232-5Report Type:Expedited (15-DaCompany Report #2003117606 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Consumer Geodon (Ziprasidone) PS ORAL 160 MG (BID), Initial or Prolonged Depression ORAL Other Euphoric Mood Paroxetine Fatigue Hydrochloride Feeling Abnormal (Paroxetine Malabsorption Hydrochloride) C Mania Lamotrigine Schizoaffective Disorder (Lamotrigine) C Sleep Attacks Benzatropine Somnolence Mesilate (Benzatropine Mesilate) C Cilest (Ethinylestradiol, Norgestimate) C Date:11/24/03ISR Number: 4241233-7Report Type:Expedited (15-DaCompany Report #2003117480 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Convulsion Foreign Ziprasidone (Caps) Hospitalization - Respiratory Arrest Health (Ziprasidone) PS ORAL 40 MG Initial or Prolonged Professional (DAILY), ORAL Company Venlafaxine Representative (Venlafaxine) C Clorazepate Dipotassium (Clorazepate Dipotassium) C 22-Feb-2006 08:32 AM Page: 437 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/03ISR Number: 4241672-4Report Type:Expedited (15-DaCompany Report #2003118285 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Geodon (Im) Other Professional (Ziprasidone) PS INTRAMUSCULAR 10 MG, Company INTRAMUSCULAR Representative Date:11/24/03ISR Number: 4241735-3Report Type:Expedited (15-DaCompany Report #2003117607 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Consumer Geodon (Ziprasidone) PS ORAL 60 MG Initial or Prolonged Suicide Attempt (DAILY), ORAL Other Topiramate (Topiramate) C Fluoxetine Hydrochloride (Fluoxetine Hydrochloride) C Bupropion Hydrochloride (Bupropion Hydrochloride) C Clonazepam (Clonazepam) C Trazodone (Trazodone) C Salbutamol (Salbutamol) C Date:11/24/03ISR Number: 4241756-0Report Type:Expedited (15-DaCompany Report #2003117724 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Decreased Foreign Zeldox (Capsules) Initial or Prolonged Dizziness Health (Ziprasidone) PS ORAL 40 MG (BID), Disability Drug Ineffective Professional ORAL Drug Interaction Risperidone Feeling Abnormal (Risperidone) SS ORAL 0.75 MG Headache (DAILY), ORAL Syncope Mirtazapine Treatment Noncompliance (Mirtazapine) C Weight Increased Date:11/25/03ISR Number: 4242120-0Report Type:Expedited (15-DaCompany Report #2003-03831 Age:47 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Clonazepam (Watson Health Laboratories) Professional (Clonazepam) Tablet PS Watson Laboratories Fluoxetine (Watson Laboratories)(Fluoxe tine) Capsule SS Watson Laboratories Ziprasidone (Ziprasidone) SS 22-Feb-2006 08:32 AM Page: 438 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/25/03ISR Number: 4242212-6Report Type:Expedited (15-DaCompany Report #2003118196 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Geodon (Ziprasidone) PS ORAL ORAL; 40 MG Initial or Prolonged Refusal Of Treatment By Professional (BID), Patient INTRAMUSCULAR Date:11/25/03ISR Number: 4242294-1Report Type:Expedited (15-DaCompany Report #03P-163-0241042-00 Age:43 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Verapamil (Isoptin) Multiple Drug Overdose Health (Verapamil) Professional (Verapamil) PS ORAL ORAL Ziprasidone SS ORAL ORAL Clonazepam SS ORAL ORAL Date:11/25/03ISR Number: 4242650-1Report Type:Expedited (15-DaCompany Report #2003038614 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Angioneurotic Oedema Foreign Zeldox (Capsules) Initial or Prolonged Health (Ziprasidone) PS ORAL 80 MG (BID), Professional ORAL Escitalopram (Escitalopram) C Quetiapine Fumarate (Quetiapine Fumarate) C Date:11/26/03ISR Number: 4243405-4Report Type:Expedited (15-DaCompany Report #2003113870 Age:36 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Akathisia Foreign Zeldox (Capsules) Drug Interaction Health (Ziprasidone) PS ORAL 80 MG (BID), Dyskinesia Professional ORAL Clozapine (Clozapine) SS ORAL 175 MG, ORAL Citalopram SS ORAL 40 MG, ORAL Date:11/26/03ISR Number: 4243694-6Report Type:Expedited (15-DaCompany Report #2003118898 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Laryngeal Oedema Foreign Ziprasidone (Caps) Panic Attack Health (Ziprasidone) PS Professional Company Representative 22-Feb-2006 08:32 AM Page: 439 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/26/03ISR Number: 4243699-5Report Type:Expedited (15-DaCompany Report #2003118836 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Foreign Zeldox (Capsules) Initial or Prolonged Condition Aggravated Health (Ziprasidone) PS 80 MG (BID) Fatigue Professional Social Avoidant Behaviour Tachycardia Vision Blurred Date:11/26/03ISR Number: 4243700-9Report Type:Expedited (15-DaCompany Report #2003118610 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination Foreign Zeldox (Capsules) Initial or Prolonged Hypomania Health (Ziprasidone) PS ORAL (BID), ORAL Professional Company Representative Date:11/26/03ISR Number: 4243701-0Report Type:Expedited (15-DaCompany Report #2003116678 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Foreign Zeldox (Capsules) Initial or Prolonged Tachycardia Health (Ziprasidone) PS ORAL 160 MG (BID), Ventricular Extrasystoles Professional ORAL Date:11/26/03ISR Number: 4244092-1Report Type:Expedited (15-DaCompany Report #2003111758 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Compartment Syndrome Foreign Zeldox Initial or Prolonged Disease Recurrence Health Peroneal Nerve Palsy Professional (Ziprasidone) PS Psychotic Disorder Company Ofloxacin Rhabdomyolysis Representative (Ofloxacin) C Metamizole Sodium (Metamizole Sodium) C Heparin-Fraction, Sodium Salt C Date:11/26/03ISR Number: 4244093-3Report Type:Expedited (15-DaCompany Report #2003118617 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Foreign Zeldox Initial or Prolonged Confusional State Health (Ziprasidone) PS ORAL 80 MG (BID), Suicidal Ideation Professional ORAL Company Representative 22-Feb-2006 08:32 AM Page: 440 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/26/03ISR Number: 4244096-9Report Type:Expedited (15-DaCompany Report #2003118823 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drug Hypersensitivity Foreign Ziprasidone (Caps) Laryngeal Oedema Health (Ziprasidone) PS Professional Company Representative Date:11/26/03ISR Number: 4244314-7Report Type:Expedited (15-DaCompany Report #2003119141 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Health Lithium (Lithium) PS Overdose Professional Geodon (Ziprasidone) SS SEE IMAGE Renal Failure Company Fluphenazaine Representative Hydrochloride (Fluphenazaine Hydrochloride) C Date:11/28/03ISR Number: 4244619-XReport Type:Expedited (15-DaCompany Report #2003037077 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Foreign Ziprasidone Other Myocardial Infarction Health Sudden Death Professional (Ziprasidone) PS ORAL 120 MG BID Company ORAL Representative Levomepromazine C Diazepam C Date:11/28/03ISR Number: 4244636-XReport Type:Expedited (15-DaCompany Report #2003119149 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Nausea Foreign Zeldox (Capsules) Sudden Cardiac Death Health (Ziprasidone) PS ORAL 160 MG (BID), Professional ORAL Company Olanzapine Representative (Olanzapine) C Lithium (Lithium) C Carbamazepine (Carbamazepine) C Antihypertensives C All Other Therapeutic Products C Date:11/28/03ISR Number: 4245048-5Report Type:Expedited (15-DaCompany Report #2003038614 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Angioneurotic Oedema Foreign Zeldox (Capsules) Hospitalization - Health (Ziprasidone) PS ORAL 80 MG (BID), Initial or Prolonged Professional ORAL Escitalopram (Escitalopram) C Quetiapine Fumarate 22-Feb-2006 08:32 AM Page: 441 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Quetiapine) C Date:11/28/03ISR Number: 4245050-3Report Type:Expedited (15-DaCompany Report #2003118823 Age:65 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hypersensitivity Foreign Ziprasidone (Caps) Laryngeal Oedema Health (Ziprasidone) PS ORAL 40 MG Pharyngitis Professional (DAILY), ORAL Speech Disorder Company Swollen Tongue Representative Date:11/28/03ISR Number: 4245362-3Report Type:Expedited (15-DaCompany Report #2003040822 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Health Geodon (Ziprasidone) PS ORAL 40 MG Initial or Prolonged Constipation Professional (DAILY), ORAL Dizziness Other Dysuria Pain Tremor Vision Blurred Vomiting Date:11/28/03ISR Number: 4245396-9Report Type:Expedited (15-DaCompany Report #2003118908 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delirium Consumer Geodon (Ziprasidone) PS ORAL 160 MG (BID), Initial or Prolonged Treatment Noncompliance ORAL Other Date:11/28/03ISR Number: 4245405-7Report Type:Expedited (15-DaCompany Report #2003114693 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatinine Consumer Geodon (Ziprasidone) PS 80 MG (BID), Initial or Prolonged Increased Health Haloperidol Other Neuroleptic Malignant Professional (Haloperidol) Syndrome (Haloperidol) SS Morphine (Morphine) SS Labetalol (Labetalol) SS Fluconazole (Fluconazole) C Ceftriaxone Sodium (Ceftriaxone Sodium) C Salbutamol (Salbutamol) C Heparin (Heparin) C Azelastine Hydrochloride (Azelastine Hydrochloride) C Fluticasone Propionate (Fluticasone 22-Feb-2006 08:32 AM Page: 442 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Propionate) C Jevity (Potassium Bicarbonate, Potassium Bitartrate, Soya Oil, Corn Oil, C Clonidine Hydrochloride (Clonidiine Hydrochloride) C Lansoprazole (Lansoprazole) C Phenytoin Sodium (Phenytoin Sodium) C Chlordiazepoxide (Chlordiazepoxide) C Oxybutynin (Oxybutynin) C Diphenhydramine Hydrochloride (Diphenhydramine Hydrochloride) C Nystatin (Nystatin) C Tetracycline (Tetracycline) C Water (Water) C Date:12/02/03ISR Number: 4245603-2Report Type:Expedited (15-DaCompany Report #2003119494 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Tongue Spasm Foreign Zeldox (Capsules) Initial or Prolonged Health (Ziprasidone) PS 240 MG Professional Company Representative Date:12/02/03ISR Number: 4246067-5Report Type:Direct Company Report #CTU 207307 Age:8 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hepatic Failure Geodon PS 20 MG , 40 MG Life-Threatening Liver Transplant Ativan SS 4/ Hospitalization - Rash Initial or Prolonged Disability Other Required Intervention to Prevent Permanent Impairment/Damage Date:12/03/03ISR Number: 4246609-XReport Type:Expedited (15-DaCompany Report #2003119681 Age:21 YR Gender:Male I/FU:I Outcome PT Other Anxiety Dry Mouth Dysphagia 22-Feb-2006 08:32 AM Page: 443 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Laryngospasm Respiratory Disorder Report Source Product Role Manufacturer Route Dose Duration Foreign Ziprasidone (Caps) Health (Ziprasidone) PS ORAL 60 MG Professional (DAILY), ORAL Company Representative Date:12/03/03ISR Number: 4246979-2Report Type:Expedited (15-DaCompany Report #2003111758 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Compartment Syndrome Foreign Zeldox (Capsules) Initial or Prolonged Paresis Health (Ziprasidone) PS ORAL 80 MG(DAILY), Disability Psychotic Disorder Professional ORAL Rhabdomyolysis Company Metamizole Sodium Representative (Metamizole Sodium) C Heparin-Fraction, Sodium Salt (Heparin-Sodium, Sodium Salt) C Ofloxacin C Date:12/04/03ISR Number: 4246714-8Report Type:Expedited (15-DaCompany Report #2003119859 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Geodon (Ziprasidone) PS Date:12/04/03ISR Number: 4246715-XReport Type:Expedited (15-DaCompany Report #2003119861 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Geodon (Ziprasidone) PS Date:12/04/03ISR Number: 4246716-1Report Type:Expedited (15-DaCompany Report #2003119854 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Geodon (Ziprasidone) PS Date:12/04/03ISR Number: 4246717-3Report Type:Expedited (15-DaCompany Report #2003119856 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Geodon (Ziprasidone) PS Date:12/04/03ISR Number: 4246718-5Report Type:Expedited (15-DaCompany Report #2003119851 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intestinal Infarction Consumer Geodon (Ziprasidone) PS Other 22-Feb-2006 08:32 AM Page: 444 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/04/03ISR Number: 4246720-3Report Type:Expedited (15-DaCompany Report #2003119852 Age:101 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Geodon (Ziprasidone) PS Date:12/04/03ISR Number: 4247040-3Report Type:Expedited (15-DaCompany Report #2003119872 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Geodon (Ziprasidone) PS Date:12/04/03ISR Number: 4247043-9Report Type:Expedited (15-DaCompany Report #2003119874 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Geodon (Ziprasidone) PS Date:12/04/03ISR Number: 4247045-2Report Type:Expedited (15-DaCompany Report #2003119870 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Geodon (Ziprasidone) PS Date:12/04/03ISR Number: 4247051-8Report Type:Expedited (15-DaCompany Report #2003119871 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Geodon (Ziprasidone) PS Date:12/04/03ISR Number: 4247054-3Report Type:Expedited (15-DaCompany Report #2003119672 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Consumer Geodon (Ziprasidone) PS ORAL 120 MG (BID), Initial or Prolonged Agitation ORAL Ammonia Abnormal Dilantin (Phenytoin Bipolar Disorder Sodium) (Phenytoin Drug Effect Decreased Sodium) SS ORAL ORAL Mental Impairment Carbamazepine Metabolic Disorder (Carbamazepine) SS Lorazepam (Lorazepam) SS Date:12/04/03ISR Number: 4247056-7Report Type:Expedited (15-DaCompany Report #2003119990 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Health Geodon (Ziprasidone) PS Panic Attack Professional Zoloft (Sertraline) SS Company Representative 22-Feb-2006 08:32 AM Page: 445 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/04/03ISR Number: 4247093-2Report Type:Expedited (15-DaCompany Report #2003120418 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Geodon (Im) Life-Threatening Professional (Ziprasidone) PS INTRAMUSCULAR INTRAMUSCULAR Other Company Chlorpromazine Representative Hydrochloride (Chlorpromazine) C Lorazepam ( Lorazepam) C Date:12/04/03ISR Number: 4247096-8Report Type:Expedited (15-DaCompany Report #2003119875 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Geodon (Ziprasidone) PS Date:12/04/03ISR Number: 4247210-4Report Type:Expedited (15-DaCompany Report #2003119867 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Geodon (Ziprasidone) PS Date:12/04/03ISR Number: 4247214-1Report Type:Expedited (15-DaCompany Report #2003119866 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Geodon (Ziprasidone) PS Date:12/04/03ISR Number: 4247217-7Report Type:Expedited (15-DaCompany Report #2003119862 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Geodon (Ziprasidone) PS Date:12/04/03ISR Number: 4247260-8Report Type:Expedited (15-DaCompany Report #2003119869 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Geodon (Ziprasidone) PS Date:12/04/03ISR Number: 4247601-1Report Type:Expedited (15-DaCompany Report #2003118610 Age:19 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination Foreign Zeldox (Capsules) Initial or Prolonged Hypomania Health (Ziprasidone) PS ORAL 40 MG Professional (DAILY), ORAL Company Representative 22-Feb-2006 08:32 AM Page: 446 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/04/03ISR Number: 4264705-8Report Type:Periodic Company Report #2003114530 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bipolar Disorder Health Geodon (Ziprasidone) PS 20 MG Drug Interaction Professional Alprazolam Sedation Company (Alprazolam) SS 4 MG Representative Date:12/04/03ISR Number: 4264706-XReport Type:Periodic Company Report #2003114538 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Geodon (Ziprasidone) PS Professional Company Representative Date:12/04/03ISR Number: 4264707-1Report Type:Periodic Company Report #2003115020 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyspnoea Health Geodon (Ziprasidone) PS 180 MG (TID) Initial or Prolonged Medication Error Professional Prescribed Overdose Company Representative Date:12/04/03ISR Number: 4264709-5Report Type:Periodic Company Report #2003026566 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drooling Health Geodon (Ziprasidone) PS ORAL ORAL Initial or Prolonged Professional Company Representative Date:12/04/03ISR Number: 4264710-1Report Type:Periodic Company Report #2003031494 Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Health Geodon (Ziprasidone) PS ORAL 80 MG (40, Prolonged Professional BID), ORAL Sleep Apnoea Syndrome Gabapentin (Gabapentin) C Citalopram Hydrobromide C Date:12/04/03ISR Number: 4278505-6Report Type:Periodic Company Report #2003033704 Age:9 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyskinesia Health Geodon (Ziprasidone) PS 80 MG (BID) Dyspnoea Professional Quetiapine Fumarate Throat Tightness Company (Quetiapine Representative Fumarate) C Olanzapine (Olanzapine) C 22-Feb-2006 08:32 AM Page: 447 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/04/03ISR Number: 4278507-XReport Type:Periodic Company Report #2003034230 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Priapism Health Geodon (Ziprasidone) PS Initial or Prolonged Professional Haloperidol Other (Haloperidol) C Date:12/04/03ISR Number: 4278508-1Report Type:Periodic Company Report #2003034807 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fatigue Health Geodon (Ziprasidone) PS ORAL 160 MG (TID), Initial or Prolonged Hallucination Professional ORAL Weight Decreased Fluoxetine Hydrochloride (Fluoxetine Hydrochloride) C Lorazepam (Lorazepam) C Pantoprazole (Pantoprazole) C Date:12/04/03ISR Number: 4278518-4Report Type:Periodic Company Report #2003035203 Age: Gender:Female I/FU:I Outcome PT Other Abnormal Dreams Agitation Confusional State Convulsion Depressed Level Of Consciousness Dizziness Drug Hypersensitivity Drug Interaction Dry Mouth Dry Throat Dysgeusia Feeling Abnormal Feeling Cold Hallucination, Visual Headache Hyperhidrosis Hypoaesthesia Insomnia Judgement Impaired Loss Of Consciousness Memory Impairment Migraine Motor Dysfunction Nausea Pain Pain In Extremity Palpitations Panic Reaction Petit Mal Epilepsy Sensation Of Foreign Body Somnolence Tremor 22-Feb-2006 08:32 AM Page: 448 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Vertigo Visual Disturbance Report Source Product Role Manufacturer Route Dose Duration Consumer Geodon (Ziprasidone) PS ORAL 20 MG (BID), ORAL Venlafaxine Hydrochloride SS ORAL ORAL Date:12/04/03ISR Number: 4278520-2Report Type:Periodic Company Report #2003035492 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Literature Geodon (Ziprasidone) PS 40 MG (20, Oculogyration Health BID) Professional Date:12/04/03ISR Number: 4278521-4Report Type:Periodic Company Report #2003035868 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Autism Health Geodon (Ziprasidone) PS ORAL 40 MG (BID), Binge Eating Professional ORAL Blood Glucose Increased Company Fluvoxamine Maleate Dizziness Representative (Fluvoxamine Loss Of Consciousness Maleate) C Vomiting Methylphenidate Weight Decreased Hydrochloride (Methylphenidate Hydrochloride) C Decongestants And Antiallergics C Olanzapine (Olanzapine) C Insulin (Insulin) C Date:12/04/03ISR Number: 4278523-8Report Type:Periodic Company Report #2003036532 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebrovascular Accident Health Geodon (Ziprasidone) PS ORAL 80 MG (BID), Professional ORAL Company Representative Date:12/04/03ISR Number: 4278525-1Report Type:Periodic Company Report #2003037090 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bundle Branch Block Right Health Geodon (Ziprasidone) PS 120 MG Professional (DAILY) 22-Feb-2006 08:32 AM Page: 449 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/04/03ISR Number: 4278526-3Report Type:Periodic Company Report #2003037307 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Health Geodon (Ziprasidone) PS 160 MG Initial or Prolonged Professional Company Representative Date:12/04/03ISR Number: 4278528-7Report Type:Periodic Company Report #2003038009 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oculogyration Health Geodon (Ziprasidone) PS Professional Company Representative Date:12/04/03ISR Number: 4278694-3Report Type:Periodic Company Report #2003038613 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Platelet Count Decreased Health Geodon (Ziprasidone) PS Professional Company Representative Date:12/04/03ISR Number: 4278695-5Report Type:Periodic Company Report #2003038687 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sinus Bradycardia Health Geodon (Ziprasidone) PS ORAL ORAL Professional All Other Therapeutic Products C Date:12/04/03ISR Number: 4278696-7Report Type:Periodic Company Report #2003040137 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Extrapyramidal Disorder Health Geodon (Ziprasidone) PS 80 MG (BID) Respiratory Distress Professional Tachycardia Company Representative Date:12/04/03ISR Number: 4278698-0Report Type:Periodic Company Report #2003040258 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Heart Rate Decreased Health Geodon (Ziprasidone) PS Initial or Prolonged Professional 22-Feb-2006 08:32 AM Page: 450 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/04/03ISR Number: 4278701-8Report Type:Periodic Company Report #2003110277 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Health Geodon (Ziprasidone) PS 80 MG (BID) Initial or Prolonged Extrapyramidal Disorder Professional Obetrol Company (Dexamfetamine Representative Sulfate, Amfetamine Sulfate, Dexamfetamine C Bupropion Hydrochloride (Bupropion Hydrochloride) C Zaleplon (Zaleplon) C Zolpidem Tartrate (Zolpidem Tartrate) C Dexamfetamine Sulfate (Dexamfetamine Sulfate) C Date:12/04/03ISR Number: 4278704-3Report Type:Periodic Company Report #2003110294 Age:5 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Health Geodon (Ziprasidone) PS Professional Company Representative Date:12/04/03ISR Number: 4278706-7Report Type:Periodic Company Report #2003110352 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Health Geodon (Ziprasidone) PS Initial or Prolonged Professional Company Representative Date:12/04/03ISR Number: 4278707-9Report Type:Periodic Company Report #2003111379 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Health Geodon (Ziprasidone) PS 160 MG Initial or Prolonged Professional Company Representative Date:12/04/03ISR Number: 4278708-0Report Type:Periodic Company Report #2003113455 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Extrapyramidal Disorder Health Geodon (Ziprasidone) PS (BID) Professional Company Representative 22-Feb-2006 08:32 AM Page: 451 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/04/03ISR Number: 4278709-2Report Type:Periodic Company Report #2003114029 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Torticollis Health Geodon (Ziprasidone) PS ORAL ORAL Initial or Prolonged Professional Prolixin Other Company (Fluphenazine Representative Hydrochloride) C Date:12/08/03ISR Number: 4249084-4Report Type:Expedited (15-DaCompany Report #2003118898 Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Nausea Foreign Ziprasidone (Caps) Panic Attack Health (Ziprasidone) PS ORAL 40 MG DAILY Salivary Hypersecretion Professional ORAL Company Clonazepam C Representative Date:12/08/03ISR Number: 4249396-4Report Type:Expedited (15-DaCompany Report #2003120322 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Level Decreased Consumer Geodon (Ziprasidone) PS ORAL Initial or Prolonged Mood Swings Lithium (Lithium) SS Other Somnolence Valproate Semisodium Weight Increased (Valproate Semisodium) C Date:12/08/03ISR Number: 4249400-3Report Type:Expedited (15-DaCompany Report #2003119937 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Magnesium Decreased Health Geodon (Ziprasidone) PS 80 MG (DAILY) Other Blood Potassium Decreased Professional Antipsychotics SS Cardiovascular Disorder Drug Ineffective Electrocardiogram Qt Prolonged Stem Cell Transplant Date:12/08/03ISR Number: 4249418-0Report Type:Expedited (15-DaCompany Report #2003120602 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Disorder Health Geodon (Ziprasidone) PS Professional Date:12/09/03ISR Number: 4248986-2Report Type:Direct Company Report #CTU 207737 Age:89 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Geodon (Ziprasidone Coma Mesylate) 20 Mg/Ml Cyanosis Pfizer PS Pfizer INTRAMUSCULAR 10 MG I.M. X Torsade De Pointes 1 DOSE Haldol SS INTRAMUSCULAR 2 MG IM 22-Feb-2006 08:32 AM Page: 452 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Seroquel SS ORAL 25 MG PO BID Date:12/09/03ISR Number: 4249846-3Report Type:Expedited (15-DaCompany Report #2003120606 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardio-Respiratory Arrest Consumer Geodon (Ziprasidone) PS UNKNOWN UNK (SEE Initial or Prolonged Urinary Tract Infection Health IMAGE) Professional Date:12/09/03ISR Number: 4249849-9Report Type:Expedited (15-DaCompany Report #2003120604 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Aspiration Consumer Geodon (Ziprasidone) PS UNKNOWN UNK Health Zithromax (Caps) Professional (Azithromycin) SS UNKNOWN UNK (UNKNOWN) , UNKNOWN Donepezil Hydrochloride (Donepezil Hydrochloride) SS UNKNOWN UNK (UNKNOWN), UNKNOWN Date:12/09/03ISR Number: 4249857-8Report Type:Expedited (15-DaCompany Report #2003121177 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fatigue Health Geodon (Ziprasidone) PS ORAL 20 MG, ORAL Initial or Prolonged Muscle Spasms Professional Donepezil Company Hydrochloride C Representative Date:12/09/03ISR Number: 4249955-9Report Type:Expedited (15-DaCompany Report #2003120602 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Arrest Consumer Geodon (Ziprasidone) PS Initial or Prolonged Respiratory Arrest Health Donepezil Other Professional Hydrochloride (Donepezil Hydrochloride) SS Oxazepam (Oxazepam) C Date:12/09/03ISR Number: 4249978-XReport Type:Expedited (15-DaCompany Report #2003119672 Age: Gender:Male I/FU:F Outcome PT Hospitalization - Abnormal Behaviour Initial or Prolonged Agitation Other Ammonia Abnormal Bipolar Disorder Convulsion Grand Mal Convulsion Hostility 22-Feb-2006 08:32 AM Page: 453 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Irritability Metabolic Disorder Nervous System Disorder Report Source Product Role Manufacturer Route Dose Duration Partial Seizures Consumer Geodon (Ziprasidone) PS ORAL 120 MG (BID), Sleep Walking ORAL Snoring Dilantin (Phenytoin Staring Sodium) (Phenytoin Temporal Lobe Epilepsy Sodium) SS ORAL ORAL Carbamazepine (Carbamazepine) SS Lorazepam (Lorazepam) SS All Other Therapeutic Products SS Date:12/11/03ISR Number: 4250778-5Report Type:Expedited (15-DaCompany Report #2003120690 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Geodon (Ziprasidone) PS ORAL 40 MG (BID), Initial or Prolonged Refusal Of Treatment By Professional ORAL Other Patient Zyrtec (Tablets) Urticaria (Cetirizine) SS Guanfacine Hydrochloride (Guanfacine Hydrochloride) C Poly-Vi-Flor (Ergocalciferol, Ascorbic Acid, Thiamine Hydrochloride, C Date:12/11/03ISR Number: 4251140-1Report Type:Expedited (15-DaCompany Report #2003015772 Age:60 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Respiratory Arrest Health Geodon (Ziprasidone) PS ORAL 40 MG (BID), Other Respiratory Failure Professional ORAL Acetylsalicylic Acid (Acetylsalicylic Acid) C Omeprazole (Omeprazole) C Pseudoephedrine Hyrochloride (Pseudoephedrine Hydrochloride) C Fexofenadine Hydrochloride (Fexofenadine Hydrochloride) C Quinapril Hydrochloride (Quinapril Hydrochloride) C Rofecoxib (Rofecoxib) C Atenolol (Atenolol) C 22-Feb-2006 08:32 AM Page: 454 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Provella-14 (Medroxyprogesterone Acetate, Estrogens Conjugated) C Date:12/11/03ISR Number: 4251277-7Report Type:Expedited (15-DaCompany Report #2003111758 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Back Pain Foreign Zeldox (Capsules) Initial or Prolonged Compartment Syndrome Health (Ziprasidone) PS ORAL 80 MG Disability Disease Recurrence Professional (DAILY), ORAL Pain In Extremity Company Ofloxacin Paresis Representative (Ofloxacin) C Psychotic Disorder Metamizole Sodium Rhabdomyolysis (Metamizole Sodium) C Heparin-Fraction, Sodium Salt (Heparin-Fraction, Sodium Salt) C Pioglitazone (Pioglitazone) C Hydrochlorothiazide (Hydrochlorothiazide ) C Insulin Glargine (Insulin Glargine) C Insulin Aspart (Insulin Aspart) C Date:12/11/03ISR Number: 4251297-2Report Type:Expedited (15-DaCompany Report #2003120903 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abasia Foreign Zoloft (Sertraline) PS 150 MG Hospitalization - Disorientation Health Zeldox (Capsules) Initial or Prolonged Drug Abuser Professional (Ziprasidone) SS 40 MG (BID) Drug Toxicity Musculoskeletal Stiffness Nuclear Magnetic Resonance Imaging Brain Abnormal Suicide Attempt Date:12/11/03ISR Number: 4251298-4Report Type:Expedited (15-DaCompany Report #2003120700 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Ziprasidone (Caps) Initial or Prolonged Hypomania Health (Ziprasidone) PS ORAL 120 MG (BID), Personality Disorder Professional ORAL Company Benzodiazepine Representative Derivatives C 22-Feb-2006 08:32 AM Page: 455 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/12/03ISR Number: 4252299-2Report Type:Expedited (15-DaCompany Report #2003120922 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Geodon (Ziprasidone) PS Professional Company Representative Date:12/15/03ISR Number: 4253480-9Report Type:Expedited (15-DaCompany Report #2003121461 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Geodon (Ziprasidone) PS Other Professional Company Representative Date:12/15/03ISR Number: 4253486-XReport Type:Expedited (15-DaCompany Report #2003120916 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fatigue Health Geodon (Ziprasidone) PS ORAL 80 MG (BID), Initial or Prolonged Heart Rate Increased Professional ORAL Other Infusion Site Reaction Aripiprazole Orthostatic Hypotension (Aripiprazole) SS Thrombosis Trazadone (Trazadone) C Date:12/16/03ISR Number: 4253628-6Report Type:Expedited (15-DaCompany Report #2003119672 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Consumer Geodon (Ziprasidone) PS ORAL 120 MG Initial or Prolonged Adrenal Disorder (BID(), ORAL Other Ammonia Abnormal Dilantin (Phenytoin Bipolar Disorder Sodium) (Phenytoin Confusional State Sodium) SS ORAL ORAL Drug Level Decreased Carbamazepine Grand Mal Convulsion (Carbamazepine) SS Hostility Lorazepam Irritability (Lorazepam) SS Mania All Other Metabolic Disorder Therapeutic Products SS Nervous System Disorder Sleep Walking Snoring Staring Date:12/16/03ISR Number: 4253761-9Report Type:Expedited (15-DaCompany Report #2003121180 Age:28 YR Gender:Male I/FU:I Outcome PT Other Disorientation Feeling Abnormal Nausea Neuroleptic Malignant Syndrome 22-Feb-2006 08:32 AM Page: 456 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Vomiting Report Source Product Role Manufacturer Route Dose Duration Foreign Geodon (Ziprasidone) PS ORAL 160 MG Health (DAILY), ORAL Professional Company Representative Date:12/17/03ISR Number: 4254021-2Report Type:Direct Company Report #CTU 208306E Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Geodon 40 Mg Initial or Prolonged Dyspnoea (Pfizer) PS Pfizer ONE DOSE QAM, Dystonia TWO DOSES QHS Fall Effexor C Feeling Abnormal Lexapro C Laryngospasm Restoril C Panic Reaction Speech Disorder Date:12/17/03ISR Number: 4254501-XReport Type:Expedited (15-DaCompany Report #2003121927 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Health Geodon (Ziprasidone) PS ORAL 80 MG (BID), Other Aspiration Professional ORAL Company Citalopram Representative Hydrobromide (Citalopram Hydrobromide) C All Other Therapeutic Products C Date:12/17/03ISR Number: 4254545-8Report Type:Expedited (15-DaCompany Report #DSA_23666_2003 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Circulatory Collapse Foreign Tavor PS ORAL 3 MG Q DAY PO Drug Interaction Health Tavor SS ORAL 2 MG Q DAY PO Fall Professional Tavor SS ORAL 1 MG Q DAY PO Head Injury Other Cipramil SS ORAL 20 MG Q DAY Memory Impairment PO Sedation Geodon SS ORAL 160 MG Q DAY Skin Laceration PO Geodon SS ORAL 80 MG Q DAY PO Date:12/17/03ISR Number: 4254620-8Report Type:Expedited (15-DaCompany Report #2003121931 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Geodon (Ziprasidone) PS Other Professional Company Representative 22-Feb-2006 08:32 AM Page: 457 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/17/03ISR Number: 4254623-3Report Type:Expedited (15-DaCompany Report #2003121929 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Myocardial Infarction Health Geodon (Ziprasidone) PS Professional Company Representative Date:12/18/03ISR Number: 4255556-9Report Type:Expedited (15-DaCompany Report #2003122952 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Foreign Zeldox (Capsules) Initial or Prolonged Extrapyramidal Disorder Health (Ziprasidone) PS ORAL 160 MG (BID), Galactorrhoea Professional ORAL Hypertonia Muscle Rigidity Tremor Date:12/18/03ISR Number: 4255707-6Report Type:Expedited (15-DaCompany Report #2003122915 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Upper Health Zithromax (Caps) Life-Threatening Activated Partial Professional (Azithromycin) PS Hospitalization - Thromboplastin Time Geodon (Ziprasidone) SS ORAL 120 MG (BID), Initial or Prolonged Prolonged ORAL Other Blood Creatinine Gatifloxacin Increased (Gatifloxacin) SS Blood Glucose Increased Paroxetine Cardiac Arrest Hydrochloride Convulsion (Paroxetine Drug Hypersensitivity Hydrochloride) C Electrocardiogram Qt Hydroxyzine Embonate Prolonged (Hydroxyzine Fall Embonate) C Head Injury Methadone Major Depression (Methadone) C Myocardial Infarction Prothrombin Time Prolonged Ventricular Fibrillation Date:12/18/03ISR Number: 4255709-XReport Type:Expedited (15-DaCompany Report #2003122645 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Geodon (Im) Professional (Ziprasidone) PS INTRAMUSCULAR INTRAMUSCULAR Company Representative 22-Feb-2006 08:32 AM Page: 458 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/18/03ISR Number: 4255761-1Report Type:Expedited (15-DaCompany Report #2003123732 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Geodon (Ziprasidone) PS Initial or Prolonged Pancreatitis Professional Other Date:12/18/03ISR Number: 4255769-6Report Type:Expedited (15-DaCompany Report #2003038491 Age:16 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Health Geodon (Ziprasidone) PS ORAL 120 MG (BID), Initial or Prolonged Electrocardiogram Professional ORAL Other Abnormal Company Salbutamol Electrocardiogram Qt Representative (Salbutamol) SS ORAL 200 PUFF(S), Corrected Interval ORAL Prolonged Escitalopram Myocardial Infarction (Escitalopram) C Suicidal Ideation Hydroxyzine Embonate (Hydroxyzine Embonate) C Date:12/18/03ISR Number: 4256493-6Report Type:Expedited (15-DaCompany Report #2003122953 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Foreign Zeldox (Capsules) Initial or Prolonged Suicidal Ideation Health (Ziprasidone) PS BID Professional Company Representative Date:12/19/03ISR Number: 4256457-2Report Type:Expedited (15-DaCompany Report #2003122950 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Agitation Foreign Zeldox (Capsules) Anxiety Health (Ziprasidone) PS ORAL 160 MG (BID), Bruxism Professional ORAL Dysphoria Orphenadrine Extrapyramidal Disorder Hydrochloride (Orphenadrine Hydrochloride) C Sertraline Hydrochloride (Sertraline Hydrochloride) C Clomipramine (Clomipramine) C Date:12/19/03ISR Number: 4256459-6Report Type:Expedited (15-DaCompany Report #2003122955 Age:26 YR Gender:Female I/FU:I Outcome PT Disability Agitation Cognitive Disorder Impulsive Behaviour 22-Feb-2006 08:32 AM Page: 459 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sleep Disorder Report Source Product Role Manufacturer Route Dose Duration Foreign Zeldox (Capsules) Health (Ziprasidone) PS ORAL 100 MG (BID), Professional ORAL Citalopram Hydrobromide (Citalopram Hydrobromide) C Risperidone (Risperidone) C Clonazepam (Clonazepam) C Date:12/19/03ISR Number: 4256538-3Report Type:Expedited (15-DaCompany Report #2003123689 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Geodon (Ziprasidone) PS Other Professional Lorazepam Company (Lorazepam) C Representative Benzatropine Mesilate (Benzatropine Mesilate) C All Other Therapeutic Products C Date:12/19/03ISR Number: 4256540-1Report Type:Expedited (15-DaCompany Report #2003123688 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Geodon (Ziprasidone) PS Other Professional Lorazepam Company (Lorazepam) C Representative Benzatropine Mesilate (Benzatropine Mesilate) C All Other Therapeutic Products C Date:12/19/03ISR Number: 4256543-7Report Type:Expedited (15-DaCompany Report #2003123687 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Geodon (Ziprasidone) PS Other Professional L0razepam Company (Lorazepam) C Representative Benzatropine Mesilate (Benzatropine Mesilate) C All Other Therapeutic Products C 22-Feb-2006 08:32 AM Page: 460 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/19/03ISR Number: 4256574-7Report Type:Expedited (15-DaCompany Report #2003123690 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Geodon (Ziprasidone) PS Other Professional Lorazepam Company (Lorazepam) C Representative Benzatropine Mesilate (Benzatropine Mesilate) C All Other Therapeutic Products C Date:12/19/03ISR Number: 4256590-5Report Type:Expedited (15-DaCompany Report #2003123735 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuropathy Health Geodon (Ziprasidone) PS ORAL 40 MG Paraesthesia Professional (DAILY), ORAL Alprazolam (Alprazolam) C Date:12/19/03ISR Number: 4256592-9Report Type:Expedited (15-DaCompany Report #2003122623 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Health Geodon (Ziprasidone) PS ORAL 120 MG (BID), Initial or Prolonged Haemoglobin Decreased Professional ORAL Neuroleptic Malignant Other Clonazepam Syndrome (Clonazepam) C Platelet Count Decreased Benzatropine Rash Mesilate Renal Failure Acute (Benzatropine Respiratory Tract Mesilate) C Infection Valproate Semisodium Urinary Incontinence (Valproate Semisodium) C Loratadine (Loratadine) C Pantoprazole (Pantoprazole) C Bactrim (Sulfamethoxazole, Trimethoprim) C Date:12/22/03ISR Number: 4257417-8Report Type:Expedited (15-DaCompany Report #2003121682 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Affective Disorder Foreign Zeldox (Capsules) Initial or Prolonged Depression Health (Ziprasidone) PS 120 MG Disease Recurrence Professional (DAILY) Headache Company Valproic Acid Psychosomatic Disease Representative (Valproic Acid) C Antidepressants C Citalopram Hydrobromide Citalopram 22-Feb-2006 08:32 AM Page: 461 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrobromide) C Lorazepam (Lorazepam) C Date:12/22/03ISR Number: 4257541-XReport Type:Expedited (15-DaCompany Report #2003123686 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bipolar Disorder Consumer Geodon (Ziprasidone) PS Initial or Prolonged Tardive Dyskinesia Lamotrigine Other (Lamotrigine) C Lithium (Lithium) C Venlafaxine Hydrochloride (Venlafaxine Hydrochloride) C Date:12/23/03ISR Number: 4256730-8Report Type:Direct Company Report #CTU 208620 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Extrapyramidal Disorder Geodon 80 Mg Pfizer PS Pfizer ORAL 80 MG BID ORAL Geodon 60 Mg SS ORAL 60- MG BID ORAL Citalopram C Date:12/23/03ISR Number: 4258249-7Report Type:Expedited (15-DaCompany Report #2003112981 Age:17 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Consumer Zoloft (Sertraline) PS ORAL 50 MG Initial or Prolonged Agoraphobia (DAILY), ORAL Other Amnesia Geodon (Ziprasidone) SS Asthenia All Other Chest Discomfort Therapeutic Products SS Condition Aggravated All Other Decreased Interest Therapeutic Products SS Delusional Perception Olanzapine Depressed Mood (Olanzapine) C Dyspnoea Exertional All Other Fear Therapeutic Products C Feeling Abnormal Hallucination Listless Liver Disorder Memory Impairment Panic Attack Prescribed Overdose Schizophrenia School Refusal Somnolence Suicidal Ideation Tremor Weight Decreased 22-Feb-2006 08:32 AM Page: 462 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/03ISR Number: 4259853-2Report Type:Expedited (15-DaCompany Report #2003124392 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pituitary Tumour Benign Health Geodon (Ziprasidone) PS Professional Date:12/26/03ISR Number: 4259865-9Report Type:Expedited (15-DaCompany Report #2003120604 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Consumer Geodon (Ziprasidone) PS ORAL 80 MG (BID), Arrhythmia Health ORAL Dysphagia Professional Zithromax (Caps) Feeling Abnormal Company (Azithromycin) SS Pneumonia Aspiration Representative Donepezil Hydrochloride (Donepezil Hydrochloride) SS Date:12/26/03ISR Number: 4259875-1Report Type:Expedited (15-DaCompany Report #2003120602 Age:87 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Consumer Geodon (Ziprasidone) PS Initial or Prolonged Agitation Health Donepezil Other Apnoea Professional Hydrochloride Blood Pressure Company (Donepezil Inadequately Controlled Representative Hydrochloride) SS Cardio-Respiratory Arrest Oxazepam (Oxazepam) C Extrapyramidal Disorder Valproate Semisodium Fall (Valproate Haematoma Semisodium) C Haemorrhagic Stroke All Other Mental Status Changes Therapeutic Products C Urinary Tract Infection Date:12/29/03ISR Number: 4261362-1Report Type:Direct Company Report #CTU 208859E Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Bradycardia Geodon 10mg Im PS INTRAMUSCULAR 10 MG IM Coma Date:12/29/03ISR Number: 4261406-7Report Type:Expedited (15-DaCompany Report #2003124604 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Interaction Health Geodon (Ziprasidone) PS 160 MG (BID), Hospitalization - Electrocardiogram Qt Professional Gatifloxacin Initial or Prolonged Prolonged Company (Gatifloxacin) SS 400 MG (QD), Hypothyroidism Representative Olanzapine Pneumonia (Olanzapine) C Lithium (Lithium) C Azithromycin (Azithryomycin) C Cefotaxime (Cefotaxime) C 22-Feb-2006 08:32 AM Page: 463 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report All Other Therapeutic Products C Date:12/29/03ISR Number: 4261409-2Report Type:Expedited (15-DaCompany Report #2003125124 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Health Geodon (Ziprasidone) PS Initial or Prolonged Professional Other Date:12/29/03ISR Number: 4261414-6Report Type:Expedited (15-DaCompany Report #2003125123 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Health Geodon (Ziprasidone) PS Initial or Prolonged Professional Other Date:12/29/03ISR Number: 4261449-3Report Type:Expedited (15-DaCompany Report #2003124609 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Geodon (Ziprasidone) PS ORAL ORAL Initial or Prolonged Constipation Professional Other Gastrointestinal Company Hypomotility Representative Intestinal Obstruction Date:12/29/03ISR Number: 4261450-XReport Type:Expedited (15-DaCompany Report #2003124529 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Grunting Consumer Geodon (Ziprasidone) PS ORAL 240 MG (BID), Speech Disorder ORAL Trismus Date:12/29/03ISR Number: 4261737-0Report Type:Expedited (15-DaCompany Report #2003120606 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardio-Respiratory Arrest Consumer Geodon (Ziprasidone) PS UNKNOWN UNK Initial or Prolonged Myocardial Infarction Health Other Urinary Tract Infection Professional Company Representative Date:12/29/03ISR Number: 4261738-2Report Type:Expedited (15-DaCompany Report #2003117606 Age:24 YR Gender:Female I/FU:F Outcome PT Hospitalization - Anxiety Initial or Prolonged Depression Other Euphoric Mood Fatigue 22-Feb-2006 08:32 AM Page: 464 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Malabsorption Mania Schizoaffective Disorder Report Source Product Role Manufacturer Route Dose Duration Sedation Consumer Geodon (Ziprasidone) PS ORAL 160 MG (BID); Self-Medication Health ORAL (SEE Sudden Onset Of Sleep Professional IMAGE) Paroxetine Hydrochloride C Lamotrigine C Benzatropine Mesilate C Cilest (Ethinylestradiol, Norgestimate) C Date:12/30/03ISR Number: 4261884-3Report Type:Expedited (15-DaCompany Report #2003125358 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Geodon (Ziprasidone) PS Other Professional Company Representative Date:12/30/03ISR Number: 4262010-7Report Type:Expedited (15-DaCompany Report #2003117443 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chills Foreign Zeldox (Capsules) Cold Sweat Health (Ziprasidone) PS ORAL 60 MG Drug Interaction Professional (DAILY), ORAL Feeling Abnormal Zoloft (Sertraline Muscle Contractions Hydrochloride) Involuntary (Sertraline) SS ORAL 150 MG (TID), Serotonin Syndrome ORAL Date:12/30/03ISR Number: 4262158-7Report Type:Expedited (15-DaCompany Report #2003125397 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Geodon (Ziprasidone) PS Other Overdose Professional Company Representative Date:12/31/03ISR Number: 4262030-2Report Type:Direct Company Report #CTU 209088 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Geodon 60 Mg Cap PS ORAL 60 MG PO BID Corrected Interval Prolonged 22-Feb-2006 08:32 AM Page: 465 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/31/03ISR Number: 4262581-0Report Type:Expedited (15-DaCompany Report #2003125837 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Burning Sensation Consumer Neurontin Feeling Abnormal (Gabapentin) PS ORAL 100 MG, ORAL Myalgia Geodon (Ziprasidone) SS ORAL ORAL Nausea Zoloft (Sertraline) SS ORAL 50 MG Pain (DAILY), ORAL Bupropion Hydrochloride (Bupropion Hydrochloride) SS ORAL ORAL Date:12/31/03ISR Number: 4262602-5Report Type:Expedited (15-DaCompany Report #2003125502 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Prolactin Increased Literature Ziprasidone (Caps) Initial or Prolonged Depressed Mood Health (Ziprasidone) PS ORAL 180 MG (TID), Flashback Professional ORAL Galactorrhoea Sertraline Insomnia (Sertraline) C Nightmare Valproic Acid Paranoia (Valproic Acid) C Suicidal Ideation Quetiapine (Quetiapine) C Date:12/31/03ISR Number: 4263001-2Report Type:Direct Company Report #CTU 209020E Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Breast Tenderness Geodon 40 Mg Pfizer PS Pfizer ORAL PO Intervention to Chest Pain Prevent Permanent Galactorrhoea Impairment/Damage Date:01/02/04ISR Number: 4262957-1Report Type:Direct Company Report #CTU 209217 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Ziprasidone PS ORAL 20 MG PO QAM/40 MG PO QPM Diphenhydramine C Date:01/02/04ISR Number: 4262971-6Report Type:Direct Company Report #CTU 209193E Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Geodon 120 Mg Bid PS ORAL 120 MG BID PO Cardiomegaly Synthroid C Mitral Valve Prolapse Gemfibrozil C Pulmonary Oedema Potassium C Ventricular Hypertrophy Topiramate C Loratidine C 22-Feb-2006 08:32 AM Page: 466 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/02/04ISR Number: 4264526-6Report Type:Expedited (15-DaCompany Report #2003126072 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pruritus Health Geodon (Ziprasidone) PS 120 MG, (BID) Initial or Prolonged Schizophrenia Professional Cortisone Company (Cortisone) SS Representative All Other Therapeutic Products C Date:01/06/04ISR Number: 4265898-9Report Type:Expedited (15-DaCompany Report #2003114291 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Increased Health Geodon (Im) Initial or Prolonged Professional (Ziprasidone) PS INTRAMUSCULAR INTRAMUSCULAR Company Representative Date:01/06/04ISR Number: 4265903-XReport Type:Expedited (15-DaCompany Report #2003124604 Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coronary Artery Stenosis Health Geodon (Ziprasidone) PS 160 MG (BID), Hospitalization - Drug Interaction Professional Gatifloxacin Initial or Prolonged Electrocardiogram Qt Company (Gatifloxacin) SS 400 MG (QD) Prolonged Representative Olanzapine Hypothyroidism (Olanzapine) C Pneumonia Lithium (Lithium) C Azithromycin (Azithromycin) C Cefotaxime (Cefotaxime) C Date:01/06/04ISR Number: 4265907-7Report Type:Expedited (15-DaCompany Report #2003126986 Age:20 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Difficulty In Walking Health Geodon (Ziprasidone) PS 200 MG Initial or Prolonged Gait Disturbance Professional Other Joint Lock Company Peroneal Nerve Palsy Representative Date:01/09/04ISR Number: 4268827-7Report Type:Expedited (15-DaCompany Report #2003122953 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Akathisia Foreign Zeldox (Capsules) Hospitalization - Insomnia Health (Ziprasidone) PS ORAL 80 MG (BID), Initial or Prolonged Suicidal Ideation Professional ORAL Company Representative 22-Feb-2006 08:32 AM Page: 467 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/13/04ISR Number: 4270727-3Report Type:Expedited (15-DaCompany Report #2003116749 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Adrenal Adenoma Health Geodon (Ziprasidone) PS ORAL ORAL Initial or Prolonged Depression Professional Zoloft (Sertraline) SS ORAL ORAL Other Drug Ineffective Clonazepam Headache (Clonazepam) C Hepatic Steatosis Ezetimibe Medication Error (Ezetimibe) C Pancreatitis Insulin (Insulin) C Suicidal Ideation Insulin Injection, Treatment Noncompliance Isophane (Insulin Injection, Isophane) C Captopril (Captopril) C Pantoprazole (Pantoprazole) C Date:01/14/04ISR Number: 4272816-6Report Type:Expedited (15-DaCompany Report #2004000976 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Potassium Decreased Health Geodon (Ziprasidone) PS Initial or Prolonged Electrocardiogram Professional Other Abnormal Company Mania Representative Date:01/14/04ISR Number: 4272819-1Report Type:Expedited (15-DaCompany Report #2003124529 Age:21 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gait Disturbance Consumer Geodon (Ziprasidone) PS ORAL 240 MG (BID), Grunting ORAL Trismus Date:01/14/04ISR Number: 4272826-9Report Type:Expedited (15-DaCompany Report #2003118196 Age:23 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Geodon (Im) Initial or Prolonged Refusal Of Treatment By Professional (Ziprasidone) PS INTRAMUSCULAR 10 MG (BID), Patient INTRAMUSCULAR Lorazepam (Lorazepam) C Date:01/14/04ISR Number: 4286347-0Report Type:Periodic Company Report #2003119224 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypotension Health Geodon (Im) Professional (Ziparasidone) PS INTRAMUSCULAR 10 MG, Company INTRAMUSCULAR Representative Trazodone (Trazodone) C Cocaine (Cocaine) C Lorazepam (Lorazepam) C 22-Feb-2006 08:32 AM Page: 468 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/14/04ISR Number: 4286348-2Report Type:Periodic Company Report #2003119226 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypotension Health Geodon (Im) Professional (Ziparasidone) PS INTRAMUSCULAR 10 MG, Company INTRAMUSCULAR Representative Lorazepam (Lorazepam) C Opioids C Benzodiazepine Derivatives C Date:01/15/04ISR Number: 4274220-3Report Type:Expedited (15-DaCompany Report #2003120922 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Health Geodon (Ziprasidone) PS ORAL 40 MG Initial or Prolonged Professional (DAILY), ORAL Other Company Topiramate Representative (Topiramate) C Venlafaxine Hydrochloride (Venlafaxine Hydrochloride) C Date:01/15/04ISR Number: 4274587-6Report Type:Expedited (15-DaCompany Report #2004000561 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Abdominal Pain Upper Foreign Zeldox (Capsules) Anxiety Health (Ziprasidone) PS ORAL 80 MG (BID) Dizziness Professional ORAL Headache Zopiclone Hypersensitivity (Zopiclone) C Psoriasis Social Avoidant Behaviour Tinnitus Date:01/16/04ISR Number: 4273651-5Report Type:Direct Company Report #CTU 210230E Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Circulatory Collapse Geodon 80 Mg Pfizer PS Pfizer ORAL 80 MG B.I.D. Sudden Death ORAL Seroquel C Valium C Lithobid C Propranolol C Glucophage C Monopril C Synthroid C 22-Feb-2006 08:32 AM Page: 469 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/16/04ISR Number: 4275459-3Report Type:Expedited (15-DaCompany Report #2003118285 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Geodon (Im) Other Mitral Valve Prolapse Professional (Ziprasidone) PS INTRAMUSCULAR 10 MG, Company INTRAMUSCULAR Representative Date:01/20/04ISR Number: 4276479-5Report Type:Expedited (15-DaCompany Report #2003119672 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abnormal Behaviour Consumer Geodon (Ziprasidone) PS ORAL 120 MG (BID), Hospitalization - Agitation ORAL Initial or Prolonged Ammonia Abnormal Dilantin (Phenytoin Other Bipolar Disorder Sodium) (Phenytoin Confusional State Sodium) SS ORAL ORAL Depression Carbamazepine Drug Level Changed (Carbamazepine) SS Drug Level Decreased Lorazepam Grand Mal Convulsion (Lorazepam) SS Hostility All Other Hypothermia Therapeutic Products SS Irritability Mania Metabolic Disorder Nervous System Disorder Partial Seizures Psychomotor Hyperactivity Sleep Disorder Sleep Walking Snoring Staring Temporal Lobe Epilepsy Date:01/20/04ISR Number: 4276504-1Report Type:Expedited (15-DaCompany Report #2004001636 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Health Geodon (Ziprasidone) PS ORAL 240 MG (BID), Other Professional ORAL Quetiapine Fumarate (Quetiapine Fumarate) C Date:01/20/04ISR Number: 4276556-9Report Type:Expedited (15-DaCompany Report #2004001063 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Literature Geodon (Ziprasidone) PS ORAL ORAL Initial or Prolonged Electrocardiogram Health Haloperidol Abnormal Professional (Haloperidol) SS Hyperprolactinaemia Risperidone Psychotic Disorder (Risperidone) SS Tardive Dyskinesia Olanzapine Weight Increased (Olanzapine) SS Quetiapine (Quetiapine) SS 22-Feb-2006 08:32 AM Page: 470 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Valproate (Valproic Acid) C Date:01/20/04ISR Number: 4277222-6Report Type:Expedited (15-DaCompany Report #2003114581 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anorexia Foreign Geodon (Ziprasidone) PS ORAL 40 MG Drug Withdrawal Syndrome Health (DAILY), ORAL Feeling Abnormal Professional (SEE IMAGE) Headache Company Valproate Sodium C Nausea Representative Lofepramine C Tremor Zopiclone C Folic Acid C Citalopram Hydrobromide C Date:01/20/04ISR Number: 4277319-0Report Type:Expedited (15-DaCompany Report #2003115539 Age:26 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Foreign Zeldox (Capsules) Initial or Prolonged Consciousness Health (Ziprasidone) PS ORAL 160 MG (BID), Other Electroencephalogram Professional ORAL Abnormal Company Zolpidem (Zolpidem) C Loss Of Consciousness Representative Diazepam (Diazepam) C Somnolence Biperiden Hydrochloride (Biperiden Hydrochloride) C Insulin Glargine (Insulin Glargine) C Insulin (Insulin) C Date:01/21/04ISR Number: 4277868-5Report Type:Expedited (15-DaCompany Report #2003034279 Age:62 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Foreign Zeldox (Capsules) Dysphagia Health (Ziprasidone) PS ORAL 40 MG (BID), Dyspnoea Professional ORAL Initial Insomnia Amitriptyline Nausea Hydrochloride (Amitriptyline Hydrochloride) C Perphenazine Decanoate (Perphenazine Decanoate) C Simvastatin (Simvastatin) C Glimepiride (Glimepiride) C 22-Feb-2006 08:32 AM Page: 471 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/22/04ISR Number: 4277935-6Report Type:Direct Company Report #CTU 210670 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Body Temperature Geodon PS INTRAMUSCULAR 10 MG X 1 Increased IM Rash Erythematous Viral Infection Date:01/22/04ISR Number: 4279032-2Report Type:Expedited (15-DaCompany Report #2004001634 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bipolar Disorder Health Geodon (Im) Other Blood Potassium Increased Professional (Ziprasidone) PS INTRAMUSCULAR 20 MG, Blood Sodium Decreased Company INTRAMUSCULAR Ejection Fraction Representative Olanzapine Decreased (Olanzapine) C Mitral Valve Stenosis Haloperidol Myocardial Infarction (Haloperidol) C Water Intoxication Oxcarbazepine (Oxcarbazepine) C Valproate Semisodium (Valproate Semisodium) C Lithium (Lithium) C Topiramate (Topiramate) C All Other Therapeutic Products C Droperidol (Droperidol) C Date:01/22/04ISR Number: 4279033-4Report Type:Expedited (15-DaCompany Report #2003126072 Age:36 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pruritus Health Geodon (Ziprasidone) PS 120 MG (BID) Initial or Prolonged Professional Hydrocortisone Company (Hydrocortisone) SS Representative Diphenhydramine Hydrochloride (Diphenhydramine Hydrochloride) SS All Other Therapeutic Products C Fluphenazine Hydrochloride (Fluphenazine Hydrochloride) C Valproate Semisodium (Valproate Semisodium) C 22-Feb-2006 08:32 AM Page: 472 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/23/04ISR Number: 4279538-6Report Type:Expedited (15-DaCompany Report #2003124529 Age:21 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Difficulty In Walking Consumer Geodon (Ziprasidone) PS ORAL 240 MG (BID), Grunting ORAL Joint Lock Motor Dysfunction Speech Disorder Date:01/23/04ISR Number: 4279552-0Report Type:Expedited (15-DaCompany Report #2004001870 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Zeldox (Capsules) Initial or Prolonged Increased Health (Ziprasidone) PS ORAL 40 MG (BID) , Aspartate Professional ORAL Aminotransferase Company Increased Representative Neuroleptic Malignant Syndrome Red Blood Cell Sedimentation Rate Increased Date:01/26/04ISR Number: 4280033-9Report Type:Expedited (15-DaCompany Report #2003120711 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Chest Pain Foreign Zeldox (Capsules) Drug Interaction Health (Ziprasidone) PS ORAL 80 MG Joint Stiffness Professional (DAILY), ORAL Malaise Other Perphenazine Muscle Rigidity (Perphenazine) SS ORAL 8 MG (BID), Musculoskeletal Stiffness ORAL Date:01/26/04ISR Number: 4280035-2Report Type:Expedited (15-DaCompany Report #2004002185 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Upper Foreign Ziprasidone (Caps) Acute Myocardial Health (Ziprasidone) PS ORAL 16 MG (BID), Infarction Professional ORAL Hypotension Valproate Magnesium Respiratory Failure (Valproate Magnesium) C Date:01/26/04ISR Number: 4280038-8Report Type:Expedited (15-DaCompany Report #2003119149 Age:63 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Upper Foreign Zeldox (Capsules) Cardiac Arrest Health (Ziprasidone) PS ORAL 160 MG (BID), Disease Recurrence Professional ORAL Nausea Company Lithium Acetate Psychotic Disorder Representative (Lithium Acetate) SS ORAL ORAL Sudden Cardiac Death Olanzapine Vomiting (Olanzapine) C 22-Feb-2006 08:32 AM Page: 473 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Carbamazepine (Carbamazepine) C Antihypertensives C All Other Therapeutic Products C Diazepam (Diazepam) C Flunitrazepam (Flunitrazepam) C Bisoprolol Fumarate (Bisoprolorl Fumarate) C Date:01/26/04ISR Number: 4280057-1Report Type:Expedited (15-DaCompany Report #2003033328 Age:59 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Foreign Zeldox (Capsules) Initial or Prolonged Fall Consumer Ziprasidone PS ORAL 30 MG, ORAL Other Feeling Abnormal Health Esomeprazole C Hip Fracture Professional Salutec Humerus Fracture Company (Hydrochlorothiazide Representative , Ramipril) C Levothyroxine Sodium C Phenprocoumon C Flupentixol Dihydrochloride (Flupentixol Dihydrochloride) C Date:01/26/04ISR Number: 4280059-5Report Type:Expedited (15-DaCompany Report #2004002187 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Upper Foreign Ziprasidone (Caps) PS ORAL 160 MG (BID), Acute Myocardial Health ORAL Infarction Professional Valproate Magnesium C Hypotension Date:01/26/04ISR Number: 4280168-0Report Type:Expedited (15-DaCompany Report #A124796 Age:46 YR Gender:Female I/FU:F Outcome PT Hospitalization - Agitation Initial or Prolonged Anger Blood Cholesterol Increased Burning Sensation Chest Pain Constipation Difficulty In Walking Fatigue Fear Heart Rate Decreased Heart Rate Increased Hostility Insomnia Muscle Tightness Musculoskeletal Stiffness 22-Feb-2006 08:32 AM Page: 474 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Nausea Nightmare Palpitations Report Source Product Role Manufacturer Route Dose Duration Personality Change Consumer Geodon (Ziprasidone) PS ORAL 80 MG (BID), Phobia Health ORAL Physical Assault Professional Olanzapine Rash (Olanzapine) SS Rash Erythematous Valproate Semisodium Rhinorrhoea (Valproate Somnolence Semisodium) SS ORAL ORAL Speech Disorder Lamotrigine Stupor (Lamotrigine) SS ORAL 250 MG (BID), Swelling ORAL Tension Diphenhydramine Tremor Hydrochloride (Diphenhydramine Hydrochloride) C Calcium (Calcium) C Levothyroxine (Levothyuroxine) C Tolterodine L-Tartrate (Tolterodine L-Tartrate) C Calcitriol (Calcitriol) C Risperidone (Risperidone) C Quetiapine Fumarate (Quetiapine Fumarate) C Date:01/26/04ISR Number: 4280194-1Report Type:Expedited (15-DaCompany Report #A200422 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Balance Disorder Consumer Geodon (Ziprasidone) PS ORAL 20 MG Initial or Prolonged Dizziness (DAILY), ORAL Dyspepsia Clozapine Fatigue (Clozapine) SS (DAILY) Feeling Hot Metamucil "Procter & Insomnia Gamble" (Glucose Laryngitis Monohydrate, Nasopharyngitis Ispaghula Husk) C Visual Disturbance Vomiting Date:01/26/04ISR Number: 4280263-6Report Type:Expedited (15-DaCompany Report #A209807 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Incontinence Consumer Zoloft (Sertraline) PS Initial or Prolonged Insomnia Geodon (Ziprasidone) SS 120 MG (TID) Nightmare Quetiapine Thyroid Disorder (Quetiapine) SS Weight Increased Acetylsalicylic Acid (Acetylsalicylic Acid) C Bupropion 22-Feb-2006 08:32 AM Page: 475 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride (Bupropion Hydrochloride) C Paroxetine Hydrochloride (Paroxetine Hydrochloride) C Citalopram (Citalopram) C Date:01/26/04ISR Number: 4280270-3Report Type:Expedited (15-DaCompany Report #2003029612 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Health Geodon (Ziprasidone) PS ORAL 60 MG (BID), Drug Interaction Professional ORAL Electrocardiogram Qt Company Sinequan (Doxepin) SS ORAL 275 MG Corrected Interval Representative (DAILY), ORAL Prolonged Venlafaxine Sinusitis Hydrochloride Sleep Apnoea Syndrome (Venlafaxine Somnolence Hydrochloride) C Dyazide (Hydrochlorothiazide , Triamterene) C Probucol (Probucol) C Date:01/26/04ISR Number: 4280289-2Report Type:Expedited (15-DaCompany Report #A123070 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chloropsia Consumer Geodon (Ziprasidone) PS BID Initial or Prolonged Decreased Appetite Benzatropine Dizziness Besilate Drug Ineffective (Benzatropine Erythropsia Besilate) C Fatigue Hydroxyzine Embonate Mental Impairment (Hydroxyzine Somnolence Embonate) C Therapeutic Response Bupropion Unexpected Hydrochloride Thinking Abnormal (Bupropion Hydrochloride) C Lithium Carbonate (Lithium Carbonate) C Risperidone (Risperidone) C Bisacodyl (Bisacodyl) C Ibuprofen (Ibuprofen) C Loperamide Hydrochloride (Loperamide Hydrochloride) C Acetylsalicylic Acid (Acetylsalicylic Acid) C Pseudoephedrine Hydrochloride 22-Feb-2006 08:32 AM Page: 476 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Pseudoephedrine Hydrochloride) C Haloperidol (Haloperidol) C Date:01/27/04ISR Number: 4280486-6Report Type:Expedited (15-DaCompany Report #2003114526 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Myocardial Infarction Foreign Zeldox Initial or Prolonged Health (Ziprasidone) PS ORAL 120 MG, BID, Other Professional ORAL Venlafaxine Hydrochloride C Date:01/27/04ISR Number: 4280576-8Report Type:Expedited (15-DaCompany Report #2003119149 Age:63 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Upper Foreign Zeldox (Capsules) Cardiac Arrest Health (Ziprasidone) PS ORAL 160 MG BID Loss Of Consciousness Professional ORAL Nausea Company Lithium Acetate Vomiting Representative (Lithium Acetate) SS ORAL ORAL Olanzapine C Carbamazepine C Antihypertensives C All Other Therapeutic Products C Diazepam C Carbamazepine C Flunitrazepam C Bisoprolol Fumarate C Date:01/27/04ISR Number: 4280606-3Report Type:Expedited (15-DaCompany Report #2004002810 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrioventricular Block Health Geodon (Ziprasidone) PS ORAL 160 MG BID Bradycardia Professional ORAL Hyperhidrosis Clonazepam C Sinus Arrhythmia Parotexine Sinus Tachycardia Hydrochloride C Supraventricular Tachycardia Syncope Date:01/29/04ISR Number: 4283031-4Report Type:Expedited (15-DaCompany Report #2004003087 Age:18 YR Gender:Female I/FU:I Outcome PT Death Anoxic Encephalopathy Brain Death Brain Herniation Brain Oedema Coma Corneal Opacity Grand Mal Convulsion 22-Feb-2006 08:32 AM Page: 477 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hepatic Encephalopathy Hepatic Failure Hepatic Necrosis Report Source Product Role Manufacturer Route Dose Duration Liver Function Test Health Geodon (Ziprasidone) PS ORAL 20 MG Abnormal Professional (DAILY), ORAL Liver Transplant Other Lorazepam Liver Transplant (Lorazepam) SS Rejection Ciprofloxacin Lymphadenopathy (Ciprofloxacin) SS Mental Status Changes Clavulin Post Procedural (Claculanate Complication Potassium, Pulmonary Alveolar Amoxicillin Haemorrhage Trihydrate) SS Pulmonary Congestion Oxcarbazepine Rash (Oxcarbazepine) SS Renal Tubular Necrosis Quetiapine Fumarate Respiratory Failure (Quetiapine Upper Respiratory Tract Fumarate) SS ORAL 100 MG Infection (DAILY), ORAL Varices Oesophageal Date:01/29/04ISR Number: 4283080-6Report Type:Expedited (15-DaCompany Report #2003126986 Age:20 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Difficulty In Walking Health Geodon (Ziprasidone) PS ORAL 200 MG (BID), Initial or Prolonged Gait Disturbance Professional ORAL Disability Peroneal Nerve Palsy Company Other Trismus Representative Date:01/29/04ISR Number: 4283083-1Report Type:Expedited (15-DaCompany Report #2004003454 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Increased Health Geodon (Ziprasidone) PS ORAL ORAL Initial or Prolonged Dyspnoea Professional Geodon (Ziprasidone) SS Other Flushing Hypoventilation Muscle Rigidity Paralysis Date:01/29/04ISR Number: 4283309-4Report Type:Expedited (15-DaCompany Report #2003121688 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Compartment Syndrome Foreign Zeldox (Capsules) Initial or Prolonged Deep Vein Thrombosis Consumer (Ziprasidone) PS ORAL 80 MG (BID), Other Disease Recurrence ORAL Fatigue Paroxetine Hypersomnia (Paroxetine) C Psychotic Disorder 22-Feb-2006 08:32 AM Page: 478 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/29/04ISR Number: 4283310-0Report Type:Expedited (15-DaCompany Report #2003031196 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Foreign Zeldox (Capsules) Initial or Prolonged Palpitations Health (Ziprasidone) PS ORAL 80 MG (BID), Sinus Tachycardia Professional ORAL Quetiapine Fumarate (Quetiapine Fumarate) C Levomepromazine (Levomepromazine) C Clonazepam (Clonazepam) C Salbutamol (Salbutamol) C Date:01/29/04ISR Number: 4283351-3Report Type:Expedited (15-DaCompany Report #2004002315 Age:24 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Foreign Zeldox (Capsules) Delusion Consumer (Ziprasidone) PS Drug Ineffective Health Flunitrazepam Feeling Abnormal Professional (Flunitrazepam) C Hallucination, Auditory Mirtazapine Insomnia (Mirtazapine) C Murder Levomepromazine Treatment Noncompliance (Levomepromazine) C Hydroxyzine Hydrochloride (Hydroxyzine Hydrochloride) C Zaleplon (Zaleplon) C Diazepam (Diazepam) C Nitrazepam (Nitrazepam) C Ranitidine Hydrochloride (Ranitidine Hydrochloride) C Diclofenac (Diclofenac) C Date:01/29/04ISR Number: 4283749-3Report Type:Direct Company Report #CTU 211133 Age:89 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Geodon 20mg/Ml Coma Pfizer PS Pfizer INTRAVENOUS 20 MG/ML DAILY INTRAVENOUS Metoprolol C Losartan C Aspirin C Multiple Vitamin C Calcium Carbonate C Ascorbic Acid C Nitroglycerin C Famotidine C 22-Feb-2006 08:32 AM Page: 479 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Darvocet C Lovenox C Clindamycin C Pentobarbital C Date:01/30/04ISR Number: 4283731-6Report Type:Direct Company Report #CTU 211132E Age:83 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Geodon 20 Mg/Ml Pneumonia Aspiration Pfizer PS Pfizer INTRAMUSCULAR 20 MG DAILY Renal Failure Acute IM Respiratory Failure Pentobarbital C Staphylococcal Sepsis Ancef C Zyvox C Xigris C Vitamins C Metamucil C Aspirin C Colace C Diazide C Lanoxin C Furosemide C Dopamine C Date:01/30/04ISR Number: 4283751-1Report Type:Direct Company Report #CTU 211136 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Feeling Abnormal Geodon 80mg Intervention to Syncope Pfizer/Roerig PS ORAL 80MG X 1 Prevent Permanent Tinnitus MORNIN ORAL Impairment/Damage Geodon SS Date:01/30/04ISR Number: 4283770-5Report Type:Direct Company Report #CTU 211155E Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypotension Geodon PS INTRAMUSCULAR 10 MG 2 DOSES Initial or Prolonged INTRAMUSCULAR Date:01/30/04ISR Number: 4284788-9Report Type:Direct Company Report #CTU 211211E Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Geodon - 20 Mg Initial or Prolonged Anxiety Capsule - Pfizer PS Pfizer 20 MG/DAY Disability Arthralgia INCREASED Bedridden OVER 6 WEEKS Dizziness TO 80MG/DAY Headache Geodon 40 Mg Muscle Twitching Capsule-Pfizer SS Pfizer ORAL 120 MG (40 AM Myalgia 80 PM ) PO 1 WK Nausea Neurontin C Palpitations Paxil Cr C Pyrexia Ativan C Vomiting 22-Feb-2006 08:32 AM Page: 480 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/02/04ISR Number: 4284767-1Report Type:Expedited (15-DaCompany Report #2004003309 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Ziprasidone (Caps) Health (Ziprasidone) PS ORAL 120 MG (BID), Professional ORAL Unspecified Benzodiazeprine C Date:02/02/04ISR Number: 4285389-9Report Type:Expedited (15-DaCompany Report #2004002187 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Upper Foreign Ziprasidone (Caps) Acute Myocardial Health (Ziprasidone) PS ORAL 160 MG BID, Infarction Professional ORAL Hypotension Valproate Magnesium (Valproate Magnesium) C Date:02/03/04ISR Number: 4285801-5Report Type:Expedited (15-DaCompany Report #2003040874 Age:89 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Death Health Geodon (Im) Other Coma Professional (Ziprasidone) PS INTRAMUSCULAR 20 MG Feeding Disorder Company (DAILY), Gastritis Erosive Representative INTRAMUSCULAR Peritonitis Pentobarbital Pulse Absent (Pentobarbital) C Respiratory Arrest Propacet Treatment Noncompliance (Paracetamol, Dextropropoxyphene Napsilate) C Isosorbide Dinitrate (Isosorbide Dinitrate) C Metoprolol (Metoprolol) C Losartan (Losartan) C Heparin-Fraction, Sodium Salt (Heparin-Fraction, Sodium Salt) C Famotidine (Famotidine) C Acetylsalicylic Acid (Acetylsalicylic Acid) C Vitamins C Calcium (Calcium) C Date:02/03/04ISR Number: 4285942-2Report Type:Expedited (15-DaCompany Report #2004005121 Age: Gender: I/FU:I Outcome PT Report Source Hospitalization - Sedation Health Initial or Prolonged Somnolence Professional 22-Feb-2006 08:32 AM Page: 481 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company Representative Product Role Manufacturer Route Dose Duration Geodon (Im) (Ziprasidone) PS INTRAMUSCULAR INTRAMUSCULAR All Other Therapeutic Products SS Date:02/03/04ISR Number: 4286004-0Report Type:Expedited (15-DaCompany Report #2003118610 Age:19 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination Foreign Zeldox (Capsules) Initial or Prolonged Hypomania Health (Ziprasidone) PS ORAL 40 MG Professional (DAILY), ORAL Company Tolterodine Representative L-Tartrate (Tolterodine L-Tartrate) C Melatonin (Melatonin) C Date:02/03/04ISR Number: 4286046-5Report Type:Expedited (15-DaCompany Report #A214068 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Arthritis Consumer Geodon (Ziprasidone) PS ORAL ORAL Hospitalization - Bipolar Disorder Carbamazepine C Initial or Prolonged Body Height Decreased Nadolol C Other Condition Aggravated Valproate Semisodium C Confusional State Clomipramine Depression Hydrochloride C Enzyme Abnormality Hydroxyzine Embonate C Feeling Abnormal Donnatal Hepatocellular Damage (Phenobarbital, Homicidal Ideation Atropine Sulfate, Medication Error Hyoscine Osteoporosis Hydrobromide, C Psychotic Disorder Clonazepam C Date:02/04/04ISR Number: 4285950-1Report Type:Expedited (15-DaCompany Report #2004004515 Age:83 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atrial Fibrillation Health Geodon (Ziprasidone) PS ORAL 10 MG Other Blood Potassium Decreased Professional (DAILY), ORAL Confusional State Digoxin (Digoxin) C Delusion Dyazide Disorientation (Hydrochlorothiazide Haemodialysis , Triamterene) C Myocardial Infarction Docusate Sodium Pneumonia Aspiration (Docusate Sodium) C Renal Impairment Acetylsalicylic Acid Sedation (Acetylsalicylic Staphylococcal Sepsis Acid) C Supraventricular Metamucil "Procter & Extrasystoles Gamble" (Glucose Ventricular Extrasystoles Monohydrate, 22-Feb-2006 08:32 AM Page: 482 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ispaghula Husk) C Vitamins C Pentobarbital (Pentobarbital) C Date:02/04/04ISR Number: 4286475-XReport Type:Expedited (15-DaCompany Report #2003120604 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Consumer Geodon (Ziprasidone) PS ORAL 80 MG (BID), Accident Health ORAL Agitation Professional Zithromax (Caps) Arrhythmia Company (Azithromycin) SS Coronary Artery Representative Donepezil Atherosclerosis Hydrochloride Dysphagia (Donepezil Dysphasia Hydrochloride) SS Hypoxia Myocardial Infarction Pneumonia Aspiration Psychotic Disorder Date:02/04/04ISR Number: 4286498-0Report Type:Expedited (15-DaCompany Report #2004003978 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Health Geodon (Ziprasidone) PS Syndrome Professional All Other Company Therapeutic Products SS Representative All Other Therapeutic Products C Date:02/04/04ISR Number: 4286507-9Report Type:Expedited (15-DaCompany Report #2004004759 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Arrest Health Geodon (Ziprasidone) PS Electrocardiogram Professional Abnormal Date:02/04/04ISR Number: 4286509-2Report Type:Expedited (15-DaCompany Report #2003120606 Age:69 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardio-Respiratory Arrest Consumer Geodon (Ziprasidone) PS Initial or Prolonged Myocardial Infarction Health Other Urinary Tract Infection Professional Company Representative Date:02/04/04ISR Number: 4286774-1Report Type:Expedited (15-DaCompany Report #2003007927 Age:28 YR Gender:Female I/FU:F Outcome PT Hospitalization - Aggression Initial or Prolonged Agitation Dysphonia 22-Feb-2006 08:32 AM Page: 483 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Irritability Mania Pressure Of Speech Report Source Product Role Manufacturer Route Dose Duration Study Geodon (Ziprasidone) PS ORAL 100 MG (BID), Health ORAL Professional Risperidone (Risperidone) C Clonazepam (Clonazepam) C Date:02/04/04ISR Number: 4286784-4Report Type:Expedited (15-DaCompany Report #2003120602 Age:87 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Consumer Geodon (Ziprasidone) PS Initial or Prolonged Agitation Health Donepezil Other Apnoea Professional Hydrochloride Blood Pressure Company (Donepezil Inadequately Controlled Representative Hydrochloride) SS Cardiac Disorder Oxazepam (Oxazepam) C Cardio-Respiratory Arrest Valoproate Cerebrovascular Accident Semisodium Extrapyramidal Disorder (Valproate Fall Semisodium) C Haematoma All Other Haemorrhagic Stroke Therapeutic Products C Mental Status Changes Respiratory Disorder Urinary Tract Infection Date:02/04/04ISR Number: 4286850-3Report Type:Expedited (15-DaCompany Report #2003118617 Age:19 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Zeldox (Capsules) Initial or Prolonged Anxiety Health (Ziprasidone) PS ORAL 80 MG (BID), Confusional State Professional ORAL Impulsive Behaviour Company Paranoid Personality Representative Disorder Schizophrenia Suicidal Ideation Date:02/05/04ISR Number: 4287421-5Report Type:Expedited (15-DaCompany Report #A208548 Age:15 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Health Lithium(Lithium) PS Required Increased Professional Ziprasidone (Caps) Intervention to Eye Movement Disorder (Ziprasidone) SS ORAL 80 MG (BID), Prevent Permanent Globulins Increased ORAL Impairment/Damage Pyelonephritis Clozaril (Clozapine) C Red Cell Distribution Depakote (Valproate Width Increased Semisodium) C Cogentin (Benzatropine Mesilate) C 22-Feb-2006 08:32 AM Page: 484 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/05/04ISR Number: 4288355-2Report Type:Expedited (15-DaCompany Report #2004004898 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Health Geodon (Ziprasidone) PS 80 MG Respiratory Arrest Professional Company Representative Date:02/05/04ISR Number: 4288394-1Report Type:Expedited (15-DaCompany Report #2003121461 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Health Geodon (Ziprasidone) PS ORAL 80 MG (BID), Other Professional ORAL Company Fluoxetine Representative Hydrochloride (Fluoxetine Hydrochloride) C Sulfadiazine Silver (Sulfadiazine Silver) C Tiagabine Hydrochloride (Tiagabine Hydrochloride ) C Tamsulosin (Tamsulosin) C Date:02/06/04ISR Number: 4291361-5Report Type:Direct Company Report #CTU 211717 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Creatine Haloperidol 10 Mg PS 10 MG BID Intervention to Phosphokinase Increased Ziprasidone 80 Mg SS 80 MG BID Prevent Permanent Body Temperature Impairment/Damage Increased Musculoskeletal Stiffness Neuroleptic Malignant Syndrome Date:02/09/04ISR Number: 4289562-5Report Type:Direct Company Report #CTU 211883E Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Geodon 20 Mg Pfizer PS Pfizer INTRAMUSCULAR 20 MG STAT Initial or Prolonged INTRAMUSCULAR Geodon 40 Mg Pfizer SS Pfizer ORAL 60 MG BID ORAL Toprol Xl C Date:02/09/04ISR Number: 4289571-6Report Type:Direct Company Report #CTU 211885E Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Decreased Geodon 20 Mg Pfizer PS Pfizer INTRAMUSCULAR 20 MG STAT Initial or Prolonged Loss Of Consciousness INTRAMUSCLAR Syncope Ambien C 22-Feb-2006 08:32 AM Page: 485 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Aricept C Dilantin C Date:02/09/04ISR Number: 4290205-5Report Type:Expedited (15-DaCompany Report #2003126986 Age:20 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Health Geodon (Ziprasidone) PS ORAL 200 MG (BID) Initial or Prolonged Peroneal Nerve Palsy Professional , ORAL Disability Trismus Company Other Representative Date:02/09/04ISR Number: 4290428-5Report Type:Expedited (15-DaCompany Report #DSA_23807_2004 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Tavor PS Initial or Prolonged Phosphokinase Increased Health Geodon SS Fatigue Professional Zyprexa SS Gamma-Glutamyltransferase Other Increased Intentional Overdose Date:02/09/04ISR Number: 4290899-4Report Type:Expedited (15-DaCompany Report #2004005828 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anxiety Foreign Zeldox (Capsules) Hospitalization - Suicide Attempt Health (Ziprasidone) PS ORAL 120 MG (BID), Initial or Prolonged Treatment Noncompliance Professional ORAL Company Diazepam (Diazepam) C Representative Biperiden Hydrochloride (Biperiden Hydrochloride) C Alprazolam (Alprazolam) C Date:02/10/04ISR Number: 4293820-8Report Type:Expedited (15-DaCompany Report #2003122950 Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Agitation Foreign Zeldox (Capsules) Anxiety Health (Ziprasidone) PS ORAL 160 MG BID, Bruxism Professional ORAL Dyskinesia Other Orphenadrine Dysphoria Hydrochloride Extrapyramidal Disorder (Orphenadrine Hydrochloride) C Clomipramine (Clomipramine) C 22-Feb-2006 08:32 AM Page: 486 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/10/04ISR Number: 4293822-1Report Type:Expedited (15-DaCompany Report #2004005892 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyskinesia Foreign Ziprasidone (Caps) Initial or Prolonged Rash Vesicular Health (Ziprasidone) PS ORAL 60 MG DAILY, Professional ORAL Date:02/11/04ISR Number: 4294592-3Report Type:Expedited (15-DaCompany Report #2004006488 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Discomfort Consumer Geodon (Ziprasidone) PS ORAL 20 MG Abdominal Pain (DAILY), ORAL Anorexia Vicodin Arrhythmia (Paracetamol, Chest Pain Hydrocodone Confusional State Bitartrate) C Cough Diazepam (Diazepam) C Drug Ineffective All Other Feeling Abnormal Therapeutic Products C Heart Rate Increased Vitamins C Insomnia Temazepam Orthostatic Hypotension (Temazepam) C Rhinitis Skin Disorder Stress Ventricular Extrasystoles Date:02/12/04ISR Number: 4293948-2Report Type:Direct Company Report #CTU 212148 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Priapism Geodon 40 Mg Pfizer PS Pfizer ORAL 40 MG BID ORAL Amlodipine C Divalproex C Date:02/13/04ISR Number: 4297197-3Report Type:Expedited (15-DaCompany Report #2004006886 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agitation Health Geodon (Ziprasidone) PS ORAL ORAL Hospitalization - Aspiration Professional Bupropion Initial or Prolonged Cardiac Arrest Company Hydrochloride Other Cardiac Disorder Representative (Bupropion Intentional Overdose Hydrochloride) SS Loss Of Consciousness All Other Multiple Drug Overdose Therapeutic Products SS Suicide Attempt Ethanol (Ethanol) SS Tachycardia Date:02/13/04ISR Number: 4297206-1Report Type:Expedited (15-DaCompany Report #2003127138 Age:21 YR Gender:Male I/FU:I Outcome PT Hospitalization - Anxiety Initial or Prolonged Circulatory Collapse 22-Feb-2006 08:32 AM Page: 487 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dyspnoea Dystonia Laryngospasm Report Source Product Role Manufacturer Route Dose Duration Muscle Spasms Health Geodon (Ziprasidone) PS 120 MG Panic Disorder Professional (DAILY) Other Venlafaxine Hydrochloride (Venlafaxine Hydrochloride) C Escitalopram (Escitalopram) C Temazepam (Temazepam) C Methylphenidate Hydrochloride (Methylphenidate Hydrochloride) C Alprazolam (Alprazolam) C Naproxen (Naproxen) C Date:02/17/04ISR Number: 4296266-1Report Type:Periodic Company Report #US-GLAXOSMITHKLINE-A0428278A Age: YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Psychotic Disorder Lamictal PS Glaxosmithkline ORAL Geodon SS Date:02/17/04ISR Number: 4297580-6Report Type:Direct Company Report #CTU 212403 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oxygen Saturation Geodon Im 20 Mg Decreased Pfizer PS Pfizer ORAL 20 MG IM BID Respiratory Rate IF REFUSES PO Decreased DOSE Tremor Lexagon C Geodon C Date:02/17/04ISR Number: 4299006-5Report Type:Expedited (15-DaCompany Report #2003124392 Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pituitary Tumour Benign Health Geodon (Ziprasidone) PS Professional Date:02/17/04ISR Number: 4299007-7Report Type:Expedited (15-DaCompany Report #2004006488 Age:53 YR Gender:Female I/FU:F Outcome PT Hospitalization - Abdominal Discomfort Initial or Prolonged Abdominal Pain Other Angina Pectoris Anorexia Cardiac Arrest Cardiac Disorder Cardiac Infection 22-Feb-2006 08:32 AM Page: 488 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Condition Aggravated Confusional State Drug Ineffective Report Source Product Role Manufacturer Route Dose Duration Endodontic Procedure Consumer Geodon (Ziprasidone) PS ORAL 20 MG Heart Rate Increased Health (DAILY), ORAL Inflammation Professional Vicodin Initial Insomnia Company (Paracetamol, Nerve Injury Representative Hydrocodone Orthostatic Hypotension Bitartrate) C Pain Diazepam (Diazepam) C Procedural Pain All Other Rhinitis Therapeutic Products C Skin Ulcer Vitamins C Ventricular Extrasystoles Temazepam (Temazepam) C Date:02/17/04ISR Number: 4299160-5Report Type:Expedited (15-DaCompany Report #2004002810 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrioventricular Block Health Geodon (Ziprasidone) PS ORAL 160 MG (BID), Bradycardia Professional ORAL Electrocardiogram Clonazepam Ambulatory Abnormal (Clonazepam) C Hyperhidrosis Paroxetine Sinus Tachycardia Hydrochloride Supraventricular (Paroxetine Tachycardia Hydrochloride) C Syncope Date:02/17/04ISR Number: 4299164-2Report Type:Expedited (15-DaCompany Report #2004001634 Age:68 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Health Geodon (Im) Other Atrioventricular Block Professional (Ziprasidone) PS INTRAMUSCULAR 20 MG, First Degree Company INTRAMUSCULAR Bundle Branch Block Left Representative Olanzapine Ejection Fraction (Olanzapine) C Decreased Haloperidol Mitral Valve Incompetence (Haloperidol) C Mitral Valve Stenosis Oxcarbazepine Myocardial Infarction (Oxcarbazepine) C Syncope Valproate Semisodium Urosepsis (Valproate Water Intoxication Semisodium) C Lithium (Lithium) C Topiramate (Topiramate) C All Other Therapeutic Products C Droperidol (Droperidol) C 22-Feb-2006 08:32 AM Page: 489 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/17/04ISR Number: 4299170-8Report Type:Expedited (15-DaCompany Report #2003122645 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Adverse Drug Reaction Health Geodon (Im) Other Professional (Ziprasidone) PS INTRAMUSCULAR INTRAMUSCULAR Company Representative Date:02/17/04ISR Number: 4299266-0Report Type:Expedited (15-DaCompany Report #2004006886 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agitation Health Geodon (Ziprasidone) PS ORAL ORAL Hospitalization - Aspiration Professional Bupropion Initial or Prolonged Cardiac Arrest Company Hydrochiloride Other Cardiac Disorder Representative (Bupropion Intentional Overdose Hydrochloride) SS Loss Of Consciousness All Other Suicide Attempt Therapeutic Products SS Tachycardia Ethanol (Ethanol) SS Date:02/17/04ISR Number: 4299282-9Report Type:Expedited (15-DaCompany Report #A112467 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Amnesia Consumer Geodon (Ziprasidone) PS ORAL 160 MG (BID), Bone Pain ORAL Condition Aggravated Thiothixene (Caps) Drug Ineffective (Tiotixene) Dyskinesia (Thiothixene) SS ORAL ORAL Fatigue Trazodone Impaired Work Ability (Trazodone) SS Pain Valsartan Pain In Extremity (Valsartan) C Paranoia Propranolol Rash Papular Hydrochloride Temperature Regulation (Propranolol Disorder Hydrochloride) C Tremor Carbamazepine White Blood Cell Count (Carbamazepine) C Increased Clonazepam (Clonazepam) C Date:02/17/04ISR Number: 4299416-6Report Type:Expedited (15-DaCompany Report #2004007003 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Foreign Zeldox (Capsules) Initial or Prolonged Hypomania Health (Ziprasidone) PS ORAL ORAL Impulsive Behaviour Professional Cipramil (Citalopram Mania Hydrobromide) C Mood Altered Suicide Attempt 22-Feb-2006 08:32 AM Page: 490 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/17/04ISR Number: 4299526-3Report Type:Expedited (15-DaCompany Report #2003124604 Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Thyroid Stimulating Health Geodon (Ziprasidone) PS ORAL 160 MG (BID), Hospitalization - Hormone Increased Professional ORAL Initial or Prolonged Coronary Artery Stenosis Company Gatifloxacin Other Drug Interaction Representative (Gatifloxacin) SS ORAL 400 MG (QD), Electrocardiogram Qt ORAL Prolonged Olanzapine Hypothyroidism (Olanzapine) C Hypoxia Lithium (Lithium) C Mental Status Changes Azithromycin Myocardial Infarction (Azithromycin) C Pneumonia Cefotaxime (Cefotaxime) C All Other Therapeutic Products C Date:02/17/04ISR Number: 4299533-0Report Type:Expedited (15-DaCompany Report #2003114583 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Geodon (Ziprasidone) PS Professional Paroxetine Company Hydrochloride Representative (Paroxetine Hydrochloride) C Bupropion Hydrochloride (Bupropion Hydrochloride) C All Other Therapeutic Products C Date:02/17/04ISR Number: 4299540-8Report Type:Expedited (15-DaCompany Report #2003124669 Age:6 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drooling Health Geodon (Ziprasidone) PS 40 MG (ONE Initial or Prolonged Dystonia Professional DOSE), Other Hypersensitivity Company Benzatropine Sedation Representative Mesilate Tongue Disorder (Benzatropine Mesilate) C Date:02/17/04ISR Number: 4299542-1Report Type:Expedited (15-DaCompany Report #2003120418 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Health Geodon (Im) Life-Threatening Arrhythmia Professional (Ziprasidone) PS INTRAMUSCULAR 40 MG (BID, Hospitalization - Sleep Apnoea Syndrome Company PRN), Initial or Prolonged Representative INTRAMUSCULAR Other Chlorpromazine Hydrochloride (Chlorpromazine Hydrochloride) SS INTRAMUSCULAR INTRAMUSCULAR Lorazepam 22-Feb-2006 08:32 AM Page: 491 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Lorazepam) C Insulin Lispro (Insulin Lispro) C Atorvastatin (Atorvastatin) C Pioglitazone (Pioglitazone) C Risperidone (Risperidone) C Aripiprazole (Aripiprazole) C Bupropion Hydrochloride (Bupropion Hydrochloride) C Escitalopram (Escitalopram) C Benzatropine Mesilate (Benzatropine Mesilate) C Date:02/17/04ISR Number: 4299668-2Report Type:Direct Company Report #CTU 212386 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Geodon 80 Mg Pfizer PS Pfizer ORAL 160 MG QHS PO Corrected Interval Klonopin C Prolonged Ambien C Ativan C Date:02/18/04ISR Number: 4300341-2Report Type:Expedited (15-DaCompany Report #2003016824 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypomania Foreign Zeldox (Capsules) Initial or Prolonged Literature (Ziprasidone) PS ORAL 100 MG ORAL Health Venlafaxine Professional Hydrochloride C Company Valproate Sodium C Representative Quetiapine Fumarate C Date:02/18/04ISR Number: 4300352-7Report Type:Expedited (15-DaCompany Report #2004002810 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrioventricular Block Health Geodon (Ziprasidone) PS ORAL 160 MG (BID), Second Degree Professional ORAL Bradycardia Company Clonazepam Cardiac Disorder Representative (Clonazepam) C Hyperhidrosis Paroxetine Sinus Arrhythmia Hydrochloride Sinus Tachycardia (Paroxetine Supraventricular Hydrochloride) C Tachycardia Syncope 22-Feb-2006 08:32 AM Page: 492 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/18/04ISR Number: 4300358-8Report Type:Expedited (15-DaCompany Report #2003040874 Age:89 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Death Health Geodon Other Cardio-Respiratory Arrest Professional (Ziprasidone) PS INTRAMUSCULAR 20 MG Device Failure Company (DAILY), Feeding Disorder Representative INTRAMUSCULAR Gastric Perforation Pentobarbital Peritonitis (Pentobarbital) C Treatment Noncompliance Propacet (Paracetamol Dextropropxyphene Napsilate) C Isosorbide Dinitrate (Isosorbide Dinitrate) C Metoprolol (Metoprolol) C Losartan (Losartan) C Heparin-Fraction, Sodium Salt C Famotidine (Famotidine) C Acetylsalicylic Acid (Acetylsalicylic) C Vitamins C Calcium (Calcium) C Ascorbic Acid (Ascorbic Acid) C Glyceryl Trinitrate (Glyceryl Trinitrate) C Clindamycin (Clindamycin) C Date:02/18/04ISR Number: 4300395-3Report Type:Expedited (15-DaCompany Report #2003118285 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Geodon (Im) Other Cardiac Myxoma Professional (Ziprasidone) PS INTRAMUSCULAR 10 MG, Mitral Valve Prolapse Company INTRAMUSCULAR Representative Date:02/18/04ISR Number: 4300424-7Report Type:Direct Company Report #CTU 212581 E Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Angioneurotic Oedema Ziprasidone PS 80 MG Q HS Initial or Prolonged Dyskinesia Combivent C Tongue Disorder Alprazolam C Divalproex C 22-Feb-2006 08:32 AM Page: 493 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/20/04ISR Number: 4302189-1Report Type:Expedited (15-DaCompany Report #2002003702 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Foreign Geodon (Ziprasidone) PS ORAL 80 MG (BID), Initial or Prolonged Suicide Attempt Health ORAL Professional Alprazolam Company (Alprazolam) SS Representative Date:02/20/04ISR Number: 4302668-7Report Type:Expedited (15-DaCompany Report #2004008313 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chest Discomfort Consumer Geodon (Ziprasidone) PS ORAL (DAILY), ORAL Chest Pain Diltiazem Therapeutic Response (Diltiazem) C Unexpected Torasemide (Torasemide) C Tamsulosin (Tamsulosin) C Gemfibrozil (Gemfibrozil) C Paroxetine Hydrochloride (Paroxetine Hydrochloride) C Hyoscyamine Sulfate (Hyoscyamine Sulfate) C Clonazepam (Clonazepam) C Potassium Chloride (Potassium Chloride) C Atorvastatin (Atorvastatin) C Pantoprazole (Pantoprazole) C Quetiapine Fumarate (Quetiapine Fumarate) C Fenofibrate (Fenofibrate) C Theophylline (Theophylline) C All Other Therapeutic Products C Date:02/20/04ISR Number: 4302675-4Report Type:Expedited (15-DaCompany Report #A208548 Age:15 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Cholesterol Health Lithium Intervention to Increased Professional (Manufacturer Prevent Permanent Eye Movement Disorder Unknown) (Lithium) PS Impairment/Damage Globulins Increased Ziprasidone (Caps) Pyelonephritis (Ziprasidone) SS ORAL 80 MG (BID), Red Cell Distribution ORAL Width Increased Clozaril (Clozapine) C Depakote (Valproate 22-Feb-2006 08:32 AM Page: 494 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Semisodium) C Cogentin (Benzatropine Mesilate) C Date:02/20/04ISR Number: 4302688-2Report Type:Expedited (15-DaCompany Report #2004007166 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Condition Aggravated Health Geodon (Ziprasidone) PS ORAL 160 MG (BID), Other Pharmaceutical Product Professional ORAL Complaint Valproate Semisodium Schizophrenia (Valproate Semisodium) C Topiramate (Topiramate) C Date:02/23/04ISR Number: 4303430-1Report Type:Expedited (15-DaCompany Report #2004007834 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Geodon (Ziprasidone) PS Professional Risperidone Company (Risperidone) SS Representative Date:02/23/04ISR Number: 4303479-9Report Type:Expedited (15-DaCompany Report #2004007836 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Glucose Increased Health Geodon (Ziprasidone) PS Cardiac Disorder Professional Olazapine Pulmonary Thrombosis Company (Olanzapine) SS Representative Date:02/23/04ISR Number: 4303484-2Report Type:Expedited (15-DaCompany Report #2004008866 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Distension Consumer Zoloft (Sertraline) PS ORAL 150 MG, ORAL Initial or Prolonged Confusional State Geodon (Ziprasidone) SS ORAL 40 MG Other Fat Tissue Increased (DAILY), ORAL Fluid Retention Tolterodine Paranoia L-Tartrate Swelling (Tolterodine Urinary Incontinence L-Tartrate) C Weight Increased Omeprazole (Omeprazole) C Rivastigmine Tartrate (Rivastigmine Tartrate) C 22-Feb-2006 08:32 AM Page: 495 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/23/04ISR Number: 4303577-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20040202825 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Study Risperidone Initial or Prolonged Health (Risperidone) Professional Unspecified PS ORAL ORAL Olanzapine (Olanzapine) SS ORAL ORAL Quetiapine (Quetiapine) SS ORAL ORAL Ziprasidone (Ziprasidone) SS ORAL ORAL Perphenazine (Perphenazine) SS ORAL ORAL Lorazepam (Lorazepam) C Date:02/24/04ISR Number: 4303566-5Report Type:Direct Company Report #CTU 213025 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Angioneurotic Oedema Geodon PS ORAL 180 MG DAILY Intervention to Swelling Face ORAL Prevent Permanent Impairment/Damage Date:02/24/04ISR Number: 4304290-5Report Type:Expedited (15-DaCompany Report #2004009465 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Health Geodon (Ziprasidone) PS ORAL 20 MG Initial or Prolonged Chest X-Ray Abnormal Professional (DAILY), ORAL Other Influenza Ciclosporin Respiratory Disorder (Ciclosporin) C Therapy Non-Responder Azathioprine (Azathioprine) C Prednisone C All Other Therapeutic Products C Date:02/24/04ISR Number: 4304438-2Report Type:Expedited (15-DaCompany Report #2004008864 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Pr Foreign Geodon (Ziprasidone) PS ORAL 780 MG, ORAL Initial or Prolonged Prolongation Health Venlafaxine Other Heart Rate Increased Professional (Venlafaxine) C Intentional Overdose Legal Problem Somnolence Suicide Attempt 22-Feb-2006 08:32 AM Page: 496 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/04ISR Number: 4307337-5Report Type:Expedited (15-DaCompany Report #2003007927 Age:28 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Study Geodon (Ziprasidone) PS ORAL 100 MG (BID), Initial or Prolonged Agitation Health ORAL Energy Increased Professional Risperidone Irritability (Risperidone) C Mania Clonazepam (Clonazepam) C Date:02/26/04ISR Number: 4307353-3Report Type:Expedited (15-DaCompany Report #2003125358 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Geodon (Ziprasidone) PS Other Professional Company Representative Date:02/26/04ISR Number: 4307355-7Report Type:Expedited (15-DaCompany Report #2004010630 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Geodon (Ziprasidone) PS Hospitalization - Professional Initial or Prolonged Date:02/26/04ISR Number: 4307358-2Report Type:Expedited (15-DaCompany Report #2004008313 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chest Discomfort Consumer Geodon (Ziprasidone) PS ORAL (DAILY), ORAL Chest Pain Diltiazem (Diltiazem) C Torasemide (Torasemide) C Tamsulosin (Tamsulosin) C Gemfibrozil (Gemfibrozil) C Paroxetine Hydrochloride (Paroxetine Hydrochloride) C Hyoscyamine Sulfate (Hyoscyamine Sulfate) C Clonazepam (Clonazepam) C Potassium Chloride (Potassium Chloride) C Atorvastatin (Atorvastatin) C Pantoprazole (Pantoprazole) C Quetiapine Fumarate (Quetiapine Fumarate) C 22-Feb-2006 08:32 AM Page: 497 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Fenofibrate (Fenofibrate) C Theophylline (Theophylline) C All Other Therapeutic Products C Date:02/26/04ISR Number: 4307869-XReport Type:Periodic Company Report #2002136966US Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Health Celebrex (Celecoxib) Initial or Prolonged Increased Professional Capsule PS ORAL 200 MG, UNK; Aspartate ORAL (SEE Aminotransferase IMAGE) Increased Geodon (Ziprasidone) SS ORAL 20 MG, QD; Bilirubin Conjugated ORAL 42 DAY Increased Tegretol C Blood Alkaline Lamictal Phosphatase Increased (Lamotrigine) C Gamma-Glutamyltransferase Increased Influenza Like Illness Liver Function Test Abnormal Nausea Vomiting Date:02/27/04ISR Number: 4306998-4Report Type:Direct Company Report #CTU 213312 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Geodon 80 Mg Pfizer PS Pfizer ORAL 160 MG Q HS Corrected Interval PO Prolonged Klonopin C Ambien C Ativan C Date:02/27/04ISR Number: 4307000-0Report Type:Direct Company Report #CTU 213313 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oxygen Saturation Geodon Im 20mg Decreased Pfizer PS Pfizer INTRAMUSCULAR 20MG IM BID Respiratory Rate IF REFUSES PO Decreased DOSE Tremor Lexapro C Date:02/27/04ISR Number: 4309187-2Report Type:Expedited (15-DaCompany Report #2004009992 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyskinesia Foreign Zeldox (Capsules) Initial or Prolonged Oesophageal Spasm Health (Ziprasidone) PS ORAL 80 MG (BID), Tongue Spasm Professional ORAL Olanzapine (Olanzapine) C 22-Feb-2006 08:32 AM Page: 498 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/01/04ISR Number: 4308666-1Report Type:Expedited (15-DaCompany Report #2004010552 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Circulatory Collapse Health Geodon (Ziprasidone) PS Initial or Prolonged Professional Company Representative Date:03/02/04ISR Number: 4310987-3Report Type:Expedited (15-DaCompany Report #2004010930 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Delirium Health Geodon (Ziprasidone) PS ORAL ORAL Hospitalization - Tachycardia Professional Risperidone Initial or Prolonged Company (Risperidone) C Representative Date:03/03/04ISR Number: 4311571-8Report Type:Direct Company Report #CTU 213749E Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abasia Ziprasidone PS ORAL 20 AND QD AND Initial or Prolonged Confusional State QHS ORAL Disorientation Divalproex Sodium SS Dysarthria Aspirin C Dyskinesia Benztropine C Mental Status Changes Divalproex Sodium C Motor Dysfunction Rosglitazone C Verapamil C Ziprasidone C Donepezil C Oxybutynin C Date:03/04/04ISR Number: 4313061-5Report Type:Expedited (15-DaCompany Report #2004011724 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hospitalisation Foreign Ziprasidone (Caps) Initial or Prolonged Health (Ziprasidone) PS ORAL ORAL Professional Date:03/04/04ISR Number: 4313309-7Report Type:Expedited (15-DaCompany Report #2003040874 Age:89 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Death Health Geodon (Im) Other Cardio-Respiratory Arrest Professional (Ziprasidone) PS INTRAMUSCULAR 20 MG(DAILY), Coma Company INTRAMUSCULAR Feeding Disorder Representative Pentobarbital Gastric Perforation Other (Pentobarbital) C Peritonitis Propacet (Paracetamol, Dextropropoxyphene Napsilate) C Isosorbide Dinitrate (Isosorbide Dinitrate) C 22-Feb-2006 08:32 AM Page: 499 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Metoprolol (Metoprolol) C Losartan (Losartan) C Heparin-Fraction, Sodium Salt (Heparin-Fraction, Sodium Salt) C Famotidine (Famotidine) C Acetylsalicylic Acid (Acetylsalicylic Acid) C Vitamins C Calcium (Calcium) C Ascorbic Acid (Ascorbic Acid) C Glyceryl Trinitrate (Glyceryl Trinitrate) C Clindamycin (Clindamycin) C Date:03/04/04ISR Number: 4313760-5Report Type:Periodic Company Report #2003119018 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delirium Consumer Geodon (Ziprasidone) PS ORAL 240 MG, ORAL Initial or Prolonged Drug Ineffective Health Medication Error Professional Overdose Unevaluable Event Vomiting Date:03/04/04ISR Number: 4313791-5Report Type:Periodic Company Report #2003119275 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Health Geodon (Ziprasidone) PS Corrected Interval Professional Lithium (Lithium) C Prolonged Company Representative Date:03/04/04ISR Number: 4313793-9Report Type:Periodic Company Report #2003119356 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Health Geodon (Ziprasidone) PS Corrected Interval Professional Haloperidol Prolonged Company (Haloperidol) C Representative Quetiapine Fumarate (Quetiapine Fumarate) C 22-Feb-2006 08:32 AM Page: 500 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/04/04ISR Number: 4313794-0Report Type:Periodic Company Report #2003119639 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Consumer Geodon (Ziprasidone) PS ORAL 60 MG Initial or Prolonged (DAILY), ORAL Methylphenidate Hydrochloride (Methylphenidate Hydrochloride) C Sertraline Hydrochloride (Sertraline Hydrochloride) C Lansoprazole (Lansoprazole) C Methylphenidate (Methylphenidate) C Date:03/04/04ISR Number: 4313795-2Report Type:Periodic Company Report #2003119662 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebrovascular Accident Health Geodon (Ziprasidone) PS Facial Paresis Professional Date:03/04/04ISR Number: 4313796-4Report Type:Periodic Company Report #2003119676 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Geodon (Ziprasidone) PS Professional Company Representative Date:03/04/04ISR Number: 4313799-XReport Type:Periodic Company Report #2003120422 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Health Geodon (Ziprasidone) PS Electrocardiogram Qt Professional All Other Prolonged Company Therapeutic Products C Representative Date:03/04/04ISR Number: 4313800-3Report Type:Periodic Company Report #2003121405 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Health Geodon (Ziprasidone) PS ORAL 160 MG Corrected Interval Professional (DAILY), ORAL Prolonged Haloperidol (Haloperidol) SS ORAL 5 MG, ORAL Quetiapine Fumarate (Quetiapine Fumarate) SS ORAL 1100 MG, ORAL Hydroxine Embonate (Hydroxyzine Embonate) C 22-Feb-2006 08:32 AM Page: 501 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Gemfibrozil (Gemfibrozil) C Lorazepam (Lorazepam) C Levothyroxine Sodium (Levothyroxine Sodium) C Ferrous Sulfate (Ferrous Sulfate) C Gabapentin (Gabapentin) C Nordette (Ethinylestradiol, Levonorgestrel) C Date:03/04/04ISR Number: 4313802-7Report Type:Periodic Company Report #2003122283 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Health Geodon (Ziprasidone) PS Professional Company Representative Date:03/04/04ISR Number: 4313809-XReport Type:Periodic Company Report #2003122959 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Health Geodon (Ziprasidone) PS Initial or Prolonged Asthenia Professional Lithium (Lithium) Confusional State (Lithium) SS Coordination Abnormal Diphenhydramine Drug Ineffective (Diphenhydramine) SS Gait Disturbance Pseudoephedrine Hypomania (Pseudoephedrine) SS Malaise Fluoxetine Mania Hydrochloride Masked Facies (Fluoxetine Memory Impairment Hydrochloride) SS Meniere'S Disease Quetiapine Fumarate Muscle Twitching (Quetiapine Myalgia Fumarate) SS Pain Of Skin Topiramate Sleep Disorder (Topiramate) C Valproate Semisodium (Valproate Semisodium) C Trazodone (Trazodone) C Hyoscyamine (Hyoscyamine) C Antidepressants C 22-Feb-2006 08:32 AM Page: 502 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/04/04ISR Number: 4313811-8Report Type:Periodic Company Report #2003122988 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Health Geodon (Ziprasidone) PS ORAL 80 MG (BID), Oculogyration Professional ORAL Valproate Semisodium (Valproate Semisodium) C Date:03/04/04ISR Number: 4313812-XReport Type:Periodic Company Report #2003124395 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Health Geodon (Ziprasidone) PS 120 MG Initial or Prolonged Insomnia Professional (DAILY) Sertraline Hydrochloride (Sertraline Hydrochloride) C Estrogens Conjugated (Estrogens Conjugated) C Date:03/04/04ISR Number: 4313814-3Report Type:Periodic Company Report #2003125740 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Muscle Rigidity Health Geodon (Ziprasidone) PS Initial or Prolonged Professional Company Representative Date:03/04/04ISR Number: 4313816-7Report Type:Periodic Company Report #2004000824 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Consumer Geodon (Ziprasidone) PS Initial or Prolonged Somnolence Other Date:03/04/04ISR Number: 4313819-2Report Type:Periodic Company Report #2004001621 Age:13.5 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Torticollis Health Geodon (Ziprasidone) PS ORAL 20 MG (QAM), Professional ORAL Valproate Semisodium (Valproate Semisodium) C Citalopram Hydrobromide (Citalopram Hydrobromide) C Levothyroxine Sodium (Levothyroxine Sodium) C Quetiapine Fumarate 22-Feb-2006 08:32 AM Page: 503 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Quetiapine Fumarate) C Obetrol (Dexamfetamine Sulfate, Amfetamine Sulfate, Dexamfetamine C Date:03/04/04ISR Number: 4313823-4Report Type:Periodic Company Report #2004004608 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Geodon (Ziprsidone) PS Professional Bupropion Company Hydrochloride Representative (Bupropion Hydrochloride) C Date:03/04/04ISR Number: 4313824-6Report Type:Periodic Company Report #2004004897 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Health Geodon (Ziprasidone) PS (DAILY) Initial or Prolonged Professional Antidepressants C Company Representative Date:03/04/04ISR Number: 4313825-8Report Type:Periodic Company Report #2004005901 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bradycardia Health Geodon (Ziprasidone) PS Professional Clonidine Company (Clonidine) SS Representative Date:03/04/04ISR Number: 4313826-XReport Type:Periodic Company Report #2004005904 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bradycardia Health Geodon (Ziprasidone) PS Professional Clonidine Company (Clonidine) SS Representative Date:03/04/04ISR Number: 4313828-3Report Type:Periodic Company Report #2004006844 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Geodon (Ziprasidone) PS 160 MG Professional (DAILY) Company Representative 22-Feb-2006 08:32 AM Page: 504 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/04/04ISR Number: 4313829-5Report Type:Periodic Company Report #2004007539 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oculogyration Health Geodon (Ziprasidone) PS UNKNOWN UNK Professional (UNKNOWN), Company UNKNOWN Representative Date:03/04/04ISR Number: 4313831-3Report Type:Periodic Company Report #2004007556 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oculogyration Health Geodon (Ziprasidone) PS UNKNOWN UNK Professional (UNKNOWN), Company UNKNOWN Representative Date:03/04/04ISR Number: 4313833-7Report Type:Periodic Company Report #2003037090 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bundle Branch Block Right Health Geodon (Ziprasidone) PS 120 MG Professional (DAILY) Paroxetine Hydrochloride (Paroxetine Hydrochloride) C Clonazepam C Date:03/04/04ISR Number: 4313838-6Report Type:Periodic Company Report #2003039458 Age:21 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Health Geodon (Ziprasidone) PS ORAL 40 MG (BID), Initial or Prolonged Professional ORAL Company Sertraline Representative Hydrochloride (Sertraline Hydrochloride) C Date:03/04/04ISR Number: 4313843-XReport Type:Periodic Company Report #2003041739 Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Blepharospasm Health Geodon (Ziprasidone) PS ORAL 120 MG Corneal Reflex Decreased Professional (DAILY) ORAL Grimacing Company Lorazepam Photophobia Representative (Lorazepam) SS UNKNOWN UNKNOWN (UNKNOWN), UNKNOWN Aripiprazole (Aripiprazole) SS ORAL 15 MG (BID), ORAL Venlafaxine Hydrochloride C Paroxetine Hydrochloride C 22-Feb-2006 08:32 AM Page: 505 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Alprazolam C Risperidone C Date:03/04/04ISR Number: 4313854-4Report Type:Periodic Company Report #2003113469 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Health Geodon (Ziprasidone) PS ORAL 160 MG (BID), Initial or Prolonged Intentional Overdose Professional ORAL Sedation Company Paroxetine Representative Hydrochloride C Topiramate C Date:03/08/04ISR Number: 4314147-1Report Type:Direct Company Report #CTU 214044 Age:17.5 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Balance Disorder Geodon PS ORAL 40 MG PO BID Dystonia Zoloft C Oculogyration Swollen Tongue Date:03/08/04ISR Number: 4314156-2Report Type:Direct Company Report #CTU 214047 Age:17.5 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Balance Disorder Geodon PS ORAL 40 MG PO BID Dystonia Zoloft C Oculogyration Swollen Tongue Date:03/08/04ISR Number: 4314361-5Report Type:Expedited (15-DaCompany Report #2004012240 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Coma Health Geodon (Ziprasidone) PS INTRAMUSCULAR INTRAMUSCULAR Medication Error Professional Company Representative Date:03/08/04ISR Number: 4314663-2Report Type:Expedited (15-DaCompany Report #2002002139 Age:49 YR Gender:Male I/FU:F Outcome PT Life-Threatening Asthenia Hospitalization - Blood Pressure Increased Initial or Prolonged Brain Damage Cardiac Arrest Delusional Disorder, Persecutory Type Drooling Dyskinesia Faecal Incontinence Feeling Abnormal Feeling Hot And Cold Head Injury 22-Feb-2006 08:32 AM Page: 506 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Loss Of Consciousness Muscle Twitching Paraesthesia Report Source Product Role Manufacturer Route Dose Duration Pulse Absent Foreign Zeldox (Ziprasidone) PS ORAL 160 MG (BID), Respiratory Arrest Health ORAL Respiratory Failure Professional Atorvastatin Salivary Hypersecretion (Atorvastatin) C Treatment Noncompliance Oxazepam (Oxazepam) C Urinary Incontinence Vomiting Date:03/08/04ISR Number: 4314667-XReport Type:Expedited (15-DaCompany Report #2002001221 Age:33 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Ziprasidone Initial or Prolonged Increased Health (Ziprasidone) PS 80 MG (TWICE Other Atrial Fibrillation Professional A DAY) Blood Lactate Zuclopenthixol Dehydrogenase Increased (Zuclopenthixol) C Gamma-Glutamyltransferase Levomepromazine Increased (Levomepromazine) C Liver Function Test Oxazepam (Oxazepam) C Abnormal Citalopram (Citalopram) C Date:03/10/04ISR Number: 4315312-XReport Type:Direct Company Report #CTU 214238 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Geodon PS ORAL 40 MG PO BID Trileptal C Klonopin C Levothroid C Premarin C Date:03/10/04ISR Number: 4315793-1Report Type:Expedited (15-DaCompany Report #2004012872 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Health Geodon (Ziprasidone) PS 80 MG (BID) Phosphokinase Increased Professional Fluoxetine Feeling Abnormal Company Hydrochloride Headache Representative (Fluoxetine Muscle Rigidity Hydrochloride) C Muscle Twitching Risperidone Neuroleptic Malignant (Risperidone) C Syndrome Pyrexia Serotonin Syndrome Date:03/10/04ISR Number: 4316001-8Report Type:Expedited (15-DaCompany Report #2004015305 Age: Gender: I/FU:I Outcome PT Report Source Other Paralysis Foreign Health 22-Feb-2006 08:32 AM Page: 507 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Product Role Manufacturer Route Dose Duration Zeldox (Capsules) (Ziprasidone) PS ORAL ORAL Date:03/11/04ISR Number: 4316618-0Report Type:Expedited (15-DaCompany Report #2004013793 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Geodon (Ziprasidone) PS Other Professional Company Representative Date:03/12/04ISR Number: 4316426-0Report Type:Direct Company Report #CTU 214316E Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neuroleptic Malignant Geodon 80 Mg Hospitalization - Syndrome Capsules Pfizer PS Pfizer ORAL SEE IMAGE Initial or Prolonged Date:03/15/04ISR Number: 4317011-7Report Type:Expedited (15-DaCompany Report #2004013789 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Geodon (Ziprasidone) PS Confusional State Professional Olanzapine Disorientation (Olanzapine) SS Date:03/15/04ISR Number: 4317014-2Report Type:Expedited (15-DaCompany Report #2004014288 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Health Geodon (Im) Other Professional (Ziprasidone) PS INTRAMUSCULAR INTRAMUSCULAR Company Representative Date:03/15/04ISR Number: 4318438-XReport Type:Expedited (15-DaCompany Report #2004016096 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Geodon (Ziprasidone) PS 80 MG (DAILY) Other Health All Other Professional Therapeutic Products C Company Representative 22-Feb-2006 08:32 AM Page: 508 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/15/04ISR Number: 4318803-0Report Type:Expedited (15-DaCompany Report #2004001636 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Geodon (Ziprasidone) PS ORAL 240 MG (BID), Other Sudden Death Professional ORAL Quetiapine Fumarate (Quetiapine Fumarate) C Date:03/15/04ISR Number: 4318816-9Report Type:Expedited (15-DaCompany Report #2004001639 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Bradycardia Health Geodon (Im) Coma Professional (Ziprasidone) PS INTRAMUSCULAR 10 MG, Drug Screen Positive Other INTRAMUSCULAR Electrocardiogram Diphenhydramine Abnormal Hydrochloride (Diphenhydramine Hydrochloride) C Date:03/15/04ISR Number: 4318835-2Report Type:Expedited (15-DaCompany Report #04P-163-0250676-00 Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Confusional State Health Depakote Er Intervention to Drug Interaction Professional (Divalproex Sodium) Prevent Permanent Extrapyramidal Disorder Company (Divalproex Sodium) PS ORAL 500 MG, 500 Impairment/Damage Fall Representative MG 2 TABS Lethargy BID, PER Musculoskeletal Stiffness ORAL; 500 MG, Overdose 3 IN 1 D, PER Urinary Incontinence Geodon (Ziprasidone Weight Increased Hydrochloride) SS ORAL 100 MG, 1 IN 1 D, PER ORAL; 40 MG, 1 IN 1 D, PER ORAL Blood Pressure Medications C Olanzapine C Date:03/15/04ISR Number: 4318891-1Report Type:Expedited (15-DaCompany Report #2004013793 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Geodon (Ziprasidone) PS 160 Other Professional Company Representative Date:03/15/04ISR Number: 4318910-2Report Type:Expedited (15-DaCompany Report #2003124529 Age:20 YR Gender:Female I/FU:F Outcome Hospitalization - Initial or Prolonged 22-Feb-2006 08:32 AM Page: 509 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Disability Other PT Report Source Product Role Manufacturer Route Dose Duration Abasia Consumer Geodon (Ziprasidone) PS ORAL 200 MG (BID), Extrapyramidal Disorder Health ORAL Gait Disturbance Professional Grunting Company Jaw Disorder Representative Joint Lock Motor Dysfunction Peroneal Nerve Palsy Date:03/17/04ISR Number: 4320236-8Report Type:Expedited (15-DaCompany Report #2004016901 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Toxic Skin Eruption Foreign Zeldox (Capsules) Viral Infection Health (Ziprasidone) PS ORAL 120 MG (BID), Professional ORAL Date:03/17/04ISR Number: 4320237-XReport Type:Expedited (15-DaCompany Report #2004016172 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Foreign Zeldox (Capsules) Initial or Prolonged Electrocardiogram Qt Health (Ziprasidone) PS ORAL 160 MG Other Corrected Interval Professional (DAILY), ORAL Prolonged Citalopram Electrocardiogram Qt Hydrobromide Prolonged (Citalopram Ventricular Extrasystoles Hydrobromide) SS ORAL 20 MG (DAILY) ORAL Lorazepam (Lorazepam) C Date:03/17/04ISR Number: 4320238-1Report Type:Expedited (15-DaCompany Report #2004014957 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Circulatory Collapse Foreign Zeldox (Capsules) Initial or Prolonged Dementia Health (Ziprasidone) PS ORAL 40 MG, ORAL Disease Progression Professional Captopril Grand Mal Convulsion (Captopril) C Furosemide (Furosemide) C Metamizole Sodium (Metamizole Sodium) C Date:03/17/04ISR Number: 4320239-3Report Type:Expedited (15-DaCompany Report #2004014597 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Foreign Zeldox (Capsules) Initial or Prolonged White Blood Cell Count Health (Ziprasidone) PS ORAL 120 MG Decreased Professional (DAILY), ORAL Olanzapine (Olanzapine) SS ORAL 20 MG 22-Feb-2006 08:32 AM Page: 510 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (DAILY), ORAL Flupentixol (Flupentixol) SS ORAL 10 MG (DAILY), ORAL Flupntixol Decanoate (Flupentixol Decanoate SS INTRAMUSCULAR INTRAMUSCULAR Lorazepam (Lorazepam) C Biperiden Hydrochloride (Biperiden Hydrochloride) C Date:03/18/04ISR Number: 4319490-8Report Type:Direct Company Report #CTU 214737 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Aggression Zoloft 200 Mg Pfizer PS Pfizer BUCCAL 200 MG ONCE Hospitalization - Agitation DAILY BUCCAL Initial or Prolonged Asthenia Geodon SS BUCCAL EGODON ONCE Disability Confusional State DAILY BUCCAL Other Depression Disturbance In Attention Hyperventilation Legal Problem Motor Dysfunction Paraesthesia Road Traffic Accident Suicidal Ideation Tremor Date:03/19/04ISR Number: 4320430-6Report Type:Direct Company Report #CTU 214857 E Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hypokalaemia Geodon (Ziprasidone) PS PT NOT ALWAYS Vomiting COMPLAINT HAD MEDS AT BEDSIDE BUT PRESCRIPTION Date:03/19/04ISR Number: 4322338-9Report Type:Expedited (15-DaCompany Report #2004000561 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Abdominal Pain Upper Foreign Zeldox (Capsule) Anxiety Health (Ziprasidone) PS ORAL SEE IMAGE Bladder Disorder Professional Zopiclone Diarrhoea (Zopiclone) C Dizziness Headache Hypersensitivity Inflammation Psoriasis Social Avoidant Behaviour Tinnitus 22-Feb-2006 08:32 AM Page: 511 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/22/04ISR Number: 4320824-9Report Type:Direct Company Report #CTU 214917 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Upper Geodon 20 Mg Chills Pfizer/Ssc Pharmacy PS Pfizer/Ssc Pharmacy ORAL ONE QD PO Feeling Abnormal Celexa 20 Mg Headache Forest/Ssc Pharmacy SS Forest/Ssc Pharmacy ORAL 1/2 QD PO Malaise L-Thyroxen C Mobility Decreased Tylenol C Pyrexia Ibuprofen C Tremor Date:03/22/04ISR Number: 4320905-XReport Type:Direct Company Report #CTU 214928E Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Back Pain Geodon 80 Mg Pfizer PS Pfizer ORAL 80 MG BID Initial or Prolonged Blood Creatine ORAL Phosphokinase Increased Diltiazem Sa C Extrapyramidal Disorder Movement Disorder Muscle Rigidity Neuroleptic Malignant Syndrome Suicidal Ideation Date:03/22/04ISR Number: 4323225-2Report Type:Expedited (15-DaCompany Report #2004002315 Age:24 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Foreign Zeldox (Capsules) Drug Ineffective Consumer (Ziprasidone) PS UNKNOWN Feeling Abnormal Health Flunitrazepam Hallucination, Auditory Professional (Flunitrazepam) C Hypersomnia Mirtazapine Insomnia (Mirtazapine) C Physical Assault Levomepromazine (Levomepromazine) C Hydroxyzine Hydrochloride (Hydroxyzine Hydrochloride) C Zaleplon (Zaleplon) C Diazepam (Diazepam) C Nitrazepam (Nitrazepam) C Ranitidine Hydrochloride (Ranitidine Hydrochloride) C Diclofenac (Diclofenac) C 22-Feb-2006 08:32 AM Page: 512 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/23/04ISR Number: 4324138-2Report Type:Expedited (15-DaCompany Report #2004014288 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Geodon (Im) Hospitalization - Convulsion Professional (Ziprasidone) PS INTRAMUSCULAR 80 MG DAILY Initial or Prolonged Hypovolaemia Company INTRAMUSCULAR Other Oral Intake Reduced Representative Supraventricular Tachycardia Date:03/23/04ISR Number: 4324179-5Report Type:Expedited (15-DaCompany Report #2004008871 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aneurysm Health Geodon (Ziprasidone) PS ORAL ORAL Other Circulatory Collapse Professional Quetiapine Fumarate C Dysgeusia Other Diazepam C Dyspnoea Lithium Carbonate C Loss Of Consciousness Propranolol C Myocardial Infarction Metformin Pain Hydrochloride C Sudden Death Fosinopril Sodium C Tooth Abscess Levothyroxine Sodium C Date:03/23/04ISR Number: 4324197-7Report Type:Expedited (15-DaCompany Report #2004016566 Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Health Geodon (Ziprasidone) PS ORAL 80 MG (BID), Initial or Prolonged Gastrointestinal Professional ORAL Other Haemorrhage Prednisone Weight Decreased (Prednisone) SS 5 MG (DAILY) Mirtazapine C Docusate C Paracetamol C Lansoprazole C Lactulose C Ipratropium Bromide C Salbutamol C Date:03/23/04ISR Number: 4324887-6Report Type:Expedited (15-DaCompany Report #2003005372 Age:70 YR Gender:Female I/FU:F Outcome PT Life-Threatening Atrial Fibrillation Hospitalization - Blood Pressure Decreased Initial or Prolonged Bundle Branch Block Left Other Circulatory Collapse Depression Dizziness Drug Interaction Electrocardiogram Qt Prolonged Paranoia Respiratory Tract Infection Tachycardia Torsade De Pointes 22-Feb-2006 08:32 AM Page: 513 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ventricular Tachycardia Vomiting Report Source Product Role Manufacturer Route Dose Duration Foreign Zeldox (Capsules) Health (Ziprasidone) PS ORAL 80 MG (BID), Professional ORAL Verapamil Hydrochloride (Verapamil Hydrochloride) SS ORAL 160 MG (BID), ORAL Theophylline (Theophylline) SS ORAL ORAL Digitoxin (Digitoxin) SS ORAL ORAL Zopiclone (Zopiclone) SS ORAL ORAL Levofloxacin (Levofloxacin) SS Date:03/24/04ISR Number: 4323824-8Report Type:Direct Company Report #CTU 215209 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Pressure Decreased Geodon 20 Mg Cerebrovascular Accident Pfizer/Omnicare Mn PS Pfizer/Omnicare ORAL 20 MG BID Coma ORAL (5 Pupil Fixed DOSES) Pupils Unequal Date:03/24/04ISR Number: 4325505-3Report Type:Expedited (15-DaCompany Report #2004017234 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anger Health Geodon (Ziprasidone) PS Initial or Prolonged Anxiety Professional Clonazepam Other Catatonia (Clonazepam) C Crying Lorazepam Delusion (Lorazepam) C Fear Diphenhydramine Hallucinations, Mixed Hydrochloride Hypokinesia (Diphenhydramine Incoherent Hydrochloride) C Mutism Neuroleptic Malignant Syndrome Psychotic Disorder Staring Date:03/24/04ISR Number: 4325512-0Report Type:Expedited (15-DaCompany Report #2004017225 Age: Gender:Male I/FU:I Outcome PT Hospitalization - Abnormal Behaviour Initial or Prolonged Contusion Other Diabetes Mellitus Eye Injury Head Injury 22-Feb-2006 08:32 AM Page: 514 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hospitalisation Periorbital Haematoma Swelling Face Report Source Product Role Manufacturer Route Dose Duration Consumer Geodon (Ziprasidone) PS ORAL 40 MG (BID), ORAL Fluphenazine (Fluphenazine) SS Valproate Semisodium (Valproate Semisodium) C Benzatropine Mesilate (Benzatropine Mesilate) C Glucose (Glucose) C Loratadine (Loratadine) C Docusate Sodium (Docusate Sodium) C Glucose (Glucose) C Date:03/24/04ISR Number: 4325543-0Report Type:Expedited (15-DaCompany Report #2004000563 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Magnesium Decreased Health Geodon (Ziprasidone) PS ORAL 120 MG (BID), Initial or Prolonged Cardiac Murmur Professional ORAL Contusion Company Bupropion Electrocardiogram Qt Representative Hydrochloride C Corrected Interval Paroxetine Prolonged Hydrochloride C Hypocalcaemia Alprazolam C Liver Palpable Subcostal Despiramine Pitting Oedema Hydrochloride C Syncope Cetirizine Hydrochloride C Tramadol Hydrochloride C Date:03/24/04ISR Number: 4325546-6Report Type:Expedited (15-DaCompany Report #2003039106 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Interaction Consumer Geodon (Ziprasidone) PS Electrocardiogram Qt Health Chlorpromazine Prolonged Professional Hydrochloride Overdose Company (Chlorpromazine Representative Hydrochloride) SS Date:03/25/04ISR Number: 4327666-9Report Type:Expedited (15-DaCompany Report #2004016096 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Geodon (Ziprasidone) PS 80 MG (DAILY) Other Condition Aggravated Health All Other Suicidal Ideation Professional Therapeutic Products C Company Representative 22-Feb-2006 08:32 AM Page: 515 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/25/04ISR Number: 4327927-3Report Type:Expedited (15-DaCompany Report #2004017260 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Health Geodon (Ziprasidone) PS Other Professional Abilify Company (Aripiprazole) C Representative Lamictal (Lamotrigine) C Date:03/25/04ISR Number: 4327951-0Report Type:Expedited (15-DaCompany Report #2004017243 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Geodon (Ziprasidone) PS (TWICE) Professional Date:03/25/04ISR Number: 4327982-0Report Type:Expedited (15-DaCompany Report #2004017231 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Albumin Increased Health Geodon (Ziprasidone) PS 160 MG (BID) Hospitalization - Blood Glucose Increased Professional Geodon (Im) Initial or Prolonged Blood Urea Increased (Ziprasidone) SS INTRAMUSCULAR 20 MG, Other Haematocrit Increased INTRAMUSCULAR Hallucination Amlodipine Besilate Neuroleptic Malignant (Amlodipine Syndrome Besilate) C Protein Total Increased Quinidine White Blood Cell Count (Quinidine) C Increased Paracetamol (Paracetamol) C Diphenhydramine Hydrochloride (Diphyenhydramine Hydrochloride) C Diltiazem (Diltiazem) C Glibenclamide (Glibenclamide) C Levothyroxine Sodium (Levothyroxine Sodium) C Lorazepam (Lorazepam) C Metformin (Metformin) C Pioglitazone (Pioglitazone) C Sertraline Hydrochloride (Sertraline Hydrochloride) C 22-Feb-2006 08:32 AM Page: 516 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/29/04ISR Number: 4330255-3Report Type:Expedited (15-DaCompany Report #2004018270 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Foreign Zeldox (Capsules) Hospitalization - Cardiac Arrest Consumer (Ziprasidone) PS ORAL 200 MG (BID), Initial or Prolonged Pulmonary Embolism Health ORAL Refusal Of Treatment By Professional Haloperidol Patient (Haloperidol) C Restlessness Clonazepam (Clonazepam) C Date:03/29/04ISR Number: 4330302-9Report Type:Expedited (15-DaCompany Report #2004017635 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Foreign Geodon (Ziprasidone) PS ORAL 120 MG (BID), Initial or Prolonged Diarrhoea Health ORAL Hypokalaemia Professional Diuretics C Hyponatraemia Lorazepam Polydipsia (Lorazepam) C Polyuria Paroxetine Vomiting (Paroxetine) C Antihypertensives C Irbesartan (Irbesartan) C Verapamil Hydrochloride (Verapamil Hydrochloride) C Prednisolone (Prednisolone) C Date:03/29/04ISR Number: 4330368-6Report Type:Expedited (15-DaCompany Report #A107389 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Foreign Ziprasidone PS ORAL 120 MG (BID), Initial or Prolonged Confusional State Study ORAL Delirium Health Lorazepam C Depressed Mood Professional Benztropine C Fall Multivitamin C Injury Quetiapine Fumarate C Schizoaffective Disorder Haloperidol C Skin Laceration Valproic Acid C Tachycardia Date:03/29/04ISR Number: 4330542-9Report Type:Expedited (15-DaCompany Report #2004004898 Age:6 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyspnoea Health Geodon (Ziprasidone) PS 80 MG Dystonia Professional Company Representative 22-Feb-2006 08:32 AM Page: 517 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/29/04ISR Number: 4330554-5Report Type:Expedited (15-DaCompany Report #2004017852 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaphylactic Reaction Consumer Geodon (Ziprasidone) PS ORAL 80 MG (BID), ORAL Methylphenidate (Methylphenidate) C Date:03/31/04ISR Number: 4331006-9Report Type:Expedited (15-DaCompany Report #2004018430 Age:5 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Health Geodon (Ziprasidone) PS ORAL 120 MG (BID), Convulsion Professional ORAL Dystonia Company Eye Rolling Representative Fall Heart Rate Abnormal Incontinence Date:03/31/04ISR Number: 4331033-1Report Type:Expedited (15-DaCompany Report #2004018978 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Geodon (Ziprasidone) PS Professional Benzatropine Mesilate (Benzatropine Mesilate) C Aripiprazole (Aripiprazole) C Date:03/31/04ISR Number: 4331035-5Report Type:Expedited (15-DaCompany Report #2004019113 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Geodon (Ziprasidone) PS 120 MG Professional Depakote (Valproate Company Semisodium) C Representative Trileptal "Ciba-Gegy" (Oxcarbazepine) C Effexor (Venlafaxine Hydrochloride) C Date:03/31/04ISR Number: 4331038-0Report Type:Expedited (15-DaCompany Report #2004019116 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Health Geodon (Ziprasidone) PS ORAL 120 MG Initial or Prolonged Hyponatraemia Professional (DAILY), ORAL Other Polydipsia Company Zoloft (Sertraline) SS ORAL 50 MG Representative (DAILY), ORAL 22-Feb-2006 08:32 AM Page: 518 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/31/04ISR Number: 4331109-9Report Type:Expedited (15-DaCompany Report #2004018729 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcohol Poisoning Health Geodon (Ziprasidone) PS 80 MG Initial or Prolonged Chest Pain Professional (DAILY), Other Electrocardiogram Qt Company Paroxetine Corrected Interval Representative Hydrochloride Prolonged (Paroxetine Suicidal Ideation Hydrochloride) C Ventricular Extrasystoles Date:03/31/04ISR Number: 4331239-1Report Type:Expedited (15-DaCompany Report #2004016011 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dermatitis Exfoliative Foreign Zeldox (Capsules) Initial or Prolonged Vasculitis Health (Ziprasidone) PS ORAL 80 MG, ORAL Professional Etilefrine Hydrochloride (Etilefrine Hydrochloride) SS ORAL ORAL Methylprednisolone (Methylprednisolone) SS 40 MG Clemastine (Clemastine) SS Melperone (Melperone) C Lyogen Depot (Fluphenazine) C Date:03/31/04ISR Number: 4332205-2Report Type:Expedited (15-DaCompany Report #2003116303 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Autonomic Nervous System Foreign Ziprasidone (Caps) Imbalance Study (Ziprasidone) PS ORAL 120 MG (BID), Bradycardia Health ORAL Cardiac Disorder Professional Delorazepam Cardiac Failure (Delorazepam) C Condition Aggravated Lormatazepam Dehydration (Lormetazepam) C Drug Ineffective Drug Interaction Hallucination, Auditory Hallucination, Olfactory Heterophoria Hypotension Nausea Oral Intake Reduced Pallor Schizophrenia Somnolence Tachycardia Vomiting 22-Feb-2006 08:32 AM Page: 519 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/01/04ISR Number: 4333217-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040202825 Age:80 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aortic Valve Incompetence Study Risperidone Initial or Prolonged Blood Creatine Health (Risperidone) PS ORAL ORAL Phosphokinase Mb Professional Olanzapine Increased (Olanzapine) SS ORAL ORAL Cerebral Atrophy Quetiapine Electrocardiogram Q Waves (Quetiapine) SS ORAL ORAL Fall Ziprasidone Hypertension (Ziprasidone) SS ORAL ORAL Mobility Decreased Perphenazine ( Myoglobin Blood Increased Perphenazine) SS ORAL ORAL Proteinuria Lorazepam Qrs Axis Abnormal (Lorazepam) C Ventricular Extrasystoles Date:04/01/04ISR Number: 4333472-1Report Type:Expedited (15-DaCompany Report #2004019290 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Serotonin Syndrome Health Geodon (Ziprasidone) PS 20 MG (DAILY) 5 DAY Professional Venlafaxine Company Hydrochloride Representative (Venlafaxine Hydrochloride) SS Date:04/01/04ISR Number: 4333496-4Report Type:Expedited (15-DaCompany Report #2004000563 Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Health Geodon (Ziprasidone) PS ORAL 120 MG (BID), Initial or Prolonged Blood Magnesium Decreased Professional ORAL Cardiac Murmur Company Bupropion Contusion Representative Hydrochloride Electrocardiogram Qt (Bupropion Corrected Interval Hydrochloride) C Prolonged Paroxetine Hypocalcaemia Hydrochloride Liver Palpable Subcostal (Paroxetine Oedema Hydrochloride) C Pitting Oedema Alprazolam Syncope (Alprazolam) C Weight Increased Desipramine Hydrochloride (Desipramine Hydrochloride) C Cetirizine Hydrochloride (Cetirizine Hydrochloride) C Tramadol Hydrochloride (Tramadol Hydrochloride) C 22-Feb-2006 08:32 AM Page: 520 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/02/04ISR Number: 4333693-8Report Type:Expedited (15-DaCompany Report #2004019819 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Consumer Geodon (Ziprasidone) PS ORAL ORAL Initial or Prolonged Aggression Donepezil Anxiety Hydrochloride Dissociative Identity (Donepezil Disorder Hydrochloride) C Insomnia Risperidone (Risperidone) C Levothyroxine Sodium (Levothyroxine Sodium) C Phenytoin Sodium (Phenytoin Sodium) C Date:04/02/04ISR Number: 4333719-1Report Type:Expedited (15-DaCompany Report #2004021193 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Foreign Ziprasidone (Caps) Health (Ziprasidone) PS ORAL ORAL Professional Date:04/02/04ISR Number: 4333720-8Report Type:Expedited (15-DaCompany Report #2004021190 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Foreign Ziprasidone (Caps) Health (Ziprasidone) PS ORAL ORAL Professional Date:04/02/04ISR Number: 4333831-7Report Type:Expedited (15-DaCompany Report #2004020657 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperammonaemia Health Geodon (Ziprasidone) PS Initial or Prolonged Psychotic Disorder Professional Valproate Semisodium Company (Valproate Representative Semisodium) SS All Other Therapeutic Products SS Date:04/06/04ISR Number: 4335536-5Report Type:Expedited (15-DaCompany Report #2004020341 Age:37 YR Gender:Male I/FU:I Outcome PT Other Confusional State Depression Difficulty In Walking Dysuria Feeling Abnormal Headache Hypoacusis Hypoaesthesia Hypokinesia Impaired Work Ability 22-Feb-2006 08:32 AM Page: 521 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Motor Dysfunction Nervous System Disorder Penis Disorder Report Source Product Role Manufacturer Route Dose Duration Tinnitus Consumer Geodon (Ziprasidone) PS ORAL 80 MG (BID) Visual Acuity Reduced ORAL Visual Disturbance Risperdal Weight Increased (Risperidone) SS ORAL 2 MG (BID) ORAL Date:04/06/04ISR Number: 4335542-0Report Type:Expedited (15-DaCompany Report #2004020336 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diarrhoea Consumer Geodon (Ziprasidone) PS 240 MG Initial or Prolonged Drug Ineffective (DAILY) Other Economic Problem Zoloft (Sertraline) SS 200 MG Rash Pruritic Amantadine Restlessness (Amantadine) SS Rhinorrhoea Hydroxyzine Embonate C Schizophrenia Tardive Dyskinesia Tremor Date:04/07/04ISR Number: 4336393-3Report Type:Expedited (15-DaCompany Report #2004020396 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neuroleptic Malignant Health Geodon (Ziprasidone) PS ORAL (TID), ORAL Hospitalization - Syndrome Professional Initial or Prolonged Other Date:04/08/04ISR Number: 4337296-0Report Type:Expedited (15-DaCompany Report #2004021434 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bedridden Foreign Zeldox (Capsules) Initial or Prolonged Dysphagia Health (Ziprasidone) PS ORAL 120 MG (BID), Extrapyramidal Disorder Professional ORAL Muscle Rigidity Company Representative Date:04/09/04ISR Number: 4342737-9Report Type:Periodic Company Report #03P-163-0214844-00 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Level Decreased Other Depakote 500mg Initial or Prolonged Mania (Depakote) (Divalproex Sodium) (Divalproex Sodium) PS ORAL 500 MG, 4 IN 1 D, PER ORAL Depakote Er (Divalproex Sodium) (Divalproex Sodium) SS ORAL PER ORAL Depakine Syrup (Depakote) (Divalproex Sodium) (Divalproex Sodium) SS ORAL 1500 MG, 2 IN 22-Feb-2006 08:32 AM Page: 522 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report 1 D, PER ORAL Ziprasidone Hydrochloride SS 60 MG, 2 IN 1 D Hydroxyzine C Lisinopril C Levothyroxine Sodium C Zinc C Lovastatin C Acetylsalicylic Acid C Glibenclamide C Gemfibrozil C Date:04/12/04ISR Number: 4339374-9Report Type:Expedited (15-DaCompany Report #2004008874 Age:83 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atrial Fibrillation Health Geodon (Im) Myocardial Infarction Professional (Ziprsidone) PS INTRAMUSCULAR 20 MG Pneumonia Aspiration Other (DAILY), Renal Failure Acute INTRAMUSCULAR Respiratory Failure Vitamins (Vitamins) C Staphylococcal Sepsis Pentobarbital Supraventricular (Pentobarbital) C Extrasystoles Cefazolin Sodium Ventricular Extrasystoles (Cefazolin Sodium) C Linezolid (Linezolid) C Drotrecogin Alfa (Drotrecogin Alfa) C Psyllium (Psyllium) C Acetylsalicylic Acid (Acetylsalicylic Acid) C Docusate Sodium (Docusate Sodium) C Gliclazide (Gliclazide) C Digoxin (Digoxin) C Furosemide (Furosemide) C Dopamine (Dopamine) C Date:04/12/04ISR Number: 4339379-8Report Type:Expedited (15-DaCompany Report #2004022130 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Health Geodon (Ziprasidone) PS Syndrome Professional Company Representative Date:04/12/04ISR Number: 4340324-XReport Type:Expedited (15-DaCompany Report #2004022322 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Geodon (Ziprasidone) PS ORAL (DAILY), ORAL Initial or Prolonged Anxiety Consumer Speech Disorder 22-Feb-2006 08:32 AM Page: 523 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/12/04ISR Number: 4341363-5Report Type:Periodic Company Report #2004007662 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Decreased Health Geodon (Im) Initial or Prolonged Heart Rate Increased Professional (Ziprasidone) PS INTRAMUSCULAR 20 MG, Company INTRAMUSCULAR Representative Date:04/12/04ISR Number: 4341364-7Report Type:Periodic Company Report #2004008869 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypotension Health Geodon (Im) Initial or Prolonged Professional (Ziprasidone) PS INTRAMUSCULAR 10 MG (2 Other DOSES), INTRAMUSCULAR Escitalopram (Escitalopram) C Metipranolol (Metipranolol) C Pilocarpine (Pilocarpine) C Dorzolamide Hydrochloride (Dorzolamide Hydrochloride) C Paracetamol (Paracetamol) C Lorazepam (Lorazepam) C Date:04/12/04ISR Number: 4341365-9Report Type:Periodic Company Report #2004015152 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oculogyration Health Geodon (Im) Professional (Ziprasidone) PS INTRAMUSCULAR INTRAMUSCULAR Company Representative Date:04/12/04ISR Number: 4341366-0Report Type:Periodic Company Report #2004015153 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oculogyration Health Geodon (Im) Professional (Ziprasidone) PS INTRAMUSCULAR INTRAMUSCULAR Company Representative Date:04/13/04ISR Number: 4340776-5Report Type:Expedited (15-DaCompany Report #2004009465 Age:39 YR Gender:Male I/FU:F Outcome PT Hospitalization - Chest X-Ray Abnormal Initial or Prolonged Idiosyncratic Drug Other Reaction Influenza 22-Feb-2006 08:32 AM Page: 524 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Respiratory Disorder Report Source Product Role Manufacturer Route Dose Duration Health Geodon (Ziprasidone) PS ORAL 20 MG Professional (DAILY), ORAL Ciclosporin (Ciclosporin) C Azathioprine (Azathioprine) C Prednisone (Prednisone) C All Other Therapeutic Products (All Other Therapeutic Products) C Date:04/13/04ISR Number: 4340905-3Report Type:Expedited (15-DaCompany Report #2004005892 Age:58 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyskinesia Foreign Ziprasidone (Caps) Initial or Prolonged Rash Maculo-Papular Health (Ziprasidone) PS ORAL 120 MG Professional (DAILY), ORAL Date:04/13/04ISR Number: 4340958-2Report Type:Expedited (15-DaCompany Report #2004022047 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Foreign Geodon (Ziprasidone) PS 120 MG Other Health (DAILY), Professional Company Representative Date:04/13/04ISR Number: 4341015-1Report Type:Expedited (15-DaCompany Report #2004021837 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypersensitivity Foreign Geodon (Ziprasidone) PS ORAL 60 MG Initial or Prolonged Oedema Health (DAILY), ORAL Professional Paroxetine Company Hydrochloride Representative (Paroxetine Hydrochloride) SS ORAL ORAL Other Nutrients (Other Nutrients) SS Date:04/15/04ISR Number: 4342021-3Report Type:Expedited (15-DaCompany Report #2004023211 Age:52 YR Gender:Female I/FU:I Outcome PT Hospitalization - Abasia Initial or Prolonged Agitation Anxiety Body Temperature Decreased 22-Feb-2006 08:32 AM Page: 525 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Bradykinesia Cogwheel Rigidity Corneal Reflex Decreased Report Source Product Role Manufacturer Route Dose Duration Delusion Literature Geodon (Ziprasidone) PS 40 MG BID Depression Health Sinemet (Carbidopa, Disorientation Professional Levodopa) C Electrocardiogram St Pramipexole Segment Abnormal (Pramipexole) C Electroencephalogram Simvastatin Abnormal (Simvastatin) C Hallucinations, Mixed Salbutamol Headache (Salbutamol) C Hyperhidrosis Levothyroxine Impaired Self-Care (Levothyroxine) C Masked Facies All Other Muscle Spasms Therapeutic Products C Neuroleptic Malignant Syndrome Parkinson'S Disease Respiratory Rate Increased Sinus Tachycardia Date:04/15/04ISR Number: 4342038-9Report Type:Expedited (15-DaCompany Report #2004023066 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Geodon (Ziprasidone) PS ORAL 80 MG (BID), Other Suicide Attempt Professional ORAL Company Prozac (Fluoxetine Representative Hydrochloride) C Valium (Diazepam) C Abilify (Aripiprazole) C Date:04/15/04ISR Number: 4342064-XReport Type:Expedited (15-DaCompany Report #2004017260 Age:27 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Health Geodon (Ziprasidone) PS Other Professional Abilify Company (Aripiprazole) C Representative Lamictal (Lamotrigine) C Date:04/16/04ISR Number: 4342363-1Report Type:Expedited (15-DaCompany Report #2004010552 Age:29 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Loss Of Consciousness Health Geodon (Ziprasidone) PS ORAL 80 MG (QHS) Somnolence Professional ORAL Company Rabeprazole Sodium C Representative Valdecoxib C 22-Feb-2006 08:32 AM Page: 526 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/16/04ISR Number: 4342386-2Report Type:Expedited (15-DaCompany Report #2004023941 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Alcohol Increased Health Geodon (Ziprasidone) PS Other Completed Suicide Professional Ethanol (Ethanol) C Date:04/16/04ISR Number: 4342397-7Report Type:Expedited (15-DaCompany Report #2004022869 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Suicide Attempt Health Geodon (Ziprasidone) PS Professional Company Representative Date:04/19/04ISR Number: 4341541-5Report Type:Direct Company Report #CTU 216900 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Geodon PS Aggression Synthroid C Apathy Dilantin C Oral Intake Reduced Screaming Sedation Social Avoidant Behaviour Staring Date:04/19/04ISR Number: 4343630-8Report Type:Expedited (15-DaCompany Report #2004023066 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Geodon (Ziprasidone) PS ORAL 160 MG (BID) Other Suicide Attempt Professional , ORAL Company Prozac (Fluoxetine Representative Hydrochloride) C Valium Diazepam) C Abilify (Aripiprazole) C Date:04/20/04ISR Number: 4345280-6Report Type:Expedited (15-DaCompany Report #2004023941 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Alcohol Increased Health Geodon (Ziprasidone) PS Other Completed Suicide Professional Ethanol (Ethanol) C Overdose Date:04/20/04ISR Number: 4345283-1Report Type:Expedited (15-DaCompany Report #2004023721 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hypokalaemia Health Geodon (Ziprasidone) PS ORAL ORAL Other Vomiting Professional Doxepin (Doxepin) C Other All Other Therapeutic Products 22-Feb-2006 08:32 AM Page: 527 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (All Other Therapeutic Products) C Date:04/21/04ISR Number: 4345104-7Report Type:Direct Company Report #CTU 217131 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Extrapyramidal Disorder Geodon 60mg Pfizer PS Pfizer Toprol Xl C Metoprolol C Abilify C Neurontin C Acetaminophen C Maalox C Chlorphenir-Amine C Benztropine C Date:04/21/04ISR Number: 4345230-2Report Type:Direct Company Report #CTU 217153 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Ziprasidone 80 Mg PS ORAL 80 MG DAILY Initial or Prolonged Syndrome ORAL Required Rhabdomyolysis Intervention to Prevent Permanent Impairment/Damage Date:04/21/04ISR Number: 4345683-XReport Type:Expedited (15-DaCompany Report #2004025168 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Overdose Health Geodon (Ziprasidone) PS Tachycardia Professional Lithium (Lithium) SS Company Representative Date:04/21/04ISR Number: 4345694-4Report Type:Expedited (15-DaCompany Report #2004025153 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Health Geodon (Im) Professional (Ziprasidone) PS INTRAMUSCULAR ONE DOSE, INTRAMUSCULAR Digoxin (Digoxin) C Warfarin (Warfarin) C Date:04/21/04ISR Number: 4345717-2Report Type:Expedited (15-DaCompany Report #2004004515 Age:83 YR Gender:Male I/FU:F Outcome PT Death Atrial Fibrillation Other Blood Potassium Decreased Confusional State Delusion Disorientation 22-Feb-2006 08:32 AM Page: 528 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Haemodialysis Myocardial Infarction Pneumonia Aspiration Report Source Product Role Manufacturer Route Dose Duration Renal Failure Acute Health Geodon (Ziprasidone) PS ORAL 10 MG DAILY Respiratory Failure Professional ORAL Sedation Other Cefazolin C Staphylococcal Sepsis Gliclazide C Supraventricular Furosemide C Extrasystoles Dopamine C Ventricular Extrasystoles Linezolid C Drotrecogin Alfa C Psyllium C Digoxin C Dyazide (Hydrochlorothiazide , Triamterene) C Docusate Sodium C Acetylsalicylic Acid C Metamucil "Procter & Gamble" (Glucose Monohydrate, Ispaghula Husk) C Vitamins C Pentobarbital C Date:04/23/04ISR Number: 4346171-7Report Type:Direct Company Report #CTU 217229 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Goedon (Ziprasidone) Prolonged 40 Mg Po Tid Pfizer PS Pfizer ORAL 40 MG PO TID Nemenda C Depakote C Lopressor C Aricept C Remeron C Digoxin C Zestril C Lasix C Colace C Lipitor C Warfarin C Metamucil C Mvi C Date:04/26/04ISR Number: 4349467-8Report Type:Expedited (15-DaCompany Report #2004008940 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bipolar Disorder Foreign Ziprasidone (Caps) Gamma-Glutamyltransferase Health (Ziprasidone) PS ORAL 40 MG (BID), Increased Professional ORAL Hepatitis C Company Sertraline Platelet Count Decreased Representative (Sertraline) Other (Sertraline) SS ORAL 100 MG (DAILY), ORAL 22-Feb-2006 08:32 AM Page: 529 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/26/04ISR Number: 4349495-2Report Type:Expedited (15-DaCompany Report #2004017234 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Health Geogon (Ziprasidone) PS Initial or Prolonged Agitation Professional Clonazepam C Other Anger Lorazepam C Anxiety Diphenhydramine Blood Glucose Increased Hydrochloride C Blood Pressure Pioglitazone C Fluctuation Diltiazem Blood Pressure Increased Hydrochloride C Crying Levothyroxine Sodium C Delusion Metformin Depression Hydrochloride C Dyskinesia Sertraline Fear Hydrochloride C Flat Affect Glibenclamide C Hallucination, Auditory Hallucination, Visual Hyperhidrosis Incoherent Intentional Self-Injury Muscle Rigidity Neuroleptic Malignant Syndrome Psychotic Disorder Rhabdomyolysis Schizophrenia, Paranoid Type Date:04/26/04ISR Number: 4349746-4Report Type:Expedited (15-DaCompany Report #2004018978 Age:66 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Health Geodon (Ziprasidone) PS Professional Benzatropine Mesilate (Benzatropine Mesilate) C Aripiprazole (Aripiprazole) C Date:04/26/04ISR Number: 4349751-8Report Type:Expedited (15-DaCompany Report #2004025130 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Health Geodon (Ziprasidone) PS Professional Date:04/27/04ISR Number: 4349044-9Report Type:Direct Company Report #CTU 217418 Age:36 YR Gender:Female I/FU:I Outcome Life-Threatening Other Required Intervention to Prevent Permanent 22-Feb-2006 08:32 AM Page: 530 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Neuroleptic Malignant Haloperidol 10 Mg Im PS INTRAMUSCULAR 10 MG IM Syndrome Geodon 20 Mg Im SS INTRAMUSCULAR 20 MG IM Risperal M Tabs C Haldol C Ablitify C Date:04/27/04ISR Number: 4350870-0Report Type:Expedited (15-DaCompany Report #2004017852 Age:14 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anaphylactic Reaction Consumer Geodon (Ziprasidone) PS ORAL 80 MG (BID) Other Health ORAL Professional Methylphenidate (Methylphenidate) C Date:04/27/04ISR Number: 4350876-1Report Type:Expedited (15-DaCompany Report #2004025661 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Geodon (Ziprasidone) PS Initial or Prolonged Hyponatraemia Professional Other Company Representative Date:04/27/04ISR Number: 4350881-5Report Type:Expedited (15-DaCompany Report #2004027684 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Complications Of Maternal Foreign Ziprasidone (Caps) Exposure To Therapeutic Health (Ziprasidone) PS ORAL ORAL Drugs Professional Eclampsia Company Pregnancy Representative Date:04/28/04ISR Number: 4350825-6Report Type:Expedited (15-DaCompany Report #2004026100 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Low Density Lipoprotein Health Geodon (Ziprasidone) PS ORAL 120 MG (BID), Initial or Prolonged Increased Professional ORAL Other Syncope Paroxetine Ventricular Tachycardia Hydrochloride (Paroxetine Hydrochloride) C Medroxyprogesterone Acetate (Medroxyprogesterone Acetate) C 22-Feb-2006 08:32 AM Page: 531 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/28/04ISR Number: 4350830-XReport Type:Expedited (15-DaCompany Report #2004026550 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Road Traffic Accident Health Geodon (Ziprasidone) PS Professional Company Representative Date:04/28/04ISR Number: 4350835-9Report Type:Expedited (15-DaCompany Report #2004026078 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Health Geodon (Ziprasidone) PS Agitation Professional Date:04/28/04ISR Number: 4350836-0Report Type:Expedited (15-DaCompany Report #2004026011 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Health Gedodon Agitation Professional (Ziprasidone) PS Date:04/29/04ISR Number: 4352787-4Report Type:Expedited (15-DaCompany Report #2004026328 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Platelet Count Decreased Consumer Geodon (Ziprasidone) PS ORAL 240 MG (TID), ORAL Clozapine (Clozapine) SS ORAL 50 MG (BID), ORAL Clonazepam (Clonazepam) C Date:04/30/04ISR Number: 4351254-1Report Type:Direct Company Report #CTU 217735 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dysuria Ziprasidone PS 80 MG BID Intervention to Prevent Permanent Impairment/Damage Date:04/30/04ISR Number: 4353472-5Report Type:Expedited (15-DaCompany Report #2004019116 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Delirium Health Geodon (Ziprasidone) PS ORAL 120 MG (BID), Hospitalization - Grand Mal Convulsion Professional ORAL Initial or Prolonged Hyponatraemia Company Zoloft (Sertraline) SS ORAL 50 MG Other Polydipsia Representative (DAILY), ORAL Psychotic Disorder 22-Feb-2006 08:32 AM Page: 532 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/30/04ISR Number: 4353473-7Report Type:Expedited (15-DaCompany Report #2004025153 Age:73 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Health Geodon (Im) Professional (Ziprasidone) PS INTRAMUSCULAR (ONE DOSE), INTRAMUSCULAR Digoxin (Digoxin) C Warfarin (Warfarin) C Date:04/30/04ISR Number: 4353494-4Report Type:Expedited (15-DaCompany Report #2004026037 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eye Haemorrhage Health Geodon (Ziprasidone) PS ORAL 40 MG (BID), Professional ORAL Company Neurontin Representative (Gabapentin) (Gabapentin) SS ORAL 1800 MG (TID), ORAL Zoloft (Sertraline) SS ORAL 50 MG (DAILY), ORAL Date:05/03/04ISR Number: 4353199-XReport Type:Direct Company Report #CTU 217861 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anuria Geodon (Ziprasidone) Hospitalization - Anxiety 40 Mg Po PS 20 MG QD THEN Initial or Prolonged Atrioventricular Block 10 MG QD, Other Second Degree THEN 40 MG Required Bladder Disorder BID Intervention to Blood Pressure Increased Effexor C Prevent Permanent Cardiac Disorder Celebrex C Impairment/Damage Convulsion Zomig C Dyskinesia Imitrex C Dyspnoea Darvocet C Headache Heart Rate Increased Medication Error Mental Disorder Paranoia Parosmia Speech Disorder Tremor Visual Disturbance Date:05/03/04ISR Number: 4354444-7Report Type:Expedited (15-DaCompany Report #2004026743 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agitation Foreign Ziprasidone (Caps) Hospitalization - Restlessness Health (Ziprasidone) PS ORAL 80 MG Initial or Prolonged Suicide Attempt Professional (DAILY), ORAL Haloperidol (Haloperidol) C 22-Feb-2006 08:32 AM Page: 533 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/03/04ISR Number: 4354548-9Report Type:Expedited (15-DaCompany Report #2004026695 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Albumin Decreased Health Geodon (Ziprasidone) PS ORAL 40 MG (TWICE Initial or Prolonged Blood Creatinine Professional A DAY), ORAL Other Increased Deonpezil Blood Glucose Decreased Hydrochloride Blood Glucose Increased (Donepezil Blood Pressure Abnormal Hydrochloride) SS Blood Pressure Increased Furosemide Blood Sodium Decreased (Furosemide) C Blood Urea Increased Amiodarone Bundle Branch Block Left (Amiodarone) C Coma Ramipril (Ramipril) C Confusional State Acetylsalicylic Acid Constipation (Acetylsalicylic Diarrhoea Acid) C Dyspnoea Glipizide Electrocardiogram Qt (Glipizide) C Prolonged Metoprolol Succinate Hyperhidrosis (Metoprolol Hypothermia Succinate) C Nodal Rhythm Carvedilol Pallor (Carvedilol) C Pco2 Decreased Hydralazine Pupil Fixed (Hydralazine) C Respiratory Disorder Haloperidol White Blood Cell Count (Haloperidol) C Decreased All Other White Blood Cell Count Therapeutic Products Increased (All Other Therapeutic Products) C Ketamine (Ketamine) C Methazolamide (Methazolamide) C Vicodin (Hydrocodone Bitartrate, Paractamol) C Cefalexin Monohydrate (Cefalexin Monohydrate) C Gatifloxacin (Gatifloxacin) C Betahanechol Chloride (Bethanechol Chloride) C Senna Fruit (Senna Fruit) C Insulin (Insulin) C Date:05/04/04ISR Number: 4353316-1Report Type:Direct Company Report #CTU 217895 Age:65 YR Gender:Female I/FU:I Outcome Death Life-Threatening Hospitalization - 22-Feb-2006 08:32 AM Page: 534 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged PT Report Source Product Role Manufacturer Route Dose Duration Neuroleptic Malignant Abilify 10 Mg Bms PS Bms ORAL 10 MG DAILY Syndrome ORAL Pneumonia Geodon 20 Mg Pfizer SS Pfizer ORAL 20 MG Q12 H Sepsis PRN ORAL Exelon C Haldol C Remeron C Zyprexa C Levaquin C Celexa C Motrin C Prevacid C Date:05/04/04ISR Number: 4355021-4Report Type:Expedited (15-DaCompany Report #2004027266 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pancreatitis Health Geodon (Ziprasidone) PS Professional Company Representative Date:05/04/04ISR Number: 4355189-XReport Type:Expedited (15-DaCompany Report #2004013789 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Geodon (Ziprasidone) PS 160 Confusional State Professional Olanzapine Disorientation Company (Olanzapine) SS Psychotic Disorder Representative Weight Increased Date:05/04/04ISR Number: 4355224-9Report Type:Expedited (15-DaCompany Report #2004014114 Age: Gender:Female I/FU:I Outcome PT Hospitalization - Agitation Initial or Prolonged Alopecia Other Anger Anorexia Anxiety Dizziness Drug Effect Decreased Drug Hypersensitivity Feeling Abnormal Hypertension Insomnia Irritability Joint Swelling Oedema Peripheral Pain Paraesthesia Paranoia Rash Rash Erythematous 22-Feb-2006 08:32 AM Page: 535 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Weight Decreased Weight Increased Report Source Product Role Manufacturer Route Dose Duration Consumer Geodon (Ziprasidone) PS ORAL ORAL Lithium (Lithium) (Lithium) SS Perphenazine (Perphenazine) SS Benzatropine Mesilate (Benzatropine Mesilate) C Diazepam (Diazepam) C Zolpidem Tartrate (Zolpidem Tartrate) C Simvastatin (Simvastatin) C Levothyroxine Sodium (Levothyroxine Sodium) C Folic Acid (Folic Acid) C Gabapentin (Gabapentin) C All Other Therapeutic Products (All Other Therapeutic Products) C Date:05/04/04ISR Number: 4355498-4Report Type:Expedited (15-DaCompany Report #2004028116 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Complications Of Maternal Foreign Ziprasidone (Caps) Exposure To Therapeutic Health (Ziprasidone) PS Drugs Professional Intra-Uterine Death Company Maternal Drugs Affecting Representative Foetus Pregnancy Date:05/05/04ISR Number: 4355624-7Report Type:Expedited (15-DaCompany Report #DSA_24259_2004 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aptyalism Foreign Tavor PS Initial or Prolonged Confusional State Health Geodon SS Convulsion Professional Fall Other Intentional Overdose Mydriasis Polytraumatism Rhabdomyolysis 22-Feb-2006 08:32 AM Page: 536 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/05/04ISR Number: 4355801-5Report Type:Expedited (15-DaCompany Report #2004017260 Age:27 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Akathisia Health Geodon (Ziprasidone) PS 80 MG (2 IN 1 Other Anxiety Professional D) Coma Company Fluoxetine Crying Representative Hydrochloride Depression (Fluoxetine Drug Effect Decreased Hydrochloride) SS (10 MG, 1 IN Euphoric Mood 1 D) Flashback Abilify Hallucination, Auditory (Aripiprazole) C Headache Lamictal Hypersomnia (Lamotrigine) C Increased Appetite Insomnia Irritability Mania Memory Impairment Mood Swings Restlessness Sedation Social Avoidant Behaviour Sudden Cardiac Death Suicidal Ideation Tension Weight Increased Date:05/07/04ISR Number: 4356086-6Report Type:Direct Company Report #CTU 218141 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Tylenol 1000mg PS 1 X Initial or Prolonged Medication Error ADMINISTRATIO Self-Medication N (OVER DOSE Somnolence OF ANOTHERS Vomiting MEDS) Colace 100 Mg SS Geodon 40 Mg SS Mvi SS Risperidone 3 Mg SS Seroquel 100 Mg SS Sertraline 150 Mg SS Date:05/07/04ISR Number: 4356765-0Report Type:Expedited (15-DaCompany Report #2004028909 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Consumer Geodon (Ziprasidone) PS Date:05/07/04ISR Number: 4357491-4Report Type:Expedited (15-DaCompany Report #HQ4041603SEP2002 Age:32 YR Gender:Male I/FU:F Outcome PT Life-Threatening Alanine Aminotransferase Hospitalization - Increased Initial or Prolonged Aspartate Aminotransferase 22-Feb-2006 08:32 AM Page: 537 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Increased Blood Creatinine Increased Cardiac Failure Report Source Product Role Manufacturer Route Dose Duration Cardiomyopathy Health Efexor Depot Decreased Appetite Professional (Venlafaxine Diarrhoea Other Hydrochloride, Gamma-Glutamyltransferase Capsule, Extended Increased Release) PS ORAL 300 MG 1X PER Liver Disorder 1 DAY Liver Function Test Geodon (Ziprasidone) SS ORAL 120 MG 3X PER Abnormal 1 DAY ORAL 6 MON Nausea Imovane (Zopiclone) C Renal Disorder Triatec (Ramipril) C Shock Seloken - Slow Vomiting Release (Metoprolol Tartrate) C Lanacrist (Digoxin) C Spironolactone Nm Pjarma (Spironolactone) C Furosemide (Furosemide) C Date:05/10/04ISR Number: 4356299-3Report Type:Direct Company Report #CTU 218286 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Geodon 80 Mg PS ORAL 80 MG BID PO Initial or Prolonged Prolonged Fall Syncope Date:05/11/04ISR Number: 4358119-XReport Type:Expedited (15-DaCompany Report #2004028900 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Eruption Foreign Zeldox (Capsules) Initial or Prolonged Inflammation Health (Ziprasidone) PS ORAL 160 MG (80 Other Oedema Peripheral Professional MG, 2 IN 1 Pruritus Company D), ORAL Representative Prothipendyl Hydrochloride (Prothipendyl Hydrochloride) C Lorazepam (Lorazepam) C Silymarin (Silymarin) C Date:05/11/04ISR Number: 4358182-6Report Type:Expedited (15-DaCompany Report #2004028913 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Consumer Geodon (Ziprasidone) PS 22-Feb-2006 08:32 AM Page: 538 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/11/04ISR Number: 4358212-1Report Type:Expedited (15-DaCompany Report #2004028463 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Ineffective Health Geodon (Im) Sudden Death Professional (Ziprasidone) PS INTRAMUSCULAR ( MULTIPLE Company TIMES)INTRAMU Representative SCULAR Lorazepam (Lorazepam) SS INTRAMUSCULAR (MULTIPLE TIMES), INTRAMUSCULAR All Other Therapeutic Product (All Other Therapeutic Products) SS Date:05/11/04ISR Number: 4358392-8Report Type:Expedited (15-DaCompany Report #2004028829 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Geodon (Ziprasidone) PS ORAL ORAL Initial or Prolonged Schizophrenia Professional All Other Other Company Therapeutic Products Representative (All Other Therapeutic Products) C Date:05/11/04ISR Number: 4358697-0Report Type:Expedited (15-DaCompany Report #2004029157 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Arrest Consumer Geodon (Ziprasidone) PS ORAL ORAL Other Eye Pain Lamotrigine Furuncle (Lamotrigine) C Infection Lorazepam Injection Site Pain (Lorazepam) C Mydriasis Haloperidol Refusal Of Treatment By (Haloperidol) C Patient Date:05/11/04ISR Number: 4358730-6Report Type:Expedited (15-DaCompany Report #2004029174 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Syncope Foreign Geodon (Ziprasidone) PS Initial or Prolonged Health Professional Company Representative Date:05/11/04ISR Number: 4358744-6Report Type:Expedited (15-DaCompany Report #2004028463 Age:18 YR Gender:Female I/FU:F Outcome Death Life-Threatening 22-Feb-2006 08:32 AM Page: 539 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hospitalization - Initial or Prolonged PT Report Source Product Role Manufacturer Route Dose Duration Abnormal Behaviour Health Geodon (Im) Agitation Professional (Ziprasidone) PS INTRAMUSCULAR REPEATED TWO Body Temperature Company HOURS LATER, Increased Representative INTRAMUSCULAR Cardiac Arrest Lorazepam Cardio-Respiratory Arrest (Lorazepam) SS INTRAMUSCULAR REPEATED TWO Catatonia HOURS LATTER, Hyperhidrosis INTRAMUSCULAR Sedation Cocaine (Cocaine) SS Sudden Death Diamorphine Tremor (Diamorphine) SS All Other Therapeutic Products C Date:05/12/04ISR Number: 4359591-1Report Type:Expedited (15-DaCompany Report #2004029499 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Geodon (Im) Professional (Ziprasidone) PS 80 MG (40 MG, 2 IN 1 Date:05/13/04ISR Number: 4359559-5Report Type:Expedited (15-DaCompany Report #2004029730 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chest Discomfort Health Geodon (Ziprasidone) PS ORAL 80 MG (2 IN 1 Chest Pain Professional D), ORAL Constipation Paroxetine Diarrhoea Hydrochloride Dizziness (Paroxetine Dizziness Postural Hydrochloride) C Dry Mouth Dysarthria Feeling Drunk Impaired Work Ability Lethargy Rash Serotonin Syndrome Somnolence Date:05/13/04ISR Number: 4359561-3Report Type:Expedited (15-DaCompany Report #2004023823 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Back Pain Health Geodon (Ziprasidone) PS ORAL 160 MG (2 IN Initial or Prolonged Neuroleptic Malignant Professional 1 D), ORAL Other Syndrome Other Diltiazem Nuchal Rigidity (Diltiazem) C Refusal Of Treatment By Diphenhydramine Patient (Diphenhydramine) C Risperidone (Risperidone) C Quetiapine (Quetiapine) C 22-Feb-2006 08:32 AM Page: 540 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydroxyzine (Hydroxyzine) C Benzatropine Mesilate (Benzatropine Mesilate) C Phenoxymethylpenicil lin Potassium (Phenoxymethylpenici llin Potassium) C Ibuprofen (Ibuprofen) C Paracetamol (Paracetamol) C Date:05/13/04ISR Number: 4359586-8Report Type:Expedited (15-DaCompany Report #2004029319 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Level Increased Health Geodon (Ziprasidone) PS 80 MG (UNK, 2 Medication Error Professional IN 1 D), Neuroleptic Malignant Company UNKNOWN Syndrome Representative Lithium (Lithium) SS 1500 Renal Failure Acute (UNKNOWN) Fluphenazine Decanoate (Fluphenazine Decanoate) C Date:05/14/04ISR Number: 4360452-2Report Type:Expedited (15-DaCompany Report #2004029472 Age:58 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Health Geodon (Ziprasidone) PS 160 MG Abnormal Professional Date:05/17/04ISR Number: 4359095-6Report Type:Direct Company Report #CTU 218258E Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Dysphonia Geodon 100 Mg Per Other Dystonia Day PS ORAL/ 1 1/2 Vocal Cord Disorder MONTH Pfizer C Date:05/17/04ISR Number: 4359324-9Report Type:Direct Company Report #CTU 218749 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Geodon 80 Mg PS ORAL 80 MG BID PO Initial or Prolonged Prolonged Fall Syncope 22-Feb-2006 08:32 AM Page: 541 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/17/04ISR Number: 4361402-5Report Type:Expedited (15-DaCompany Report #2004004898 Age:16 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyspnoea Health Geodon (Ziprasidone) PS ORAL 80 MG (2 IN 1 Dystonia Professional D), ORAL Muscle Contractions Company Fluoxetine Involuntary Representative Hydrochloride (Fluoxetine Hydrochloride) C ORAL 10 MG (1 IN 1 D), ORAL Date:05/18/04ISR Number: 4362399-4Report Type:Expedited (15-DaCompany Report #2004028829 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Geodon (Ziprasidone) PS ORAL ORAL Initial or Prolonged Dependence Professional All Other Other Schizophrenia Company Therapeutic Products C Treatment Noncompliance Representative Date:05/18/04ISR Number: 4362814-6Report Type:Expedited (15-DaCompany Report #2004030948 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyspnoea Health Geodon (Ziprasidone) PS ORAL ORAL Initial or Prolonged Fibrin D Dimer Increased Professional Ranitidine Heart Rate Increased Hydrochloride C Pulmonary Embolism Date:05/19/04ISR Number: 4364363-8Report Type:Expedited (15-DaCompany Report #2004018430 Age:5 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Health Geodon (Ziprasidone) PS ORAL 120 MG (2 IN Convulsion Professional 1 D), ORAL Dystonia Company Oxcarbazepine Fall Representative (Oxcarbazepine) C Heart Rate Irregular Guanfacine Incontinence Hydrochloride Muscle Tightness (Guanfacine Oculogyration Hydrochloride) C Sedation Date:05/20/04ISR Number: 4365766-8Report Type:Expedited (15-DaCompany Report #2004030632 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Lactate Foreign Zeldox (Capsules) Initial or Prolonged Dehydrogenase Increased Health (Ziprasidone) PS Professional 22-Feb-2006 08:32 AM Page: 542 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/21/04ISR Number: 4363775-6Report Type:Expedited (15-DaCompany Report #2004030413 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aphasia Foreign Ziprasidone (Caps) Blood Creatine Study (Ziprasidone) PS ORAL 40 MG AND 80 Phosphokinase Increased Health MG (2 IN 1 Confusional State Professional D), ORAL Dysphagia Haloperidol Movement Disorder (Haloperidol) C Muscle Rigidity Clonazepam Neuroleptic Malignant (Clonazepam) C Syndrome Biperiden Prostration (Biperiden) C Tachycardia Levomepromazine Tremor (Levomepromazine) C Imipramine Hydrochloride (Imipramine Hydrochloride) C Lorazepam (Lorazepam) C Ziprasidone (Ziprasidone) C Flurazepam (Flurazepam) C Date:05/24/04ISR Number: 4366680-4Report Type:Expedited (15-DaCompany Report #2004031607 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pulmonary Oedema Foreign Geodon (Ziprasidone) PS 160 MG (80 Initial or Prolonged Health MG, 2 IN 1 Professional D), UNKNOWN Company Penfluridol Representative (Penfluridol) C Carbamazepine (Carbamazepine) C Date:05/24/04ISR Number: 4366781-0Report Type:Expedited (15-DaCompany Report #2004019604 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dermatitis Allergic Foreign Ziprasidone (Caps) Other Dyspnoea Health (Ziprasidone) PS ORAL 120 G (2 IN 1 Generalised Oedema Professional D), ORAL Pruritus Company Carbamazepine Somnolence Representative (Carbamazepine) C Clonazepam (Clonazepam) C Lithium Carbonate (Lithium Carbonate) C Date:05/24/04ISR Number: 4366986-9Report Type:Expedited (15-DaCompany Report #2004031711 Age: Gender:Unknown I/FU:I Outcome PT Report Source Other Dystonia Health Oropharyngeal Swelling Professional 22-Feb-2006 08:32 AM Page: 543 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company Representative Product Role Manufacturer Route Dose Duration Geodon (Ziprasidone) PS ORAL 80 MG DAILY, ORAL Benzatropine Mesilate (Benzatropine Mesilate) SS ORAL ORAL Antihistamines (Antihistamines) C Date:05/24/04ISR Number: 4366987-0Report Type:Expedited (15-DaCompany Report #2004031514 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancreatitis Health Geodon (Ziprasidone) PS ORAL 100 MG (2 IN Initial or Prolonged Professional 1 D), ORAL Other Lansoprazole (Lansoprazole) C Date:05/24/04ISR Number: 4367000-1Report Type:Expedited (15-DaCompany Report #2004032283 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Visual Acuity Reduced Health Geodon (Ziprasidone) PS Professional Company Representative Date:05/25/04ISR Number: 4365663-8Report Type:Direct Company Report #CTU 219397 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Rash Ziprasidone PS Date:05/25/04ISR Number: 4365666-3Report Type:Direct Company Report #CTU 219398 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neuroleptic Malignant Ziprasidone PS Hospitalization - Syndrome Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage Date:05/25/04ISR Number: 4368912-5Report Type:Expedited (15-DaCompany Report #2004032070 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Geodon (Ziprasidone) PS 120 MG (60 Initial or Prolonged Insomnia Professional MG, BID Social Avoidant Behaviour Company INTERVAL: Representative EVERY DAY) 22-Feb-2006 08:32 AM Page: 544 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Diphenhydramine Hydrochloride (Diphenhydramine Hydrochloride) SS (50 MG) Olanzapine SS (20 MG) Zolpidem Tartrate (Zolpidem Tartrate) SS (20 MG) Date:05/25/04ISR Number: 4368921-6Report Type:Expedited (15-DaCompany Report #2004019113 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Attention-Seeking Health Geodon (Ziprasidone) PS 120 MG Behaviour Professional Valproate Semisodium Convulsion Company (Valproate Representative Semisodium) C Oxcarbazepine (Oxcarbazepine) C Venlafaxine Hydrochloride (Venlafaxine Hydrochloride) C Date:05/25/04ISR Number: 4368924-1Report Type:Expedited (15-DaCompany Report #2004032182 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bone Marrow Depression Health Zoloft (Sertraline) PS Laboratory Test Abnormal Professional Geodon (Ziprasidone) SS Company Representative Date:05/25/04ISR Number: 4369778-XReport Type:Expedited (15-DaCompany Report #2004031607 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pulmonary Oedema Foreign Geodon (Ziprasidone) PS 160 MG (80 Initial or Prolonged Health MG, 2 IN 1 Professional D), Company Penfluridol Representative (Penfluridol) C Carbamazepine (Carbamazepine) C Date:05/25/04ISR Number: 4369958-3Report Type:Expedited (15-DaCompany Report #2004021434 Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Zeldox (Capsules) Initial or Prolonged Phosphokinase Increased Health (Ziprasidone) PS ORAL 120 MG (BID), Extrapyramidal Disorder Professional ORAL Company Representative 22-Feb-2006 08:32 AM Page: 545 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/25/04ISR Number: 4369963-7Report Type:Expedited (15-DaCompany Report #2004018270 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Foreign Zeldox (Capsules) Hospitalization - Arterial Thrombosis Limb Consumer (Ziprasidone) PS ORAL 200 MG (BID), Initial or Prolonged Cardiac Arrest Health ORAL Pulmonary Embolism Professional Haloperidol Restlessness (Haloperidol) C Treatment Noncompliance Clonazepam (Clonazepam) C Date:05/26/04ISR Number: 4372395-9Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040502860 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dialysis Foreign Haldol-Janssen Drug Interaction Health (Haloperidol) Neuroleptic Malignant Professional Unspecified PS ORAL 6 MG, IN 1 Syndrome DAY, ORAL Renal Failure Acute Zeldox (Ziprasidone Rhabdomyolysis Hydrochloride) SS ORAL ORAL Date:05/26/04ISR Number: 4372768-4Report Type:Expedited (15-DaCompany Report #2004032913 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Health Geodon (Ziprasidone) PS Professional Date:05/26/04ISR Number: 4373068-9Report Type:Expedited (15-DaCompany Report #2004031917 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Suicide Attempt Foreign Ziprasidone (Caps) Hospitalization - Health (Ziprasidone) PS ORAL ORAL 1 WK Initial or Prolonged Professional Olanzapine (Olanzapine) SS ORAL ORAL Antidepressants (Antidepressants) C Lithium Carbonate (Lithium Carbonate) C Anxiolytics (Anxiolytics) C Date:05/26/04ISR Number: 4373070-7Report Type:Expedited (15-DaCompany Report #2004032054 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancreatitis Foreign Ziprasidone (Caps) Initial or Prolonged Health (Ziprasidone) PS Other Professional 22-Feb-2006 08:32 AM Page: 546 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/26/04ISR Number: 4373083-5Report Type:Expedited (15-DaCompany Report #2004022322 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Geodon (Ziprasidone) PS ORAL ( 1 IN 1 D), Initial or Prolonged Anxiety Consumer ORAL Logorrhoea Date:05/27/04ISR Number: 4366997-3Report Type:Direct Company Report #CTU 219655E Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Pressure Geodon 20 Mg PS INTRAMUSCULAR 20 MG X 1 Hospitalization - Fluctuation INTRAMUSCULAR Initial or Prolonged Blood Pressure Increased Coma Depressed Level Of Consciousness Extrasystoles Suicidal Ideation Date:05/27/04ISR Number: 4368717-5Report Type:Expedited (15-DaCompany Report #2004032702 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Geodon (Ziprasidone) PS Professional All Other Company Therapeutic Products Representative (All Other Therapeutic Products) SS Date:05/27/04ISR Number: 4369102-2Report Type:Expedited (15-DaCompany Report #2004032706 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Geodon (Ziprasidone) PS 240 MG (80 Professional MG, 1 IN 1 D) Company All Other Representative No-Therapeutic Products (All Other Non-Therapeutic Products) SS Lorazepam (Lorazepam) SS Escitalopram (Escitalopram) SS Topiramate (Topiramate) C Diazepam (Diazepam) C Date:05/27/04ISR Number: 4369147-2Report Type:Expedited (15-DaCompany Report #2004032674 Age: Gender: I/FU:I Outcome PT Report Source Other Neuroleptic Malignant Health Syndrome Professional Company 22-Feb-2006 08:32 AM Page: 547 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Representative Product Role Manufacturer Route Dose Duration Geodon (Ziprasidone) PS Date:05/27/04ISR Number: 4369155-1Report Type:Expedited (15-DaCompany Report #2004022130 Age:74 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Geodon (Ziprasidone) PS 180 MG (60 Initial or Prolonged Syndrome Professional MG, 3 IN 1D); Other Company SEVERAL DAYS Representative Date:05/27/04ISR Number: 4369842-5Report Type:Expedited (15-DaCompany Report #2004032901 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Rhabdomyolysis Foreign Zeldox (Capsules) Initial or Prolonged Health (Ziprasidone) PS Other Professional Risperidone Company (Risperidone) C Representative Date:05/28/04ISR Number: 4368744-8Report Type:Expedited (15-DaCompany Report #2004022869 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Suicide Attempt Foreign Geodon (Ziprasidone) PS Health Professional Company Representative Date:06/01/04ISR Number: 4367848-3Report Type:Direct Company Report #CTU 219827 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyspnoea Geodon 80 Mg PS ORAL 80 MG PO BID Initial or Prolonged Dystonia Swollen Tongue Date:06/01/04ISR Number: 4367853-7Report Type:Direct Company Report #CTU 219821 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Rash Geodon 20mg Pfizer PS Pfizer ORAL 20MG BID ORAL Cyclobenzaprine C Ranitidine C Carbamazepine C Clonazepam C Lansoprazole C Multivitamin C Oxycodone C Methadone C 22-Feb-2006 08:32 AM Page: 548 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/01/04ISR Number: 4371060-1Report Type:Expedited (15-DaCompany Report #2004030413 Age:19 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Ziprasidone (Caps) Initial or Prolonged Phosphokinase Increased Study Ziprasidone) PS SEE IMAGE Other Communication Disorder Health Haloperidol Confusional State Professional (Haloperidol) C Dysphagia Clonazepam Heart Rate Increased (Clonazepam) C Hypertension Biperiden Movement Disorder (Biperiden) C Muscle Rigidity Levomepromazine Neuroleptic Malignant (Levomepromazine) C Syndrome Imipramine Prostration Hydrochloride Pyrexia (Imipramine Tachycardia Hydrochloride) C Tremor Lorazepam (Lorazepam) C Ziprasidone (Ziprasidone) C Flurazepam (Flurazepam) C Date:06/01/04ISR Number: 4371637-3Report Type:Expedited (15-DaCompany Report #2004025130 Age: Gender:Unknown I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Health Geodon (Ziprasidone) PS Professional Date:06/02/04ISR Number: 4368670-4Report Type:Expedited (15-DaCompany Report #2004021193 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Foreign Ziprasidone (Caps) Health (Ziaprasidone) PS ORAL ORAL Professional Date:06/02/04ISR Number: 4368671-6Report Type:Expedited (15-DaCompany Report #2004021190 Age: Gender:Unknown I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Foreign Ziprasidone (Caps) Health (Ziprasidone) PS ORAL ORAL Professional Date:06/02/04ISR Number: 4371460-XReport Type:Expedited (15-DaCompany Report #2004023066 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Geodon (Ziprasidone) PS ORAL 160 MG (BID), Other Suicide Attempt Professional ORAL Company Fluoxetine Representative Hydrochloride (Fluoxetine Hydrochloride) C 22-Feb-2006 08:32 AM Page: 549 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Diazepam C Aripiprazole (Aripiprazole) C Date:06/02/04ISR Number: 4371468-4Report Type:Expedited (15-DaCompany Report #2004017260 Age:26 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Akathisia Health Geodon (Ziprasidone) PS 80 MG (2 IN 1 Other Anxiety Professional D), UNKNOWN Coma Company Fluoxetine Depression Representative Hydrochloride Flashback (Fluoxetine Hallucination, Auditory Hydrochloride) SS UNK (10 MG, 1 Headache IN 1 D) Hyperphagia UNKNOWN Hypersomnia Insomnia Irritability Mania Memory Impairment Restlessness Sedation Sudden Cardiac Death Suicidal Ideation Treatment Noncompliance Weight Increased Date:06/02/04ISR Number: 4371586-0Report Type:Expedited (15-DaCompany Report #2004029472 Age:58 YR Gender:Unknown I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Health Geodon (Ziprasidone) PS Corrected Interval Professional Prolonged Date:06/02/04ISR Number: 4371591-4Report Type:Expedited (15-DaCompany Report #2004023721 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Caffeine Increased Health Geodon (Ziprasidone) PS ORAL ORAL Other Hypokalaemia Professional Doxepin (Doxepin) C Treatment Noncompliance Other All Other Vomiting Therapeutic Products (All Other Therapeutic Products) C Caffeine (Caffeine) C Date:06/02/04ISR Number: 4372042-6Report Type:Expedited (15-DaCompany Report #2004031607 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Hospitalization - Pulmonary Oedema Foreign Initial or Prolonged Health Professional Company 22-Feb-2006 08:32 AM Page: 550 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Representative Product Role Manufacturer Route Dose Duration Geodon (Ziprasidone) PS ORAL 160 MG (80 MG, 2 IN 1 D), ORAL Penfluridol (Penfluridol) C Carbamazepine (Carbamazepine) C Date:06/03/04ISR Number: 4371969-9Report Type:Direct Company Report #CTU 220066 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pain In Jaw Geodon 40 Mg Pfizer PS Pfizer ORAL 2 TABS B.I.D. Swollen Tongue ORAL Date:06/04/04ISR Number: 4374676-1Report Type:Expedited (15-DaCompany Report #2004026550 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Head Injury Health Geodon (Ziprasidone) PS 160 MG (2 IN Other Road Traffic Accident Professional 1 D) Company Representative Date:06/04/04ISR Number: 4374802-4Report Type:Expedited (15-DaCompany Report #2004015305 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Monoplegia Foreign Zeldox (Capsules) Initial or Prolonged Health (Ziprasidone) PS ORAL 160 MG (80 Other Professional MG, 2 IN 2 D), ORAL Zopiclone (Zopiclone) C Alimemazine Tartrate (Alimemazine Tartrate) C Date:06/08/04ISR Number: 4374207-6Report Type:Direct Company Report #CTU 220320 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bradycardia Geodon 80 Mg Capsules PS 80 MG BID Date:06/08/04ISR Number: 4376716-2Report Type:Expedited (15-DaCompany Report #2004035634 Age: Gender:Female I/FU:I Outcome PT Other Abnormal Behaviour Anxiety Delusion Dyskinesia 22-Feb-2006 08:32 AM Page: 551 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Insomnia Knee Arthroplasty Loss Of Employment Report Source Product Role Manufacturer Route Dose Duration Movement Disorder Health Geodon Obsessive Thoughts Professional (Ziprasidone) PS ORAL 40 MG (20 MG, Obsessive-Compulsive 2 IN 1 D), Disorder ORAL Somnolence Neurontin Thinking Abnormal (Gabapentin) SS ORAL ORAL Toe Deformity Clonazepam Tremor (Clonazepam) C Dyazide (Hydrochlorothizide, Triameterene) C Lorazepam (Lorazepam) C Date:06/08/04ISR Number: 4376769-1Report Type:Expedited (15-DaCompany Report #2004029257 Age:12 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Upper Consumer Geodon (Ziprasidone) PS ORAL 60 MG (2 IN 1 Initial or Prolonged Abnormal Behaviour Health D), ORAL Antipsychotic Drug Level Professional Oxcarbazine Below Therapeutic (Oxcarbazine) SS ORAL 1800 MG (3 IN Bipolar Disorder 1 D), ORAL Drug Interaction Atomoxetine Migraine Hydrochloride Psychotic Disorder (Atomoxeitine Vomiting Hydrochloride) SS ORAL 80 (40, 2 IN Weight Decreased 1 D), ORAL Gabapentin (Gabapentin) C Quetiapine Fumarate (Quetiapine Fumarate) C Date:06/08/04ISR Number: 4399747-5Report Type:Periodic Company Report #FROV000176 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Consumer Frova (Frovatriptan Succinate) PS ORAL 7.5 MG ORAL Geodon (Ziprasidone Hcl) SS Date:06/09/04ISR Number: 4378799-2Report Type:Expedited (15-DaCompany Report #2004036161 Age: Gender:Female I/FU:I Outcome PT Hospitalization - Agitation Initial or Prolonged Depressed Level Of Other Consciousness Drug Level Decreased Drug Toxicity Fatigue Insomnia Psychotic Disorder 22-Feb-2006 08:32 AM Page: 552 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Somnolence Vomiting Report Source Product Role Manufacturer Route Dose Duration Consumer Geodon (Ziprasidone) PS 40 MG (20 MG, 2 IN 1 D) Oxcarbazepine (Oxcarbazepine) SS ORAL ORAL Valproate Semisodium (Valproate Semisodium) C Famotidine (Famotidine) C Ranitidine (Ranitidine) C Date:06/10/04ISR Number: 4378928-0Report Type:Expedited (15-DaCompany Report #2004028116 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Exposure During Foreign Ziprasidone (Caps) Other Pregnancy Health (Ziprasidone) PS INTERVAL Intra-Uterine Death Professional Valproate Magnesium Company (Valproate Representative Magnesium) C Date:06/10/04ISR Number: 4379101-2Report Type:Expedited (15-DaCompany Report #2004023721 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Caffeine Consumption Health Geodon (Ziprasidone) PS ORAL ORAL Other Hypokalaemia Professional Caffeine (Cafeine) SS Vomiting Other Doxepin (Doxepin) C All Other Therapeutic Products (All Other Therapeutic Products) C Date:06/10/04ISR Number: 4379103-6Report Type:Expedited (15-DaCompany Report #2004036303 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Jaw Fracture Health Geodon (Ziprasidone) PS Professional Company Representative Date:06/10/04ISR Number: 4379279-0Report Type:Expedited (15-DaCompany Report #2004017240 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Health Geodon (Ziprasidone) PS ORAL 80 MG (80 MG, Dizziness Postural Professional 1 IN 1 D), Dysstasia Company ORAL Loss Of Consciousness Representative Fluphenazine Syncope Decanoate (Fluphenazine 22-Feb-2006 08:32 AM Page: 553 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Decanoate) C Oxcarbamazepine (Oxcarbamazepine) C Benzatropine Mesilate (Benzatropine Mesilate) C Date:06/11/04ISR Number: 4376496-0Report Type:Direct Company Report #CTU 220580 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hypothermia Geodon 20mg Cap PS Life-Threatening Rhabdomyolysis Lactulose Syrup C Hospitalization - Ferrous Sulfate Initial or Prolonged Elixir C Disability Magnesium Oxide C Required Insulin Reg Human C Intervention to Docusate C Prevent Permanent Omeprazole C Impairment/Damage Multivitamins Liq C Omeprazole Cap C Potassium Chloride Liquid C Famotidine C Zheparin C Hydrocotisone C Sodium Polystyrene Sulfate C Bisacodyl C Multivitamins C Docusate C Insulin, Glargine C Benztropine C Ziprasidone C Quetiapine Fumarate C Trazodone C Lorazepam C Sodium Biphosphate/Sodium Phosphate Edema C Hydrocortisone Valerate C Lubriderm Lotion C Alendronate Sod C Ziprasidone Inj C Insulin Aspart C Insulin Aspart, Human C Ferrous Sulfate C Haloperidol C Lisinopril C Folic Acid C Olanzapine C Lorazepam C Olanzapine C Insulin Human Lispro C Drxtrose C 22-Feb-2006 08:32 AM Page: 554 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/14/04ISR Number: 4377176-8Report Type:Direct Company Report #CTU 220640 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hair Growth Abnormal Risperdal .5 Mg PS ORAL 1 MG IN AM 2 MG IN PM ORAL Geodon 20 Mg SS ORAL 20 MG IN AM AND ORAL Geodon C Lamictal C Klonopin C Abilify C Topamax C Clonidine C Seroquel C Trileptal C Depakote C Lithium C Zyprexa C Date:06/14/04ISR Number: 4378311-8Report Type:Direct Company Report #CTU 220705 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dystonia Ziprasidone PS 80 MG BID Intervention to Visual Disturbance Prevent Permanent Impairment/Damage Date:06/14/04ISR Number: 4379219-4Report Type:Expedited (15-DaCompany Report #2004028829 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Geodon (Ziprasidone) PS ORAL ORAL Initial or Prolonged Schizophrenia Professional All Other Other Company Therapeutic Products Representative (All Other Therapeutic Products) C Date:06/14/04ISR Number: 4379546-0Report Type:Expedited (15-DaCompany Report #2004037796 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ankle Fracture Consumer Geodon (Ziprasidone) PS Drug Interaction Post Procedural Complication Psychotic Disorder Date:06/15/04ISR Number: 4381849-0Report Type:Expedited (15-DaCompany Report #2004030632 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Zeldox (Capsules) Initial or Prolonged Phosphokinase Increased Health (Ziprasidone) PS ORAL 120 MG (60 Blood Lactate Professional MG, 2 IN 1 Dehydrogenase Increased D), ORAL 22-Feb-2006 08:32 AM Page: 555 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Chlorprothixene Hydrochloride (Chlorprothixene Hydrochloride) C Date:06/15/04ISR Number: 4382174-4Report Type:Expedited (15-DaCompany Report #2004037071 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Geodon (Ziprasidone) PS Professional Company Representative Date:06/15/04ISR Number: 4382175-6Report Type:Expedited (15-DaCompany Report #2004036973 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acne Consumer Geodon (Ziprasidone) PS ORAL 1 IN 1 D, Initial or Prolonged Condition Aggravated ORAL Confusional State Quetiapine Fumarate Crying (Quetiapine Cyst Fumarate) SS ORAL 200 MG, ORAL Dry Mouth Gabapentin Haemorrhage (Gabapentin) C Headache Paracetamol Muscle Twitching (Paracetamol) C Nervousness Schizophrenia Weight Increased Date:06/15/04ISR Number: 4382186-0Report Type:Expedited (15-DaCompany Report #2004037831 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Health Geodon (Ziprasidone) PS Syndrome Professional Company Representative Date:06/17/04ISR Number: 4382925-9Report Type:Expedited (15-DaCompany Report #2004025153 Age:77 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Apnoea Health Geodon (Im) Coma Professional (Ziprasidone) PS INTRAMUSCULAR 10 MG (10 MG, Coronary Artery Embolism ONE DOSE) Dyspnoea INTRAMUSCULAR Pulse Absent Digoxin (Digoxin) C Warfarin (Warfarin) C Thiamine (Thiamine) C Folic Acid (Folic Acid) C Donepezil Hydrochloride (Donepezil Hydrochloride) C 22-Feb-2006 08:32 AM Page: 556 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Potassium Chloride (Potassium Chloride) C Atorvastatin (Atorvastatin) C Furosemide (Furosemide) C Carvedilol (Carvedilol) C Combivent (Ipratropium Bromide, Salbutamol Sulfate) C Valproate Semisodium (Valproate Semisodium) C Mirtazapine (Mirtazapine) C Quetiapine Fumarate (Quetiapine Fumarate) C Date:06/18/04ISR Number: 4383100-4Report Type:Expedited (15-DaCompany Report #2004038419 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Brain Damage Consumer Neurontin Initial or Prolonged Feeling Abnormal (Gabapentin) PS Other Injury Geodon (Ziprasidone Loss Of Consciousness Hydrochloride) Memory Impairment (Ziprasidone) SS Pain Pain In Extremity Sexual Assault Victim Syncope Vision Blurred Date:06/18/04ISR Number: 4383129-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031102715 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypercholesterolaemia Study Risperidone Weight Increased Health (Risperidone) Professional Unspecified PS Olanzapine (Olanzapine) SS Quetiapine (Quetiapine) SS Ziprasidone (Ziprasidone) SS Perphenazine (Perphenazine) SS Date:06/18/04ISR Number: 4384213-3Report Type:Expedited (15-DaCompany Report #2004031711 Age:16 YR Gender:Male I/FU:F Outcome PT Report Source Other Dystonia Health Oropharyngeal Swelling Professional 22-Feb-2006 08:32 AM Page: 557 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company Representative Product Role Manufacturer Route Dose Duration Geodon (Ziprasidone) PS ORAL 80 MG (40 MG, 2 IN 1 D), ORAL Benzatropine Mesilate (Benzatropine Mesilate) SS ORAL ORAL Erythromycin (Erythromycin) SS Date:06/21/04ISR Number: 4384120-6Report Type:Expedited (15-DaCompany Report #2004038111 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Health Geodon (Ziprasidone) PS Syndrome Professional Date:06/21/04ISR Number: 4384122-XReport Type:Expedited (15-DaCompany Report #2004037071 Age: Gender:Unknown I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Geodon (Ziprasidone) PS Other Electrocardiogram Qt Professional Antipsychotics Prolonged Company (Antipsychotics) SS Sudden Death Representative Treatment Noncompliance Date:06/21/04ISR Number: 4384125-5Report Type:Expedited (15-DaCompany Report #2004038312 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Increased Literature Ziprasidone (Caps) Initial or Prolonged Hypersensitivity Health (Ziprasidone) PS ORAL 20 MG (20 MG, Lupus-Like Syndrome Professional 1 IN 1 D), Renal Failure ORAL All Other Products (All Other Therapeutic Products) C Date:06/21/04ISR Number: 4384157-7Report Type:Expedited (15-DaCompany Report #2004038105 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Disease Recurrence Health Geodon (Ziprasidone) PS ORAL 80 MG (40 MG, Initial or Prolonged Neuroleptic Malignant Professional 2 IN 1 D), Syndrome ORAL Psychotic Disorder 22-Feb-2006 08:32 AM Page: 558 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/21/04ISR Number: 4384672-6Report Type:Expedited (15-DaCompany Report #2004038108 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Epistaxis Foreign Zeldox Red Blood Cell Health (Capsules)(Ziprasido Sedimentation Rate Professional ne) PS ORAL 120 MG (60 MG Increased Company 2 IN 1 D) Representative ORAL Date:06/21/04ISR Number: 4384674-XReport Type:Expedited (15-DaCompany Report #2004038511 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Medication Error Foreign Geodon (Ziprasidone) PS 40 MG Initial or Prolonged Psychotic Disorder Health Pramipexole Professional Dihydrochloride Company (Pramipexole Representative Dihydrochloride) C Cardiovascular System Drugs (Cardiovascular System Drugs) C Date:06/21/04ISR Number: 4384675-1Report Type:Expedited (15-DaCompany Report #2004028900 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Eruption Foreign Zeldox Initial or Prolonged Inflammation Health (Capsules)(Ziprasido Other Oedema Peripheral Professional ne) PS ORAL 160 MG (80MG, Pruritus Company 2 IN 1 D) Urticaria Generalised Representative ORAL Prothipendyl Hydrochloride (Prothipendyl Hydrochloride) C Lorazepam (Lorazepam) C Silymarin (Silymarin) C Penfluridol (Penfluridol) C Date:06/22/04ISR Number: 4385915-5Report Type:Expedited (15-DaCompany Report #2004039088 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Geodion Initial or Prolonged Catatonia Professional (Ziprasidone) PS Other Extrapyramidal Disorder Company Neuroleptic Malignant Representative Syndrome 22-Feb-2006 08:32 AM Page: 559 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/22/04ISR Number: 4386143-XReport Type:Expedited (15-DaCompany Report #2004036161 Age:12 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Upper Consumer Geodon (Ziprasidone) PS ORAL 60 MG (20 MG, Initial or Prolonged Abnormal Behaviour Health 2 IN 1 D), Other Agitation Professional ORAL Anticonvulsant Drug Level Oxcarbazepine Decreased (Oxcarbazepine) SS ORAL 1800 MG (3 IN Antipsychotic Drug Level 1 D) , ORAL Below Therapeutic Atomoxetine Bipolar Disorder Hydrochloride Constipation (Atomoxetine Depressed Level Of Hydrochloride) SS ORAL 80 (40, 2 IN Consciousness 1 D) ,ORAL Drug Interaction Valproate Semisodium C Fatigue Famotidine C Insomnia Ranitidine C Loss Of Consciousness Gabapentin C Migraine Quetiapine Fumarate C Psychotic Disorder Somnolence Therapeutic Agent Toxicity Treatment Noncompliance Vomiting Weight Decreased Date:06/24/04ISR Number: 4384811-7Report Type:Direct Company Report #CTU 221449 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Geodon PS ORAL 80 MG X 1 PO Initial or Prolonged Medication Error Required Overdose Intervention to Prevent Permanent Impairment/Damage Date:06/24/04ISR Number: 4385089-0Report Type:Direct Company Report #CTU 221431 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Restlessness Zipasidone 60 Mg PS ORAL 60 MG BID ORAL Stelazine C Trazodone C Lorazepam C Benztropine C Combivent C Simvastatin C Date:06/24/04ISR Number: 4385090-7Report Type:Direct Company Report #CTU 221433 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Muscle Contractions Ziprasidone 40 Mg PS ORAL 40 MG HS ORAL Involuntary Lorazepam C Tongue Disorder Venlafaxine C 22-Feb-2006 08:32 AM Page: 560 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/24/04ISR Number: 4385117-2Report Type:Direct Company Report #CTU 221439 Age:89 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Unevaluable Event Geodon 20 Mg/Ml Pfizer PS Pfizer INTRAMUSCULAR 20 MG DAILY IM Date:06/24/04ISR Number: 4385693-XReport Type:Direct Company Report #CTU 221512E Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Exertional Ziprasidone 80 Mg PS ORAL 160 MG AT Initial or Prolonged BEDTIME ORAL Ziprasidone 40 Mg SS ORAL 40 MG AT BEDTIME ORAL Ibuprofen C Diazepam C Clonazepam C Venlafaxine C Buproprion C Date:06/24/04ISR Number: 4388504-1Report Type:Expedited (15-DaCompany Report #2004032918 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hemiparesis Foreign Zeldox (Capsules) Initial or Prolonged Respiratory Failure Health (Ziprasidone) PS ORAL 40 MG, ORAL Tuberculosis Professional All Other Company Therapeutic Products Representative (All Other Therapeutic Products) C Vitamins Nos (Vitamins Nos) C Amitriptyline (Amitriptyline) C Methylprednisolone (Methylprednisolone) C Date:06/24/04ISR Number: 4388578-8Report Type:Expedited (15-DaCompany Report #2004040817 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Zeldox (Capsules) Initial or Prolonged Hallucination Health (Ziprasidone) PS ORAL 160 MG (80 Vomiting Professional MG, 2 IN 1 Company D), ORAL Representative Clonazepam (Clonazepam) C Date:06/24/04ISR Number: 4388685-XReport Type:Expedited (15-DaCompany Report #2004040658 Age:42 YR Gender:Female I/FU:I Outcome PT Death Beta Haemolytic Hospitalization - Streptococcal Infection Initial or Prolonged Cardiac Arrest 22-Feb-2006 08:32 AM Page: 561 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Migraine Pyrexia Report Source Product Role Manufacturer Route Dose Duration Health Geodon (Ziprasidone) PS ORAL 120 MG (60 Professional MG, 2 IN 1 Company D), ORAL Representative Trazodone (Trazodone) C All Other Therapeutic Products (All Other Therapeutic Products) C Date:06/24/04ISR Number: 4388748-9Report Type:Expedited (15-DaCompany Report #2004023066 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Geodon (Ziprasidone) PS ORAL 160 MG (80 Other Cardiac Arrest Professional MG, 2 IN 1 Multiple Drug Overdose Company D), ORAL Suicide Attempt Representative All Other Therapeutic Products (All Other Therapeutic Products) SS Fluoxetine Hydrochloride (Fluoxetine Hydrochloride) C Diazepam (Diazepam) C Date:06/24/04ISR Number: 4388750-7Report Type:Expedited (15-DaCompany Report #2003035329 Age:76 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Geodon (Ziprasidone) PS Life-Threatening Cardiac Arrest Professional Other Ventricular Fibrillation Company Representative Date:06/25/04ISR Number: 4388196-1Report Type:Expedited (15-DaCompany Report #2004038419 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abasia Consumer Neurontin Initial or Prolonged Bipolar Disorder (Gabapentin) PS Other Brain Damage Geodon (Ziprasidone Dizziness Hydrochloride) Feeling Abnormal (Ziprasidone) SS Homeless Pain Pain In Extremity Syncope Victim Of Crime Vision Blurred 22-Feb-2006 08:32 AM Page: 562 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/25/04ISR Number: 4388203-6Report Type:Expedited (15-DaCompany Report #2004040223 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pituitary Tumour Health Geodon (Ziprasidone) PS Professional Company Representative Date:06/25/04ISR Number: 4388205-XReport Type:Expedited (15-DaCompany Report #2003123689 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Geodon (Ziprasidone) PS Other Professional Lorazepam Company (Lorazepam) C Representative Benzatropine Besilate (Benzatropine Besilate) C All Other Therapeutic Products C Date:06/28/04ISR Number: 4386906-0Report Type:Direct Company Report #CTU 221721 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Priapism Geodon PS ORAL 40 MG TWO PO Paxil C Date:06/28/04ISR Number: 4388844-6Report Type:Expedited (15-DaCompany Report #2004041525 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrioventricular Block Health Geodon (Ziprasidone) PS Professional Company Representative Date:06/28/04ISR Number: 4388917-8Report Type:Expedited (15-DaCompany Report #2003123690 Age: Gender:Unknown I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Geodon (Ziprasidone) PS Other Electroconvulsive Therapy Professional Lorazepam Company (Lorazepam0 C Representative Benzatropine Mesilate (Benzatropine Mesilate) C All Other Therapeutic Products (All Other Therapeutic Products) C 22-Feb-2006 08:32 AM Page: 563 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/28/04ISR Number: 4388920-8Report Type:Expedited (15-DaCompany Report #2003123688 Age: Gender:Unknown I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Geodon (Ziprasidone) PS Other Electroconvulsive Therapy Professional Lorazepam Company (Lorazepam) C Representative Benzatropine Mesilate (Benzatropine Mesilate) C All Other Therapeutic Products (All Other Therapeutic Products) C Date:06/28/04ISR Number: 4388925-7Report Type:Expedited (15-DaCompany Report #2004021278 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Health Geodon (Ziprasidone) PS ORAL 160 MG (1 IN Disturbance In Attention Professional 1 D), ORAL Nephrocalcinosis Company Sertraline Nephrolithiasis Representative Hydrochloride Sedation (Sertraline Somnolence Hydrochloride) C Sudden Onset Of Sleep Zolpidem Tartrate Treatment Noncompliance (Zolpidem Tartrate) C Vision Blurred Cyclobenzaprine Hydrochloride (Cyclobenzaprine Hydrochloride) C Date:06/28/04ISR Number: 4389211-1Report Type:Expedited (15-DaCompany Report #2003123687 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Geodon (Ziprasidone) PS Other Professional Lorazepam Company (Lorazepam) C Representative Benzatropine Mesilate (Benzatropine Mesilate) C All Other Therapeutic Products (All Other Therapeutic Products) C Date:06/29/04ISR Number: 4388116-XReport Type:Direct Company Report #CTU 221739 Age:71 YR Gender:Male I/FU:I Outcome Hospitalization - Initial or Prolonged Required Intervention to 22-Feb-2006 08:32 AM Page: 564 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Cardiac Failure Levolfoxacin 500mg Congestive And 250mg PS INTRAVENOUS 500 AND 250 Condition Aggravated MG ONCE EACH Loss Of Consciousness INTRAVENOUS Pneumonia Ziprasidone 60mg SS ORAL 60MG BID ORAL Pulse Absent . C Torsade De Pointes Date:06/30/04ISR Number: 4389814-0Report Type:Expedited (15-DaCompany Report #2003035576 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Foreign Ziprasidone (Caps) Health (Ziprasidone) PS ORAL 40 MG (2 IN Professional 1D), ORAL Atenolol (Atenolol) C Date:06/30/04ISR Number: 4390027-0Report Type:Expedited (15-DaCompany Report #2004038511 Age:65 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Disorientation Foreign Geodon (Ziprasidone) PS (40 MG) Initial or Prolonged Medication Error Health Pramipexole Psychotic Disorder Due To Professional Dihydrochloride C A General Medical Company Cardiovascular Condition Representative System Drugs C Date:06/30/04ISR Number: 4390029-4Report Type:Expedited (15-DaCompany Report #2004027684 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Complications Of Maternal Foreign Geodon (Ziprasidone) PS ORAL 80 MG (1 IN Exposure To Therapeutic Health 1), ORAL Drugs Professional Chlorpromazine C Eclampsia Company Carbamazepine C Infection Representative Postpartum Disorder Pregnancy Date:06/30/04ISR Number: 4390666-7Report Type:Expedited (15-DaCompany Report #2003117120 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebral Haemorrhage Health Geodon (Ziprasidone) PS Hospitalization - Circulatory Collapse Professional Initial or Prolonged Electrocardiogram Qt Company Other Corrected Interval Representative Prolonged Hypertension Renal Failure 22-Feb-2006 08:32 AM Page: 565 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/30/04ISR Number: 4390668-0Report Type:Expedited (15-DaCompany Report #2003120418 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anoxic Encephalopathy Health Geodon (Im) Life-Threatening Arrhythmia Professional (Ziprasidone) PS INTRAMUSCULAR 40 MG (2 IN 1 Hospitalization - Blood Pressure Company D), Initial or Prolonged Fluctuation Representative INTRAMUSCULAR Other Blood Pressure Chlorpromazine Inadequately Controlled Hydrochloride Coma (Chlorpromazine Condition Aggravated Hydrochloride) SS INTRAMUSCULAR INTRAMUSCULAR Convulsion Lorazepam Diabetes Mellitus (Lorazepam) C Pyrexia Insulin Lispro Sleep Apnoea Syndrome (Insulin Lispro) C Snoring Atorvastatin Ventricular Fibrillation (Atorvastatin) C Pioglitazone (Pioglitazone) C Risperidone (Risperidone) C Aripiprazole (Aripiprazole) C Bupropion Hydrochloride (Bupropion Hydrochloride) C Escitalopram (Escitalopram) C Benzatropine Mesilate (Benzatropine Mesilate) C Date:06/30/04ISR Number: 4390674-6Report Type:Expedited (15-DaCompany Report #2004042041 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Glomerulonephritis Focal Health Geodon (Ziprasidone) PS Professional Company Representative Date:06/30/04ISR Number: 4390675-8Report Type:Expedited (15-DaCompany Report #2004041466 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Musculoskeletal Stiffness Health Geodon (Ziprasidone) PS 80 MG (40 MG, Initial or Prolonged Neuroleptic Malignant Professional 2 IN 1 D), Other Syndrome Lorazepam (Lorazepam) C Date:06/30/04ISR Number: 4390676-XReport Type:Expedited (15-DaCompany Report #2004023721 Age:26 YR Gender:Male I/FU:F Outcome PT Death Caffeine Consumption Hypokalaemia 22-Feb-2006 08:32 AM Page: 566 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Treatment Noncompliance Vomiting Report Source Product Role Manufacturer Route Dose Duration Health Geodon (Ziprasidone) PS ORAL ORAL Professional Caffeine (Caffeine) SS Other Doxepin (Doxepin) C All Other Therapeutic Products (All Other Therapeutic Products) C Date:06/30/04ISR Number: 4390733-8Report Type:Expedited (15-DaCompany Report #2004040664 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Health Geodon (Ziprasidone) PS 40 MG (40 MG, Blood Glucose Decreased Professional 1 IN 1 D) Contusion Fluid Retention Muscle Twitching Pain Sensation Of Foreign Body Swollen Tongue Tremor Date:06/30/04ISR Number: 4415731-7Report Type:Periodic Company Report #2004016174 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Amnesia Health Zoloft (Sertraline) PS 200 MG Initial or Prolonged Confusional State Professional (UNKNOWN) , Other Crying Company UNKNOWN Depression Representative Geodon (Ziprasidone) SS ORAL 40 MG (UNKNOWN), ORAL Zolpidem Tartrate (Zolpidem Tartrate) C Propacet (Paracetamol, Dextropropoxyphen Napsilate) C Date:07/01/04ISR Number: 4391556-6Report Type:Expedited (15-DaCompany Report #2004037831 Age:73 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Health Geodon (Ziprasidone) PS 80 MG (80 MG, Initial or Prolonged Blood Magnesium Abnormal Professional 1 IN 1 D) Other Blood Potassium Abnormal Company Zaleplon (Zaleplon) C Chest Pain Representative Clopidogrel Sulfate Hypoaesthesia (Clopidogrel Myalgia Sulfate) C Neuroleptic Malignant Esomeprazole Syndrome (Esomeprazole) C Potassium (Potassium) C Calcium (Calcium) C 22-Feb-2006 08:32 AM Page: 567 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Iron (Iron) C Chondroitin/Glucosam ine (Chondroitin, Glucosamine) C Ascorbic Acid (Ascorbic Acid) C Multivitamins (Ascorbic Acid, Ergocalciferol, Folic Acid, Nicotinamide, C Hydrochlorothiazide (Hydrochlorothiazide ) C Date:07/01/04ISR Number: 4391700-0Report Type:Expedited (15-DaCompany Report #2003125358 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Multiple Drug Overdose Health Geodon (Ziprasidone) PS Accidental Professional Bupropion Company Hydrochloride Representative (Bupropion Hydrochloride) SS Clonazepam (Clonazepam) SS Date:07/01/04ISR Number: 4391705-XReport Type:Expedited (15-DaCompany Report #2003033059 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Geodon (Ziprasidone) PS 160 MG (80 Other Professional MG, 2 IN 1 D) Company Representative Date:07/01/04ISR Number: 4391726-7Report Type:Expedited (15-DaCompany Report #2004042265 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination, Auditory Health Geodon (Ziprasidone) PS Initial or Prolonged Suicidal Ideation Professional Company Representative Date:07/01/04ISR Number: 4391732-2Report Type:Expedited (15-DaCompany Report #2003116181 Age:89 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Geodon (Im) Electromechanical Professional (Ziprasidone) PS INTRAMUSCULAR INTRAMUSCULAR Dissociation Company Quetiapine Fumarate Representative (Quetiapine Fumarate) SS 25 MG Pip/Tazo (Piperacillin Sodium, Tazobactam 22-Feb-2006 08:32 AM Page: 568 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sodium) C Metoprolol Tartrate (Metoprolol Tartrate) C Haloperidol (Haloperidol) C Date:07/01/04ISR Number: 4391982-5Report Type:Expedited (15-DaCompany Report #B0335849A Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrial Fibrillation Literature Wellbutrin Sr Initial or Prolonged Bundle Branch Block Left Health Tablet-Controlled Delirium Professional Release (Bupropion Disorientation Hydrochloride) PS ORAL ORAL Electrocardiogram Qt Ziprasidone Hcl Corrected Interval Unspecified Tablet Prolonged (Ziprasidone Hcl) SS ORAL ORAL Electrocardiogram T Wave Semisodium Valproate Abnormal Tablet (Divalproex Grand Mal Convulsion Sodium) SS ORAL ORAL Hallucination, Visual Fluoxetine Tablet Lethargy (Fluoxetine) SS ORAL ORAL Multiple Drug Overdose Sinus Tachycardia Supraventricular Tachycardia Date:07/01/04ISR Number: 4393484-9Report Type:Expedited (15-DaCompany Report #2004016096 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Geodon (Ziprasidone) PS 80 MG (1 IN 1 Other Health D) Professional All Other Company Therapeutic Products Representative (All Other Therapeutic Products) C Date:07/01/04ISR Number: 4393486-2Report Type:Expedited (15-DaCompany Report #2004042258 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zeldox (Capsules) Drug Ineffective Health (Ziprasidone) PS 160 MG (80 Professional MG, 2 IN 1 D) Company Representative Date:07/02/04ISR Number: 4392279-XReport Type:Expedited (15-DaCompany Report #2004042041 Age:15 YR Gender:Female I/FU:F Outcome PT Other Dehydration Dialysis General Physical Health Deterioration 22-Feb-2006 08:32 AM Page: 569 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Glomerulonephritis Focal Renal Failure Report Source Product Role Manufacturer Route Dose Duration Health Geodon (Ziprasidone) PS Professional Company Representative Date:07/02/04ISR Number: 4393929-4Report Type:Expedited (15-DaCompany Report #2003122915 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Upper Health Zithromax (Caps) Life-Threatening Activated Partial Professional (Azithromycin) PS Hospitalization - Thromboplastin Time Geodon (Ziprasidone) SS ORAL 120 MG (BID), Initial or Prolonged Prolonged ORAL Other Blood Creatinine Gatifloxacin Increased (Gatifloxacin) SS Blood Glucose Increased Paroxetine Cardio-Respiratory Arrest Hydrochloride Convulsion (Paroxetine Depression Hydrochloride) C Drug Hypersensitivity Hydroxyzine Embonate Electrocardiogram Qt (Hydroxyzine Prolonged Embonate) C Fall Methadone Head Injury (Methadone) C Myocardial Infarction Prothrombin Time Prolonged Psychotic Disorder Ventricular Fibrillation Ventricular Tachycardia Date:07/06/04ISR Number: 4394333-5Report Type:Expedited (15-DaCompany Report #2003111889 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatinine Health Geodon (Im) Other Increased Professional (Ziprasidone) PS INTRAMUSCULAR (10 MG, 12 IN Cardiac Arrest Other 1 D), Electrocardiogram INTRAMUSCULAR Abnormal Levofloxacin Electrocardiogram Qrs (Levofloxacin) SS INTRAVENOUS 250 MG (1 IN Complex Prolonged 1 D), Electrocardiogram Qt INTRAVENOUS Corrected Interval Lisinopril Prolonged (Lisinopril) C Electrocardiogram Qt Gliclazide Prolonged (Gliclazide) C Hyperkalaemia Alendronate Sodium Respiratory Failure (Alendronate Sodium) C Sinus Bradycardia Prednisone Ventricular Extrasystoles (Prednisone) C Ventricular Tachycardia Budesonide (Budesonide) C Cobivent (Ipratropium Bromide, Salbutamol 22-Feb-2006 08:32 AM Page: 570 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sulfate) C Date:07/06/04ISR Number: 4394645-5Report Type:Expedited (15-DaCompany Report #2004041583 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Throat Tightness Health Geodon (Ziprasidone) PS Professional Company Representative Date:07/06/04ISR Number: 4394649-2Report Type:Expedited (15-DaCompany Report #2004001636 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Geodon(Ziprasidone) PS ORAL 240 MG (120 Other Sudden Death Professional MG, 2 IN 1 D), ORAL Quetiapine Fumarate(Quetiapine Fumarate) C Date:07/06/04ISR Number: 4394894-6Report Type:Expedited (15-DaCompany Report #2004030413 Age:19 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Foreign Ziprasidone (Caps) Initial or Prolonged Syndrome Study (Ziprasidone) PS ORAL SEE IMAGE Other Health Haloperidol Professional (Haloperidol) C Clonazepam (Clonazepam) C Biperiden (Biperiden) C Levomepromazine (Levomepromazine) C Imipramine Hydrochloride (Imipramine Hydrochloride) C Lorazepam (Lorazepam) C Ziprasidone (Ziprasidone) C Flurazepam (Flurazepam) C Date:07/06/04ISR Number: 4394904-6Report Type:Expedited (15-DaCompany Report #2004042616 Age:57 YR Gender:Female I/FU:I Outcome PT Life-Threatening Anxiety Blood Pressure Increased Blood Prolactin Decreased Electrocardiogram Qt Corrected Interval Prolonged Heart Rate Increased 22-Feb-2006 08:32 AM Page: 571 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Multiple Drug Overdose Oxygen Saturation Decreased Report Source Product Role Manufacturer Route Dose Duration Somnolence Foreign Ziprasidone (Caps) Tremor Literature (Ziprasidone) PS ORAL (160 MG), Health ORAL Professional Clomethiazole (Clomethiazole) SS (384 MG) Flunitrazepam (Flunitrazepam) SS (2 MG) Paroxetine (Paroxetine) C Lorazepam (Lorazepam) C Date:07/07/04ISR Number: 4394799-0Report Type:Expedited (15-DaCompany Report #2004042930 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Myocardial Infarction Health Geodon(Ziprasidone) PS 80 MG (40 MG, Professional 2 IN 1 D) Company Representative Date:07/07/04ISR Number: 4394803-XReport Type:Expedited (15-DaCompany Report #2004042831 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Complex Partial Seizures Health Geodon(Ziprasidone) PS Professional All Other Company Therapeutic Representative Products(All Other Therapeutic Products) C Potassium (Potassium) C Date:07/07/04ISR Number: 4394813-2Report Type:Expedited (15-DaCompany Report #2004032024 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiomyopathy Health Geodon(Ziprasidone) PS ORAL 160 MG (1 IN Initial or Prolonged Chronic Obstructive Professional 1 D), ORAL 18 MON Pulmonary Disease Escitalopram Depression (Escitalopram) C Electrocardiogram St Trazodone Segment Abnormal Hydrochloried Hypothyroidism (Trazadone Medication Error Hydrochloride) C Obesity Clonazepam Pericardial Disease (Clonazepam) C 22-Feb-2006 08:32 AM Page: 572 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/07/04ISR Number: 4394821-1Report Type:Expedited (15-DaCompany Report #2004036814 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Health Geodon(Ziprasidone) PS ORAL 40 MG (20 MG, Initial or Prolonged Aggression Professional 2 IN 1D), Disability Condition Aggravated ORAL Other Dyskinesia Allopurinol Dystonia (Allopurinol) C Eosinophilia Acetylsalicylic Therapeutic Response Acid(Acetylsalicylic Decreased Acid) C Atenolol (Atenolol) C Citalorpam (Citalopram) C Enoxaparin (Heparin) C Folic Acid (Folic Acid) C Insulin(Insulin) C Isosorbide Dinitrate (Isosorbide Dinitrate ) C Levothyroxine (Levothyroxine) C Magnesium Oxide (Magnesium Oxide) C Megestrol (Megestrol) C Oxycodone (Oxycodone) C Phenytoin (Phenytoin) C Ranitidine (Ranitidine) C Verpamil (Verapamil) C Zinc (Zinc) C Furosemide (Furosemide) C Date:07/07/04ISR Number: 4395041-7Report Type:Expedited (15-DaCompany Report #2004043442 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Disease Recurrence Health Geodon (Ziprasidone) PS Feeling Of Despair Professional Lamotrigine Suicidal Ideation Company (Lamotrigine) C Representative Oxcarbazepine (Oxcarbazepine) C Date:07/07/04ISR Number: 4395042-9Report Type:Expedited (15-DaCompany Report #2004032706 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Geodon (Ziprasidone) PS 240 MG (80 Professional MG, 3 IN 1 D) Lorazepam (Lorazepam) SS Escitalopram (Escitalopram) SS All Other 22-Feb-2006 08:32 AM Page: 573 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Non-Therapeutic Products SS Topiramate C Diazepam C Date:07/07/04ISR Number: 4395044-2Report Type:Expedited (15-DaCompany Report #2004032702 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Geodon (Ziprasidone) PS Professional All Other Therapeutic Products SS Date:07/08/04ISR Number: 4395534-2Report Type:Expedited (15-DaCompany Report #2004043088 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaphylactic Reaction Health Geodon Professional (Ziprasidone) PS Company Representative Date:07/08/04ISR Number: 4395538-XReport Type:Expedited (15-DaCompany Report #2004042971 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyspnoea Health Geodon (Ziprasidone) PS Dystonia Professional Throat Tightness Company Tongue Disorder Representative Date:07/08/04ISR Number: 4396003-6Report Type:Expedited (15-DaCompany Report #2004042966 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Geodon (Ziprasidone) PS ORAL 40 MG (20 MG, Condition Aggravated Professional 2 IN 1 D), Depression Company ORAL Thermal Burn Representative Zoloft (Sertraline) SS ORAL ORAL Venlafaxine Hydrochloride (Venlafaxine Hydrochloride) C Date:07/08/04ISR Number: 4397048-2Report Type:Expedited (15-DaCompany Report #2004040471 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bladder Disorder Foreign Zeldox (Capsules) Initial or Prolonged Kidney Enlargement Health (Ziprasidone) PS ORAL 200 MG, ORAL Other Renal Failure Professional Lorazepam Urinary Retention Company (Lorazepam) C Representative Metformin Hydrochloride (Metformin Hydrochloride) C Hydrochlorothiazide 22-Feb-2006 08:32 AM Page: 574 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Hydrochlorothiazide ) C Acetylcysteine (Acetylcysteine) C All Other Therapeutic Products (All Other Therapeutic Products) C All Other Non-Therapeutic Products (All Other Non-Therapeutic Products) C Esomeprazole (Esomeprazole) C Folic Acid (Folic Acid) C Date:07/09/04ISR Number: 4395498-1Report Type:Expedited (15-DaCompany Report #2004043580 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Health Geodon (Ziprasidone) PS ORAL 120 MG (1 IN Blood Prolactin Increased Professional 1 D), ORAL Prolactinoma Company Topiramate Representative (Topiramate) C Lorazepam (Lorazepam) C Date:07/09/04ISR Number: 4395499-3Report Type:Expedited (15-DaCompany Report #2004029499 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fall Health Geodon (Im) Professional (Ziprasidone) PS INTRAMUSCULAR 80 MG (40 MG, 2 IN 1 D), INTRAMUSCULAR Date:07/12/04ISR Number: 4398375-5Report Type:Expedited (15-DaCompany Report #2004044147 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fear Foreign Zeldox (Capsules) Initial or Prolonged Suicide Attempt Health (Ziprasidone) PS ORAL 80 MG (40 MG, Professional 2 IN 1 D), Company ORAL Representative Date:07/12/04ISR Number: 4399255-1Report Type:Expedited (15-DaCompany Report #2004044086 Age:46 YR Gender:Female I/FU:I Outcome PT Hospitalization - Affective Disorder Initial or Prolonged Anxiety Other Arteriosclerosis Blood Cholesterol Increased 22-Feb-2006 08:32 AM Page: 575 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Condition Aggravated Depression Eye Disorder Report Source Product Role Manufacturer Route Dose Duration Fatigue Health Geodon (Ziprasidone) PS ORAL 40 MG (20 MG, Feeling Abnormal Professional 2 IN 1 D), Headache ORAL Insomnia Lipitor Intentional Self-Injury (Atrovastatin) SS Medication Error Zoloft (Sertraline) SS Self-Injurious Ideation Valproate Semisodium Suicidal Ideation (Valproate Tongue Ulceration Semisodium) SS Treatment Noncompliance Topiramate Tremor (Topiramate) SS Weight Decreased Quetiapine Fumarate Weight Increased (Quetiapine Fumarate) SS 200 MG (UNK, 1 IN 1 D) Lithium Carbonate (Lithium Carbonate) SS ORAL ORAL Docusate (Docusate) C Trazodone (Trazodone) C Tocopherol (Tocopherol) C Hydroxyzine Embonate (Hydroxyzine Embonate) C Estradiol (Estradiol) C Estratest Hs (Estrogens Esterified, Methyltestosterone) C Desloratadine (Desloratadine) C Calcium (Calcium) C Centrum (Minerals Nos, Vitamins Nos) C Bupropion Hydrochloride (Bupropion Hydrochloride) C Date:07/12/04ISR Number: 4399294-0Report Type:Expedited (15-DaCompany Report #2004031514 Age:18 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Headache Health Geodon (Ziprasidone) PS ORAL 100 MG (2 IN Initial or Prolonged Pancreatitis Professional 1 D), ORAL Other Photophobia Lansoprazole (Lansoprazole) C Topiramate (Topiramate) C Guanfacine Hydrochloride (Guanfacine Hydrochloride) C 22-Feb-2006 08:32 AM Page: 576 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/12/04ISR Number: 4399359-3Report Type:Expedited (15-DaCompany Report #2004038105 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Disease Recurrence Health Geodon (Ziprasidone) PS ORAL 80 MG (40 MG, Initial or Prolonged Neuroleptic Malignant Professional 2 IN 1 D), Other Syndrome ORAL Psychotic Disorder Date:07/13/04ISR Number: 4398096-9Report Type:Expedited (15-DaCompany Report #2004032901 Age:73 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hypertensive Crisis Foreign Zeldox (Capsules) Hospitalization - Rhabdomyolysis Health (Ziprasidone) PS ORAL 40 MG, ORAL Initial or Prolonged Professional Risperidone Other Company (Risperidone) C Representative Ace Inhibitor Nos (Ace Inhibitor Nos) C Date:07/13/04ISR Number: 4398114-8Report Type:Expedited (15-DaCompany Report #DSA_24531_2004 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Tavor PS ORAL 50 MG ONCE PO Initial or Prolonged Blood Creatine Health Atosil SS 1000 MG ONCE Phosphokinase Increased Professional Geodon SS ORAL 240 MG ONCE Blood Lactate Other PO Dehydrogenase Increased Melperone SS ORAL 100 MG ONCE C-Reactive Protein PO Increased Disorientation Multiple Drug Overdose Intentional Somnolence Suicide Attempt Tachycardia Date:07/13/04ISR Number: 4398122-7Report Type:Expedited (15-DaCompany Report #2004043606 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Geodon (Ziprasidone) PS 40 MG (20 MG, General Physical Health Professional 2 IN 1 D) Deterioration Thermal Burn Date:07/13/04ISR Number: 4398123-9Report Type:Expedited (15-DaCompany Report #2004043981 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiomyopathy Health Geodon (Im) Hospitalization - Professional (Ziprasidone) PS INTRAMUSCULAR INTRAMUSCULAR Initial or Prolonged Company Representative 22-Feb-2006 08:32 AM Page: 577 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/13/04ISR Number: 4398144-6Report Type:Expedited (15-DaCompany Report #2004045285 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebrovascular Disorder Health Geodon (Ziprasidone) PS Transient Ischaemic Professional Attack Company Representative Date:07/14/04ISR Number: 4401609-1Report Type:Expedited (15-DaCompany Report #2004043981 Age:64 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiomyopathy Health Geodon (Im) Hospitalization - Professional (Ziprasidone) PS INTRAMUSCULAR INTRAMUSCULAR Initial or Prolonged Company Representative Date:07/14/04ISR Number: 4401613-3Report Type:Expedited (15-DaCompany Report #2004044086 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Health Geodon (Ziprasidone) PS ORAL 40 MG (20 MG, Initial or Prolonged Blood Cholesterol Professional 2 IN 1 D), Other Increased ORAL Depression Lipitor Eye Disorder (Atorvastatin) SS Fatigue Zoloft (Sertraline) SS Feeling Abnormal Valproate Semisodium Headache (Valproate Insomnia Semisodium) SS Intentional Self-Injury Topiramate Medication Error (Topiramate) SS Self-Injurious Ideation Quetiapine Fumarate Suicidal Ideation (Quetiapine Tongue Ulceration Fumarate) SS 200 MG (1 IN Tremor 1 D) Weight Decreased Lithium Carbonate Weight Increased (Lithium Carbonate) SS ORAL ORAL Trazodone (Trazodone) C Tocopherol (Tocopherol) C Hydroxyzine Embonate (Hydroxyzine Embonate) C Estradiol (Estradiol) C Estratest Hs (Estrogens Esterified, Methyltestosterone) C Desloratadine (Desloratadine) C Calcium (Calcium) C Centrum (Minerals Nos, Vitamins Nos) C Docusate (Docusate) C Bupropion Hydrochloride 22-Feb-2006 08:32 AM Page: 578 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Bupropion Hydrochloride) C Date:07/14/04ISR Number: 4401627-3Report Type:Expedited (15-DaCompany Report #2004023721 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Exposure Health Geodon (Ziprasidone) PS ORAL ORAL Blood Caffeine Increased Professional Caffeine (Caffeine) SS Drug Toxicity Other Doxepin (Doxepin) C Hypokalaemia All Other Medication Error Therapeutic Products Self-Medication (All Other Sudden Death Therapeutic Treatment Noncompliance Products) C Vomiting Date:07/15/04ISR Number: 4403392-2Report Type:Expedited (15-DaCompany Report #2004027326 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dialysis Health Geodon (Ziprasidone) PS ORAL 160 MG (2 IN Drug Interaction Professional 1 D), ORAL Nausea Prochlorperazine Treatment Noncompliance Edisylate Vomiting (Prochlorperazine Edisylate) SS ORAL ORAL Date:07/19/04ISR Number: 4421405-9Report Type:Periodic Company Report #2004036984 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Geodon (Im) Professional (Ziprasidone) PS INTRAMUSCULAR INTRAMUSCULAR Company Clozapine Representative (Clozapine) SS Date:07/19/04ISR Number: 4421406-0Report Type:Periodic Company Report #2003119224 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypotension Health Geodon (Im) Professional (Ziprasidone) PS INTRAMUSCULAR 10 MG Company INTRAMUSCULAR Representative Trazodone C Cocaine C Lorazepam C Date:07/19/04ISR Number: 4421407-2Report Type:Periodic Company Report #2003119226 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypotension Health Geodon (Im) Professional (Ziprasidone) PS INTRAMUSCULAR 10 MG Company INTRAMUSCULAR Representative Lorazepam C Opioids C 22-Feb-2006 08:32 AM Page: 579 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Benzodiazepine Derivatives C Date:07/20/04ISR Number: 4404421-2Report Type:Expedited (15-DaCompany Report #2004032706 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Geodon (Ziprasidone) PS 240 MG (80 Professional MG, 3 IN 1 D) Lorazepam (Lorazepam) SS Escitalopram (Escitalopram) SS Topiramate (Topiramate) C Diazepam (Diazepam) C Date:07/20/04ISR Number: 4404434-0Report Type:Expedited (15-DaCompany Report #2004046187 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Health Geodon (Ziprasidone) PS Other Professional Company Representative Date:07/20/04ISR Number: 4404435-2Report Type:Expedited (15-DaCompany Report #2004045603 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Consumer Ziprasidone (Caps) Other Injury Asphyxiation (Ziprasidone) PS Victim Of Homicide Brompheniramine (Brompheniramine) SS Date:07/21/04ISR Number: 4407280-7Report Type:Expedited (15-DaCompany Report #2004046563 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaphylactic Reaction Health Geodon (Ziprasidone) PS Professional Company Representative Date:07/21/04ISR Number: 4407397-7Report Type:Expedited (15-DaCompany Report #2004045285 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Transient Ischaemic Health Geodon (Ziprasidone) PS Attack Professional Company Representative 22-Feb-2006 08:32 AM Page: 580 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/21/04ISR Number: 4407678-7Report Type:Expedited (15-DaCompany Report #2004045976 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Deafness Health Geodon (Ziprasidone) PS Other Professional Clozapine Company (Clozapine) SS Representative Date:07/21/04ISR Number: 4407680-5Report Type:Expedited (15-DaCompany Report #2004046555 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaphylactic Reaction Health Geodon (Ziprasidone) PS Professional Company Representative Date:07/22/04ISR Number: 4405220-8Report Type:Direct Company Report #CTU 223352 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Coordination Abnormal Geodon 80 Mg Cap PS Intervention to Diplopia Trazodone Hcl C Prevent Permanent Dyskinesia Atenolol C Impairment/Damage Aspirin C . C . C Date:07/23/04ISR Number: 4408661-8Report Type:Expedited (15-DaCompany Report #2004030632 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Zeldox (Ziprasidone) PS ORAL 60 MG (60 MG, Initial or Prolonged Phosphokinase Increased Health 2 IN 1 D), Blood Lactate Professional ORAL Dehydrogenase Increased Other Chlorprothixene Hydrochloride C Levomepromazine Maleate C Date:07/23/04ISR Number: 4408673-4Report Type:Expedited (15-DaCompany Report #2003116303 Age:30 YR Gender:Male I/FU:F Outcome PT Life-Threatening Bradycardia Cardiac Disorder Cardiac Failure Dehydration Depressed Level Of Consciousness Drug Ineffective Drug Interaction Eating Disorder Hallucination, Auditory Hallucination, Olfactory Heterophoria Hypotension 22-Feb-2006 08:32 AM Page: 581 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Nausea Pallor Schizophrenia Report Source Product Role Manufacturer Route Dose Duration Somnolence Foreign Ziprasidone Tachycardia Study ((Ziprasidone) PS ORAL SEE IMAGE Vomiting Health Delorazepam Professional 9delorazepam) C Lormetazepam (Lormetazepam) C Date:07/23/04ISR Number: 4408693-XReport Type:Expedited (15-DaCompany Report #2004042258 Age:22 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Akathisia Foreign Zeldox (Capsules) Completed Suicide Company (Ziprasidone) PS ORAL 160 MG (2 IN Drug Ineffective Representative 1 D), ORAL Food Craving Risperidone Weight Increased (Risperidone) SS Aripiprazole(Aripipr azole) SS Isopromethazine Hydrochloride (Isopromethazine Hydrochloride) C Reboxetine (Reboxetine) C Date:07/23/04ISR Number: 4409454-8Report Type:Expedited (15-DaCompany Report #2004040233 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Pressure Increased Health Geodon (Im) Hospitalization - Coma Professional (Ziprasidone) PS INTRAMUSCULAR 20 MG, Initial or Prolonged Depressed Level Of Other INTRAMUSCULAR Other Consciousness Ventricular Extrasystoles Date:07/23/04ISR Number: 4409469-XReport Type:Expedited (15-DaCompany Report #2004041466 Age:17 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Geodon (Ziprasidone) PS ORAL 80 MG(40 MG, Initial or Prolonged Phosphokinase Increased Professional 2 IN 1 D), Other Fluid Intake Reduced ORAL General Physical Health Lorazepam Deterioration (Lorazepam) SS ORAL 2 MG (0.5 MG, Musculoskeletal Stiffness 4 IN 1D), Neuroleptic Malignant ORAL Syndrome Oral Intake Reduced Weight Decreased 22-Feb-2006 08:32 AM Page: 582 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/26/04ISR Number: 4410584-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040705660 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Atrial Fibrillation Health Levofloxacin Blood Pressure Increased Professional (Levofloxacin) PS Bundle Branch Block Left Digoxin (Digoxin) SS ORAL ORAL Circulatory Collapse Theophylline Condition Aggravated (Theophylline) SS ORAL ORAL Depression Zeldox (Ziprasidone Diabetes Mellitus Hydrochloride) SS ORAL 80 MG 2 IN 1 Dizziness DAY ORAL Electrocardiogram Qt Zopiclone Prolonged (Zopiclone) SS ORAL ORAL Myocardial Infarction Verapamil Paranoia (Verapamil) SS ORAL 160 MG, 2 IN Respiratory Tract 1 DAY ORAL Infection Citalopram Torsade De Pointes Hydrobromide Ventricular Tachycardia (Citalopram Vomiting Hydrobromide) C Donepezil Hydrochloride (Donepezil Hydrochloride) C Date:07/26/04ISR Number: 4410686-3Report Type:Expedited (15-DaCompany Report #2003029187 Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anxiety Foreign Ziprasidone (Caps) Hospitalization - Blood Pressure Increased Literature (Ziprasidone) PS ORAL 160 MG (2 IN Initial or Prolonged Coma Health 1 D), ORAL Other Electrocardiogram Qt Professional Clomethiazole Corrected Interval (Clomethiazole) SS ORAL 384 MG Prolonged (DAILY), ORAL Heart Rate Increased Flunitrazepam Multiple Drug Overdose (Flunitrazepam) SS ORAL 2 MG (BID), Oxygen Saturation ORAL Increased Paroxetine Poisoning (Paroxetine) C Somnolence Lorazepam Suicide Attempt (Lorazepam) C Tremor Sodium Picosulfate (Sodium Picosulfate) C Date:07/26/04ISR Number: 4410687-5Report Type:Expedited (15-DaCompany Report #2004047227 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hospitalisation Health Geodon (Ziprasidone) PS Initial or Prolonged Professional Company Representative 22-Feb-2006 08:32 AM Page: 583 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/26/04ISR Number: 4410688-7Report Type:Expedited (15-DaCompany Report #2004047230 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Unevaluable Event Health Geodon (Ziprasidone) PS Initial or Prolonged Professional Company Representative Date:07/26/04ISR Number: 4410689-9Report Type:Expedited (15-DaCompany Report #2004038108 Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Epistaxis Foreign Zeldox (Capsules) Pulmonary Tuberculosis Health (Ziprasidone) PS ORAL 120 MG (60 Red Blood Cell Professional MG, 2 IN 1 Sedimentation Rate Company D), ORAL Increased Representative Sudden Death Date:07/26/04ISR Number: 4410710-8Report Type:Expedited (15-DaCompany Report #2004046701 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Foreign Ziprasidone (Caps) Dizziness Health (Ziprasidone) PS ORAL 160 MG (80 Epilepsy Professional MG, 2 IN 1 Mental Impairment Company D), ORAL Scratch Representative Gabapentin Skin Lesion (Gabapentin) SS ORAL 1800 MG (600 MG, 3 IN 1 D), ORAL Lamotrigine (Lamotrigine) SS ORAL 300 MG, ORAL Ranitidine Hydrochloride (Ranitidine Hydrochloride) SS ORAL ORAL Midazolam (Midazolam) SS ORAL ORAL Dexchlorpheniramine Maleate (Dexchlorpheniramine Maleate) SS Olanzapine (Olanzapine) C Date:07/27/04ISR Number: 4409691-2Report Type:Direct Company Report #CTU 223636 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Triglycerides Ziprasidone PS Increased Lithium C Venlafaxine C 22-Feb-2006 08:32 AM Page: 584 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/27/04ISR Number: 4412797-5Report Type:Expedited (15-DaCompany Report #2004048769 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Geodon Feeling Abnormal Professional (Ziprasidone) PS ORAL 320 MG (1 IN Metabolic Syndrome Company 1 D) ORAL Representative Date:07/27/04ISR Number: 4412799-9Report Type:Expedited (15-DaCompany Report #2004047917 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Discomfort Consumer Geodon (Ziprasidone) PS ORAL 160 MG (80 MG Initial or Prolonged Bowel Sounds Abnormal 2 IN 1 D) Diarrhoea ORAL Gastrointestinal Disorder Zoloft (Sertraline) SS ORAL 150 MG ( 1 IN 1 D) ORAL Olanzapine (Olanzapine) SS Quetiapine Fumarate (Quetiapine Fumarate) C Esomeprazole (Esomeprazole) C Date:07/28/04ISR Number: 4413239-6Report Type:Expedited (15-DaCompany Report #2004042305 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Tardive Dyskinesia Health Geodon (Ziprasidone) PS ORAL 1 IN 1 D , Professional ORAL Company Venlafaxine Representative Hydrochloride (Venlafaxine Hydrochloride) SS ORAL 375 MG (375MG, 1 IN 1 D), ORAL Date:07/28/04ISR Number: 4413240-2Report Type:Expedited (15-DaCompany Report #2004041583 Age:19 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Health Geodon (Ziprasidone) PS ORAL 40 MG, ORAL Dyskinesia Professional Valproate Semisodium Feeling Abnormal Company (Valproate Grimacing Representative Semisodium) C Muscle Twitching Swollen Tongue Throat Tightness Date:07/28/04ISR Number: 4413954-4Report Type:Expedited (15-DaCompany Report #2004021190 Age: Gender:Male I/FU:F Outcome PT Report Source Death Sudden Death Foreign Health Professional 22-Feb-2006 08:32 AM Page: 585 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company Representative Product Role Manufacturer Route Dose Duration Geodon (Ziprasidone) PS ORAL 80 MG (80 MG, 1 IN 1D),ORAL Haloperidol (Haloperidol) C Diazepam (Diazepam) C Date:07/28/04ISR Number: 4413958-1Report Type:Expedited (15-DaCompany Report #2004021193 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Foreign Geodon (Ziprasidone) PS ORAL ORAL Health Phenytoin Professional (Phenytoin) C Company Phenobarbital Representative (Phenobarbital) C Haloperidol Decanoate (Haloperidol Decanoate) C Haloperidol (Haloperidol) C Date:07/29/04ISR Number: 4443713-8Report Type:Periodic Company Report #US-JNJFOC-20040200880 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Health Risperdal Syndrome Professional (Risperidone) Tablets PS ORAL 2 MG, 2 IN 1 DAY, ORAL; 1 MG, 2 IN 1 DAY, ORAL Geodon (Ziprasidone Hydrochloride) SS 20 MG Seroquel (Quetiapine Fumarate) SS 100 MG Date:07/29/04ISR Number: 4443969-1Report Type:Periodic Company Report #US-JNJFOC-20030704993 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Body Temperature Health Risperdal Initial or Prolonged Increased Professional (Risperidone) Musculoskeletal Stiffness Company Tablets PS ORAL ORAL Neuroleptic Malignant Representative Paxil (Paroxetine Syndrome Hydrochloride) SS Tachycardia Geodon (Ziprasidone Hydrochloride) SS 60 MG, 2 IN 1 DAY Zyprexa (Olanzapine) SS 22-Feb-2006 08:32 AM Page: 586 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/30/04ISR Number: 4412924-XReport Type:Direct Company Report #CTU 223910E Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Geodon 40 Mg , Initial or Prolonged Neuroleptic Malignant Pfizer PS Pfizer 40 MG AM , Syndrome 120 PM [ 2 WEEKS (DOSE INCREASE 2-3 DAYS AGO)] 2 WK Date:07/30/04ISR Number: 4416050-5Report Type:Expedited (15-DaCompany Report #2004036887 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cold Sweat Health Geodon (Ziprasidone) PS 280 MG (140 Initial or Prolonged Depressed Level Of Professional MG, 2 IN 1 D) Consciousness Company Tiagabine Depression Representative Hydrochloride Fall (Tiagabine Foot Fracture Hydrochloride) SS 16 MG (8 MG, Hyperhidrosis 2 IN 1 D), Enalapril Maleate (Enalapril Maleate) C Metformin Hydrochloride (Metformin Hydrochloride) C Insulin Glargine (Insulin Glargine) C Amantadine Hydrochloride (Amantadine Hydrochloride) C Venlafaxine Hydrochloride (Venlafaxine Hydrochloride) C Escitalopram (Escitalopram) C Date:08/02/04ISR Number: 4413103-2Report Type:Direct Company Report #CTU 224011 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Ziprasidone 80 Mg Emotional Distress Pfizer PS Pfizer ORAL 80 MG BID Muscle Spasms ORAL Torticollis Date:08/02/04ISR Number: 4417293-7Report Type:Expedited (15-DaCompany Report #2004049295 Age: Gender:Female I/FU:I Outcome PT Hospitalization - Back Pain Initial or Prolonged Blood Urine Other Coordination Abnormal Diarrhoea Drooling 22-Feb-2006 08:32 AM Page: 587 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dysarthria Dyskinesia Dyspnoea Report Source Product Role Manufacturer Route Dose Duration Fatigue Consumer Geodon (Ziprasidone) PS ORAL 40 MG (20 MG, Gait Disturbance 2 IN 1D), Haemorrhage ORAL Hostility Donepezil Hyperaesthesia Hydrochloride Nausea (Donepezil Skin Disorder Hydrochloride) SS Sleep Disorder Propacet Tremor (Dextropropoxyphene Upper Respiratory Tract Napsilate, Infection Paracetamol) SS Risedronate Sodium (Risedronate Sodium) C Levothyroxine Sodium (Levothyroxine Sodium) C Olmesartan Medoxomil (Olmesartan Medoxomil) C Bisoprolol Fumarate (Bisoprolol Fumarate) C Celecoxib (Celecoxib) C Lotrel (Amlodipine, Benazepril Hydrochloride) C K-Droppar (Cyclopentolate, Epinephrine, Tropicamide) C Calcium Carbonate (Calcium Carbonate) C Donepezil Hydrochloride (Donepezil Hydrochloride) C Alprazolam (Alprazolam) C Escitalopram (Escitalopram) C Date:08/02/04ISR Number: 4417356-6Report Type:Expedited (15-DaCompany Report #2004048702 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Company Geodon (Im) Representative (Ziprasidone) PS INTRAMUSCULAR INTRAMUSCULAR Date:08/03/04ISR Number: 4417417-1Report Type:Expedited (15-DaCompany Report #2004049431 Age:46 YR Gender:Male I/FU:I Outcome PT Disability Amnesia Other Anxiety Cardiac Arrest 22-Feb-2006 08:32 AM Page: 588 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Cardiac Pacemaker Insertion Condition Aggravated Report Source Product Role Manufacturer Route Dose Duration Fall Consumer Geodon (Ziprasidone) PS Limb Injury Lorazepam Loss Of Consciousness (Lorazepam) C Loss Of Employment Sertraline Procedural Complication Hydrochloride (Sertraline Hydrochloride) C Date:08/03/04ISR Number: 4417421-3Report Type:Expedited (15-DaCompany Report #2004048702 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Health Geodon (Im) Other Professional (Ziprasidone) PS INTRAMUSCULAR INTRAMUSCULAR Company Vicodin (Hydrocodone Representative Bitartrate, Paracetamol) SS All Other Therapeutic Products (All Other Therapeutic Products) SS Date:08/03/04ISR Number: 4417428-6Report Type:Expedited (15-DaCompany Report #2004042971 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyskinesia Health Geodon (Ziprasidone) PS ORAL 160 MG (80 Initial or Prolonged Dyspnoea Professional MG, 2 IN 1 Other Dystonia Company D), ORAL Muscle Spasms Representative Musculoskeletal Stiffness Obstructive Airways Disorder Throat Tightness Tongue Disorder Date:08/03/04ISR Number: 4417434-1Report Type:Expedited (15-DaCompany Report #2004032913 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other No Adverse Effect Health Geodon (Ziprasidone) PS Professional Date:08/03/04ISR Number: 4417738-2Report Type:Expedited (15-DaCompany Report #2004050005 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arrhythmia Foreign Zeldox (Capsules) Electrocardiogram Qt Health (Ziprasidone) PS ORAL 160 MG, ORAL Prolonged Professional Fluphenazine Company Hydrochloride Representative (Fluphenazine Hydrochloride) C 22-Feb-2006 08:32 AM Page: 589 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/03/04ISR Number: 4418010-7Report Type:Expedited (15-DaCompany Report #2004049045 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neuroleptic Malignant Foreign Zeldox (Capsules) Hospitalization - Syndrome Health (Ziprasidone) PS ORAL 160 MG (80 Initial or Prolonged Professional MG, 2 IN 1 D), ORAL Lithium Sulfate C Date:08/04/04ISR Number: 4416028-1Report Type:Direct Company Report #CTU 224187 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Drug Interaction Risperdal PS Intervention to Dystonia Geodon SS Prevent Permanent Tenex C Impairment/Damage Zoloft C Concerta C Date:08/04/04ISR Number: 4416030-XReport Type:Direct Company Report #CTU 224191 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Priapism Geodon 40 Mg Three Required At Hs PS MONTHS Intervention to Adderall Xr C Prevent Permanent Impairment/Damage Date:08/04/04ISR Number: 4421876-8Report Type:Expedited (15-DaCompany Report #2004049742 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Serotonin Syndrome Health Geodon (Ziprasidone) PS Professional Nardil (Phenelzine Company Sulfate) SS Representative Date:08/04/04ISR Number: 4421898-7Report Type:Expedited (15-DaCompany Report #2004049916 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Disease Recurrence Health Geodon (Ziprasidone) PS Neuroleptic Malignant Professional Syndrome Date:08/04/04ISR Number: 4421905-1Report Type:Expedited (15-DaCompany Report #2004049973 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Health Geodon (Ziprasidone) PS ORAL 200 MG (100 Initial or Prolonged Menstrual Disorder Professional MG, 2 IN 1 D), ORAL 22-Feb-2006 08:32 AM Page: 590 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/04/04ISR Number: 4421908-7Report Type:Expedited (15-DaCompany Report #2004037796 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ankle Fracture Consumer Geodon (Ziprasidone) PS Drug Interaction All Other Psychotic Disorder Therapeutic Products SS Schizoaffective Disorder Date:08/05/04ISR Number: 4421889-6Report Type:Expedited (15-DaCompany Report #2004051909 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Health Geodon (Ziprasidone) PS Syndrome Professional Company Representative Date:08/05/04ISR Number: 4422419-5Report Type:Expedited (15-DaCompany Report #2004050971 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Heart Rate Decreased Health Geodon (Ziprasidone) PS Initial or Prolonged Professional Company Representative Date:08/05/04ISR Number: 4423178-2Report Type:Expedited (15-DaCompany Report #2004050914 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaphylactic Shock Consumer Geodon (Ziprasidone) PS ORAL 80 MG (40 MG, Insomnia 2 IN 1 D), Mania ORAL Rash Vicodin (Hydrocodone Bitartrate, Paracetamol) C Oxycodone Hydrochloride (Oxycodone Hydrochloride) C Topiramate (Topiramate) C Date:08/05/04ISR Number: 4423614-1Report Type:Expedited (15-DaCompany Report #2004051554 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperprolactinaemia Foreign Ziprasidone (Caps) Initial or Prolonged Health (Ziprasidone) PS ORAL 160 MG (80 Professional MG, 2 IN 1 Company D), ORAL Representative 22-Feb-2006 08:32 AM Page: 591 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/05/04ISR Number: 4423617-7Report Type:Expedited (15-DaCompany Report #2004021193 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Foreign Geodon (Ziprasidone) PS ORAL ORAL Health Haloperidol Professional Decanoate Company (Haloperidol Representative Decanoate) C Haloperidol (Haloperidol) C Phenytoin (Phenytoin) I C Date:08/05/04ISR Number: 4423632-3Report Type:Expedited (15-DaCompany Report #2004021190 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Foreign Geodon (Ziprasidone) PS ORAL 80 MG (80 MG, Health 1 IN 1 D), Professional ORAL Company Haloperidol Representative (Haloperidol) C Diazepam (Diazepam) C Date:08/05/04ISR Number: 4423692-XReport Type:Expedited (15-DaCompany Report #2004046701 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dizziness Foreign Ziprasidone (Caps) Pruritus Health (Ziprasidone) PS ORAL 160 MG (80 Scratch Professional MG, 2 IN 1 D) Skin Lesion Company ORAL Torsade De Pointes Representative Gabapentin (Gabapentin) SS ORAL 1800 MG (600 MG, 3 IN 1 D), ORAL Lamotrigine (Lamotrigine) SS ORAL 300 MG, ORAL Ranitidine Hydrochloride (Ranitidine Hydrochloride) SS ORAL ORAL Midazolam (Midazolam) SS ORAL ORAL Dexchlorpheniramine Maleate (Dexchlorpheniramine Maleate) SS Olanzapine (Olanzapine) C Date:08/05/04ISR Number: 4423759-6Report Type:Expedited (15-DaCompany Report #2004031607 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Hospitalization - Acute Respiratory Failure Foreign Initial or Prolonged Pneumonia Viral Health Pulmonary Oedema Professional 22-Feb-2006 08:32 AM Page: 592 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company Representative Product Role Manufacturer Route Dose Duration Geodon (Ziprasidone) PS ORAL 160 MG (80 MG, 2 IN 1 D), ORAL Penfluridol (Penfluridol) C Carbamazepine (Carbamazepine) C Date:08/06/04ISR Number: 4421838-0Report Type:Expedited (15-DaCompany Report #2004017234 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Acute Psychosis Health Geodon (Ziprasidone) PS ORAL SEE IMAGE Hospitalization - Anxiety Professional Clonazepam Initial or Prolonged Catatonia Other (Clonazepam) C Other Cranial Nerve Disorder Lorazepam Disease Progression (Lorazepam) C Hypertension Diphenydramine Incoherent Hydrochloride C Intentional Self-Injury Pioglitazone Neuroleptic Malignant (Pioglitazone) C Syndrome Diltiazem Overdose Hydrochloride Schizophrenia, Paranoid (Diltiazem Type Hydrochloride) C Levothyroxine Sodium (Levothyroxine Sodium) C Metformin Hydrochloride (Metformin Hydrochloride) C Sertraline Hydrochloride (Sertraline Hydrochloride) C Glibenclamide (Glibenclamide) C Amlodipine (Amlodiine) C Quinidine (Quinidine) C Paracetamol (Paracetamol) C Docusate Sodium (Docusate Sodium) C Date:08/11/04ISR Number: 4427048-5Report Type:Expedited (15-DaCompany Report #2003122645 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Geodon (Im) Other Professional (Ziprasidone) PS INTRAMUSCULAR INTRAMUSCULAR Company Opioids C Representative All Other Non-Therapeutic 22-Feb-2006 08:32 AM Page: 593 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Products C Vicodin (Hydrocodone Bitartrate, Paracetamol) C Date:08/12/04ISR Number: 4427656-1Report Type:Expedited (15-DaCompany Report #2004UW16742 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Seroquel PS Cardiovascular Disorder Professional Geodon SS Date:08/13/04ISR Number: 4428012-2Report Type:Expedited (15-DaCompany Report #2004052127 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Geodon (Ziprasidone) PS Convulsion Professional Risperidone Cough Company (Risperidone) C Epilepsy Representative Date:08/16/04ISR Number: 4428916-0Report Type:Expedited (15-DaCompany Report #2004052204 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Delusion Consumer Geodon (Ziprasidone) PS Visual Acuity Reduced Date:08/17/04ISR Number: 4430001-9Report Type:Direct Company Report #CTU 225088E Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Palpitations Ziprasidone PS ORAL 160 MG PO QHS Intervention to Prevent Permanent Impairment/Damage Date:08/18/04ISR Number: 4429410-3Report Type:Direct Company Report #CTU 225240 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cogwheel Rigidity Ziprosidone Hcl 80 Nystagmus Mg Po Bid PS ORAL PO BID Tremor Risperidone 3 Mg Po Hs SS ORAL PO HS Date:08/20/04ISR Number: 4432584-1Report Type:Expedited (15-DaCompany Report #2004039088 Age: Gender:Male I/FU:F Outcome PT Hospitalization - Blood Creatine Initial or Prolonged Phosphokinase Increased Other Catatonia Extrapyramidal Disorder Muscle Rigidity Neuroleptic Malignant 22-Feb-2006 08:32 AM Page: 594 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Syndrome Report Source Product Role Manufacturer Route Dose Duration Health Geodon (Ziprasidone) PS 160 MG (80 Professional MG, 2 IN 1 D) Company Diphenhydramine Representative Hydrochloride) (Diphenhydramine Hydrochloride) SS 50 MG Date:08/20/04ISR Number: 4432592-0Report Type:Expedited (15-DaCompany Report #2004055655 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Electrocardiogram Qt Health Geodon (Ziprasidone) PS Corrected Interval Professional Company Representative Date:08/20/04ISR Number: 4432601-9Report Type:Expedited (15-DaCompany Report #2004037796 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ankle Fracture Consumer Geodon (Ziprasidone) PS Drug Interaction All Other Open Fracture Therapeutic Products Post Procedural (All Other Complication Therapeutic Psychotic Disorder Products) SS Schizoaffective Disorder Date:08/23/04ISR Number: 4433163-2Report Type:Expedited (15-DaCompany Report #2004054836 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthma Consumer Neurontin Condition Aggravated (Gabapentin) PS Fatigue Geodon (Ziprasidone Pain In Jaw Hydrochloride) Sexual Dysfunction (Ziprasidone) SS 40 MG Somnolence Risperidone Vision Blurred (Risperidone) SS Paracetamol (Paracetamol) SS Olanzapine (Olanzapine) SS Aripiprazole (Aripiprazole) SS Date:08/23/04ISR Number: 4433172-3Report Type:Expedited (15-DaCompany Report #2004054765 Age:55 YR Gender:Female I/FU:I Outcome PT Hospitalization - Abdominal Discomfort Initial or Prolonged Abdominal Distension Other Abdominal Pain Blood Triglycerides 22-Feb-2006 08:32 AM Page: 595 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Increased Chest Pain Constipation Depression Report Source Product Role Manufacturer Route Dose Duration Diarrhoea Consumer Geodon (Ziprasidone) PS ORAL 100 MG (1 IN Disease Recurrence 1 D), ORAL Disturbance In Attention Dexamfetamine Dyspepsia (Dexamfetamine) SS ORAL 60 MG (15 MG, Fatigue 2 IN 1 D), Flatulence ORAL Food Intolerance Venlafaxine Medication Error Hydrochloride Nausea (Venlafaxine Phagophobia Hydrochloride) SS ORAL 300 MG (1 IN Retching 1 D), ORAL Somnolence Valproate Semisodium (Valproate Semisodium) C Levothyroxine Sodium (Levothyroxine Sodium) C Nifedipine (Nifedipine) C Mirtazapine (Mirtazapine) C Date:08/23/04ISR Number: 4433183-8Report Type:Expedited (15-DaCompany Report #2004054148 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anticonvulsant Drug Level Health Geodon (Ziprasidone) PS ORAL 160 MG (1 IN Increased Professional 1 D), ORAL Arthralgia Company Valproate Semisodium Coordination Abnormal Representative (Valproate Fatigue Semisodium) SS 1000 MG (1 IN Headache 1 D) Myalgia Date:08/24/04ISR Number: 4433731-8Report Type:Direct Company Report #CTU 225474 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Diastolic Geodon 80 Mg Pfizer PS Pfizer 80 MG BY Decreased MOUTH TWICE A Diarrhoea DAY Drug Interaction Zoloft 100 Mg Pfizer SS Pfizer 100 MG BY Heart Rate Decreased MOUTH EACH AM Hyperhidrosis Flagyl 500 Mg SS 500 MG BY Serotonin Syndrome MOUTH TWICE A Tremor DAY Zyprexa C Hydroxyzine C Cyproheptadine C Amantdine C Neurontin C Relafen C Flagyl C Oyster Shell Calcium C Elimite/Permethrin C Milk Of Magnesia C 22-Feb-2006 08:32 AM Page: 596 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Maalox C Chapstick C Multivitamin + Zinc/ No Iron C Ibuprofen C Date:08/25/04ISR Number: 4434117-2Report Type:Expedited (15-DaCompany Report #2004055638 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Zeldox (Capsules) Initial or Prolonged Agitation Health (Ziprasidone) PS ORAL 120 MG (60 Suicidal Ideation Professional MG, 2 IN 1 D), ORAL Date:08/25/04ISR Number: 4434274-8Report Type:Expedited (15-DaCompany Report #2004055648 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Paranoia Foreign Zeldox (Capsules) Initial or Prolonged Health (Ziprasidone) PS ORAL 80 MG (40 MG, Professional 2 IN 1 D), ORAL Midazolam (Midazolam) C Date:08/26/04ISR Number: 4435565-7Report Type:Expedited (15-DaCompany Report #2004046354 Age:72 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Zeldox (Capsules) Initial or Prolonged Phosphokinase Increased Health (Ziprasidone) PS 80 MG (1 IN 1 Chills Professional D) Extrapyramidal Disorder Perazine (Perazine) SS 400 (200) Fall Fluphenazine Neuroleptic Malignant (Fluphenazine) SS 3 MG (3 MG) Syndrome Somnolence Date:08/27/04ISR Number: 4435363-4Report Type:Direct Company Report #CTU 225757 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Geodon 40 Mg Twice Emotional Distress Daily Pfizer PS Pfizer ORAL 40 MG TWICE A Feeling Abnormal DA ORAL Flat Affect Insomnia Date:08/27/04ISR Number: 4437087-6Report Type:Expedited (15-DaCompany Report #2004051909 Age:51 YR Gender:Female I/FU:F Outcome PT Hospitalization - Blood Potassium Decreased Initial or Prolonged Blood Pressure Systolic Other Increased 22-Feb-2006 08:32 AM Page: 597 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Blood Sodium Increased Body Temperature Increased Report Source Product Role Manufacturer Route Dose Duration Catatonia Health Geodon (Ziprasidone) PS ORAL (1 IN 1 D), Heart Rate Increased Professional ORAL Muscle Rigidity Company Mirtazapine Neuroleptic Malignant Representative (Mirtazapine) C Syndrome Date:08/30/04ISR Number: 4438692-3Report Type:Direct Company Report #CTU 225926 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Anorexia Ziprasidone PS 160 MG BID Intervention to Weight Decreased Prevent Permanent Impairment/Damage Date:08/30/04ISR Number: 4438895-8Report Type:Expedited (15-DaCompany Report #2003019890 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alcohol Use Consumer Geodon (Ziprasidone) PS ORAL ORAL Multiple Drug Overdose Health Clonazepam Torsade De Pointes Professional (Clonazepam) SS Company Ethanol (Ethanol) SS Representative Date:08/30/04ISR Number: 4438967-8Report Type:Expedited (15-DaCompany Report #2004056975 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Ziprasidone (Im) Initial or Prolonged Agitation Health (Ziprasidone) PS INTRAMUSCULAR 40 MG (20 Drug Ineffective Professional MG), INTRAMUSCULAR Date:08/31/04ISR Number: 4440008-3Report Type:Expedited (15-DaCompany Report #2004051554 Age:26 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Galactorrhoea Foreign Ziprasidone(Caps) Initial or Prolonged Hyperprolactinaemia Health (Ziprasidone) PS ORAL 240 MG (160 Professional MG, BID Company INTERVAL: Representative DAILY), ORAL Date:09/01/04ISR Number: 4439509-3Report Type:Direct Company Report #CTU 226018 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Trismus Clozaril PS ORAL PO [PRIOR TO Initial or Prolonged ADMISSION] Geodon SS PO (PRIOR TO ADMISSION) Prozac SS PO (PRIOR TO 22-Feb-2006 08:32 AM Page: 598 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ADMISSION) Date:09/01/04ISR Number: 4441846-3Report Type:Expedited (15-DaCompany Report #2004058017 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zeldox (Capsules) Delusion Health (Ziprasidone) PS 120 MG Professional Lorazepam Company (Lorazepam) C Representative Date:09/01/04ISR Number: 4443479-1Report Type:Expedited (15-DaCompany Report #2004057896 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Geodon (Ziprasidone) PS ORAL 120 MG (69 Professional MG, 2 IN 1 Company D), ORAL Representative Oxcarbazepine (Oxcarbazepine) C Lorazepam (Lorazepam) C Olanzapine (Olanzapine) C Date:09/02/04ISR Number: 4441123-0Report Type:Direct Company Report #CTU 226247E Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Body Height Increased Geodon PS 40 MG Intervention to Diabetes Mellitus Clonidine SS 40 MG Prevent Permanent Weight Increased Zoloft SS 120 MG Impairment/Damage Date:09/02/04ISR Number: 4444480-4Report Type:Expedited (15-DaCompany Report #2004050963 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Tardive Dyskinesia Health Geodon (Ziprasidone) PS 80 MG (40 MG, Professional 2 IN 1 D) Company Alprazolam Representative (Alprazolam) C Date:09/02/04ISR Number: 4444600-1Report Type:Expedited (15-DaCompany Report #2004049916 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Health Geodon (Ziprasidone) PS Syndrome Professional Risperidone (Risperidone) SS 22-Feb-2006 08:32 AM Page: 599 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/02/04ISR Number: 4444630-XReport Type:Expedited (15-DaCompany Report #2004046187 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Geodon (Ziprasidone) PS UNKNOWN UNK, UNKNOWN Other Pulmonary Embolism Professional Sudden Death Company Representative Date:09/02/04ISR Number: 4445866-4Report Type:Expedited (15-DaCompany Report #2004058787 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Foreign Geodon (Ziprasidone) PS ORAL 80 MG (40 Initial or Prolonged Convulsion Consumer MG,2 IN 1 D), Self Injurious Behaviour ORAL Carbamazepine (Carbamazepine) C Lithium Carbonate (Lithium Carbonate) C Date:09/03/04ISR Number: 4443568-1Report Type:Direct Company Report #CTU 226332E Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrial Fibrillation Ziprasidone PS INTRAVENOUS 20 MG ONETIME Initial or Prolonged Mental Status Changes IM Date:09/03/04ISR Number: 4446088-3Report Type:Expedited (15-DaCompany Report #2004059441 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Geodon (Ziprasidone) PS Life-Threatening Depression Professional Zoloft (Sertraline) C Other Date:09/03/04ISR Number: 4446183-9Report Type:Expedited (15-DaCompany Report #2004046448 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Health Geodon (Ziprasidone) PS ORAL 200 MG (1 IN Initial or Prolonged Electrocardiogram P Wave Professional 1 D), ORAL Other Abnormal Other Ibuprofen Sinus Arrhythmia (Ibuprofen) C Sinus Bradycardia Diazepam (Diazepam) C Swollen Tongue Clonazepam (Clonazepam) C Venlafaxine (Venlafaxine) C Bupropion (Bupropion) C 22-Feb-2006 08:32 AM Page: 600 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/07/04ISR Number: 4443234-2Report Type:Direct Company Report #CTU 226425 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Insulin Decreased Geodon/Ziprasidon 20 Initial or Prolonged Diabetes Mellitus Mg PS ORAL 20 MG ONE Other Erythema DAILY ORAL Required Gastrointestinal Disorder Allesse Birth Intervention to Inflammation Control C Prevent Permanent Insomnia Lexapro C Impairment/Damage Weight Increased Date:09/07/04ISR Number: 4446329-2Report Type:Expedited (15-DaCompany Report #2004060194 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Geodon (Im) Initial or Prolonged Syndrome Professional (Ziprasidone) PS SEE IMAGE Other Psychotic Disorder Levofloxacin (Levofloxacin) C Zolpidem Tartrate (Zolpidem Tartrate) C Date:09/07/04ISR Number: 4446353-XReport Type:Expedited (15-DaCompany Report #2004058622 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Catecholamines Health Geodon (Ziprasidone) PS ORAL 60 MG (60 MG, Abnormal Professional 1 IN 1 D), Breast Cancer Female ORAL Glucose Tolerance Test Zocor (Simvastatin) C Abnormal Xanax (Alprazolam) C Hypoglycaemia Synthroid Norepinephrine Increased (Levothyroxine Normetanephrine Urine Sodium) C Increased Paxil (Paroxetine Pancreatic Mass Hydrohcloride) C Panic Attack Phaeochromocytoma Date:09/07/04ISR Number: 4446404-2Report Type:Expedited (15-DaCompany Report #2004058786 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Deafness Unilateral Health Geodon (Ziprasidone) PS ORAL 80 MG (40 MG, Other Professional 2 IN 1 D), ORAL Bupropion Hydrochloride (Bupropion Hydrochloride) C Fluoxetine Hydrochloride (Fluoxetine Hydrochloride) C Quetiapine Fumarate (Quetiapine Fumarate) C 22-Feb-2006 08:32 AM Page: 601 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/07/04ISR Number: 4446407-8Report Type:Expedited (15-DaCompany Report #2004057896 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Geodon (Ziprasidone) PS ORAL 120 MG (50 Professional MG, 2 IN 1 Company D), ORAL Representative Oxcarbazepine (Oxcarbazepine) C Lorazepam (Lorazepam) C Olanzapine (Olanzapine) C Date:09/08/04ISR Number: 4446588-6Report Type:Expedited (15-DaCompany Report #2004052509 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cholecystitis Health Geodon (Ziprasidone) PS ORAL 80 MG (80 MG, Cholelithiasis Professional 1 IN 1 D), Drug Hypersensitivity ORAL Liver Function Test Methylprednisolone SS Abnormal Levothyroxine Sodium SS 50 MCG (50 Mania MCG, 1 IN 1 Reaction To Preservatives D) Splenomegaly Oxcarbazepine SS Methylphenidate Hydrochloride C Escitalopram C Multivitamins (Ascorbic Acid, Ergocalciferol, Folic Acid, Nicotinamide, C Date:09/08/04ISR Number: 4446677-6Report Type:Expedited (15-DaCompany Report #2004060301 Age:15 YR Gender:Male I/FU:I Outcome PT Hospitalization - Band Neutrophil Initial or Prolonged Percentage Increased Blood Bicarbonate Decreased Blood Chloride Increased Blood Creatine Phosphokinase Increased Blood Creatinine Increased Blood Glucose Increased Blood Ph Decreased Blood Pressure Decreased Blood Urea Increased Blood Urine Convulsion Depressed Level Of Consciousness Heart Rate Increased Hyperhidrosis Incoherent Muscle Rigidity 22-Feb-2006 08:32 AM Page: 602 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Myoglobinuria Neuroleptic Malignant Syndrome Report Source Product Role Manufacturer Route Dose Duration Nystagmus Literature Ziprasidone (Caps) Pyrexia Health (Ziprasidone) PS 80 MG (1 IN 1 Respiratory Rate Professional D) Increased Bupropion (Bupropion Tremor ) C Urinary Incontinence Valproic Acid White Blood Cell Count (Valproic Acid) C Increased Tetracycline White Blood Cells Urine (Tetracycline) C Positive Date:09/09/04ISR Number: 4448677-9Report Type:Expedited (15-DaCompany Report #2004059886 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Foreign Zeldox (Capsules) Depression Health (Ziprasidone) PS ORAL ORAL Drug Dependence Professional Drug Withdrawal Syndrome Feeling Cold Muscle Tightness Date:09/09/04ISR Number: 4449551-4Report Type:Expedited (15-DaCompany Report #2004053618 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Geodon (Ziprasidone) PS 120 MG (40 Initial or Prolonged Drug Ineffective Professional MG, 2 IN 1 D) Electrocardiogram Qt Other Corrected Interval Prolonged Lethargy Neuroleptic Malignant Syndrome Oral Intake Reduced Tremor Date:09/10/04ISR Number: 4446745-9Report Type:Expedited (15-DaCompany Report #2004059880 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Venous Thrombosis Foreign Zeldox (Capsules) Hospitalization - Health (Ziprasidone) PS 80 MG Initial or Prolonged Professional Flupentixol Disability (Flupentixol) C Biperiden (Biperiden) C Date:09/14/04ISR Number: 4450562-3Report Type:Expedited (15-DaCompany Report #2004047917 Age:48 YR Gender:Male I/FU:F Outcome PT Hospitalization - Abdominal Discomfort Initial or Prolonged Bowel Sounds Abnormal 22-Feb-2006 08:32 AM Page: 603 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Diarrhoea Schizophrenia Report Source Product Role Manufacturer Route Dose Duration Consumer Geodon (Ziprasidone) PS ORAL 160 MG (80 Health MG, 2 IN 1 Professional D), ORAL Zoloft (Sertraline) SS ORAL 150 MG (1 IN 1 D), ORAL Olanzapine (Olanzapine) SS Quetiapine Fumarate (Quetiapine Fumarate) C Esomeprazole (Esomeprazole) C Date:09/14/04ISR Number: 4450564-7Report Type:Expedited (15-DaCompany Report #2004060851 Age:84 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Geodon (Im) Professional (Ziprasidone) PS INTRAMUSCULAR INTRAMUSCULAR Company All Other Representative Therapeutic Products (All Other Therapeutic Products) C Antibiotics (Antibiotics) C Date:09/15/04ISR Number: 4451509-6Report Type:Expedited (15-DaCompany Report #2004061832 Age:95 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Body Temperature Health Geodon (Ziprasidone) PS ORAL 10 MG (10 MG, Initial or Prolonged Increased Professional 1 IN 1 D), Other Delirium Company ORAL Neuroleptic Malignant Representative Donepezil Syndrome Hydrochloride Pneumonia (Donepezil Hydrochloride) C All Other Therapeutic Products (All Other Therapeutic Products) C Date:09/15/04ISR Number: 4451612-0Report Type:Expedited (15-DaCompany Report #2004061366 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Suicidal Ideation Health Geodon (Ziprasidone) PS ORAL 80 MG, 2 IN 1 Hospitalization - Professional D, ORAL Initial or Prolonged Oxcarbazepine (Oxcarbazepine) C Lamotrigine (Lamotrigine) C Venlafaxine 22-Feb-2006 08:32 AM Page: 604 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride (Venlafaxine Hydrochloride) C Amantadine (Amantadine) C Lansoprazole (Lansoprazole) C Cetirizine Hydrochloride (Cetirizine Hydrochloride) C Atorvastatin (Atorvastatin) C Levothyroxine Sodium (Levothyroxine Sodium) C Date:09/15/04ISR Number: 4451645-4Report Type:Expedited (15-DaCompany Report #2004019604 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Depressed Mood Foreign Ziprasidone (Caps) Other Dermatitis Allergic Health (Ziprasidone) PS ORAL 120 MG (2 IN Dyspnoea Professional 1 D), ORAL Generalised Oedema Company Carbamazepine Pruritus Generalised Representative (Carbamazepine) C Psychotic Disorder Clonazepam Somnolence (Clonazepam) C Lithium Carbonate (Lithium Carbonate) C Date:09/15/04ISR Number: 4451648-XReport Type:Expedited (15-DaCompany Report #2004058806 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyskinesia Foreign Zeldox (Capsules) Initial or Prolonged Tardive Dyskinesia Health (Ziprasidone) PS ORAL 40 MG (40 MG, Professional 1 IN 1 D), ORAL Oxazepam (Oxazepam) C Zopiclone (Zopiclone) C Date:09/16/04ISR Number: 4452965-XReport Type:Expedited (15-DaCompany Report #2004062349 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Health Geodon (Ziprasidone) PS ORAL 80 MG (40 MG, Initial or Prolonged Amnesia Professional 2 IN 1 D), Other Drug Effect Decreased Company ORAL Dysarthria Representative Paroxetine Dystonia Hydrochloride (Paroxetine Hydrochloride) C Zolpidem Tartrate (Zolpidem Tartrate) C Aripiprazole (Aripiprazole) C Cocaine (Cocaine) C 22-Feb-2006 08:32 AM Page: 605 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Oxycocet (Oxycodone Hydrochloride, Paracetamol) C Date:09/16/04ISR Number: 4452966-1Report Type:Expedited (15-DaCompany Report #2004062983 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypersensitivity Health Geodon (Ziprasidone) PS Initial or Prolonged Professional Other Company Representative Date:09/16/04ISR Number: 4452974-0Report Type:Expedited (15-DaCompany Report #2004062711 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Palpitations Health Ziprasidone (Caps) Initial or Prolonged Treatment Noncompliance Professional (Ziprasidone) PS ORAL 160 MG (160 Required Other MG, 1 IN 1 Intervention to D), ORAL Prevent Permanent Impairment/Damage Date:09/17/04ISR Number: 4455294-3Report Type:Expedited (15-DaCompany Report #2004040817 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Zeldox (Capsules) Initial or Prolonged Drug Effect Decreased Health (Ziprasidone) PS ORAL 160 MG (80 Hallucination Professional MG, 2 IN 1 Vomiting Company D), ORAL Representative Clonazepam (Clonazepam) C Date:09/17/04ISR Number: 4458288-7Report Type:Periodic Company Report #US-JNJFOC-20040102083 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Health Topamax (Topiramate) PS Initial or Prolonged Confusional State Professional Geodon (Ziprasidone Gait Disturbance Hydrochloride) SS Mania Geodon (Ziprasidone Masked Facies Hydrochloride) SS 80 MG, 2 IN 1 Myalgia DAY Pain Of Skin Seroquel (Quetiapine Fumarate) C Diphenydramine (Diphenydramine) C Depakote (Valproate Semisodium) C Trazodone (Trazodone) C 22-Feb-2006 08:32 AM Page: 606 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/20/04ISR Number: 4456114-3Report Type:Expedited (15-DaCompany Report #2004022897 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Liver Function Test Foreign Zeldox (Capsules) Initial or Prolonged Abnormal Health (Ziprasidone) PS ORAL 80 MG (2 IN 1 Professional D), ORAL Promethazine (Promethazine) C Date:09/20/04ISR Number: 4456116-7Report Type:Expedited (15-DaCompany Report #2004040817 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Zeldox (Capsules) Initial or Prolonged Hallucination Health (Ziprasidone) PS ORAL 160 MG (80 Psychotic Disorder Professional MG, 2 IN 1 Vomiting Company D), ORAL Representative Clonazepam (Clonazepam) C Date:09/20/04ISR Number: 4456134-9Report Type:Expedited (15-DaCompany Report #2004062996 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pancreatitis Health Geodon (Ziprasidone) PS Professional Company Representative Date:09/20/04ISR Number: 4456135-0Report Type:Expedited (15-DaCompany Report #2004063256 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Foreign Zeldox (Capsules) Initial or Prolonged Prolonged Health (Ziprasidone) PS ORAL 1120 MG (20 Overdose Professional MG, ONCE), Somnolence ORAL Date:09/20/04ISR Number: 4456137-4Report Type:Expedited (15-DaCompany Report #2004063204 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Foreign Zeldox (Capsules) Initial or Prolonged Consciousness Health (Ziprasidone) PS ORAL 1000 MG (1 IN Electrocardiogram Qt Professional 1 D), ORAL Prolonged Overdose Tachycardia Date:09/20/04ISR Number: 4456138-6Report Type:Expedited (15-DaCompany Report #2004063199 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Foreign Zeldox (Capsules) Initial or Prolonged Refusal Of Treatment By Health (Ziprasidone) PS ORAL 840 MG (840 Patient Professional MG, 1 IN 1 22-Feb-2006 08:32 AM Page: 607 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report D), ORAL Date:09/20/04ISR Number: 4456139-8Report Type:Expedited (15-DaCompany Report #2004063193 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fatigue Foreign Zeldox (Capsules) Initial or Prolonged Overdose Health (Ziprasidone) PS ORAL 480 MG (80 Somnolence Professional MG, 1 IN 1 D), ORAL Propiomazine (Propiomazine) C Date:09/20/04ISR Number: 4456140-4Report Type:Expedited (15-DaCompany Report #2004063187 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Apathy Foreign Zeldox (Capsules) Initial or Prolonged Depressed Level Of Health (Ziprasidone) PS ORAL 720 MG (60 Consciousness Professional MG, 1 IN 1 Overdose D), ORAL Date:09/20/04ISR Number: 4456141-6Report Type:Expedited (15-DaCompany Report #2004063176 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Apathy Foreign Zeldox (Capsules) Initial or Prolonged Blood Pressure Systolic Health (Ziprosidone) PS ORAL 1440 MG (20 Decreased Professional MG, 1 IN 1 Depressed Level Of D), ORAL Consciousness Overdose Po2 Decreased Date:09/20/04ISR Number: 4456142-8Report Type:Expedited (15-DaCompany Report #2004063184 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Foreign Zeldox (Capsules) Initial or Prolonged Prolonged Health (Ziprasidone) PS ORAL 1320 MG (60 Overdose Professional MG, ONCE), Somnolence ORAL Date:09/20/04ISR Number: 4456143-XReport Type:Expedited (15-DaCompany Report #2004063152 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Apathy Foreign Zeldox (Capsules Initial or Prolonged Depressed Level Of Health (Ziprasidone) PS ORAL 800 MG (20 Consciousness Professional MG, ONCE), Overdose ORAL 22-Feb-2006 08:32 AM Page: 608 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/20/04ISR Number: 4456144-1Report Type:Expedited (15-DaCompany Report #2004063171 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Foreign Zeldox (Capsules) Initial or Prolonged Health (Ziprasidone) PS ORAL 1400 MG (20 Professional MG, ONCE), ORAL Date:09/20/04ISR Number: 4456145-3Report Type:Expedited (15-DaCompany Report #2004063160 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Apathy Foreign Zeldox (Capsules) Initial or Prolonged Depressed Level Of Health (Ziprasidone) PS ORAL 840 MG (20 Consciousness Professional MG, 1 IN 1 Overdose D), ORAL Ethanol (Ethanol) C Date:09/21/04ISR Number: 4457247-8Report Type:Expedited (15-DaCompany Report #2004049431 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Anxiety Consumer Geodon(Ziprasidone) PS Other Cardiac Arrest Health Sertraline Cardiac Disorder Professional Hydrochloride Fall (Sertraline Limb Injury Hydrochloride) SS Loss Of Consciousness Lorazepam (Lorazepam) C Date:09/22/04ISR Number: 4457282-XReport Type:Expedited (15-DaCompany Report #2003010033 Age:31 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Literature Geodon (Ziprasidone) PS ORAL 80 MG (40 MG, Initial or Prolonged Dyspnoea Health 2 IN 1 D), Other Dystonia Professional ORAL Tongue Disorder Sertraline Torticollis Hydrochloride (Sertraline Hydrochloride) C Metronidazole (Metronidazole) C Bactrim (Sulfamethoxazole, Trimethoprim) C Triamcinolone (Triamcinolone) C Date:09/22/04ISR Number: 4457291-0Report Type:Expedited (15-DaCompany Report #2004052509 Age: Gender:Female I/FU:F Outcome PT Other Cholecystitis Cholelithiasis Drug Hypersensitivity Mania 22-Feb-2006 08:32 AM Page: 609 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Reaction To Preservatives Splenomegaly Report Source Product Role Manufacturer Route Dose Duration Health Geodon (Ziprasidone) PS ORAL 80 MG (80 MG, Professional 1 IN 1 D), ORAL Methylprednisolone (Methylprednisolone) SS Levothyroxine Sodium (Levothyroxine Sodium) SS 50 MCG (50 MCG, 1 IN 1 D) Oxcarbazepine (Oxcarbazepine) SS Methylphenidate Hydrochloride (Methylphenidate Hydrochloride) C Escitalopram (Escitalopram) C Multivitamins (Ascorbic Acid/Ergocalciferol/ Folic Acid/Nicotinamide/Pa C Date:09/22/04ISR Number: 4457631-2Report Type:Expedited (15-DaCompany Report #2004S1002442 Age:58 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Health Clozapine Tablets 25 Constipation Professional Mg Mylan PS ORAL 25MG, TID, Intestinal Obstruction Other ORAL Pneumonia Aspiration Clozapine Tablets Sepsis 100 Mg Mylan SS Mylan ORAL 400MG HS, ORAL Benzotropine (Purepac) SS 2MG BID 2 WK Geodon(Pfizer) SS 160 MG QAM AND 80MG Q 5PM Bisacodyl C Magnesium Citrate C Polyehtylene Glycol C Divalproex C Date:09/22/04ISR Number: 4457750-0Report Type:Expedited (15-DaCompany Report #2004063984 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Foreign Zeldox (Capsules) Health (Ziprasidone) PS ORAL 40 MG (40 MG, Professional 1 IN 1 D), ORAL 22-Feb-2006 08:32 AM Page: 610 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/23/04ISR Number: 4457843-8Report Type:Direct Company Report #USP 56854 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Geodon PS Pfizer CAPSULE Accolate SS Astrazeneca TABLET Date:09/24/04ISR Number: 4461682-1Report Type:Direct Company Report #CTU 227993E Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Body Temperature Geodon PS ORAL ORAL Hospitalization - Increased Amitriptyline C Initial or Prolonged Depressed Level Of Fluoxetine C Required Consciousness Intervention to Mental Status Changes Prevent Permanent Rhabdomyolysis Impairment/Damage Date:09/24/04ISR Number: 4462194-1Report Type:Expedited (15-DaCompany Report #2004062349 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Health Geodon (Ziprasidone) PS ORAL 80 MG (40 MG, Initial or Prolonged Amnesia Professional 2 IN 1 D), Other Dysarthria Company ORAL Dystonia Representative Paroxetine Facial Palsy Hydrochloride Facial Paresis (Paroxetine Hydrochlordie) C Zolpidem Tartrate (Zolpidem Tartrate) C Aripiprazole (Aripiprazole) C Cocaine (Cocaine) C Oxycocet (Oxycodone Hydrochloride, Paracetamol) C Date:09/24/04ISR Number: 4462196-5Report Type:Expedited (15-DaCompany Report #2004065096 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Tardive Dyskinesia Health Geodon (Ziprasidone) PS ORAL 120 MG (1 IN Initial or Prolonged Professional 1 D), ORAL Company Representative Date:09/24/04ISR Number: 4462292-2Report Type:Expedited (15-DaCompany Report #2004066266 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypokalaemia Health Geodon (Ziprasidone) PS ORAL 60 MG (1 IN 1 Torsade De Pointes Professional D), ORAL Company Escitalopram Representative (Escitalopram) C Oxcarbazepine (Oxcarbazepine) C 22-Feb-2006 08:32 AM Page: 611 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Quetiapine Fumarate (Quetiapine Fumarate) C Clonazepam (Clonazepam) C Levothyroxine Sodium (Levothyroxine Sodium) C Antihypertensives (Antihypertensives) C Date:09/24/04ISR Number: 4462297-1Report Type:Expedited (15-DaCompany Report #2004043606 Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bipolar Disorder Health Geodon (Ziprasidone) PS 40 MG (20 MG, Completed Suicide Professional 2 IN 1 D), Insomnia Zoloft (Sertraline) SS ORAL 100 MG (100 Refusal Of Treatment By MG, 1 IN 1 Patient D), ORAL Suicidal Ideation Zaleplon (Zaleplon) SS ORAL 10 MG (10 MG, Thermal Burn 1 IN 1 D), ORAL Date:09/24/04ISR Number: 4462353-8Report Type:Expedited (15-DaCompany Report #2004049431 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Anxiety Consumer Geodon (Ziprasidone) PS ORAL ORAL Other Cardiac Arrest Health Lorazepam Cardiac Pacemaker Professional (Lorazepam) C Insertion Sertraline Cardiovascular Function Hydrochloride Test Abnormal (Sertraline Fall Hydrochloride) C Foot Fracture Foot Operation Impaired Work Ability Loss Of Consciousness Syncope Date:09/27/04ISR Number: 4462065-0Report Type:Direct Company Report #CTU 228066 E Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Coordination Abnormal Geodon 80mg PS ORAL 80 MG BID PO Extrapyramidal Disorder Effexor Xr C Parkinsonian Rest Tremor Wellbutrin C Tremor Lithium Carbonate C Alprazolam C Nph Insulin C Lantus Insulin C Metformin C Glyburide C Pravachol C 22-Feb-2006 08:32 AM Page: 612 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/27/04ISR Number: 4462066-2Report Type:Direct Company Report #CTU 228062 E Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Balance Disorder Geodon 40mg PS ORAL PO 1 TAB, QHS Coordination Abnormal Depakote C Tremor Actos C Glucophage C Aciphex C Avalide C Date:09/27/04ISR Number: 4462695-6Report Type:Expedited (15-DaCompany Report #2004-120356-NL Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Remeron /Net/ PS ORAL 30 MG QD ORAL Initial or Prolonged Anxiety Professional Geodon SS ORAL 160 MG QD Hostility ORAL Insomnia Geodon SS ORAL 80 MG QD ORAL Paranoia Date:09/27/04ISR Number: 4462711-1Report Type:Expedited (15-DaCompany Report #2004066291 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Myocardial Infarction Health Geodon (Ziprasidone) PS Professional Company Representative Date:09/27/04ISR Number: 4462805-0Report Type:Expedited (15-DaCompany Report #2004025544 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pituitary Tumour Benign Health Geodon (Ziprasidone) PS Professional Topiramate Company (Topiramate) C Representative Lorazepam (Lorazepam) C Date:09/27/04ISR Number: 4462972-9Report Type:Expedited (15-DaCompany Report #2004063984 Age:75 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Perforated Ulcer Foreign Zeldox (Capsules) Other Health (Ziprasidone) PS ORAL 40 MG (40 MG, Professional 1 IN 1 D), ORAL Date:09/28/04ISR Number: 4463328-5Report Type:Expedited (15-DaCompany Report #2004062983 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypersensitivity Health Geodon (Ziprasidone) PS Initial or Prolonged Professional Other Company Representative 22-Feb-2006 08:32 AM Page: 613 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/28/04ISR Number: 4463329-7Report Type:Expedited (15-DaCompany Report #2004025130 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bradycardia Health Geodon (Ziprasidone) PS INTRAMUSCULAR 20 MG (20 MG, Other Cardiac Arrest Professional ONCE), Neuroleptic Malignant INTRAMUSCULAR Syndrome Haloperidol Respiratory Distress Decanoate Sudden Death (Haloperidol Decanoate) C Mirtazapine (Mirtazapine) C Diphenhydramine Hydrochloride (Diphenhydramine Hydrochloride) C Date:09/28/04ISR Number: 4463426-6Report Type:Expedited (15-DaCompany Report #2004066266 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diarrhoea Health Geodon (Ziprasidone) PS ORAL 60 MG (1 IN 1 Initial or Prolonged Electrocardiogram Qt Professional D), ORAL Other Prolonged Company Escitalopram Hypokalaemia Representative (Escitalopram) C Torsade De Pointes Oxcarbazepine Ventricular Fibrillation (Oxcarbazepine) C Quetiapine Fumarate (Quetiapine Fumarate) C Clonazepam (Clonazepam) C Levothyroxine Sodium (Levothyroxine Sodium) C Antihypertensives (Antihypertensives) C Date:09/30/04ISR Number: 4466849-4Report Type:Expedited (15-DaCompany Report #2004069529 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Geodon (Ziprasidone) PS Professional Company Representative Date:10/04/04ISR Number: 4467026-3Report Type:Expedited (15-DaCompany Report #2004066266 Age: Gender:Male I/FU:F Outcome PT Hospitalization - Arrhythmia Initial or Prolonged Cardio-Respiratory Arrest Other Diarrhoea Electrocardiogram Qt Prolonged Hypokalaemia Torsade De Pointes 22-Feb-2006 08:32 AM Page: 614 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ventricular Fibrillation Report Source Product Role Manufacturer Route Dose Duration Health Geodon (Ziprasidone) PS ORAL 60 MG (1 IN1 Professional D), ORAL Company Escitalopram Representative (Escitalopram) C Oxcarbazepine (Oxcarbazepine) C Quetiapine Fumarate (Quetiapine Fumarate) C Clonazepam (Clonazepam) C Levothyroxine Sodium (Levothyroxine Sodium) C Antihypertensive (Antihypertensives) C Date:10/04/04ISR Number: 4467029-9Report Type:Expedited (15-DaCompany Report #2004069541 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Hypersensitivity Consumer Geodon (Ziprasidone) PS Initial or Prolonged Risperidone (Risperidone) SS Sertraline Hydrochloride (Sertraline Hydrochloride) C Date:10/04/04ISR Number: 4467844-1Report Type:Expedited (15-DaCompany Report #2004063984 Age:75 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Perforated Ulcer Foreign Zeldox (Capsules) Other Peritonitis Health (Ziprasidone) PS ORAL 80 MG (40 MG, Professional 2 IN 1 D), Other ORAL Magnecyl-Kodein (Acetylsalicylic Acid, Codeine Phosphate, Magnesium Oxide) C Date:10/04/04ISR Number: 4467851-9Report Type:Expedited (15-DaCompany Report #2004058787 Age:23 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Foreign Geodon (Ziprasidone) PS ORAL 40 MG (40 MG, Initial or Prolonged Convulsion Consumer 1 IN 1 D), Crying ORAL Malaise Carbamazepine Self Injurious Behaviour (Carbamazepine) C Vomiting Lithium Carbonate (Lithium Carbonate) C 22-Feb-2006 08:32 AM Page: 615 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/04/04ISR Number: 4468080-5Report Type:Expedited (15-DaCompany Report #2004068846 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Circulatory Collapse Foreign Zeldox (Capsules) Initial or Prolonged Electrocardiogram Qt Health (Ziprasidone) PS 120 MG Corrected Interval Professional Prolonged Company Representative Date:10/04/04ISR Number: 4468105-7Report Type:Expedited (15-DaCompany Report #2004044147 Age:20 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fear Of Disease Foreign Zeldox (Capsules) Initial or Prolonged Suicide Attempt Health (Ziprasidone) PS ORAL 80 MG (40 MG, Professional 2 IN 1 D), Company ORAL Representative Date:10/05/04ISR Number: 4469170-3Report Type:Expedited (15-DaCompany Report #2004066266 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Health Geodon (Ziprasidone) PS ORAL 60 MG (1 IN 1 Initial or Prolonged Prolonged Professional D), ORAL Other Hypokalaemia Company Escitalopram Loss Of Consciousness Representative (Escitalopram) C Torsade De Pointes Oxcarbazepine Ventricular Fibrillation (Oxcarbazepine) C Quetiapine Fumarate (Quetiapine Fumarate) C Clonazepam (Clonazepam) C Levothyroxine Sodium (Levothyroxine Sodium) C Antihypertensives (Antihypertensives) C Date:10/05/04ISR Number: 4469441-0Report Type:Expedited (15-DaCompany Report #2004022897 Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatic Enzyme Increased Foreign Zeldox (Capsules) Initial or Prolonged Health (Ziprasidone) PS ORAL 80 MG (2 IN 1 Professional D), ORAL Promethazine (Promethazine) SS Date:10/05/04ISR Number: 4470459-2Report Type:Direct Company Report #CTU 228903 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Geodon 30 Mg Im/Po Circulatory Collapse Pfizer PS Pfizer INTRAMUSCULAR 20 MG IM, 20 Heart Rate Increased MG PO 22-Feb-2006 08:32 AM Page: 616 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Seroquel 100 Mg Zeneca SS Zeneca Haldol C Date:10/05/04ISR Number: 4470609-8Report Type:Expedited (15-DaCompany Report #2004055638 Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Zeldox (Capsules) Initial or Prolonged Agitation Health (Ziprasidone) PS ORAL 120 MG (60 Suicidal Ideation Professional MG, 2 IN 1 D), ORAL Date:10/05/04ISR Number: 4470612-8Report Type:Expedited (15-DaCompany Report #2004069676 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Physical Assault Health Zeldox (Capsules) Professional (Ziprasidone) PS Company Representative Date:10/05/04ISR Number: 4470642-6Report Type:Expedited (15-DaCompany Report #2004055648 Age:36 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Paranoia Foreign Zeldox (Capsules) Initial or Prolonged Health (Ziprasidone) PS ORAL 80 MG (40 MG, Professional 2 IN 1 D), ORAL Midazolam (Midazolam) C Date:10/05/04ISR Number: 4470831-0Report Type:Expedited (15-DaCompany Report #2004070771 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Literature Ziprasidone (Caps) Initial or Prolonged Aggression Health (Ziprasidone) PS 40 MG (20 MG Agitation Professional , 2 IN 1 D) Condition Aggravated Carbamazepine Confusional State (Gabapentin) Disorientation (Carbamazepine) SS 400 MG (200 Disturbance In Attention MG, 2 IN 1 D) Drug Ineffective Gabapentin Hallucinations, Mixed (Escitalopram) Incoherent (Gabapentin) SS 900 MG (300 Mood Swings MG IN 1 D) Speech Disorder Escitalopram (Escitalopram) SS 10 MG (10 MG, 1 IN 1 D) 22-Feb-2006 08:32 AM Page: 617 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/06/04ISR Number: 4471520-9Report Type:Expedited (15-DaCompany Report #2004042966 Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accident Health Geodon (Ziprasidone) PS ORAL 40 MG (20 MG, Completed Suicide Professional 2 IN 1 D), Depression Company ORAL Insomnia Representative Zoloft (Sertraline) SS ORAL 100 MG (1 IN Pyromania 1 D), ORAL Zaleplon SS 10 MG (1 IN 1 D) Venlafaxine Hydrochloride C Date:10/06/04ISR Number: 4471523-4Report Type:Expedited (15-DaCompany Report #2004070092 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaphylactic Reaction Health Geodon (Ziprasidone) PS Initial or Prolonged Professional Company Representative Date:10/06/04ISR Number: 4471851-2Report Type:Expedited (15-DaCompany Report #2004071877 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Somnolence Foreign Zeldox (Capsules) Suicide Attempt Health (Ziprasidone) PS ORAL 120 MG (60 Professional MG, 2 IN 1 Company D), ORAL Representative Alprazolam (Alprazolam) C Date:10/06/04ISR Number: 4471869-XReport Type:Expedited (15-DaCompany Report #2004057896 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Geodon (Ziprasidone) PS ORAL 120 MG (60 Professional MG, 2 IN 1 Company D), ORAL Representative Oxcarbazepine (Oxcarbazepine) C Lorazepam (Lorazepam) C Olanzapine (Olanzapine) C Date:10/07/04ISR Number: 4470795-XReport Type:Direct Company Report #CTU 229082 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Angina Pectoris Geodon PS Pain In Extremity 22-Feb-2006 08:32 AM Page: 618 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/07/04ISR Number: 4472341-3Report Type:Expedited (15-DaCompany Report #2004071878 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Health Geodon (Ziprasidone) PS 240 MG (2 IN Other Foreign Body Aspiration Professional 1 D) Intestinal Obstruction Benzatropine Pneumonia Aspiration Mesilate Sepsis (Benzatropine Mesilate) SS 4 MG (2 IN 1 D) Clozapine (Clozapine) SS ORAL 475 MG, ORAL Bisacodyl (Bisacodyl) C Magnesium Citrate (Magnesium Citrate) C Macrogol (Macrogol) C Valproic Acid (Valproic Acid) C Date:10/07/04ISR Number: 4472940-9Report Type:Direct Company Report #CTU 229104 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Akathisia Haldol PS ORAL 10 MG PO BID Intervention to Geodon SS ORAL 80 MG PO TID Prevent Permanent Impairment/Damage Date:10/08/04ISR Number: 4472213-4Report Type:Expedited (15-DaCompany Report #2004062996 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Geodon (Ziprasidone) PS ORAL 2 IN 1 D, Initial or Prolonged Pancreatitis Professional ORAL Other Company Representative Date:10/12/04ISR Number: 4474830-4Report Type:Expedited (15-DaCompany Report #2004074610 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Foreign Geodon (Ziprasidone) PS ORAL 40 MG Initial or Prolonged Chorea Health (DAILY), ORAL Hyponatraemia Professional Risperidone Pyrexia Company (Risperidone) C Restlessness Representative All Other Tremor Therapeutic Products (All Other Therapeutic Products) C 22-Feb-2006 08:32 AM Page: 619 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/12/04ISR Number: 4475923-8Report Type:Expedited (15-DaCompany Report #2003033328 Age:59 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Foreign Zeldox (Capsules) Initial or Prolonged Fall Consumer (Ziprasidone) PS ORAL 40 MG (20 MG, Other Feeling Abnormal Health 2 IN 1 D), Hip Fracture Professional ORAL Humerus Fracture Company Esomeprazole Peripheral Nerve Injury Representative (Esomeprazole) C Upper Limb Fracture Salutec (Hydrochlorothiazide , Ramipril) C Levothyroxine Sodium (Levothyroxine Sodium) C Phenprocoumon (Phenprocoumon) C Flupentixol Dihydrochloride (Flupentixol Dihydrochloride) C Fluanxol (Flupentixol Dihydrochloride) C Haloperidol (Haloperidol) C Date:10/12/04ISR Number: 4475924-XReport Type:Expedited (15-DaCompany Report #2004069676 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Foreign Zeldox (Capsules) Health (Ziprasidone) PS Professional Company Representative Date:10/12/04ISR Number: 4475951-2Report Type:Expedited (15-DaCompany Report #2004072572 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Screen False Health Geodon (Ziprasidone) PS ORAL ORAL Positive Professional All Other Intestinal Obstruction Company Therapeutic Products Urinary Retention Representative (All Other Therapeutic Products) C Date:10/12/04ISR Number: 4476062-2Report Type:Expedited (15-DaCompany Report #2004055660 Age:55 YR Gender:Female I/FU:I Outcome PT Life-Threatening Bradycardia Hospitalization - Cardiac Failure Initial or Prolonged Congestive Other Carditis Cerebrovascular Accident Chronic Obstructive 22-Feb-2006 08:32 AM Page: 620 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pulmonary Disease Coronary Artery Disease Device Related Infection Diabetes Mellitus Report Source Product Role Manufacturer Route Dose Duration Non-Insulin-Dependent Health Geodon (Ziprasidone) PS 120 MG (60 Electrocardiogram Qt Professional MG, 2 IN 1 D) Shortened Company Lovastatin Staphylococcal Infection Representative (Lovastatin) C Metformin (Metformin) C Glipizide (Glipizide) C Metoprolol Succinate (Metoprolol Succinate) C Captopril (Captopril) C Bupropion Hydrochloride (Bupropion Hydrochloride) C Ipratropium Bromide (Ipratropium Bromide) C Salbutamol (Salbutamol) C Date:10/12/04ISR Number: 4476453-XReport Type:Expedited (15-DaCompany Report #2004071266 Age:34 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Ziprasidone (Caps) Other Completed Suicide Health (Ziprasidone) PS Multiple Drug Overdose Professional Olanzapine (Olanzapine) SS Clonazepam (Clonazepam) SS Date:10/12/04ISR Number: 4476469-3Report Type:Expedited (15-DaCompany Report #2004052203 Age:6 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Heart Rate Irregular Consumer Geodon (Ziprasidone) PS (1 IN 1 D) Restlessness All Other Therapeutic Products (All Other Therapeutic Products) C Date:10/12/04ISR Number: 4476470-XReport Type:Expedited (15-DaCompany Report #2004071910 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Health Geodon (Ziprasidone) PS Syndrome Professional Company Representative 22-Feb-2006 08:32 AM Page: 621 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/13/04ISR Number: 4476617-5Report Type:Expedited (15-DaCompany Report #2004072645 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Priapism Health Geodon (Ziprasidone) PS Professional Navane (Capsules) Company (Tiotixene) Representative (Thiothixene) SS Date:10/13/04ISR Number: 4476928-3Report Type:Expedited (15-DaCompany Report #2003015783 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Foreign Ziprasidone Initial or Prolonged Fluctuation Health (Ziprasidone) PS ORAL 4480 MG, ORAL Overdose Professional Clomethiazole Sedation Company Edisilate Suicide Attempt Representative (Clomethiazole Edisilate) SS ORAL ORAL Clorazepate Dipotassium (Clorazepate Dipotassium) C Date:10/13/04ISR Number: 4478461-1Report Type:Expedited (15-DaCompany Report #2004072648 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Foreign Zeldox (Capsules) Initial or Prolonged Syndrome Health (Ziprasidone) PS Professional Clopazine Company (Clopazine) C Representative Date:10/14/04ISR Number: 4477331-2Report Type:Expedited (15-DaCompany Report #2004062983 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Health Geodon (Ziprasidone) PS ORAL 80 MG (40 MG, Initial or Prolonged Hypersensitivity Professional 2 IN 1 D), Other Mental Disorder Company ORAL Muscle Contractions Representative Lamotrigine Involuntary (Lamotrigine) C Nausea Fluoxetine Vomiting Hydrochloride (Fluoxetine Hydrochloride) C Clonazepam (Clonazepam) C Date:10/14/04ISR Number: 4477770-XReport Type:Expedited (15-DaCompany Report #2004073296 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cognitive Deterioration Health Geodon (Ziprasidone) PS 160 MG Pain Professional Neurontin Paraesthesia Company (Gabapentin) SS Speech Disorder Representative Quetiapine Fumarate 22-Feb-2006 08:32 AM Page: 622 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Quetiapine Fumarate) SS 100 MG Cannabis (Cannabis) SS Date:10/14/04ISR Number: 4478199-0Report Type:Expedited (15-DaCompany Report #2004075152 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypotension Foreign Ziprasidone (Caps) Initial or Prolonged Health (Ziprasidone) PS INTRAMUSCULAR 20 MG (20 MG, Professional 1 IN 1 D), Company INTRAMUSCULAR Representative Date:10/18/04ISR Number: 4480059-6Report Type:Expedited (15-DaCompany Report #2003015276 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arthropathy Consumer Geodon (Ziprasidone) PS ORAL 2 IN 1 D, Initial or Prolonged Blood Potassium Decreased ORAL Disability Blood Pressure Erythromycin Other Fluctuation (Erythromycin) Blood Pressure (Erythromycin) SS Immeasurable Rofecoxib Cerebrovascular Accident (Rofecoxib) SS ORAL 50 MG (2 IN 1 Coma D), ORAL Dizziness Oxycocet Drug Interaction (Paracetamol, Feeling Abnormal Oxycodone Hypertension Hydrochloride) SS Kidney Infection Temazepam Laboratory Test Abnormal (Temazepam) SS Migraine Cyclobenzaprine Nasopharyngitis Hydrochloride Pain (Cyclobenzaprine Tooth Abscess Hydrochloride) SS Tremor Fluoxetine Ulcer Hydrochloride Uterine Neoplasm (Fluoxetine Weight Fluctuation Hydrochloride) C Omeprazole (Omeprazole) C Diazepam (Diazepam) C Sucralfate (Sucralfate) C Metoclopramide (Metoclopramide) C Phentermine (Phentermine) C Paracetamol (Paracetamol) C Antihistamines (Antihistamines) C :Benzfetamine Hydrochloride (Benzfetamine C Ketorolac Tromethamine (Ketorolac Tromethamine) C 22-Feb-2006 08:32 AM Page: 623 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Estrogens Conjugated (Estrogens Conjugated) C Lotrel (Amlodipine, Benazepril Hydrochloride) C Cotylenol (Paracetamol, Chlorphenamine Maleate, Dextromethorphan C Medinite (Ethanol, Paracetamol, Dextromethorphan Hydrobromide, Ephedrine Sulfate, C Furosemide (Furosemide) C Bupropion Hydrochloride (Bupropion Hydrochloride) C Zolpidem Tartrate (Zolpidem Tartrate) C Topiramate (Topiramate) C Propacet (Paracetamol, Dextropropoxyphene Napsilate) C Oxycodone Hydrochloride (Oxycodone Hydrochloride) C All Other Therapeutic Products C Date:10/18/04ISR Number: 4480063-8Report Type:Expedited (15-DaCompany Report #2004074866 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Hypersensitivity Study Ziprasidone (Caps) Panic Attack Health (Ziprasidone) PS ORAL 40 MG (1 IN 1 Professional D), ORAL Date:10/18/04ISR Number: 4480067-5Report Type:Expedited (15-DaCompany Report #2004075568 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Increased Health Zoloft (Sertraline) PS 100 MG Initial or Prolonged Heart Rate Increased Professional Geodon (Ziprasidone) SS 40 MG Hyperhidrosis Lorazepam (Lorazepam) C 22-Feb-2006 08:32 AM Page: 624 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/18/04ISR Number: 4505167-2Report Type:Periodic Company Report #2004065070 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Health Geodon (Im) Initial or Prolonged Corrected Interval Professional (Ziprasidone) PS INTRAMUSCULAR INTRAMUSCULAR Prolonged Company Representative Date:10/18/04ISR Number: 4505170-2Report Type:Periodic Company Report #2003119224 Age: Gender:Unknown I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypotension Health Geodon (Im) Professional (Ziprasidone) PS INTRAMUSCULAR 10 MG, Company INTRAMUSCULAR Representative Trazodone (Trazodone) C Cocaine (Cocaine) C Lorazepam (Lorazepam) C Date:10/18/04ISR Number: 4505172-6Report Type:Periodic Company Report #2003119226 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypotension Health Geodon (Im) Initial or Prolonged Professional (Ziprasidone) PS INTRAMUSCULAR 10 MG, Other Company INTRAMUSCULAR Representative Cocaine (Cocaine) SS Opioids (Opioids) SS Lorazepam (Lorazepam) C Benzodiazepine Derivatives (Benzodiazepine Derivatives) C Date:10/19/04ISR Number: 4480730-6Report Type:Expedited (15-DaCompany Report #2004076089 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Geodon (Ziprasidone) PS Professional Company Representative Date:10/20/04ISR Number: 4482249-5Report Type:Expedited (15-DaCompany Report #2004076193 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coronary Artery Stenosis Foreign Geodon (Ziprasidone) PS Initial or Prolonged Health Professional Company Representative 22-Feb-2006 08:32 AM Page: 625 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/20/04ISR Number: 4483484-2Report Type:Expedited (15-DaCompany Report #2004076135 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Health Geodon (Im) Professional (Ziprasidone) PS INTRAMUSCULAR 20 MG, Company INTRAMUSCULAR Representative All Other Therapeutic Products (All Other Therapeutic Products) C Date:10/21/04ISR Number: 4483628-2Report Type:Direct Company Report #CTU 230189 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaphylactic Reaction Geodon 40mg Cap PS Initial or Prolonged Anxiety Hydrochlorothiazide Required Swollen Tongue Tab C Intervention to Guaifenesin C Prevent Permanent Azithromycin Tab C Impairment/Damage Acetaminophen (Inpt-Ud) Tab C Simvastatin Tab C Omeprazole Cap,Sa C Metoprolol Tab C Hctz 12.5 / Irbesartan C Diphenhydramine Cap C Olanzapine Tab C Date:10/21/04ISR Number: 4483858-XReport Type:Direct Company Report #CTU 230149 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pharmaceutical Product Geodon Phizer PS Phizer Complaint Date:10/21/04ISR Number: 4485556-5Report Type:Expedited (15-DaCompany Report #2004076721 Age:42 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebrovascular Accident Health Nardil (Phenelzine Professional Sulfate) PS Company Geodon (Ziprasidone) SS Representative Date:10/21/04ISR Number: 4485557-7Report Type:Expedited (15-DaCompany Report #2004076283 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Consumer Geodon (Ziprasidone) PS 160 MG (80 Initial or Prolonged Drug Ineffective MG, 2 IN 1 D) Insomnia All Other Medication Error Therapeutic Products Rash (All Other Therapeutic 22-Feb-2006 08:32 AM Page: 626 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Products) SS Lithium (Lithium) C Date:10/21/04ISR Number: 4485558-9Report Type:Expedited (15-DaCompany Report #2004076722 Age:54 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebral Haemorrhage Health Nardil (Phenelzine Professional Sulfate) PS Company Geodon (Ziprasidone) SS Representative Date:10/25/04ISR Number: 4488711-3Report Type:Expedited (15-DaCompany Report #2004080302 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertensive Crisis Foreign Zeldox (Capsules) Health (Ziprasidone) PS ORAL 80 MG (1 IN 1 Professional D) ORAL 6 MON Company Valproate Sodium C Representative Date:10/25/04ISR Number: 4488732-0Report Type:Expedited (15-DaCompany Report #2004072648 Age:76 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neuroleptic Malignant Foreign Zeldox (Capsules) Hospitalization - Syndrome Health (Ziprasidone) PS ORAL 80 MG, ORAL Initial or Prolonged Professional Clopazine Company (Clopazine) SS 12.5 MG Representative Clonazepam (Clonazepam) C Bromazepam (Bromazepam) C Date:10/26/04ISR Number: 4486558-5Report Type:Direct Company Report #CTU 230486 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Akathisia Geodon 80 Mg PS ORAL BID PO Intervention to Quetiapine 300 Mg SS ORAL 3 PO QHS Prevent Permanent Impairment/Damage Date:10/26/04ISR Number: 4488209-2Report Type:Expedited (15-DaCompany Report #2004077508 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Health Geodon Ziprasidone) PS 80 MG Syndrome Professional Risperidone Company (Risperidone) SS 1 MG Representative 22-Feb-2006 08:32 AM Page: 627 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/27/04ISR Number: 4487779-8Report Type:Direct Company Report #CTU 230586 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Increased Geodon 60 Mg Chest Pain Pfizer PS Pfizer BUCCAL 60 BID Tachycardia BUCCAL Ibuprofen C Lorazepam C Date:10/27/04ISR Number: 4490196-8Report Type:Expedited (15-DaCompany Report #2004079238 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Abuser Health Geodon (Ziprasidone) PS Professional Olanzapine Company (Olanzapine) SS Representative Drug Unspecified SS Date:10/27/04ISR Number: 4490203-2Report Type:Expedited (15-DaCompany Report #2004076283 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Consumer Geodon (Ziprasidone) PS 160 MG (80 Initial or Prolonged Drug Ineffective MG, 2 IN 1 D) Prescribed Overdose All Other Rash Therapeutic Prdoucts (All Other Therapeutic Products) SS Lithium (Lithium) C Date:10/27/04ISR Number: 4490217-2Report Type:Expedited (15-DaCompany Report #2004079230 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Death Foreign Zeldox (Capsules) Cardiomegaly Health (Ziprasidone) PS ORAL ORAL Drug Effect Decreased Professional Quetiapine Fumarate Drug Interaction Company (Quetiapine Dyskinesia Representative Fumarate) SS ORAL 600 MG (1 IN Electrocardiogram Qt 1 D), ORAL Shortened Herbal Preparation (Herbal Preparation) SS Date:10/28/04ISR Number: 4490027-6Report Type:Expedited (15-DaCompany Report #2004079254 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Toxicity Health Ziprasidone (Caps) Initial or Prolonged Electrocardiogram Qt Professional (Ziprasidone) PS Other Corrected Interval Lithium (Lithium) SS Prolonged Fluconazole Torsade De Pointes (Fluconazole) SS 22-Feb-2006 08:32 AM Page: 628 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/28/04ISR Number: 4490064-1Report Type:Expedited (15-DaCompany Report #2004049431 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Anxiety Consumer Geodon (Ziprasidone) PS ORAL ORAL Other Cardiac Arrest Health Lorazepam Electrocardiogram T Wave Professional (Lorazepam) C Amplitude Decreased Sertraline Fall Hydrochloride Foot Fracture (Sertraline Impaired Work Ability Hydrochloride) C Limb Injury Loss Of Consciousness Personality Change Syncope Date:10/28/04ISR Number: 4490256-1Report Type:Expedited (15-DaCompany Report #2004079269 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Ziprasidone (Im) Professional (Ziprasidone) PS INTRAMUSCULAR INTRAMUSCULAR Date:10/28/04ISR Number: 4490616-9Report Type:Expedited (15-DaCompany Report #2004081572 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Foreign Ziprasidone (Caps) Initial or Prolonged Medication Error Consumer (Ziprasidone) PS ORAL ORAL Overdose Respiratory Disorder Date:10/29/04ISR Number: 4491974-1Report Type:Direct Company Report #CTU 230773 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anger Geodon PS SEE IMAGE Suicidal Ideation Abilify SS ORAL 10 MG, PO, QAM Date:10/29/04ISR Number: 4492425-3Report Type:Expedited (15-DaCompany Report #2004079365 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Foreign Body Trauma Health Geodon (Ziprasidone) PS Initial or Prolonged Gastric Operation Professional Other Date:11/01/04ISR Number: 4491231-3Report Type:Direct Company Report #CTU 230878E Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Electrocardiogram Qt Ziprasidone PS ORAL 80 MG PO BID 3 DAY Required Corrected Interval Fluconazole SS ORAL 100 MG PO QOD 7 DAY Intervention to Prolonged Ciprofloxacin C Prevent Permanent Heart Rate Decreased Synthroid C Impairment/Damage Ventricular Tachycardia Prednisone C 22-Feb-2006 08:32 AM Page: 629 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevecid C Klonopin C Keppra C Trazodone C Date:11/01/04ISR Number: 4491591-3Report Type:Expedited (15-DaCompany Report #2004084292 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Foreign Zeldox (Capsules) Initial or Prolonged Disinhibition Health (Ziprasidone) PS ORAL 120 MG, ORAL Excessive Masturbation Professional Fluoxetine Sexual Dysfunction (Fluoxetine) SS ORAL 1 IN 1 D, ORAL Diazepam (Diazepam) C Flurazepam (Flurazepam) C Date:11/01/04ISR Number: 4491759-6Report Type:Expedited (15-DaCompany Report #2004071878 Age:58 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Geodon (Ziprasidone) PS UNKNOWN 240 MG (2 IN Other Intestinal Obstruction Professional 1 D) UNKNOWN Pneumonia Aspiration Benzatropine Respiratory Arrest Mesilate Sepsis (Benzatropine Mesilate) SS ORAL 4 MG (2 MG, 2 IN 1 D), ORAL Clozapine (Clozapine) SS ORAL 475 MG (4 IN 1 D) ORAL Bisacodyl (Bisacodyl) C Magnesium Citrate (Magnesium Citrate) C Macrogol (Macrogol) C Valproic Acid (Valproic Acid) C Date:11/01/04ISR Number: 4492090-5Report Type:Expedited (15-DaCompany Report #2004080312 Age: Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Geodon(Ziprasidone) PS Professional Company Representative Date:11/01/04ISR Number: 4492097-8Report Type:Expedited (15-DaCompany Report #2004065096 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Tardive Dyskinesia Health Geodon (Ziprasidone) PS ORAL 120 MG(1 IN 1 Initial or Prolonged Professional D), ORAL Company Representative 22-Feb-2006 08:32 AM Page: 630 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/02/04ISR Number: 4493327-9Report Type:Expedited (15-DaCompany Report #2003034801 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetic Hyperglycaemic Health Geodon (Ziprasidone) PS ORAL 10 MG (1 IN 1 Hospitalization - Coma Professional D), ORAL Initial or Prolonged Paranoia Company Lithium (Lithium) Representative (Lithium) SS ORAL 900 MG (2 IN 1 D), ORAL Bupropion Hydrochloride (Bupropion Hydrochloride) C Anti-Diabetics (Anti-Diabetics) C Date:11/02/04ISR Number: 4493330-9Report Type:Expedited (15-DaCompany Report #2004076762 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other No Adverse Drug Effect Health Geodon (Ziprasidone) PS Professional Tamoxifen Company (Tamoxifen) SS Representative Date:11/02/04ISR Number: 4493333-4Report Type:Expedited (15-DaCompany Report #2004081664 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonitis Health Geodon (Ziprasidone) PS (2 IN 1 D) Initial or Prolonged Professional Company Representative Date:11/02/04ISR Number: 4494150-1Report Type:Expedited (15-DaCompany Report #2004082301 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Foreign Geodon (Ziprasidone) PS ORAL 160 MG (80 White Blood Cell Count Health MG, 2 IN 1 Decreased Professional D), ORAL Company Zoloft (Sertraline) SS ORAL 50 MG (50 MG, Representative 1 IN 1 D), ORAL Date:11/03/04ISR Number: 4494626-7Report Type:Expedited (15-DaCompany Report #2004082870 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Opisthotonus Foreign Zeldox (Capsules) Initial or Prolonged Health (Ziprasidone) PS ORAL 120 MG (60 Professional MG, 2 IN 1 Company D), ORAL Representative 22-Feb-2006 08:32 AM Page: 631 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/04ISR Number: 4494660-7Report Type:Expedited (15-DaCompany Report #2004080302 Age:11 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Foreign Zeldox (Capsules) Anxiety Health (Ziprasidone) PS ORAL 80 MG (1 IN 1 Hypertensive Crisis Professional D), ORAL 6 MON Psychotic Disorder Company Valproate Sodium Representative (Valproate Sodium) C Date:11/03/04ISR Number: 4495638-XReport Type:Expedited (15-DaCompany Report #2004081893 Age:36 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aggression Health Geodon (Ziprasidone) PS Intentional Self-Injury Professional Geodon (Im) Company (Ziprasidone) Representative (Ziprasidone) SS INTRAMUSCULAR INTRAMUSCULAR Olanzapine (Olanzapine) C All Therapeutic Products (All Other Therapeutic Products) C Date:11/03/04ISR Number: 4495640-8Report Type:Expedited (15-DaCompany Report #2004084170 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Wolff-Parkinson-White Health Geodon (Ziprasidone) PS Syndrome Professional Date:11/04/04ISR Number: 4497390-0Report Type:Expedited (15-DaCompany Report #2004082868 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other General Symptom Health Geodon (Ziprasidone) PS Hemiplegia Professional Swollen Tongue Company Representative Date:11/05/04ISR Number: 4494958-2Report Type:Direct Company Report #CTU 231396E Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypotension Geodon 40mg Initial or Prolonged Pfizer PS Pfizer ORAL 40MG BID ORAL Date:11/05/04ISR Number: 4497655-2Report Type:Expedited (15-DaCompany Report #2004076777 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Prolactin Increased Health Geodon (Ziprasidone) PS ORAL 240 MG (240 Galactorrhoea Professional MG) ORAL Malignant Melanoma Company Fluvoxamine Maleate C Off Label Use Representative Bupropion 22-Feb-2006 08:32 AM Page: 632 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride C Tiagabine Hydrochloride C Modafinil C Clonazepam C Zolpidem Tartrate C Date:11/08/04ISR Number: 4498730-9Report Type:Expedited (15-DaCompany Report #2004070098 Age:13 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Grand Mal Convulsion Health Zoloft (Sertraline) PS OROPHARINGEAL 50 MG (50 MG, Premenstrual Syndrome Professional 1 IN 1 D), Company ORAL Representative Geodon (Ziprasidone) SS ORAL 180 MG (60 MG, 1 IN 1 D), ORAL Buspirone Hydrochloride (Buspirone Hydrochloride) SS Clonidine (Clonidine) SS Quetiapine Fumarate (Quetiapine Fumarate) C Trazodone (Trazodone) C Date:11/08/04ISR Number: 4498741-3Report Type:Expedited (15-DaCompany Report #2004076283 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Consumer Geodon (Ziprasidone) PS 160 MG (80 Initial or Prolonged Drug Ineffective MG, 2 IN 1 D) Drug Level Increased All Other Impaired Driving Ability Therapeutic Products Impaired Work Ability (All Other Rash Therapeutic Sleep Disorder Products) SS Lithium (Lithium) C Date:11/08/04ISR Number: 4498744-9Report Type:Expedited (15-DaCompany Report #2004079254 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Magnesium Decreased Health Geodon (Ziprasidone) PS Initial or Prolonged Blood Potassium Decreased Professional Lithium (Lithium) SS Other Electrocardiogram Qt Fluconazole Corrected Interval (Fluconazole) SS Prolonged Torsade De Pointes 22-Feb-2006 08:32 AM Page: 633 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/08/04ISR Number: 4499648-8Report Type:Expedited (15-DaCompany Report #2004056975 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Ziprasidone (Im) Initial or Prolonged Drug Ineffective Health (Ziprasidone) PS INTRAMUSCULAR 40 MG (20 Professional MG), INTRAMUSCULAR Date:11/08/04ISR Number: 4499706-8Report Type:Expedited (15-DaCompany Report #2004084905 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Parkinsonism Foreign Zeldox Initial or Prolonged Restlessness Health (Capsules)(Ziprasido Professional ne) PS ORAL 80 MG, ORAL Citalopram Hydrobromide (Citalopram Hydrobromide) C Urtica Extract (Urtica Extract) C Date:11/08/04ISR Number: 4499710-XReport Type:Expedited (15-DaCompany Report #2004084627 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcohol Withdrawal Foreign Zeldox Initial or Prolonged Syndrome Health (Capsules)(Ziprasido Other Enuresis Professional ne) PS ORAL 160 MG, ORAL Grand Mal Convulsion Oxazepam (Oxazepam) C Tongue Biting Citalopram Hydrobromide (Citalopram Hydrobromide) C Date:11/08/04ISR Number: 4499745-7Report Type:Expedited (15-DaCompany Report #2004087302 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aphagia Health Geodon (Ziprasidone) PS 80 MG (40 MG, Other Aphasia Professional 2 IN 1 D) Dementia Company Bactrim Depression Representative (Sulfamethoxazole, Myocardial Infarction Trimethoprim) SS Neuromyopathy Amlodipine Besilate Psychotic Disorder (Amlodipine Besilate) C Date:11/09/04ISR Number: 4500893-3Report Type:Expedited (15-DaCompany Report #2004085981 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Serotonin Syndrome Health Geodon (Ziprasidone) PS Professional Fluoxetine Company Hydrochloride Representative (Fluoxetine Hydrochloride) SS 22-Feb-2006 08:32 AM Page: 634 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/09/04ISR Number: 4500972-0Report Type:Expedited (15-DaCompany Report #2004085979 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Serotonin Syndrome Health Geodon (Ziprasidone) PS 1 IN 1 D Professional Fluoxetine Company Hydrochloride Representative (Fluoxetine Hydrochloride) SS ORAL 60 MG (1 IN 1 D), ORAL Date:11/10/04ISR Number: 4498908-4Report Type:Direct Company Report #CTU 231763E Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Geodon PS ORAL 40 MG -> 60 Required Grand Mal Convulsion MG Q HS ORAL Intervention to Movement Disorder Klonopin C Prevent Permanent Risperdal C Impairment/Damage Date:11/10/04ISR Number: 4501142-2Report Type:Expedited (15-DaCompany Report #2004085776 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Consumer Geodon (Ziprasidone) PS 80 MG (20 MG, Initial or Prolonged Drug Ineffective 4 IN 1 D) Fatigue Escitalopram Hepatic Enzyme Increased (Escitalopram) C Hypersomnia Lorazepam Mental Impairment (Lorazepam) C Ursodeoxycholic Acid (Ursodeoxycholic Acid) C Date:11/12/04ISR Number: 4500550-3Report Type:Direct Company Report #CTU 231768 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Geodon PS 80 MG BID Convulsion Date:11/15/04ISR Number: 4503760-4Report Type:Expedited (15-DaCompany Report #2004084292 Age:19 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abnormal Behaviour Foreign Zeldox (Capsules) Disinhibition Health (Ziprasidone) PS ORAL 120 MG, ORAL Exhibitionism Professional Fluoxetine Sexual Offence (Fluoxetine) SS ORAL UNK (1 IN 1 D), ORAL Diazepam (Diazepam) C Flurazepam (Flurazepam) C 22-Feb-2006 08:32 AM Page: 635 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/15/04ISR Number: 4503854-3Report Type:Expedited (15-DaCompany Report #2004087654 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Gastric Ulcer Perforation Foreign Geodon (Im) Other Peritonitis Health (Ziprasidone) PS INTRAMUSCULAR 20 MG (20 MG, Professional 2 IN 1 D), Company INTRAMUSCULAR Representative Haloperidol (Haloperidol) C Famotidine (Famotidine) C Date:11/15/04ISR Number: 4503875-0Report Type:Expedited (15-DaCompany Report #2004086750 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukaemia Foreign Ziprasidone (Caps) Initial or Prolonged Health (Ziprasidone) PS ORAL 80 MG (1 IN 1 Other Professional D), ORAL Clozapine (Clozapine) SS Date:11/15/04ISR Number: 4504335-3Report Type:Expedited (15-DaCompany Report #2004087627 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Heart Rate Decreased Health Geodon (Im) Initial or Prolonged Loss Of Consciousness Professional (Ziprasidone) PS 10 MG (10 MG, Company 1 IN 1) Representative Date:11/15/04ISR Number: 4504337-7Report Type:Expedited (15-DaCompany Report #2004087438 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Consumer Geodon (Ziprasidone) PS ORAL 80 MG (20 MG, Initial or Prolonged Alanine Aminotransferase 4 IN 1 D), Other Increased ORAL Aspartate Lorazepam Aminotransferase (Lorazepam) SS 2 MG (1 MG, 2 Increased IN 1 D) Condition Aggravated Citalopram Delusion Hydrobromide C Discomfort Normensal Drug Ineffective (Ethinylestradiol, Hypersomnia Norethisterone) C Lacrimation Increased Mydriasis Panic Attack Paranoia Psychotic Disorder Tachyarrhythmia 22-Feb-2006 08:32 AM Page: 636 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/15/04ISR Number: 4504422-XReport Type:Expedited (15-DaCompany Report #2004087434 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arrhythmia Consumer Geodon (Ziprasidone) PS ORAL 80 MG (20 MG, Initial or Prolonged Heart Rate Irregular 4 IN 1 D), Other Hepatic Enzyme Increased ORAL Hypersomnia Mydriasis Nervousness Palpitations Physical Assault Psychomotor Hyperactivity Psychotic Disorder Suicide Attempt Date:11/16/04ISR Number: 4504578-9Report Type:Expedited (15-DaCompany Report #2002073360 Age:17 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Prolactin Increased Literature Geodon (Ziprasidone) PS ORAL 180 MG (3 IN Initial or Prolonged Depressed Mood Health 1 D), ORAL Galactorrhoea Professional Sertraline Paranoia (Sertraline) C Suicidal Ideation Olanzapine (Olanzapine) C Quetiapine (Quetiapine) C Valproate Semisodium (Valproate Semisodium) C Date:11/17/04ISR Number: 4506627-0Report Type:Expedited (15-DaCompany Report #2004079238 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Health Geodon (Ziprasidone) PS Professional Olanzapine Company (Olanzapine) SS 5 MG Representative Drug, Unspecified (Drug, Unspecified) SS Haloperidol Decanoate (Haloperidol Decanoate) C Date:11/17/04ISR Number: 4506879-7Report Type:Expedited (15-DaCompany Report #2004235243HU Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Multiple Drug Overdose Foreign Alprazolam Suicide Attempt Health (Alprazolam) PS ORAL SEE IMAGE Professional Ziprasidone (Ziprasidone) SS ORAL SEE IMAGE 22-Feb-2006 08:32 AM Page: 637 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/17/04ISR Number: 4506886-4Report Type:Expedited (15-DaCompany Report #2004087627 Age:72 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Heart Rate Decreased Health Geodon (Im) Initial or Prolonged Loss Of Consciousness Professional (Ziprasidone) PS INTRAMUSCULAR 10 MG (10 MG, Company 1 IN 1D), Representative INTRAMUSCULAR Date:11/17/04ISR Number: 4506892-XReport Type:Expedited (15-DaCompany Report #2004082301 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Foreign Geodon (Ziprasidone) PS ORAL 160 MG (80 White Blood Cell Count Health MG, 2 IN 1 Decreased Professional D), ORAL Company Zoloft (Sertraline) SS ORAL 50 MG (50 MG, Representative 1 IN 1 D), ORAL Date:11/17/04ISR Number: 4506907-9Report Type:Expedited (15-DaCompany Report #2004071877 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Overdose Foreign Zeldox (Capsules) Initial or Prolonged Somnolence Health (Ziprasidone) PS ORAL 120 MG (60 Other Suicide Attempt Professional MG, 2 IN 1 Company D), ORAL Representative Alprazolam (Alprazolam) C Date:11/18/04ISR Number: 4507407-2Report Type:Expedited (15-DaCompany Report #2004087438 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Consumer Geodon (Ziprasidone) PS ORAL 80 MG (20 MG, Initial or Prolonged Alanine Aminotransferase 4 IN 1 D), Other Increased ORAL Aspartate Lorazepam Aminotransferase (Lorazepam) SS 2 MG (1 MG, 2 Increased IN 1 D), Delusion Citalopram Drug Effect Decreased Hydrobromide Drug Ineffective (Citalopram Fear Hydrobromide) C Heart Rate Increased Normensal Heart Rate Irregular (Ethinylestradiol, Hypersomnia Norethisterone) C Lacrimation Increased Medication Error Mydriasis Panic Disorder Paranoia Pharmaceutical Product Complaint Somnolence Yawning 22-Feb-2006 08:32 AM Page: 638 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/18/04ISR Number: 4507524-7Report Type:Expedited (15-DaCompany Report #2004089110 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Foreign Zeldox Initial or Prolonged Parkinsonism Health (Ziprasidone) PS ORAL 100 MG, ORAL Professional Biperiden Hydrochloride C Date:11/19/04ISR Number: 4509476-2Report Type:Expedited (15-DaCompany Report #2004090030 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fatigue Consumer Geodon (Ziprasidone) PS Initial or Prolonged Sedation Diphenydramine Suicide Attempt Hydrochloride (Diphenydramine Hydrochloride) SS Esctialopram (Esctialopram) SS Date:11/19/04ISR Number: 4509852-8Report Type:Expedited (15-DaCompany Report #2003033328 Age:59 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Foreign Zeldox (Capsules) Initial or Prolonged Drug Intolerance Consumer (Ziprasidone) PS ORAL 40 MG (20 MG, Other Epilepsy Health 2 IN 1 D), Fall Professional ORAL Feeling Abnormal Company Esomeprazole C Humerus Fracture Representative Salutec Limb Injury (Hydrochlorothiazide Loss Of Consciousness , Ramipril) C Nerve Injury Levothyroxine Sodium C Phenprocoumon C Flupentixol Dihydrochloride C Fluanxol (Flupentixol Dihydrochloride) C Haloperidol C Date:11/19/04ISR Number: 4512927-0Report Type:Direct Company Report #CTU 232483 Age:43 YR Gender:Male I/FU:I Outcome PT Disability Alopecia Back Disorder Blister Blood Pressure Increased Burning Sensation Chest Pain Chills Condition Aggravated Dry Skin Erectile Dysfunction Exercise Capacity Decreased Exfoliative Rash 22-Feb-2006 08:32 AM Page: 639 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Extrasystoles Fatigue Feeling Cold Report Source Product Role Manufacturer Route Dose Duration Food Craving Geodon PS 40 MG DAILY Gastrointestinal Disorder Paxil C Hypoaesthesia Vitamins C Intervertebral Disc Protrusion Irritable Bowel Syndrome Keloid Scar Medication Error Meniscus Lesion Nervousness Pain In Extremity Prostatic Disorder Psychomotor Hyperactivity Rash Sexual Dysfunction Sleep Disorder Weight Increased Date:11/22/04ISR Number: 4510550-5Report Type:Expedited (15-DaCompany Report #2004094477 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Geodon (Ziprasidone) PS Professional Company Representative Date:11/22/04ISR Number: 4510552-9Report Type:Expedited (15-DaCompany Report #2004087614 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Geodon (Ziprasidone) PS Professional Company Representative Date:11/22/04ISR Number: 4510689-4Report Type:Expedited (15-DaCompany Report #2004090802 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Electrocardiogram Qt Foreign Zeldox (Capsules) Prolonged Health (Ziprasidone) PS ORAL 160 MG (80 Fall Professional MG, 2 IN 1 Head Injury D), ORAL Olanzapine (Olanzapine) C Zopiclone (Zopiclone) C Warfarin Sodium (Warfarin Sodium) C Oxazepam (Oxazepam) C 22-Feb-2006 08:32 AM Page: 640 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/22/04ISR Number: 4510723-1Report Type:Expedited (15-DaCompany Report #2004088663 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Feeling Abnormal Foreign Zeldox (Capsules) Sudden Cardiac Death Health (Ziprasidone) PS ORAL 120 MG (2 IN Professional 1 D), ORAL Company Loratadine Representative (Loratadine) C Salbutamol (Salbutamol) C Beclometasone Dipropionate (Beclometasone Dipropionate) C Mometasone Furoate (Mometasone Furoate) C Propanolol Hydrochloride (Propanolol Hydrochloride) C Levothyroxine Sodium (Levothyroxine Sodium) C Sinuselect (Homeopatics Nos) C Selenide Sodium (Selenide Sodium) C Antihistamines (Antihistamines) C Date:11/23/04ISR Number: 4512070-0Report Type:Expedited (15-DaCompany Report #2004079254 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Magnesium Decreased Health Geodon (Ziprasidone) PS Initial or Prolonged Blood Potassium Decreased Professional Lithium (Lithium) SS Other Cardiomyopathy Fluconazole Electrocardiogram Qt (Fluconazole0 SS Corrected Interval Prolonged Electrocardiogram St-T Change Electrolyte Imbalance Therapeutic Agent Toxicity Torsade De Pointes Date:11/23/04ISR Number: 4512078-5Report Type:Expedited (15-DaCompany Report #2004090465 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Geodon(Ziprasidone) PS 22-Feb-2006 08:32 AM Page: 641 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/26/04ISR Number: 4514202-7Report Type:Expedited (15-DaCompany Report #2004062349 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Health Geodon (Ziprasidone) PS ORAL 120 MG (40 Initial or Prolonged Amnesia Professional MG, 3 IN 1 Other Cerebrovascular Accident Company D), ORAL Dysarthria Representative Paroxetine Dystonia Hydrochloride Facial Palsy (Paroxetine Therapeutic Response Hydrochloride) C Decreased Zolpidem Tartrate Transient Ischaemic (Zolpidem Tartrate) C Attack Aripiprazole (Aripiprazole) C Cocaine (Cocaine) C Oxycocet (Oxycodone Hydrochloride, Paracetamol) C Date:11/26/04ISR Number: 4514923-6Report Type:Expedited (15-DaCompany Report #2004066826 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Treatment Noncompliance Foreign Ziprasidone (Caps) Other Health (Ziprasidone) PS ORAL 120 MG (60 Professional MG, 2 IN 1 D), ORAL Clozapine (Clozapine) SS Pimozide (Pimozide) SS Date:11/26/04ISR Number: 4514964-9Report Type:Expedited (15-DaCompany Report #2003033328 Age:59 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Axillary Nerve Injury Foreign Zeldox (Capsules) Initial or Prolonged Convulsion Consumer (Ziprasidone) PS ORAL 40 MG (20 MG, Other Epilepsy Health 2 IN 1 D), Fall Professional ORAL Feeling Abnormal Company Esomeprazole Hip Fracture Representative (Esomeprazole) C Humerus Fracture Salutec Loss Of Consciousness (Hydrochlorothiazide Overweight , Ramipril) C Surgery Levothyroxine Sodium (Levothyroxine Sodium) C Phenprocoumon (Phenprocoumon) C Flupentixol Dihydrochloride (Flupentixol Dihydrochloride) C Fluanxol (Flupentixol Dihydrochloride) C Haloperidol (Haloperidol) C 22-Feb-2006 08:32 AM Page: 642 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/26/04ISR Number: 4515002-4Report Type:Expedited (15-DaCompany Report #2003033328 Age:59 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Axillary Nerve Injury Foreign Zeldox (Capsules) Initial or Prolonged Comminuted Fracture Consumer (Ziprasidone) PS ORAL 40 MG (20 MG, Other Convulsion Health 2 IN 1 D), Emotional Disorder Professional ORAL Epilepsy Company Esomeprazole Fall Representative (Esomeprazole) C Hip Fracture Salutec Humerus Fracture (Hydrochlorothiazide Mobility Decreased , Ramipril) C Muscular Weakness Levothyroxine Sodium (Levothyroxine Sodium) C Phenprocoumon (Phenprocoumon) C Flupentixol Dihydrochloride (Flupentixol Dihydrochloride) C Fluanxol (Flupentixol Dihydrochloride) C Haloperidol (Haloperidol) C Date:11/26/04ISR Number: 4515332-6Report Type:Expedited (15-DaCompany Report #HQWYE740903AUG04 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Consumer Effexor (Venlafaxine Alopecia Hydrochloride, Anhedonia Capsule Extended Anxiety Release) PS SEE IMAGE Confusional State Depakote (Valproate Crying Semisodium) SS 500 MG Depression Dexedrine Diarrhoea (Dexamfetamine Disease Recurrence Sulfate) SS SIX (5 MG) Disturbance In Attention TABS MORNING Drug Withdrawal Syndrome AND AFTERNOON Fatigue Effexor (Venlafaxine Headache Hydrochloride, Hyperhidrosis Tablet) SS ORAL 100 MG 3 X Irritability PER 1 DAY, Middle Insomnia ORAL Mood Swings Geodon (Ziprasidone) SS SEE IMAGE Overdose Klonopin Panic Attack (Clonazepam) SS 0.5 MG IN THE Serotonin Syndrome AFTERNOON, 1 Social Avoidant Behaviour MG HS Suicidal Ideation Remeron (Mirtazapine) SS SEE IMAGE Ritalin (Methylphenidate Hydrochloride) SS Zoloft (Sertraline Hydrochloride) SS 100 MG 22-Feb-2006 08:32 AM Page: 643 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/26/04ISR Number: 4515369-7Report Type:Expedited (15-DaCompany Report #2004093169 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Sodium Decreased Consumer Geodon (Ziprasidone) PS ORAL 80 MG (40 MG, Bruxism 2 IN 1 D), Fatigue ORAL Loss Of Consciousness Lithium (Lithium) SS ORAL ORAL Road Traffic Accident Diazepam (Diazepam) C Somnolence Oxcarbazepine Speech Disorder (Oxcarbazepine) C Tongue Biting Metformin Tongue Disorder Hydrochloride Tremor (Metformin Hydrochloride) C Glipizide (Glipizide) C Pantoprazole (Pantoprazole) C Trihexyphenidyl (Trihexyphenidyl) C Procyclidine Hydrochloride (Procyclidine Hydrochloride) C Novolin 20/80 (Insulin Human, Insulin Isophane, Human Biosynthetic) C Acetylsalicylic Acid (Acetylsalicylic Acid) C Date:11/26/04ISR Number: 4515394-6Report Type:Expedited (15-DaCompany Report #2004093230 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Self-Medication Consumer Geodon (Ziprasidone) PS Initial or Prolonged Somnolence Date:11/26/04ISR Number: 4515396-XReport Type:Expedited (15-DaCompany Report #2004093236 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Self-Medication Consumer Geodon (Ziprasidone) PS Somnolence Date:11/26/04ISR Number: 4515401-0Report Type:Expedited (15-DaCompany Report #2004093194 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Self-Medication Consumer Geodon (Ziprasidone) PS Somnolence 22-Feb-2006 08:32 AM Page: 644 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/26/04ISR Number: 4515412-5Report Type:Expedited (15-DaCompany Report #2004079238 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Health Geodon (Ziprasidone) PS Professional Olanzapine Company (Olanzapine) SS 5 MG Representative Drug, Unspecified (Drug, Unspecified) SS Haloperidol Decanoate (Haloperidol Decanoate) C Date:11/26/04ISR Number: 4515414-9Report Type:Expedited (15-DaCompany Report #2004066266 Age:56 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Health Geodon (Ziprasidone) PS ORAL 60 MG (1 IN 1 Initial or Prolonged Increased Professional D), ORAL Other Aspartate Company Quetiapine Fumarate Aminotransferase Representative (Quetiapine Increased Fumarate) SS ORAL ORAL Blood Electrolytes Escitalopram Abnormal (Escitalopram) C Blood Pressure Increased Oxcarbazepine Bradycardia (Oxcarbazepine) C Cardiac Arrest Clonazepam Coma (Clonazepam) C Cyanosis Levothyroxine Sodium Diarrhoea (Levothyroxine Electrocardiogram Qt Sodium) C Corrected Interval Antihypertensives Electrocardiogram Qt (Antihypertensives) C Prolonged Co-Diovan Fall (Hydrochlorothiazide Heart Rate Decreased , Valsartan) C Heart Rate Increased Estradiol Hypertriglyceridaemia (Estradiol) C Hypokalaemia Diltiazem Laboratory Test Abnormal Hydrochloride Leukocytosis (Diltiazem Long Qt Syndrome Hydrochloride) C Pneumonia Aspiration Oxcarbazepine Respiratory Arrest (Oxcarbazepine) C Torsade De Pointes Temazepam Ventricular Fibrillation (Temazepam) C Nicotinic Acid (Nicotinic Acid) C Clindamycin (Clindamycin) C Clonidine (Clonidine) C Isradipine (Isradipine) C Potassium Chloride (Potassium Chloride) C Quinapril Hydrochloride (Quinapril Hydrochloride) C 22-Feb-2006 08:32 AM Page: 645 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Aripiprazole (Aripiprazole) C Date:11/26/04ISR Number: 4515415-0Report Type:Expedited (15-DaCompany Report #2004083738 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Serotonin Syndrome Health Geodon (Ziprasidone) PS ORAL 40 MG (1 IN 1 Professional D), ORAL Escitalopram (Escitalopram) SS ORAL 20 MG (1 IN 1 D), ORAL Lorazepam (Lorazepam) C Date:11/26/04ISR Number: 4515429-0Report Type:Expedited (15-DaCompany Report #2004092047 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypotension Health Geodon (Ziprasidone) PS ORAL 80 MG (40 MG, Initial or Prolonged Professional 2 IN 1 D), Other ORAL Dyazide (Hydrochlorothiazide , Triamterene) C Lisinopril (Lisinopril) C Date:11/26/04ISR Number: 4515469-1Report Type:Expedited (15-DaCompany Report #2004092442 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Health Geodon (Ziprasidone) PS Professional Company Representative Date:11/26/04ISR Number: 4515597-0Report Type:Expedited (15-DaCompany Report #2004093147 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Geodon (Ziprasidone) PS Health Professional Company Representative Date:11/30/04ISR Number: 4515249-7Report Type:Direct Company Report #CTU 233215 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depressed Level Of Geodon (Ziprasidone Consciousness ) 80 Mg PS ORAL 80 MG PO BID Treatment Noncompliance [ADMITTED WITH IT (>2 WEEKS)] 22-Feb-2006 08:32 AM Page: 646 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/30/04ISR Number: 4517059-3Report Type:Expedited (15-DaCompany Report #2004094546 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Foreign Ziprasidone (Caps) Locked-In Syndrome Health (Ziprasidone) PS ORAL 80 MG (40 MG, Professional 2 IN 1 D), Company ORAL Representative Date:11/30/04ISR Number: 4517774-1Report Type:Expedited (15-DaCompany Report #2004081572 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Foreign Ziprasidone (Caps) Initial or Prolonged Coma Consumer (Ziprasidone) PS ORAL ORAL Euphoric Mood Bromazepam SS ORAL ORAL Intentional Overdose Medical Device Complication Medication Error Nosocomial Infection Pneumonia Respiratory Disorder Date:12/01/04ISR Number: 4517900-4Report Type:Direct Company Report #CTU 233342 E Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Nausea Geodon 40 PS ORAL 2 BID PO Other Vomiting Eskalith C Ca Li Co3 C Lamictal C Wellbutin Xl C Methergine C Date:12/02/04ISR Number: 4519449-1Report Type:Expedited (15-DaCompany Report #2004093147 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Geodon (Ziprasidone) PS Health Professional Company Representative Date:12/03/04ISR Number: 4518914-0Report Type:Direct Company Report #CTU 233627 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Priapism Geodon (Ziprasidone) Initial or Prolonged 60 Mg PS 140 MG QHS Geodon 80 Mg (Pfizer) SS Pfizer Trileptal C Seroquel C Synthroid C Paxil C 22-Feb-2006 08:32 AM Page: 647 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Vistaril C Date:12/03/04ISR Number: 4518989-9Report Type:Direct Company Report #CTU 233649 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abdominal Pain Upper Geodon PS INTRAMUSCULAR ONE INJECTION Disability Arthralgia INTRAMUSCULAR Required Depression Intervention to Fear Prevent Permanent Loss Of Consciousness Impairment/Damage Migraine Muscle Disorder Myalgia Nausea Speech Disorder Date:12/06/04ISR Number: 4520386-7Report Type:Direct Company Report #CTU 233703 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Geodon 20 Mg Initial or Prolonged Blood Pressure Increased Pfizer PS Pfizer ORAL 20 MG BID Body Temperature ORAL Increased Muscle Rigidity Date:12/06/04ISR Number: 4521932-XReport Type:Expedited (15-DaCompany Report #2004097045 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Health Geodon (Ziprasidone) PS 80 MG (40 MG, Professional 2 IN 1 D) Company Representative Date:12/06/04ISR Number: 4522009-XReport Type:Expedited (15-DaCompany Report #2004098307 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Myocardial Infarction Consumer Geodon (Ziprasidone) PS Health Professional Date:12/07/04ISR Number: 4521935-5Report Type:Expedited (15-DaCompany Report #2004099298 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Health Geodon (Ziprasidone) PS ORAL 80 MG (40 MG, Initial or Prolonged Paranoia Professional 2 IN 1 D), ORAL Paracetamol (Paracetamol) C Glibenclamide (Glibenclamide) C Insulin (Insulin) C 22-Feb-2006 08:32 AM Page: 648 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Metformin (Metformin) C Dimetcone, Activated (Simeticone) C Date:12/07/04ISR Number: 4522182-3Report Type:Expedited (15-DaCompany Report #2004099444 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anticonvulsant Drug Level Health Geodon (Ziprasidone) PS 200 MG (2 IN Hospitalization - Decreased Professional 1 D) Initial or Prolonged Neuroleptic Malignant Company Valproate Semisodium Syndrome Representative (Valproate Semisodium) C Date:12/07/04ISR Number: 4522283-XReport Type:Expedited (15-DaCompany Report #2004085695 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Corneal Oedema Foreign Zeldox (Capsules) Oedema Peripheral Health (Ziprasidone) PS ORAL 60 MG, ORAL; Visual Disturbance Professional SEE IMAGE 3 DAY Company Representative Date:12/08/04ISR Number: 4523212-5Report Type:Expedited (15-DaCompany Report #2004SE06648 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Foreign Seroquel PS ORAL 50 MG DAILY Sudden Death Health PO Professional Zeldox SS ORAL 20 MG BID PO Other Renitec C Imdur C Calcium C Triobe C Fosamax C Digitoxin C Marevan C Date:12/08/04ISR Number: 4524945-7Report Type:Expedited (15-DaCompany Report #2004073851 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Balance Disorder Health Geodon (Ziprasidone) PS Coordination Abnormal Professional Bupropion Difficulty In Walking Company Hydrochloride C Extrapyramidal Disorder Representative Lithium C Tremor Insulin Injection, Isophane C Metformin Hydrochloride C Glibenclamide C Pravastatin Sodium C Lithium Carbonate C Alprazolam C Insulin Glargine C 22-Feb-2006 08:32 AM Page: 649 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Venlafaxine Hydrochloride C Date:12/09/04ISR Number: 4523397-0Report Type:Expedited (15-DaCompany Report #2004073860 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Balance Disorder Health Geodon (Ziprasidone) PS ORAL 160 MG (2 IN Coordination Abnormal Professional 1 D), ORAL Difficulty In Walking Company Valproate Semisodium Gait Disturbance Representative (Valproate Tremor Semisodium) C Pioglitazone (Pioglitazone) C Rabeprazole Sodium (Rabeprazole Sodium) C Meloxicam (Meloxicam) C Metformin Hydrochloride (Metformin Hydrochloride) C Tramadol Hydrochloride (Tramadol Hydrochloride) C Cetirizine Hydrochloride (Cetirizine Hydrochloride) C Karvea Hct (Hydrochlorothiazide , Irbesartan) C Date:12/09/04ISR Number: 4524052-3Report Type:Expedited (15-DaCompany Report #2004080302 Age:11 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Foreign Zeldox (Capsules) Anxiety Health (Ziprasidone) PS ORAL 80 MG (1 IN 1 Hypertensive Crisis Professional D), ORAL 6 MON Psychotic Disorder Company Valproate Representative Sodium(Valproate Sodium) C Date:12/09/04ISR Number: 4524117-6Report Type:Expedited (15-DaCompany Report #2004101967 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyspnoea Foreign Geodon (Ziprasidone) PS Initial or Prolonged Pharyngeal Oedema Health Levomepromazine Rash Professional (Levomepromazine) C Type Iv Hypersensitivity Company Haloperidol Reaction Representative (Haloperidol) C 22-Feb-2006 08:32 AM Page: 650 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/10/04ISR Number: 4525349-3Report Type:Expedited (15-DaCompany Report #2004066266 Age:56 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Health Geodon (Ziprasidone) PS ORAL 06 MG (1 IN 1 Initial or Prolonged Increased Professional D), ORAL Other Arrhythmia Company Quetiapine Fumarate Aspartate Representative (Quetiapine Fumrate) SS ORAL ORAL Aminotransferase Escitalopram Increased (Escitalopram) C Blood Pressure Increased Oxcarbazepine Cardio-Respiratory Arrest (Oxcarbazepine) C Coma Clonazepam Cyanosis (Clonazepam) C Diarrhoea Levothyroxine Sodium Electrocardiogram Qt (Levothyroxine Prolonged Sodium) C Heart Rate Irregular Antihypertensives Hypertriglyceridaemia (Antihypertensives) C Hypokalaemia Co-Diovan Loss Of Consciousness (Hydrochlorothiazide Pneumonia Aspiration , Valsartarn) C Torsade De Pointes Estradiol Ventricular Fibrillation (Estradiol) C Diltazem Hydrochloride (Diltazem Hydrochloride) C Temazepam (Temazepam) C Nicotinic Acid (Nicotinic Acid) C Clindamycin (Clindamycin) C Clonidine (Clonidine) C Isradipine (Isradipine) C Potassium Chloride (Potassium Chloride) C Quinapril Hydrochloride (Quinapril Hydcrochloride) C Aripiprazole (Aripiprazole) C Date:12/10/04ISR Number: 4525358-4Report Type:Expedited (15-DaCompany Report #2004105547 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Geodon (Ziprasidone) PS ORAL 200 MG (100 Initial or Prolonged Syndrome Professional MG, 2 IN 1 Company D), ORAL Representative 22-Feb-2006 08:32 AM Page: 651 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/10/04ISR Number: 4525360-2Report Type:Expedited (15-DaCompany Report #2004102186 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Renal Failure Health Geodon (Ziprasidone) PS Professional Date:12/13/04ISR Number: 4526593-1Report Type:Expedited (15-DaCompany Report #2004101613 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Geodon (Im) Sudden Cardiac Death Professional (Ziprasidone) PS Date:12/13/04ISR Number: 4526596-7Report Type:Expedited (15-DaCompany Report #200401449 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Failure Health Geodon (Im) Professional (Ziprasidone) PS Date:12/13/04ISR Number: 4526605-5Report Type:Expedited (15-DaCompany Report #2004101618 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Respiratory Failure Health Geodon (Ziprasidone) PS Initial or Prolonged Professional Date:12/13/04ISR Number: 4526734-6Report Type:Expedited (15-DaCompany Report #2004101239 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bone Disorder Consumer Geodon (Ziprasidone) PS SEE IMAGE Initial or Prolonged Dyspepsia Lithium (Lithium) SS ORAL ORAL Oesophageal Pain Pollakiuria Stress Tooth Disorder Date:12/13/04ISR Number: 4526735-8Report Type:Expedited (15-DaCompany Report #2004040233 Age:67 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Pressure Increased Health Geodon (Im) Hospitalization - Coma Professional (Ziprasidone) PS INTRAMUSCULAR 20 MG, Initial or Prolonged Ventricular Extrasystoles Other INTRAMUSCULAR Other Date:12/13/04ISR Number: 4526736-XReport Type:Expedited (15-DaCompany Report #A118566 Age:29 YR Gender:Male I/FU:F Outcome Hospitalization - Initial or Prolonged Required Intervention to 22-Feb-2006 08:32 AM Page: 652 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Atrial Fibrillation Literature Ziprasidone Bundle Branch Block Left Health (Ziprasidone) PS (80 MG) Delirium Professional Bupropion Disorientation Company Hydrochloride Electrocardiogram Qrs Representative (Bupropion Complex Prolonged Hydrochloride) SS (100 MG) Electrocardiogram Qt Fluoxetine Corrected Interval Hydrochloride Prolonged (Fluoxetine Electrocardiogram Qt Hydrochloride) SS (40 MG) Prolonged Valproate Semisodium Electrocardiogram St (Valproate Segment Abnormal Semisodium) SS (250 MG) Electrocardiogram St Segment Depression Electrocardiogram T Wave Abnormal Grand Mal Convulsion Hallucination, Visual Lethargy Multiple Drug Overdose Myocardial Infarction Sinus Tachycardia Supraventricular Tachycardia Date:12/13/04ISR Number: 4526818-2Report Type:Expedited (15-DaCompany Report #2004084170 Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other No Adverse Drug Effect Health Geodon (Ziprasidone) PS Professional Date:12/13/04ISR Number: 4526820-0Report Type:Expedited (15-DaCompany Report #2004081893 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aggression Health Geodon (Ziprasidone) PS 160 MG (80 Life-Threatening Agitation Professional MG, 2 IN 1 Hospitalization - Condition Aggravated Company D), Initial or Prolonged Neuroleptic Malignant Representative Geodon (Im) Syndrome (Ziprasidone) Self Injurious Behaviour (Ziprasidone) SS INTRAMUSCULAR INTRAMUSCULAR Ventricular Tachycardia Olanzapine (Olanzapine) SS All Other Therapeutic Products (All Other Therapeutic Products) C 22-Feb-2006 08:32 AM Page: 653 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/13/04ISR Number: 4526826-1Report Type:Expedited (15-DaCompany Report #2004097045 Age:36 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Health Geodon (Ziprasidone) PS 80 MG (40 MG, Professional 2 IN 1 D), Company Representative Date:12/13/04ISR Number: 4527019-4Report Type:Expedited (15-DaCompany Report #2004103897 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hallucination Foreign Zeldox (Capsules) Myocardial Infarction Health (Ziprasidone) PS ORAL 40 MG (20 MG, Osteoporosis Professional 2 IN 1 D), Sudden Death ORAL Seroquel (Quetiapine Fumarate) SS ORAL 50 MG (50 MG, 1 IN 1 D), ORAL Enalapril Maleate (Enalapril Maleate) C Isosorbide Mononitrate (Isosorbide Mononitrate) C Calcium Carbonate (Calcium Carbonate) C Triobe (Cyanocobalamin, Folic Acid, Pyridoxine) C Alendronate Sodium (Alandronate Sodium) C Digitoxin (Digitoxin) C Warfarin (Warfarin) C Date:12/13/04ISR Number: 4527035-2Report Type:Expedited (15-DaCompany Report #2004088663 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Death Foreign Zeldox (Capsule) Malaise Health (Ziprasidone) PS ORAL 120 MG (2 IN Sudden Death Professional 1 D), ORAL Company Loratadine Representative (Loratadine) C Salbutamol (Salbutamol) C Beclometasone Dipropionate (Beclometasone Dipropionate) C Mometasone Furoate (Mometasone Furoate) C Propranolol Hydrochloride (Propranolol Hydrochloride) C 22-Feb-2006 08:32 AM Page: 654 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Levothyroxine Sodium (Levothyroxine Sodium) C Sinuselect (Homeopatics Nos) C Selenide Sodium (Selenide Sodium) C Antihistamines (Antihistamines) C Date:12/14/04ISR Number: 4528914-2Report Type:Expedited (15-DaCompany Report #2004087627 Age:72 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Heart Rate Decreased Health Geodon (Im) Initial or Prolonged Loss Of Consciousness Professional (Ziprasidone) PS INTRAMUSCULAR 10 MG (10 MG, Company 1 IN 1 D), Representative INTRAMUSCULAR Date:12/14/04ISR Number: 4529311-6Report Type:Expedited (15-DaCompany Report #2004103282 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Cardiac Death Foreign Zeldox (Capsules) Health (Ziprasidone) PS ORAL 160 MG (80 Professional MG, 2 IN 1 Company D), ORAL Representative Olanzapine (Olanzapine) C Zopiclone (Zopiclone) C Oxazepam (Oxazepam) C Warfarin Sodium (Warfarin Sodium) C Date:12/14/04ISR Number: 4529315-3Report Type:Expedited (15-DaCompany Report #2004092672 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Foreign Zeldox (Capsules) Dyskinesia Health (Ziprasidone) PS ORAL 40 MG (40 MG, Muscle Spasms Professional 1 IN 1 D), Nasopharyngeal Disorder ORAL Citalopram Hydrobromide (Citalopram Hydrobromide) SS ORAL 20 MG (20 MG, 1 IN 1 D), ORAL Date:12/15/04ISR Number: 4530342-0Report Type:Expedited (15-DaCompany Report #2004105290 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Laryngeal Oedema Foreign Geodon (Ziprasidone) PS Health Professional 22-Feb-2006 08:32 AM Page: 655 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/15/04ISR Number: 4530344-4Report Type:Expedited (15-DaCompany Report #2004105291 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Laryngeal Oedema Foreign Geodon (Ziprasidone) PS Health Professional Date:12/15/04ISR Number: 4530350-XReport Type:Expedited (15-DaCompany Report #2004105289 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Laryngeal Oedema Foreign Geodon (Ziprasidone) PS Health Professional Date:12/15/04ISR Number: 4530353-5Report Type:Expedited (15-DaCompany Report #2004101967 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthma Foreign Geodon (Ziprasidone) PS Initial or Prolonged Pharyngeal Oedema Health Levomepromazine Rash Professional (Levomepromazine) C Type Iv Hypersensitivity Company Haloperidol Reaction Representative (Haloperidol) C Date:12/15/04ISR Number: 4530357-2Report Type:Expedited (15-DaCompany Report #2004103893 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Increased Foreign Geodon (Ziprasidone) PS ORAL 80 MG (80 MG, Initial or Prolonged Tremor Consumer 1 IN 1 D), ORAL Biperiden Hydrochloride (Biperiden Hydrochloride) C Haloperidol (Haloperidol) C Chlorpromazine (Chlorpromazine) C Enalapril (Enalapril) C Date:12/16/04ISR Number: 4530449-8Report Type:Direct Company Report #CTU 234473 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Geodon PS ORAL 60MG BID Blood Pressure Decreased ORAL Cardiac Arrest Geodon SS INTRAMUSCULAR 20MG ONCE Hyperthermia INTRAMUSCU Neuroleptic Malignant Syndrome Ventricular Tachycardia 22-Feb-2006 08:32 AM Page: 656 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/16/04ISR Number: 4530677-1Report Type:Expedited (15-DaCompany Report #2004030413 Age:19 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Ziprasidone (Caps) Initial or Prolonged Phosphokinase Increased Study (Ziprasidone) PS ORAL SEE IMAGE Other Communication Disorder Health Haloperidol Hostility Professional (Haloperidol) C Movement Disorder Clonazepam Neuroleptic Malignant (Clonazepam) C Syndrome Biperiden 9biperiden) C Levomepromazine (Levomepromazine) C Imipramine Hydrochloride (Imipramine Hydrochloride) C Lorazepam (Lorazepam) C Ziprasidone (Ziprasidone0 C Flurazepam (Flurazepam) C Date:12/16/04ISR Number: 4531692-4Report Type:Expedited (15-DaCompany Report #2004105218 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Geodon (Ziprasidone) PS Initial or Prolonged Syndrome Professional Lithium (Lithium) C Company Representative Date:12/16/04ISR Number: 4531714-0Report Type:Expedited (15-DaCompany Report #2004069516 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Triglycerides Health Geodon (Ziprasidone) PS 200 MG 3 IN 1 Increased Professional D Body Height Increased Other Clonidine Diabetes Mellitus (Clonidine) C Weight Increased Sertraline Hydrochloride (Sertraline Hydrochloride) C Obetrol (Amfetamine Aspartate, Amfetamine Sulfate, Dexamfetamine Saccharate, C Topiramate (Topiramate) C 22-Feb-2006 08:32 AM Page: 657 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/20/04ISR Number: 4536543-XReport Type:Expedited (15-DaCompany Report #2004079254 Age:28 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Geodon (Ziprasidone) PS ORAL 80 MG (2 IN 1 Initial or Prolonged Anaemia Professional D), ORAL Other Blood Magnesium Decreased Fluconazole Blood Potassium Decreased (Fluconazole) SS ORAL 100 MG (1 IN Bradycardia 1 D), ORAL Candiduria Lithium Carbonate Electrocardiogram Qt (Lithium Carbonate) SS Corrected Interval Escitalopram Prolonged (Escitalopram) SS ORAL 15 MG, 1 IN 1 Electrolyte Imbalance D, ORAL Myocardial Infarction Topiramate Myocardial Ischaemia (Topiramate) SS ORAL 100 MG, 1 IN Therapeutic Agent 1 D, ORAL Toxicity Loratadine Torsade De Pointes (Loratadine) SS ORAL 10 MG, 1 IN 1 Urinary Tract Infection D, ORAL Ventricular Tachycardia Lansoprazole (Lansoprazole) C All Other Therapeutic Products (All Other Therapeutic Products) C Clonazepam (Clonazepam) C Olanzapine (Olanzapine) C Levetiracetam (Levetiracetam) C Ciprofloxacin (Ciprofloxacin) C Trazodone (Trazodone) C Metoprolol (Metoprolol) C Levothyroxine Sodium (Levothyroxine Sodium) C Prednisone (Prednisone) C Date:12/20/04ISR Number: 4536632-XReport Type:Expedited (15-DaCompany Report #2004066728 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bundle Branch Block Right Consumer Geodon (Ziprasidone) PS ORAL 80 MG (40 MG, Drug Effect Decreased Health 2 IN 1 D), Drug Ineffective Professional ORAL 1 MON Electrocardiogram Qt Quetiapine Fumarate Corrected Interval (Quetiapine Prolonged Fumarate) SS Electrocardiogram St-T Topiramate Change (Topiramate) C Electrocardiogram T Wave Citalopram Abnormal Hydrobromide Myocardial Ischaemia (Citalopram Hydrobromide) C 22-Feb-2006 08:32 AM Page: 658 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Venlafaxine Hydrochloride (Venlafaxine Hydrochloride) C Diphenhydramine Hydrochloride (Diphenhydramine Hydrochloride) C Acetylsalicylic Acid (Acetylsalicylic Acid) C Methylphenidate Hydrochloride (Medhylphenidate Hydrochloride) C Date:12/21/04ISR Number: 4538198-7Report Type:Expedited (15-DaCompany Report #2004109859 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Foreign Geodon (Ziprasidone) PS ORAL 80 MG (40 MG, Initial or Prolonged Suicidal Ideation Health 1 IN 1 D), Professional ORAL Alprazolam (Alprazolam) C Date:12/22/04ISR Number: 4539749-9Report Type:Expedited (15-DaCompany Report #2004067383 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dysmenorrhoea Health Geodon (Ziprasidone) PS 160 MG (80 Haematocrit Decreased Professional MG, 2 IN 1 Menorrhagia Company D), Representative Venlafaxine Hydrochloride (Venlafaxine Hydrochloride) C Haloperidol (Haloperidol) C Date:12/22/04ISR Number: 4539782-7Report Type:Expedited (15-DaCompany Report #2004080312 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Geodon (Ziprasidone) PS Other Post Procedural Professional Complication Company Representative Date:12/23/04ISR Number: 4538484-0Report Type:Direct Company Report #CTU 235067 Age:49 YR Gender:Male I/FU:I Outcome PT Death Agitation Blood Creatinine Increased Blood Gases Abnormal 22-Feb-2006 08:32 AM Page: 659 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Cholinergic Syndrome Dialysis Diarrhoea Report Source Product Role Manufacturer Route Dose Duration Electrolyte Imbalance Clozapine 800 Mg/Day PS SEE IMAGE Hallucination Abilify 15 Mg/Day SS 15 MG /DAY Incoherent Haldol Prn SS Lethargy Geodon X 1 SS SEE IMAGE Neuroleptic Malignant Syndrome Urinary Retention Date:12/23/04ISR Number: 4539920-6Report Type:Expedited (15-DaCompany Report #2004055655 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Geodon (Ziprasidone) PS Professional Company Representative Date:12/27/04ISR Number: 4541555-6Report Type:Expedited (15-DaCompany Report #2004113307 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blepharospasm Foreign Geodon (Ziprasidone) PS ORAL 20 MG (20 MG, Extrapyramidal Disorder Consumer 1 IN 1 D), Eye Disorder ORAL Eye Irritation All Other Eye Movement Disorder Therapeutic Products Tardive Dyskinesia (All Other Therapeutic Products) SS Date:12/27/04ISR Number: 4541773-7Report Type:Expedited (15-DaCompany Report #2004088663 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dizziness Foreign Zeldox (Capsules) Dyspnoea Health (Ziprasidone) PS ORAL 120 MG (2 IN Hyperhidrosis Professional 1 D), ORAL Nausea Company Loratadine Sudden Cardiac Death Representative (Loratadine) C Syncope Salbutamol Tachycardia (Salbutamol) C Beclometasone Dipropionate (Beclometasone Dipropionate) C Mometasone Furoate (Mometasone Furoate) C Propanolol Hydrochloride (Propanolol Hydrochloride) C Levothyroxine Sodium (Levothyroxine Sodium) C Sinuselect 22-Feb-2006 08:32 AM Page: 660 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Homeopatics Nos) C Selenide Sodium (Selenide Sodium) C Antihistamines (Antihistamines) C Date:12/27/04ISR Number: 4541786-5Report Type:Expedited (15-DaCompany Report #2004112572 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Foreign Zeldox (Capsules) Initial or Prolonged Blood Sodium Decreased Health (Ziprasidone) PS ORAL 120 MG (4 IN Fall Professional 1 ), ORAL Polydipsia Company Levomepromazine Sleep Disorder Representative (Levomepromazine) C Date:12/27/04ISR Number: 4542273-0Report Type:Expedited (15-DaCompany Report #2004112322 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anxiety Health Geodon (Ziprasidone) PS ORAL 80 MG (40 MG, Other Electrocardiogram Qt Professional 2 IN 1 D), Corrected Interval Company ORAL Prolonged Representative Zoloft (Sertraline) SS ORAL 200 MG, ORAL Neuroleptic Malignant Remeron Syndrome (Mirtazapine) C Date:12/27/04ISR Number: 4542283-3Report Type:Expedited (15-DaCompany Report #2004112591 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Geodon (Im) Professional (Ziprasidone) PS Date:12/27/04ISR Number: 4542290-0Report Type:Expedited (15-DaCompany Report #ZICO001152 Age:50 YR Gender:Female I/FU:I Outcome PT Life-Threatening Aggression Hospitalization - Agitation Initial or Prolonged Blood Potassium Decreased Confusional State Drug Toxicity Electrocardiogram Qt Corrected Interval Prolonged Electrocardiogram Qt Prolonged Electrocardiogram R On T Phenomenon Electrocardiogram St-T Segment Abnormal Hallucination Hypersomnia Hypoglycaemia Hypotension Insomnia Memory Impairment 22-Feb-2006 08:32 AM Page: 661 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Overdose Paranoia Psychotic Disorder Report Source Product Role Manufacturer Route Dose Duration Pulse Absent Study Ziconotide Rhabdomyolysis Health (Ziconotide) PS INTRATHECAL 0.0 MCG/HR Sinus Tachycardia Professional INTRATHECAL Torsade De Pointes Methadone Troponin Increased (Methadone) SS Ventricular Tachycardia Geodon (Geodon) SS Actiq (Fentanyl Citrate) C Duragesic Patch (Duragesic Patch) C Date:12/27/04ISR Number: 4542300-0Report Type:Expedited (15-DaCompany Report #2004112390 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arrhythmia Health Geodon (Ziprasidone) PS Initial or Prolonged Breast Cancer Female Professional Zoloft (Sertraline) SS Condition Aggravated Thinking Abnormal Date:12/29/04ISR Number: 4543067-2Report Type:Expedited (15-DaCompany Report #2004084292 Age:19 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disinhibition Foreign Zeldox (Capsules) Health (Ziprasidone) PS ORAL 120 MG, ORAL Professional Fluoxetine (Fluoxetine) SS ORAL (1 IN 1 D), ORAL Diazepam (Diazepam0 C Flurazepam (Flurazepam) C Date:12/30/04ISR Number: 4544584-1Report Type:Expedited (15-DaCompany Report #2004115908 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Geodon (Ziprasidone) PS ORAL ORAL Initial or Prolonged Consumer Date:12/30/04ISR Number: 4544594-4Report Type:Expedited (15-DaCompany Report #2004115872 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Geodon (Ziprasidone) PS ORAL ORAL Consumer Date:12/30/04ISR Number: 4544597-XReport Type:Expedited (15-DaCompany Report #2004115866 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Geodon (Ziprasidone) PS ORAL ORAL Consumer 22-Feb-2006 08:32 AM Page: 662 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/30/04ISR Number: 4544598-1Report Type:Expedited (15-DaCompany Report #2004115860 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Geodon (Ziprasidone) PS ORAL ORAL Other Health Professional Date:12/30/04ISR Number: 4544607-XReport Type:Expedited (15-DaCompany Report #2004114895 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Health Geodon (Im) Other Professional (Ziprasidone) PS Company Haloperidol Representative (Haloperidol) SS Date:12/30/04ISR Number: 4544608-1Report Type:Expedited (15-DaCompany Report #2004116564 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Health Geodon (Im) Professional (Ziprasidone) PS INTRAMUSCULAR INTRAMUSCULAR Company Representative Date:12/30/04ISR Number: 4544609-3Report Type:Expedited (15-DaCompany Report #2004114755 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Geodon (Ziprasidone) PS Initial or Prolonged Psychotic Disorder Professional Clozapine Therapy Non-Responder (Clozapine) SS ORAL 225 MG, ORAL Topiramate (Topiramate) C Benzatropine Mesilate (Benzatropine Mesilate) C Date:12/30/04ISR Number: 4544764-5Report Type:Expedited (15-DaCompany Report #2004103893 Age:62 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Increased Foreign Geodon (Ziprasidone) PS ORAL 80 MG (80 MG, Initial or Prolonged Consumer 1 IN 1 D), ORAL Biperiden Hydrochloride (Biperiden Hydrochloride) C Haloperidol (Haloperidol) C Chlorpromazine (Chlorpromazine) C Enalapril (Enalapril) C 22-Feb-2006 08:32 AM Page: 663 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/03/05ISR Number: 4545879-8Report Type:Expedited (15-DaCompany Report #2004112591 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Body Temperature Health Geodon (Im) Hospitalization - Increased Professional (Ziprasidone) PS INTRAMUSCULAR INTRAMUSCULAR Initial or Prolonged Cardio-Respiratory Arrest Haloperidol Coma (Haloperidol) C Respiratory Rate Benzatropine Increased Mesilate Screaming (Benzatropine Sinus Tachycardia Mesilate) C Somnolence Metformin (Metformin) C Lithium (Lithium) C All Other Therapeutic Products C Lamotrigine (Lamotrigine) C Date:01/03/05ISR Number: 4545881-6Report Type:Expedited (15-DaCompany Report #2004112322 Age:63 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anxiety Health Geodon (Ziprasidone) PS ORAL 80 MG (40 MG, Other Electrocardiogram Qt Professional 2 IN 1 D), Corrected Interval Company ORAL Prolonged Representative Zoloft (Sertraline) SS ORAL 200 MG, ORAL Neuroleptic Malignant Mirtazapine Syndrome (Mirtazapine) C Pharmaceutical Product Complaint Date:01/03/05ISR Number: 4545886-5Report Type:Expedited (15-DaCompany Report #2004118460 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Health Geodon (Ziprasidone) PS Syndrome Professional Company Representative Date:01/03/05ISR Number: 4545912-3Report Type:Expedited (15-DaCompany Report #2003010421 Age:76 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrial Fibrillation Health Geodon (Ziprasidone) PS ORAL 40 MG (2 IN 1 Dilatation Atrial Professional D), ORAL Electrocardiogram Company Geodon (Im) Repolarisation Representative (Ziprasidone) SS INTRAMUSCULAR 20 MG, Abnormality INTRAMUSCULAR Myocardial Ischaemia Amiodarone Sinus Bradycardia Hydrochloride Supraventricular (Amiodarone Extrasystoles Hydrochloride) SS Torsade De Pointes Acetylsalicylic Ventricular Hypertrophy Acid(Acetylsalicylic Aicd) C 22-Feb-2006 08:32 AM Page: 664 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Diltiazem Hydrochloride (Diltiazem Hydrochloride) C Heparin -Fraction, Sodium Salt (Heparin-Fraction, Sodium Salt) C Furosemide (Furosemide) C Isosorbide Mononitrate (Isosorbide Mononitrate) C Pneumococcal Vaccine (Pneumococcal Vaccine0 C Metoprolol Tartrate (Metoprolol Tartrate0 C Ramipril (Ramipril) C Magnesium Oxide (Magnesium Oxide0 C Date:01/03/05ISR Number: 4546317-1Report Type:Expedited (15-DaCompany Report #2004080312 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Geodon (Ziprasidone) PS Other Brain Death Professional Zyrtec (Tablets) Circulatory Collapse Company (Cetirizine) SS Fall Representative Lipitor Loss Of Consciousness (Atorvastatin) SS Post Procedural Ibuprofen Complication (Ibuprofen) SS Oxacarbazepine (Oxcarbazepine) SS Escitalopram (Escitalopram) SS Lorazepam C Metoprolol C Zolpidem Tartrate C Methylphenidate Hydrochloride C Lansoprazole C Date:01/03/05ISR Number: 4546341-9Report Type:Expedited (15-DaCompany Report #2004116594 Age:51 YR Gender:Female I/FU:I Outcome PT Death Bronchitis Acute Hospitalization - Coma Initial or Prolonged Diabetes Mellitus Other Inadequate Control Headache Mania Psychotic Disorder Respiratory Failure Resuscitation 22-Feb-2006 08:32 AM Page: 665 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Therapeutic Response Decreased Wheezing Report Source Product Role Manufacturer Route Dose Duration Health Geodon (Ziprasidone) PS Professional Haloperidol (Haloperidol) SS Valproate Semisodium (Valproate Semisodium) SS Clozapine (Clozapine) SS ORAL 300 MG, ORAL Glimepiride (Glimepiride) C Azithromycin (Azithromycin) C Hydrochlorothiazide (Hydrochlorothiazide ) C Lisinopril (Lisinopril) C Metformin (Metformin) C Date:01/03/05ISR Number: 4546400-0Report Type:Expedited (15-DaCompany Report #2004118673 Age:29 DY Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Extrapyramidal Disorder Foreign Ziprasidone (Caps) Neuroleptic Malignant Study (Ziprasidone) PS ORAL 160 MG (80 Syndrome Health MG, 2 IN 1 Pyrexia Professional D), ORAL Clonazepam (Clonazepam) C Trihexyphenidyl Hydrochloride (Trihexyphenidyl Hydrochloride0 C Phenolphthalein (Phenolphthalein) C All Other Therapeutic Products (All Other Therapeutic Products) C Date:01/03/05ISR Number: 4874337-6Report Type:Direct Company Report #CTU 266028 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Geodon PS ORAL 80 MG BID Chills ORAL; 40 QD Dizziness ORAL Joint Stiffness Movement Disorder Muscle Tightness Musculoskeletal Stiffness Swollen Tongue Tongue Disorder Tremor 22-Feb-2006 08:32 AM Page: 666 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/04/05ISR Number: 4545778-1Report Type:Direct Company Report #USP 57041 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Geodon PS Pfizer CAPSULE Dizziness Drug Toxicity Feeling Abnormal Headache Hypoaesthesia Medication Error Pain Paraesthesia Date:01/05/05ISR Number: 4547184-2Report Type:Expedited (15-DaCompany Report #2004120618 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychomotor Hyperactivity Health Geodon (Ziprasidone) PS Initial or Prolonged Professional Company Representative Date:01/07/05ISR Number: 4549696-4Report Type:Expedited (15-DaCompany Report #2004122049 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Consumer Geodon (Ziprasidone) PS Syndrome Health Professional Date:01/07/05ISR Number: 4550141-3Report Type:Expedited (15-DaCompany Report #2004120692 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Alkaline Health Geodon (Ziprasidone) PS ORAL 40 MG (40 MG, Initial or Prolonged Phosphatase Increased Professional 1 IN 1 D), Other Hepatitis B Surface ORAL Antigen Positive Oxycarbazepine Homicidal Ideation (Oxcarbazepine ) C Escitalopram (Escitalopram) C Benzatropine Mesilate (Benzatropine Mesilate) C Date:01/10/05ISR Number: 4549711-8Report Type:Expedited (15-DaCompany Report #2004098274 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dystonia Health Geodon (Ziprasidone) PS 160 MG (80 Musculoskeletal Stiffness Professional MG, 2 IN 1 D) Torticollis Company Lorazepam Representative (Lorazepam) C 22-Feb-2006 08:32 AM Page: 667 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/10/05ISR Number: 4549718-0Report Type:Expedited (15-DaCompany Report #2004122003 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Grand Mal Convulsion Health Geodon (Im) Other Professional (Ziprasidone) PS 20 MG (1 IN 1) Date:01/10/05ISR Number: 4550107-3Report Type:Expedited (15-DaCompany Report #2005001267 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Geodon (Ziprasidone) PS ORAL 80 MG, ORAL Date:01/10/05ISR Number: 4551274-8Report Type:Expedited (15-DaCompany Report #DSA_25531_2004 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Tavor PS ORAL DF ONCE PO Initial or Prolonged Phosphokinase Increased Health Geodon SS ORAL DF ONCE PO Convulsion Professional Hoggar N SS ORAL DF ONCE PO Multiple Drug Overdose Other Ludiomil SS ORAL DF ONCE PO Intentional Date:01/10/05ISR Number: 4551904-0Report Type:Expedited (15-DaCompany Report #2004027924 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Foreign Ziprasidone Initial or Prolonged Delirium Study (Ziprasidone) PS ORAL SEE IMAGE Disease Recurrence Health Haloperidol Drug Interaction Professional (Haloperidol) SS INTRAMUSCULAR SEE IMAGE Hallucinations, Mixed Clonazepam Paranoia (Clonazepam) C Psychotic Disorder Biperiden (Biperiden) C Date:01/11/05ISR Number: 4551623-0Report Type:Expedited (15-DaCompany Report #2004122009 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Grand Mal Convulsion Health Geodon (Im) Life-Threatening Professional (Ziprasidone) PS INTRAMUSCULAR INTRAMUSCULAR Other Date:01/12/05ISR Number: 4553423-4Report Type:Expedited (15-DaCompany Report #2004030089 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Foreign Zeldox (Capsules) Initial or Prolonged Galactorrhoea Study (Ziprasidone) PS ORAL 140 MG (2 IN Hypersomnia Health 1 D), ORAL Professional Lorazepam (Lorazepam) C Lamotrigine (Lamotrigine) C Valproate Sodium 22-Feb-2006 08:32 AM Page: 668 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Valproate Sodium) C Date:01/12/05ISR Number: 4553425-8Report Type:Expedited (15-DaCompany Report #2004044528 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agitation Foreign Ziprasidone (Caps) Hospitalization - Akathisia Study (Ziprasidone) PS ORAL 100 MG (1 IN Initial or Prolonged Anxiety Health 1 D), ORAL Delirium Professional Clonazepam Homicidal Ideation (Clonazepam) C Hyperhidrosis Impulse-Control Disorder Incontinence Insomnia Nervous System Disorder Psychomotor Hyperactivity Psychotic Disorder Restlessness Sense Of Oppression Suicidal Ideation Date:01/12/05ISR Number: 4553427-1Report Type:Expedited (15-DaCompany Report #2004066278 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychomotor Hyperactivity Foreign Geodon (Ziprasidone) PS ORAL 180 MG (1 IN Initial or Prolonged Study 1 D), ORAL Health Carbamazepine Professional (Carbamazepine) C Biperiden (Biperiden) C Diazepam (Diazepam) C Etilefrine Hydrochloride (Etilefrine Hydrochloride) C Haloperidol (Haloperidol) C Alprazolam (Alprazolam) C Date:01/12/05ISR Number: 4553428-3Report Type:Expedited (15-DaCompany Report #2004050714 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Ziprasidone (Caps) Initial or Prolonged Akathisia Study (Ziprasidone) PS ORAL 40 MG (40 MG, Anxiety Health 1 IN 1 D), Insomnia Professional ORAL Muscle Rigidity Risperidone Psychomotor Hyperactivity (Risperidone) C Biperiden (Biperiden) C 22-Feb-2006 08:32 AM Page: 669 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/13/05ISR Number: 4552988-6Report Type:Expedited (15-DaCompany Report #2005007564 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aortic Disorder Consumer Geodon (Ziprasidone) PS ORAL 20 MG (20 Arterial Disorder MG), ORAL Chest Pain Dehydration Dizziness Gastroenteritis Viral Muscle Spasms Muscle Tightness Date:01/13/05ISR Number: 4553204-1Report Type:Expedited (15-DaCompany Report #2005001680 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Health Geodon (Ziprasidone) PS ORAL 80 MG (40 MG, Confusional State Professional 2 IN 1 D), Sleep Disorder ORAL Thyroid Gland Cancer Alprazolam Weight Increased (Alprazolam) C Zolpidem Tartrate (Zolpidem Tartrate) C Calcium With Vitamin D (Calcium Phosphate, Calcium Sodium Lactate, Ergocalciferol) C Liothyronine Sodium (Liothyronine Sodium) C Trazodone (Trazodone) C Date:01/14/05ISR Number: 4556726-2Report Type:Expedited (15-DaCompany Report #2005003210 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Disease Recurrence Consumer Navane (Capsules) Drug Effect Decreased (Thiothixene) PS ORAL ORAL Feeling Abnormal Geodon (Ziprasidone) SS ORAL 160 MG (80 Hallucination MG, 2 IN 1 Loss Of Consciousness D), ORAL Sertraline Hydrochloride (Sertraline Hydrochloride) C Quetiapine Fumarate (Quetiapine Fumarate) C Valproate Semisodium (Valproate Semisodium) C Trazodone (Trazodone) C 22-Feb-2006 08:32 AM Page: 670 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/18/05ISR Number: 4555351-7Report Type:Direct Company Report #CTU 237037 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pyrexia Ziprasidone 80 Mg PS ORAL 160MG QDORAL Tachycardia Tremor Date:01/18/05ISR Number: 4555370-0Report Type:Direct Company Report #CTU 237026 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hyperhidrosis Seroquel PS 25 MG AM 50MG Hospitalization - Muscle Rigidity PM Initial or Prolonged Neuroleptic Malignant Geodon Inj SS INTRAMUSCULAR 10MG 100MG HS Syndrome IM Tachypnoea Paroxetine C Verapamil C Crestor C Prednisone C Date:01/18/05ISR Number: 4556616-5Report Type:Expedited (15-DaCompany Report #2005004881 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Overdose Consumer Geodon (Ziprasidone) PS Psychotic Disorder All Other Rhabdomyolysis Therapeutic Products Ventricular Tachycardia (All Other Therapeutic Products) SS Date:01/18/05ISR Number: 4556619-0Report Type:Expedited (15-DaCompany Report #2005006101 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aortic Dilatation Consumer Geodon (Ziprasidone) PS 20 MG (20 MG, Initial or Prolonged Chest Discomfort 11 IN 1 D) Other Muscle Spasms Cilest Muscle Tightness (Ethinylestradi9l Muscle Twitching Norgestriamte) C Musculoskeletal Chest Pain Neck Pain Date:01/18/05ISR Number: 4556627-XReport Type:Expedited (15-DaCompany Report #2005003210 Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Disease Recurrence Consumer Navane (Capsules) Feeling Abnormal (Thiothixene) PS ORAL ORAL Hallucination Geodon (Ziprasidone) SS ORAL 160 MG (80 Loss Of Consciousness MG, 2 IN 1 Pharmaceutical Product D), ORAL Complaint Sertraline Treatment Noncompliance Hydrochloride (Sertraline Hydrochloride) C 22-Feb-2006 08:32 AM Page: 671 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Quetiapine Fumarate (Quetiapine Fumarate) C Valproate Semisodium (Valproate Semisodium) C Trazodone (Trazodone) C Date:01/18/05ISR Number: 4556851-6Report Type:Expedited (15-DaCompany Report #ZICO001152 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Aggression Study Prialt (Ziconotide Hospitalization - Agitation Health Intrathecal Initial or Prolonged Blood Creatine Professional Infusion) PS INTRATHECAL 0.0 MCG/HR, Phosphokinase Mb INTRATHECAL Increased Methadone Blood Lactate (Methadone) SS Dehydrogenase Increased Geodon (Geodon) SS Blood Potassium Decreased Actiq (Actiq) C Confusional State Duragesic Patch Electrocardiogram R On T (Fentanyl Patch) C Phenomenon Electrocardiogram St-T Segment Abnormal Electrolyte Imbalance Hallucination Hypoglycaemia Hypotension Immobile Insomnia Leukocytosis Memory Impairment Overdose Paranoia Psychotic Disorder Pulse Absent Rhabdomyolysis Sinus Tachycardia Torsade De Pointes Troponin Increased Ventricular Tachycardia Date:01/18/05ISR Number: 4576606-6Report Type:Periodic Company Report #2004086357 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Health Geodon (Im) Initial or Prolonged Corrected Interval Professional (Ziprasidone) PS INTRAMUSCULAR 10 MG (10 MG, Other Prolonged Company 1 IN 1 D), Representative INTRAMUSCULAR Lisinopril (Lisinopril) C Valproate Semisodium (Valproate Semisodium) C Ezetimibe (Ezetimibe) C 22-Feb-2006 08:32 AM Page: 672 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Atrovastatin (Atorvastatin) C Ramipril (Ramipril) C Acetylsalicylic Acid (Acetylsalicylic Acid) C Donepezil Hydrochloride (Donepezil Hydrochloride) C Risperidone (Riseperidone) C Date:01/18/05ISR Number: 4576607-8Report Type:Periodic Company Report #2004065070 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Health Geodon (Im) Initial or Prolonged Corrected Interval Professional (Ziprasidone) PS INTRAMUSCULAR INTRAMUSCULAR Prolonged Company Representative Date:01/20/05ISR Number: 4559971-5Report Type:Direct Company Report #CTU 237481 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperhidrosis Ziprasidone PS ORAL 80 MG PO Hypotension DAILY [ONE DOSE] Date:01/21/05ISR Number: 4558859-3Report Type:Direct Company Report #CTU 237554 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Accidental Needle Stick Geodon Im 5mg Intervention to Blister Pfizer PS Pfizer INTRAPERICARDIA Prevent Permanent Feeling Abnormal L 5MG X 1 Impairment/Damage Muscle Rigidity DOSE Pain In Extremity INTRAPERIC Secretion Discharge Skin Exfoliation Date:01/21/05ISR Number: 4561409-9Report Type:Expedited (15-DaCompany Report #2005007918 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chest Pain Consumer Geodon (Ziprasidone) PS ORAL 80 MG (40 MG, Drug Withdrawal Syndrome 2 IN 1 D), Insomnia ORAL Morbid Thoughts Tremor 22-Feb-2006 08:32 AM Page: 673 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/21/05ISR Number: 4562992-XReport Type:Expedited (15-DaCompany Report #2005011265 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Infection Foreign Zeldox (Capsules) Rash Generalised Health (Ziprasidone) PS ORAL 40 MG (40 MG, Rash Maculo-Papular Professional 1 IN 1 D), ORAL Venlafaxine Hydrochloride (Venlafaxine Hydrochloride) C Oxazepam (Oxazepam) C Date:01/24/05ISR Number: 4561349-5Report Type:Expedited (15-DaCompany Report #2005014571 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Heart Rate Irregular Health Geodon (Ziprasidone) PS 80 MG (40 MG, Professional 2 IN 1 D) Company Representative Date:01/24/05ISR Number: 4561393-8Report Type:Expedited (15-DaCompany Report #2004072645 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Priapism Health Geodon (Ziprasidone) PS ORAL 80 MG (40 MG, Professional 2 IN 1 D), Company ORAL Representative Navane (Capsules) (Tiotixene) (Thiothixene) SS ORAL 10 MG (5 MG, 2 IN 1 D), ORAL Trazodone Hydrochloride (Trazodone Hydrochloride) SS Benzatropine Mesilate (Benzatropine Mesilate) C Date:01/24/05ISR Number: 4561664-5Report Type:Expedited (15-DaCompany Report #2004112591 Age:39 YR Gender:Female I/FU:F Outcome PT Death Body Temperature Hospitalization - Increased Initial or Prolonged Cardio-Respiratory Arrest Other Coma Electrocardiogram St-T Segment Abnormal Extrapyramidal Disorder Mood Altered Rash Respiratory Rate Increased 22-Feb-2006 08:32 AM Page: 674 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sinus Tachycardia Somnolence Report Source Product Role Manufacturer Route Dose Duration Health Geodon (Im) Professional (Ziprasidone) PS INTRAMUSCULAR SEE IMAGE Haloperidol (Haloperidol) C Benzatropine Mesilate (Benzatropine Mesilate) C Metformin (Metformin) C Lithium (Lithium) C All Other Therapeutic Products (All Other Therapeutic Products) C Lamotrigine (Lamotrigine) C Glipizide (Glipizide) C Insulin (Insulin) C Methylprednisolone (Methylprednisolone) C Date:01/24/05ISR Number: 4562340-5Report Type:Expedited (15-DaCompany Report #2004105231 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrioventricular Block Health Geodon (Ziprasidone) PS First Degree Professional Lithium (Lithium) SS ORAL 1200 MG, ORAL Electrocardiogram Pr Lamotrigine Prolongation (Lamotrigine) C Sinus Bradycardia Date:01/25/05ISR Number: 4563654-5Report Type:Expedited (15-DaCompany Report #2005012790 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Foreign Zeldox (Capsules) Seminoma Health (Ziprasidone) PS ORAL 160 MG, ORAL 1 YR Professional Alprazolam Company (Alprazolam) C Representative Date:01/25/05ISR Number: 4565343-XReport Type:Direct Company Report #CTU 237765 Age:9 YR Gender:Male I/FU:I Outcome PT Life-Threatening Aggression Required Agitation Intervention to Bundle Branch Block Right Prevent Permanent Electrocardiogram Qt Impairment/Damage Corrected Interval Prolonged Electrocardiogram Qt 22-Feb-2006 08:32 AM Page: 675 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prolonged Sinus Arrhythmia Sinus Bradycardia Report Source Product Role Manufacturer Route Dose Duration Geodon 40mg Caps And 20mg Vial PS Pfizer 40MG PO /10 MG PO BID /IMSTAT Clonidine 0.1mg SS ORAL 0.2 MG HS ORAL Date:01/25/05ISR Number: 4565479-3Report Type:Direct Company Report #CTU 237843 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Decreased Geodon 20mg PS ORAL 20MG PO ORAL Zoloft C Topomax C Date:01/25/05ISR Number: 4570116-8Report Type:Direct Company Report #CTU 237860 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alopecia Geodon 80 Mg Pfizer Hypertension V7#6 PS Pfizer 80 MG P.M. Lymphadenopathy Pollakiuria Respiratory Disorder Thirst Date:01/26/05ISR Number: 4565045-XReport Type:Expedited (15-DaCompany Report #2004025652 Age:17 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcohol Poisoning Foreign Ziprasidone (Caps) Initial or Prolonged Health (Ziprasidone) PS ORAL 40 MG (1 IN 1 Professional D), ORAL Ethanol (Ethanol) SS Date:01/26/05ISR Number: 4566324-2Report Type:Direct Company Report #CTU 238134 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tachycardia Geodon Im 20mg Pfizer PS Pfizer INTRAVENOUS 40MG Q8H INTRAVENOU Date:01/26/05ISR Number: 4566520-4Report Type:Direct Company Report #USP 57044 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Geodon PS Pfizer INJECTABLE 22-Feb-2006 08:32 AM Page: 676 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/26/05ISR Number: 4566529-0Report Type:Direct Company Report #CTU 238150 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Ziprasodone 20mg Initial or Prolonged Pfizer PS Pfizer ORAL 20MG TWO Required TIMES/DAY Intervention to ORAL Prevent Permanent Temazepam C Impairment/Damage Aripiprazole C Cocaine C Marijuana C Date:01/26/05ISR Number: 4566686-6Report Type:Expedited (15-DaCompany Report #2004102407 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Geodon (Ziprasidone) PS ORAL 1 IN 1 D, Initial or Prolonged Grand Mal Convulsion Professional ORAL Other Hallucination, Auditory Other Clonazepam Required Movement Disorder (Clonazepam) C Intervention to Risperidone Prevent Permanent (Risperidone) C Impairment/Damage Date:01/26/05ISR Number: 4566697-0Report Type:Expedited (15-DaCompany Report #2004076089 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Geodon (Ziprasidone) PS Professional Diazepam (Diazepam) C Company Representative Date:01/27/05ISR Number: 4567266-9Report Type:Expedited (15-DaCompany Report #2005015050 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Macrocytic Literature Ziprasidone (Caps) Full Blood Count Health (Ziprasidone) PS ORAL 120 MG, ORAL Decreased Professional Quetiapine Macrocytosis (Quetiapine) SS ORAL 600 MG, ORAL Myelodysplastic Syndrome Date:01/27/05ISR Number: 4567295-5Report Type:Expedited (15-DaCompany Report #2005014959 Age: Gender:Male I/FU:I Outcome PT Hospitalization - Anxiety Initial or Prolonged Balance Disorder Bipolar Disorder Blood Potassium Increased Blood Pressure Increased Bronchitis Condition Aggravated Crying Depression Difficulty In Walking 22-Feb-2006 08:32 AM Page: 677 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dizziness Fatigue Muscle Spasms Report Source Product Role Manufacturer Route Dose Duration Consumer Neurontin (Gabapentin) PS Geodon (Ziprasidone) SS ORAL 120 MG ORAL Gabapentin (Gabapentin) SS Buspirone Hydrochloride (Buspirone Hydrochloride) SS Olanzapine (Olanzapine) SS All Other Non-Therapeutic Products SS Diphenhydramine Hydrochloride C Clomipramine C Pantoprazole C Metoprolol (Metoprolol) C Amlodipine Besilate (Amlodipine Besilate) C Valsartan (Valsartan) C Pravastatin Sodium (Pravastatin Sodium) C Triamcinolone (Triamcinolone) C Ciclopirox Olamine (Ciclopirox Olamine) C Miconazole (Miconazole) C Date:01/27/05ISR Number: 4567751-XReport Type:Expedited (15-DaCompany Report #2004093147 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Zeldox Health (Capsules)(Ziprasido Professional ne) PS 22-Feb-2006 08:32 AM Page: 678 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/31/05ISR Number: 4568316-6Report Type:Expedited (15-DaCompany Report #2005015230 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Foreign Zeldox (Capsules) Delusion Health (Ziprasidone) PS ORAL 40 MG (40 MG, Professional 1 IN 1 D), ORAL Moclobemide (Moclobemide) C Rosuvastatin (Rosuvastatin) C Deanol (Deanol) C Diclofenac (Diclofenac) C Magnesium (Magnesium) C Ascorbic Acid (Ascorbic Acid) C Date:01/31/05ISR Number: 4569769-XReport Type:Expedited (15-DaCompany Report #2005001267 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Road Traffic Accident Consumer Geodon (Ziprasidone) PS ORAL 80 MG, ORAL Date:01/31/05ISR Number: 4569789-5Report Type:Expedited (15-DaCompany Report #2005014764 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Female Health Geodon (Ziprasidone) PS Thyroid Gland Cancer Professional Date:01/31/05ISR Number: 4601863-7Report Type:Periodic Company Report #200419094US Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Nervousness Health Telithromycin Professional (Ketek) PS 800 MG 6 DAY Ziprasidone Hydrochloride (Geodon) SS 60 MG BID 1 YR Date:02/02/05ISR Number: 4571141-3Report Type:Expedited (15-DaCompany Report #2005019468 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Alcohol Increased Foreign Zeldox (Capsules) Other Cardiac Disorder Health (Ziprasidone) PS ORAL ORAL Cardiomegaly Professional Ethanol (Ethanol) SS Hepatic Steatosis Company Candesartan Myocardial Fibrosis Representative Cilexetil C Metoprolol Tartrate C 22-Feb-2006 08:32 AM Page: 679 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/02/05ISR Number: 4571800-2Report Type:Expedited (15-DaCompany Report #2004122009 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Grand Mal Convulsion Health Geodon (Im) Life-Threatening Professional (Ziprasidone) PS INTRAMUSCULAR INTRAMUSCULAR Other Date:02/02/05ISR Number: 4572033-6Report Type:Expedited (15-DaCompany Report #2004122003 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Grand Mal Convulsion Health Geodon (Im) Other Professional (Ziprasidone) PS INTRAMUSCULAR 20 MG (1 IN 1), INTRAMUSCULAR Date:02/02/05ISR Number: 4578362-4Report Type:Direct Company Report #CTU 238888 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Ziprasidone (Geodon) PS ORAL 160 MG PO BID Initial or Prolonged Gait Disturbance Zyprexa C Muscle Spasticity Depakote C Muscular Weakness Refusal Of Treatment By Patient Treatment Noncompliance Date:02/04/05ISR Number: 4574080-7Report Type:Expedited (15-DaCompany Report #2005020134 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pyrexia Health Geodon (Ziprasidone) PS Other Professional All Otehr Company Therapeutic Products Representative (All Other Therapeutic Products) C Date:02/04/05ISR Number: 4574426-XReport Type:Expedited (15-DaCompany Report #2004101239 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bipolar Disorder Consumer Geodon (Ziprasidone) PS PARENTERAL SEE IMAGE Initial or Prolonged Bone Disorder Health Lithium (Lithium) SS ORAL ORAL Chest Pain Professional Disease Recurrence Dyspepsia Musculoskeletal Pain Oesophageal Pain Palpitations Pollakiuria Stress Tooth Disorder 22-Feb-2006 08:32 AM Page: 680 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/04/05ISR Number: 4574546-XReport Type:Expedited (15-DaCompany Report #2005018072 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Consumer Geodon (Ziprasidone) PS ORAL 100 MG (1 IN Convulsion 1 D), ORAL Drug Ineffective Valproate Semisodium Dyskinesia (Valproate Fatigue Semisodium) C Hypothalamo-Pituitary Topiramate Disorders (Topiramate) C Menstruation Irregular Movement Disorder Muscle Spasms Musculoskeletal Stiffness Road Traffic Accident Somnolence Thyroid Mass Tremor Date:02/04/05ISR Number: 4575873-2Report Type:Expedited (15-DaCompany Report #2005020720 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Breech Presentation Foreign Zeldox (Capsules) Initial or Prolonged Caesarean Section Health (Ziprasidone) PS ORAL 80 MG, ORAL Other Drug Exposure During Professional Pregnancy Pregnancy Date:02/04/05ISR Number: 4576157-9Report Type:Expedited (15-DaCompany Report #2005020730 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Atrioventricular Block Foreign Zeldox Hospitalization - Left Ventricular Failure Health (Ziprasidone) PS ORAL 80 MG, ORAL Initial or Prolonged Professional Date:02/04/05ISR Number: 4598273-8Report Type:Periodic Company Report #PHEH2004US05437 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clozaril (Clozapine) Feeling Abnormal Professional Tablet PS ORAL 100 MG, TID ; Sedation 75MG Somnolence BID+100MG, HS : ORAL Geodon (Ziprasisone Hydrochloride) SS 60 MG ; 40 MG Klonopin (Clonazepam) C Lithobid (Lithium Carbonate) C Cogentin (Benzatropine Mesilate) C Lexapro (Escitalopram Oxalate) C 22-Feb-2006 08:32 AM Page: 681 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/04/05ISR Number: 4598304-5Report Type:Periodic Company Report #PHEH2004US06394 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Disorientation Consumer Clozaril Initial or Prolonged (Clozapine)Tablet PS ORAL ORAL Geodon (Ziprasidone Hydrochloride) SS ORAL ORAL Date:02/07/05ISR Number: 4576440-7Report Type:Expedited (15-DaCompany Report #2005019468 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hyperlipidaemia Foreign Zeldox (Capsules) Other Health (Ziprasidone) PS ORAL 20 MG (20 MG, Professional 1 IN 1 D), Company ORAL Representative Ethanol (Ethanol) SS Candesartan Cilexetil (Candesartan Cilexetil) C Metoprolol Tartrate (Metoprolol Tartrate) C Date:02/07/05ISR Number: 4576494-8Report Type:Expedited (15-DaCompany Report #2005AC00142 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Anaemia Macrocytic Literature Quetiapine PS ORAL 600 MG DAILY Intervention to Blood Disorder Health PO Prevent Permanent Blood Test Abnormal Professional Quetiapine SS ORAL 600 MG DAILY Impairment/Damage Myelodysplastic Syndrome PO Ziprasidone SS ORAL 40 MG DAILY PO Ziprasidone SS 120 MG DAILY PAR Date:02/07/05ISR Number: 4576786-2Report Type:Expedited (15-DaCompany Report #2005019479 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Myocardial Infarction Health Geodon (Ziprasidone) PS Professional Company Representative Date:02/07/05ISR Number: 4578660-4Report Type:Direct Company Report #CTU 239405 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Bradycardia Geodon 60 Mg Pfizer PS Pfizer ORAL 1 CAPSULE TWICE DAILY ORAL 22-Feb-2006 08:32 AM Page: 682 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/08/05ISR Number: 4577208-8Report Type:Expedited (15-DaCompany Report #2005020573 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Health Geodon (Ziprasidone) PS ORAL (20 MG, 2 IN Initial or Prolonged Myoclonus Professional 1 D), Other ORAL/31MAY - 02JUN Quetiapine Fumarate (Quetiapine Fumarate) C Venlafaxine Hydrochloride (Venlafaxine Hydrochloride) C Clonazepam (Clonazepam) C Gabapentin (Gabapentin) C Citalopram Hydrobromide (Citalopram Hydrobromide) C Levothyroxine Sodium (Levothyroxine Sodium) C Omeprazole (Omeprazole) C Trimethobenzamide (Trimethobenzamide) C Carbamazepine (Carbamazepine) C Date:02/08/05ISR Number: 4577209-XReport Type:Expedited (15-DaCompany Report #2005021161 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination Health Geodon (Ziprasidone) PS 160 MG Initial or Prolonged Professional All Other Company Therapeutic Products Representative (All Other Therapeutic Products) SS Date:02/08/05ISR Number: 4577550-0Report Type:Expedited (15-DaCompany Report #2005021159 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Ziprasidone Initial or Prolonged Schizophrenia Health Tachycardia Professional (Ziprasidone) PS Ventricular Arrhythmia Date:02/09/05ISR Number: 4575662-9Report Type:Expedited (15-DaCompany Report #DE-GLAXOSMITHKLINE-D0045821A Age:65 YR Gender:Female I/FU:I Outcome PT Hospitalization - Drug Interaction Initial or Prolonged Dystonia 22-Feb-2006 08:32 AM Page: 683 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Extrapyramidal Disorder Gait Disturbance Pleurothotonus Report Source Product Role Manufacturer Route Dose Duration Quilonum Retard PS Glaxosmithkline 675MG per day Zeldox SS UNKNOWN 80MG per day 14 DAY Remergil SS UNKNOWN 30MG per day Tavor C UNKNOWN .5MG per day 272 DAY Date:02/09/05ISR Number: 4578022-XReport Type:Expedited (15-DaCompany Report #2004112572 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drug Ineffective Foreign Zeldox (Capsules) Hospitalization - Dysarthria Health (Ziprasidone) PS ORAL 150 MG (25 MG Initial or Prolonged Fall Professional QID) ORAL Other Fatigue Company Hyponatraemia Representative Mania Memory Impairment Polydipsia Water Intoxication Date:02/09/05ISR Number: 4579307-3Report Type:Expedited (15-DaCompany Report #2004112390 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrioventricular Block Health Geodon (Ziprasidone) PS Initial or Prolonged First Degree Professional Zoloft (Sertraline) SS Other Blood Pressure Decreased Blood Pressure Increased Breast Cancer Coronary Artery Disease Depressed Level Of Consciousness Feeling Abnormal Femur Fracture Heart Rate Increased Heart Rate Irregular Thrombosis Date:02/11/05ISR Number: 4583507-6Report Type:Expedited (15-DaCompany Report #2004097604 Age:10 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Health Geodon (Ziprasidone) PS ORAL 80 MG (80 MG, Diabetes Mellitus Professional 1 IN 1 D), Insulin-Dependent Company ORAL Representative Bupropion Hydrochloride (Bupropion Hydrochloride) C 22-Feb-2006 08:32 AM Page: 684 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/11/05ISR Number: 4584681-8Report Type:Expedited (15-DaCompany Report #2005021639 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Health Geodon (Ziprasidone) PS Syndrome Professional Company Representative Date:02/11/05ISR Number: 4584710-1Report Type:Expedited (15-DaCompany Report #2005022933 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Health Geodon (Ziprasidone) PS ORAL 120 MG (BID Initial or Prolonged Prolonged Professional INTEVAL: Other Palpitations EVERY DAY), Suicidal Ideation ORAL Alprazolam (Alprazolam) C Risperidone (Risperidone) C Venlafaxine Hydrochloride (Venlafaxine Hydrochloride) C Date:02/14/05ISR Number: 4581016-1Report Type:Periodic Company Report #US-GLAXOSMITHKLINE-A0518813A Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Rash Lamictal PS Glaxosmithkline ORAL 100MG Per day 1 YR Geodon SS UNKNOWN 120MG Per day Xanax C UNKNOWN 3MG Per day Wellbutrin Xl C Glaxosmithkline ORAL 150MG Per day Temazepam C UNKNOWN 30MG Per day Depakote C Date:02/14/05ISR Number: 4581515-2Report Type:Periodic Company Report #US-GLAXOSMITHKLINE-A0533086A Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Attention Lamictal PS Glaxosmithkline ORAL 100MG Twice Deficit/Hyperactivity per day 5 MON Disorder Geodon SS 3 MON Date:02/14/05ISR Number: 4585340-8Report Type:Expedited (15-DaCompany Report #2005019479 Age:70 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Failure Health Geodon (Ziprasidone) PS Congestive Professional Myocardial Infarction Company Representative 22-Feb-2006 08:32 AM Page: 685 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/14/05ISR Number: 4585431-1Report Type:Expedited (15-DaCompany Report #2004112591 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Affective Disorder Health Geodon (Im) Hospitalization - Body Temperature Professional (Ziprasidone) PS INTRAMUSCULAR SEE IMAGE Initial or Prolonged Increased Haloperidol Other Cardio-Respiratory Arrest (Haloperidol) C Coma Benzatropine Crying Mesilate Electrocardiogram St-T (Benzatropine Segment Abnormal Mesilate) C Extrapyramidal Disorder Metformin Psychotic Disorder (Metformin) C Rash Lithium (Lithium) C Respiratory Rate All Other Increased Therapeutic Products Sinus Tachycardia (All Other Somnolence Therapeutic Prdoucts) C Lamotrigine (Lamotrigine) C Glipizide (Glipizide) C Insulin (Insulin) C Methylprednisolone (Methylprednisolone) C Date:02/14/05ISR Number: 4586487-2Report Type:Expedited (15-DaCompany Report #2005020581 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Tardive Dyskinesia Foreign Zeldox (Capsules) Initial or Prolonged Health (Ziprasidone) PS ORAL 80 MG (40 MG, Professional 2 IN 1 D), Company ORAL Representative Mirtazapine (Mirtazapine) C Lormetazepam (Lormetazepam) C Date:02/14/05ISR Number: 4586755-4Report Type:Expedited (15-DaCompany Report #2005024463 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pruritus Consumer Geodon (Ziprasidone) PS ORAL 20 MG (20 MG, Rash Erythematous 1 IN 1 D), Skin Burning Sensation ORAL Urticaria Generalised Metoprolol Succinate (Metoprolol Succinate) SS All Other Therapeutic Products (All Other Therapeutic Products) SS Cefazolin Sodium (Cefazolin Sodium) SS Alprazolam (Alprazolam) C 22-Feb-2006 08:32 AM Page: 686 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Zolpidem Tartrate (Zolpidem Tartrate) C Date:02/15/05ISR Number: 4587490-9Report Type:Expedited (15-DaCompany Report #2005025143 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Health Geodon (Ziprasidone) PS ORAL ORAL Initial or Prolonged Corrected Interval Professional Other Prolonged Company Overdose Representative Suicide Attempt Date:02/15/05ISR Number: 4587492-2Report Type:Expedited (15-DaCompany Report #2005025408 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Consumer Geodon (Ziprasidone) PS ORAL 80 MG (40 MG, Drug Ineffective 2 IN 1 D), Neutropenia ORAL Neutrophil Count Zoloft (Sertraline) SS ORAL 50 MG (50 MG, Decreased 1 IN 1 D), White Blood Cell Count ORAL Decreased Mirtazapine (Mirtazapine) SS Bupropion Hydrochloride (Bupropion Hydrochloride) C Date:02/16/05ISR Number: 4588803-4Report Type:Expedited (15-DaCompany Report #2005028239 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Health Geodon (Ziprasidone) PS ORAL 160 MG (1 IN Professional 1 D), ORAL Company Representative Date:02/16/05ISR Number: 4588811-3Report Type:Expedited (15-DaCompany Report #2005025716 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Difficulty In Walking Health Geodon (Ziprasidone) PS ORAL 20 MG (2 IN 1 Initial or Prolonged Tremor Professional D), ORAL Company Valproate Semisodium Representative (Valproate Semisodium) SS ORAL SEE IMAGE Levothyroxine Sodium (Levothyroxine Sodium) C Propranolol Hydrochloride (Propranolol Hydrochloride) C Carbidopa/Entacapone /Levodopa Carbidopa, 22-Feb-2006 08:32 AM Page: 687 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Entacapone, Levodopa) C Date:02/16/05ISR Number: 4588812-5Report Type:Expedited (15-DaCompany Report #2004105547 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Catatonia Health Geodon (Ziprasidone) PS INTRAMUSCULAR SEE IMAGE Initial or Prolonged Dehydration Professional Valproate Semisodium Other Neuroleptic Malignant Company (Valproate Syndrome Representative Semisodium) C Renal Failure Acute Lorazepam Schizophrenia, Catatonic (Lorazepam) C Type White Blood Cell Count Increased Date:02/16/05ISR Number: 4588839-3Report Type:Expedited (15-DaCompany Report #2004102186 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Chloride Decreased Health Geodon (Ziprasidone) PS ORAL 80 MG (20 MG, Other Blood Magnesium Increased Professional 4 IN 1 D), Blood Sodium Increased ORAL Renal Failure Cyanocobalamin Ventricular Extrasystoles (Cyanocobalamin) C Ranitidine Hydrochloride (Ranitidine Hydrochloride) C Senna Fruit (Senna Fruit) C Hydrochlorothiazide (Hydrochlorothiazide ) C Magnesium Hydroxide (Magnesium Hydroxide) C Tocopherol (Tocopherol) C Potassium Chloride (Potassium Chloride) C All Other Therapeutic Products (All Other Therapeutic Products) C Mirtazapine (Mirtazapine) C Quetiapine Fumarate (Quetiapine Fumarate) C Date:02/16/05ISR Number: 4588913-1Report Type:Expedited (15-DaCompany Report #2005025709 Age:30 YR Gender:Female I/FU:I Outcome Hospitalization - Initial or Prolonged 22-Feb-2006 08:32 AM Page: 688 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other PT Report Source Product Role Manufacturer Route Dose Duration Cerebral Thrombosis Health Geodon (Ziprasidone) PS ORAL 20 MG (20 MG, Convulsion Professional 1 IN 1 D), ORAL Levothyroxine Sodium (Levothyroxine Sodium) C Oral Contraceptive Nos (Oral Contraceptive Nos) C Date:02/17/05ISR Number: 4590124-0Report Type:Expedited (15-DaCompany Report #2004090802 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alcohol Use Foreign Zeldox (Capsules) Anxiety Health (Ziprasidone) PS ORAL 160 MG (80 Electrocardiogram Qt Professional MG, 2 IN 1 Prolonged Other D), ORAL Fall Zopiclone Hallucinations, Mixed (Zopiclone) SS ORAL ORAL Head Injury Oxazepam (Oxazepam) SS ORAL ORAL Sleep Disorder Ethanol (Ethanol) SS ORAL ORAL Sudden Cardiac Death Olanzapine Treatment Noncompliance (Olanzapine) C Warfarium Sodium (Warfarin Sodium) C Date:02/17/05ISR Number: 4590228-2Report Type:Expedited (15-DaCompany Report #2005025408 Age:19 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Consumer Geodon (Ziprasidone) PS ORAL 80 MG (40 MG, Drug Ineffective 2 IN 1 D), Neutropenia ORAL Zoloft (Sertraline) SS ORAL 50 MG (50 MG, 1 IN 1 D), ORAL Mirtazapine (Mirtazapine) SS Bupropion Hydrochloride (Bupropion Hydrochloride) C Date:02/22/05ISR Number: 4590980-6Report Type:Direct Company Report #CTU 241000 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cardiac Disorder Geodon Pfizer PS Pfizer 150 MG Intervention to Hyperhidrosis Prevent Permanent Insomnia Impairment/Damage Loss Of Consciousness Muscle Spasms Palpitations 22-Feb-2006 08:32 AM Page: 689 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/22/05ISR Number: 4590987-9Report Type:Direct Company Report #CTU 240995 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Zisprasidone PS ORAL 60 MG BID Initial or Prolonged ORAL Colace C Folic Acid C Asa C Multivitamin C Prevacid C Celexa C Neurontin C Depakote C Date:02/22/05ISR Number: 4591488-4Report Type:Expedited (15-DaCompany Report #2005027347 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Torsade De Pointes Health Geodon (Ziprasidone) PS 140 MG (2 IN Professional 1 D) Company Representative Date:02/22/05ISR Number: 4591497-5Report Type:Expedited (15-DaCompany Report #2005028371 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Serotonin Syndrome Consumer Zoloft (Sertraline) PS 200 MG Health Geodon (Ziprasidone) SS Professional Date:02/22/05ISR Number: 4591524-5Report Type:Expedited (15-DaCompany Report #2005027310 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Health Geodon (Ziprasidone) PS ORAL 120 MG (60 Professional MG, 2 IN 1 D) ORAL Olanzapine C Lithium C Valproate Semisodium C Date:02/22/05ISR Number: 4591527-0Report Type:Expedited (15-DaCompany Report #2005026763 Age:12 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Foreign Zeldox (Capsules) Syndrome Health (Ziprasidone) PS ORAL 120 MG (2 IN Professional 1 D),ORAL Company Representative 22-Feb-2006 08:32 AM Page: 690 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/22/05ISR Number: 4591619-6Report Type:Expedited (15-DaCompany Report #2005026985 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Geodon (Ziprasidone) PS ORAL ORAL Initial or Prolonged Extrapyramidal Disorder Health Psychotic Disorder Professional Company Representative Date:02/22/05ISR Number: 4591936-XReport Type:Expedited (15-DaCompany Report #2004114895 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Abuser Health Geodon (Im) Other Overdose Professional (Ziprasidone) PS Sudden Death Company Haloperidol Representative (Haloperidol) SS Cocaine (Cocaine) SS Date:02/22/05ISR Number: 4591951-6Report Type:Expedited (15-DaCompany Report #2005014571 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Heart Rate Irregular Health Geodon (Ziprasidone) PS 80 MG (40 MG, Professional 2 IN 1 D), Company Representative Date:02/22/05ISR Number: 4592731-8Report Type:Expedited (15-DaCompany Report #2005027771 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Disease Recurrence Consumer Zeldox (Capsules) Initial or Prolonged Dizziness (Ziprasidone) PS ORAL 20 MG (20 MG, Treatment Noncompliance 1 IN 1 D), ORAL Valproic Acid (Valproic Acid) C Date:02/23/05ISR Number: 4595017-0Report Type:Expedited (15-DaCompany Report #2003010421 Age:76 YR Gender:Female I/FU:F Outcome PT Other Arrhythmia Atrial Fibrillation Dilatation Atrial Electrocardiogram Abnormal Electrocardiogram Qt Corrected Interval Prolonged Electrocardiogram Qt Prolonged Electrocardiogram Repolarisation Abnormality Electrocardiogram St 22-Feb-2006 08:32 AM Page: 691 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Segment Abnormal Electrocardiogram St Segment Depression Electrocardiogram T Wave Report Source Product Role Manufacturer Route Dose Duration Abnormal Health Geodon Electrocardiogram T Wave Professional (Ziprasidone) PS ORAL 40 MG (2 IN 1 Inversion Company D), ORAL Heart Injury Representative Amiodarone Myocardial Ischaemia Hydrochloride Sinus Bradycardia (Amiodarone Torsade De Pointes Hydrochloride) SS Ventricular Extrasystoles Acetylsalicylic Acid C Ventricular Hypertrophy Diltiazem Hydrochloride C Heparin-Fraction, Sodium Salt C Furosemide C Isosorbide Mononitrate C Penumococcal Vaccine C Metoprolol Tartrate C Ramipril C Magnesium Oxide C Date:02/23/05ISR Number: 4595059-5Report Type:Expedited (15-DaCompany Report #2005027347 Age:65 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Stress Test Health Geodon (Ziprasidone) PS 140 MG (2 IN Initial or Prolonged Abnormal Professional 1 D) Other Coronary Artery Occlusion Company Electrocardiogram Qt Representative Prolonged Monoplegia Torsade De Pointes Troponin Increased Date:02/23/05ISR Number: 4595065-0Report Type:Expedited (15-DaCompany Report #2004040658 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Beta Haemolytic Health Geodon (Ziprasidone) PS ORAL (2 IN 1 D), Hospitalization - Streptococcal Infection Professional ORAL Initial or Prolonged Cardiac Arrest Company Trazodone Other Cardio-Respiratory Arrest Representative (Trazodone) C Electrocardiogram Qt Corrected Interval Prolonged Pyrexia Ventricular Extrasystoles Date:02/23/05ISR Number: 4595151-5Report Type:Expedited (15-DaCompany Report #2004090465 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drowning Consumer Geodon (Ziprasidone) PS Other Quetiapine Fumarate (Quetiapine Fumarate) C 22-Feb-2006 08:32 AM Page: 692 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Anti-Diabetics (Anti-Diabetics) C Date:02/24/05ISR Number: 4595206-5Report Type:Expedited (15-DaCompany Report #2005027310 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Health Geodon Professional (Ziprasidone) PS ORAL 120 MG (60 MG, 2 IN 1 D), ORAL Olanzapine (Olanzapine) C Lithium (Lithium) C Valproate Semisodium (Valproate Semisodium) C Date:02/24/05ISR Number: 4595222-3Report Type:Expedited (15-DaCompany Report #2005029648 Age:40 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Geodon (Ziprasidone) PS ORAL ORAL Professional Company Representative Date:02/24/05ISR Number: 4595703-2Report Type:Expedited (15-DaCompany Report #2005026763 Age:12 YR Gender:Unknown I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Foreign Zeldox (Capsules) Muscle Rigidity Health (Ziprasidone) PS ORAL 120 MG (2 IN Pyrexia Professional 1 D) ORAL Company Representative Date:02/24/05ISR Number: 4595723-8Report Type:Expedited (15-DaCompany Report #2005019468 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Foreign Zeldox (Capsules) Other Cardiomegaly Health (Ziprasidone) PS ORAL 20 MG (20 MG Hepatic Steatosis Professional 1 IN 1 D), Myocardial Fibrosis Company ORAL Representative Ethanol (Ethanol) SS Candesartan Cilexetil (Candesartan Cilexetil) C Metoprolol Tartrate (Metoprolol Tartrate) C 22-Feb-2006 08:32 AM Page: 693 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/24/05ISR Number: 4595774-3Report Type:Expedited (15-DaCompany Report #A044-002-005478 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Aricept (Donepezil Initial or Prolonged Haemodialysis Health Hydrochloride) PS ORAL 10 MG, 1 IN 1 Neuroleptic Malignant Professional D, ORAL Syndrome Seroquel (Quetiapine Renal Failure Acute Fumarate) SS 400 MG Rhabdomyolysis Tavor (Lorazepam) SS 6 MG Thombran (Trazodone Hydrochloride) SS 400 MG Quilonum (Lithium Acetate) SS 675 MG Zyprexa (Olanzapine) SS 20 MG Zeldox (Ziprasidone Hydrochloride) SS 80 MG Haldol (Haloperidol) SS 6 MG Date:02/24/05ISR Number: 4595787-1Report Type:Expedited (15-DaCompany Report #2005011557 Age:24 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Foreign Zeldox (Capsules) Initial or Prolonged Hypokinesia Health (Ziprasidone) PS ORAL 160 MG (80 Other Intentional Overdose Professional MG, 2 IN 1 Muscle Rigidity Company D), ORAL Psychotic Disorder Representative Valproate Sodium Restlessness (Valproate Sodium) C Suicide Attempt Quetiapine Fumarate Tremor (Quetiapine Fumarate) C Valproic Acid (Valproic Acid) C Quetiapine (Quetiapine) C Date:02/28/05ISR Number: 4596331-5Report Type:Expedited (15-DaCompany Report #2005PK00290 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anuria Foreign Seroquel PS ORAL 400 MG DAILY Initial or Prolonged Blood Creatinine Health PO Required Increased Professional Tavor SS 6 MG DAILY Intervention to Drug Interaction Other Thombran SS 400 DAILY Prevent Permanent Haemodialysis Aricept SS 10 MG DAILY Impairment/Damage Neuroleptic Malignant Zeldox /Gfr/ SS 80 MG DAILY Syndrome Haldol "Janssen" SS 6 MG DAILY Renal Failure Acute Rhabdomyolysis Date:02/28/05ISR Number: 4596429-1Report Type:Expedited (15-DaCompany Report #2004022047 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Death Sudden Death Foreign Other Health Professional Company 22-Feb-2006 08:32 AM Page: 694 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Representative Product Role Manufacturer Route Dose Duration Ziprasidone (Caps) (Ziprasidone) PS Chlorpromazine Hydrochloride SS Date:02/28/05ISR Number: 4596431-XReport Type:Expedited (15-DaCompany Report #2005017952 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Foreign Zeldox (Capsules) Initial or Prolonged Bradycardia Health (Ziprasidone) PS ORAL 200 MG (2 IN Condition Aggravated Professional 1 D), ORAL Dizziness Company Clozapine Schizophrenia Representative (Clozapine) SS Suicidal Ideation Buspirone C Date:02/28/05ISR Number: 4596624-1Report Type:Expedited (15-DaCompany Report #2005020863 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Health Geodon (Im) Hospitalization - Dyspnoea Professional (Ziprasidone) PS INTRAMUSCULAR (10 MG), Initial or Prolonged Iatrogenic Injury Company INTRAMUSCULAR Other Unevaluable Event Representative Benadryl (Diphenhydramine Hydrochloride) (Diphenhydramine) SS Levofloxacin (Levofloxacin) C Rivastigmine Tartrate (Rivastigmine Tartrate) C Date:02/28/05ISR Number: 4596663-0Report Type:Expedited (15-DaCompany Report #2005030482 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Sodium Decreased Health Geodon (Ziprasidone) PS 80 MG Dysarthria Professional Bupropion Dyspnoea Company Hydrochloride Haemoglobin Decreased Representative (Bupropion Swollen Tongue Hydrochloride C Lamotrigine (Lamotrigine) C Carvedilol (Carvedilol) C Valsartan (Valsartan) C 22-Feb-2006 08:32 AM Page: 695 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/05ISR Number: 4596989-0Report Type:Expedited (15-DaCompany Report #2005029832 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Movement Disorder Health Geodon (Ziprasidone) PS 160 MG Initial or Prolonged Tardive Dyskinesia Professional Obetrol (Amfetamine Company Aspartate, Representative Amfetamine Sulfate, Dexamfetamine Saccharate, C Valproate Semisodium (Valproate Semisodium) C Date:02/28/05ISR Number: 4597003-3Report Type:Expedited (15-DaCompany Report #2005031822 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Health Geodon (Ziprasidone) PS Victim Of Crime Professional Duloxetine Company Hydrochloride Representative (Duloxetine Hydrochloride) SS Date:02/28/05ISR Number: 4597006-9Report Type:Expedited (15-DaCompany Report #2005031774 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pancreatitis Health Geodon (Ziprasidone) PS 320 MG Professional Valproate Semisodium Company (Valproate Representative Semisodium) SS Date:03/01/05ISR Number: 4598222-2Report Type:Direct Company Report #CTU 241681 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Geodon Unknown Hospitalization - Overdose Unknown PS ORAL ORAL Initial or Prolonged Paxil C Trazadone C Date:03/01/05ISR Number: 4598845-0Report Type:Expedited (15-DaCompany Report #2004113171 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Fatigue Health Geodon (Ziprasidone) PS Supraventricular Professional Tachycardia Company Representative Date:03/01/05ISR Number: 4598869-3Report Type:Expedited (15-DaCompany Report #2005030771 Age: Gender:Male I/FU:I Outcome Hospitalization - Initial or Prolonged 22-Feb-2006 08:32 AM Page: 696 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other PT Report Source Product Role Manufacturer Route Dose Duration Condition Aggravated Health Geodon (Ziprasidone) PS ORAL 80 MG (40 MG, Grand Mal Convulsion Professional 2 IN 1 D), Hallucination ORAL Nicotine (Nicotine) C Lorazepam (Lorazepam) C Date:03/03/05ISR Number: 4599297-7Report Type:Direct Company Report #CTU 241998 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Geodon PS ORAL 40 MG / 60 MG Blood Prolactin Increased QAM / QPM ORAL Risperdal C Date:03/04/05ISR Number: 4600527-3Report Type:Expedited (15-DaCompany Report #2004092442 Age:16 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Heart Rate Irregular Health Geodon (Ziprasidone) PS ORAL (2 IN 1 D), Palpitations Professional ORAL Weight Decreased Company Methylphenidate Weight Increased Representative Hydrochloride (Methylphenidate Hydrochloride) C Escitalopram (Escitalopram) C Date:03/04/05ISR Number: 4600577-7Report Type:Expedited (15-DaCompany Report #2002071345 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Insomnia Foreign Ziprasidone (Caps) Initial or Prolonged Sleep Disorder Study (Ziprasidone) PS ORAL 80 MG BID, Health ORAL Professional Insulin (Insulin) C Biperiden (Biperiden) C Sertraline (Sertraline) C Date:03/04/05ISR Number: 4600808-3Report Type:Expedited (15-DaCompany Report #2005020730 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Atrioventricular Block Foreign Zeldox (Capsules) Hospitalization - Complete Health (Ziprasidone) PS ORAL 80 MG, ORAL Initial or Prolonged Left Ventricular Failure Professional Olanzapine (Olanzapine) C 22-Feb-2006 08:32 AM Page: 697 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/07/05ISR Number: 4602477-5Report Type:Expedited (15-DaCompany Report #2005035202 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bipolar I Disorder Literature Ziprasidone (Caps) Initial or Prolonged Condition Aggravated Health (Ziprasidone) PS 20 MG (20 MG, Drug Ineffective Professional 1 IN 1 D) Drug Resistance Sertraline Mania (Sertraline) SS 200 MG (QHS) Paraesthesia Lithium (Lithium) SS 1200 MG (QD) Speech Disorder Clonazepam Suicidal Ideation (Clonazepam) SS 2 MG (QID) Treatment Noncompliance Fluoxetine (Fluoxetine) SS Topiramate (Topiramate) SS Quetiapine (Quetiapine) C Lamotrigine (Lamotrigine) C Oxcarbazepine (Oxcarbazepine) C Verapamil (Verapamil) C Citalopram (Citalopram) C Date:03/07/05ISR Number: 4602501-XReport Type:Expedited (15-DaCompany Report #2004071266 Age:34 YR Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Ziprasidone (Caps) Other Completed Suicide Health (Ziprasidone) PS Multiple Drug Overdose Professional Olanzapine Intentional (Olanzapine) SS Clonazepam (Clonazepam) SS Date:03/07/05ISR Number: 4602532-XReport Type:Expedited (15-DaCompany Report #2005036745 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Emotional Disorder Consumer Geodon (Ziprasidone) PS ORAL ORAL Feeling Abnormal Venlafaxine Insomnia Hydrochloride C Medication Error Obetrol Amfetamine Muscle Spasms Aspartate, Restlessness Amfetamine Sulfate, Thirst Dexamfetamine Saccharate, C Date:03/07/05ISR Number: 4602670-1Report Type:Expedited (15-DaCompany Report #2005017952 Age:31 YR Gender:Female I/FU:F Outcome PT Hospitalization - Anxiety Initial or Prolonged Bradycardia Disease Recurrence Dizziness 22-Feb-2006 08:32 AM Page: 698 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Psychotic Disorder Suicidal Ideation Report Source Product Role Manufacturer Route Dose Duration Foreign Zeldox (Capsules) Health (Ziprasidone) PS ORAL 200 MG (2 IN Professional 1 D), ORAL Company Clozapine Representative (Clozapine) SS Buspirone (Buspirone) C Date:03/07/05ISR Number: 4602735-4Report Type:Expedited (15-DaCompany Report #2004071265 Age:31 YR Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Ziprasidone (Caps) Other Completed Suicide Health (Ziprasidone) PS Multiple Drug Overdose Professional Amitriptyline Intentional (Amitriptyline) SS Clonazepam (Clonazepam) SS Date:03/07/05ISR Number: 4602936-5Report Type:Expedited (15-DaCompany Report #2005035266 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anuria Foreign Lithium (Lithium) PS 675 MG Initial or Prolonged Drug Interaction Health Lorazepam Haemodialysis Professional (Lorazepam) SS ORAL 6 MG, ORAL Neuroleptic Malignant Trazodone Syndrome Hydrochloride Renal Failure Acute (Trazodone Rhabdomyolysis Hydrochloride) SS 400 MG Ziprasidone (Caps) (Ziprasidone) SS 80 MG Haloperidol (Haloperidol) SS 6 MG Donepezil Hydrochloride (Donepezil Hydrochloride) SS 10 MG (1 IN 1 D) Quetiapine Fumarate (Quetiapine Fumarate) SS 400 MG Olanzapine (Olanzapine) SS 20 MG Date:03/07/05ISR Number: 4602995-XReport Type:Expedited (15-DaCompany Report #2005035736 Age:63 YR Gender:Female I/FU:I Outcome PT Hospitalization - Body Temperature Initial or Prolonged Increased Other Chills Delirium Diarrhoea Drug Interaction 22-Feb-2006 08:32 AM Page: 699 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Haemodialysis Neuroleptic Malignant Syndrome Report Source Product Role Manufacturer Route Dose Duration Renal Failure Acute Foreign Zeldox (Capsules) Rhabdomyolysis Health (Ziprasidone) PS ORAL 80 MG (1 D), Professional ORAL Aricept (Donepezil) SS ORAL 10 MG (1 D), ORAL Quetiapine Fumarate (Quetiapine Fumarate) SS 400 MG (1 D) Lorazepam (Lorazepam) SS 6 MG (1 D) Trazodone Hydrochloride (Trazodone Hydrochloride) SS 400 MG (1 D) Haloperidol (Haloperidol) SS 6 MG (1 D) Lithium Acetate (Lithium Acetate) C Olanzapine (Olanzapine) C Date:03/07/05ISR Number: 4603203-6Report Type:Expedited (15-DaCompany Report #2005036607 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyspnoea Foreign Geodon (Ziprasidone) PS ORAL 40 MG (40 MG, Initial or Prolonged Peripheral Coldness Consumer 1 IN 1 D), Tremor ORAL Date:03/08/05ISR Number: 4603745-3Report Type:Direct Company Report #CTU 242339 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oedema Peripheral Geodon 60 Pfizer PS Pfizer ORAL 120MG BID ORAL Depakote C Benztropine C Maalox C Mom C Acetaminophen C Date:03/08/05ISR Number: 4603846-XReport Type:Expedited (15-DaCompany Report #2005038149 Age:28 YR Gender:Female I/FU:I Outcome PT Hospitalization - Abdominal Operation Initial or Prolonged Abnormal Behaviour Agitation Blood Pressure Diastolic Increased Cogwheel Rigidity Confusional State Creatine Phosphokinase Decreased 22-Feb-2006 08:32 AM Page: 700 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Drooling Drug Toxicity Feeling Jittery Report Source Product Role Manufacturer Route Dose Duration Heart Rate Increased Literature Ziprasidone (Caps) Leukocytosis Health (Ziprasidone) PS 40 MG Mental Status Changes Professional Haloperidol Movement Disorder (Haloperidol) SS Poverty Of Speech Psychotic Disorder Pyrexia Sepsis Tremor Date:03/08/05ISR Number: 4603910-5Report Type:Expedited (15-DaCompany Report #2005036935 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neoplasm Growth Health Geodon Accelerated Professional (Ziprasidone) PS ORAL 20 MG, ORAL 3 WK Therapeutic Response Company Alprazolam Unexpected Representative (Alprazolam) C Sertraline Hydrochloride (Sertraline Hydrochloride) C Date:03/08/05ISR Number: 4604253-6Report Type:Expedited (15-DaCompany Report #2005038713 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Loss Of Consciousness Health Geodon (Ziprasidone) PS ORAL 60 MG, ORAL Professional Date:03/09/05ISR Number: 4606983-9Report Type:Expedited (15-DaCompany Report #2004120897 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Health Geodon (Ziprasidone) PS ORAL 40 MG (1 D), Initial or Prolonged Electrocardiogram Qt Professional ORAL Corrected Interval Company Prolonged Representative Platelet Count Decreased Syncope Date:03/09/05ISR Number: 4608893-XReport Type:Expedited (15-DaCompany Report #2005037080 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Foreign Ziprasidone (Caps) Initial or Prolonged Speech Disorder Company (Ziprasidone) PS ORAL 40 MG (40 MG, Therapy Non-Responder Representative 1 IN 1 D), ORAL 22-Feb-2006 08:32 AM Page: 701 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/09/05ISR Number: 4608906-5Report Type:Expedited (15-DaCompany Report #2005039055 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Epilepsy Foreign Zeldox (Capsules) Health (Ziprasidone) PS Professional Date:03/09/05ISR Number: 4608912-0Report Type:Expedited (15-DaCompany Report #2005036990 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Ziprasidone (Caps) Initial or Prolonged Obsessive-Compulsive Health (Ziprasidone) PS ORAL ORAL Disorder Professional Risperidone Tardive Dyskinesia (Risperidone) C Date:03/10/05ISR Number: 4606966-9Report Type:Expedited (15-DaCompany Report #2005038241 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Decreased Health Geodon (Ziprasidone) PS ORAL 60 MG (20 MG, Eating Disorder Professional 1 IN 1 D), Somnolence ORAL Weight Decreased Clonidine (Clonidine) SS ORAL 0.2 MG (0.1 MG, 2 IN 1 D), ORAL Date:03/10/05ISR Number: 4607004-4Report Type:Expedited (15-DaCompany Report #2005040229 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Myocardial Infarction Health Geodon (Ziprasidone) PS Suicide Attempt Professional Company Representative Date:03/11/05ISR Number: 4608533-XReport Type:Direct Company Report #CTU 242902 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Akathisia Geodon PS Pfizer ORAL 80MG 2XDAILY Condition Aggravated ORAL Dyskinesia Dysphagia Dystonia Mania Muscle Spasms Tardive Dyskinesia Tooth Disorder Trismus 22-Feb-2006 08:32 AM Page: 702 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/11/05ISR Number: 4609044-8Report Type:Expedited (15-DaCompany Report #2005028239 Age:18 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Facial Palsy Health Geodon (Ziprasidone) PS ORAL 160 MG (1 IN Tardive Dyskinesia Professional 1 D), ORAL Tongue Oedema Company Azithromycin Representative (Azithromycin) C Date:03/14/05ISR Number: 4609172-7Report Type:Expedited (15-DaCompany Report #DSA_25983_2005 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Foreign Tavor PS 6 MG Q DAY Initial or Prolonged Drug Interaction Health Aricept SS 10 MG Q DAY Haemodialysis Professional Geodon SS 80 MG Q DAY Neuroleptic Malignant Other Geodon SS 160 MG Q DAY Syndrome Haldol "Janssen" SS Janssen 6 MG Q DAY Renal Failure Acute Seroquel SS 400 MG Q DAY Rhabdomyolysis Thrombran SS 400 MG Q DAY Zeldox SS DF Quilonum C Zyprexa C Date:03/14/05ISR Number: 4609315-5Report Type:Expedited (15-DaCompany Report #2005020581 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Tardive Dyskinesia Foreign Zeldox (Capsules) Initial or Prolonged Health (Ziprasidone) PS ORAL 80 MG (40 MG, Professional 2 IN 1 D), Company ORAL Representative Mirtazapine (Mirtazapine) C Lormetazepam (Lormetazepam) C Date:03/14/05ISR Number: 4609336-2Report Type:Expedited (15-DaCompany Report #2005035736 Age:63 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anuria Foreign Zeldox (Capsules) Initial or Prolonged Diarrhoea Health (Ziprasidone) PS ORAL 80 MG ( 1IN 1 Other Drug Interaction Professional D), ORAL Haemodialysis Aricept (Donepezil) SS ORAL 10 MG (1 IN 1 Neuroleptic Malignant D), ORAL Syndrome Quetiapine Fumarate Renal Failure Acute (Quetiapine Rhabdomyolysis Fumarate) SS 400 MG (1 IN 1 D) Lorazepam (Lorazepam) SS 6 MG (1 D) Trazodone Hydrochloride (Trazodone Hydrochloride) SS 400 MG (1 D) Haloperidol (Haloperidol) C 6 MG (1 IN 1 D) 22-Feb-2006 08:32 AM Page: 703 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lithium Acetate (Lithium Acetate) C Olanzapine (Olanzapine) C Date:03/14/05ISR Number: 4609396-9Report Type:Expedited (15-DaCompany Report #2004038108 Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Epistaxis Foreign Zeldox (Capsules) Red Blood Cell Health (Ziprasidone) PS ORAL 120 MG (60 Sedimentation Rate Professional MG, 2 IN 1 Increased Company D), ORAL Sudden Death Representative Date:03/15/05ISR Number: 4613206-3Report Type:Expedited (15-DaCompany Report #2005020730 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Atrioventricular Block Foreign Zeldox (Capsules) Hospitalization - Dyspnoea Health (Ziprasidone) PS ORAL 80 MG, ORAL Initial or Prolonged Heart Rate Decreased Professional Olanzapine Left Ventricular Failure (Olanzapine) C Date:03/15/05ISR Number: 4613214-2Report Type:Expedited (15-DaCompany Report #2005040816 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arrhythmia Foreign Ziprasidone (Caps) Initial or Prolonged Dyspnoea Health (Ziprasidone) PS ORAL 80 MG (40 MG, Professional 2 IN 1 D), ORAL Memantine (Memantine) C Date:03/15/05ISR Number: 4613244-0Report Type:Expedited (15-DaCompany Report #2005040463 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Oropharyngeal Spasm Foreign Zeldox (Capsules) Initial or Prolonged Parkinsonism Health (Ziprasidone) PS Professional Risperidone (Risperidone) C Date:03/15/05ISR Number: 4614085-0Report Type:Expedited (15-DaCompany Report #2005035202 Age:21 YR Gender:Female I/FU:F Outcome PT Hospitalization - Bipolar I Disorder Initial or Prolonged Condition Aggravated Drug Ineffective Drug Resistance Major Depression Mania Mood Swings Paraesthesia 22-Feb-2006 08:32 AM Page: 704 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Psychotic Disorder Skin Reaction Speech Disorder Report Source Product Role Manufacturer Route Dose Duration Suicidal Ideation Literature Ziprasidone (Caps) Treatment Noncompliance (Ziprasidone) PS ORAL 20 MG (20 MG, Weight Increased 1 IN 1 D), ORAL Sertrline (Sertraline) SS 200 MG (QHS), Lithium (Lithium) SS 1200 MG (QD), Clonazepam (Clonazepam) SS 2 MG (QID), Fluoxetine (Fluoxetine) SS ML Topiramate (Topiramate) SS Risperidone (Risperidone) C Valproate Semisodium (Valproate Semisodium) C Quetiapine (Quetiapine) C Lamotrigine (Lamotrigine) C Oxcarbazepine (Oxcarbazepine) C Verapamil (Verapamil) C Citalopram (Citalopram) C Date:03/15/05ISR Number: 4614181-8Report Type:Expedited (15-DaCompany Report #2005039830 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Health Geodon (Ziprasidone) PS ORAL 120 MG (60 Initial or Prolonged Prolonged Professional MG, 2 IN 1 Other Hypokalaemia D), ORAL Syncope Citalopram Torsade De Pointes Hydrobromide (Citalopram Hydrobromide) SS ORAL 40 MG (1 IN 1 D), ORAL All Other Therapeutic Products (All Other Therapeutic Products) C Date:03/16/05ISR Number: 4613801-1Report Type:Expedited (15-DaCompany Report #ZICO001152 Age:50 YR Gender:Female I/FU:F Outcome PT Life-Threatening Aggression Hospitalization - Agitation Initial or Prolonged Alanine Aminotransferase Increased Aspartate 22-Feb-2006 08:32 AM Page: 705 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Aminotransferase Increased Blood Creatine Phosphokinase Mb Report Source Product Role Manufacturer Route Dose Duration Increased Study Prialt (Ziconotide Blood Lactate Health Intrathecal Dehydrogenase Increased Professional Infusion) PS CONTINUED Blood Potassium Decreased Methadone Confusional State (Methadone) SS Electrocardiogram Qt Geodon (Geodon) SS INTRATHECAL 0.0 MCG/HR Corrected Interval INTRATHECAL Prolonged Actiq (Actiq) C Electrocardiogram Qt Duragesic Patch Prolonged (Fentanyl Patch) C Electrocardiogram R On T Phenomenon Electrocardiogram St-T Change Electrolyte Imbalance Hallucination Hypersomnia Hypoglycaemia Hypotension Insomnia Laboratory Test Abnormal Leukocytosis Memory Impairment Overdose Paranoia Psychotic Disorder Pulse Absent Rhabdomyolysis Sinus Tachycardia Torsade De Pointes Troponin Increased Ventricular Tachycardia Date:03/17/05ISR Number: 4612721-6Report Type:Direct Company Report #CTU 243529 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Tardive Dyskinesia Geodon 20 Mg Intervention to Pfizer PS Pfizer ORAL 20 MG DAY Prevent Permanent ORAL Impairment/Damage Depakote C Lexapro C Date:03/17/05ISR Number: 4615461-2Report Type:Expedited (15-DaCompany Report #2005041540 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pruritus Foreign Zeldox (Capsules) Initial or Prolonged Rash Health (Ziprasidone) PS ORAL 120 MG, ORAL Professional 22-Feb-2006 08:32 AM Page: 706 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/17/05ISR Number: 4615466-1Report Type:Expedited (15-DaCompany Report #2005041516 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Activities Of Daily Foreign Zeldox (Capsules) Initial or Prolonged Living Impaired Health (Ziprasidone) PS ORAL 40 M G, ORAL Asthenia Professional Promethazine Difficulty In Walking Hydrochloride Dysstasia (Promethazine Gait Disturbance Hydrochloride) SS ORAL 150 MG ORAL Hyperhidrosis Oxazepam (Oxazepam) SS ORAL 15 MG ORAL Hypokalaemia Mirtazapine Hypotonia (Mirtazapine) SS ORAL 45 MG ORAL Impaired Self-Care MONTHS Masked Facies Citalopram Muscle Rigidity Hydrobromide Posture Abnormal (Citalopram Tension Hydrobromide) C Tremor Isosorbide Mononitrate (Isosorbide Mononitrate) C Pantoprazole Sodium (Pantoprazole Sodium) C Molsidomine (Molsidomine) C Lefax /Old Form/ (Dimeticone, Silicon Dioxide, Colloidal ) C Date:03/17/05ISR Number: 4615820-8Report Type:Expedited (15-DaCompany Report #GXKR2005US00689 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bundle Branch Block Left Literature Divalproex Initial or Prolonged Cardiovascular Disorder Health (Ngx)(Divalproex) PS ORAL ORAL Disorientation Professional Ziprasidone (Ngx) Electrocardiogram Qt (Ziprasidone) SS ORAL 5920 MG, ORAL Corrected Interval Bupropion (Ngx) Prolonged (Bupropion) SS ORAL 15700 MG Grand Mal Convulsion (PROBABLY Intentional Overdose FEWER), ORAL Lethargy Fluoxetine (Ngx) Medication Error (Fluoxetine) SS ORAL 72 G, ORAL Overdose Supraventricular Tachycardia Date:03/18/05ISR Number: 4614979-6Report Type:Direct Company Report #CTU 243759 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oculogyration Geodon PS ORAL 120 MG PO BID 22-Feb-2006 08:32 AM Page: 707 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/18/05ISR Number: 4616418-8Report Type:Expedited (15-DaCompany Report #2005040515 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Health Geodon (Ziprasidone) PS UNKNOWN 120 MG (60 Overdose Professional MG, 2 IN 1 Rhabdomyolysis Company D), UNKNOWN Representative Ibuprofen (Ibuprofen) SS UNKNOWN UNKNOWN Date:03/18/05ISR Number: 4616419-XReport Type:Expedited (15-DaCompany Report #2005042284 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Multiple Drug Overdose Consumer Zoloft (Sertraline) PS UNKNOWN UNKNOWN Suicide Attempt Health Geodon (Ziprasidone) SS UNKNOWN UNKNOWN Professional Lamotrigine (Lamotrigine) SS UNKNOWN UNKNOWN Zolpidem Tartrate (Zolpidem Tartrate) SS UNKNOWN UNKNOWN Date:03/18/05ISR Number: 4616604-7Report Type:Expedited (15-DaCompany Report #L04-USA-07403-31 Age:29 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Areflexia Literature Lexapro Hospitalization - Blood Ph Decreased Health (Escitalopram) PS Initial or Prolonged Blood Pressure Systolic Professional Doxepin SS Increased Mirtazapine SS Cardiac Arrest Ziprasidone SS Coma Clonazepam SS Completed Suicide Heart Rate Increased Multiple Drug Overdose Intentional Pco2 Decreased Pupil Fixed Torsade De Pointes Unresponsive To Pain Stimuli Ventricular Extrasystoles Ventricular Tachycardia Date:03/21/05ISR Number: 4616031-2Report Type:Expedited (15-DaCompany Report #2005036607 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyspnoea Foreign Geodon (Ziprasidone) PS ORAL 40 MG (40 MG, Initial or Prolonged Peripheral Coldness Consumer 1 IN 1 D), Tremor ORAL Promethazine (Promethazine) C 22-Feb-2006 08:32 AM Page: 708 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/21/05ISR Number: 4616347-XReport Type:Expedited (15-DaCompany Report #2003039927 Age:43 YR Gender:Unknown I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Ziprasidone (Caps) Multiple Drug Overdose Health (Ziprasidone) PS Intentional Professional Verapamil (Verapamil) (Verapamil) SS Clonazepam (Clonazepam) (Clonazepam) SS All Other Therapeutic Products (All Other Therapeutic Products) SS Date:03/21/05ISR Number: 4616386-9Report Type:Expedited (15-DaCompany Report #2003039953 Age:38 YR Gender:Unknown I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Literature Ziprasidone (Caps) Other Completed Suicide Health (Ziprasidone) PS ORAL ORAL Respiratory Arrest Professional Paroxetine (Paroxetine) SS ORAL ORAL Methadone Hydrochloride (Methadone) (Methadone Hydrochloride) SS ORAL ORAL All Other Therapeutic Products (All Other Therapeutic Products) SS ORAL ORAL Date:03/21/05ISR Number: 4616387-0Report Type:Expedited (15-DaCompany Report #2003039904 Age:47 YR Gender:Unknown I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Literature Ziprasidone (Caps) Other Completed Suicide Health (Ziprasidone) PS ORAL ORAL Respiratory Arrest Professional Fluoxetine (Fluoxetine) (Fluoxetine) SS ORAL ORAL Clonazepam (Clonazepam) (Clonazepam) SS ORAL ORAL Date:03/21/05ISR Number: 4616670-9Report Type:Expedited (15-DaCompany Report #2005032983 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Foreign Zeldox (Im) Initial or Prolonged Fall Health (Ziprasidone) PS INTRAMUSCULAR 120 MG (40 Fibula Fracture Professional MG, 3 IN 1 Nausea Company D), Orthostatic Hypotension Representative INTRAMUSCULAR 22-Feb-2006 08:32 AM Page: 709 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/21/05ISR Number: 4616906-4Report Type:Expedited (15-DaCompany Report #2005035736 Age:63 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anuria Foreign Zeldox (Capsules) Initial or Prolonged Body Temperature Health (Ziprasidone) PS ORAL 80 MG (1 IN 1 Other Increased Professional D), ORAL Catatonia Aricept (Donepezil) SS ORAL 10 MG (1 IN 1 Chills D), ORAL Delirium Lithium Acetate Diarrhoea (Lithium Acetate) SS 675 MG (1 IN Drug Interaction 1 D) Haemodialysis Trazaodne Neuroleptic Malignant (Trazadone) SS 400 MG (1 IN Syndrome 1 D) Renal Failure Acute Haloperidol Rhabdomyolysis (Haloperidol) SS ORAL 6 MG ( 1 IN 1 D), ORAL Lorazepam (Lorazepam) SS ORAL 6 MG ( 1 IN 1 D), ORAL Quetiapone Fumarte (Quetiapine Fumarate) C Olanzapine (Olanzapine) C Date:03/22/05ISR Number: 4618010-8Report Type:Expedited (15-DaCompany Report #2005037080 Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Foreign Ziprasidone (Caps) Initial or Prolonged Speech Disorder Health (Ziprasidone) PS ORAL 40 MG, 1 IN 1 Professional D, ORAL Company Representative Other Date:03/22/05ISR Number: 4618110-2Report Type:Expedited (15-DaCompany Report #2005019471 Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Health Geodon Initial or Prolonged Corrected Interval Professional (Ziprasidone) PS 80 MG (40 MG, Other Prolonged Company 2 IN 1 D) Suicide Attempt Representative Escitalopram (Escitalopram) C Clonazepam (Clonazepam) C Amlodipine Besilate (Amlodipine Besilate) C Levothyroxine Sodium (Levothyroxine Sodium) C 22-Feb-2006 08:32 AM Page: 710 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/22/05ISR Number: 4618149-7Report Type:Expedited (15-DaCompany Report #2003039698 Age: Gender:Unknown I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Amlodipine Intentional Misuse Health (Amlodipine) PS ORAL ORAL Professional Ziprasidone (Caps) (Ziprasidone) SS ORAL ORAL Verapamil Hydrochloride Caplet (Verapamil) (Verapamil Hydrochloride) SS ORAL ORAL Date:03/22/05ISR Number: 4618167-9Report Type:Expedited (15-DaCompany Report #2004095660 Age:62 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Parkinsonism Health Geodon (Im) Initial or Prolonged Professional (Ziprasidone) PS INTRAMUSCULAR 20 MG, Company INTRAMUSCULAR Representative Valproic Acid (Valproic Acid) C Escitalopram (Escitalopram) C Quetiapine Fumarate (Quetiapine Fumarate) C Furosemide (Furosemide) C Famotidine (Famotidine) C Lorazepam (Lorazepam) C Benazepril (Benazepril) C Date:03/23/05ISR Number: 4618555-0Report Type:Expedited (15-DaCompany Report #2005044441 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Status Epilepticus Foreign Zeldox (Capsules) Initial or Prolonged Health (Ziprasidone) PS ORAL 40 MG (20 MG, Professional 2 IN 1 D), Company ORAL Representative Fluspirilene (Fluspirilene) C Date:03/23/05ISR Number: 4618767-6Report Type:Expedited (15-DaCompany Report #2005043618 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Geodon (Ziprasidone) PS ORAL 200 MG (2 IN Professional 1 D), ORAL Company Axotal (Old Form) Representative (Butalbital, Caffeine, Paracetamol) C Risperidone 22-Feb-2006 08:32 AM Page: 711 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Risperidone) C Metformin Hydrochloride (Metformin Hydrochloride) C Trazodone 9trazodone) C Lamotrigine (Lamotrigine) C Quetiapine Fumarate (Quetiapine Fumarate) C Modafinil (Modafinil) C Date:03/23/05ISR Number: 4618775-5Report Type:Expedited (15-DaCompany Report #2005044135 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination, Auditory Health Geodon (Ziprasidone) PS ORAL 160 MG (80 Initial or Prolonged Professional MG, 2 IN 1 D), ORAL Date:03/23/05ISR Number: 4618866-9Report Type:Expedited (15-DaCompany Report #2004004515 Age:83 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atrial Fibrillation Health Geodon (Im) Other Blood Potassium Decreased Professional (Ziprasidone) PS INTRAMUSCULAR 10 MG (1 IN 1 Confusional State Other D), Delusion INTRAMUSCULAR Dialysis Cefazolin Disorientation (Cefazolin) C Myocardial Infarction Gliclazide Pneumonia Aspiration (Gliclazide) C Renal Failure Acute Furosemide Respiratory Failure (Furosemide) C Sedation Dopamine (Dopamine) C Staphylococcal Sepsis Linezolid Supraventricular (Linezolid) C Extrasystoles Drotrecogin Alfa Ventricular Extrasystoles (Drotrecogin Alfa) C Psyllium (Psyllium) C Digoxin (Digoxin) C Dyazide (Hydrochlorothiazide , Triamterene) C Docusate Sodium (Docusate Sodium) C Acetylsalicylic Acid (Acetylsalicylic Acid) C Metamucil Procter & Gamble (Glucose Monohydrate, Ispaghula Husk) C Procter & Gamble Vitamins (Vitamins) C Pentobarbital (Pentobarbital) C 22-Feb-2006 08:32 AM Page: 712 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/24/05ISR Number: 4620599-XReport Type:Expedited (15-DaCompany Report #2005044287 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Prolactin Increased Health Geodon (Ziprasidone) PS ORAL 160 MG (80 Initial or Prolonged Blood Thyroid Stimulating Professional MG, 2 IN 1 Other Hormone Increased D), ORAL Overdose Pantoprazole C Levofloxacin C Levothyroxinesodium C Atorvastatin C Clonidine C Thiamine C Paroxetine Hydrochloride C Oxcarbazepine C Multiple Vitamins (Ascorbic Acid, Ergocalciferol, Folic Acid, Retinol, Tocopherol, Vitamin C Loratadine C Folic Acid C Date:03/25/05ISR Number: 4620791-4Report Type:Expedited (15-DaCompany Report #2005044379 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Geodon (Im) Psychotic Disorder Professional (Ziprasidone) PS INTRAMUSCULAR 60 MG (20 MG, Company 3 IN 1 D), Representative INTRAMUSCULAR Haloperidol (Haloperidol) SS 10 MG Date:03/25/05ISR Number: 4621117-2Report Type:Expedited (15-DaCompany Report #2005044476 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardio-Respiratory Arrest Foreign Zeldox (Im) Health (Ziprasidone) PS INTRAMUSCULAR (20), Professional INTRAMUSCULAR Date:03/25/05ISR Number: 4622484-6Report Type:Direct Company Report #CTU 244383 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Aggression Geodon; Ziprasidone; Aspiration Pfizer; Neuroleptic Malignant Antipsychotics; ;; PS Pfizer INTRAMUSCULAR 10MG, IM Syndrome Sensory Loss 22-Feb-2006 08:32 AM Page: 713 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/28/05ISR Number: 4620523-XReport Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0548225A Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Lamictal PS Glaxosmithkline ORAL 6 WK Akathisia Geodon SS Amnesia Wellbutrin Xl C Glaxosmithkline Anxiety Ativan C Hyperacusis Zyprexa C Hypomania Stereotypy Thinking Abnormal Visual Disturbance Date:03/28/05ISR Number: 4621664-3Report Type:Expedited (15-DaCompany Report #2004071266 Age:34 YR Gender:Unknown I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Geodon (Ziprasidone) PS Other Completed Suicide Consumer Olanzapine Multiple Drug Overdose (Olanzapine) SS Clonazepam (Clonazepam) SS Date:03/28/05ISR Number: 4621668-0Report Type:Expedited (15-DaCompany Report #2005027347 Age:65 YR Gender:Female I/FU:F Outcome PT Life-Threatening Anaemia Hospitalization - Aortic Aneurysm Initial or Prolonged Arthralgia Other Arthritis Asthenia Benign Ovarian Tumour Bradycardia Cardiac Enzymes Increased Cardiac Stress Test Abnormal Cerebrovascular Accident Chronic Obstructive Pulmonary Disease Coronary Artery Occlusion Coronary Artery Surgery Depression Dysaesthesia Electrocardiogram Poor R-Wave Progression Electrocardiogram Qt Corrected Interval Prolonged Electrocardiogram Qt Prolonged Electroencephalogram Abnormal Femoral Arterial Stenosis Gastrooesophageal Reflux Disease Hyperlipidaemia Hypertension Hypothyroidism 22-Feb-2006 08:32 AM Page: 714 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Intracranial Aneurysm Mania Myocardial Infarction Report Source Product Role Manufacturer Route Dose Duration Osteoarthritis Health Geodon (Ziprasidone) PS ORAL 140 MG (2 IN Paraesthesia Professional 1 D), ORAL Peripheral Vascular Company Acetylsalicylic Acid Disorder Representative (Acetylsalicylic Psychotic Disorder Acid) C Rectal Cancer Valproate Semisodium Schizoaffective Disorder (Valproate Torsade De Pointes Semisodium) C Ventricular Tachycardia Estrogens Conjugated (Estrogens Conjugated) C Nicotine (Nicotine) C Levothyroxine Sodium (Levothyroxine Sodium) C Diazepam (Diazepam) C Pyridoxine Hydrochloride (Pyridoxine Hydrochloride) C Date:03/29/05ISR Number: 4621561-3Report Type:Expedited (15-DaCompany Report #2005043618 Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Geodon (Ziprasidone) PS ORAL 200 MG (2 IN Professional 1 D), ORAL Company Axotal (Old Form) Representative (Butalbital, Caffeine, Paracetamol) C Risperidone (Risperidone) C Metformin Hydrochloride (Metformin Hydrochloride) C Trazodone (Trazodone) C Lamotrigine (Lamotrigine) C Quetiapine Fumarate (Quetiapine Fumarate) C Modafinil (Modafinil) C Date:03/29/05ISR Number: 4623179-5Report Type:Expedited (15-DaCompany Report #2005047054 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Economic Problem Consumer Geodon (Ziprasidone) PS Initial or Prolonged Hallucinations, Mixed Other Treatment Noncompliance 22-Feb-2006 08:32 AM Page: 715 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/30/05ISR Number: 4626175-7Report Type:Expedited (15-DaCompany Report #2004021190 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Foreign Geodon (Ziprasidone) PS ORAL 80 MG (80 MG, Health 1 IN 1 D), Professional ORAL Company Haloperidol Representative (Haloperidol) C Diazepam (Diazepam) C Date:03/30/05ISR Number: 4626185-XReport Type:Expedited (15-DaCompany Report #2004021193 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Foreign Geodon (Ziprasidone) PS ORAL 80 MG (1 IN 1 Health D), ORAL Professional Phenytoin Company (Phenytoin) C Representative Phenobarbital (Phenobarbital) C Haloperidol Decanoate (Haloperidol Decanoate) C Haloperidol (Haloperidol) C Date:04/01/05ISR Number: 4626801-2Report Type:Direct Company Report #CTU 245091 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Medication Error Geodon PS ORAL SEE IMAGE Intervention to Overdose Prevent Permanent Impairment/Damage Date:04/01/05ISR Number: 4627510-6Report Type:Expedited (15-DaCompany Report #2005044135 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hallucination, Auditory Health Geodon (Ziprasidone) PS ORAL 160 MG (80 Professional MG, 2 IN 1 D), ORAL Date:04/01/05ISR Number: 4627639-2Report Type:Direct Company Report #CTU 245076 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Body Temperature Haloperidol 5 Mg PS INTRAVENOUS 5 MG PRN Hospitalization - Increased INTRAVENOUS Initial or Prolonged Confusional State Ziprasidone 20 Mg SS INTRAMUSCULAR 20 MG X1 Required Convulsion DOSEIN Intervention to Therapeutic Product INTRAMUSCU Prevent Permanent Ineffective Impairment/Damage 22-Feb-2006 08:32 AM Page: 716 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/04/05ISR Number: 4627949-9Report Type:Direct Company Report #CTU 245208 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Generalised Oedema Geodon Pfizer PS Pfizer ORAL 20MG BID Intervention to ORAL Prevent Permanent Impairment/Damage Date:04/04/05ISR Number: 4628251-1Report Type:Expedited (15-DaCompany Report #2005044476 Age:56 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agitation Foreign Zeldox (Im) Cardio-Respiratory Arrest Health (Ziprasidone) PS INTRAMUSCULAR INTRAMUSCULAR Professional Date:04/04/05ISR Number: 4628446-7Report Type:Expedited (15-DaCompany Report #2005030504 Age:17 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Consumer Geodon (Ziprasidone) PS ORAL 120 MG (20 Initial or Prolonged Arthralgia Health MG, 6 IN 1 Crying Professional D), ORAL Depression Trimspa (Enzymes Disturbance In Attention Nos, Herbal Nos, Insomnia Minerals Nos, Pain In Extremity Vitamins Nos) C Restlessness Sedation Date:04/05/05ISR Number: 4627401-0Report Type:Expedited (15-DaCompany Report #2004073860 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Balance Disorder Health Geodon (Ziprasidone) PS ORAL 160 MG (40 Coordination Abnormal Professional MG, 2 IN 1 Difficulty In Walking Company D), ORAL Tremor Representative Valproate Semisdoium Other (Valproate Semisodium) C Pioglitaozne (Piogltiazone) C Rabeprazole Sodium (Rabeprazole Sodium) C Meloxicam (Meloxicam) C Merfromin Hydrochloride (Metformin Hydrochloride) C Tramadol Hydrochloride (Tramadol Hydrochloride) C Cetirizine Hydrochloride (Cetirizine Hydrochloride0 C 22-Feb-2006 08:32 AM Page: 717 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Karvea Hct (Hydrochlorothiazide , Irbesartan) C Date:04/05/05ISR Number: 4627404-6Report Type:Expedited (15-DaCompany Report #2005019479 Age:70 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Geodon (Ziprasidone) PS Hospitalization - Cardiac Failure Professional Hydrochlorothiazide Initial or Prolonged Congestive Company (Hydrochlorithiazide Other Myocardial Infarction Representative 0 C Multivitamins(Ascorb ic Acid, Ergocalciferol, Folic Aicd, Nicotinamide, C Ranitidine Hydrochloride (Ranitidine Hydrochloride) C Docusate Sodium (Docusate Sodium) C Trazadone 9trazadone0 C Lorazepam (Lorazepam) C Glyceryl Trinitrate (Glyceryl Trinitrate) C Olmesartan Mdeoxomil (Olmesartan Medoxomil) C Date:04/05/05ISR Number: 4627549-0Report Type:Expedited (15-DaCompany Report #2005048138 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Cholesterol Health Geodon (Ziprasidone) PS 160 MG (80 Initial or Prolonged Increased Professional MG, 2 IN 1 D) Other Pulmonary Thrombosis Date:04/05/05ISR Number: 4627556-8Report Type:Expedited (15-DaCompany Report #2005048884 Age:14 YR Gender:Female I/FU:I Outcome PT Hospitalization - Abasia Initial or Prolonged Agitation Other Anger Diplopia Fatigue Feeling Abnormal Insomnia Intentional Overdose Muscle Twitching Oppositional Defiant Disorder Somnolence 22-Feb-2006 08:32 AM Page: 718 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Suicide Attempt Vomiting Report Source Product Role Manufacturer Route Dose Duration Consumer Geodon (Ziprasidone) PS ORAL ORAL Valproate Semisodium (Valproate Semisodium) SS ORAL 1000 MG (500 MG, 2 IN 1 D), ORAL Oxcarbazepine (Oxcarbazepine) SS ORAL ORAL All Other Therapeutic Products (All Other Therapeutic Products) SS Date:04/05/05ISR Number: 4627599-4Report Type:Expedited (15-DaCompany Report #2004073851 Age:66 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Agitation Health Geodon (Ziprasidone) PS ORAL 160 MG (80 Coordination Abnormal Professional MG), ORAL Difficulty In Walking Company Bupropion Extrapyramidal Disorder Representative Hydrochloride Gait Disturbance (Bupropion Tremor Hydrochloride) C Lithium (Lithium) C Insulin Injection, Isophane (Insulin Injection, Isophane) C Metformin Hydrochloride (Metformin Hydrochloride) C Glibenclamide (Glibenclamide) C Pravastatin Sodium (Pravastatin Sodium) C Lithium Carbonate (Lithium Carbonate) C Alprazolam (Alpazolam) C Insulin Glargine (Insulin Glargine) C Venlafaxine Hydrochloride (Venlafaxine Hydrochloride) C Date:04/05/05ISR Number: 4657371-0Report Type:Periodic Company Report #2004034907 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Geodon (Ziprasidone) PS Vision Blurred Professional Quetiapine Fumarate Company (Quetiapine Representative Fumarate) SS Valsartan 22-Feb-2006 08:32 AM Page: 719 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Valsartan) SS Date:04/05/05ISR Number: 4657372-2Report Type:Periodic Company Report #2004037190 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Health Geodon (Ziprasidone) PS 120 MG (2 IN Corneal Reflex Decreased Professional 1 D) Dyskinesia Company Zoloft (Sertraline) SS 100 MG Dysphagia Representative Levothyroxine Sodium Dystonia (Levothyroxine Hallucination, Visual Sodium) SS 0.15 MG Muscle Tightness Tremor Vision Blurred Date:04/05/05ISR Number: 4657373-4Report Type:Periodic Company Report #2004038106 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Triglycerides Health Geodon (Ziprasidone) PS ORAL ORAL Increased Professional Sertraline Bundle Branch Block Left Hydrochloride Electrocardiogram Qrs (Sertraline Complex Prolonged Hydrochloride) C Electrocardiogram Qt Citalopram Prolonged Hydrobromide (Citalopram Hydrobromide) C Date:04/05/05ISR Number: 4657374-6Report Type:Periodic Company Report #2004038249 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Geodon (Ziprasidone) PS 80 MG (1 IN 1 Initial or Prolonged Anxiety Professional D) Heart Rate Increased Company Representative Date:04/05/05ISR Number: 4657375-8Report Type:Periodic Company Report #2004038704 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Hallucination, Visual Health Geodon (Ziprasidone) PS ORAL 120 MG (60 Insomnia Professional MG, 2 IN 1 Musculoskeletal Pain Company D), ORAL Musculoskeletal Stiffness Representative Olanzapine (Olanzapine) SS 5 MG (1 IN 1 D) Bupropion Hydrochloride (Bupropion Hydrochloride) C Benzatropine Mesilate (Benzatropine Mesilate) C All Other 22-Feb-2006 08:32 AM Page: 720 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Therapeutic Products (All Other Therapeutic Products) C Lorazepam (Lorazepam) C Lithium Carbonate (Lithium Carbonate) C Sertraline Hydrochloride (Sertraline Hydrochloride) C Zolpidem Tartrate (Zolpidem Tartrate) C Temazepam (Temazepam) C Codeine (Codeine) C Date:04/05/05ISR Number: 4657376-XReport Type:Periodic Company Report #2004038962 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Health Geodon (Ziprasidone) PS ORAL 160 MG (80 Blood Creatine Professional MG, 2 IN 1 Phosphokinase Increased D), ORAL Extrapyramidal Disorder Globulinuria Date:04/05/05ISR Number: 4657377-1Report Type:Periodic Company Report #2004042176 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cogwheel Rigidity Health Geodon (Ziprasidone) PS 80 MG (40 MG, Extrapyramidal Disorder Professional 2 IN 1 D), Parkinsonism Date:04/05/05ISR Number: 4657378-3Report Type:Periodic Company Report #2004042609 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Mania Health Geodon (Ziprasidone) PS ORAL 40 MG, ORAL Swollen Tongue Professional Oxcarbazepine Company (Oxcarbazepine) C Representative Date:04/05/05ISR Number: 4657379-5Report Type:Periodic Company Report #2004043469 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bruxism Consumer Geodon (Ziprasidone) PS ORAL 160 MG (80 Dysarthria Health MG, 2 IN 1 Dyspnoea Professional D), ORAL Facial Palsy Aripiprazole Hypersensitivity (Aripiprazole) SS ORAL 10 MG (10 MG, Speech Disorder 1 IN 1 D), Swollen Tongue ORAL Tardive Dyskinesia Escitalopram Trismus (Escitalopram) C 22-Feb-2006 08:32 AM Page: 721 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Atomoxetine Hydrochloride (Atomoxetine Hydrochloride) C Clonazepam (Clonazepam) C Pantoprazole (Pantoprazole) C Date:04/05/05ISR Number: 4657380-1Report Type:Periodic Company Report #2004043573 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Upper Health Geodon (Ziprasidone) PS ORAL ORAL Constipation Professional Sudafed Dizziness (Pseudoephedrine) SS Dysphagia Caffeine (Caffeine) SS Eructation Guaifenesin Flatulence (Guaifenesin) SS Hyperhidrosis Benzatropine Orthostatic Hypotension Mesilate Respiratory Rate (Benzatropine Increased Mesilate) C Tachycardia Oral Contraceptive Nos (Oral Contraceptive Nos) C Ibuprofen (Ibuprofen) C Paracetamol (Paracetamol) C Date:04/05/05ISR Number: 4657381-3Report Type:Periodic Company Report #2004044022 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Insomnia Consumer Geodon (Ziprasidone) PS Initial or Prolonged Date:04/05/05ISR Number: 4657382-5Report Type:Periodic Company Report #2004045490 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Health Geodon (Ziprasidone) PS ORAL (20 MG), ORAL Initial or Prolonged Professional Atenolol (Atenolol) C Company Representative Date:04/05/05ISR Number: 4657383-7Report Type:Periodic Company Report #2004047423 Age:32 YR Gender:Male I/FU:I Outcome PT Other Body Temperature Decreased Dyskinesia Fear Gait Disturbance Hypoaesthesia 22-Feb-2006 08:32 AM Page: 722 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Paranoia Restless Legs Syndrome Visual Disturbance Report Source Product Role Manufacturer Route Dose Duration Health Geodon (Ziprasidone) PS ORAL 80 MG (40 MG, Professional 2 IN 1 D), ORAL Bupropion Hydrochloride (Bupropion Hydrochloride) C Lithium Carbonate (Lithium Carbonate) C Mesalazine (Mesalazine) C Date:04/05/05ISR Number: 4657384-9Report Type:Periodic Company Report #2004048281 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Health Geodon (Ziprasidone) PS 160 MG (80 Initial or Prolonged Choreoathetosis Professional MG, 2 IN 1 Tremor Company D), Representative All Other Therapeutic Products (All Other Therapeutic Products) SS Benzatropine Mesilate (Benzatropine Mesilate) C Lamotrigine (Lamotrigine) C Temazepam (Temazepam) C Escitalopram (Escitalopram) C Date:04/05/05ISR Number: 4657385-0Report Type:Periodic Company Report #2004051383 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Health Geodon (Ziprasidone) PS Syndrome Professional Company Representative Date:04/05/05ISR Number: 4657386-2Report Type:Periodic Company Report #2004052157 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Health Geodon (Ziprasidone) PS Prolonged Professional Company Representative 22-Feb-2006 08:32 AM Page: 723 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/05/05ISR Number: 4657387-4Report Type:Periodic Company Report #2004053979 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Health Geodon (Ziprasidone) PS Increased Professional Lipitor Blood Cholesterol Company (Atorvastatin) SS ORAL 80 MG (80MG, Increased Representative 1 IN 1 D), Blood Creatine ORAL Phosphokinase Increased Trazodone Blood Creatine (Trazodone) C Phosphokinase Mb Fexofenadine Increased Hydrochloride Blood Glucose Increased (Fexofenadine Blood Phosphorus Hydrochloride) C Decreased Perphenazine Blood Triglycerides (Perphenazine) C Increased Drug Interaction Epstein-Barr Virus Antibody Positive High Density Lipoprotein Decreased Low Density Lipoprotein Increased Parvovirus B19 Serology Positive Urine Protein, Quantitative Date:04/05/05ISR Number: 4657388-6Report Type:Periodic Company Report #2004054027 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Health Geodon (Ziprasidone) PS Abnormal Professional Risperidone Company (Risperidone) SS Representative Lamotrigine (Lamotrigine) SS Citalopram Hydrobromide (Citalopram Hydrobromide) C All Other Therapeutic Products (All Other Therapeutic Products) C Date:04/05/05ISR Number: 4657389-8Report Type:Periodic Company Report #2004055849 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dysphagia Health Geodon (Ziprasidone) PS 80 MG (40 MG, Swelling Face Professional 2 IN 1 D), Tongue Paralysis Company Representative 22-Feb-2006 08:32 AM Page: 724 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/05/05ISR Number: 4657390-4Report Type:Periodic Company Report #2004057016 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Glucose Decreased Health Geodon (Ziprasidone) PS 80 MG (1 IN 1 Other Professional D), Clozapine (Clozapine) C Topiramate (Topiramate) C Phenelzine Sulfate (Phenelzine Sulfate) C Date:04/05/05ISR Number: 4657391-6Report Type:Periodic Company Report #2004058569 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Health Geodon (Ziprasidone) PS ORAL ORAL Initial or Prolonged Professional Company Representative Date:04/05/05ISR Number: 4657392-8Report Type:Periodic Company Report #2004060848 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyspnoea Health Geodon (Ziprasidone) PS ORAL 40 MG (40 MG, Dystonia Professional 1 IN 1 D), Muscle Contractions Company ORAL Involuntary Representative Obetrol (Amfetamine Speech Disorder Aspartate, Amfetamine Sulfate, Dexamfetamine Saccharate, C Date:04/05/05ISR Number: 4657393-XReport Type:Periodic Company Report #2004060854 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Syncope Health Geodon (Ziprasidone) PS 160 MG (1 IN Initial or Prolonged Professional 1 D) Company Representative Date:04/05/05ISR Number: 4657394-1Report Type:Periodic Company Report #2004061975 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Geodon (Ziprasidone) PS ORAL ORAL Initial or Prolonged Amenorrhoea Professional Venlafaxine Blood Prolactin Increased Company Hydrochloride C Depression Representative Mirtazapine C Methylphenidate Hydrochloride C 22-Feb-2006 08:32 AM Page: 725 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/05/05ISR Number: 4657395-3Report Type:Periodic Company Report #2004063994 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Geodon (Ziprasidone) PS Professional Methylphenidate Company Hydrochloride SS Representative All Other Therapeutic Products SS Date:04/05/05ISR Number: 4657396-5Report Type:Periodic Company Report #2004064550 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oculogyration Health Geodon (Ziprasidone) PS 80 MG (40 MG, Professional IN 1 D) Company Representative Date:04/05/05ISR Number: 4657397-7Report Type:Periodic Company Report #2004066255 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Health Geodon (Ziprasidone) PS ORAL ORAL Intentional Misuse Professional Valproate Semisodium C Risperidone C Quetiapine Fumarate C Sertraline Hydrochloride C Zonisamide C Date:04/05/05ISR Number: 4657398-9Report Type:Periodic Company Report #2004067378 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dysmenorrhoea Health Geodon (Ziprasidone) PS 80 MG (40 MG, Initial or Prolonged Menstrual Disorder Professional 2 IN 1 D) Uterine Haemorrhage Company Tiagabine Representative Hydrochloride C Paroxetinehydrochlor ide C Lansoprazole C Date:04/05/05ISR Number: 4657399-0Report Type:Periodic Company Report #2004069097 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrial Fibrillation Health Geodon (Ziprasidone) PS INTRAMUSCULAR 20 MG (20 MG, Initial or Prolonged Professional ONCE, INTRAMUSCULAR Date:04/05/05ISR Number: 4657400-4Report Type:Periodic Company Report #2004076161 Age:19 YR Gender:Male I/FU:I Outcome PT Other Electrocardiogram Qt Corrected Interval 22-Feb-2006 08:32 AM Page: 726 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prolonged Report Source Product Role Manufacturer Route Dose Duration Health Geodon (Ziprasidone) PS ORAL 160 MG (80 Professional MG, 2 IN 1 Company D), ORAL Representative Olanzapine C Lithium C Date:04/05/05ISR Number: 4657523-XReport Type:Periodic Company Report #2004076507 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Extrapyramidal Disorder Health Geodon (Ziprasidone) PS ORAL 160 MG (80 Professional MG,2 IN 1 Company D),ORAL Representative Escitalopram (Escitalopram) SS Date:04/05/05ISR Number: 4657525-3Report Type:Periodic Company Report #2004076529 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Extrapyramidal Disorder Health Geodon (Ziprasidone) PS ORAL 160 MG Professional (80MG,2 IN 1 Company D),ORAL Representative Date:04/05/05ISR Number: 4657527-7Report Type:Periodic Company Report #2004076792 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Health Geodon (Ziprasidone) PS ORAL 160 MG (80 Bruxism Professional MG,2 IN 1 Dyskinesia Company D),ORAL Dystonia Representative Sertraline Jaw Disorder Hydrochloride Muscle Tightness (Sertraline Obsessive-Compulsive Hydrochloride) C Disorder Levothyroxine Sodium Rash (Levothyroxine Tic Sodium) C Acetylsalicylic Acid (Acetylsalicylic Acid) C Date:04/05/05ISR Number: 4657529-0Report Type:Periodic Company Report #2004077391 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Syncope Health Geodon (Ziprasidone) PS ORAL 40 MG(20 MG,2 Initial or Prolonged Professional IN 1 D),ORAL Other Company Ethanol (Ethanol) C Representative 22-Feb-2006 08:32 AM Page: 727 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/05/05ISR Number: 4657532-0Report Type:Periodic Company Report #2004077409 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Health Geodon (Ziprasidone) PS ORAL 80 MG (1 IN 1 Syncope Professional D),ORAL Company Levetiracetam Representative (Levetiracetam) SS ORAL 500 MG (1 IN 1 D),ORAL Trazodone (Trazodone) C Clonazepam (Clonazepam) C Pantoprazole (Pantoprazole) C Date:04/05/05ISR Number: 4657536-8Report Type:Periodic Company Report #2004077507 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Health Geodon (Ziprasidone) PS Initial or Prolonged Professional Company Representative Date:04/05/05ISR Number: 4657537-XReport Type:Periodic Company Report #2004080332 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Health Geodon (Ziprasidone) PS ORAL ORAL Corrected Interval Professional Anti-Diabetics Prolonged Company (Anti-Diabetics) C Representative Date:04/05/05ISR Number: 4657538-1Report Type:Periodic Company Report #2004081963 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Health Geodon (Ziprasidone) PS ORAL 160 MG (80 Initial or Prolonged Restless Legs Syndrome Professional MG,2 IN 1 Other Company D),ORAL Representative Lithium Carbonate (Lithium Carbonate) C Clonazepam (Clonazepam) C Quetiapine Fumarate (Quetiapine Fumarate) C Date:04/05/05ISR Number: 4657539-3Report Type:Periodic Company Report #2004082293 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Geodon (Ziprasidone) PS ORAL 80 MG (40 MG, Initial or Prolonged Phosphokinase Increased Professional 2 IN 1 Other Pyrexia D),ORAL All Other Therapeutic Products 22-Feb-2006 08:32 AM Page: 728 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (All Other Therapeutic Products) C Date:04/05/05ISR Number: 4657541-1Report Type:Periodic Company Report #2004082871 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Health Geodon (Ziprasidone) PS ORAL 120 MG (40 Initial or Prolonged Corrected Interval Professional MG,2 IN 1 D), Other Prolonged Company ORAL Representative Date:04/05/05ISR Number: 4657542-3Report Type:Periodic Company Report #2004085780 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Health Geodon (Ziprasidone) PS Corrected Interval Professional Prolonged Company Representative Date:04/05/05ISR Number: 4657543-5Report Type:Periodic Company Report #2004089392 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Adverse Drug Reaction Health Geodon (Ziprasidone) PS ORAL 80 MG (40 Dystonia Professional MG,2 IN 1 Company D),ORAL Representative Benzatropine Mesilate (Benzatropine Mesilate) SS Oxcarbazepine (Oxcarbazepine) C Fluoxetine Hydrochloride (Fluoxetine Hydrochloride) C Date:04/05/05ISR Number: 4657544-7Report Type:Periodic Company Report #2004090613 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Health Geodon (Ziprasidone) PS Initial or Prolonged Professional Date:04/05/05ISR Number: 4657546-0Report Type:Periodic Company Report #2004092319 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Health Geodon (Ziprasidone) PS Convulsion Professional Lorazepam Drug Interaction (Lorazepam) SS Somnolence 22-Feb-2006 08:32 AM Page: 729 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/05/05ISR Number: 4657549-6Report Type:Periodic Company Report #2004097853 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Health Geodon (Ziprasidone) PS Initial or Prolonged Extrapyramidal Disorder Professional Olanzapine Salivary Hypersecretion Company (Olanzapine) C Tongue Oedema Representative Citalopram Hydrobromide (Citalopram Hydrobromide) C Benzatropine Mesilate (Benzatropine Mesilate) C Gabapentin (Gabapentin) C Clonazepam (Clonazepam) C Diphenhydramine Hydrochloride (Diphenhydramine Hydrochloride) C Bezatropine Mesilate C Date:04/05/05ISR Number: 4657557-5Report Type:Periodic Company Report #2004105113 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Geodon (Ziprasidone) PS Professional Company Representative Date:04/05/05ISR Number: 4657558-7Report Type:Periodic Company Report #2004110520 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Nausea Health Geodon (Ziprasidone) PS ORAL 160 MG (40 Vomiting Professional MG, 2 IN 1 Other D),ORAL Lithium Carbonate (Lithium Carbonate) C Lamotrigine (Lamotrigine) C Bupropion Hydrochloride (Bupropion Hydrochloride) C Methadone (Methadone) C Date:04/05/05ISR Number: 4657560-5Report Type:Periodic Company Report #2004110965 Age:56 YR Gender:Male I/FU:I Outcome PT Hospitalization - Anxiety Initial or Prolonged Depression Other Extrapyramidal Disorder 22-Feb-2006 08:32 AM Page: 730 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tardive Dyskinesia Report Source Product Role Manufacturer Route Dose Duration Health Geodon (Ziprasidone) PS ORAL 80 MG (40 Professional MG,BID Company INTERVAL: Representative EVERY DAY),ORAL Lithium (Lithium) C Antidepressants (Antidepressants) C Atorvastatin (Atorvastatin) C Escitalopram (Escitalopram) C Date:04/05/05ISR Number: 4657562-9Report Type:Periodic Company Report #2004112466 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Geodon (Ziprasidone) PS ORAL (20 MG),ORAL Initial or Prolonged Professional Xanax Xr Other Company (Alprazolam) SS (1 MG) Representative Paroxetine Hydrochloride (Paroxetine Hydrochloride) C Risperidone (Risperidone) C Date:04/05/05ISR Number: 4657564-2Report Type:Periodic Company Report #2004115947 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Health Geodon (Ziprasidone) PS Corrected Interval Professional Prolonged Company Representative Date:04/05/05ISR Number: 4657566-6Report Type:Periodic Company Report #2005001700 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Health Geodon (Ziprasidone) PS ORAL 120 MG (40 Blood Glucose Increased Professional MG, 2 IN 1 Disease Recurrence D), ORAL Insomnia Venlafaxine Mania Hydrochloride C Hydroxyzine Hydrochloride C Clonazepam C Rosiglitazone Maleate C Metformin Hydrochloride C Atenolol C Atorvastatin C Fenofibrate C 22-Feb-2006 08:32 AM Page: 731 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Triobe (Cyanocobalamin, Folic Acid, Pyridoxine) C Date:04/05/05ISR Number: 4657567-8Report Type:Periodic Company Report #2005008011 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Rash Health Geodon (Ziprasidone) PS ORAL 240 MG (2 IN Initial or Prolonged Professional 1 D), ORAL Company Representative Date:04/05/05ISR Number: 4657569-1Report Type:Periodic Company Report #2005014707 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Grand Mal Convulsion Health Geodon (Ziprasidone) PS Professional Company Representative Date:04/05/05ISR Number: 4657570-8Report Type:Periodic Company Report #2005020501 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Geodon (Ziprasidone) PS ORAL 80 MG (80 MG, Initial or Prolonged Rectal Haemorrhage Professional 1 IN 1 D), Sleep Disorder ORAL Benadryl Allergy (Diphenhydramine)(Be nadryl Allergy)(Diphenhydra mine) SS ORAL ORAL Ethanol C Cocaine C Naproxen C Date:04/05/05ISR Number: 4657571-XReport Type:Periodic Company Report #2005020564 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dementia Health Geodon (Ziprasidone) PS ORAL 20 MG (20 MG, Hypocalcaemia Professional 1 IN 1 D), Psychotic Disorder ORAL Date:04/05/05ISR Number: 4657572-1Report Type:Periodic Company Report #2005026271 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Consumer Geodon (Ziprasidone) PS ORAL 120 MG (40 Dizziness MG, 1 D), Malaise ORAL Syncope Alprazolam C 22-Feb-2006 08:32 AM Page: 732 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/05/05ISR Number: 4657573-3Report Type:Periodic Company Report #2005026963 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diarrhoea Health Geodon (Ziprasidone) PS ORAL 160 MG (80 Extrapyramidal Disorder Professional MG, 2 IN 1 Haematochezia Company D), ORAL Representative Date:04/05/05ISR Number: 4657574-5Report Type:Periodic Company Report #2002002578 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Urinary Retention Health Geodon (Ziprasidone) PS ORAL 160 MG (BID), Professional ORAL Citalopram C Rabeprazole C Date:04/05/05ISR Number: 4657575-7Report Type:Periodic Company Report #2003037090 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bundle Branch Block Right Health Geodon (Ziprasidone) PS 120 MG Professional (DAILY) Paroxetine Hydrochloride C Clonazepam C Date:04/05/05ISR Number: 4657576-9Report Type:Periodic Company Report #2003040258 Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Heart Rate Decreased Health Ziprasidone (Caps) Initial or Prolonged Professional (Ziprasidone) PS ORAL 20 MG (EVERY NIGHT), ORAL Donepezil Hydrochloride C Metoprolol C All Other Therapeutic Products C Enalapril C Date:04/05/05ISR Number: 4657577-0Report Type:Periodic Company Report #2004007839 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Orthostatic Hypotension Health Geodon (Ziprasidone) PS Initial or Prolonged Professional Company Representative Date:04/05/05ISR Number: 4657578-2Report Type:Periodic Company Report #2004008696 Age: Gender:Female I/FU:I Outcome PT Report Source Other Convulsion Health Professional 22-Feb-2006 08:32 AM Page: 733 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company Representative Product Role Manufacturer Route Dose Duration Geodon (Ziprasidone) PS 40 MG (BID) Date:04/05/05ISR Number: 4657579-4Report Type:Periodic Company Report #2004010629 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Health Geodon (Ziprasidone) PS ORAL ORAL Electrocardiogram Qt Professional Citalopram Corrected Interval Company Hydrobromide Prolonged Representative (Citalopram Hydrobromide) C Trazodone (Trazodone) C Bupropion Hydrochloride (Bupropion Hydrochloride) C Anovlar (Ethinylestradiol, Norethisterone Acetate) C Date:04/05/05ISR Number: 4657581-2Report Type:Periodic Company Report #2004011013 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Disorientation Consumer Geodon (Ziprasidone) PS ORAL 20 MG Dizziness (DAILY), ORAL Feeling Jittery Sertraline Heart Rate Increased Hydrochloride C Impaired Driving Ability Clonazepam C Dyazide (Hydrochlorothiazide , Triamterene) C Acetylsalicylic Acid C Date:04/05/05ISR Number: 4657583-6Report Type:Periodic Company Report #2004012870 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Heart Rate Increased Consumer Geodon (Ziprasidone) PS Loss Of Consciousness Date:04/05/05ISR Number: 4657586-1Report Type:Periodic Company Report #2004013889 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Geodon (Ziprasidone) PS Drug Administration Error Professional Valproate Semisodium SS Intentional Misuse Company Overdose Representative 22-Feb-2006 08:32 AM Page: 734 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/05/05ISR Number: 4657588-5Report Type:Periodic Company Report #2004016035 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Consumer Geodon (Ziprasidone) PS ORAL 80 MG Mood Swings (DAILY), ORAL Petit Mal Epilepsy Phenytoin Sodium C Date:04/05/05ISR Number: 4657590-3Report Type:Periodic Company Report #2004019257 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Health Geodon (Ziprasidone) PS 120 MG Professional (DAILY) Company Representative Date:04/05/05ISR Number: 4657591-5Report Type:Periodic Company Report #2004019587 Age:16.5 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Health Geodon (Ziprasidone) PS 80 MG (BID) Professional Penicillin Nos SS Company Representative Date:04/05/05ISR Number: 4657593-9Report Type:Periodic Company Report #2004023213 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Priapism Health Geodon (Ziprasidone) PS Professional Company Representative Date:04/05/05ISR Number: 4657594-0Report Type:Periodic Company Report #2004023507 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Health Geodon (Ziprasidone) PS ORAL 60 MG Body Temperature Professional (DAILY), ORAL Increased Company Escitalopram Bruxism Representative (Escitalopram) SS UNK (DAILY), Convulsion UNKNOWN Drug Interaction Dyskinesia Date:04/05/05ISR Number: 4657596-4Report Type:Periodic Company Report #2004024801 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Urine Present Health Geodon (Ziprasidone) PS 320 MG (2 IN Intentional Misuse Professional 1 D) Thrombocytopenia Company Valproate Semisodium Representative (Valproate Semisodium) SS 3000 MG (2 IN 1 D) 22-Feb-2006 08:32 AM Page: 735 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/05/05ISR Number: 4657597-6Report Type:Periodic Company Report #2004026994 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Geodon (Ziprasidone) PS ORAL 160 MG (80, 2 Initial or Prolonged Phosphokinase Increased Professional IN 1 D), ORAL Other Micturition Disorder Company Risperidone Neck Pain Representative (Risperidone) SS Syncope Clonazepam White Blood Cell Count (Clonazepam) C Increased Propranolol Hydrochloride (Propranolol Hydrochloride) C Tocopherol (Tocopherol) C Date:04/05/05ISR Number: 4657598-8Report Type:Periodic Company Report #2004027328 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Health Geodon (Ziprasidone) PS ORAL 160 MG (BID), Dystonia Professional ORAL Road Traffic Accident Benzatropine Somnolence Mesilate Swollen Tongue (Benzatropine Mesilate) SS INTRAMUSCULAR 2 MG (ONCE), INTRAMUSCULAR Levothyroxine Sodium (Levothyroxine Sodium) C Citalopram (Citalopram C Olanzapine (Olanzapine) C Date:04/05/05ISR Number: 4657599-XReport Type:Periodic Company Report #2004030072 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arthralgia Consumer Geodon (Ziprasidone) PS 80 MG (40 MG, Chest Discomfort 2 IN 1 D), Constipation UNKNOWN Diarrhoea Drug Withdrawal Syndrome Dyspnoea Headache Muscle Spasms Poisoning Tremor Vision Blurred Date:04/05/05ISR Number: 4657600-3Report Type:Periodic Company Report #2004030454 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Geodon (Ziprasidone) PS Professional 22-Feb-2006 08:32 AM Page: 736 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/05/05ISR Number: 4657601-5Report Type:Periodic Company Report #2004032275 Age:5 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Extrapyramidal Disorder Health Geodon (Ziprasidone) PS UNK (20 MG) Professional Company Representative Date:04/05/05ISR Number: 4657602-7Report Type:Periodic Company Report #2004032279 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Insomnia Health Geodon (Ziprasidone) PS 120 MG (60 Initial or Prolonged Social Avoidant Behaviour Professional MG, 2 IN 1 D) Company Representative Date:04/05/05ISR Number: 4657604-0Report Type:Periodic Company Report #2004032571 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Geodon (Ziprasidone) PS 80 MG Professional Company Representative Date:04/05/05ISR Number: 4657606-4Report Type:Periodic Company Report #2004034255 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Pneumonia Consumer Geodon (Ziprasidone) PS ORAL UNK, ORAL Restless Legs Syndrome Clonazepam Tremor (Clonazepam) C Doxazosin (Doxazosin) C Date:04/05/05ISR Number: 4657618-0Report Type:Periodic Company Report #2003116617 Age:14 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Increased Health Geodon (Ziprasidone) PS ORAL 60 MG (TID), Pneumonia Aspiration Professional ORAL Sedation Concerta (Methylphenidate Hydrochloride) SS ORAL 54 MG, ORAL Venlafaxine Hydrochloride C Mellaril (Thioridazine Hydrochloride) C 22-Feb-2006 08:32 AM Page: 737 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/05/05ISR Number: 4657619-2Report Type:Periodic Company Report #2003121405 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Electrocardiogram Qt Health Geodon (Ziprasidone) PS ORAL 160 MG (BID), Other Corrected Interval Professional ORAL Prolonged Haloperidol SS ORAL 5 MG (DAILY), ORAL Quetiapine Fumarate SS ORAL 1100 MG, ORAL Hydroxyzine Embonate C Gemfibrozil C Lorazepam C Levothyroxine Sodium C Ferrous Sulfate C Gabapentin C Nordette (Ethinylestradiol, Levonorgestrel) C Date:04/05/05ISR Number: 4657625-8Report Type:Periodic Company Report #2004004897 Age:6 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Health Geodon (Ziprasidone) PS Initial or Prolonged Professional Antidepressants Company (Antidepressants) C Representative Date:04/05/05ISR Number: 4657626-XReport Type:Periodic Company Report #2004005901 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bradycardia Health Geodon (Ziprasidone) PS Professional Clonidine SS Company Representative Date:04/06/05ISR Number: 4628841-6Report Type:Expedited (15-DaCompany Report #2004018430 Age:5 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Health Geodon (Ziprasidone) PS ORAL 120 MG (2 IN Convulsion Professional 1 D); ORAL Dystonia Company Obetrol (Amfetamine Fall Representative Aspartate, Heart Rate Abnormal Amfetamine Sulfate, Incontinence Dexamfetamine Muscle Tightness Saccharate, C Oculogyration Oxcarbazepine C Sedation Guanfacine Hydrochloride C Date:04/06/05ISR Number: 4630375-XReport Type:Expedited (15-DaCompany Report #2005050070 Age: Gender:Male I/FU:I Outcome PT Other Dermatitis Exfoliative Rash 22-Feb-2006 08:32 AM Page: 738 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Stevens-Johnson Syndrome Report Source Product Role Manufacturer Route Dose Duration Health Geodon (Ziprasidone) PS ORAL 120 MG (60 Professional MG, 2 IN 1 Company D), ORAL Representative Haloperidol (Haloperidol) C Date:04/11/05ISR Number: 4634362-7Report Type:Expedited (15-DaCompany Report #2004041946 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Feeling Abnormal Foreign Ziprasidone Initial or Prolonged Impulsive Behaviour Health Insomnia Professional (Ziprasidone) PS ORAL 80 MG (40 MG, Overdose 2 IN 1 D), ORAL Zopiclone (Zopiclone) C Date:04/11/05ISR Number: 4634381-0Report Type:Expedited (15-DaCompany Report #2004063984 Age:75 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Perforated Ulcer Foreign Zeldox (Capsules) Other Peritonitis Consumer (Ziprasidone) PS ORAL 80 MG (40 MG, Health 2 IN 1 D), Professional ORAL Magnecyl-Kodein (Acetylsalicylic Acid, Codeine Phosphate, Magnesium Oxide) C Date:04/11/05ISR Number: 4635033-3Report Type:Expedited (15-DaCompany Report #2005051613 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancreatitis Health Geodon (Ziprasidone) PS Initial or Prolonged Professional Olanzapine Other Company (Olanzapine) SS Representative Date:04/11/05ISR Number: 4635278-2Report Type:Expedited (15-DaCompany Report #2005028239 Age:18 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Facial Nerve Disorder Health Geodon (Ziprasidone) PS ORAL 160 MG (1 IN Tardive Dyskinesia Professional 1 D), ORAL Tongue Oedema Company Azithromycin Representative (Azithromycin) C 22-Feb-2006 08:32 AM Page: 739 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/12/05ISR Number: 4633297-3Report Type:Expedited (15-DaCompany Report #2005022933 Age:21 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Palpitations Health Geodon (Ziprasidone) PS ORAL 120 MG (40 Initial or Prolonged Suicidal Ideation Professional MG, 3 IN 1 Other Wolff-Parkinson-White D), ORAL Syndrome Alprazolam (Alprazolam) C Risperidone (Risperidone) C Venlafaxine Hydrochloride (Venlafaxine Hydrochloride) C Date:04/12/05ISR Number: 4634414-1Report Type:Expedited (15-DaCompany Report #2004081893 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aggression Health Geodon (Ziprasidone) PS INTRAMUSCULAR 160 MG (80 Life-Threatening Body Temperature Professional MG, 2 IN 1 D) Hospitalization - Increased Company Olanzapine Initial or Prolonged Heart Rate Increased Representative (Olanzapine) SS Intentional Self-Injury All Other Neuroleptic Malignant Therapeutic Products Syndrome (All Other Ventricular Tachycardia Therapeutic Products) C Date:04/12/05ISR Number: 4634416-5Report Type:Expedited (15-DaCompany Report #2005051964 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Oxygen Saturation Health Geodon (Ziprasidone) PS ORAL 80 MG (40 MG Decreased Professional , 2 IN 1 D), Respiratory Arrest Company ORAL Sleep Apnoea Syndrome Representative Fluoxetine Hydrochloride) Fluoxetine Hydrochloride) C Topiramate (Topiramate) C Lorazepam (Lorazepam) C Date:04/13/05ISR Number: 4634660-7Report Type:Expedited (15-DaCompany Report #2005052177 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Geodon (Ziprasidone) PS ORAL 160 MG (80 Initial or Prolonged Professional MG, 2 IN 1 D), ORAL 22-Feb-2006 08:32 AM Page: 740 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/13/05ISR Number: 4635435-5Report Type:Expedited (15-DaCompany Report #2004040233 Age:67 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Pressure Health Geodon (Im) Hospitalization - Fluctuation Professional (Ziprasidone) PS INTRAMUSCULAR 20 MG, Initial or Prolonged Coma Other INTRAMUSCULAR Other Depressed Level Of Consciousness Ventricular Extrasystoles Date:04/13/05ISR Number: 4635540-3Report Type:Expedited (15-DaCompany Report #2005027310 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Screen Positive Consumer Geodon (Ziprasidone) PS ORAL 120 MG (60 Sudden Death Health MG, 2 IN 1 Professional D), ORAL Olanzapine(Olanzapin e) C Lithium (Lithium) C Valproate Semisodium (Valproate Semisodium) C Date:04/13/05ISR Number: 4635542-7Report Type:Expedited (15-DaCompany Report #2004102186 Age:83 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aggression Health Geodon (Ziprasidone) PS ORAL 80 MG (20 MG, Other Atrioventricular Block Professional 4 IN 1 D), First Degree ORAL Blood Chloride Decreased Cyanocobalamin Blood Magnesium Increased (Cyanocobalamin) C Blood Sodium Increased Ranitidine General Physical Health Hydrochloride Deterioration (Rantidine Renal Failure Hydrochloride) C Ventricular Extrasystoles Senna Fruit (Senna Fruit) C Hydrochlorothiazide (Hydrochlorothiazide ) C Magensium Hydroxide (Magnesium Hydroxide) C Tocopherol (Tocopherol) C Potassium Chloride (Potassium Chloride) C All Other Therapetutic Products (All Other Therapeutic Products) C Mirtazapine (Mirtazapine) C Quetiapine Fumarate (Quetiapine Fumarate) C 22-Feb-2006 08:32 AM Page: 741 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/13/05ISR Number: 4635556-7Report Type:Expedited (15-DaCompany Report #2004087302 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aphasia Health Geodon (Ziprasidone) PS ORAL 80 MG (40 MG, Other Dementia Professional 2 IN 1 D), Depression Company ORAL Dysphagia Representative Bactrim Feeding Disorder (Sulfamethoxazole, Myocardial Infarction Trimethoprim) SS Neuromyopathy Amlodipine Besilate C Psychotic Disorder Selective Mutism Thinking Abnormal Date:04/14/05ISR Number: 4636704-5Report Type:Expedited (15-DaCompany Report #2005052957 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Self-Medication Health Geodon (Ziprasidone) PS Professional Bupropion Company Hydrochloride Representative (Bupropion Hydrochloride) SS Olanzapine/Fluoxetin e Hydrochloride (Fluoxetine Hydrochloride, Olanzapine) SS Mirtazapine (Mirtazepine) SS Obetrol (Amfetamine Aspartate, Amfetamine Sulfate, Dexamfetamine Saccharate, SS Date:04/14/05ISR Number: 4636761-6Report Type:Expedited (15-DaCompany Report #2005052177 Age: Gender:Unknown I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Geodon (Ziprasidone) PS ORAL 160 MG (80 Initial or Prolonged Pharmaceutical Product Professional MG,2 IN 1 D), Complaint ORAL Schizophrenia Date:04/14/05ISR Number: 4637038-5Report Type:Expedited (15-DaCompany Report #2005054161 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dialysis Health Geodon (Ziprasidone) PS Neuroleptic Malignant Professional Geodon (Ziprasidone) SS Syndrome Company Representative 22-Feb-2006 08:32 AM Page: 742 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/15/05ISR Number: 4638021-6Report Type:Expedited (15-DaCompany Report #2005055483 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Foreign Geodon (Ziprasidone) PS ORAL 80 MG, ORAL Consumer Date:04/15/05ISR Number: 4638120-9Report Type:Expedited (15-DaCompany Report #2005022933 Age:21 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Palpitations Health Geodon (Ziprasidone) PS ORAL 120 MG (40 Initial or Prolonged Sinus Tachycardia Professional MG, 3 IN 1 Other Suicidal Ideation D), ORAL Wolff-Parkinson-White Alprazolam Syndrome (Alprazolam) C Risperidone (Risperidone) C Venlafaxine Hydrochloride (Venlafaxine Hydrochloride) C Date:04/15/05ISR Number: 4639622-1Report Type:Expedited (15-DaCompany Report #2005055422 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Loss Of Consciousness Health Geodon (Ziprasidone) PS Professional Company Representative Date:04/15/05ISR Number: 4663968-4Report Type:Periodic Company Report #2005015578 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Health Geodon (Im) Prolonged Professional (Ziprasidone) PS INTRAMUSCULAR UNK, INTRAMUSCULAR Haloperidol (Haloperidol) C Duloxetine Hydrochloride (Duloxetine Hydrochloride) C Methadone (Methadone) C Date:04/18/05ISR Number: 4639088-1Report Type:Expedited (15-DaCompany Report #2005056020 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Geodon (Ziprasidone) PS Drug Exposure During Consumer All Other Pregnancy Non-Therapeutic Pregnancy Products (All Other Non-Therapeutic Products) SS 22-Feb-2006 08:32 AM Page: 743 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Clomipramine Hydrochloride (Clomipramine Hydrochloride) C Thioridazine (Thioridazine) C Date:04/18/05ISR Number: 4639329-0Report Type:Expedited (15-DaCompany Report #2005055621 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Appetite Disorder Consumer Zoloft (Sertraline) PS ORAL 100 MG (100 Dehydration MG, 1 IN 1 Dental Caries D), ORAL Depression Geodon (Ziprasidone) SS ORAL 60 MG (60 MG, Dry Mouth 1 IN 1 D), Gastric Disorder ORAL Headache Quetiapine Fumarate Mood Swings (Quetiapine Nausea Fumarate) SS ORAL 300 MG (1 IN Post Procedural 1 D), ORAL Haemorrhage Folic Acid (Folic Procedural Pain Acid) C Vomiting Weight Decreased Date:04/18/05ISR Number: 4640009-6Report Type:Expedited (15-DaCompany Report #2005054991 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardio-Respiratory Arrest Health Geodon (Ziprasidone) PS Torsade De Pointes Professional Droperidol Company (Droperidol) SS Representative Date:04/19/05ISR Number: 4640617-2Report Type:Expedited (15-DaCompany Report #2005021159 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Ziprasidone (Caps) Initial or Prolonged Schizophrenia Health (Ziprasidone) PS Tachycardia Professional Ventricular Arrhythmia Date:04/19/05ISR Number: 4640627-5Report Type:Expedited (15-DaCompany Report #2004022047 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Foreign Geodon (Ziprasidone) PS Other Sudden Death Health Chlorpromazine Professional Hydrochloride Company (Chlorpromazine Representative Hydrochloride) SS Other 22-Feb-2006 08:32 AM Page: 744 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/20/05ISR Number: 4642078-6Report Type:Expedited (15-DaCompany Report #2005034242 Age:23 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Geodon (Ziprasidone) PS ORAL SEE IMAGE Initial or Prolonged Delusion Professional Other Eye Luxation Company Nerve Injury Representative Self Injurious Behaviour Date:04/20/05ISR Number: 4642083-XReport Type:Expedited (15-DaCompany Report #2005052957 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Self-Medication Health Geodon (Ziprasidone) PS Professional Bupropion Company Hydrochloride Representative (Bupropion Hydrochloride) SS Olanzapine/Fluoxetin e Hydrochloride (Fluoxetine Hydrochloride, Olanzapine) SS Mirtazapine (Mirtazapine) SS Obetrol (Amfetamine Aspartate, Amfetamine Sulfate, Dexamethaosne Saccharate, SS Date:04/20/05ISR Number: 4642367-5Report Type:Expedited (15-DaCompany Report #2004022047 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Foreign Geodon (Ziprasidone) PS Other Health Chlorpromazine Professional Hydrochloride Company (Chlorpromazine Representative Hydrochloride) SS Date:04/20/05ISR Number: 4642394-8Report Type:Expedited (15-DaCompany Report #2005021159 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Ziprasidone (Caps) Initial or Prolonged Schizophrenia Health (Ziprasidone) PS Tachycardia Professional Ventricular Arrhythmia Date:04/21/05ISR Number: 4642196-2Report Type:Expedited (15-DaCompany Report #2005S1001288 Age:61 YR Gender:Male I/FU:F Outcome PT Death Acquired Diaphragmatic Eventration Back Pain 22-Feb-2006 08:32 AM Page: 745 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Cardio-Respiratory Arrest Cough Dyspnoea Report Source Product Role Manufacturer Route Dose Duration Oxygen Saturation Health Clozapine Tablets Decreased Professional (25 Mg) PS ORAL 50 MG; HS; PO Restlessness Other Clozapine Tablets (100 Mg) SS ORAL 400 MG; HS; PO Geodon SS 160 MG; BID; Escitalopram C Lansoprazole C Psyllium Hydrophilic C Mucilloid C Valproate Semisodium C Benzatropine Mesilate C Ascorbic Acid/Tocopherol/Reti nol C Macrogol C Date:04/21/05ISR Number: 4642863-0Report Type:Expedited (15-DaCompany Report #2004071877 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Foreign Zeldox (Capsules) Initial or Prolonged Somnolence Health (Ziprasidone) PS ORAL 120 MG (60 Other Suicide Attempt Professional MG, 2 IN 1 Company D), ORAL Representative Xanax Xr (Alprazolam) SS ORAL 3 MG (2 IN 1 D),ORAL Date:04/21/05ISR Number: 4643059-9Report Type:Expedited (15-DaCompany Report #2004079230 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Death Foreign Zeldox (Capsules) Cardiomegaly Health (Ziprasidone) PS ORAL ORAL Drug Ineffective Professional Quetiapine Fumarate Drug Interaction Company (Quetiapine Representative Fumarate) SS ORAL 600 MG (1 IN 1 D), ORAL Herbal Preparation (Herbal Preparation) C Date:04/21/05ISR Number: 4643288-4Report Type:Expedited (15-DaCompany Report #2005054991 Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Disorder Health Geodon (Ziprasidone) PS Cardio-Respiratory Arrest Professional Droperidol Electrocardiogram Qt Company (Droperidol) SS Corrected Interval Representative Prolonged Nausea Torsade De Pointes 22-Feb-2006 08:32 AM Page: 746 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/22/05ISR Number: 4643081-2Report Type:Expedited (15-DaCompany Report #2004076135 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Health Geodon (Im) Hospitalization - Electrocardiogram Qt Professional (Ziprasidone) PS INTRAMUSCULAR 20 MG Initial or Prolonged Corrected Interval Company INTRAMUSCULAR Prolonged Representative Antipsychotics (Antipsychotics) SS Date:04/22/05ISR Number: 4643150-7Report Type:Expedited (15-DaCompany Report #2005034242 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Geodon (Ziprasidone) PS INTRAMUSCULAR 20 MG, Initial or Prolonged Delusion Professional INTRAMUSCULAR Other Eyeball Avulsion Company Self Mutilation Representative Date:04/25/05ISR Number: 4645549-1Report Type:Expedited (15-DaCompany Report #2005056020 Age:38 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Foreign Geodon (Ziprasidone) PS ORAL 80 MG, ORAL Completed Suicide Consumer All Other Depression Non-Therapeutic Drug Exposure During Products (All Other Pregnancy Non-Therapeutic Irritability Products) SS Pregnancy Clomipramine Hydrochloride (Clomipramine Hydrochloride) C Thioridazine Hydrochloride (Thioridazine Hydrochloride) C Haloperidol (Haloperidol) C Clonazepam (Clonazepam) C Date:04/25/05ISR Number: 4645722-2Report Type:Expedited (15-DaCompany Report #2005055483 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Foreign Geodon (Ziprasidone) PS ORAL (80 MG), ORAL Consumer Date:04/25/05ISR Number: 4645775-1Report Type:Expedited (15-DaCompany Report #2005058111 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiomegaly Health Geodon (Ziprasidone) PS Professional Company Representative 22-Feb-2006 08:32 AM Page: 747 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/25/05ISR Number: 4646006-9Report Type:Expedited (15-DaCompany Report #2003028413 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Geodon (Ziprasidone) PS Professional Company Representative Date:04/25/05ISR Number: 4646021-5Report Type:Expedited (15-DaCompany Report #2004023066 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Geodon (Ziprasidone) PS ORAL 160 MG 980 Other Cardiac Arrest Professional MG, 2 IN 1 Electrolyte Imbalance Company D), ORAL Intentional Misuse Representative All Other Suicide Attempt Therapeutic Products Treatment Noncompliance (All Other Therapeutic Products) SS Fluoxetine Hydrochloride (Fluoxetine Hydrochloride) C Diazepam (Diazepam) C Date:04/26/05ISR Number: 4647152-6Report Type:Expedited (15-DaCompany Report #2004035732 Age:73 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Electrocardiogram Foreign Zeldox (Capsules) Abnormal Health (Ziprasidone) PS ORAL 40 MG (20 MG, Electrocardiogram Qt Professional 2 IN 1 Corrected Interval D),ORAL Prolonged Haloperidol Ventricular Tachycardia (Haloperidol) C Amisulpride (Amisulpride) C Maprotiline Hydrochloride (Maprotiline Hydrochloride) C Bisoprolol Fumarate (Bisoprolol Fumarate) C Cilazapril (Cilazapril) C Prothipendyl Hydrochloride (Prothipendyl Hydrochloride) C Date:04/26/05ISR Number: 4647273-8Report Type:Expedited (15-DaCompany Report #2005059988 Age:35 YR Gender:Female I/FU:I Outcome PT Hospitalization - Antipsychotic Drug Level Initial or Prolonged Below Therapeutic 22-Feb-2006 08:32 AM Page: 748 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Depression Fatigue General Physical Health Report Source Product Role Manufacturer Route Dose Duration Deterioration Consumer Geodon (Ziprasidone) PS UNKNOWN UNKNOWN Malaise Lithium (Lithium) SS UNKNOWN UNKNOWN Self-Medication Trazodone Sleep Disorder (Trazodone) SS UNKNOWN UNKNOWN Weight Increased Escitalopram (Escitalopram) SS UNKNOWN UNKNOWN Topiramate (Topiramate) SS UNKNOWN UNKNOWN Lorazepam (Lorazepam) C Date:04/26/05ISR Number: 4647466-XReport Type:Expedited (15-DaCompany Report #2005059961 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Brain Damage Consumer Geodon (Ziprasidone) PS Impaired Work Ability Valproate Semisodium Road Traffic Accident (Valproate Semisodium) SS Date:04/26/05ISR Number: 4647564-0Report Type:Expedited (15-DaCompany Report #2005060756 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Myocardial Foreign Zeldox (Capsules) Initial or Prolonged Infarction Health (Ziprasidone) PS ORAL 40 MG (40 MG, Arrhythmia Professional 1 IN 1 D), Bradycardia Company ORAL Representative Citalopram (Citalopram) C Valproic Acid (Valproic Acid) C All Other Therapeutic Products C Date:04/26/05ISR Number: 4648249-7Report Type:Expedited (15-DaCompany Report #2004025153 Age:77 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Geodon (Im) Coronary Artery Professional (Ziprasidone) PS INTRAVENOUS 10 MG (10 MG, Atherosclerosis 1 IN 1 D), Dyspnoea INTRAVENOUS Loss Of Consciousness Digoxin (Digoxin) C Pulse Absent Warfarin Sodium (Warfarin Sodium) C Thiamine (Thiamine) C Folic Acid (Folic Acid) C Donepezil Hydrochloride (Donepezil Hydrochloride) C Potassium Chloride (Potassium Chloride) C 22-Feb-2006 08:32 AM Page: 749 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Atorvastatin (Atorvastatin) C Furosemide (Furosemide) C Carvedilol (Carvedilol) C Combivent (Ipratropium Bromide, Salbutamol Sulfate) C Valproate Semisodium (Valproate Semisodium) C Mirtazapine (Mirtazapine) C Quetiapine Fumarate (Quetiapine Fumarate) C Date:04/27/05ISR Number: 4649463-7Report Type:Expedited (15-DaCompany Report #2005054991 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Health Geodon (Ziprasidone) PS 120 MG (60 Initial or Prolonged Blood Magnesium Decreased Professional MG, 2 IN 1 D) Other Blood Potassium Decreased Company Droperidol Bradycardia Representative (Droperidol) SS Cardiac Disorder Morphine (Morphine) C Cardio-Respiratory Arrest Topiramate Edentulous (Topiramate) C Electrocardiogram Qt Venlafaxine Corrected Interval Hydrochloride Prolonged (Venlafaxine Electrocardiogram T Wave Hydrochloride) C Abnormal Alprazolam Nausea (Alprazolam) C Torsade De Pointes Ventricular Tachycardia Vomiting Date:04/28/05ISR Number: 4647935-2Report Type:Expedited (15-DaCompany Report #US-KINGPHARMUSA00001-K200500497 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Overdose Sonata PS King Initial or Prolonged Overdose Pharmaceuticals, Somnolence Inc. ORAL 14 tablets/10 mg each, single 1440 MIN Zeldox /Gfr/ SS ORAL 30 tablets/80 mg each, single 1440 MIN 22-Feb-2006 08:32 AM Page: 750 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/28/05ISR Number: 4649503-5Report Type:Direct Company Report #CTU 247348 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Body Temperature Ziprasidone PS ORAL 40MG PO QD Life-Threatening Increased PRIOR TO Hospitalization - HOSPITAL ADM Initial or Prolonged Date:04/28/05ISR Number: 4650181-XReport Type:Expedited (15-DaCompany Report #2004093147 Age:60 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Zeldox (Capsules) Health (Ziprasidone) PS Professional Company Representative Date:04/28/05ISR Number: 4650566-1Report Type:Expedited (15-DaCompany Report #2005061305 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Injury Health Geodon (Ziprasidone) PS 140 MG Mania Professional Company Representative Date:04/29/05ISR Number: 4651018-5Report Type:Expedited (15-DaCompany Report #2004046187 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Health Geodon (Ziprasidone) PS Other Pulmonary Embolism Professional Sudden Death Company Representative Date:04/29/05ISR Number: 4651031-8Report Type:Expedited (15-DaCompany Report #2004025153 Age:77 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Geodon (Im) Arterial Rupture Professional (Ziprasidone) PS INTRAMUSCULAR 10 MG (10 MG, Chronic Obstructive 1 IN 1 D), Pulmonary Disease INTRAMUSCULAR Coronary Artery Digoxin (Digoxin) C Atherosclerosis Warfarin Sodium Coronary Artery Disease (Warfarin Sodium) C Hypertension Thiamine (Thiamine) C Loss Of Consciousness Folic Acid (Folic Pulse Absent Acid) C Donepezil Hydrochloride (Donepezil Hydrochloride) C Potassium Chloride (Potassium Chloride) C Atorvastatin 22-Feb-2006 08:32 AM Page: 751 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Atorvastatin) C Furosemide (Furosemide) C Carvedilol (Carvedilol) C Combivent (Ipartropium Bromide, Salbutamol Sulfate) C Valproate Semisodium (Valproate Semisodium) C Mirtazapine (Mirtazapine) C Queitapine Fumarate (Queitapine Fumarate) C Date:05/02/05ISR Number: 4651462-6Report Type:Expedited (15-DaCompany Report #2005059988 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcohol Use Consumer Geodon (Ziprasidone) PS Initial or Prolonged Depression Lithium (Lithium) SS Drug Interaction Trazodone Drug Level Decreased (Trazodone) SS Fatigue Escitalopram General Physical Health (Escitalopram) SS Deterioration Topiramate Malaise (Topiramate) SS Pharmaceutical Product Lorazepam Complaint (Lorazepam) C Self-Medication Sleep Disorder Weight Increased Date:05/02/05ISR Number: 4651553-XReport Type:Expedited (15-DaCompany Report #2004046187 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Health Geodon (Ziprasidone) PS Other Pulmonary Embolism Professional Sudden Death Company Representative Date:05/02/05ISR Number: 4651979-4Report Type:Direct Company Report #CTU 247480 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Hypersensitivity Geodon PS BID Dystonia Muscle Spasms 22-Feb-2006 08:32 AM Page: 752 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/02/05ISR Number: 4652050-8Report Type:Expedited (15-DaCompany Report #2003034801 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anger Health Geodon (Ziprasidone) PS ORAL ORAL Hospitalization - Chest Pain Professional Lithium (Lithium) SS ORAL 900 MG (2 IN Initial or Prolonged Depressed Level Of Company 1 D), ORAL Other Consciousness Representative Bupropion Diabetic Hyperglycaemic Hydrochloride Coma (Bupropion Dizziness Hydrochloride) C Glucose Tolerance Anti-Diabetics Impaired (Anti-Diabetics) C Hepatitis C Date:05/02/05ISR Number: 4652149-6Report Type:Expedited (15-DaCompany Report #2005064410 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oculogyration Health Geodon (Ziprasidone) PS Professional Company Representative Date:05/02/05ISR Number: 4652225-8Report Type:Expedited (15-DaCompany Report #2005026763 Age:12 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Extrapyramidal Disorder Foreign Zeldox (Capsules) Pyrexia Health (Ziprasidone) PS ORAL 160 MG (80 Therapy Non-Responder Professional MG, 2 IN 1 D) Company ORAL Representative Diazepam C Date:05/02/05ISR Number: 4652689-XReport Type:Expedited (15-DaCompany Report #2005063029 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hyperthermia Foreign Geodon (Ziprasidone) PS ORAL ORAL Muscle Rigidity Health Sertraline Neuroleptic Malignant Professional (Sertraline) C Syndrome Company Pneumonia Representative Renal Failure Date:05/02/05ISR Number: 4652693-1Report Type:Expedited (15-DaCompany Report #2004115860 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Geodon (Ziprasidone) PS ORAL ORAL Other Consumer 22-Feb-2006 08:32 AM Page: 753 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/02/05ISR Number: 4652725-0Report Type:Expedited (15-DaCompany Report #2005060756 Age:65 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Myocardial Foreign Zeldox (Capsules) Initial or Prolonged Infarction Company (Ziprasidone) PS ORAL 40 MG (40 MG, Arrhythmia Representative 1 IN 1 D), Bradycardia ORAL Escitalopram (Escitalopram) C Lithium Carbonate (Lithium Carbonate) C Date:05/02/05ISR Number: 4653157-1Report Type:Direct Company Report #CTU 247541 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Crying Geodon 40 Mg Initial or Prolonged Drooling Pfizer PS Pfizer ORAL ONCE DAY Required Dyskinesia ORAL Intervention to Eye Movement Disorder Prevent Permanent Speech Disorder Impairment/Damage Tardive Dyskinesia Date:05/03/05ISR Number: 4652754-7Report Type:Expedited (15-DaCompany Report #2005S1001288 Age:61 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Back Pain Health Clozapine Tablets Cardio-Respiratory Arrest Professional (25 Mg) PS ORAL 50 MG; HS; PO Cough Other Clozapine Tablets Dyspnoea (100 Mg) SS ORAL 400 MG; HS; Loss Of Consciousness PO Restlessness Geodon SS 160 MG; BID; Wheezing Escitalopram C Lansoprazole C Psyllium Hydrophilic C Mucilloid C Valproate Semisodium C Benzatropine Mesilate C Ascorbic Acid/Tocopherol/Reti nol C Mcrogol C Albuterol C Magnesium C Date:05/03/05ISR Number: 4653295-3Report Type:Direct Company Report #CTU 247651 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Difficulty In Walking Geodon PS 40 MG DAILY Other Dystonia Required Movement Disorder Intervention to Muscle Contractions Prevent Permanent Involuntary Impairment/Damage Pain Posture Abnormal 22-Feb-2006 08:32 AM Page: 754 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/03/05ISR Number: 4654556-4Report Type:Direct Company Report #CTU 247593 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Syncope Geodon 40mg Initial or Prolonged Pfizer PS Pfizer ORAL 40MG BID WITH MEALS ORAL Escitalopram C Apap C Lorazepam C Maalox C Mom C Date:05/04/05ISR Number: 4653961-XReport Type:Expedited (15-DaCompany Report #2005064921 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicidal Ideation Foreign Zeldox (Capsules) Initial or Prolonged Health (Ziprasidone) PS ORAL ORAL Professional Date:05/04/05ISR Number: 4654399-1Report Type:Expedited (15-DaCompany Report #2005066658 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Literature Ziprasidone (Caps) Initial or Prolonged Akathisia Consumer (Ziprasidone) PS 40 MG (2 IN 1 Anorexia D) Feeling Abnormal Fluphenazine Hallucination, Auditory (Fluphenazine) SS 1 IN 2 WK Insomnia Irritability Mania Psychomotor Hyperactivity Tremor Date:05/04/05ISR Number: 4654742-3Report Type:Expedited (15-DaCompany Report #2005060756 Age:65 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Myocardial Foreign Zeldox (Capsules) Initial or Prolonged Infarction Health (Ziprasidone) PS ORAL 40 MG (40 MG, Bradyarrhythmia Professional 1 IN 1 D), Company ORAL Representative Escitalopram (Escitalopram) C Lithium Carbonate (Lithium Carbonate) C Date:05/04/05ISR Number: 4654954-9Report Type:Expedited (15-DaCompany Report #KII-2005-0016295 Age:33 YR Gender:Male I/FU:I Outcome PT Hospitalization - Blood Pressure Increased Initial or Prolonged Coma Other Drug Screen Positive Respiratory Depression 22-Feb-2006 08:32 AM Page: 755 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sinus Tachycardia Somnolence Report Source Product Role Manufacturer Route Dose Duration Study Morphine Sulfate Health (Similar To Nda Professional 19-516) (Morphine Other Sulfate) PS ORAL ORAL Ziprasidone (Ziprasidone) SS ORAL ORAL Date:05/05/05ISR Number: 4655549-3Report Type:Expedited (15-DaCompany Report #2005063643 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Consumer Geodon (Ziprasidone) PS ORAL 160 MG (80 MG Initial or Prolonged Decreased Appetite 2 IN 1 D) Other Glycosylated Haemoglobin ORAL Increased Metformin Nasopharyngitis Hydrochloride Oedema Peripheral (Metformin Thrombosis Hydrochloride) C Weight Decreased Venlafaxine Hydrochloride (Venlafaxine Hydrochloride) C Valproate Semisodium (Valproate Semisodium) C Fenofibrate (Fenofibrate) C Pravastatin Sodium (Pravastatin Sodium) C Omeprazole (Omeprazole) C Date:05/05/05ISR Number: 4655948-XReport Type:Expedited (15-DaCompany Report #2004068846 Age:23 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Circulatory Collapse Foreign Zeldox (Capsules) Initial or Prolonged Electrocardiogram Qt Health (Ziprasidone) PS ORAL 1210 MG (2 IN Corrected Interval Professional 1 D), ORAL Prolonged Company Sertraline Representative Hydrochloride (Sertraline Hydrochloride) C Date:05/09/05ISR Number: 4658538-8Report Type:Expedited (15-DaCompany Report #2005067529 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Myocardial Infarction Health Geodon (Ziprasidone) PS Professional Company Representative 22-Feb-2006 08:32 AM Page: 756 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/10/05ISR Number: 4658429-2Report Type:Direct Company Report #CTU 248116 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Generalised Oedema Lamictal PS 300 MG AT 8 Initial or Prolonged Rash AM AND 8 PM Geodon SS Artane C Ativan C Chlorpromazine C Zoloft C Date:05/10/05ISR Number: 4659555-4Report Type:Expedited (15-DaCompany Report #2005062127 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Foreign Ziprasidone Initial or Prolonged Condition Aggravated Study Dizziness Health Fall Professional (Ziprasidone) PS ORAL 40 MG (20 MG, Gait Disturbance Other 2 IN 1 D), Hallucination, Auditory ORAL Headache Flunitrazepam C Hypotension Haloperidol C Loss Of Consciousness Trihexyphenidyl C Psychiatric Symptom Syncope Vertigo Date:05/10/05ISR Number: 4659835-2Report Type:Expedited (15-DaCompany Report #2002071345 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Insomnia Foreign Ziprasidone (Caps) Initial or Prolonged Study (Ziprasidone) PS ORAL 80 MG (2 IN 1 Health D), ORAL Professional Insulin (Insulin) C Biperiden (Biperiden) C Sertraline (Sertraline) C Date:05/11/05ISR Number: 4661053-9Report Type:Expedited (15-DaCompany Report #2005067549 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anger Consumer Xanax Tablet Initial or Prolonged Anxiety Disorder (Alprazolam) PS ORAL 1.5 MG (0.5 Other Aphagia MG, 3 IN 1 Drug Dependence D), ORAL Drug Ineffective Neurontin Drug Withdrawal Syndrome (Gabapentin) SS ORAL 3 IN 1 D, Emotional Distress ORAL Intentional Misuse Geodon (Ziprasidone) SS ORAL ORAL Overdose Obetrol (Amfetamine Phobia Aspartate, Unevaluable Event Amfetamine Sulfate, Dexamfetamine Saccharate, C 22-Feb-2006 08:32 AM Page: 757 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Fluoxetine Hydrochloride (Fluoxetine Hydrochloride) C Date:05/12/05ISR Number: 4661562-2Report Type:Direct Company Report #CTU 248378 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atherosclerosis Geodon PS Dementia Dextroamphetamine C Myocardial Infarction Primidone C Respiratory Failure Atenolol C Treatment Noncompliance Docusate C Terazosin Hcl C Warfarin C Omeprazole C Aerobid Inhaler Flunisolide C Pentoxyfilline C Date:05/12/05ISR Number: 4661996-6Report Type:Expedited (15-DaCompany Report #2005070068 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Heat Stroke Health Geodon (Ziprasidone) PS ORAL 180 MG (90 Other Professional MG, 2 IN 1 D), ORAL Date:05/12/05ISR Number: 4662122-XReport Type:Expedited (15-DaCompany Report #2005022933 Age:21 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Health Geodon (Ziprasidone) PS ORAL 120 MG (40 Initial or Prolonged Abnormal Professional MG, 3 IN 1 Other Electrocardiogram Pr D), ORAL Shortened Alprazolam Electrocardiogram Qt (Alprazolam) C Corrected Interval Risperidone Prolonged (Risperidone) C Electrocardiogram Qt Venlafaxine Prolonged Hydrochloride Electrocardiogram (Venlafaxine Repolarisation Hydrochloride) C Abnormality Heart Rate Increased Palpitations Respiratory Rate Increased Sinus Tachycardia Suicidal Ideation Wolff-Parkinson-White Syndrome 22-Feb-2006 08:32 AM Page: 758 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/12/05ISR Number: 4662129-2Report Type:Expedited (15-DaCompany Report #2005063643 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Consumer Geodon (Ziprasidone) PS ORAL 160 MG (80 Initial or Prolonged Decreased Appetite MG, 2 IN 1 Other Glycosylated Haemoglobin D), ORAL Increased Glipizide Extended Nasopharyngitis Release (Glipizide) SS 2.5 MG Thrombosis Metformin Weight Decreased Hydrochloride (Metformin Hydrochloride) C Venlafaxine Hydrochloride (Venlafaxine Hydrochloride) C Valproate Semisodium (Valproate Semisodium) C Fenofibrate (Fenofibrate) C Pravastatin Sodium (Pravastatin Sodium) C Omeprazole (Omeprazole) C Date:05/12/05ISR Number: 4662386-2Report Type:Expedited (15-DaCompany Report #2005060706 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Foreign Zeldox (Capsules) Arrhythmia Health (Ziprasidone) PS ORAL 80 MG (80 MG, Supraventricular Professional 1 IN 1 D), Bradycardia Company ORAL Fatigue Representative Priadel (Lithium Hypotension Carbonate) C Lamictal (Lamotrigine) C Propanolol (Propanolol) C Date:05/13/05ISR Number: 4662569-1Report Type:Direct Company Report #CTU 248470 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Acute Myocardial Ziprasidone 40mg Hospitalization - Infarction Pfizer PS Pfizer ORAL 40MG HS ORAL Initial or Prolonged Divalproex C Required Lithium C Intervention to Lansoprazole C Prevent Permanent Clonidine C Impairment/Damage Gabapentin C Lorazepam C Ibuprofen C Aluminum-Magnesium Hydroxide/Simethicon e C 22-Feb-2006 08:32 AM Page: 759 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/13/05ISR Number: 4662572-1Report Type:Direct Company Report #CTU 248472 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Ziprasidone 80mg Pfizer PS Pfizer ORAL 80MG BID ORAL Hydroxychloroquine Sulfate C Simvastatin C Ziprasidone C Date:05/16/05ISR Number: 4663741-7Report Type:Expedited (15-DaCompany Report #2005072183 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dysphagia Health Geodon (Ziprasidone) PS ORAL ORAL Gastric Bypass Professional Date:05/16/05ISR Number: 4663871-XReport Type:Expedited (15-DaCompany Report #2005069676 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Geodon (Ziprasidone) PS 80 MG (80 MG, Initial or Prolonged Fatigue Professional 1 IN 1 D) Other Hemiplegia Sudafed Loss Of Consciousness (Pseudoephedrine Metabolic Encephalopathy Hydrochloride)(Pseud Nasopharyngitis oephedrine) SS Pneumonia Aspiration Metformin Unresponsive To Pain (Metformin) SS Stimuli Bupropion Vomiting Hydrochloride (Bupropion Hydrochloride) SS Olanzapine (Olanzapine) C Morphine (Morphine) C Date:05/16/05ISR Number: 4663872-1Report Type:Expedited (15-DaCompany Report #2005069296 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Myocardial Infarction Health Geodon (Ziprasidone) PS 40 MG Professional Date:05/16/05ISR Number: 4663896-4Report Type:Expedited (15-DaCompany Report #2005068535 Age:38 YR Gender:Female I/FU:I Outcome PT Hospitalization - Blood Creatinine Initial or Prolonged Increased Coma Fatigue Hemiplegia Hepatic Enzyme Increased Metabolic Encephalopathy Mobility Decreased 22-Feb-2006 08:32 AM Page: 760 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pneumonia Aspiration Unresponsive To Pain Stimuli Report Source Product Role Manufacturer Route Dose Duration Vomiting Health Sudafed White Blood Cell Count Professional (Pseudoephedrine) PS ORAL ORAL Increased Geodon (Ziprasidone Hydrochloride ) (Ziperazidone) SS 80 MG QD Olanzapine (Olanzapine) C Bupropion Hydrochloride (Bupropion Hydrochloride) C Metformin (Metformin) C Morphine (Morphine) C Date:05/16/05ISR Number: 4664270-7Report Type:Direct Company Report #CTU 248632 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Abnormal Dreams Geodon (Ziprasidone) Required Anorexia Pfizer PS Pfizer 60 MG QD Intervention to Anxiety Lithium Carbonate C Prevent Permanent Chills Impairment/Damage Depressed Mood Diarrhoea Disturbance In Attention Feeling Abnormal Hyperhidrosis Insomnia Psychomotor Hyperactivity Suicidal Ideation Thinking Abnormal Thirst Date:05/16/05ISR Number: 4664806-6Report Type:Expedited (15-DaCompany Report #2003117985 Age:19 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Foreign Ziprasidone (Caps) Health (Ziprasidone) PS ORAL 100 MG Professional (DAILY), ORAL Company Trazodone Representative (Trazodone) C Paroxetine (Paroxetine) C Clonazepam (Clonazepam) C Biperiden (Biperiden) C Nitrazepam (Nitrazepam) C Laxatives (Laxatives) C 22-Feb-2006 08:32 AM Page: 761 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/17/05ISR Number: 4664961-8Report Type:Direct Company Report #CTU 248779 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Ziprasidone PS Phosphokinase Increased Delirium Pyrexia Date:05/17/05ISR Number: 4664962-XReport Type:Direct Company Report #CTU 248780 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Delirium Ziprasidone PS Hypotension Pyrexia Date:05/17/05ISR Number: 4665125-4Report Type:Expedited (15-DaCompany Report #2004085695 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Corneal Oedema Foreign Zeldox Oedema Peripheral Health Visual Disturbance Professional (Ziprasidone) PS ORAL 40 MG (1 IN 1 Company D), ORAL Representative Date:05/17/05ISR Number: 4665167-9Report Type:Expedited (15-DaCompany Report #2005070568 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Embolism Foreign Ziprasidone (Caps) Sudden Death Health (Ziprasidone) PS ORAL 120 MG, ORAL Professional Insulin (Insulin) C Company Acetylsalicylic Acid Representative (Acetylsalicylic Acid) C Losartan (Losartan) C Clonazepam (Clonazepam) C Date:05/17/05ISR Number: 4665314-9Report Type:Expedited (15-DaCompany Report #2005072011 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Adverse Event Consumer Geodon (Ziprasidone) PS ORAL ORAL Initial or Prolonged Brain Damage Citalopram Other Cardiac Arrest Hydrobromide Coma (Citalopram Hypoxia Hydrobromide) C Respiratory Arrest Valproate Semisodium Weight Increased (Valproate Semisodium) C 22-Feb-2006 08:32 AM Page: 762 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/17/05ISR Number: 4665315-0Report Type:Expedited (15-DaCompany Report #2005072197 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Incorrect Route Of Drug Health Geodon (Im) Initial or Prolonged Administration Professional (Ziprasidone) PS INTRAVENOUS 20 MG, INTRAVENOUS Date:05/18/05ISR Number: 4666254-1Report Type:Direct Company Report #CTU 249057 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Body Temperature Geodon PS 30 MG Q AM Initial or Prolonged Increased /160 MG Q PM Confusional State Lisinopril C Drug Dependence Hctz C Hypotension Cogentin C Lethargy Ambien C Sepsis Xanax Xr C Date:05/18/05ISR Number: 4666464-3Report Type:Expedited (15-DaCompany Report #2005044135 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hallucination, Auditory Health Geodon (Ziprasidone) PS ORAL 160 MG(80 MG, Professional 2 IN 1 D), ORAL Date:05/19/05ISR Number: 4668306-9Report Type:Expedited (15-DaCompany Report #2005054991 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Health Geodon (Ziprasidone) PS 120 MG (60 Initial or Prolonged Blood Electrolytes Professional MG, 2 IN 1 D) Other Decreased Company Inapsine "Janssen" Blood Magnesium Decreased Representative (Droperidol) SS Blood Potassium Decreased Morphine (Morphine) C Cardio-Respiratory Arrest Topamax (Topiramate) C Condition Aggravated Effexor (Venlafaxine Edentulous Hydrochloride) C Nausea Xanax (Alprazolam) C Torsade De Pointes Vascular Access Complication Ventricular Fibrillation Vomiting Date:05/19/05ISR Number: 4668351-3Report Type:Expedited (15-DaCompany Report #2005027347 Age:65 YR Gender:Female I/FU:F Outcome PT Life-Threatening Adhesion Hospitalization - Anaemia Initial or Prolonged Aortic Aneurysm Other Arthralgia Asthenia Benign Ovarian Tumour Cerebrovascular Accident 22-Feb-2006 08:32 AM Page: 763 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Chronic Obstructive Pulmonary Disease Coronary Artery Occlusion Report Source Product Role Manufacturer Route Dose Duration Depression Health Geodon (Ziprasidone) PS ORAL 140 MG (2 IN Dysaesthesia Professional 1 D), ORAL Electrocardiogram Poor Company Acetylsalicylic Acid R-Wave Progression Representative (Acetylsalicylic Electroencephalogram Acid) C Abnormal Depakote (Valproate Femoral Arterial Stenosis Semisodium) C Gastrooesophageal Reflux Premarin (Estrogens Disease Conjugated) C Hyperlipidaemia Habitrol (Nicotine) C Hypertension Synthroid Hypothyroidism (Levothyroxine Intervertebral Disc Sodium) C Disorder Valium (Dizaepam) C Intracranial Aneurysm Vitamin B6 (Vitamin Mania B6) C Myocardial Infarction Obesity Osteoarthritis Paraesthesia Peripheral Vascular Disorder Rectal Cancer Torsade De Pointes Ventricular Tachycardia Date:05/19/05ISR Number: 4668548-2Report Type:Expedited (15-DaCompany Report #2005069296 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Acute Myocardial Health Geodon (Ziprasidone) PS ORAL (40 MG, Infarction Professional ONCE), ORAL Arteriogram Coronary Company Carnitine Representative (Carnitine) C Lorazepam (Lorazepam) C Gabapentin (Gabapentin) C All Other Non-Therapeutic Products (All Other Non-Therapeutic Products) C Date:05/19/05ISR Number: 4669459-9Report Type:Expedited (15-DaCompany Report #2005074216 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Foreign Geodon Initial or Prolonged Erection Increased Health (Ziprasidone) PS ORAL SEE IMAGE Excessive Masturbation Professional Sexual Activity Increased Company Representative Other 22-Feb-2006 08:32 AM Page: 764 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/19/05ISR Number: 4669469-1Report Type:Expedited (15-DaCompany Report #2005062127 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Foreign Ziprasidone PS ORAL 40 MG (20 MG, Initial or Prolonged Drug Effect Decreased Study 2 IN 1 D), Fall Health ORAL Gait Disturbance Professional Flunitrazepam Hallucination, Auditory Other (Flunitrazepam) C Headache Haloperidol Hypotension (Haloperidol) C Loss Of Consciousness Trihexyphenidyl Syncope (Trihexyphenidyl) C Vertigo Date:05/20/05ISR Number: 4669651-3Report Type:Expedited (15-DaCompany Report #05-02-0295 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Loss Of Consciousness Health Clozapine - Ivax Myocardial Infarction Professional Pharmaceuticals, Weight Increased Other Inc. Tablets PS ORAL 100MG TID ORAL Geodon SS 80MG BID Date:05/20/05ISR Number: 4669852-4Report Type:Expedited (15-DaCompany Report #2005074046 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Failure Health Geodon (Ziprasidone) PS Congestive Professional Company Representative Date:05/23/05ISR Number: 4672812-0Report Type:Expedited (15-DaCompany Report #2005064921 Age:18 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anxiety Foreign Zeldox (Capsules) Hospitalization - Depression Health (Ziprasidone) PS ORAL 80 MG (40 MG, Initial or Prolonged Suicidal Ideation Professional 2 IN 1 D), ORAL Date:05/23/05ISR Number: 4672916-2Report Type:Expedited (15-DaCompany Report #2005073197 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Liver Function Test Health Geodon (Ziprasidone) PS 160 MG 980 Abnormal Professional MG, 2 IN 1 Neuroleptic Malignant Company D), Syndrome Representative Lithium (Lithium) SS Pneumonia Quetiapine (Quetiapine) SS 22-Feb-2006 08:32 AM Page: 765 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/23/05ISR Number: 4672961-7Report Type:Expedited (15-DaCompany Report #2005075978 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Geodon (Ziprasidone) PS 120 MG Professional Lexapro Company (Escitalopram) C Representative Xanax (Alprazolam) C Antihistamines (Antihistamines) C Date:05/23/05ISR Number: 4672962-9Report Type:Expedited (15-DaCompany Report #2005075333 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaphylactic Shock Health Geodon (Ziprasidone) PS 40 MG ( 20 Cardio-Respiratory Arrest Professional MG, 2 IN 1 D) Dyskinesia Company Lexapro Extrapyramidal Disorder Representative (Escitalopram) C Heart Rate Increased Date:05/23/05ISR Number: 4673404-XReport Type:Expedited (15-DaCompany Report #2005073184 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Zeldox PS ORAL (2 IN 1 D), Initial or Prolonged Health ORAL Professional All Other Company Therapeutic Products Representative (All Other Other Therapeutic Products0 C Date:05/23/05ISR Number: 4673510-XReport Type:Expedited (15-DaCompany Report #2005048374 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Ziprasidone PS ORAL 120 MG (60 Initial or Prolonged Alanine Aminotransferase Study MG, 2 IN 1 Other Increased Health D), ORAL Aspartate Professional Aminotransferase Increased Blood Creatine Phosphokinase Increased Blood Lactate Dehydrogenase Increased Drug Ineffective Grand Mal Convulsion Hyponatraemia Polydipsia Somnolence Vomiting 22-Feb-2006 08:32 AM Page: 766 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/23/05ISR Number: 4673715-8Report Type:Expedited (15-DaCompany Report #2005073394 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Coronary Syndrome Literature Ziprasidone (Caps) Other Back Pain (Ziprasidone) PS UNKNOWN 90 MG (30 MG, Chest Pain 3 IN 1 D), Coronary Artery Occlusion UNKNOWN Fatigue Analgesics High Density Lipoprotein (Analgesics) C Decreased Clonazepam Pain (Clonazepam) C Sedation Sleep Disorder Sudden Death Weight Increased Date:05/23/05ISR Number: 4673718-3Report Type:Expedited (15-DaCompany Report #2005072978 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Health Geodon (Ziprasidone) PS ORAL 120 MG (60 Completed Suicide Professional MG, 2 IN 1 Company D), ORAL Representative Date:05/23/05ISR Number: 4673722-5Report Type:Expedited (15-DaCompany Report #2002059583 Age:19 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Literature Geodon (Ziprasidone) PS 160 MG (80 Initial or Prolonged Anxiety Health MG, 2 IN 1 D) Other Blunted Affect Professional Bundle Branch Block Right Cogwheel Rigidity Electrocardiogram Qt Corrected Interval Prolonged Electrocardiogram Qt Corrected Interval Shortened Electrocardiogram Qt Prolonged Electrocardiogram Qt Shortened Extrapyramidal Disorder Hallucination, Auditory Intentional Misuse Musculoskeletal Stiffness Sedation Date:05/23/05ISR Number: 4673724-9Report Type:Expedited (15-DaCompany Report #2005073716 Age:40 YR Gender:Male I/FU:I Outcome PT Hospitalization - Blood Glucose Increased Initial or Prolonged Blood Pressure Increased Body Temperature Increased 22-Feb-2006 08:32 AM Page: 767 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Catatonia Central Nervous System Infection Report Source Product Role Manufacturer Route Dose Duration Delirium Literature Ziprasidone (Caps) Drug Toxicity Health (Ziprasidone) PS 80 MG (2 IN 1 Heart Rate Increased Professional D) Hyperhidrosis Clozapine Hypertonia (Clozapine) SS 400 MG (1 IN Loss Of Consciousness 1 D) Mental Status Changes Citalopram Muscle Rigidity (Citalopram) SS 80 MG (1 IN 1 Musculoskeletal Stiffness D) Mydriasis Valproic Acid Neuroleptic Malignant (Valproic Acid) SS 2000 MG (1 IN Syndrome 1 D) Respiratory Rate Increased Serotonin Syndrome Tachycardia Treatment Noncompliance Weight Increased White Blood Cell Count Increased Date:05/23/05ISR Number: 4673737-7Report Type:Expedited (15-DaCompany Report #2005003130 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Geodon (Ziprasidone) PS ORAL 160 MG (80 Initial or Prolonged Hostility Professional MG, 2 IN 1 Treatment Noncompliance D), ORAL Klonopin (Clonazepam) C Date:05/24/05ISR Number: 4673023-5Report Type:Expedited (15-DaCompany Report #2005072348 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaesthetic Complication Foreign Zeldox (Capsules) Initial or Prolonged Drug Interaction Health (Ziprasidone) PS ORAL 120 MG (60 Disability Tardive Dyskinesia Professional MG, 2 IN 1 D), ORAL; 80 MG (40 MG, 2 IN 1 D), ORAL All Other Therapeutic Products SS Diazepam (Diazepam) C Date:05/24/05ISR Number: 4673971-6Report Type:Expedited (15-DaCompany Report #2005062127 Age:37 YR Gender:Male I/FU:F Outcome PT Hospitalization - Asthenia Initial or Prolonged Condition Aggravated Difficulty In Walking Dizziness Fall Gait Disturbance 22-Feb-2006 08:32 AM Page: 768 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hallucination, Auditory Headache Hypotension Report Source Product Role Manufacturer Route Dose Duration Loss Of Consciousness Foreign Ziprasidone (Caps) Psychotic Disorder Study (Ziprasidone) PS ORAL 40 MG (20 MG, Syncope Health 2 IN 1 D) Vertigo Professional ORAL Flunitrazepam C Haloperidol C Trihexyphenidyl C Date:05/24/05ISR Number: 4674114-5Report Type:Direct Company Report #CTU 249428 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Pressure Increased Ziprasideone Hospitalization - Bronchospasm (Geodon) Pfizer PS Pfizer 20 MG , 047, Initial or Prolonged Drooling BID Required Dyskinesia Valproic Acid C Intervention to Dysphagia Benztropine C Prevent Permanent Dyspnoea Lorazepam C Impairment/Damage Erythema Extrapyramidal Disorder Gaze Palsy Muscle Spasms Musculoskeletal Stiffness Speech Disorder Urticaria Date:05/25/05ISR Number: 4676597-3Report Type:Expedited (15-DaCompany Report #2005060706 Age:29 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Foreign Zeldox PS ORAL 80 MG (40 MG, Asthenia Health 2 IN 1 D), Bradycardia Professional ORAL Dizziness Company Priadel Electrocardiogram Change Representative (Lithium Exercise Tolerance Other Carbonate) C Decreased Lamictal Fatigue (Lamotrigine) C Hypotension ........ C Malaise .................. C Sinus Arrhythmia Propanolol (Propranolol) C Alprazolam (Alprazolam) C Risperidone (Risperidone) C Date:05/25/05ISR Number: 4677110-7Report Type:Direct Company Report #CTU 249570 Age:43 YR Gender:Male I/FU:I Outcome Hospitalization - Initial or Prolonged Required Intervention to 22-Feb-2006 08:32 AM Page: 769 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Agitation Geodon Pfizer, Anuria Inc. PS Pfizer, Inc. ORAL 40MG BID Muscle Rigidity ORAL Neuroleptic Malignant Buspirone C Syndrome Zolpidem Tartrate C Rhabdomyolysis Lithium Xr C Clonazepam C Tiagibine C Benztropine C Date:05/26/05ISR Number: 4675865-9Report Type:Direct Company Report #CTU 249689 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drooling Ziprasidone Im 20 Flat Affect Mg / Pfizer PS Pfizer INTRAMUSCULAR 20 MG BID IM Gait Disturbance Parkinsonian Rest Tremor Date:05/26/05ISR Number: 4676950-8Report Type:Expedited (15-DaCompany Report #2004079254 Age:28 YR Gender:Female I/FU:F Outcome PT Hospitalization - Abdominal Tenderness Initial or Prolonged Activated Partial Other Thromboplastin Time Required Prolonged Intervention to Aggression Prevent Permanent Agitation Impairment/Damage Ammonia Abnormal Anaemia Anxiety Bacterial Infection Blood Chloride Decreased Blood Creatine Phosphokinase Increased Blood Creatine Phosphokinase Mb Increased Blood Creatinine Increased Blood Magnesium Decreased Blood Sodium Decreased Blood Urea Increased Candidiasis Cardiomegaly Central Line Infection Cholelithiasis Confusional State Contusion Decreased Appetite Delirium Dialysis Disorientation Ecchymosis Ejection Fraction 22-Feb-2006 08:32 AM Page: 770 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Decreased Electrocardiogram St Segment Abnormal Electrocardiogram T Wave Report Source Product Role Manufacturer Route Dose Duration Abnormal Health Geodon (Ziprasidone) PS ORAL 240 MG (120 Electrocardiogram T Wave Professional MG, 2 IN 1 Biphasic D), ORAL Electrolyte Imbalance Fluconazole Eye Injury (Fluconazole) SS ORAL 100 MG (1 IN Gallop Rhythm Present 1 D), ORAL Headache Claritin Heparin-Induced (Loratadine) SS ORAL 10 MG, 1 IN 1 Thrombocytopenia D, ORAL Hypokalaemia Lithobid (Lithium Incoherent Carbonate) SS ORAL 1200 MG (600 Lupus Nephritis MG, 2 IN 1 Mental Status Changes D), ORAL Migraine Lexapro Mucosal Dryness (Escitalopram) SS ORAL 15 MG, 1 IN 1 Pain D, ORAL Platelet Count Decreased Topiramate Proteinuria (Topiramate) SS ORAL 100 MG, 1 IN Prothrombin Time 1 D, ORAL Prolonged Prednisone Pyrexia (Prednisone) C Renal Failure Vancomycin Sepsis (Vancomycin) C Skin Striae Tylenol Somnolence (Paracetamol) C Therapeutic Agent Heparin (Heparin) C Toxicity Excedrin Tooth Disorder (Caffeine, Torsade De Pointes Paracetamol) C Treatment Noncompliance Aspirin Tremor (Acetylsalicylic Tricuspid Valve Acid) C Incompetence Protonix Urinary Casts (Pantoprazole) C Urinary Tract Infection Prevacid Urine Ketone Body Present (Lansoprazole) C Urine Leukocyte Esterase Klonopin Positive (Clonazepam) C Ventricular Extrasystoles Zyprexa (Olanzapine) C Vomiting Keppra White Blood Cells Urine (Levetiracetam) C Ciprofloxacin (Ciprofloxacin) C Trazodone (Trazodone) C Metoprolol (Metoprolol) C Synthroid (Levothyroxine Sodium) C Diflucan (Fluconazole) C Lactaid (Tilactase) C Prozac (Fluoxetine Hydrochloride) C Ferrous Sulfate (Ferrous Sulfate) C Clonazepam 22-Feb-2006 08:32 AM Page: 771 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Clonazepam) C Simethicone (Simethicone) C Naltrexone (Naltrexone) C Abilify (Aripiprazole) C Plaquenil (Hydroxychloroquine Phosphate) C Fioricet (Butalbital, Caffeine, Paracetamol) C Date:05/26/05ISR Number: 4677624-XReport Type:Direct Company Report #CTU 249591 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Abnormal Dreams Geodon Required Anorexia (Ziprazsidone) Intervention to Anxiety Pfizer PS Pfizer 60 MG QD Prevent Permanent Chills Lithium Carbonate C Impairment/Damage Depressed Mood Diarrhoea Disturbance In Attention Feeling Abnormal Hyperhidrosis Insomnia Suicidal Ideation Thinking Abnormal Thirst Date:05/27/05ISR Number: 4675341-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12819264 Age:18 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coordination Abnormal Abilify PS Otsuka Initial or Prolonged Pharmaceutical Company, Ltd. ORAL Increased to 15 mg/day 1 DAY Abilify SS Otsuka Pharmaceutical Company, Ltd. ORAL Increased to 15 mg/day 1 DAY Geodon SS Trileptal C Lexapro C Zyprexa C Date:05/27/05ISR Number: 4676885-0Report Type:Expedited (15-DaCompany Report #2005073197 Age:60 YR Gender:Male I/FU:F Outcome PT Other Liver Function Test Abnormal Neuroleptic Malignant Syndrome Pneumonia 22-Feb-2006 08:32 AM Page: 772 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Unevaluable Event Report Source Product Role Manufacturer Route Dose Duration Health Geodon (Ziprasidone) PS 160 MG (80 Professional MG, 2 IN 1 D) Company Lithium (Lithium) SS Representative Quetiapine (Quetiapine) SS Date:05/27/05ISR Number: 4676888-6Report Type:Expedited (15-DaCompany Report #2005077281 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Myocardial Infarction Health Geodon (Ziprasidone) PS 160 MG (80 Professional MG, 2 IN 1 D) Company Representative Date:05/27/05ISR Number: 4679278-5Report Type:Expedited (15-DaCompany Report #2005077982 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dialysis Health Geodon (Ziprasidone) PS ORAL 120 MG (60 Initial or Prolonged Pulmonary Embolism Professional MG, 2 IN 1 Other D), ORAL Clomipramine (Clomipramine) C Seroquel (Quetiapine Fumarate) C Date:05/31/05ISR Number: 4678741-0Report Type:Expedited (15-DaCompany Report #2005079555 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Mental Disorder Due To A Health Geodon (Ziprasidone) PS General Medical Condition Professional Company Representative Date:05/31/05ISR Number: 4678751-3Report Type:Expedited (15-DaCompany Report #2005079552 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Mental Disorder Due To A Health Geodon (Ziprasidone) PS General Medical Condition Professional Company Representative Date:05/31/05ISR Number: 4678820-8Report Type:Expedited (15-DaCompany Report #2005067549 Age: Gender:Male I/FU:I Outcome PT Hospitalization - Anger Initial or Prolonged Anxiety Disorder Other Diet Refusal Disturbance In Social 22-Feb-2006 08:32 AM Page: 773 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Behaviour Drug Dependence Drug Withdrawal Syndrome Intentional Misuse Report Source Product Role Manufacturer Route Dose Duration Overdose Consumer Xanax Tablet Phobia Health (Alprazolam) PS ORAL 4 MG (0.5 MG, Psychotic Disorder Professional 3 IN 1 D), Self-Medication ORAL Treatment Noncompliance Neurontin (Gabapentin) SS ORAL (3 IN 1 D), ORAL Geodon (Ziprasidone) SS ORAL Nyquil (Dextromethorphan Hydrobromide, Doxylamine Succinate, Ephedrine SS All Other Non-Therapeutic Products (All Other Non-Therapeutic Products) SS Adderall (Amfetamine Aspartate, Amfetamine Sulfate, Dexamfetamine Saccharate, C Prozac (Fluoxetine Hydrochloride) C Ambien (Zolpidem Tartrate) C Soma (Carisoprodol) C Date:05/31/05ISR Number: 4678842-7Report Type:Expedited (15-DaCompany Report #S05-USA-02675-01 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Consumer Lexapro Initial or Prolonged Death Of Friend (Esctialopram) PS ORAL 10 MG QD PO Depression Lexapro Drug Ineffective (Esctialopram) SS ORAL 20 MG QD PO Hallucination Lexapro Overdose (Esctialopram) SS ORAL 30 MG QD PO Post-Traumatic Stress Lexapro Disorder (Esctialopram) SS ORAL 40 MG QD PO Suicidal Ideation Lexapro Suicide Attempt (Esctialopram) SS ORAL 50 MG QD PO Therapeutic Product Lexapro Ineffective For (Esctialopram) SS ORAL 30 MG QD PO Unapproved Indication Lexapro (Esctialopram) SS ORAL 50 MG QD PO Elavil (Amitriptyline Hydrochloride) SS 50 MG QD Klonopin (Clonazepam) SS 1 MG QD Ritalin (Methylphenidate Hydrochloride) SS 30 MG QD Ability (Aripiprazole) SS 22-Feb-2006 08:32 AM Page: 774 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Geodon (Ziprasidone Hydrochloride) SS ORAL 40 MG QD PO Date:05/31/05ISR Number: 4678848-8Report Type:Expedited (15-DaCompany Report #2005072978 Age:28 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Health Geodon (Ziprasidone) PS ORAL 120 MG (60 Completed Suicide Professional MG, 2 IN 1 Company D), ORAL Representative Date:05/31/05ISR Number: 4678940-8Report Type:Expedited (15-DaCompany Report #2005076164 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Myocardial Infarction Health Geodon (Ziprasidone) PS 160 MG(80 MG, Initial or Prolonged Professional 2 IN 1 D) Other Company Depakote (Valproate Representative Semisodium) SS Zyprexa (Olanzapine) SS All Other Therapeutic Products (All Other Therapeutic Products) SS Date:05/31/05ISR Number: 4679707-7Report Type:Expedited (15-DaCompany Report #2005073197 Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Health Geodon (Ziprasidone) PS 160 MG (80 Liver Function Test Professional MG, 2 IN 1 D) Abnormal Company Lithium (Lithium) SS Neuroleptic Malignant Representative Quetiapine Syndrome (Quetiapine) SS Pneumonia Date:06/01/05ISR Number: 4681056-8Report Type:Expedited (15-DaCompany Report #2005004881 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Consumer Geodon (Ziprasidone) PS UNKNOWN UNKNOWN Initial or Prolonged Agitation Health Methadone Other Alkalosis Professional (Methadone) SS UNKNOWN UNKNOWN Asthma All Other Cardiac Arrest Therapeutic Products Hallucination (All Other Hyperkalaemia Therapeutic Hypomagnesaemia Products) SS UNKNOWN UNKNOWN Mental Status Changes Duragesic (Fentanyl) SS UNKNOWN UNKNOWN Pain Fentanyl (Fentanyl) SS UNKNOWN UNKNOWN Psychotic Disorder Rhabdomyolysis Torsade De Pointes Ventricular Tachycardia 22-Feb-2006 08:32 AM Page: 775 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/02/05ISR Number: 4681492-XReport Type:Expedited (15-DaCompany Report #2005079766 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Infertility Health Geodon (Ziprasidone) PS ORAL ORAL Professional Date:06/02/05ISR Number: 4681559-6Report Type:Expedited (15-DaCompany Report #2005077877 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Consumer Geodon (Ziprasidone) PS ORAL 40 MG (40 MG Chest Pain 1 IN 1 D) Condition Aggravated ORAL Convulsion Benadryl SS ORAL 50 MG (25 MG Depression 1 IN 1 D) Drug Withdrawal Syndrome ORAL Eye Rolling Duloxetine Feeling Abnormal Hydrochloride Loss Of Consciousness (Duloxetine Restlessness Hydrochloride) SS ORAL ORAL Somnolence Tremor Date:06/02/05ISR Number: 4681886-2Report Type:Expedited (15-DaCompany Report #2005048374 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Ziprasidone PS ORAL 120 MG (60 Initial or Prolonged Alanine Aminotransferase Study MG, 2 IN 1 Other Increased Health D), ORAL Aspartate Professional Aminotransferase Increased Blood Creatine Phosphokinase Increased Blood Lactate Dehydrogenase Increased Drug Ineffective Grand Mal Convulsion Hyponatraemia Polydipsia Somnolence Vomiting Date:06/02/05ISR Number: 4682330-1Report Type:Direct Company Report #CTU 250255 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Geodon PS Date:06/03/05ISR Number: 4684698-9Report Type:Expedited (15-DaCompany Report #2005078628 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Consumer Geodon (Ziprasidone) PS ORAL ORAL Initial or Prolonged Syndrome Zyprexa (Olanzapine) C Other 22-Feb-2006 08:32 AM Page: 776 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/03/05ISR Number: 4685184-2Report Type:Expedited (15-DaCompany Report #2005074216 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Foreign Geodon (Ziprasidone) PS ORAL 120 MG (60 Initial or Prolonged Erection Increased Company MG, 2 IN 1 D) Excessive Masturbation Representative ORAL Geodon (Ziprasidone) SS INTRAMUSCULAR INTRAMUSCULAR Date:06/06/05ISR Number: 4686339-3Report Type:Expedited (15-DaCompany Report #2004000563 Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Health Geodon (Ziprasidone) PS ORAL 120 MG (60 Initial or Prolonged Blood Magnesium Decreased Professional MG, 2 IN 1 Cardiac Murmur Company D), ORAL Contusion Representative Bupropion Electrocardiogram Qt Hydrochloride Corrected Interval (Bupropion Prolonged Hydrochloride) C Hypocalcaemia Paroxetine Jugular Vein Distension Hydrochloride Liver Disorder (Paroxetine Oedema Hydrochloride) C Oedema Peripheral Alprazolam Pitting Oedema (Alprazolam) C Syncope Desipramine Weight Increased Hydrochloride (Desipramine Hydrochloride) C Cetirizine Hydrochloride (Cetirizine Hydrochloride) C Tramadol Hydrochloride (Tramadol Hydrochloride) C Date:06/06/05ISR Number: 4686368-XReport Type:Expedited (15-DaCompany Report #2005079741 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delirium Foreign Ziprasidone (Caps) Initial or Prolonged Insomnia Health (Ziprasidone) PS ORAL 160 MG (1 IN Mental Disorder Professional 1 D), ORAL Clonazepam (Clonazepam) C Date:06/06/05ISR Number: 4686521-5Report Type:Expedited (15-DaCompany Report #2005020134 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hyperthermia Malignant Health Geodon (Ziprasidone) PS Other Professional All Other Company Therapeutic Products Representative (All Other Therapeutic Products) C 22-Feb-2006 08:32 AM Page: 777 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/06/05ISR Number: 4686537-9Report Type:Expedited (15-DaCompany Report #2005080875 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Health Geodon (Ziprasidone) PS INTRAMUSCULAR 5 MG (5 MG, Syndrome Professional ONCE), Renal Disorder INTRAMUSCULAR Date:06/06/05ISR Number: 4686567-7Report Type:Expedited (15-DaCompany Report #2005079138 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Bradyarrhythmia Literature Ziprasidone (Caps) Clinodactyly Health (Ziprasidone) PS Congenital Nail Disorder Professional Congenital Nose Malformation Drug Exposure During Pregnancy Electrocardiogram Qt Prolonged Facial Dysmorphism Finger Hypoplasia Foetal Arrhythmia Foetal Growth Retardation Foetal Malformation Neonatal Hypoxia Phalangeal Hypoplasia Premature Baby Reperfusion Injury Small For Dates Baby Toe Deformity Date:06/06/05ISR Number: 4687018-9Report Type:Expedited (15-DaCompany Report #2005081498 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Angioneurotic Oedema Foreign Zeldox (Capsules) Initial or Prolonged Food Allergy Health (Ziprasidone) PS ORAL 120 MG (60 Other Urticaria Professional MG, 2 IN 1 Company D), ORAL Representative Date:06/07/05ISR Number: 4686464-7Report Type:Expedited (15-DaCompany Report #2005050070 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Rash Health Geodon (Ziprasidone) PS ORAL 120 MG (60 Self-Medication Professional MG, 2 IN 1 Skin Exfoliation Company D), ORAL Representative Haloperidol (Haloperidol) C 22-Feb-2006 08:32 AM Page: 778 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/07/05ISR Number: 4686495-7Report Type:Expedited (15-DaCompany Report #2005075978 Age:56 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Multiple Allergies Health Geodon (Ziprasidone) PS 120 MG Professional Lexapro Company (Escitalopram) C Representative Xanax (Alprazolam) C Antihistamines (Antihistamines) C Date:06/07/05ISR Number: 4686601-4Report Type:Expedited (15-DaCompany Report #2005082297 Age:23 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Health Geodon (Im) Professional (Ziprasidone) PS Date:06/08/05ISR Number: 4686697-XReport Type:Expedited (15-DaCompany Report #2005081197 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blindness Transient Foreign Ziprasidone (Caps) Blindness Unilateral Study (Ziprasidone) PS ORAL 160 MG (80 Cataract Cortical Health MG, 2 IN 1 Professional D), ORAL Acetaminophen (Paracetamol) C Cogentin (Benzatropine Mesilate) C Date:06/08/05ISR Number: 4686787-1Report Type:Expedited (15-DaCompany Report #2005081508 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Foreign Zeldox (Capsules) Fall Health (Ziprasidone) PS ORAL 40 MG (40 MG, Loss Of Consciousness Professional 1 IN 1 D) Nausea Company ORAL Tonic Convulsion Representative Date:06/08/05ISR Number: 4687316-9Report Type:Expedited (15-DaCompany Report #2005080600 Age:73 YR Gender:Male I/FU:I Outcome PT Hospitalization - Abnormal Behaviour Initial or Prolonged Anorexia Other Back Pain Condition Aggravated Dizziness Fall Feeling Abnormal Heart Rate Decreased Loss Of Consciousness Malaise Mobility Decreased Myocardial Infarction 22-Feb-2006 08:32 AM Page: 779 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Parkinson'S Disease Pneumonia Pulmonary Thrombosis Report Source Product Role Manufacturer Route Dose Duration Salivary Hypersecretion Consumer Geodon (Ziprasidone) PS ORAL 180 MG (60 MG, 3 IN 1 D), ORAL Lexapro (Esctialopram) C Aricept (Donepezil) C All Other Therapeutic Products (All Other Therapeutic Products) C Date:06/08/05ISR Number: 4687317-0Report Type:Expedited (15-DaCompany Report #2005080520 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Carbon Monoxide Poisoning Consumer Geodon (Ziprasidone) PS Completed Suicide Date:06/08/05ISR Number: 4687353-4Report Type:Expedited (15-DaCompany Report #2004031173 Age:20 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Consumer Neurontin Disability Anhedonia (Gabapentin) PS Other Anxiety Geodon (Ziprasidone) SS 80 MG (40 MG, Completed Suicide 2 IN 1 D) Drug Toxicity Acetaminophen Emotional Disorder (Paracetamol) SS Incorrect Dose Paxil (Paroxetine Administered Hydrochloride) SS 60 MG (30 MG, Injury 2 IN 1 D) Mental Disorder Pain Pharmaceutical Product Complaint Date:06/08/05ISR Number: 4687401-1Report Type:Expedited (15-DaCompany Report #2005073197 Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Acute Coronary Syndrome Health Geodon (Ziprasidone) PS 160 MG (80 Neuroleptic Malignant Professional MG, 2 IN 1 Syndrome Company D), Pneumonia Representative Lithium (Lithium) SS Quetiapine (Quetiapine) SS Date:06/09/05ISR Number: 4688033-1Report Type:Expedited (15-DaCompany Report #2005081677 Age:46 YR Gender:Male I/FU:I Outcome PT Death Fall Other Myocardial Infarction 22-Feb-2006 08:32 AM Page: 780 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Weight Increased White Blood Cell Count Increased Report Source Product Role Manufacturer Route Dose Duration Health Geodon (Ziprasidone) PS 160 MG (80 Professional MG, 2 IN 1 D) Clozapine (Clozapine) SS ORAL 300 MG (100 MG, 3 IN 1 D), ORAL Date:06/09/05ISR Number: 4688113-0Report Type:Expedited (15-DaCompany Report #2005075333 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaphylactic Shock Health Geodon (Ziprasidone) PS 40 MG (20 MG, Dyskinesia Professional 2 IN 1 D) Extrapyramidal Disorder Company Lexapro Heart Rate Increased Representative (Escitalopram) C Hypersensitivity Swollen Tongue Unevaluable Event Date:06/10/05ISR Number: 4687629-0Report Type:Expedited (15-DaCompany Report #PHEH2005US06346 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Depression Ritalin PS Novartis Sector: Hospitalization - Drug Ineffective Pharma ORAL 30 mg, QD Initial or Prolonged Hallucination Lexapro SS ORAL 10 mg, QD 10080MIN Other Post-Traumatic Stress Lexapro SS ORAL 20 mg, QD 10080MIN Disorder Lexapro SS ORAL 30 mg, QD 10080MIN Suicidal Ideation Lexapro SS ORAL 40 mg, QD 10080MIN Suicide Attempt Lexapro SS ORAL 50 mg, QD Lexapro SS ORAL 30 mg, QD Lexapro SS ORAL 50 mg, QD Elavil SS ORAL 50 mg, QD Klonopin SS ORAL 1 mg, QD Abilify SS ORAL UNK, UNK 104 DAY Geodon SS ORAL 40 mg, QD Date:06/10/05ISR Number: 4691026-1Report Type:Expedited (15-DaCompany Report #2004115908 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Geodon (Ziprasidone) PS ORAL ORAL Initial or Prolonged Amnesia Consumer Cardiac Disorder Health Drug Ineffective Professional Euphoric Mood Date:06/10/05ISR Number: 4691101-1Report Type:Expedited (15-DaCompany Report #2005084613 Age:39 YR Gender:Male I/FU:I Outcome PT Death Acute Myocardial Infarction Agitation 22-Feb-2006 08:32 AM Page: 781 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Cardio-Respiratory Arrest Insomnia Loss Of Consciousness Report Source Product Role Manufacturer Route Dose Duration Palpitations Foreign Zeldox (Capsules) Syncope Health (Ziprasidone) PS Tremor Professional Date:06/13/05ISR Number: 4690679-1Report Type:Expedited (15-DaCompany Report #2005082077 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arthralgia Consumer Geodon (Ziprasidone) PS ORAL ORAL Decreased Appetite Nardil (Phenelzine Drug Hypersensitivity Sulfate) SS ORAL ORAL Serotonin Syndrome Stress Vomiting Weight Decreased Weight Increased Date:06/13/05ISR Number: 4690690-0Report Type:Expedited (15-DaCompany Report #2005075978 Age:56 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Geodon (Ziprasidone) PS ORAL 120 MG (60 Other Professional MG, 2 IN 1 Company D), ORAL Representative Albuterol (Salbutamol) C Lexapro (Escitalopram) C Xanax (Alprazolam) C Antihistamines (Antihistamines) C Date:06/13/05ISR Number: 4690790-5Report Type:Expedited (15-DaCompany Report #2005060756 Age:65 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Myocardial Foreign Zeldox Initial or Prolonged Infarction Health (Ziprasidone) PS ORAL 40 MG (40 MG, Bradyarrhythmia Professional 1 IN 1 D), Convulsion Company ORAL Electrocardiogram Qt Representative Escitalopram Prolonged Other (Escitalopram) C Myocardial Ischaemia Lithium Carbonate Syncope (Lithium Carbnate) C Ventricular Arrhythmia Date:06/14/05ISR Number: 4691860-8Report Type:Direct Company Report #CTU 251155 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Geodon PS Pharmaceutical Product Complaint 22-Feb-2006 08:32 AM Page: 782 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/14/05ISR Number: 4692302-9Report Type:Expedited (15-DaCompany Report #2005084733 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chills Foreign Zeldox (Capsules) Initial or Prolonged Depression Health (Ziprasidone) PS ORAL 120 MG ORAL Extrapyramidal Disorder Professional Zyprexa (Olanzapine) C Date:06/15/05ISR Number: 4691410-6Report Type:Expedited (15-DaCompany Report #2005072978 Age:28 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Health Geodon (Ziprasidone) PS ORAL 120 MG (60 Completed Suicide Professional MG, 2 IN 1 Company D), ORAL Representative Date:06/15/05ISR Number: 4692168-7Report Type:Expedited (15-DaCompany Report #2005084843 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Rhabdomyolysis Foreign Zeldox (Capsules) Hospitalization - Health (Ziprasidone) PS Initial or Prolonged Professional Zyprexa (Olanzapine) C Company Beloc Zok Representative (Metoprolol Succinate) C Date:06/15/05ISR Number: 4693465-1Report Type:Expedited (15-DaCompany Report #2005075978 Age:56 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fall Health Geodon (Ziprasidone) PS Other Myocardial Infarction Professional Provigil (Modafinil) C Somnolence Company Albuterol Representative (Salbutamol) C Lexapro (Escitalopram) C Xanax (Alprazolam) C Antihistamines (Antihistamines) C Date:06/15/05ISR Number: 4693861-2Report Type:Expedited (15-DaCompany Report #2005085099 Age: Gender:Male I/FU:I Outcome PT Hospitalization - Abnormal Behaviour Initial or Prolonged Aggression Disability Complex Partial Seizures Other Convulsion Drooling Electroencephalogram Abnormal Excessive Masturbation Fall Loss Of Consciousness Muscle Rigidity Paraesthesia 22-Feb-2006 08:32 AM Page: 783 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Repetitive Speech Urinary Incontinence Report Source Product Role Manufacturer Route Dose Duration Consumer Geodon (Ziprasidone) PS ORAL 80 MG (40 MG, 2 IN 1 D), ORAL Depakote (Valproate Semisodium) C Tenex (Guanfacine Hydrochloride) C Date:06/16/05ISR Number: 4694061-2Report Type:Expedited (15-DaCompany Report #2005086379 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Consumer Celebrex (Celecoxib) PS Vioxx (Rofecoxib) SS . SS Date:06/16/05ISR Number: 4694062-4Report Type:Expedited (15-DaCompany Report #2005086013 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Bicarbonate Health Geodon (Ziprasidone) PS ORAL 320 MG (80 Increased Professional MG, 2 IN 1 Blood Creatinine D), ORAL Increased Eskalith (Lithium Blood Glucose Decreased Carbonate) C Oculogyration Depakote (Valproate Red Cell Distribution Semisodium) C Width Increased Ativan (Lorazepam) C White Blood Cell Count Haladol Decreased (Haloperidol) C Date:06/20/05ISR Number: 4694360-4Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12998167 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Abilify PS Otsuka Initial or Prolonged Drug Ineffective Pharmaceutical Hallucination Company, Ltd. Intentional Misuse Lexapro SS ORAL Post-Traumatic Stress Elavil SS ORAL Disorder Klonopin SS Suicidal Ideation Ritalin SS Suicide Attempt Geodon SS ORAL Date:06/20/05ISR Number: 4696123-2Report Type:Expedited (15-DaCompany Report #2005086430 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Deep Vein Thrombosis Foreign Geodon (Ziprasidone) PS ORAL ORAL Health Professional 22-Feb-2006 08:32 AM Page: 784 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/20/05ISR Number: 4696302-4Report Type:Expedited (15-DaCompany Report #2005054161 Age:31 YR Gender:Male I/FU:F Outcome PT Hospitalization - Abnormal Behaviour Initial or Prolonged Activated Partial Other Thromboplastin Time Prolonged Agitation Alanine Aminotransferase Increased Anaemia Aspartate Aminotransferase Increased Asthenia Back Pain Bladder Distension Bladder Stenosis Blood Albumin Increased Blood Alkaline Phosphatase Decreased Blood Amylase Increased Blood Calcium Decreased Blood Chloride Increased Blood Glucose Increased Blood Magnesium Decreased Blood Ph Decreased Blood Phosphorus Increased Blood Pressure Systolic Increased Blood Sodium Increased Blood Thyroid Stimulating Hormone Decreased Blood Uric Acid Increased Bundle Branch Block Left C-Reactive Protein Increased Carbon Dioxide Decreased Cellulitis Clostridium Colitis Dehydration Dialysis Diarrhoea Drug Screen Positive Dry Mouth Electrocardiogram Pr Prolongation Electrocardiogram Qrs Complex Prolonged Electrocardiogram Qt Corrected Interval Prolonged Electrocardiogram Qt Prolonged Fall Fatigue Gallbladder Disorder Headache Hyperhidrosis Hypotension 22-Feb-2006 08:32 AM Page: 785 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Judgement Impaired Leukocytosis Lipase Increased Report Source Product Role Manufacturer Route Dose Duration Loss Of Consciousness Health Geodon (Ziprasidone) PS ORAL 120 MG (60 Lymphocyte Percentage Professional MG, 2 IN 1 Decreased Company D), ORAL Monocyte Count Increased Representative Lidocaine Myoglobinuria (Lidocaine) SS Myositis Trileptal "Novartis" Neuroleptic Malignant (Oxcarbazepine) C Syndrome Abilify Neutrophil Count (Aripiprazole) C Increased Trazodone Neutrophil Percentage (Trazodone) C Increased Diovan "Novartis" Platelet Count Increased (Valsartan) C Protein Total Increased Tegretol Prothrombin Time (Carbamazepine) C Prolonged Red Cell Distribution Width Increased Renal Failure Acute Respiratory Rate Increased Rhabdomyolysis Screaming Shift To The Left Somnolence Spinal Deformity Stress Ultrasound Scan Abnormal Unresponsive To Verbal Stimuli Urinary Incontinence Urinary Tract Infection Date:06/20/05ISR Number: 4697343-3Report Type:Expedited (15-DaCompany Report #DSA_26565_2005 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Prolactin Increased Foreign Temesta PS DF Prolactinoma Health Zeldox SS ORAL 160 MG Q DAY Treatment Noncompliance Professional PO Other Zeldox SS ORAL 140 MG Q DAY PO Zeldox SS ORAL 120 MG Q DAY PO L-Thyroxin C Nexium C Risperdal C Date:06/21/05ISR Number: 4697246-4Report Type:Direct Company Report #CTU 251596 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Sodium Decreased Geodon PS ORAL 280 MG PO QPM Initial or Prolonged Condition Aggravated Diltiazem C Depression Altace C Suicidal Ideation Furosemide C 22-Feb-2006 08:32 AM Page: 786 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Premarin C Lexapro C Xanax Xr C Trileptal C Benedryl C Cozaar C Lunesta C Date:06/22/05ISR Number: 4697217-8Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0563685A Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Alkaline Lamictal PS Glaxosmithkline Initial or Prolonged Phosphatase Increased Geodon SS 39 DAY Blood Creatine Lexapro C Phosphokinase Increased Diarrhoea Headache Hepatic Enzyme Increased Nausea Pruritus Rash Vomiting Date:06/22/05ISR Number: 4697688-7Report Type:Expedited (15-DaCompany Report #2005087479 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cyst Health Geodon (Ziprasidone) PS ORAL 120 MG (60 Gynaecomastia Professional MG, 2 IN 1 D), ORAL Lexapro (Escitalopram) C Norvasc (Amlodipine) C Hydrochlorothiazide (Hydrochlorothiazide ) C Flonase (Fluticasone Propionate) C Date:06/22/05ISR Number: 4697693-0Report Type:Expedited (15-DaCompany Report #2005079766 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Infertility Female Health Geodon (Ziprasidone) PS ORAL ORAL Professional Date:06/22/05ISR Number: 4698603-2Report Type:Expedited (15-DaCompany Report #2005087572 Age:13 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Belligerence Health Geodon (Ziprasidone) PS ORAL 20 MG, ORAL Completed Suicide Professional Risperdal Gun Shot Wound (Risperidone) C Head Injury 22-Feb-2006 08:32 AM Page: 787 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/22/05ISR Number: 4698946-2Report Type:Direct Company Report #CTU 251712 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Body Temperature Ziprasidone PS INTRAVENOUS 20 MG IM PRN Hospitalization - Increased Risperidone SS 1 MG Q HS Initial or Prolonged Convulsion Phenytoin C Neuroleptic Malignant Ceftriaxone C Syndrome Tylenol C Ibuprofen C Date:06/22/05ISR Number: 4699214-5Report Type:Expedited (15-DaCompany Report #2005087937 Age:16 MON Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Exposure Foreign Ziprasidone (Caps) Initial or Prolonged Irritability Health (Ziprasidone) PS ORAL (1 IN 1 Pyrexia Professional TOTAL), ORAL Date:06/22/05ISR Number: 4699524-1Report Type:Expedited (15-DaCompany Report #2005087540 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zeldox (Capsules) Health (Ziprasidone) PS ORAL 80 MG (40 Professional MG,2 IN 1 Company D),ORAL Representative Date:06/24/05ISR Number: 4701019-3Report Type:Expedited (15-DaCompany Report #2005063643 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Consumer Geodon Initial or Prolonged Decreased Appetite Health (Ziprasidone) PS ORAL 160 MG (80 Other Glycosylated Haemoglobin Professional MG, 2 IN 1 Increased D), ORAL Nasopharyngitis Glipizide Extended Oedema Peripheral Release Thrombosis (Glipizide) SS ORAL 2.5 MG Weight Decreased Metformin Hydrochloride (Metformin Hydrochloride) C Venlafaxine Hydrochloride C Valproate Semisodium (Valproate Semisodium) C Fenofibrate (Fenofibrate) C Pravastatin Sodium (Pravastatin Sodium) C Omeprazole (Omeprazole) C 22-Feb-2006 08:32 AM Page: 788 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/24/05ISR Number: 4701210-6Report Type:Expedited (15-DaCompany Report #2005089211 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Geodon Initial or Prolonged Drooling Professional (Ziprasidone) PS ORAL 120 MG (1 D), Other Dystonia Company ORAL Jaw Disorder Representative Strattera Oral Intake Reduced (Atomoxetine Sydenham'S Chorea Hydrochloride) SS ORAL ORAL Conerta (Methylphenidate Hydrochloride) SS ORAL ORAL Depakote (Valproate Semisodium) C ORAL ORAL Date:06/27/05ISR Number: 4701223-4Report Type:Direct Company Report #CTU 252033 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Geodon PS SEE IMAGE Burning Sensation Zoloft Dc'D On Restless Legs Syndrome 6/19/05 SS Requip C Lamicial C Lexapro C Date:06/27/05ISR Number: 4701600-1Report Type:Expedited (15-DaCompany Report #2004068846 Age:23 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Circulatory Collapse Foreign Zeldox PS ORAL 120 MG (2 IN Initial or Prolonged Electrocardiogram Qt Health 1 D), ORAL Corrected Interval Professional Zoloft Prolonged Company (Sertraline) C Representative Other Date:06/27/05ISR Number: 4701722-5Report Type:Expedited (15-DaCompany Report #2005083576 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Foreign Zeldox Extrapyramidal Disorder Health (Ziprasidone) PS ORAL 120 MG (1 IN Hallucination, Visual Professional 1 D), ORAL Oropharyngeal Spasm Other Abilify Thinking Abnormal (Aripiprazole) SS ORAL 15 MG (1 IN 1 D), ORAL Zolpidem (Zolpidem) SS ORAL 10 MG (1 IN 1 D), ORAL Temesta (Lorazepam) SS ORAL 5 MG (1 IN 1 D), ORAL 22-Feb-2006 08:32 AM Page: 789 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/27/05ISR Number: 4701890-5Report Type:Expedited (15-DaCompany Report #2005090509 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Consumer Geodon (Ziprasidone) PS ORAL 20 MG (20 Dizziness MG,1 IN 1 Electrocardiogram T Wave D),ORAL Abnormal Lipitor Rash Generalised (Atorvastatin) C Prilosec (Omeprazole) C Date:06/28/05ISR Number: 4703065-2Report Type:Direct Company Report #CTU 252113 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Band Neutrophil Count Geodon 29 Mg, 40 Mg, Hospitalization - Increased 80 Mg To Make Proper Initial or Prolonged Blood Sodium Decreased Dose PS SEE IMAGE Required Hepatitis Acute Risperdal C Intervention to Hypotension Seroquel C Prevent Permanent Inflammation Asikatid C Impairment/Damage Pharyngolaryngeal Pain Atenolol C Postnasal Drip Benzotropine C Pyrexia Tylenol C Rash Macular Milk Of Magnesia C Tachycardia Maalox C Urinary Tract Infection Clotrimazole C Viral Infection Carmol C Sunscreen Spf-35 C Date:06/28/05ISR Number: 4703070-6Report Type:Direct Company Report #CTU 252108 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Geodon 60 Mg PS ORAL 60 MG PO BID Date:06/28/05ISR Number: 4703073-1Report Type:Direct Company Report #CTU 252110 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Geodon 60mg PS ORAL 60MG PO BID Discomfort Date:06/28/05ISR Number: 4703219-5Report Type:Expedited (15-DaCompany Report #2005081197 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cataract Cortical Foreign Ziprasidone (Caps) Tardive Dyskinesia Study (Ziprasidone) PS ORAL 160 MG (80 Health MG, 2 IN 1 Professional D), ORAL Acetaminophen (Paracetamol) C Cogentin (Benzatropine Mesilate) C 22-Feb-2006 08:32 AM Page: 790 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/29/05ISR Number: 4704511-0Report Type:Expedited (15-DaCompany Report #2005090437 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dysphagia Foreign Zeldox (Im) Dyspnoea Health (Ziprasidone) PS ORAL SEE IMAGE Hypotension Professional Muscle Spasms Tongue Disorder Date:06/29/05ISR Number: 4705665-2Report Type:Expedited (15-DaCompany Report #2005081508 Age:27 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Foreign Zeldox (Capsules) Fall Health (Ziprasidone) PS ORAL 40 MG (40 MG, Loss Of Consciousness Professional 1 IN 1 D), Nausea Company ORAL Tonic Convulsion Representative Date:06/29/05ISR Number: 4705748-7Report Type:Expedited (15-DaCompany Report #2005081498 Age:32 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Angioneurotic Oedema Foreign Zeldox PS ORAL 120 MG (60 Initial or Prolonged Food Allergy Health MG, 2 IN 1 Other Professional D), ORAL Company Representative Other Date:06/29/05ISR Number: 4705903-6Report Type:Expedited (15-DaCompany Report #2005092179 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicide Attempt Foreign Zeldox (Capsules) Initial or Prolonged Health (Ziprasidone) PS ORAL 80 MG (40 MG, Professional 2 IN 1 D), Company ORAL Representative Rivotril (Clonazepam) SS ORAL ORAL Date:06/29/05ISR Number: 4706064-XReport Type:Expedited (15-DaCompany Report #2005091865 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abasia Consumer Geodon (Ziprasidone) PS Initial or Prolonged Amnesia All Other Other Aphasia Therapeutic Products Asthenia (All Other Depressed Level Of Therapeutic Consciousness Products) C Dysarthria Neurontin Feeling Jittery (Gabapentin) C Loss Of Consciousness Antihypertensives (Antihypertensives) C Antidepressants (Antidepressants) C 22-Feb-2006 08:32 AM Page: 791 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/30/05ISR Number: 4704587-0Report Type:Expedited (15-DaCompany Report #2005090654 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agitation Health Geodon (Im) Hospitalization - Anoxia Professional (Ziprasidone) PS INTRAMUSCULAR INTRAMUSCULAR Initial or Prolonged Apnoea Company Propofol (Propofol) SS Myocardial Infarction Representative Versed (Midazolam Pulmonary Embolism Hydrochloride) SS Road Traffic Accident All Other Therapeutic Products (All Therapeutic Products) C Date:06/30/05ISR Number: 4704697-8Report Type:Expedited (15-DaCompany Report #2005090503 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Drug Ineffective Health Geodon (Ziprasidone) PS ORAL 160 MG (80 Insomnia Professional MG, 2 IN 1 Somnolence D), ORAL Tremor Benadryl Urinary Incontinence (Diphenhydramine) SS ORAL 25 MG (25 MG, 1 IN 1 D), ORAL Detrol Tablet (Tolterodine L-Tartrate) SS ORAL 4 MG (2 MG, 2 IN 1 D), ORAL Date:06/30/05ISR Number: 4704713-3Report Type:Expedited (15-DaCompany Report #2005077982 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dialysis Health Geodon (Ziprasidone) PS ORAL 120 MG (60 Hospitalization - Pulmonary Embolism Professional MG, 2 IN 1 Initial or Prolonged D), ORAL Other Quetiapine (Quetiapine) SS ORAL 400 MG (200 MG, 2 IN 1 D), ORAL Clomipramine (Clomipramine) C Seroquel (Quetiapine Fumarate) C Date:07/05/05ISR Number: 4706800-2Report Type:Expedited (15-DaCompany Report #2005085099 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Complex Partial Seizures Consumer Geodon (Ziprasidone) PS ORAL 80 MG (40 MG, Initial or Prolonged Convulsion Health 2 IN 1 D) Disability Drooling Professional ORAL Other Electroencephalogram Depakote (Valproate Abnormal Semisodium) C Loss Of Consciousness Tenex (Guanfacine Hydrochloride) C 22-Feb-2006 08:32 AM Page: 792 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/05/05ISR Number: 4709193-XReport Type:Expedited (15-DaCompany Report #2005072183 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gastric Bypass Health Geodon (Ziprasidone) PS ORAL ORAL Professional Date:07/05/05ISR Number: 4709236-3Report Type:Expedited (15-DaCompany Report #2005092078 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gastrointestinal Disorder Health Geodon (Ziprasidone) PS ORAL ORAL Professional Zyprexa (Olanzapine) C Date:07/06/05ISR Number: 4709516-1Report Type:Expedited (15-DaCompany Report #2005093217 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Zeldox Initial or Prolonged Increased Health Hepatic Enzyme Increased Professional (Ziprasidone) PS ORAL 120 MG, ORAL Other Akineton (Biperiden Hydrochloride) C Tavor (Lorazepam) C Taxilan (Perazine) C Risperdal (Risperidone) C Date:07/06/05ISR Number: 4709537-9Report Type:Expedited (15-DaCompany Report #2005084613 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Myocardial Foreign Zeldox (Capsules) Infarction Health (Ziprasidone) PS ORAL 120 MG (60 Agitation Professional MG, 2 IN 1 Cardio-Respiratory Arrest D), ORAL Insomnia Thioridazine Loss Of Consciousness (Thioridazine) C Palpitations Syncope Tremor Date:07/06/05ISR Number: 4709555-0Report Type:Expedited (15-DaCompany Report #2005083576 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chills Foreign Zeldox Drug Ineffective Health Extrapyramidal Disorder Professional (Ziprasidone) PS ORAL 120 MG (1 IN Hallucination, Visual Other 1 D), ORAL Hypokinesia Abilify Laryngospasm (Aripiprazole) SS ORAL 15 MG (1 IN 1 Thinking Abnormal D), ORAL Zolpidem 22-Feb-2006 08:32 AM Page: 793 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Zolpidem) SS ORAL 10 MG (1 IN 1 D), ORAL Temesta (Lorazepam) SS ORAL 5 MG (1 IN 1 D), ORAL Date:07/07/05ISR Number: 4708985-0Report Type:Expedited (15-DaCompany Report #2005090509 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Consumer Geodon (Ziprasidone) PS ORAL 20 MG (20 MG, Dizziness Health 1 IN 1 D), Electrocardiogram T Wave Professional ORAL Abnormal Lipitor Rash Generalised (Atorvastatin) C Urticaria Prilosec (Omeprazole) C Date:07/07/05ISR Number: 4709037-6Report Type:Expedited (15-DaCompany Report #2005063279 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Paranoia Foreign Zeldox Initial or Prolonged Somnolence Health (Ziprasidone) PS ORAL 160 MG (80 Stupor Professional MG, 2 IN 1 Therapy Non-Responder Company D), ORAL Representative Trevilor Other (Venlafaxine Hydrochloride) C Date:07/07/05ISR Number: 4709043-1Report Type:Expedited (15-DaCompany Report #2005093189 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Zeldox Health Professional (Ziprasidone) PS Other Date:07/07/05ISR Number: 4709046-7Report Type:Expedited (15-DaCompany Report #2005090878 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Foreign Ziprasidone (Caps) Blood Pressure Increased Literature (Ziprasidone) PS 160 MG (1 D) Electrocardiogram Qt Health All Other Corrected Interval Professional Therapeutic Products Prolonged (All Other Heart Rate Increased Therapeutic Intentional Misuse Products) SS 384 MG (1 D) Overdose Flunitrazepam Oxygen Saturation (Flunitrazepam) SS 2 MG (1 D) Decreased Paroxetine Somnolence (Paroxetine) C Tremor Lorazepam (Lorazepam) C 22-Feb-2006 08:32 AM Page: 794 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/07/05ISR Number: 4709048-0Report Type:Expedited (15-DaCompany Report #2005093671 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Foreign Geodon (Ziprasidone) PS ORAL ORAL Initial or Prolonged Health Professional Date:07/07/05ISR Number: 4710638-XReport Type:Expedited (15-DaCompany Report #2005093445 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Foreign Zeldox (Capsules) Initial or Prolonged Dizziness Health (Ziprasidone) PS ORAL 80 MG (40 MG, Other Fatigue Professional 2 IN 1 D), Hypotension ORAL Incorrect Drug Administration Rate Somnolence Date:07/08/05ISR Number: 4711399-0Report Type:Expedited (15-DaCompany Report #2005072011 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acidosis Consumer Geodon (Ziprasidone) PS ORAL ORAL Initial or Prolonged Amnesia Citalopram Disability Anoxic Encephalopathy Hydrobromide C Other Anticonvulsant Drug Level Valproate Semisodium C Increased Cogentin Apnoea (Benzatropine Brain Damage Mesilate) C Cardiac Arrest Cognitive Disorder Coma Disorientation Dysphagia Electromechanical Dissociation Feeling Abnormal Flat Affect Hypoxia Insomnia Lobar Pneumonia Loss Of Consciousness Memory Impairment Nightmare Pulse Absent Respiratory Arrest Respiratory Distress Respiratory Failure Rhabdomyolysis Sinus Bradycardia Speech Disorder Staphylococcal Bacteraemia Staring Treatment Noncompliance Weight Increased 22-Feb-2006 08:32 AM Page: 795 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/08/05ISR Number: 4711682-9Report Type:Expedited (15-DaCompany Report #2005095393 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardio-Respiratory Arrest Health Geodon (Ziprasidone) PS 160 MG (80 Initial or Prolonged Sick Sinus Syndrome Professional MG, 2 IN 1 Other Company D), Representative Depakote (Valproate Semisodium) C Date:07/08/05ISR Number: 4711698-2Report Type:Direct Company Report #CTU 252872 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Sertraline PS ORAL 100 MG QHS Initial or Prolonged Prolonged ORAL Ziprasidone SS ORAL 60MG QD ORAL Date:07/11/05ISR Number: 4712324-9Report Type:Expedited (15-DaCompany Report #2004031173 Age:20 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anhedonia Consumer Neurontin Disability Anxiety Health (Gabapentin) PS ORAL ORAL Other Completed Suicide Professional Geodon (Ziprasidone) SS ORAL 80 MG (40 MG, Drug Toxicity 2 IN 1 D), Emotional Distress ORAL Incorrect Dose Acetaminophen Administered (Paracetamol) SS Mental Disorder Paxil (Paroxetine Pain Hydrochloride) SS ORAL 60 MG (30 MG, Pharmaceutical Product 2 IN 1 D), Complaint ORAL Polytraumatism Sudden Death Date:07/11/05ISR Number: 4712373-0Report Type:Expedited (15-DaCompany Report #A210937 Age:73 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arachnoid Cyst Consumer Geodon (Ziprasidone) PS ORAL 40 MG (2 IN 1 Condition Aggravated Health D), ORAL Constipation Professional Lithane (Lithium) SS ORAL ORAL Convulsion Levoxyl Dry Mouth (Levothyroxine Dyskinesia Sodium) C Feeling Abnormal Lipitor Heart Rate Irregular (Atorvastatin) C Insomnia Hydrochlorothiazide/ Major Depression Triamterene C Muscle Twitching Multivitamins C Parkinson'S Disease Vitamin E Tachycardia (Tocopherol) C Tardive Dyskinesia Glucosamine C Calcium C Acetylsalicylic Acid C Cenestin (Estrogens Conjugated) C 22-Feb-2006 08:32 AM Page: 796 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/11/05ISR Number: 4712472-3Report Type:Expedited (15-DaCompany Report #2005067194 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Obesity Health Geodon (Ziprasidone) PS ORAL 180 MG (60 MG Professional 3 IN 1 D) Company ORAL Representative Prevacid (Lansoprazole) C Baclofen (Baclofen) C Propanolol C Seroquel (Quetiapine Fumarate) C Keflex (Cefalexin Monohydrate) C Hydrochlorothiazide( Hydrochlorothiazide) C Gaviscon (Sodium Alginate, Sodium Bicarbonate) C Accupril (Quinapril Hydrochloride) C Vistaril (Hydroxyzine Embonate) C Date:07/11/05ISR Number: 4712511-XReport Type:Expedited (15-DaCompany Report #2005087479 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Prolactin Increased Health Geodon (Ziprasidone) PS ORAL 120 MG (60 Breast Cyst Professional MG, 2 IN 1 Gynaecomastia D), ORAL Lexapro (Escitalopram) SS (30 MG) Norvasc (Amlodipine) C Hydrochlorothiazide (Hydrochlorothiazide ) C Flonase (Fluticasone Propionate) C Date:07/12/05ISR Number: 4713857-1Report Type:Expedited (15-DaCompany Report #2005077877 Age:15 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Consumer Geodon (Ziprasidone) PS ORAL 40 MG (40 MG, Chest Pain Health 1 IN 1 D), Condition Aggravated Professional ORAL Convulsion Benadryl SS ORAL 50 MG (25 MG, Depression 1 IN 1 D), Drug Ineffective ORAL Drug Withdrawal Syndrome Duloxetine Eye Rolling Hydrochloride Feeling Abnormal (Duloxetine Loss Of Consciousness Hydrochloride) SS ORAL ORAL Restlessness Somnolence Tremor 22-Feb-2006 08:32 AM Page: 797 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/12/05ISR Number: 4713907-2Report Type:Expedited (15-DaCompany Report #2005095835 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Affective Disorder Health Geodon (Ziprasidone) PS UNKNOWN UNKNOWN Initial or Prolonged Mental Disorder Professional Xanax (Alprazolam) C Other Date:07/12/05ISR Number: 4714665-8Report Type:Expedited (15-DaCompany Report #2005062127 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Foreign Ziprasidone (Caps) Initial or Prolonged Condition Aggravated Study (Ziprasidone) PS ORAL 40 MG (20 MG, Dizziness Health 2 IN 1 D), Early Morning Awakening Professional ORAL Fall Flunitrazepam C Gait Disturbance Haloperidol C Hallucinations, Mixed Trihexyphenidyl C Headache Hypotension Insomnia Loss Of Consciousness Psychotic Disorder Syncope Therapy Non-Responder Unevaluable Event Vertigo Wound Date:07/13/05ISR Number: 4715435-7Report Type:Expedited (15-DaCompany Report #2005072011 Age:54 YR Gender:Female I/FU:F Outcome PT Hospitalization - Acidosis Initial or Prolonged Acute Respiratory Failure Disability Adverse Event Other Anoxic Encephalopathy Anxiety Arrhythmia Brain Damage Cardiac Arrest Cognitive Disorder Coma Disorientation Dysphagia Electromechanical Dissociation Flat Affect Hypoxia Insomnia Intubation Complication Long Qt Syndrome Loss Of Consciousness Nightmare Pneumonia Respiratory Arrest Rhabdomyolysis Sinus Bradycardia Staphylococcal 22-Feb-2006 08:32 AM Page: 798 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Bacteraemia Staring Treatment Noncompliance Weight Increased Report Source Product Role Manufacturer Route Dose Duration Consumer Geodon (Ziprasidone) PS ORAL ORAL Zyprexa (Olanzapine) SS Celexa (Citalopram Hydrobromide) C Depakote (Valproate Semisodium) C Cogentin (Benzatropine Mesilate) C Date:07/13/05ISR Number: 4715436-9Report Type:Expedited (15-DaCompany Report #2005067194 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Obesity Health Geodon (Ziprasidone) PS ORAL 180 MG (60 Professional MG, 3 IN 1 Company D), ORAL Representative Prevacid (Lansoprazole) C Baclofen (Baclofen) C Propanolol (Propranolol) C Seroquel (Quetiapine Fumarate) C Keflex (Cefalexin Monohydrate) C Hydrochlorothiazide (Hydrochlorothiazide ) C Gaviscon (Sodium Alginate, Sodium Bicarbonate) C Accupril (Quinapril Hydrochloride) C Vistaril (Hydroxyzine Embonate) C Date:07/13/05ISR Number: 4715556-9Report Type:Expedited (15-DaCompany Report #2005073197 Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Liver Function Test Health Geodon (Ziprasidone) PS 160 MG (80 Abnormal Professional MG, 2 IN 1 D) Neuroleptic Malignant Company Lithium (Lithium) SS Syndrome Representative Quetiapine Pneumonia (Quetiapine) SS Pyrexia Date:07/13/05ISR Number: 4716584-XReport Type:Expedited (15-DaCompany Report #2005097309 Age:47 YR Gender:Female I/FU:I Outcome PT Hospitalization - Aggression Initial or Prolonged Agitation 22-Feb-2006 08:32 AM Page: 799 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Suicidal Ideation Report Source Product Role Manufacturer Route Dose Duration Foreign Zeldox (Capsule) Health (Ziprasidone) PS ORAL 120 MG (30 Professional MG, 2 IN 1 D), ORAL Date:07/14/05ISR Number: 4716690-XReport Type:Expedited (15-DaCompany Report #2005060406 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dysphagia Health Geodon (Ziprasidone) PS ORAL 1600 MG (80 Muscle Spasms Professional MG, 2 IN 1 Oropharyngeal Spasm Company D), ORAL Respiratory Distress Representative Throat Tightness Tongue Disorder Date:07/14/05ISR Number: 4716764-3Report Type:Expedited (15-DaCompany Report #2005080520 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Carbon Monoxide Poisoning Consumer Geodon (Ziprasidone) PS Completed Suicide Family Stress Sick Relative Stress Date:07/15/05ISR Number: 4715430-8Report Type:Direct Company Report #CTU 253307 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Erythema Ziprasidone (Geodon) PS INTRAMUSCULAR 10 MG IM X 1 Incorrect Route Of Drug , REPEART Q 1 Administration HR FOR Infusion Site Erythema EXTREME Lethargy AGITATION TO Oedema Peripheral Oxygen Saturation Decreased Pain Sinus Tachycardia Date:07/15/05ISR Number: 4715814-8Report Type:Direct Company Report #CTU 253300 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Test Abnormal Geodon PS ORAL 40 MG AM/120 Initial or Prolonged Cholecystitis MG PM PO Hepatic Enzyme Increased Xanax Xr C Pancreatitis Multivitamin C Hydrocodone C Imitrex C Colonite C Albuterol C Sonata C 22-Feb-2006 08:32 AM Page: 800 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochorot C Date:07/15/05ISR Number: 4717305-7Report Type:Expedited (15-DaCompany Report #2005098165 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Immune System Disorder Health Geodon (Ziprasidone) PS Therapy Non-Responder Professional Date:07/15/05ISR Number: 4717385-9Report Type:Expedited (15-DaCompany Report #2005098173 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Geodon (Ziprasidone) PS ORAL 20 MG (20 MG, Hallucination Professional 1 IN 1 D), Immune System Disorder ORAL Nasopharyngitis Ativan (Lorazepam) C Sedation Risperdal Upper Respiratory Tract (Risperidone) C Infection Date:07/15/05ISR Number: 4717692-XReport Type:Expedited (15-DaCompany Report #KII-2005-0017506 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bundle Branch Block Right Study Hydromorphone Hcl Initial or Prolonged Disorientation Health (Similar To Nda Electrocardiogram Qrs Professional 21-044) Complex Prolonged Other (Hydromorphone Electrocardiogram T Wave Hydrochloride) PS ORAL SEE TEXT, Inversion ORAL Overdose Ziprasidone Somnolence (Ziprasidone) SS ORAL ORAL Tonic Clonic Movements Propranolol (Propranolol) SS ORAL ORAL Acetaminophen W/Hydrocodone Bitartrate (Paracetamol, Hydrocodone SS ORAL ORAL Antidepressants ( ) SS ORAL ORAL Acetylsalicylic Acid (Acetylsalicylic Acid) SS ORAL ORAL Antiepileptics ( ) SS ORAL ORAL Antiinflammatory/Ant irheumatic Products ( ) SS ORAL ORAL Nsaids ( ) SS ORAL ORAL Acetaminophen W/Oxycodone (Oxycodone Hydrochloride, Paracetamol) SS ORAL ORAL Angiotensin Receptor Blocker ( ) SS ORAL ORAL 22-Feb-2006 08:32 AM Page: 801 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/18/05ISR Number: 4717913-3Report Type:Periodic Company Report #2005052563 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Health Geodon (Im) Professional (Ziprasidone) PS INTRAMUSCULAR UNK Company (UNKNOWN), Representative INTRAMUSCULAR Date:07/18/05ISR Number: 4717914-5Report Type:Periodic Company Report #2005060316 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Health Geodon (Im) Professional (Ziprasidone) PS INTRAMUSCULAR UNKNOWN (20 Company MG, UNKNOWN), Representative INTRAMUSCULAR Date:07/18/05ISR Number: 4717919-4Report Type:Periodic Company Report #2004086357 Age:73 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Health Geodon (Im) Initial or Prolonged Corrected Interval Professional (Ziprasidone) PS INTRAMUSCULAR 10 (10 MG, 1 Other Prolonged Company IN 1 D), Representative INTRAMUSCULAR Lisinopril (Lisinopril) C Depakote (Valproate Semisodium) C Zetia (Ezetimibe) C Lipitor (Atorvastatin) C Altace (Ramipril) C Acetylsalicylic Acid (Acetylsalicylic Acid) C Aricept (Donepezil) C Risperdal (Risperidone) C Date:07/19/05ISR Number: 4718704-XReport Type:Expedited (15-DaCompany Report #S05-USA-02675-01 Age:17 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Consumer Lexapro Initial or Prolonged Condition Aggravated (Escitalopram) PS ORAL 50 MG QD PO Depression Lexapro Drug Ineffective (Escitalopram) SS ORAL 10 MG QD PO Hallucination Lexapro Intentional Misuse (Escitalopram) SS ORAL 20 MG QD PO Overdose Lexapro Post-Traumatic Stress (Escitalopram) SS ORAL 30 MG QD PO Disorder Lexapro Suicidal Ideation (Escitalopram) SS ORAL 40 MG QD PO Suicide Attempt Lexapro Treatment Noncompliance (Escitalopram) SS ORAL 50 MG QD PO Lexapro (Escitalopram) SS ORAL 30 MG QD PO 22-Feb-2006 08:32 AM Page: 802 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Elavil (Amitriptyline Hydrochloride) SS 50 MG QD Klonopin (Clonazepam) SS 1 MG QD Ritalin (Methylphenidate Hydrochloride) SS 30 MG QD Abilify (Aripiprazole) SS Geodon(Ziprasidone Hydrochloride) SS ORAL 40 MG QD PO Date:07/19/05ISR Number: 4718766-XReport Type:Expedited (15-DaCompany Report #A109802 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ageusia Health Geodon (Ziprasidone) PS ORAL 40 MG (20 MG, Initial or Prolonged Agitation Professional 2 IN 1 D), Required Akathisia ORAL Intervention to Asthenia Lithium (Lithium) SS ORAL 1200 MG, ORAL Prevent Permanent Cognitive Disorder Seroquel (Quetiapine Impairment/Damage Cogwheel Rigidity Fumarate) SS ORAL 200 MG, ORAL Contusion Propranolol Coordination Abnormal (Propranolol) SS ORAL 60 MG, ORAL Drug Ineffective Paxil (Paroxetine Dysphagia Hydrochloride) C Dystonia Nortriptyline Extrapyramidal Disorder (Nortriptyline) C Fall Thiamine (Thiamine) C Hallucination Folic Acid (Folic Hallucination, Auditory Acid) C Hot Flush Clonazepam Hypertrophy (Clonazepam) C Hypomania Benadryl C Incontinence Logorrhoea Movement Disorder Muscle Rigidity Muscle Spasms Muscle Twitching Myoclonus Neuroleptic Malignant Syndrome Oral Intake Reduced Parkinsonian Gait Restlessness Serotonin Syndrome Sleep Disorder Sleep Talking Tongue Discolouration Tongue Disorder Tremor 22-Feb-2006 08:32 AM Page: 803 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/19/05ISR Number: 4718965-7Report Type:Expedited (15-DaCompany Report #2005092179 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Zeldox Initial or Prolonged Schizophrenia Health (Ziprasidone) PS ORAL 160 MG (40 Other Suicide Attempt Professional MG, 2 IN 1 Company D), ORAL Representative Rivotril Other (Clonazepam) SS ORAL ORAL Date:07/19/05ISR Number: 4720656-3Report Type:Expedited (15-DaCompany Report #2005098954 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Study Ziprasidone (Caps) Initial or Prolonged Priapism Health (Ziprasidone) PS ORAL 160 MG (80 Professional MG, 2 IN 1 D) ORAL Date:07/19/05ISR Number: 4720765-9Report Type:Expedited (15-DaCompany Report #2005099678 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiomegaly Health Geodon (Ziprasidone) PS Other Sudden Death Professional Company Representative Date:07/20/05ISR Number: 4720875-6Report Type:Expedited (15-DaCompany Report #2005098860 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Health Geodon (Ziprasidone) PS 20 MG (20 Laryngeal Disorder Professional MG,1 IN 1 D) Company Representative Date:07/20/05ISR Number: 4720877-XReport Type:Expedited (15-DaCompany Report #2005100246 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Intolerance Health Geodon (Ziprasidone) PS 100 MG (20 Initial or Prolonged Electrocardiogram Qt Professional MG,4 IN 1 D) Other Corrected Interval Asa Prolonged (Acetylsalicyclic Insomnia Acid) C Mania Avandia Myocardial Infarction (Rosiglitazone Treatment Noncompliance Maleate) C Vascular Stenosis Glyburide (Glibenclamide) C Glucotrol (Glipizide) C Insulin (Insulin) C Nph Insulin (Insulin Injection, Isophane) C Plavix (Clopidogrel 22-Feb-2006 08:32 AM Page: 804 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sulfate) C Topamax (Topiramate) C Zetia (Ezetimibe) C Seroquel (Quetiapine Fumarate) C Date:07/20/05ISR Number: 4720996-8Report Type:Expedited (15-DaCompany Report #2004048195 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Epilepsy Foreign Geodon (Ziprasidone) PS ORAL 160 MG (180 Initial or Prolonged Study MG, 2 IN 1 Health D), ORAL Professional Zaleplon (Zaleplon) C Lorazepam (Lorazepam) C Date:07/20/05ISR Number: 4721227-5Report Type:Expedited (15-DaCompany Report #2005099017 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Foreign Geodon (Ziprasidone) PS ORAL 40 MG (40 MG, Initial or Prolonged Respiratory Disorder Consumer 1 IN 1 D) Other ORAL Date:07/20/05ISR Number: 4722618-9Report Type:Expedited (15-DaCompany Report #2005098173 Age:28 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Immune System Disorder Health Geodon (Ziprasidone) PS 20 MG (20 MG, Malaise Professional 1 IN Nasopharyngitis Ativan (Lorazepam) C Sedation Risperdal Upper Respiratory Tract (Risperidone) C Infection Date:07/21/05ISR Number: 4724601-6Report Type:Expedited (15-DaCompany Report #2005054219 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Foreign Zeldox (Capsules) Initial or Prolonged Smoker Health (Ziprasidone) PS ORAL 80 MG (40 MG, Suicidal Ideation Professional 2 IN 1 D), Company ORAL Representative Lamictal (Lamotrigine) C Date:07/21/05ISR Number: 4725065-9Report Type:Expedited (15-DaCompany Report #2005085099 Age: Gender:Male I/FU:F Outcome PT Hospitalization - Abnormal Behaviour Initial or Prolonged Aggression Disability Convulsion Other Drooling Drug Ineffective Excessive Masturbation 22-Feb-2006 08:32 AM Page: 805 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Fall Loss Of Consciousness Muscle Rigidity Report Source Product Role Manufacturer Route Dose Duration Paraesthesia Consumer Geodon (Ziprasidone) PS ORAL 80 MG (40 MG, Speech Disorder Health 2 IN 1 D), Professional ORAL Depakote (Valproate Semisodium) C Tenex (Guanfacine Hydrochloride) C Date:07/22/05ISR Number: 4723813-5Report Type:Expedited (15-DaCompany Report #2005098867 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Health Geodon (Ziprasidone) PS ORAL 120 MG (60 Initial or Prolonged Overdose Professional MG, 2 IN 1 Other Refusal Of Examination D), ORAL Suicide Attempt Klonopin (Clonazepam) SS 1 MG (1 MG, 1 IN 1 D) Cymbalta (Duloxetine Hydrochloride) C Strattera (Atomoxetine Hydrochloride) C Armour Thyroid (Thyroid) C Date:07/22/05ISR Number: 4723908-6Report Type:Expedited (15-DaCompany Report #2005034733 Age:12 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Upper Health Geodon (Ziprasidone) PS ORAL 40 MG (40 MG, Discomfort Professional 1 IN 1 D) , Dystonia Company ORAL Fear Representative Zoloft (Sertraline) SS Pain Prozac (Fluoxetine Treatment Noncompliance Hydrochloride) SS ORAL 30 MG (10 MG, 1 IN1 D), ORAL Date:07/22/05ISR Number: 4723909-8Report Type:Expedited (15-DaCompany Report #2005027347 Age:65 YR Gender:Female I/FU:F Outcome PT Life-Threatening Anaemia Hospitalization - Angiopathy Initial or Prolonged Arrhythmia Other Bradycardia Cardiac Stress Test Abnormal Cerebrovascular Accident Coronary Artery Occlusion Depression Electrocardiogram Delta Waves Abnormal Electrocardiogram Poor 22-Feb-2006 08:32 AM Page: 806 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report R-Wave Progression Electrocardiogram Qt Corrected Interval Prolonged Report Source Product Role Manufacturer Route Dose Duration Electrocardiogram Qt Health Geodon (Ziprasidone) PS ORAL 140 MG (2 IN Prolonged Professional 1 D), ORAL Electrocardiogram St Company Acetylsalicylic Acid Segment Abnormal Representative (Acetylsalicylic Electrocardiogram T Wave Acid) C Inversion Depakote (Valproate Femoral Arterial Stenosis Semisodium) C Heart Rate Increased Premarin (Estrogens Hypoaesthesia Conjugated0 C Intervertebral Disc Habitrol (Nicotine) C Degeneration Synthroid Mania (Levothyroxine Myocardial Infarction Sodium) C Myocardial Ischaemia Valium (Diazepam) C Osteoarthritis Vitamin B6 (Vitamin Paraesthesia B6) C Post Procedural Complication Psychotic Disorder Sinus Bradycardia Torsade De Pointes Ventricular Tachycardia Date:07/22/05ISR Number: 4725535-3Report Type:Direct Company Report #CTU 254102 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Geodon 20 Mg Pfizer PS Pfizer ORAL 40 MG 2X20 Non-Insulin-Dependent DAILY ORAL Diabetic Complication Lexapro C Hyperglycaemia Stress Vision Blurred Weight Decreased Date:07/25/05ISR Number: 4723390-9Report Type:Expedited (15-DaCompany Report #PHEH2005US06346 Age:17 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Depression Ritalin PS Novartis Sector: Hospitalization - Drug Ineffective Pharma ORAL 30 mg, QD Initial or Prolonged Hallucination Lexapro SS ORAL 10 mg, QD 10080MIN Other Overdose Lexapro SS ORAL 20 mg, QD 10080MIN Post-Traumatic Stress Lexapro SS ORAL 30 mg, QD 10080MIN Disorder Lexapro SS ORAL 40 mg, QD 10080MIN Suicidal Ideation Lexapro SS ORAL 50 mg, QD Suicide Attempt Lexapro SS ORAL 30 mg, QD Lexapro SS ORAL 50 mg, QD Elavil SS ORAL 50 mg, QD Klonopin SS ORAL 1 mg, QD 341 DAY Abilify SS ORAL UNK, UNK 135 DAY Geodon SS ORAL 40 mg, QD 46080MIN 22-Feb-2006 08:32 AM Page: 807 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/25/05ISR Number: 4725216-6Report Type:Expedited (15-DaCompany Report #2005100444 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Study Ziprasidone (Caps) Initial or Prolonged Agitation Health (Ziprasidone) PS ORAL 80 MG (40 MG, Disease Progression Professional 2 IN 1 D), Hallucination, Auditory ORAL Haldol (Haloperidol) C Lamictal (Lamotrigine) C Cogentin (Benzatropine Mesilate) C Reminyl (Galantamine) C Zonegran (Zonisamide) C Date:07/25/05ISR Number: 4726077-1Report Type:Expedited (15-DaCompany Report #2004090802 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accident Foreign Zeldox (Capsules) Electrocardiogram Qt Health (Ziprasidone) PS ORAL 160 MG (80 Prolonged Professional MG, 2 IN 1 Fall Company D), ORAL Hallucination Representative Zopiclone Head Injury (Zopiclone) SS ORAL ORAL Sudden Death Oxazepam (Oxazepam) SS ORAL ORAL Alcohol (Ethanol) SS ORAL ORAL Zyprexa (Olanzapine) C Marevan Forte (Warfarin Sodium) C Date:07/25/05ISR Number: 4726105-3Report Type:Expedited (15-DaCompany Report #2005087937 Age:16 MON Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Drug Intake By Foreign Ziprasidone (Caps) Initial or Prolonged Child Health (Ziprasidone) PS ORAL (40 MG, 1 IN Decreased Activity Professional 1 TOTAL), Electrocardiogram Qt ORAL Corrected Interval Prolonged Glasgow Coma Scale Abnormal Irritability Miosis Neurological Symptom Pupil Fixed Pyrexia Date:07/25/05ISR Number: 4726150-8Report Type:Expedited (15-DaCompany Report #2005102866 Age: Gender:Female I/FU:I Outcome PT Report Source Other Myocardial Infarction Foreign Health 22-Feb-2006 08:32 AM Page: 808 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Product Role Manufacturer Route Dose Duration Geodon (Ziprasidone) PS ORAL ORAL Date:07/25/05ISR Number: 4726928-0Report Type:Direct Company Report #CTU 254184 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Geodon 80mg PS ORAL 2 X 80 MG Initial or Prolonged Fall DAILY ORAL Loss Of Consciousness Date:07/25/05ISR Number: 4733333-XReport Type:Periodic Company Report #USA-2004-0018123 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Consumer Ms Contin Tablets Other Drug Abuser Health (Morphine Sulfate) PS Multiple Drug Overdose Professional Percocet Other (Paracetamol, Oxycodone Hydrochloride) SS Acetaminophen (Paracetamol) SS Gabapentin (Gabapentin) SS Paroxetine (Paroxetine) SS Alprazolam (Alprazolam) SS Ziprasidone (Ziprasidone) SS Trazodone (Trazodone) SS Atropine (Atropine) SS Valproic Acid (Valproic Acid) SS Lodine C Date:07/26/05ISR Number: 4724958-6Report Type:Expedited (15-DaCompany Report #US-ROCHE-410971 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Klonopin PS Roche UNKNOWN Initial or Prolonged Drug Effect Decreased Klonopin SS Roche UNKNOWN OVERDOSE Hallucination THERAPY. Post-Traumatic Stress Lexapro SS ORAL 7 DAY Disorder Lexapro SS ORAL 7 DAY Suicidal Ideation Lexapro SS ORAL 7 DAY Suicide Attempt Lexapro SS ORAL 7 DAY Lexapro SS ORAL Lexapro SS ORAL Lexapro SS ORAL Elavil SS UNKNOWN Ritalin SS UNKNOWN Abilify SS UNKNOWN 104 DAY Geodon SS ORAL 22-Feb-2006 08:32 AM Page: 809 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/26/05ISR Number: 4727137-1Report Type:Direct Company Report #CTU 254277 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicidal Ideation Geodon 20 Mg PS ORAL 20 MG PO AM Initial or Prolonged Geodon 60 Mg SS ORAL 220 MG PO PM Provigil C Zoloft C Xanax Xr C Adderall Xr C Multivitamin C Hydrocodone C Mobic C Date:07/26/05ISR Number: 4727415-6Report Type:Expedited (15-DaCompany Report #2005004881 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Consumer Geodon (Ziprasidone) PS Initial or Prolonged Agitation Health Methadone Other Alkalosis Professional (Methadone) SS Asthma All Other Cardiac Arrest Therapeutic Products Electrocardiogram Qt (All Other Prolonged Therapeutic Hallucination Products) SS Hyperkalaemia Duragesic (Fentanyl) SS Hypomagnesaemia Fentanyl (Fentanyl) SS Mental Status Changes Overdose Psychotic Disorder Rhabdomyolysis Torsade De Pointes Ventricular Tachycardia Date:07/27/05ISR Number: 4728143-3Report Type:Expedited (15-DaCompany Report #2004055638 Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Zeldox (Capsules) Initial or Prolonged Agitation Health (Ziprasidone) PS ORAL 120 MG (60 Suicidal Ideation Professional MG, 2 IN 1 Other D), ORAL Date:07/27/05ISR Number: 4728333-XReport Type:Expedited (15-DaCompany Report #2005067194 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Obesity Health Geodon (Ziprasidone) PS ORAL SEE IMGE Professional Prevacid Company (Lansoprazole) C Representative Baclofen (Baclofen) C Propanolol (Propanolol) C Seroquel (Quetiapine Fumarate) C Keflex (Cefalexin Monohydrate) C Hydrochlorothiazide 22-Feb-2006 08:32 AM Page: 810 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Hydrochlorothiazide ) C Gaviscon (Sodium Alginate, Sodium Bicarbonate) C Accupril (Quinapril Hydrochloride) C Vistaril (Hydroxyzine Embonate) C Date:07/27/05ISR Number: 4728348-1Report Type:Expedited (15-DaCompany Report #2005103497 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Feeling Guilty Consumer Zoloft (Sertraline) PS ORAL ORAL Initial or Prolonged Hunger Neurontin Increased Appetite (Gabapentin) SS ORAL ORAL Nausea Geodon (Ziprasidone) SS 40 MG Neurosis Lamictal Road Traffic Accident (Lamotrigine0 C Stress All Other Suicide Attempt Therapeutic Products Ulcer (All Other Victim Of Crime Therapeutic Products) C Date:07/28/05ISR Number: 4727642-8Report Type:Direct Company Report #CTU 254614 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Geodon PS ORAL 80 MG BID PO Dystonia Musculoskeletal Stiffness Date:07/28/05ISR Number: 4729656-0Report Type:Expedited (15-DaCompany Report #2005098954 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Study Ziprasidone (Caps) Initial or Prolonged Priapism Health (Ziprasidone) PS ORAL 160 MG (80 Professional MG, 2 IN 1 D) ORAL Date:07/28/05ISR Number: 4731182-XReport Type:Expedited (15-DaCompany Report #2005102866 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other No Adverse Drug Effect Foreign Geodon (Ziprasidone) PS ORAL ORAL Health Professional 22-Feb-2006 08:32 AM Page: 811 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/29/05ISR Number: 4734149-0Report Type:Expedited (15-DaCompany Report #2005103980 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Myocardial Infarction Health Geodon (Ziprasidone) PS ORAL 40 MG (20 MG, Professional 2 IN 1 D), Company ORAL Representative Date:07/29/05ISR Number: 4734152-0Report Type:Expedited (15-DaCompany Report #2005104854 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abasia Consumer Geodon (Ziprasidone) PS ORAL 120 MG (60 Adverse Drug Reaction MG, 2 IN 1 Alcoholism D), ORAL Anxiety Neurontin Arthritis (Gabapentin) SS ORAL ORAL Attention Risperdal Deficit/Hyperactivity (Risperidone) SS Disorder Klonopin Bipolar Disorder (Clonazepam) C Cartilage Injury Flexeril Condition Aggravated (Cyclobenzaprine Disturbance In Attention Hydrochloride) C Drug Dose Omission Metoprolol Gait Disturbance (Metoprolol) C Heart Rate Increased Hyoscyamine Psychomotor Hyperactivity (Hyoscyamine) C Refusal Of Treatment By Patient Tendonitis Thinking Abnormal Weight Increased Date:07/29/05ISR Number: 4734599-2Report Type:Expedited (15-DaCompany Report #2005039830 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Health Geodon (Ziprasidone) PS ORAL 120 MG (60 Initial or Prolonged Prolonged Professional MG, 2 IN 1 Other Hypokalaemia D), ORAL Syncope Citalopram Torsade De Pointes Hydrobromide (Citalopram Hydrobromide) SS ORAL 40 MG (1 IN 1 D), ORAL All Other Therapeutic Products (All Other Therapeutic Products) C Date:07/29/05ISR Number: 4735239-9Report Type:Expedited (15-DaCompany Report #2005095393 Age:62 YR Gender:Male I/FU:F Outcome Hospitalization - Initial or Prolonged 22-Feb-2006 08:32 AM Page: 812 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other PT Report Source Product Role Manufacturer Route Dose Duration Bradycardia Health Geodon (Ziprasidone) PS 160 MG (80 Cardiac Arrest Professional MG, 2 IN 1 Cardio-Respiratory Arrest Company D), Cardiovascular Disorder Representative Depakote (Valproate Mental Disorder Semisodium) C Pyrexia Rash Sick Sinus Syndrome Tachycardia Ventricular Arrhythmia Date:08/01/05ISR Number: 4732658-1Report Type:Expedited (15-DaCompany Report #2005098954 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Study Ziprasidone (Caps) Initial or Prolonged Delusion Health (Ziprasidone) PS ORAL ORAL Priapism Professional Date:08/03/05ISR Number: 4734762-0Report Type:Direct Company Report #CTU 255293 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Swelling Ziprasidone PS Date:08/04/05ISR Number: 4735187-4Report Type:Expedited (15-DaCompany Report #2005075827 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Dreams Health Geodon (Ziprasidone) PS ORAL 100 MG (100 Anorexia Professional MG, 1 IN 1 Anxiety Company D), ORAL Chills Representative Lithium Carbonate Depressed Mood (Lithium Carbonate) C Diarrhoea Disturbance In Attention Drug Withdrawal Syndrome Feeling Abnormal Hyperhidrosis Insomnia Psychomotor Hyperactivity Suicidal Ideation Thinking Abnormal Thirst Date:08/04/05ISR Number: 4735885-2Report Type:Direct Company Report #CTU 255413 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Foaming At Mouth Geodon 20 Mg PS ORAL 20 MG Q A.M. Initial or Prolonged Loss Of Consciousness ORAL Movement Disorder Geodon 40 Mg SS ORAL 40 MG QP.M. ORAL Depakote C 22-Feb-2006 08:32 AM Page: 813 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Zoloft C Focalin C Advair C Singulair C Albuterol C Date:08/04/05ISR Number: 4736279-6Report Type:Expedited (15-DaCompany Report #2005100444 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Study Ziprasidone (Caps) Initial or Prolonged Agitation Health (Ziprasidone) PS ORAL 80 MG (40 MG, Disease Progression Professional 2 IN 1 D), Hallucination, Auditory ORAL Haldol (Haloperidol) C Lamictal (Lamotrigine) C Cogentin (Benzatropine Mesilate) C Reminyl (Galantamine) C Zonegran (Zonisamide) C Date:08/04/05ISR Number: 4736408-4Report Type:Expedited (15-DaCompany Report #2005068966 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Hypersensitivity Health Geodon (Ziprasidone) PS 60 MG (60 MG, Initial or Prolonged Dyspnoea Professional 1 IN 1 D) Other Dystonia Suffocation Feeling Swollen Tongue Date:08/04/05ISR Number: 4738799-7Report Type:Expedited (15-DaCompany Report #2005099017 Age:66 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Increased Foreign Geodon (Ziprasidone) PS ORAL 40 MG (40 MG, Initial or Prolonged Pneumonia Consumer 1 IN 1 D), Other ORAL Captopril (Captopril) C Clorana (Hydrochlorothiazide ) C Insulin (Insulin) C Asa (Acetylsalicylic Acid) C Glucoformin (Metformin Hydrochloride) C Hydralazine (Hydralazine) C 22-Feb-2006 08:32 AM Page: 814 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/05/05ISR Number: 4735707-XReport Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12998167 Age:17 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Abilify PS Otsuka Initial or Prolonged Drug Ineffective Pharmaceutical Hallucination Company, Ltd. Intentional Misuse Lexapro SS ORAL Post-Traumatic Stress Elavil SS ORAL Disorder Klonopin SS Suicidal Ideation Ritalin SS Suicide Attempt Geodon SS ORAL Date:08/05/05ISR Number: 4737404-3Report Type:Expedited (15-DaCompany Report #2005075333 Age:16 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anaphylactic Shock Health Geodon (Ziprasidone) PS ORAL 60 MG (20 MG, Hospitalization - Cardio-Respiratory Arrest Professional 3 IN 1 D), Initial or Prolonged Dyskinesia Company ORAL Other Extrapyramidal Disorder Representative Lexapro Obstructive Airways (Escitalopram) SS Disorder Swollen Tongue Date:08/08/05ISR Number: 4741437-0Report Type:Expedited (15-DaCompany Report #2005098165 Age:28 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Decreased Immune Health Geodon (Ziprasidone) PS ORAL ORAL Responsiveness Professional Upper Respiratory Tract Infection Viral Infection Date:08/08/05ISR Number: 4741440-0Report Type:Expedited (15-DaCompany Report #2005107773 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Health Geodon (Ziprasidone) PS ORAL 160 MG (80 Initial or Prolonged Overdose Professional MG, 2 IN 1 Other Company D), ORAL Representative All Other Therapeutic Products (All Other Therapeutic Products) SS Date:08/08/05ISR Number: 4742392-XReport Type:Expedited (15-DaCompany Report #2005108138 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cholelithiasis Literature Ziprasidone (Caps) Initial or Prolonged Electrocardiogram Qt Health (Ziprasidone) PS UNKNOWN 160 MG (80 Other Corrected Interval Professional MG, 2 IN 1 Prolonged D), UNKNOWN Rhabdomyolysis Olanzapine (Olanzapine) C 22-Feb-2006 08:32 AM Page: 815 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Naproxen (Naproxen) C Propanolol (Propanolol) C Clonazepam (Clonazepam) C Zolpidem (Zolpidem) C Benztropeine (Benztropeine) C Ranitidine (Ranitidine Hydrochloride) C Docusate Sodium (Docusate Sodium) C Albuterol (Salbutamol) C Fluticasone (Fluticasone) C Date:08/08/05ISR Number: 4742416-XReport Type:Expedited (15-DaCompany Report #2005109736 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancreatitis Health Geodon (Ziprasidone) PS Initial or Prolonged Professional Other Company Representative Date:08/08/05ISR Number: 4742609-1Report Type:Expedited (15-DaCompany Report #2005093671 Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Foreign Geodon (Ziprasidone) PS ORAL ORAL Initial or Prolonged Health Professional Date:08/09/05ISR Number: 4744433-2Report Type:Expedited (15-DaCompany Report #2005099678 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiomegaly Consumer Geodon (Ziprasidone) PS Other Health Professional Company Representative Date:08/11/05ISR Number: 4742580-2Report Type:Expedited (15-DaCompany Report #US-ROCHE-410971 Age:17 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Klonopin PS Roche UNKNOWN 341 DAY Initial or Prolonged Hallucination Klonopin SS Roche UNKNOWN OVERDOSE Overdose THERAPY. Post-Traumatic Stress Lexapro SS ORAL 7 DAY Disorder Lexapro SS ORAL 7 DAY Self Injurious Behaviour Lexapro SS ORAL 7 DAY Suicidal Ideation Lexapro SS ORAL 7 DAY Suicide Attempt Lexapro SS ORAL 22-Feb-2006 08:32 AM Page: 816 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lexapro SS ORAL Lexapro SS ORAL Elavil SS UNKNOWN Ritalin SS UNKNOWN Ritalin SS UNKNOWN THE PATIENT WAS WEANED OFF THE DRUG. Abilify SS UNKNOWN 135 DAY Geodon SS ORAL 32 DAY Date:08/11/05ISR Number: 4743188-5Report Type:Expedited (15-DaCompany Report #2005070068 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Heat Stroke Health Geodon (Ziprasidone) PS ORAL 200 MG (100 Other Professional MG, 2 IN 1 D), ORAL Topamax (Topiramate) C Percocet (Oxycodone Hydrochloride, Paracematol) C Zantac (Ranitidine Hydrochloride) C Naproxen (Naproxen) C Date:08/15/05ISR Number: 4746344-5Report Type:Expedited (15-DaCompany Report #2005084843 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neuroleptic Malignant Foreign Zeldox (Capsules) Hospitalization - Syndrome Health (Ziprasidone) PS ORAL 120 MG, ORAL Initial or Prolonged Rhabdomyolysis Professional Zyprexa (Olanzapine) C Company Beloc Zok Representative (Metoprolol Succinate) C Date:08/15/05ISR Number: 4746623-1Report Type:Expedited (15-DaCompany Report #2005109736 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancreatitis Health Geodon (Ziprasidone) PS ORAL 80 MG (40 MG, Initial or Prolonged Professional 2 IN 1 D), Other Company ORAL Representative Zoloft (Sertraline) SS 200 MG (1 IN 1 D) Topamax (Topiramate) C Lunesta (Eszopiclone) C Date:08/15/05ISR Number: 4746680-2Report Type:Expedited (15-DaCompany Report #2005109810 Age: Gender:Male I/FU:I Outcome PT Other Abasia Aphasia Overdose Somnolence 22-Feb-2006 08:32 AM Page: 817 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Visual Disturbance Report Source Product Role Manufacturer Route Dose Duration Consumer Geodon (Ziprasidone) PS Lorazepam (Lorazepam) SS Haladol Decanoate (Haloperidol Decanoate) C Risperdal (Risperidone) C All Tohter Therapeutic Products All Tohter Therapeutic Products) C Parenteral (Calcium Chloride Hexahydrate, Potassium Chloride, Sodium Acetate C Date:08/15/05ISR Number: 4747243-5Report Type:Expedited (15-DaCompany Report #2005110795 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Health Geodon (Ziprasidone) PS Syndrome Professional All Other Company Therapeutic Products Representative (All Other Therapeutic Products) C Date:08/17/05ISR Number: 4747527-0Report Type:Direct Company Report #CTU 256341 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Geodon 60mg Gaze Palsy Roerig, Division Of Musculoskeletal Stiffness Pfizer Inc PS Roerig, Division Of Speech Disorder Pfizer Inc ORAL 60MG BEDTIME Torticollis ORAL 1 NIGHT Ambien C Albuterol Inhaler C Levaquin C Date:08/17/05ISR Number: 4747795-5Report Type:Direct Company Report #CTU 256401 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Asthenia Ziprasidone 20mg Dizziness Pfizers PS Pfizers ORAL 40MG BID ORAL 22-Feb-2006 08:32 AM Page: 818 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/17/05ISR Number: 4748879-8Report Type:Expedited (15-DaCompany Report #2005093454 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Consumer Geodon (Ziprasidone) PS ORAL 40 MG (40 MG, Initial or Prolonged Increased Health 1 IN 1 D), Other Aspartate Professional ORAL Aminotransferase Lamictal Increased (Lamotrigine) SS ORAL 25 MG (25 MG, Blood Alkaline 1 IN 1 D), Phosphatase Increased ORAL Blood Creatine Lexapro Phosphokinase Increased (Escitalopram) C Depression Tylenol (Paraetamol) C Diarrhoea Drug Eruption Glaucoma Headache Insomnia Nausea Optic Neuritis Rash Generalised Rash Pruritic Vomiting White Blood Cell Count Increased Date:08/17/05ISR Number: 4748880-4Report Type:Expedited (15-DaCompany Report #2005112421 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Health Geodon (Ziprasidone) PS Initial or Prolonged Economic Problem Professional Date:08/18/05ISR Number: 4748443-0Report Type:Expedited (15-DaCompany Report #2005090503 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Drug Ineffective Health Geodon (Ziprasidone) PS ORAL 160 MG (80 Sedation Professional MG, 2 IN 1 Tremor D), ORAL Urinary Incontinence Benadryl (Diphenhydramine) SS ORAL 25 MG (25 MG, 1 IN 1 D), ORAL Detrol Tablet (Tolterodine L-Tartrate) SS ORAL 4 MG (2 MG, 2 IN 1 D), ORAL Remeron (Mirtazapine) C Paxil (Paroxetine Hydrochloride) C 22-Feb-2006 08:32 AM Page: 819 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/18/05ISR Number: 4748561-7Report Type:Direct Company Report #CTU 256435 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Bruxism Geodon 20mg PS ORAL 20MG QDAY Intervention to Choreoathetosis ORAL Prevent Permanent Dyskinesia Wellbutrin Sr C Impairment/Damage Mvi/Minerals C Date:08/19/05ISR Number: 4750156-6Report Type:Expedited (15-DaCompany Report #2005090654 Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Apnoea Health Geodon (Im) Hospitalization - Respiratory Arrest Professional (Ziprasidone) PS INTRAMUSCULAR 20 MG (10 Initial or Prolonged Company MG), Other Representative INTRAMUSCULAR Propofol (Propofol) SS INTRAVENOUS INTRAVENOUS Versed (Midazolam Hydrochloride) SS INTRAMUSCULAR 2.5, INTRAMUSCULAR All Other Therapeutic Products (All Other Therapeutic Products) C Date:08/19/05ISR Number: 4750158-XReport Type:Expedited (15-DaCompany Report #2005039830 Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Withdrawal Syndrome Health Geodon (Ziprasidone) PS PARENTERAL 120 MG (60 Initial or Prolonged Electrocardiogram Qt Professional MG, 2 IN 1 Other Prolonged D), ORAL Hypokalaemia Celexa (Citalopram Syncope Hydrobromide) SS ORAL 40 MG (1 IN 1 Torsade De Pointes D), ORAL All Other Therapeutic Products (All Other Therapeutic Products) C Date:08/22/05ISR Number: 4751019-2Report Type:Expedited (15-DaCompany Report #2005027310 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Consumer Geodon (Ziprasidone) PS ORAL 120 MG (60 Sleep Apnoea Syndrome Health MG, 2 IN 1 Sudden Death Professional D), ORAL Methadone (Methadone) SS Zyprexa (Olanzapine) C Lithium (Lithium) C Depakote (Valproate Semisodium) C 22-Feb-2006 08:32 AM Page: 820 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/22/05ISR Number: 4751062-3Report Type:Expedited (15-DaCompany Report #2005112558 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Fall Consumer Geodon (Ziprasidone) PS 220 MG Suicide Attempt (DAILY), 3 WK Date:08/22/05ISR Number: 4751107-0Report Type:Expedited (15-DaCompany Report #2005098954 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Study Ziprasidone (Caps) Initial or Prolonged Delusion Health (Zirpasidone) PS ORAL 180 MG (60 Other Priapism Professional MG), ORAL Date:08/22/05ISR Number: 4751340-8Report Type:Expedited (15-DaCompany Report #2005115821 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Health Geodon (Ziprasidone) PS 180 MG (1 D) Initial or Prolonged Prolonged Professional Risperdal Other Palpitations Company (Risperidone) SS Representative Date:08/22/05ISR Number: 4751599-7Report Type:Direct Company Report #CTU 256661 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Geodon 20 Mg Inj PS INTRAMUSCULAR 20 MG IM Q 12 Initial or Prolonged Laryngeal Disorder HOUR Musculoskeletal Stiffness Lithium C Speech Disorder Depakote C Seroquel C Methadone C Date:08/22/05ISR Number: 4751654-1Report Type:Expedited (15-DaCompany Report #2005112550 Age:69 YR Gender:Female I/FU:I Outcome PT Other Alanine Aminotransferase Increased Aspartate Aminotransferase Increased Bilirubin Conjugated Increased Blood Alkaline Phosphatase Increased Blood Bilirubin Increased Blood Immunoglobulin E Increased Blood Lactate Dehydrogenase Increased Body Temperature Increased Eosinophil Percentage Increased Faeces Pale 22-Feb-2006 08:32 AM Page: 821 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Gamma-Glutamyltransferase Increased Heart Rate Increased Report Source Product Role Manufacturer Route Dose Duration Jaundice Foreign Ziprasidone (Caps) Rash Literature (Ziprasidone) PS ORAL 80 MG, ORAL Health Professional Date:08/22/05ISR Number: 4751753-4Report Type:Expedited (15-DaCompany Report #2005113723 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Disinhibition Foreign Ziprasidone (Caps) Initial or Prolonged Dysphoria Study (Ziprasidone) PS ORAL 80 MG (40 MG, Grandiosity Health 2 IN 1 D), Hypomania Professional ORAL Insomnia Diazepam (Diazepam) C Psychomotor Hyperactivity Zuclophenthixol Speech Disorder (Zuclopenthixol) C Suicidal Ideation Therapy Non-Responder Treatment Noncompliance Date:08/23/05ISR Number: 4751348-2Report Type:Direct Company Report #CTU 256717 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Geodon Pfizer PS Pfizer ORAL 40 MG Q AM PO Initial or Prolonged Drug Abuser Geodon Pfizer SS Pfizer ORAL 160MG QPM PO Provigil C Cogentin C Imitrex C Klonopin C Flexeril C Lunesta C Zoloft C Requip C Date:08/23/05ISR Number: 4752756-6Report Type:Expedited (15-DaCompany Report #2005077877 Age:15 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Consumer Geodon (Ziprasidone) PS ORAL 40 MG(40 MG, Chest Pain Health 1 IN 1 D), Convulsion Professional ORAL Depression Benadryl SS ORAL 50 MG (25 MG, Drug Ineffective 1 IN 1 D), Drug Withdrawal Syndrome ORAL Eye Rolling Duloxetine Feeling Abnormal Hydrochloride Loss Of Consciousness (Duloxetine Restlessness Hydrochloride) SS ORAL ORAL Somnolence Tremor 22-Feb-2006 08:32 AM Page: 822 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/23/05ISR Number: 4752766-9Report Type:Expedited (15-DaCompany Report #2005109736 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Insomnia Health Geodon (Ziprasidone) PS ORAL 80 MG (40 MG, Initial or Prolonged Pancreatitis Professional 2 IN 1 D), Other Company ORAL Representative Zoloft (Sertraline) SS 200 MG (1 IN 1 D) Topomax 9topiramate) C Lunesta (Esopiclone) C Date:08/23/05ISR Number: 4752821-3Report Type:Expedited (15-DaCompany Report #2005004881 Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Consumer Geodon (Ziprasidone) PS Initial or Prolonged Agitation Health Methadone Other Alkalosis Professional (Methadone) SS Cardiac Arrest All Other Hallucination Therapeutic Products Hyperkalaemia (All Other Hypomagnesaemia Therapeutic Overdose Products) SS Psychotic Disorder Duragesic (Fentanyl) SS Rhabdomyolysis Fentanyl (Fentanyl) SS Torsade De Pointes Ventricular Tachycardia Date:08/24/05ISR Number: 4752129-6Report Type:Direct Company Report #CTU 256878 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Ziprasidone 20mg Glycosylated Haemoglobin Pfizer PS Pfizer ORAL 80MG TWICE Increased DAILY PO Weight Increased Divalproex Sodium C Atorvastatin C Date:08/24/05ISR Number: 4752628-7Report Type:Expedited (15-DaCompany Report #2005088028 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Parkinsonism Health Geodon (Ziprasidone) PS 100 MG (2 IN Professional 1 D) Date:08/24/05ISR Number: 4753288-1Report Type:Expedited (15-DaCompany Report #2005076976 Age:81 YR Gender:Female I/FU:I Outcome PT Hospitalization - Body Height Decreased Initial or Prolonged Depression Drug Ineffective Eructation Flatulence Gastric Disorder Glucose Tolerance Impaired 22-Feb-2006 08:32 AM Page: 823 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Headache Nausea Oculogyration Report Source Product Role Manufacturer Route Dose Duration Overdose Consumer Geodon (Ziprasidone) PS ORAL 160 MG (160 Somnolence Health MG, 1 IN 1 Visual Disturbance Professional D), ORAL Acetylsalicylic Acid (Acetylsalicylic Acid) SS Zyprexa (Olanzapine) SS 2.5 MG (2.5 MG, 1 IN 1 D), Wellbutrin (Bupropion Hydrochloride) C Levothyroid (Levothyroxine Sodium) C Multivitamins (Multivitamins) C Docusate (Docusate) C Oscal (Calcium Carbonate) C Psyllium Hydrophilic Mucilloid (Psyllium Hydrophilic Mucilloid) C Vitamin C (Vitamin C) C Lipitor (Atorvastatin) C Detrol La (Tolterodine L-Tartrate) C Vitamin E (Vitamin E) C Valsartan (Valsartan) C Hydrochlorothiazide (Hydrochlorothiazide ) C Date:08/25/05ISR Number: 4753938-XReport Type:Expedited (15-DaCompany Report #2005087572 Age:13 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Belligerence Health Geodon (Ziprasidone) PS ORAL 40 MG (20 MG, Completed Suicide Professional 2 IN 1 D), Gun Shot Wound ORAL Head Injury Risperdal Irritability (Risperidone) C Oppositional Defiant Disorder Weight Increased 22-Feb-2006 08:32 AM Page: 824 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/25/05ISR Number: 4754189-5Report Type:Periodic Company Report #FLX20040005 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Delirium Literature Fluoxetine 40 Mg Hospitalization - Electrocardiogram Qt Health Unknown PS ORAL 180 TABS ONCE Initial or Prolonged Corrected Interval Professional PO Prolonged Ziprasidone 80 Mg Grand Mal Convulsion Unknown SS ORAL 74 TABS ONCE Lethargy PO Multiple Drug Overdose Divalproex 250 Mg Unknown SS ORAL 300 TABS ONCE PO Bupropion Er 100 Mg Unknown SS ORAL 157 TABS ONCE PO Date:08/25/05ISR Number: 4754837-XReport Type:Expedited (15-DaCompany Report #2004118673 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neuroleptic Malignant Foreign Ziprasidone (Caps) Syndrome Study (Ziprasidone) PS ORAL 160 MG (80 Health MG, 2 IN 1 Professional D), ORAL Clonazepam (Clonazepam) C Trihexyphenidyl Hydrochloride (Trihexyphenidyl Hydrochloride) C Phenolphthalein (Phenolphthalein) C All Other Therapeutic Products (All Other Therapeutic Products) C Risperidone (Risperidone) C Date:08/26/05ISR Number: 4753957-3Report Type:Expedited (15-DaCompany Report #2005116356 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Health Geodon (Ziprasidone) PS 40 MG (20 MG, Depression Professional 2 IN 1 D) Hypochromic Anaemia Antipsychotics Insomnia Antipsychotics SS Microcytic Anaemia Celexa (Citalopram Parkinson'S Disease Hydrobromide) SS 60 MG (1 IN 1 Restless Legs Syndrome D) Tardive Dyskinesia Mirapex (Pramipexole) SS Trazodone (Trazodone) C All Other Therapeutic Products (All Other Therapeutic 22-Feb-2006 08:32 AM Page: 825 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Products) C Anti-Diabetic (Anti-Diabetics C Date:08/26/05ISR Number: 4755420-2Report Type:Direct Company Report #CTU 256980 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hyperventilation Geodon PS Date:08/26/05ISR Number: 4758640-6Report Type:Expedited (15-DaCompany Report #2005117595 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aphasia Foreign Zeldox (Capsules) Initial or Prolonged Fatigue Consumer (Ziprasidone) PS ORAL 160 MG (80 Headache MG, 2 IN 1 Hypoaesthesia D), ORAL Leukocytosis Neurological Symptom Visual Field Defect Date:08/26/05ISR Number: 4758855-7Report Type:Expedited (15-DaCompany Report #2005118137 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsions Local Consumer Geodon (Ziprasidone) PS 80 MG (40 MG, Fatigue 2 IN 1 D) Feeling Cold Benadryl Injection Insomnia (Diphenhydramine) SS INTRAVENOUS 50 MG (50 MG, Muscular Weakness ONCE) INTRAVENOUS Paxil (Paroxetine Hydrochloride) C Dalmane (Flurazepam Hydrochloride) C Ativan (Lorazepam) C Methadone (Methadone) C Date:08/26/05ISR Number: 4761748-2Report Type:Periodic Company Report #USA-2005-0019651 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Polysubstance Abuse Consumer Oxycontin Tablets Other (Oxycodone Hydrochloride) PS Oxycodone Hydrochloride (Similar To Nda 20-553) (Oxycodone Hydrochloride) SS Lorazepam (Lorazepam) SS Wellbutrin (Amfebutamone Hydrochloride) SS Effexor (Venlafaxine 22-Feb-2006 08:32 AM Page: 826 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) SS Geodon SS Mobic (Meloxicam) SS Date:08/29/05ISR Number: 4757105-5Report Type:Expedited (15-DaCompany Report #2005039830 Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Withdrawal Syndrome Health Geodon (Ziprasidone) PS ORAL 120 MG (60 Initial or Prolonged Electrocardiogram Qt Professional MG, 2 IN 1 Other Prolonged D), ORAL Hypokalaemia Celexa (Citalopram Syncope Hydrobromide) SS ORAL 40 MG (1 IN 1 Torsade De Pointes D), ORAL All Other Therapeutic Products (All Other Therapeutic Products C Date:08/29/05ISR Number: 4757153-5Report Type:Expedited (15-DaCompany Report #2005090503 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Activities Of Daily Health Geodon (Ziprasidone) PS ORAL 160 MG (80 Living Impaired Professional MG, 2 IN 1 Drug Ineffective D), ORAL Somnolence Detrol La Tremor (Tolterodine Urinary Incontinence L-Tartrate) SS ORAL 2 MG, ORAL Diphenhydramine (Diphenhydramine) SS Remeron (Mirtazapine) C Paxil (Paroxetine Hydrochloride) C Date:08/29/05ISR Number: 4757534-XReport Type:Expedited (15-DaCompany Report #2005117531 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Study Ziprasidone (Caps) Initial or Prolonged Delusion Health (Ziprasidone) PS ORAL 40 MG (20 MG, Disease Progression Professional 2 IN 1 D), Fractured Coccyx ORAL Lithium (Lithium) C Fluoxetine (Fluoxetine) C Date:08/29/05ISR Number: 4757761-1Report Type:Expedited (15-DaCompany Report #2004076089 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alcohol Poisoning Health Geodon (Ziprasidone) PS Drug Abuser Professional Alcohol (Ethanol) SS Multiple Drug Overdose Company All Other Representative Therapeutic Products (All Other Therapeutic 22-Feb-2006 08:32 AM Page: 827 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Products) SS Valium (Diazepam) C Date:08/30/05ISR Number: 4757938-5Report Type:Expedited (15-DaCompany Report #2005070068 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Heat Stroke Health Geodon (Ziprasidone) PS ORAL 200 MG (100 Hospitalization - Professional MG, 2 IN 1 Initial or Prolonged D), ORAL Other Topamax (Topiramate) C Percocet (Oxycodone Hydrochloride, Paracetamol) C Zantac (Ranitidine Hydrochloride) C Naproxen (Naproxen) C Date:08/31/05ISR Number: 4759263-5Report Type:Expedited (15-DaCompany Report #2004088663 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Zeldox (Capsules) Malaise Health (Ziprasidone) PS ORAL 120 MG (2 IN Sudden Death Professional 1 D), ORAL Company Loratadine C Representative Salbutamol C Beclometasone Dipropionate C Mometasone Furoate C Propranolol Hydrochloride C Levothyroxine Sodium C Sinuselect (Homeopatics Nos) C Selenide Sodium C Antihistamines C Date:09/01/05ISR Number: 4761440-4Report Type:Direct Company Report #CTU 257480 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatinine Ziprasidone 120 Increased Mg PS 120 MG BID Depressed Level Of Levothyroxine Consciousness -Synthroid(R)- C Diarrhoea Lamotrigine Grand Mal Convulsion -Lamictal(R)- C Heart Rate Increased Lithium Hyponatraemia -Eskalith(R)- C Incorrect Dose Clonazepam Administered -Klonopin(R)- C Neuroleptic Malignant Escitalopram Syndrome -Lexapro(R)- C Serotonin Syndrome White Blood Cell Count Increased 22-Feb-2006 08:32 AM Page: 828 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/06/05ISR Number: 4761688-9Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050300056 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination, Auditory Risperidone PS ORAL Initial or Prolonged Injury Fluoxetin SS Thinking Abnormal Zeldox SS Lorazepam C Date:09/06/05ISR Number: 4764061-2Report Type:Expedited (15-DaCompany Report #2005120254 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Geodon (Ziprasidone) PS Professional Company Representative Date:09/06/05ISR Number: 4764081-8Report Type:Expedited (15-DaCompany Report #2005098954 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Study Ziprasidone (Caps) Initial or Prolonged Delusion Health (Ziprasidone) PS ORAL 180 MG (60 Other Priapism Professional MG), ORAL Date:09/06/05ISR Number: 4765638-0Report Type:Expedited (15-DaCompany Report #2005118670 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination Foreign Zeldox (Capsules) Initial or Prolonged Study (Ziprasidone) PS 120 MG Health (DAILY) Professional Tegretal (Carbamazepine) C Sepram (Citalopram Hydrobromide) C Date:09/07/05ISR Number: 4765073-5Report Type:Expedited (15-DaCompany Report #2005120526 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Allergy To Chemicals Consumer Geodon (Ziprasidone) PS ORAL ORAL Arthralgia Clozaril (Clozapine) C Bipolar Disorder Insomnia Intervertebral Disc Injury Nerve Compression Weight Increased Date:09/08/05ISR Number: 4766626-0Report Type:Expedited (15-DaCompany Report #2005110795 Age:35 YR Gender:Female I/FU:F Outcome Death Hospitalization - 22-Feb-2006 08:32 AM Page: 829 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged Other PT Report Source Product Role Manufacturer Route Dose Duration Anxiety Health Geodon (Ziprasidone) PS ORAL 80 MG (40 MG, Bacterial Infection Professional 2 IN 1 D), Blood Urine Company ORAL Cardiac Failure Representative Advair (Fluticasone Congestive Propionate, Cardiac Murmur Salmeterol Catheter Related Xinafoate) C Infection Xopenex Cystitis (Levosalbutamol) C Dehydration Albuterol Depressed Level Of (Salbutamol) C Consciousness Asa (Acetylsalicylic Depressed Mood Acid) C Diarrhoea Plavix (Clopidogrel Disease Recurrence Sulfate) C General Physical Health Clonazepam Deterioration (Clonazepam) C Haemoglobin Decreased Effexor-Xr Mucosal Dryness (Venlafaxine Neuroleptic Malignant Hydrochloride) C Syndrome Fluoxetine Obesity (Fluoxetine) C Platelet Count Increased Neurontin Proteus Infection (Gabapentin) C Renal Impairment Lithium (Lithium) C Urine Ketone Body Trazodone Urosepsis (Trazadone) C Weight Decreased Diclofenac (Diclofenac Sodium) C Fentanyl (Fentanyl) C Ditropan Xl (Oxybutynin Hydrochloride) C Cranberry (Vacciniujm Macrocarpon) C Docusate (Docusate) C Reglan (Metroclopramide) C Prevaicd (Lansoprazole) C Flonase (Fluticasone Propionate) C Loratadine (Loratadine) C Lasix (Furosemide) C Levothroid (Levothyroxine Sodium) C Lipitor (Atorvastatin) C Glucophage (Metformin Hydrochloride) C Potassium Chloride (Potassium Chloride) C 22-Feb-2006 08:32 AM Page: 830 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/09/05ISR Number: 4766368-1Report Type:Expedited (15-DaCompany Report #2004046701 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dizziness Foreign Ziprasidone (Caps) Pruritus Health (Ziprasidone) PS ORAL 160 MG (80 Scratch Professional MG, 2 IN 1 Skin Lesion Company D), ORAL Torsade De Pointes Representative Gabapentin (Gabapentin) SS ORAL 1800 MG (600 MG, 3 IN 1 D), ORAL Lamotrigine (Lamotrigine) SS ORAL 300 MG , ORAL Ranitidine Hydrochloride (Ranitidine Hydrochloride) SS ORAL ORAL Midazolam (Midazolam) SS ORAL ORAL Dexchlorpheniramine Maleate (Dexchlorpheniramine Maleate) C Olanzapine (Olanzapine0 C Date:09/09/05ISR Number: 4767159-8Report Type:Direct Company Report #CTU 257903 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrioventricular Block Geodon 20 Mg Pfizer PS Pfizer ORAL 20 MG DAILY Initial or Prolonged First Degree PO Required Electrocardiogram Intervention to Abnormal Prevent Permanent Electrocardiogram Qt Impairment/Damage Corrected Interval Prolonged Date:09/12/05ISR Number: 4765995-5Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0570262A Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Body Temperature Lamictal PS Glaxosmithkline ORAL 345 DAY Increased Geodon SS ORAL 60MG Twice Dystonia per day 57 DAY Rash Rhabdomyolysis Date:09/12/05ISR Number: 4766693-4Report Type:Expedited (15-DaCompany Report #2005123392 Age:42 YR Gender:Male I/FU:I Outcome PT Hospitalization - Antipsychotic Drug Level Initial or Prolonged Below Therapeutic Other Blood Calcium Decreased Blood Magnesium Decreased Blood Potassium Decreased Coronary Artery Occlusion 22-Feb-2006 08:32 AM Page: 831 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Diabetic Complication Myocardial Infarction Pericardial Effusion Report Source Product Role Manufacturer Route Dose Duration Stent Occlusion Consumer Geodon (Ziprasidone) PS ORAL 20 MG, FOUR Ventricular Tachycardia TIMES A DAY Vertigo AS NEEDED, ORAL Prevacid (Lansoprazole) C Neurontin (Gabapentin) C Zocor (Simvastatin) C Asa (Acetylsalicylic Acid) C Vicodin (Hydrocodone Bitartrate, Paracetamol) C Atenolol C Lisinopril C Actos (Pioglitazone) C Klonopin (Clonazepam) C Zoloft (Sertraline) C Lithium C Glucovance (Glibenclamide, Metformin Hydrochloride) C Garlic C Omega 3 (Fish Oil) C Nitroglycerin C Atrovent (Ipratropium Bromide) C Rhinocort Aqua (Budesonide) C Date:09/12/05ISR Number: 4767822-9Report Type:Expedited (15-DaCompany Report #2004093169 Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bruxism Consumer Geodon (Ziprasidone) PS ORAL 80 MG (40 MG, Condition Aggravated Health 2 IN 1 D), Confusional State Professional ORAL Diabetes Mellitus Lithium (Lithium) SS ORAL ORAL Dysphasia Diazepam (Diazepam) C Fatigue Tripleptal Hyponatraemia (Oxcarbazepine) C Ketoacidosis Glucophage Loss Of Consciousness (Metformin No Therapeutic Response Hydrochloride) C Road Traffic Accident Glucotrol Xl Somnolence (Gilipizide) C Tongue Disorder Protonx Tremor (Pantoprazole) C Underdose Trihexyphenidyl (Trihexyphenidyl) C Kemadrin (Procyclidine Hydrochloride) C 22-Feb-2006 08:32 AM Page: 832 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Humulin (Insulin Human, Insulin Isophane, Human Biosynthetic) C Cartia (Acetyslalicylic Acid) C Date:09/12/05ISR Number: 4767833-3Report Type:Expedited (15-DaCompany Report #2005122887 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Mania Health Geodon (Ziprasidone) PS Other Myocardial Infarction Professional Cocaine (Cocaine) SS Overdose Company Representative Date:09/12/05ISR Number: 4767835-7Report Type:Expedited (15-DaCompany Report #2005123295 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sinoatrial Block Health Geodon (Ziprasidone) PS ORAL 40 MG, ORAL Sinus Arrhythmia Professional Trazodone Syncope Company (Trazodone) C Representative Wellbutrin (Bupropion Hydrochloride) C Ssri (Ssri) C Date:09/12/05ISR Number: 4767910-7Report Type:Expedited (15-DaCompany Report #2005121189 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Health Geodon (Ziprasidone) PS Initial or Prolonged Professional Company Representative Date:09/13/05ISR Number: 4768518-XReport Type:Expedited (15-DaCompany Report #2005122866 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Literature Ziprasidone (Caps) Initial or Prolonged Disorientation Health (Ziprasidone) PS 80 MG (40 MG, Other Ecchymosis Professional 2 IN 1 D) Hallucination, Auditory Polydipsia Refusal Of Treatment By Patient Rhabdomyolysis 22-Feb-2006 08:32 AM Page: 833 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/13/05ISR Number: 4769025-0Report Type:Expedited (15-DaCompany Report #2005113723 Age:18 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dysphoria Foreign Ziprasidone (Caps) Initial or Prolonged Grandiosity Study (Ziprasidone) PS ORAL 80 MG (40 MG, Hypomania Health 2 IN 1 D), Insomnia Professional ORAL Logorrhoea Diazepam (Diazepam) C Mania Zuclopenthixol Psychomotor Hyperactivity (Zuclopenthixol) C Suicidal Ideation Olanzapine Treatment Noncompliance (Olanzapine) C Date:09/14/05ISR Number: 4768551-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050902024 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatinine Haldol PS Increased Ziprasidone SS Hepatic Enzyme Increased Benztropine SS Hyperpyrexia Escitalopram SS Hypotension Clonazepam SS Muscle Rigidity Simvastatin SS Ventricular Tachycardia Buproprion SS Date:09/14/05ISR Number: 4768552-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20050902025 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atrial Fibrillation Haloperidol PS Completed Suicide Valproic Acid SS Electrocardiogram Qt Ziprasidone SS Corrected Interval Ranitdine SS Prolonged Benztropine Mesylate SS Hyperpyrexia Intentional Misuse Date:09/14/05ISR Number: 4770754-3Report Type:Expedited (15-DaCompany Report #2003113217 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Adverse Event Foreign Ziprasidone (Caps) Initial or Prolonged Anxiety Study (Ziprasidone) PS ORAL 140 MG (BID), Hallucination Health ORAL Professional Placebo (Placebo) SS ORAL 0 MG (0 MG, 2 Other IN 1 D), ORAL Lorazepam (Lorazepam) C Telmisartan (Telmisartan) C Date:09/14/05ISR Number: 4771141-4Report Type:Expedited (15-DaCompany Report #2005124166 Age: Gender:Male I/FU:I Outcome PT Other Bradycardia Drug Ineffective 22-Feb-2006 08:32 AM Page: 834 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Liver Function Test Abnormal Report Source Product Role Manufacturer Route Dose Duration Health Geodon (Ziprasidone) PS Professional Lithium (Lithium) SS Company Representative Date:09/15/05ISR Number: 4770601-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20050901955 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Brain Death Risperdal PS Cardiac Arrest Benztropine SS Cardio-Respiratory Arrest Citalopram SS Cerebrovascular Accident Clonazepam SS Electrocardiogram Qt Lorazepam SS Corrected Interval Quetiapine SS Prolonged Ziprasidone SS Hepatocellular Damage Hyperpyrexia Neuroleptic Malignant Syndrome Rhabdomyolysis Supraventricular Tachycardia Torsade De Pointes Ventricular Fibrillation Date:09/19/05ISR Number: 4774588-5Report Type:Expedited (15-DaCompany Report #2005113723 Age:18 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypomania Foreign Ziprasidone (Caps) Initial or Prolonged Suicidal Ideation Study (Ziprasidone) PS ORAL 80 MG (40 MG, Treatment Noncompliance Health 2 IN 1 D), Professional ORAL Diazepam (Diazepam) C Zuclopenthixol (Zuclopenthixol) C Olanzapine (Olanzapine) C Date:09/19/05ISR Number: 4774869-5Report Type:Expedited (15-DaCompany Report #2005125435 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Health Neurontin Cerebrovascular Accident Professional (Gabapentin) PS Drug Dose Omission Zoloft (Sertraline) SS Dysarthria Geodon (Ziprasidone) SS Facial Palsy Headache Hypoaesthesia Migraine Paraesthesia Swelling 22-Feb-2006 08:32 AM Page: 835 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/20/05ISR Number: 4775134-2Report Type:Expedited (15-DaCompany Report #2005126101 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arthritis Consumer Geodon (Ziprasidone) PS Arthropathy Cerebral Lobotomy Gastrointestinal Disorder Hypoaesthesia Inflammation Meniscus Lesion Pain Peripheral Embolism Phlebitis Systemic Lupus Erythematosus Date:09/20/05ISR Number: 4788403-7Report Type:Periodic Company Report #S05-USA-00939-01 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Health Celexa (Citalopram Initial or Prolonged Prolonged Professional Hydrobromide) PS ORAL 40 MG QD PO Hypokalaemia Geodon (Ziprasidone Torsade De Pointes Hydrochloride) SS ORAL 60 MG BID PO Multiple Medications (Nos) C Date:09/21/05ISR Number: 4775162-7Report Type:Expedited (15-DaCompany Report #US-MERCK-0509USA02137 Age:49 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Cogentin PS Merck & Co., Inc ORAL Ziprasidone Hydrochloride SS ORAL Memantine SS ORAL Date:09/21/05ISR Number: 4776315-4Report Type:Expedited (15-DaCompany Report #2003116303 Age:30 YR Gender:Male I/FU:F Outcome PT Life-Threatening Aphagia Autonomic Nervous System Imbalance Bradycardia Cardiac Disorder Condition Aggravated Dehydration Depressed Level Of Consciousness Drug Ineffective Drug Interaction Hallucination, Auditory Hallucination, Olfactory Heterophoria Hypotension Nausea Pallor Schizophrenia 22-Feb-2006 08:32 AM Page: 836 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Somnolence Tachycardia Vomiting Report Source Product Role Manufacturer Route Dose Duration Foreign Ziprasidone (Caps) Study (Ziprasidone) PS ORAL 120 MG (60 Health MG, 2 IN 1 Professional D), ORAL Ziprasidone (Caps) (Ziprasidone) SS INTRAMUSCULAR 10 MG (10 MG, 1 IN 1 D), INTRAMUSCULAR Delorazepam (Delorazepam) C Lormetazepam (Lormetazepam) C Date:09/22/05ISR Number: 4775798-3Report Type:Expedited (15-DaCompany Report #2005AC01403 Age:32 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Adverse Drug Reaction Quetiapine PS Zeneca Pharmaceutical ORAL Ziprasidone SS PARENTERAL Risperidone SS Date:09/22/05ISR Number: 4775821-6Report Type:Expedited (15-DaCompany Report #US-MERCK-0509USA02199 Age:59 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Adverse Event Cogentin PS Merck & Co., Inc ORAL Death Cogentin SS Merck & Co., Inc ORAL Haloperidol SS ORAL Ziprasidone Hydrochloride SS ORAL Date:09/22/05ISR Number: 4778494-1Report Type:Expedited (15-DaCompany Report #2005127228 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Coma Consumer Geodon (Ziprasidone) PS Skin Discolouration Date:09/26/05ISR Number: 4780615-1Report Type:Expedited (15-DaCompany Report #2005098954 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Study Ziprasidone (Caps) Initial or Prolonged Condition Aggravated Health (Ziprasidone) PS ORAL 180 MG (60 Other Delusion Professional MG), ORAL Priapism 22-Feb-2006 08:32 AM Page: 837 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/27/05ISR Number: 4781854-6Report Type:Expedited (15-DaCompany Report #2005129983 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Administration Error Consumer Geodon (Ziprasidone) PS Initial or Prolonged Facial Bones Fracture Facial Palsy Femur Fracture Muscle Contracture Peroneal Nerve Palsy Victim Of Crime Date:09/27/05ISR Number: 4781888-1Report Type:Expedited (15-DaCompany Report #2005129989 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Geodon (Ziprasidone) PS Professional All Other Company Therapeutic Products Representative (All Other Therapeutic Products) C Date:09/27/05ISR Number: 4782005-4Report Type:Expedited (15-DaCompany Report #2005128249 Age:45 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Multiple Drug Overdose Literature Ziprasidone (Caps) Health (Ziprasidone) PS Professional Valproic Acid (Valproci Acid) SS Fluphenazine (Fluphenazine) SS Date:09/27/05ISR Number: 4782006-6Report Type:Expedited (15-DaCompany Report #2005128255 Age:31 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Ziprasidone (Caps) Multiple Drug Overdose Health (Ziprasidone) PS Professional Haloperidol (Haloperidol) SS Valproic Acid (Valproic Acid) SS All Other Therapeutic Products (All Other Theapeutic Products) SS Date:09/27/05ISR Number: 4782044-3Report Type:Expedited (15-DaCompany Report #2005128231 Age:49 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Ziprasidone (Caps) Multiple Drug Overdose Health (Ziprasidone) PS Professional Benztropine Mesylate (Benztropine Mesilate) SS 22-Feb-2006 08:32 AM Page: 838 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/27/05ISR Number: 4782800-1Report Type:Expedited (15-DaCompany Report #2005128246 Age:41 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Ziprasidone (Caps) Multiple Drug Overdose Health (Ziprasidone) PS Professional Lorazepam (Lorazepam) SS Bupropion (Bupropion) SS Date:09/27/05ISR Number: 4782804-9Report Type:Expedited (15-DaCompany Report #2005128244 Age:20 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Ziprasidone (Caps) Completed Suicide Health (Ziprasidone) PS Overdose Professional Duloxetine Hydrochloride (Duloxetine Hydrochloride) SS Date:09/27/05ISR Number: 4782850-5Report Type:Expedited (15-DaCompany Report #2005128237 Age:59 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Adverse Event Literature Ziprasidone (Caps) Health (Ziprasidone) PS Professional Haloperidol (Haloperidol) SS Benztropine Mesylate (Benzatropine Mesilate) SS All Other Therapeutic Products (All Other Therapeutic Products) SS Date:09/27/05ISR Number: 4782853-0Report Type:Expedited (15-DaCompany Report #2005128241 Age:32 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Therapeutic Agent Literature Ziprasidone (Caps) Toxicity Health (Ziprasidone) PS Professional Quetiapine (Quetiapine) SS All Other Therapeutic Products (All Other Therapeutic Products) SS Risperidone (Risperidone) SS 22-Feb-2006 08:32 AM Page: 839 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/27/05ISR Number: 4782860-8Report Type:Expedited (15-DaCompany Report #2005128233 Age:19 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Ziprasidone (Caps) Completed Suicide Health (Ziprasidone) PS Drug Toxicity Professional Venlafaxine Multiple Drug Overdose (Venlafaxine) SS Atomoxetine Hydrochloride (Atomoxetine Hydrochloride) SS All Other Therapeutic Products (All Other Therapeutic Products) SS Date:09/27/05ISR Number: 4782862-1Report Type:Expedited (15-DaCompany Report #2005128236 Age:43 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Ziprasidone (Caps) Intentional Misuse Health (Ziprasidone) PS Overdose Professional Trazadone (Trazodone) SS Venlafaxine (Venlafaxine) SS All Other Therapeutic Products (All Other Therapeutic Products) SS Date:09/27/05ISR Number: 4782866-9Report Type:Expedited (15-DaCompany Report #2005109290 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Anxiety Consumer Geodon (Ziprasidone) PS ORAL 80 MG (80 MG Depression Health , 1 IN 1 D), Diarrhoea Professional ORAL Disturbance In Attention Prozac (Fluoxetine Fatigue Nydrochloride) C Impaired Work Ability Fluoxetine Lethargy (Fluoxetine) C Mood Altered Nausea Sedation Sleep Disorder Date:09/28/05ISR Number: 4783239-5Report Type:Direct Company Report #CTU 258972 Age:56 YR Gender:Female I/FU:I Outcome Hospitalization - Initial or Prolonged Required Intervention to Prevent Permanent 22-Feb-2006 08:32 AM Page: 840 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Anxiety Geodon 80 Mg PS 80 MG TWICE Chest Pain DAILY Dyskinesia Heart Rate Increased Hypertension Laboratory Test Abnormal Nervousness Vomiting Date:09/29/05ISR Number: 4785307-0Report Type:Expedited (15-DaCompany Report #2005130684 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Depressive Delusion Foreign Zeldox (Capsules) Hospitalization - Fall Health (Ziprasidone) PS ORAL 80 MG (1 IN 1 Initial or Prolonged Gait Disturbance Professional D), ORAL Headache Zoloft (Sertraline) SS ORAL 200 MG (1 IN Hypertension 1 D), ORAL Injury Zyprexa (Olanzapine) SS ORAL 20 MG (1 IN 1 Polytraumatism D), ORAL Suicide Attempt Visual Disturbance Date:09/29/05ISR Number: 4785388-4Report Type:Expedited (15-DaCompany Report #2005118670 Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination Foreign Zeldox (Capsules) Initial or Prolonged (Ziprasidone) PS 120 MG (DAILY Tegretal (Carbamazepine) C Sepram (Citalopram Hydrobromide) C Date:09/29/05ISR Number: 4785637-2Report Type:Expedited (15-DaCompany Report #2005117531 Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Study Ziprasidone (Caps) Initial or Prolonged Disease Progression Health (Ziprasidone) PS ORAL 40 MG (20 MG, Fractured Coccyx Professional 2 IN 1 D), Schizophrenia ORAL Lithium (Lithium) C Fluoxetine (Fluoxetine) C Date:09/30/05ISR Number: 4786227-8Report Type:Expedited (15-DaCompany Report #2005107773 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Health Geodon (Ziprasidone) PS ORAL 160 MG (80 Initial or Prolonged Overdose Professional MG, 2 IN 1 Other Company D), ORAL Representative All Other 22-Feb-2006 08:32 AM Page: 841 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Therapeutic Products (Al Othe Therapeutic Products) SS Date:09/30/05ISR Number: 4786740-3Report Type:Expedited (15-DaCompany Report #2005130779 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Consumer Geodon (Ziprasidone) PS Initial or Prolonged Mood Swings Haloperidol Other Multiple Drug Overdose (Haloperidol) SS Suicidal Ideation All Other Therapeutic Products (All Other Therapeutic Products) C Date:09/30/05ISR Number: 4786749-XReport Type:Expedited (15-DaCompany Report #2005131511 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dependence Health Geodon (Ziprasidone) PS Drug Screen False Professional Positive Date:09/30/05ISR Number: 4786853-6Report Type:Expedited (15-DaCompany Report #2005133148 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Fall Health Geodon (Ziprasidone) PS Insomnia Professional Trazodone Hydrochloride (Trazodone Hydrochloride) SS Date:09/30/05ISR Number: 4786910-4Report Type:Expedited (15-DaCompany Report #2005124166 Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bradycardia Health Geodon (Ziprasidone) PS ORAL 20 MG (20 MG, Cardiac Pacemaker Professional 1 IN 1 D), Insertion Company ORAL Drug Ineffective Representative Lithium (Lithium) SS Liver Function Test Lithobid (Lithium Abnormal Carbonate) C Renal Failure Ambien (Zolpidem Tartrate) C Date:09/30/05ISR Number: 4786930-XReport Type:Expedited (15-DaCompany Report #2005132433 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Consumer Geodon (Ziprasidone) PS UNKNOWN 240 MG (80 Initial or Prolonged Hangover MG, 1 IN 1 Other Mood Altered D), UNKNOWN Weight Decreased Lamictal (Lamotrigine) C 22-Feb-2006 08:32 AM Page: 842 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/03/05ISR Number: 4787451-0Report Type:Expedited (15-DaCompany Report #2005102702 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dermatitis Allergic Health Geodon (Ziprasidone) PS 200 MG Dysphagia Professional Cogentin Dyspnoea Company (Benzatropine Hyperhidrosis Representative Mesilate) C Pruritus Lithobid (Lithium Carbonate) C Date:10/03/05ISR Number: 4787460-1Report Type:Expedited (15-DaCompany Report #2005027347 Age:65 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anaemia Health Geodon (Ziprasidone) PS ORAL 140 MG (2 IN Hospitalization - Arrhythmia Professional 1 D), ORAL Initial or Prolonged Cerebrovascular Accident Company Acetylsalicylic Acid Other Coronary Artery Disease Representative (Acetylsalicylic Coronary Artery Occlusion Acid) C Electrocardiogram Qt Depakote (Valproate Prolonged Semisodium) C Electroencephalogram Premarin (Estrogens Abnormal Conjugated) C Femoral Arterial Stenosis Habitrol Hyperlipidaemia (Nicotine) C Intervertebral Disc Synthroid Disorder (Levothyroxine Intracranial Aneurysm Sodium) C Myocardial Infarction Valium Myocardial Ischaemia (Diazepam) C Osteoarthritis Vitamin B6 Paraesthesia (Vitamin B6) C Post Procedural Complication Sinus Bradycardia Torsade De Pointes Ventricular Tachycardia Weight Increased Date:10/03/05ISR Number: 4788265-8Report Type:Expedited (15-DaCompany Report #2003114592 Age:44 YR Gender:Female I/FU:F Outcome PT Hospitalization - Abasia Initial or Prolonged Abnormal Behaviour Disability Bradyphrenia Other Cholelithiasis Coordination Abnormal Depression Diplegia Disorientation Dizziness Drug Dependence Drug Interaction Drug Withdrawal Syndrome Dry Mouth Dysarthria Feeling Abnormal Feeling Cold 22-Feb-2006 08:32 AM Page: 843 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Gait Disturbance Glossodynia Hallucination Report Source Product Role Manufacturer Route Dose Duration Headache Consumer Geodon (Ziprasidone) PS ORAL 80 MG Hot Flush (DAILY), ORAL Hyperhidrosis Xanax Tablet Impaired Work Ability (Alprazolam) SS Major Depression Lexapro Mental Disorder (Escitalopram) SS Mood Swings Topamax (Topiramate) SS 100 MG Oral Pain Proazac (Fluoxetine Panic Attack Hydrochloride) SS 40 MG (QD Paranoia INTERVAL: Photophobia EVERY DAY) Photopsia Cymbalta (Duloxetine Psychotic Disorder Hydrochloride) SS Schizoaffective Disorder Climara "Berlex" Sjogren'S Syndrome (Estradiol) C Stupor Adderall (Amfetamine Suicidal Ideation Aspartate, Amfetamine Sulfate, Dexamfetamine Saccharate, C Date:10/04/05ISR Number: 4788992-2Report Type:Expedited (15-DaCompany Report #DSA_27154_2005 Age:41 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Lorazepam PS ORAL DF PO Multiple Drug Overdose Health Ziprasidone SS ORAL DF PO Professional Bupropion (Long Acting) SS ORAL DF PO Date:10/04/05ISR Number: 4789673-1Report Type:Expedited (15-DaCompany Report #2005133817 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zeldox (Capsules) Condition Aggravated Health (Ziprasidone) PS ORAL 160 MG, ORAL Fear Professional Cisordinol Paranoia (Clopenthixol Hydrochloride) C Date:10/05/05ISR Number: 4790197-6Report Type:Direct Company Report #CTU 259692 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drooling Ziprazidone 160 Mg PS ORAL 160 MG PO BID 6 MON Initial or Prolonged Swollen Tongue Depakote C Ventolin C Clonazepam C 22-Feb-2006 08:32 AM Page: 844 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/05/05ISR Number: 4790387-2Report Type:Expedited (15-DaCompany Report #2005133628 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Amphetamines Positive Health Geodon (Ziprasidone) PS Fatigue Professional Malaise Company Representative Date:10/06/05ISR Number: 4793663-2Report Type:Expedited (15-DaCompany Report #2005118137 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Consumer Geodon (Ziprasidone) PS ORAL 80 MG (40 MG, Convulsion Health 2 IN 1 D), Drug Hypersensitivity Professional ORAL Fatigue Benadryl Injection Feeling Abnormal (Diphenydramine) SS INTRAVENOUS 50 MG (50 MG, Imprisonment ONCE), Insomnia INTRAVENOUS Muscle Spasms Benzodazepine Posture Abnormal Derivatives Treatment Noncompliance (Denzodiazepine Derivatives) SS Paxil (Paroxetine Hydrochloride) C Dalmane (Flurazepam Hydrochloride) C Ativan (Lorzepam) C Methadone (Methadone) C Date:10/06/05ISR Number: 4793694-2Report Type:Expedited (15-DaCompany Report #2005027347 Age:65 YR Gender:Female I/FU:F Outcome PT Life-Threatening Anaemia Hospitalization - Aortic Aneurysm Initial or Prolonged Arthralgia Other Arthritis Asthenia Atrial Tachycardia Bradycardia Cerebrovascular Accident Chronic Obstructive Pulmonary Disease Coronary Artery Disease Coronary Artery Occlusion Dysaesthesia Electrocardiogram Poor R-Wave Progression Electrocardiogram Qt Prolonged Electroencephalogram Abnormal Exercise Lack Of Femoral Arterial Stenosis Gastrooesophageal Reflux Disease Hyperlipidaemia 22-Feb-2006 08:32 AM Page: 845 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hypertension Hypoaesthesia Hypothyroidism Report Source Product Role Manufacturer Route Dose Duration Intervertebral Disc Health Geodon (Ziprasidone) PS ORAL 140 MG (2 IN Disorder Professional 1 D), ORAL Intracranial Aneurysm Company Acetylsalicylic Acid Mania Representative (Acetylsalicylic Myocardial Infarction Acid) C Myocardial Ischaemia Depakote (Valproate Obesity Semisodium) C Osteoarthritis Premarin (Estrogens Ovarian Neoplasm Conjugated) C Paraesthesia Habitrol (Nicotine) C Paranoia Synthroid Peripheral Vascular (Levothyroxine Disorder Sodium) C Post Procedural Valium (Diazepam) C Complication Vitamin B6 (Vitamin Rectal Cancer B6) C Schizoaffective Disorder Sinus Bradycardia Torsade De Pointes Ventricular Tachycardia Weight Increased Date:10/06/05ISR Number: 4794034-5Report Type:Expedited (15-DaCompany Report #2005AP000760 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Serotonin Syndrome Literature Citalopram Initial or Prolonged Treatment Noncompliance Health Hydrobromide Tablets PS 80 MG; QD; D Professional Ziprasidone SS ORAL 80 MG; BID; PO Valproic Acid C Clozapine C Date:10/06/05ISR Number: 4795062-6Report Type:Expedited (15-DaCompany Report #PAR_0285_2005 Age:59 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Adverse Drug Reaction Literature Haloperidol PS ORAL DF, PO Multiple Drug Overdose Health Benztropine SS ORAL DF, PO Professional Ziprasidone SS ORAL DF, PO Date:10/06/05ISR Number: 4795159-0Report Type:Direct Company Report #CTU 259996 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asphyxia Geodon PS ORAL PO Completed Suicide Lexapro SS ORAL PO Date:10/07/05ISR Number: 4795366-7Report Type:Direct Company Report #CTU 260110 Age: Gender:Male I/FU:I Outcome Required Intervention to 22-Feb-2006 08:32 AM Page: 846 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Sinus Tachycardia Geodon 80mg Pfizer PS Pfizer ORAL 160MG BID PO 2 DAY Divalproex C Date:10/10/05ISR Number: 4792893-3Report Type:Expedited (15-DaCompany Report #2005UW14963 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Seroquel PS Zeneca Pharmaceutical ORAL Geodon SS Date:10/11/05ISR Number: 4799700-3Report Type:Expedited (15-DaCompany Report #2005134889 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Myocardial Infarction Foreign Zeldox (Capsules) Initial or Prolonged Health (Ziprasidone) PS ORAL UNKNOWN,ORAL Professional Company Representative Date:10/11/05ISR Number: 4799705-2Report Type:Expedited (15-DaCompany Report #2005135276 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Zeldox (Capsules) Initial or Prolonged Overdose Health (Ziprasidone) PS ORAL UNK (20 MG, 2 Other Suicide Attempt Professional IN 1 D), ORAL Date:10/11/05ISR Number: 4799750-7Report Type:Direct Company Report #CTU 260407 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypersomnia Geodon PS ORAL PO (THERAPY Initial or Prolonged Lethargy DATES: PRIOR TO ADMISSION) Zyprexa C Bentyl C Prevacid C Fiber C Date:10/11/05ISR Number: 4799751-9Report Type:Direct Company Report #CTU 260408 Age: Gender:Female I/FU:I Outcome PT Hospitalization - Aphasia Initial or Prolonged Drooling Dysphagia Dystonia Movement Disorder Muscle Rigidity Neuroleptic Malignant Syndrome 22-Feb-2006 08:32 AM Page: 847 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Stupor Urinary Incontinence Report Source Product Role Manufacturer Route Dose Duration Geodon PS ORAL PO (THERAPY DATES: PRIOR TO ADMISSION) Vitamin E C Lorazepam C Celexa C Depakote C Date:10/11/05ISR Number: 4801451-3Report Type:Expedited (15-DaCompany Report #2005136958 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Deep Vein Thrombosis Health Geodon (Ziprasidone) PS Professional Date:10/11/05ISR Number: 4802088-2Report Type:Expedited (15-DaCompany Report #2005134687 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrophy Consumer Geodon (Ziprasidone) PS Skin Burning Sensation Date:10/11/05ISR Number: 4802463-6Report Type:Expedited (15-DaCompany Report #2003003751 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Consumer Nardil (Phenelzine Initial or Prolonged Condition Aggravated Sulfate) PS ORAL ORAL Other Depression Geodon (Ziprasidone) SS Drug Ineffective Oxcarbazepine Insomnia (Oxcarbazepine) C Suicide Attempt Thyroid Function Test Abnormal Weight Increased Date:10/11/05ISR Number: 4802465-XReport Type:Expedited (15-DaCompany Report #2005136861 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Geodon (Ziprasidone) PS Mania Professional Antipsychotics Thinking Abnormal Company (Antipsychotics) C Weight Abnormal Representative Date:10/13/05ISR Number: 4799680-0Report Type:Expedited (15-DaCompany Report #2005134380 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arrhythmia Foreign Ziprasidone Initial or Prolonged Extrapyramidal Disorder Health ((Ziprasidone) PS ORAL 160 MG 80 MG, Other Hypotension Professional 2 1 D), ORAL Quadriparesis Other Risperidone 22-Feb-2006 08:32 AM Page: 848 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Risperidone) SS Biperiden (Biperiden) C Diazepam (Diazepam) C Valproate Sodium (Valproate Sodium) C Date:10/13/05ISR Number: 4802398-9Report Type:Expedited (15-DaCompany Report #2005136951 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Head Injury Consumer Geodon (Ziprasidone) PS ORAL ORAL Initial or Prolonged Victim Of Crime Other Date:10/13/05ISR Number: 4802434-XReport Type:Expedited (15-DaCompany Report #2005137681 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Movement Disorder Health Geodon (Ziprasidone) PS 60 MG Somnolence Professional Company Representative Date:10/13/05ISR Number: 4802487-9Report Type:Expedited (15-DaCompany Report #2005137548 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Electrocardiogram Qt Health Geodon (Ziprasidone) PS Corrected Interval Professional Quinolone Prolonged Company Antibacterials C Representative Antibiotics C Date:10/14/05ISR Number: 4803497-8Report Type:Expedited (15-DaCompany Report #2005133817 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zeldox (Capsules) Condition Aggravated Health (Ziprasidone) PS ORAL 160 MG , ORAL Fear Professional Cisordinol Paranoia Other (Clopenthixol Hydrochloride) C Date:10/14/05ISR Number: 4804048-4Report Type:Expedited (15-DaCompany Report #2004032509 Age: Gender:Female I/FU:F Outcome PT Other Cheilitis Chest Pain Condition Aggravated Cough Diarrhoea Dizziness Drug Interaction Feeling Drunk Formication 22-Feb-2006 08:32 AM Page: 849 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hypertension Hypothyroidism Nausea Report Source Product Role Manufacturer Route Dose Duration Obsessive-Compulsive Consumer Zoloft (Sertraline) PS ORAL 100 MG (100 Disorder MG, 1 IN 1 Palpitations D), ORAL Panic Attack Geodon (Ziprasidone) SS 80 MG (80 MG, Paranoia 1 IN 1 D), Rash Dexamfetamine Restlessness (Dexamfetamine) SS Rhinorrhoea Abilify Serotonin Syndrome (Aripiprazole) SS Somnolence Risperdal Tunnel Vision (Risperidone) SS Vertigo Clonazepam Vomiting (Clonazepam) C Weight Increased Levoxyl (Levothyroxine Sodium) C Multivitamins (Multivitamins) C Vitamin C (Vitamin C) C Calcium (Calcium) C Vitamin B Complex (Calcium Pantothenate, Nicotinamide, Pyridoxine C Hydroxyzine (Hydroxyzine) C Benadryl C Date:10/14/05ISR Number: 4804050-2Report Type:Expedited (15-DaCompany Report #2005138272 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Cholesterol Consumer Geodon (Ziprasidone) PS ORAL 80 MG (80 MG, Initial or Prolonged Increased 1 IN 1 D), Disability Condition Aggravated ORAL Other Diarrhoea Navane (Capsules) Drug Ineffective (Thiothixene) SS ORAL ORAL Eating Disorder Valproic Acid Gastrooesophageal Reflux (Valproic Acid) SS Disease Risperdal Insomnia (Risperidone) SS Loss Of Employment All Other Sleep Apnoea Syndrome Therapeutic Products Therapeutic Response (All Other Unexpected With Drug Therapeutic Substitution Products) SS Tremor All Other Therapeutic Products (All Other Therapeutic Products) SS Insulin (Insulin) C Anti-Diabetics (Anti-Diabetics) C Metformin 22-Feb-2006 08:32 AM Page: 850 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Metformin) C Citalopram (Citalopram) C Date:10/14/05ISR Number: 4804055-1Report Type:Expedited (15-DaCompany Report #2005138265 Age:10 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agitation Consumer Geodon (Ziprasidone) PS 40 MG (40 MG, Hospitalization - Anger 1 IN 1 D), Initial or Prolonged Condition Aggravated Other Conduct Disorder Incorrect Dose Administered Initial Insomnia Lethargy Mood Swings Suicidal Ideation Tremor Weight Increased Date:10/14/05ISR Number: 4804638-9Report Type:Expedited (15-DaCompany Report #2005138241 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chills Consumer Geodon (Ziprasidone) PS ORAL 120 MG (60 Hallucination MG, 2 IN 1 Insomnia D), ORAL Loss Of Consciousness Zyprexa (Olanzapine) C Overdose Restlessness Date:10/17/05ISR Number: 4804206-9Report Type:Expedited (15-DaCompany Report #B0395833A Age:41 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Wellbutrin Sr Health Tablet-Controlled Professional Release (Bupropion Hydrochloride) PS UNKNOWN UNKNOWN Ziprasidone Hcl (Formulation Unknown) (Ziprasidone Hcl) SS ORAL UNKNOWN/ORAL Lorazepam (Formulation Unknown) (Lorazepam) SS UNKNOWN UNKNOWN Date:10/17/05ISR Number: 4804349-XReport Type:Expedited (15-DaCompany Report #2005138867 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Mental Impairment Health Geodon (Ziprasidone) PS 160 MG (80 Parkinson'S Disease Professional MG, 2 IN 1 Tremor Company D), Representative 22-Feb-2006 08:32 AM Page: 851 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/17/05ISR Number: 4804873-XReport Type:Expedited (15-DaCompany Report #12629 Age:59 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Toxicity Literature Haloperidol PS Multiple Drug Overdose Health Ziprasidone SS Professional Benztropine SS Date:10/17/05ISR Number: 4804879-0Report Type:Expedited (15-DaCompany Report #12651 Age:31 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Haloperidol PS Other Drug Toxicity Health Ziprasidone SS Multiple Drug Overdose Professional Valproic Acid SS Date:10/18/05ISR Number: 4805431-3Report Type:Expedited (15-DaCompany Report #2005135276 Age:21 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Zeldox (Capsules) Initial or Prolonged Overdose Health (Ziprasidone) PS ORAL 240 MG (20 Other Suicide Attempt Professional MG), ORAL Date:10/18/05ISR Number: 4805676-2Report Type:Expedited (15-DaCompany Report #2005137870 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Geodon (Ziprasidone) PS 40 MG (2 IN 1 Initial or Prolonged Agitation Professional D) Drug Prescribing Error Company Cymbalta (Duloxetine Feeling Abnormal Representative Hydrochloride) C Treatment Noncompliance Lamotrigine (Lamotrigine) C Date:10/20/05ISR Number: 4805159-XReport Type:Expedited (15-DaCompany Report #US-ABBOTT-05P-163-0314058-00 Age:31 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Valproic Acid PS Not reported Ziprasidone SS Not reported Haloperidol SS Not reported Date:10/20/05ISR Number: 4805174-6Report Type:Expedited (15-DaCompany Report #US-ABBOTT-05P-163-0314057-00 Age:45 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Valproic Acid PS Not reported Ziprasidone SS Not reported Fluphenazine SS Not reported 22-Feb-2006 08:32 AM Page: 852 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/20/05ISR Number: 4807355-4Report Type:Direct Company Report #CTU 261048 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Increased Ziprisadone PS 80 MG BID Initial or Prolonged Heart Rate Increased Required Muscle Rigidity Intervention to Neuroleptic Malignant Prevent Permanent Syndrome Impairment/Damage Date:10/20/05ISR Number: 4807579-6Report Type:Expedited (15-DaCompany Report #2005140440 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Consumer Geodon (Ziprasidone) PS Feeling Abnormal Xanax Tablet Gun Shot Wound (Alprazolam) SS Self Injurious Behaviour Wellbutrin (Bupropion Hydrochloride) SS Date:10/20/05ISR Number: 4807580-2Report Type:Expedited (15-DaCompany Report #2005140553 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anxiety Consumer Xanax Xr Blood Pressure Increased (Alprazolam) PS ORAL 2 MG (1 MG, 2 Completed Suicide IN 1 D), ORAL Drug Interaction Geodon (Ziprasidone) SS Dysarthria Wellbutrin Sr Feeling Drunk (Bupropion Gun Shot Wound Hydrochloride) SS 400 MG (200 MG, 2 IN 1 D) Date:10/20/05ISR Number: 4807667-4Report Type:Expedited (15-DaCompany Report #2005140553 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Consumer Xanax Xr Adverse Event (Alprazolam) PS ORAL 2 MG (1 MG, 2 Anxiety IN 1 D), ORAL Blood Pressure Abnormal Geodon (Ziprasidone) SS Drug Interaction Wellbutrin Sr Dysarthria (Bupropion Feeling Abnormal Hydrochloride) SS 400 MG (200 Gun Shot Wound MG, 2 IN 1 D) Intentional Self-Injury Date:10/20/05ISR Number: 4807669-8Report Type:Expedited (15-DaCompany Report #2005140440 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Consumer Geodon (Ziprasidone) PS Feeling Abnormal Xanax Tablet Gun Shot Wound (Alprazolam) SS Intentional Self-Injury Wellbutrin (Bupropion 22-Feb-2006 08:32 AM Page: 853 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) SS Date:10/20/05ISR Number: 4807762-XReport Type:Expedited (15-DaCompany Report #2005141177 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Geodon (Im) Professional (Ziprasidone) PS INTRAMUSCULAR INTRAMUSCULAR Company Representative Date:10/24/05ISR Number: 4809757-9Report Type:Expedited (15-DaCompany Report #2005123295 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sinoatrial Block Health Geodon (Ziprasidone) PS ORAL 40 MG, ORAL Syncope Professional Trazodone Company (Trazodone) C Representative Wellbutrin (Bupropion Hydrochloride) C Ssri (Ssri) C Date:10/24/05ISR Number: 4809886-XReport Type:Expedited (15-DaCompany Report #2005142348 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Health Geodon (Ziprasidone) PS 60 MG Eye Rolling Professional Zyprexa (Olanzapine) SS Weight Increased Company Representative Date:10/24/05ISR Number: 4810782-2Report Type:Expedited (15-DaCompany Report #2005142348 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Health Geodon (Ziprasidone) PS 60 MG Akathisia Professional Zyprexa (Olanzapine) SS Eye Rolling Company Incorrect Dose Representative Administered Treatment Noncompliance Weight Increased Date:10/24/05ISR Number: 4810822-0Report Type:Expedited (15-DaCompany Report #2005123295 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sinoatrial Block Health Geodon (Ziprasidone) PS ORAL 40 MG, ORAL Sinus Arrhythmia Professional Trazodone Syncope Company (Trazodone) C Representative Wellbutrin (Bupropion Hydrochloride) C Ssri (Ssri) C 22-Feb-2006 08:32 AM Page: 854 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/25/05ISR Number: 4810501-XReport Type:Direct Company Report #CTU 261402 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Pressure Decreased Ziprasidone 40 Mg Body Temperature Pfizer PS Pfizer ORAL 40 MG TID PO Increased Ziprasidone 80 Mg Heart Rate Increased Pfizer SS Pfizer ORAL 80 MG Q2000 Loss Of Consciousness PO Oxygen Saturation Docusate Sodium C Decreased Aricept C Cymbalta C Namenda C Sorbitol C Trazodone C Ziprasidone C Date:10/25/05ISR Number: 4810936-5Report Type:Expedited (15-DaCompany Report #2005142338 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Consumer Geodon (Ziprasidone) PS Gastric Bypass Date:10/25/05ISR Number: 4811559-4Report Type:Expedited (15-DaCompany Report #2005142207 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Ineffective Foreign Geodon (Ziprasidone) PS INTRAMUSCULAR SEE IMAGE Respiratory Failure Health Antibiotics Professional (Antibiotics) C Date:10/26/05ISR Number: 4811811-2Report Type:Expedited (15-DaCompany Report #2005134380 Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arrhythmia Foreign Ziprasidone (Caps) Initial or Prolonged Extrapyramidal Disorder Consumer (Ziprasidone) PS ORAL 160 MG (80 Other Hypotension Health MG, 2 IN 1 Quadriparesis Professional D), ORAL Risperidone (Risperidone) SS Biperiden (Biperiden) C Diazepam (Diazepam) C Valproate Sodium (Valproate) C Date:10/26/05ISR Number: 4811818-5Report Type:Expedited (15-DaCompany Report #2005144640 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Caesarean Section Foreign Zeldox (Capsules) Drug Exposure During Health (Ziprasidone) PS ORAL 120 MG (60 Pregnancy Professional MG, 1 IN 1 Dyskinesia D), ORAL Sleep Disorder 22-Feb-2006 08:32 AM Page: 855 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/27/05ISR Number: 4811827-6Report Type:Expedited (15-DaCompany Report #2005142398 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Panic Attack Foreign Zeldox (Capsules) Initial or Prolonged Consumer (Ziprasidone) PS ORAL 40 MG (40 MG, 1 IN 1 D), ORAL Zoloft (Sertraline) C Lexotan (Bromazepam) C Depakene (Valproate Sodium) C All Other Therapeutic Products C Date:10/31/05ISR Number: 4817413-6Report Type:Expedited (15-DaCompany Report #2005142398 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Foreign Zeldox (Capsules) Initial or Prolonged Heart Rate Increased Consumer (Ziprasidones) PS ORAL 40 MG (40 MG, Panic Attack 1 IN 1 D), ORAL Zoloft (Sertraline) C Lexotan (Bromazepam) C All Other Therapeutic Products (All Other Therapeutic Products) C Depakene (Valproate Sodium) C Date:10/31/05ISR Number: 4817561-0Report Type:Expedited (15-DaCompany Report #2005130846 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bone Neoplasm Malignant Foreign Zeldox (Capsules) Cogwheel Rigidity Health (Ziprasidone) PS ORAL ORAL Extrapyramidal Disorder Professional Muscle Spasms Company Restless Legs Syndrome Representative Tremor Date:10/31/05ISR Number: 4817567-1Report Type:Expedited (15-DaCompany Report #2004008864 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Overdose Foreign Geodon (Ziprasidone) PS ORAL 780 MG, ORAL Initial or Prolonged Legal Problem Literature Venlafaxine(Venlafax Other Self Injurious Behaviour Health ine) C Somnolence Professional 22-Feb-2006 08:32 AM Page: 856 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/31/05ISR Number: 4817568-3Report Type:Expedited (15-DaCompany Report #2003029187 Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anxiety Foreign Ziprasidone (Caps) Hospitalization - Blood Pressure Increased Literature (Ziprasidone) PS ORAL 160 MG (2 IN Initial or Prolonged Coma Health 1 D), ORAL Other Electrocardiogram Qt Professional Clomethiazole Corrected Interval (Clomethiazole) SS ORAL 384 MG Prolonged (DAILY), ORAL Heart Rate Increased Flunitrazepam Intentional Overdose (Flunitrazepam) SS ORAL 2 MG (BID), Oxygen Saturation ORAL Decreased Paroxetine Poisoning (Paroxetine) C Somnolence Lorazepam Suicide Attempt (Lorazepam) C Tremor Sodium Picosulfate (Sodium Picosulfate) C Date:10/31/05ISR Number: 4817569-5Report Type:Expedited (15-DaCompany Report #2003015783 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypotension Foreign Ziprasidone Initial or Prolonged Intentional Overdose Literature (Ziprasidone) PS ORAL 4480 MG, ORAL Sedation Health Clomethiazole Suicide Attempt Professional Edisilate Company (Clomethiazole Representative Edisilate) SS ORAL ORAL Clorazepate Dipotassium (Clorazepate Dipotassium) C Date:10/31/05ISR Number: 4818358-8Report Type:Expedited (15-DaCompany Report #2005144318 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Back Pain Health Geodon (Ziprasidone) PS ORAL 240 MG (1 IN Dizziness Professional 1D), ORAL Dyspepsia Lexapro Nausea (Escitalopram) C Renal Failure Depo-Provera (Medroxyprogesterone Acetate) C Seroquel (Quetiapine Fumarate) C Cogentin (Benzatropine Mesilate) C Topamax (Topiramate) C Date:10/31/05ISR Number: 4818522-8Report Type:Expedited (15-DaCompany Report #2005143605 Age: Gender:Unknown I/FU:I Outcome PT Report Source Other Loss Of Consciousness Health Professional 22-Feb-2006 08:32 AM Page: 857 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company Representative Product Role Manufacturer Route Dose Duration Geodon (Ziprasidone) PS INTRAMUSCULAR INTRAMUSCULAR Date:10/31/05ISR Number: 4818529-0Report Type:Expedited (15-DaCompany Report #2005138272 Age:36 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Cholesterol Consumer Geodon (Ziprasidone) PS ORAL 80 MG (80 MG, Initial or Prolonged Increased 1 IN 1 D), Disability Condition Aggravated ORAL Other Diarrhoea Navane (Capsules) Drug Ineffective (Thiothixene) SS ORAL ORAL Gastrooesophageal Reflux Depakote (Valproate Disease Semisodium) SS Hallucinations, Mixed Risperdal Insomnia (Risperidone) SS Oral Intake Reduced All Other Paranoia Therapeutic Products Sleep Apnoea Syndrome (All Other Therapeutic Response Therapeutic Unexpected With Drug Products) SS Substitution All Other Tremor Therapeutic Products (All Other Therapeutic Products) SS Insulin (Insulin) C Anti-Diabetics (Anti-Diabetics) C Metformin (Metformin) C Citalopram (Citalopram) C Date:11/01/05ISR Number: 4818815-4Report Type:Expedited (15-DaCompany Report #2005137548 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Electrocardiogram Qt Health Geodon (Ziprasidone) PS Corrected Interval Professional Quinolone Prolonged Company Antibacterials Representative (Quinolone Antibacterials) C Antibiotics (Antibiotics) C Date:11/01/05ISR Number: 4818911-1Report Type:Expedited (15-DaCompany Report #2003030892 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Overdose Foreign Ziprasidone (Caps) Initial or Prolonged Miosis Literature (Ziprasidone) PS ORAL 160 MG (2 IN Other Mydriasis Health 1 D), ORAL Restlessness Professional Zuclopenthixol Suicide Attempt (Zuclopenthixol) C Clonazepam 22-Feb-2006 08:32 AM Page: 858 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Clonazepam) C Alprazolam (Alprazolam) C Sertraline (Sertraline) C Date:11/01/05ISR Number: 4819021-XReport Type:Expedited (15-DaCompany Report #2005145946 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anxiety Foreign Zeldox (Capsules) Hospitalization - Condition Aggravated Health (Ziprasidone) PS ORAL 160 MG (2 IN Initial or Prolonged Disorientation Professional 1 D), ORAL Lumbar Radiculopathy Gladem (Sertraline) SS ORAL 50 MG, ORAL Psychotic Disorder Lamictal (Lamotrigine) SS ORAL 200 MG, ORAL Voltaren (Diclofenac Sodium) SS ORAL 200 MG (1 IN 1 D),ORAL Neodolpasse (Diclofenac Sodium, Orphenadrine Citrate) SS INTRAVENOUS 250 ML (1 IN 1 D), INTRAVENOUS Trittico (Trazodone Hydrochloride) SS ORAL 150 MG, ORAL Temesta (Lorazepam) C Temesta (Lorazepam) C Date:11/02/05ISR Number: 4819546-7Report Type:Direct Company Report #CTU 262069 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Choreoathetosis Geodon 60 + 80 Mg Intervention to Tab PS 120 MG Q HS Prevent Permanent Impairment/Damage Date:11/02/05ISR Number: 4819709-0Report Type:Direct Company Report #CTU 262235 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Rash Erythematous Geodon PS ORAL 40MG PO BID Initial or Prolonged PC AND @ 1000 PM WITH FOOD Date:11/02/05ISR Number: 4819868-XReport Type:Expedited (15-DaCompany Report #2005146395 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zeldox (Capsules) Health (Ziprasidone) PS ORAL 120 MG (60 Professional MG, 2 IN 1 Company D), ORAL Representative 22-Feb-2006 08:32 AM Page: 859 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/05ISR Number: 4819120-2Report Type:Expedited (15-DaCompany Report #2005UW14963 Age:18 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Seroquel PS Zeneca Drug Toxicity Pharmaceutical ORAL 190 DAY Hepatomegaly Geodon SS ORAL Obesity Overdose Date:11/03/05ISR Number: 4821161-6Report Type:Expedited (15-DaCompany Report #2005148238 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Zoloft (Sertraline) PS 200 MG Other Multiple Drug Overdose Professional Geodon (Ziprasidone) SS 160 MG Company Anafranil Representative (Clomipramine Hydrochloride) SS 250 MG Date:11/07/05ISR Number: 4823021-3Report Type:Direct Company Report #CTU 262500 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abnormal Behaviour Geodon Pfizer PS Pfizer 240 MG ?? 3 MON Hospitalization - Aggression Initial or Prolonged Personality Change Physical Assault Screaming Date:11/07/05ISR Number: 4823276-5Report Type:Expedited (15-DaCompany Report #2005147299 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Diabetes Mellitus Foreign Zeldox Hospitalization - Diabetic Ketoacidotic Health Initial or Prolonged Hyperglycaemic Coma Professional (Ziprasidone) PS ORAL 80 MG, ORAL Other Electrocardiogram Qt Other Lithium (Lithium) C Prolonged Mirtazapine Sinus Tachycardia (Mirtazapine) C Ramipril (Ramipril) C Date:11/07/05ISR Number: 4823683-0Report Type:Expedited (15-DaCompany Report #2005147937 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Muscle Rigidity Foreign Zeldox (Capsules) Initial or Prolonged Parkinsonism Health (Ziprasidone) PS ORAL 20 MG (20 MG, Professional 1 IN 1 D), Company ORAL Representative Lorazepam (Lorazepam) C Cymbalta (Duloxetine Hydrochloride) C Lithium (Lithium) C 22-Feb-2006 08:32 AM Page: 860 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/08/05ISR Number: 4823220-0Report Type:Direct Company Report #CTU 262628 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Geodon PS ORAL ORAL Initial or Prolonged Muscle Rigidity Cogentin C Neuroleptic Malignant Lamictal C Syndrome Lithium C Rhabdomyolysis Buspor C Xanax C Demerol C Baclofen C Ativan C Tylenol Es C Phenergan C Date:11/08/05ISR Number: 4823361-8Report Type:Direct Company Report #CTU 262593 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardio-Respiratory Arrest Geodon PS 10MG BID Dystonia INTRA CORP Laryngeal Disorder (2 DOSES) Date:11/08/05ISR Number: 4824362-6Report Type:Expedited (15-DaCompany Report #2005069021 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Spontaneous Consumer Geodon (Ziprasidone) PS ORAL 80 MG (80 MG, Anxiety Health 1 IN 1 D), Drug Dependence Professional ORAL Drug Exposure During Zoloft (Sertraline) SS (50 MG) Pregnancy Ambien (Zolpidem Insomnia Tartrate) C Pregnancy On Oral Oral Contraceptive Contraceptive Nos (Oral Contraceptive Nos) C Trifluoperazine (Trifluoperazine) C Hydroxyzine (Hydroxyzine) C Date:11/10/05ISR Number: 4828111-7Report Type:Expedited (15-DaCompany Report #2005143963 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fatigue Foreign Zeldox (Capsules) Initial or Prolonged Oral Candidiasis Health (Ziprasidone) PS ORAL 60 MG (20 Professional MG), ORAL Date:11/15/05ISR Number: 4829856-5Report Type:Expedited (15-DaCompany Report #2005122887 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Geodon (Ziprasidone) PS Disability Drug Abuser Professional Cocaine (Cocaine) SS Other Myocardial Infarction Company Overdose Representative 22-Feb-2006 08:32 AM Page: 861 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/15/05ISR Number: 4830294-XReport Type:Expedited (15-DaCompany Report #2005152890 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsive Threshold Foreign Zeldox (Capsules) Lowered Health (Ziprasidone) PS ORAL ORAL Professional Company Representative Date:11/15/05ISR Number: 4830297-5Report Type:Expedited (15-DaCompany Report #2005152888 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsive Threshold Foreign Zeldox (Capsules) Lowered Health (Ziprasidone) PS ORAL ORAL Professional Company Representative Date:11/15/05ISR Number: 4830548-7Report Type:Expedited (15-DaCompany Report #2004032509 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Consumer Zoloft (Sertraline) PS ORAL 100 MG (100 Cheilitis Health MG, 1 IN 1 Chest Pain Professional D); ORAL Condition Aggravated Geodon (Ziprasidone) SS 80 MG (80 MG, Cough 1 IN 1 D); Diarrhoea UNKNOWN Dizziness Dexamfetamine Drug Interaction (Dexamfetamine) SS Feeling Abnormal Abilify Feeling Drunk (Aripirazole) SS Formication Risperdale Hypertension (Risperidone) SS Hypothyroidism Clonazepam C Nausea Levoxyl Obsessive-Compulsive (Levothyroxine Disorder Sodium) C Palpitations Multivitamins C Panic Reaction Vitamin C C Paranoia Calcium C Rash Vitamin B Complex Restlessness (Calcium Rhinorrhoea Pantothenate, Serotonin Syndrome Nicotinamide, Somnolence Pyridoxine C Tunnel Vision Hydroxyzine C Vertigo Benadryl C Vomiting Weight Increased Date:11/16/05ISR Number: 4831255-7Report Type:Direct Company Report #CTU 263291 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Geodon PS PLEASE SEE ITEM B5 22-Feb-2006 08:32 AM Page: 862 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lexapro C Date:11/16/05ISR Number: 4831603-8Report Type:Expedited (15-DaCompany Report #2005151905 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diarrhoea Health Geodon (Ziprasidone) PS ORAL 240 MG ORAL Initial or Prolonged Drug Ineffective Professional Diphenhydramine Dyskinesia Injection Dyspnoea (Diphenhydramine) SS INTRAVENOUS 50 MG Dystonia INTRAVENOUS Fall Joint Lock Musculoskeletal Stiffness Oculogyration Date:11/16/05ISR Number: 4831608-7Report Type:Expedited (15-DaCompany Report #2005148238 Age:19 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Zoloft (Sertraline) PS 200 MG Other Cardio-Respiratory Arrest Professional Geodon (Ziprasidone) SS Convulsion Company Anafranil Multiple Drug Overdose Representative (Clomipramine Hydrochloride) SS 250 MG Date:11/16/05ISR Number: 4831648-8Report Type:Expedited (15-DaCompany Report #2005142398 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Foreign Zeldox (Capsules) Initial or Prolonged Heart Rate Increased Consumer (Ziprasidone) PS ORAL 40 MG (40 MG, Irritability 1 IN 1 D), Panic Attack ORAL Somnolence Zoloft (Sertraline) C Treatment Noncompliance Lexotan (Bromazepam) C All Other Therapeutic Products (All Other Therapeutic Products) C Depakene (Valproate Sodium) C Date:11/18/05ISR Number: 4833414-6Report Type:Expedited (15-DaCompany Report #2005153439 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiomegaly Health Geodon (Ziprasidone) PS 160 MG Hospitalization - Drug Interaction Professional Heroin (Diamorphine) SS Initial or Prolonged Overdose Company Other Psychotic Disorder Representative 22-Feb-2006 08:32 AM Page: 863 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/18/05ISR Number: 4835817-2Report Type:Expedited (15-DaCompany Report #2005153514 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Consumer Geodon (Ziprasidone) PS ORAL (1 IN 1 D), Initial or Prolonged Impaired Gastric Emptying ORAL Other Pancreatitis Acute Reglan Vocal Cord Neoplasm (Metoclopramide) SS ORAL ORAL Adderall (Amfetamine Aspartate, Amfetamine Sulfate, Dexamfetamine Saccharate, C Clonidine (Clonidine) C Date:11/18/05ISR Number: 4835885-8Report Type:Expedited (15-DaCompany Report #2005140440 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anxiety Consumer Geodon (Ziprasidone) PS Other Blood Pressure Abnormal Xanax Xr Completed Suicide (Alprazolam) SS ORAL 2 MG (1 MG, 2 Drug Interaction IN 1 D), ORAL Dysarthria Wellbutrin Sr Feeling Drunk (Bupropion Gun Shot Wound Hydrochloride) SS 400 MG (200 Sensation Of Heaviness MG, 2 IN 1 D) Date:11/18/05ISR Number: 4836494-7Report Type:Expedited (15-DaCompany Report #2005153453 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Decreased Foreign Ziprasidone (Caps) Initial or Prolonged Coma Health (Ziprasidone) PS ORAL 40 MG (1 IN 1 Disorientation Professional D), ORAL Intentional Overdose Miosis Somnolence Suicide Attempt Date:11/21/05ISR Number: 4836551-5Report Type:Expedited (15-DaCompany Report #2005147937 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Muscle Rigidity Foreign Zeldox (Capsules) Initial or Prolonged Parkinsonism Health (Ziprasidone) PS ORAL 20 MG (20 MG, Professional 1 IN 1 D), Company ORAL Representative Lorazepam (Lorazepam) C Cymbalta (Duloxetine Hydrochloride) C Lithium (Lithium) C 22-Feb-2006 08:32 AM Page: 864 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/21/05ISR Number: 4836845-3Report Type:Expedited (15-DaCompany Report #2004046701 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Foreign Ziprasidone (Caps) Other Cerebral Haemorrhage Health (Ziprasidone) PS ORAL 160 MG (80 Collapse Of Lung Professional MG, 2 IN 1 Dizziness Company D), ORAL Ecchymosis Representative Gabapentin Pruritus (Gabapentin) SS ORAL 1800 MG (600 Pulmonary Haemorrhage MG, 3 IN 1 Pulmonary Oedema D), ORAL Scratch Lamotrigine Skin Lesion (Lamotrigine) SS ORAL 300 MG (100 Sudden Death MG, 3 IN 1 Torsade De Pointes D), ORAL Viral Rash Ranitidine Hydrochloride (Ranitidine Hydrochloride) SS ORAL (150 MG), ORAL Midazolam (Midazolam) SS ORAL (7.5 MG), ORAL Dexchlorpheniramine Maleate (Dexchlorpheniramine Maleate) SS (, 1 IN 1 D) Olanzapine (Olanzapine) C Topiramate (Topiramate) C Date:11/23/05ISR Number: 4838270-8Report Type:Expedited (15-DaCompany Report #2005155757 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Echocardiogram Abnormal Foreign Zeldox (Capsules) Initial or Prolonged Electrocardiogram Qt Health (Ziprasidone) PS ORAL 120 MG, ORAL Corrected Interval Professional Edronax (Reboxetine) SS ORAL 6 MG, ORAL Prolonged Zyprexa (Olanzapine) C Ventricular Hypertrophy L-Thyroxin (Levothyroxine Sodium) C Date:11/23/05ISR Number: 4838354-4Report Type:Expedited (15-DaCompany Report #2005078628 Age:66 YR Gender:Male I/FU:F Outcome PT Hospitalization - Abnormal Behaviour Initial or Prolonged Aggression Other Agitation Bipolar Disorder Cognitive Disorder Confusional State Constipation Dehydration Delusion Diarrhoea Disturbance In Attention 22-Feb-2006 08:32 AM Page: 865 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Drug Ineffective Dyspepsia Eating Disorder Report Source Product Role Manufacturer Route Dose Duration Gait Disturbance Consumer Geodon (Ziprasidone) PS ORAL 80 MG (40 MG, Hallucination Health 2 IN 1 D), Hallucination, Auditory Professional ORAL Insomnia Geodon (Im) Mania (Ziprasidone) SS INTRAMUSCULAR 20 MG (1 D), Neuroleptic Malignant INTRAMUSCULAR Syndrome Lithium (Lithium) SS ORAL 900 MG (3 IN Pain 1 D), ORAL Psychotic Disorder Ambien (Zolpidem Refusal Of Treatment By Tartrate) C Patient Zyprexa (Olanzapine) C Treatment Noncompliance Ativan (Lorazepam) C Date:11/23/05ISR Number: 4838396-9Report Type:Expedited (15-DaCompany Report #2005156821 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Abasia Health Geodon (Ziprasidone) PS 40 MG (1 IN 1 Agitation Professional D) Tachyphrenia Company Lamictal Representative (Lamotrigine) SS 200 MG (1 IN 1 D) Zyprexa (Olanzapine) SS 5 MG Date:11/23/05ISR Number: 4838399-4Report Type:Expedited (15-DaCompany Report #2005156819 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Health Geodon (Ziprasidone) PS 80 UNK (2 IN Initial or Prolonged Professional 1 D) Company Seroquel (Quetiapine Representative Fumarate) SS Benzodiazepine Derivatives (Benzodiazepine Derivatives) SS Date:11/25/05ISR Number: 4841801-5Report Type:Expedited (15-DaCompany Report #2005-BP-19675RO Age:41 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Lorazepam Multiple Drug Overdose Health (Lorazepam) PS Intentional Professional Ziprasidone (Ziprasidone) SS Bupropion (Bupropion) SS Date:11/25/05ISR Number: 4842799-6Report Type:Expedited (15-DaCompany Report #2005153439 Age:21 YR Gender:Male I/FU:F Outcome Death Hospitalization - 22-Feb-2006 08:32 AM Page: 866 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged Other PT Report Source Product Role Manufacturer Route Dose Duration Cardiomegaly Health Geodon (Ziprasidone) PS 160 MG Drug Abuser Professional Heroin (Diamorphine) SS Drug Interaction Company Overdose Representative Psychotic Disorder Date:11/25/05ISR Number: 4845413-9Report Type:Expedited (15-DaCompany Report #2005156706 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Zeldox (Capsules) Initial or Prolonged Phosphokinase Increased Health (Ziprasidone) PS ORAL 120 MG, ORAL Other Professional Diazepam (Diazepam) SS Haldol (Haloperidol) SS ORAL 10 MG, ORAL Glibenclamide (Glibenclamide) C Date:11/25/05ISR Number: 4845455-3Report Type:Expedited (15-DaCompany Report #2005157846 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gaze Palsy Foreign Zeldox (Capsules) Initial or Prolonged Health (Ziprasidone) PS 80 MG Professional Edronax Other (Reboxetine) SS ORAL 8 MG (DAILY), ORAL Seroquel (Quetiapine Fumarate) C ORAL Date:11/25/05ISR Number: 4846347-6Report Type:Expedited (15-DaCompany Report #2005134889 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Myocardial Infarction Foreign Zeldox (Capsules) Initial or Prolonged Health (Ziprasidone) PS ORAL 80 MG (80 MG, Professional 1 IN 1 D), Company ORAL Representative Enap (Enalapril) C Efetin (Venlafaxine Hydrochloride) C Date:11/25/05ISR Number: 4846363-4Report Type:Expedited (15-DaCompany Report #2005150886 Age:54 YR Gender:Female I/FU:I Outcome PT Life-Threatening Alanine Aminotransferase Hospitalization - Increased Initial or Prolonged Aspartate Other Aminotransferase Increased Blood Bilirubin Increased Blood Creatine 22-Feb-2006 08:32 AM Page: 867 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Phosphokinase Increased Blood Lactate Dehydrogenase Increased Blunted Affect Report Source Product Role Manufacturer Route Dose Duration Cogwheel Rigidity Foreign Zeldox (Capsules) Confusional State Study (Ziprasidone) PS ORAL 120 MG (60 Parkinsonian Gait Health MG, 2 IN 1 Psychotic Disorder Professional D), ORAL Restlessness Diazepam (Diazepam) C White Blood Cell Count Benzhexol Increased (Trihexyphenidyl) C Norflex For Injection (Orphenadrine Citrate, Sodium Bisulfite, Sodium C Date:11/25/05ISR Number: 4846367-1Report Type:Expedited (15-DaCompany Report #2005147937 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Parkinsonism Foreign Zeldox (Capsules) Initial or Prolonged Health (Ziprasidone) PS ORAL 20 MG (20 MG, Professional 1 IN 1 D), Company ORAL Representative Lorazepam (Lorazepam) C Cymbalta (Duloxetine Hydrochloride) C Lithium (Lithium) C Nitrazepam (Nitrazepam) C Date:11/29/05ISR Number: 4842691-7Report Type:Expedited (15-DaCompany Report #2005157348 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Health Geodon (Im) Syndrome Professional (Ziprasidone) PS INTRAMUSCULAR INTRAMUSCULAR Resuscitation Company Representative Date:12/01/05ISR Number: 4846773-5Report Type:Expedited (15-DaCompany Report #2005138272 Age:36 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Cholesterol Consumer Geodon (Ziprasidone) PS ORAL 80 MG (80 MG, Initial or Prolonged Increased Health 1 IN 1 D), Disability Condition Aggravated Professional ORAL Other Diarrhoea Navane (Capsules) Drug Ineffective (Thiothixene) SS ORAL ORAL Gastrooesophageal Reflux Depakote (Valproate Disease Semisodium) SS Insomnia All Other Sleep Apnoea Syndrome Therapeutic Agents SS Tremor Risperdal Weight Increased (Risperidone) SS All Other Therapeutic Agents SS 22-Feb-2006 08:32 AM Page: 868 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Insulin (Insulin) C Anti-Diabetics (Anti-Diabetics) C Metformin (Metformin) C Citalopram (Citalopram) C Date:12/01/05ISR Number: 4846774-7Report Type:Expedited (15-DaCompany Report #2005138265 Age:10 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agitation Consumer Geodon (Ziprasidone) PS 40 MG (40 MG, Hospitalization - Anger Health 1 IN1 D) Initial or Prolonged Condition Aggravated Professional Other Hallucination, Visual Impaired Self-Care Incorrect Dose Administered Insomnia Lethargy Mood Swings Suicidal Ideation Tremor Weight Increased Date:12/02/05ISR Number: 4846441-XReport Type:Expedited (15-DaCompany Report #2005159160 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Adverse Drug Reaction Consumer Zoloft (Sertraline) PS ORAL 200 MG (200 Initial or Prolonged Delusion MG, 1 IN 1 Other Fatigue D), ORAL Hallucination Geodon (Ziprasidone) SS ORAL ORAL Heart Rate Irregular Risperdal Overweight (Risperidone) SS Somnolence Vomiting Weight Increased Date:12/02/05ISR Number: 4846896-0Report Type:Expedited (15-DaCompany Report #2005156831 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Foreign Zeldox (Capsules) Initial or Prolonged Drug Abuser Health (Ziprasidone) PS ORAL 120 MG (60 Other Status Epilepticus Professional MG, 2 IN 1 D) Company ORAL Representative Date:12/02/05ISR Number: 4846910-2Report Type:Expedited (15-DaCompany Report #2005159603 Age:30 YR Gender:Male I/FU:I Outcome PT Hospitalization - Condition Aggravated Initial or Prolonged Delirium Drug Ineffective 22-Feb-2006 08:32 AM Page: 869 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Insomnia Psychotic Disorder Schizophrenia Report Source Product Role Manufacturer Route Dose Duration Social Avoidant Behaviour Foreign Zeldox (Capsules) Health (Ziprasidone) PS ORAL 160 MG (80 Professional MG, 2 IN 1 D) Company ORAL Representative Zolpidem C Date:12/05/05ISR Number: 4847613-0Report Type:Expedited (15-DaCompany Report #2005160175 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gaze Palsy Foreign Zeldox (Capsules) Initial or Prolonged Oropharyngeal Spasm Health (Ziprasidone) PS ORAL 100 MG, ORAL Parkinsonism Professional Jodthyrox Psychotic Disorder (Levothyroxine Sodium, Potassium Iodide) C Date:12/06/05ISR Number: 4847078-9Report Type:Direct Company Report #CTU 264483E Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Pressure Decreased Geodon PS ORAL 20 BEFORE BED Hospitalization - Fear PO Initial or Prolonged Feeling Abnormal Heart Rate Decreased Loss Of Consciousness Date:12/06/05ISR Number: 4848651-4Report Type:Expedited (15-DaCompany Report #2005160892 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bilirubin Conjugated Foreign Zeldox (Capsules) Initial or Prolonged Increased Health (Ziprasidone) PS ORAL 20 MG (20 MG, Blood Bilirubin Increased Professional DAILY), ORAL Platelet Count Decreased Equasym (Methylphenidate Hydrochloride) SS ORAL 20 MG, ORAL Date:12/07/05ISR Number: 4847932-8Report Type:Direct Company Report #CTU 264550 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Respiratory Failure Geodon 40mg Initial or Prolonged Bradycardia Pfizer PS Pfizer ORAL 40MG Q Electrocardiogram Qt BEDTIME PO Prolonged Amiodarone C Nosocomial Infection Lisinopril C Pneumonia Albuterol C Ipratropium C Multivitamin C Aspirin C Atorvastatin C Amlodipine C Bisacodyl C 22-Feb-2006 08:32 AM Page: 870 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lactulose C Ceftriaxone C Azithromycin C Pantoprazole C Zosyn C Vancomycin C Magnesium Sulfate C Potassium Chloride C Lexapro C Metformin C Regular Insulin C Glyburide C Doxazosin C Diazepam C Levalbuterol C Acetaminophen C Enoxaparin C Date:12/07/05ISR Number: 4849342-6Report Type:Expedited (15-DaCompany Report #2005133817 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anxiety Foreign Zeldox Completed Suicide Health Condition Aggravated Professional (Ziprasidone) PS ORAL 160 MG, ORAL Fear Other Cisordinol Injury Asphyxiation Paranoia (Clopenthixol Hydrochloride) C Zuclopenthixol (Zuclopenthixol) C Date:12/07/05ISR Number: 4849344-XReport Type:Expedited (15-DaCompany Report #2005141513 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Health Geodon (Ziprasidone) PS 80 MG (2 IN 1 Corrected Interval Professional D), Prolonged Company Clonidine Electrocardiogram T Wave Representative (Clonidine) SS ORAL 0.2 MG (0.2 Abnormal MG, 1 IN 1 Insomnia D), ORAL Date:12/07/05ISR Number: 4849481-XReport Type:Expedited (15-DaCompany Report #2005161761 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Drooling Foreign Zeldox (Capsules) Grimacing Health (Ziprasidone) PS ORAL 80 MG (40 MG, Musculoskeletal Stiffness Professional 2 IN 1 D), Speech Disorder ORAL Tension Escitalopram Tic (Escitalopram) C Oxazepam (Oxazepam) C 22-Feb-2006 08:32 AM Page: 871 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/07/05ISR Number: 4849568-1Report Type:Expedited (15-DaCompany Report #2005127652 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Hunger Foreign Zeldox (Capsules) Treatment Noncompliance Health (Ziprasidone) PS ORAL 40 MG (40 MG, Weight Increased Professional 1 IN 1 D), Company ORAL Representative Zoloft (Sertraline) C Date:12/07/05ISR Number: 4850445-0Report Type:Direct Company Report #CTU 264609 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Quetiapine PS ORAL 100MG PO ONE Initial or Prolonged Blood Creatine TIME Required Phosphokinase Increased Ziprasidone SS INTRAMUSCULAR 20MG IM ONE Intervention to Blood Creatinine TIME Prevent Permanent Increased Impairment/Damage Hyperpyrexia Neuroleptic Malignant Syndrome Posturing Urinary Incontinence Date:12/08/05ISR Number: 4850513-3Report Type:Expedited (15-DaCompany Report #2005163401 Age:90 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Foreign Geodon (Ziprasidone) PS 40 MG (1 IN 1 Balance Disorder Health D), Cognitive Disorder Professional Flunitrazepam Confusional State (Flunitrazepam) C Dizziness Vitamins (Vitamins) C Dysstasia Acetylsalicylic Acid Fall (Acetylsalicylic Gait Disturbance Acid) C Hallucination Motor Dysfunction Nervous System Disorder Orthostatic Hypotension Vascular Dementia Date:12/08/05ISR Number: 4850924-6Report Type:Expedited (15-DaCompany Report #2005140440 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Pressure Abnormal Consumer Xanax Xr Other Completed Suicide Health (Alprazolam) PS ORAL 2 MG (1 MG, 2 Drug Interaction Professional IN 1 D), ORAL Drug Screen Positive Geodon (Ziprasidone) SS 180 MG (60 Dysarthria MG, 1 IN 1 D) Feeling Abnormal Wellbutrin Sr Stress (Bupropion Hydrochloride) SS ORAL 400 MG (200 MG, 2 IN 1 D), ORAL Viagra (Sildenafil) C 22-Feb-2006 08:32 AM Page: 872 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/08/05ISR Number: 4851203-3Report Type:Expedited (15-DaCompany Report #2005163454 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Geodon (Ziprasidone) PS Professional Company Representative Date:12/09/05ISR Number: 4853562-4Report Type:Expedited (15-DaCompany Report #2005153439 Age:21 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiomegaly Health Geodon (Ziprasidone) PS 160 MG Hospitalization - Drug Abuser Professional Heroin (Diamorphine) SS Initial or Prolonged Drug Interaction Company Depakote - Slow Other Mental Impairment Representative Release (Valproate Overdose Semisodium) C Psychotic Disorder Zonegran (Zonisamide) C Abilify (Aripiprazole) C Zoloft (Sertraline) C Naltrexone (Naltrexone) C Date:12/12/05ISR Number: 4853742-8Report Type:Expedited (15-DaCompany Report #2005164248 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Renal Failure Health Geodon (Ziprasidone) PS ORAL 240 MG, ORAL Weight Increased Professional Celexa (Citalopram Hydrobromide) C Seroquel (Quetiapine Fumarate) C Lexapro (Escitalopram) C Topamax (Topiramate) C Date:12/12/05ISR Number: 4853777-5Report Type:Expedited (15-DaCompany Report #2005130246 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Health Geodon (Ziprasidone) PS 160 MG (80 Increased Professional MG, 2 IN 1 D) Anxiety Company Zoloft (Sertraline) SS ORAL ORAL Aspartate Representative Clonazepam Aminotransferase (Clonazepam) C Increased Blood Sodium Decreased Depression Diabetes Mellitus Laboratory Test Abnormal 22-Feb-2006 08:32 AM Page: 873 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/13/05ISR Number: 4854193-2Report Type:Expedited (15-DaCompany Report #2005163379 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Health Nardil (Phenelzine Bipolar Disorder Professional Sulfate) PS ORAL 60 MG (15 MG, Diarrhoea 1 IN 1 D), Drug Interaction ORAL Dysgeusia Geodon (Ziprasidone) SS ORAL 40 MG (20 MG, Hallucination, Visual 2 IN 1 D), Hyperhidrosis ORAL Insomnia Seroquel (Quetiapine Mania Fumarate) SS (AS Psychotic Disorder NECESSARY), Sedation Valium (Diazepam) C Serotonin Syndrome Ibuprofen Tremor (Ibuprofen) C Lortab (Hydrocodone Bitartrate, Paracetamol) C Soma (Carisoprodol) C Pulmicort (Budesonide) C Date:12/14/05ISR Number: 4855067-3Report Type:Expedited (15-DaCompany Report #2005165119 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eating Disorder Health Geodon (Ziprasidone) PS Long Qt Syndrome Professional All Others Nonspecific Reaction Company Therapeutic Products Ventricular Fibrillation Representative (All Other Therapeutic Products) SS All Others Therapeutic Products (All Other Therapeutic Products) SS Date:12/14/05ISR Number: 4855983-2Report Type:Expedited (15-DaCompany Report #2005150886 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Alanine Aminotransferase Foreign Zeldox (Capsules) Hospitalization - Increased Study (Ziprasidone) PS ORAL 120 MG (60 Initial or Prolonged Aspartate Health MG, 2 IN 1 Other Aminotransferase Professional D), ORAL Increased Diazepam (Diazepam) C Blood Lactate Benzhexol Dehydrogenase Increased (Trihexyphenidyl) C Neuroleptic Malignant Norflex For Syndrome Injection Psychotic Disorder (Orphenadrine Citrate, Sodium Bisulfite, Sodium C 22-Feb-2006 08:32 AM Page: 874 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/15/05ISR Number: 4855754-7Report Type:Direct Company Report #CTU 265112 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatic Steatosis Geodon 40 Mg Pfizer PS Pfizer BUCCAL 40 MG TWICE Initial or Prolonged Hepatocellular Damage PER DAY Disability BUCCAL Other Required Intervention to Prevent Permanent Impairment/Damage Date:12/16/05ISR Number: 4861612-4Report Type:Expedited (15-DaCompany Report #2005165999 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Geodon (Ziprasidone) PS Professional Company Representative Date:12/19/05ISR Number: 4863944-2Report Type:Direct Company Report #CTU 265323 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Diabetes Mellitus Seroquel 300mg Intervention to Hepatic Steatosis Astra Zeneca PS Astra Zeneca ORAL 300MG ONCE A Prevent Permanent DAY PO Impairment/Damage Geodon 40mg Pfizer SS Pfizer ORAL 20MG TWICE PER DAY PO Date:12/19/05ISR Number: 4864028-XReport Type:Direct Company Report #CTU 265302 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Malaise Geodon PS ORAL 80 ML PO BID Neuroleptic Malignant Haldol C Syndrome Date:12/19/05ISR Number: 4864073-4Report Type:Direct Company Report #CTU 265331 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anxiety Ziprazadone PS ORAL 60 MG TWICE Hospitalization - Neuroleptic Malignant DAILY PO Initial or Prolonged Syndrome Lexapro Relacore Required (Magnolia Bark) SS ORAL 10 MG DAILY Intervention to PO Prevent Permanent Impairment/Damage 22-Feb-2006 08:32 AM Page: 875 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/19/05ISR Number: 4864182-XReport Type:Expedited (15-DaCompany Report #2005166307 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zeldox (Capsules) Other Condition Aggravated Health (Ziprasidone) PS ORAL 120 MG (60 Insomnia Professional MG, 2 IN 1 Psychotic Disorder Company D), ORAL Restlessness Representative Diazepam (Diazepam) C Schizophrenia Date:12/20/05ISR Number: 4865626-XReport Type:Expedited (15-DaCompany Report #2005165890 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Myocardial Infarction Health Geodon (Ziprasidone) PS 80 MG, Professional Date:12/20/05ISR Number: 4865855-5Report Type:Expedited (15-DaCompany Report #2005155757 Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diastolic Dysfunction Foreign Zeldox (Capsules) Initial or Prolonged Drug Interaction Health (Ziprasidone) PS ORAL 120 MG, ORAL Other Electrocardiogram Qt Professional Edronax (Reboxetine) SS ORAL 6 MG, ORAL Corrected Interval Flupentixol Prolonged (Flupentixol) SS 2 MG, Ventricular Hypertrophy Solian (Amisulpride) SS ORAL 400 MG, ORAL Magnesium (Magnesium) C Zyprexa (Olanzapine) C L-Thyroxin (Levothyroxine Sodium) C Date:12/20/05ISR Number: 4886711-2Report Type:Periodic Company Report #HQWYE904127JAN05 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Effexor Xr PS ORAL 150 DAILY, Initial or Prolonged Professional ORAL Other Company Geodon (Ziprasidone) SS ORAL 40/120 TWICE Representative DAILY, ORAL Advair (Fluticasone Propionate/Salmetero l Xinafoate) C Flonase (Fluticasone Propionate) C Calcium Citrate (Calcium Citrate) C Coenzyme Q10 (Ubidecarenone) C Lisinopril (Lisinopril) C Prempro (Conjugated Estrogens/Medroxypro gesterone Acetate) C 22-Feb-2006 08:32 AM Page: 876 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/21/05ISR Number: 4862854-4Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-13211149 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Abilify PS Otsuka Pharmaceuticals Europe Limited Geodon SS Lamictal SS Date:12/21/05ISR Number: 4866328-6Report Type:Expedited (15-DaCompany Report #2005168151 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Consumer Geodon (Ziprasidone) PS ORAL 60 MG (60 MG, Menorrhagia Health 1 IN 1 D), Professional ORAL Fish Oil (Fish Oil) SS All Other Therapeutic Products (All Other Therapeutic Products) SS Klonopin (Clonazepam) C Date:12/21/05ISR Number: 4866733-8Report Type:Expedited (15-DaCompany Report #2005147937 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Parkinsonism Foreign Zeldox (Capsules) Initial or Prolonged Health (Ziprasidone) PS ORAL 20 MG (20 MG, Professional 1 IN 1 D), Company ORAL Representative Lorazepam (Lorazepam) C Cymbalta (Duloxetine Hydrochloride) C Lithium (Lithium) C Nitrazepam (Nitrazepam) C Date:12/22/05ISR Number: 4867168-4Report Type:Expedited (15-DaCompany Report #2005169486 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Health Geodon (Im) Mental Status Changes Professional (Ziprasidone) PS INTRAMUSCULAR INTRAMUSCULAR Date:12/22/05ISR Number: 4867169-6Report Type:Expedited (15-DaCompany Report #2005169224 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dizziness Health Geodon (Ziprasidone) PS 120 MG (1 IN Hospitalization - Nausea Professional 1 D), UNKNOWN Initial or Prolonged Vomiting Clozapine (Clozapine) SS ORAL 600 MG, ORAL Macrogol (Macrogol) C 22-Feb-2006 08:32 AM Page: 877 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Docusate (Docusate) C Haldol (Haloperidol) C Trihexyphenidyl (Trihexyphenidyl) C Gemfibrozil (Gemfibrozil) C Metoclopramide (Metoclopramide) C Pantoprazole (Pantoprazole) C Magnesium Oxide (Magnesium Oxide) C Date:12/22/05ISR Number: 4867173-8Report Type:Expedited (15-DaCompany Report #2005169120 Age:80 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Pacemaker Health Geodon (Ziprasidone) PS Insertion Professional Company Representative Date:12/22/05ISR Number: 4867233-1Report Type:Expedited (15-DaCompany Report #2005157348 Age:18 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agitation Health Geodon (Im) Hospitalization - Blood Creatine Professional (Ziprasidone) PS INTRAMUSCULAR 20 MG, Initial or Prolonged Phosphokinase Increased Company INTRAMUSCULAR Other Body Temperature Representative Sodium Bicarbonate Increased (Sodium Bicarbonate) SS Corneal Reflex Decreased Haloperidol Delirium (Haloperidol) SS INTRAMUSCULAR 10 MG, Hyperhidrosis INTRTAMUSCULA Hypertonia R Metabolic Alkalosis Myoclonus Neuroleptic Malignant Syndrome Retching Sinus Tachycardia Tachycardia Tachypnoea White Blood Cell Count Increased Date:12/23/05ISR Number: 4868537-9Report Type:Expedited (15-DaCompany Report #2005169442 Age:47 YR Gender:Male I/FU:I Outcome PT Hospitalization - Abasia Initial or Prolonged Agitation Other Alanine Aminotransferase Increased Anticonvulsant Drug Level Below Therapeutic Aspartate Aminotransferase 22-Feb-2006 08:32 AM Page: 878 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Increased Blood Creatine Phosphokinase Increased Blood Creatinine Report Source Product Role Manufacturer Route Dose Duration Increased Literature Lithium (Lithium) PS 450 MG (2 IN Blood Iron Decreased Health 1 D) Blood Potassium Increased Professional Ziprasidone (Caps) Blood Pressure Decreased (Ziprasidone) SS INTRAMUSCULAR SEE IMAGE Blood Sodium Increased Divalproex (Valproic Depressed Level Of Acid) C Consciousness Losartan (Losartan) C Drug Ineffective Ibuprofen Dyspnoea (Ibuprofen) C Myoglobinuria Furosemide Nephrogenic Diabetes (Furosemide) C Insipidus Diphenhydramine Neuroleptic Malignant (Diphenhydramine) C Syndrome Acetaminophen Pyrexia (Paracetamol) C Sepsis Ipratropium Somnolence (Ipratropium) C Tachypnoea Flunisolide Treatment Noncompliance (Flunisolide) C White Blood Cell Count Increased Date:12/23/05ISR Number: 4868608-7Report Type:Expedited (15-DaCompany Report #2005169442 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abasia Literature Lithium (Lithium) PS 450 MG (2 IN Initial or Prolonged Alanine Aminotransferase Health 1D ) Other Increased Professional Ziprasidone (Caps) Antipsychotic Drug Level (Ziprasidone) SS INTRAMUSCULAR 160 MG (2 IN Increased 1 D), 20 MG, Aspartate INTRAMUSCULAR Aminotransferase Divalproex (Valproic Increased Acid) C Blood Creatinine Losartan (Losartan) C Increased Ibuprofen Blood Iron Increased (Ibuprofen) C Blood Potassium Increased Furosemide Blood Pressure Decreased (Furosemide) C Blood Sodium Increased Diphenhydramine Diabetes Insipidus (Diphenhydramine) C Drug Level Decreased Acetaminophen Dyspnoea (Paracetamol) C Loss Of Consciousness Ipratropium Neuroleptic Malignant (Ipratropium) C Syndrome Flunisolide Sepsis (Flunisolide) C Treatment Noncompliance Date:12/23/05ISR Number: 4868694-4Report Type:Expedited (15-DaCompany Report #2004017260 Age:26 YR Gender:Female I/FU:F Outcome PT Death Akathisia Life-Threatening Anxiety Other Arrhythmia 22-Feb-2006 08:32 AM Page: 879 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Condition Aggravated Depression Discomfort Report Source Product Role Manufacturer Route Dose Duration Fear Of Weight Gain Consumer Geodon (Ziprasidone) PS 80 MG (2 IN 1 Flashback Health D), Frustration Professional Prozac (Fluoxetine Headache Company Hydrochloride) SS (10 MG, 1 IN Hypersomnia Representative 1 D), Insomnia Abilify Loss Of Consciousness (Aripiprazole) SS Mania Lamictal Restlessness (Lamotrigine) SS Sedation Sudden Cardiac Death Suicidal Ideation Tension Therapeutic Response Decreased Treatment Noncompliance Date:12/23/05ISR Number: 4868832-3Report Type:Expedited (15-DaCompany Report #2005161622 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Lithium (Lithium) PS 1200 MG DAILY Initial or Prolonged Diarrhoea Literature Ziprasidone (Im) Drug Level Above Health (Ziprasidone) SS INTRAMUSCULAR 80 MG DAILY Therapeutic Professional INTRAMUSCULAR Drug Toxicity All Other Irritability Therapeutic Products Psychotic Disorder (All Other Somnolence Therapeutic Products) SS Date:12/29/05ISR Number: 4871097-XReport Type:Expedited (15-DaCompany Report #2005147299 Age:62 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anorexia Foreign Zeldox (Capsules) Hospitalization - Diabetes Mellitus Health (Ziprasidone) PS ORAL 80 MG, ORAL Initial or Prolonged Diabetic Ketoacidotic Professional Lithium (Lithium) C Other Hyperglycaemic Coma Mirtazapine Electrocardiogram Qt (Mirtazapine) C Prolonged Ramipril (Ramipril) C Hyperglycaemia Polyuria Sinus Tachycardia Somnolence Thirst Vomiting Date:01/03/06ISR Number: 4874314-5Report Type:Direct Company Report #CTU 266021 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Geodon 80 Mg PS Initial or Prolonged Psychotic Disorder 22-Feb-2006 08:32 AM Page: 880 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/04/06ISR Number: 4873899-2Report Type:Expedited (15-DaCompany Report #2005172576 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Consumer Viagra (Sildenafil) PS Drug Effect Decreased Cardura (Doxazosin Erectile Dysfunction Mesilate) SS Norvasc (Amlodipine) SS Lipitor (Atorvastatin) SS Geodon (Ziprasidone) SS Neuprontin (Gabapentin) SS Plavix (Clopidogrel Sulfate) SS Pacerone (Amiodarone Hydrochloride) SS Wellbutrin (Bupropion Hydrochloride) SS Date:01/04/06ISR Number: 4874079-7Report Type:Expedited (15-DaCompany Report #2005172064 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Body Height Decreased Consumer Dilantin Kapseals Burning Sensation (Phenytoin Sodium) PS ORAL 300 MG (100 Convulsion MG 3 IN 1 D) Mastectomy ORAL Treatment Noncompliance Norvasc (Amlodipine) SS Goeodon (Ziprasidone) SS Anastrozole (Anastrozole) C Hydrochlorothiazide (Hydrochlorothiazide ) C Feosol (Ferrous Sulfate) C Date:01/04/06ISR Number: 4874184-5Report Type:Expedited (15-DaCompany Report #2005170554 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abscess Limb Consumer Neurontin Initial or Prolonged Affect Lability (Gabapentin) PS Other Agitation Lyrica (Pregabalin) SS Confusional State Geodon (Ziprasidone) SS 120 MG (60 Crying MG, 2 IN 1 D) Drug Ineffective Insulin (Insulin) C Nephrolithiasis Metformin Paranoia (Metformin) C Psychotic Disorder Screaming Sepsis Thinking Abnormal 22-Feb-2006 08:32 AM Page: 881 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/04/06ISR Number: 4874980-4Report Type:Expedited (15-DaCompany Report #2005159603 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Zeldox Capsules Initial or Prolonged Delirium Health (Ziprasidone) PS ORAL 160 MG *80 Drug Ineffective Professional MG2 IN 1 D) Hallucinations, Mixed Company ORAL Insomnia Representative Psychotic Disorder Schizophrenia Social Avoidant Behaviour Date:01/04/06ISR Number: 4875050-1Report Type:Expedited (15-DaCompany Report #2005172607 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Spontaneous Foreign Zeldox Drug Exposure Before Consumer Pregnancy Other (Ziprasidone) PS ORAL 40 MG (20 MG, Hormone Level Abnormal 2 IN 1 D), ORAL Trevilor (Venlafaxine Hydrochloride) SS ORAL 75 MG, ORAL Seroquel SS ORAL 25 MG, ORAL Date:01/04/06ISR Number: 4875173-7Report Type:Expedited (15-DaCompany Report #2005168295 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Systolic Health Geodon (Ziprasidone) PS 40 MG (20 MG, Increased Professional 2 IN 1 D), Bradycardia Company Paxil (Paroxetine Hyponatraemia Representative Hydrochloride) SS Long Qt Syndrome Fluoxetine Loss Of Consciousness (Fluoxetine) C Torsade De Pointes Metformin Ventricular Tachycardia (Metformin) C Viral Infection Protonix Vomiting (Pantoprazole) C Propranolol (Propranolol) C Lipitor (Atorvastatin) C Zocor (Simvastatin) C All Other Therapeutic Products (All Other Therapeutic Products) C Date:01/06/06ISR Number: 4876108-3Report Type:Direct Company Report #CTU 266293 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Quetiapine PS 200MG QHS Initial or Prolonged Diarrhoea Ziprasidone SS 60 MG QPM 22-Feb-2006 08:32 AM Page: 882 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/09/06ISR Number: 4877572-6Report Type:Expedited (15-DaCompany Report #2006000464 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diarrhoea Health Geodon (Ziprasidone) PS ORAL 80 MG (40 MG, Initial or Prolonged Drug Dependence Professional 2 IN 1 D), Other Gastritis ORAL; UNK, Nausea INTRAMUSCULAR Vomiting Restoril (Temazepam) C Weight Decreased Levoxyl (Levothyroxine Sodium) C Lisinopril (Lisinopril) C Climara (Estradiol) C Cymbalta (Duloxetine Hyudrochloride) C Prozac (Fluoxetine Hydrochloride) C Date:01/09/06ISR Number: 4877622-7Report Type:Direct Company Report #CTU 266382 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drooling Geodon 80 Mg X 2 PS ORAL PO Hospitalization - Dyspnoea Zoloft SS ORAL PO Initial or Prolonged Economic Problem Vitamins/Primatene Other Facial Pain Mist C Paralysis Speech Disorder Stress Tongue Disorder Trismus Date:01/10/06ISR Number: 4877995-5Report Type:Expedited (15-DaCompany Report #2005163454 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Geodon (Im) Health (Ziprasidone) PS INTRAMUSCULAR INTRAMUSCULAR Professional ; ORAL Company Representative Date:01/10/06ISR Number: 4878026-3Report Type:Expedited (15-DaCompany Report #2006000098 Age:44 YR Gender:Female I/FU:I Outcome PT Hospitalization - Antipsychotic Drug Level Initial or Prolonged Above Therapeutic Other Delusion Extrapyramidal Disorder Incorrect Dose Administered Intentional Misuse Mania Muscle Tightness Palpitations Psychotic Disorder 22-Feb-2006 08:32 AM Page: 883 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Restlessness Somnolence Weight Increased Report Source Product Role Manufacturer Route Dose Duration Consumer Lithium (Lithium) PS ORAL ORAL Geodon (Ziprasidone) SS ORAL 160 MG (80 MG, 1 IN 1 D), ORAL Benadryl (Diphenhydramine) SS ORAL ORAL Alcohol (Ethanol) SS ORAL ORAL Seroquel (Quetiapine Fumarate) SS ORAL ORAL Klonopin (Clonazepam) SS ORAL ORAL Date:01/10/06ISR Number: 4878088-3Report Type:Expedited (15-DaCompany Report #2006000530 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Literature Ziprasidone (Caps) Initial or Prolonged Depression Health (Ziprasidone) PS 120 MG Other White Blood Cell Count Professional Mirtazapine Decreased (Mirtazapine) SS 30 MG Date:01/11/06ISR Number: 4879708-XReport Type:Expedited (15-DaCompany Report #2006003505 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Affective Disorder Foreign Zeldox (Capsules) Agitation Health (Ziprasidone) PS ORAL 20 MG (20 MG, Self Mutilation Professional 1 IN 1 D), ORAL Date:01/11/06ISR Number: 4880180-4Report Type:Expedited (15-DaCompany Report #2006003122 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Health Geodon (Im) Cardio-Respiratory Arrest Professional (Ziprasidone) PS INTRAMUSCULAR INTRAMUSCULAR Moaning Company Thorazine No Reaction On Previous Representative (Chlorpromazine Exposure To Drug Hydrochloride) C Lithium (Lithium) C Date:01/11/06ISR Number: 4880208-1Report Type:Expedited (15-DaCompany Report #2005090503 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Drug Ineffective Health Geodon (Ziprasidone) PS ORAL 160 MG (80 Somnolence Professional MG, 2 IN 1 Tremor D), ORAL Urinary Incontinence Detrol La (Tolterodine L-Tartrate) SS ORAL (2 MG), ORAL Diphenhydramine (Diphenhydramine) SS Remeron 22-Feb-2006 08:32 AM Page: 884 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Mirtazapine) C Paxil (Paroxetine Hydrochloride) C Date:01/11/06ISR Number: 4881370-7Report Type:Direct Company Report #CTU 266655 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Geodon PS INTRAVENOUS 10 MG IM X 1 Initial or Prolonged Aphasia Dystonia Muscle Twitching Physical Assault Swollen Tongue Date:01/12/06ISR Number: 4881780-8Report Type:Expedited (15-DaCompany Report #2006003256 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Activities Of Daily Consumer Geodon (Ziprasidone) PS 160 MG (80 Initial or Prolonged Living Impaired MG,2 IN 1 D) Anxiety Valium (Diazepam) SS Drug Dose Omission All Other Dyskinesia Therapeutic Products Feeling Jittery (All Other Nervousness Therapeutic Photophobia Products) SS Somnolence Treatment Noncompliance Date:01/12/06ISR Number: 4881864-4Report Type:Direct Company Report #CTU 266731 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Arrest Geodon 20 Mg Pfizer PS Pfizer INTRAMUSCULAR 20 MG ONE TIME IM Lorazepam C Pepcid C Protonix C Regular Insulin Sliding Scale C Folic Acid C Thiamine C Multivits C Lactulose C Lacutlose C Heparin C Folic Acid C Regular Insulin Drip C Clonidine C Hadol C Clonidine Patch C Clonidine C Potassium Phosphate C Calcium Chloride C Duoneb C 22-Feb-2006 08:32 AM Page: 885 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/12/06ISR Number: 4882296-5Report Type:Expedited (15-DaCompany Report #2005156154 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Consumer Geodon (Ziprasidone) PS ORAL ORAL Initial or Prolonged Diarrhoea Actos (Pioglitazone) C Other Gastric Disorder Cogentin Haematemesis (Benzatropine Hypertension Mesilate) C Memory Impairment Zyprexa (Olanzapine) C Mental Disorder Nausea Renal Disorder Vomiting Weight Increased Date:01/13/06ISR Number: 4882494-0Report Type:Expedited (15-DaCompany Report #2005133148 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Health Geodon (Ziprasidone) PS ORAL 140 MG (2 IN Initial or Prolonged Fall Professional 1 D), ORAL Other Insomnia Trazodone Hydrochloride (Trazodone Hydrochloride) SS 50 MG (ONE TIME ONLY), UNKNOWN Date:01/13/06ISR Number: 4882498-8Report Type:Expedited (15-DaCompany Report #2005165890 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Acute Myocardial Health Geodon (Ziprasidone) PS 120 MG (40 Other Infarction Professional MG, 3 IN 1 D) Atenolol (Atenolol) C Lipitor (Atorvastatin) C Date:01/16/06ISR Number: 4881508-1Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0505416A Age:27 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Lamictal PS Glaxosmithkline ORAL 150MG Twice Depressed Level Of per day Consciousness Abilify SS 15MG Per day Drug Prescribing Error Geodon SS 160MG At Medication Error night YR Sudden Cardiac Death Date:01/18/06ISR Number: 4886283-2Report Type:Expedited (15-DaCompany Report #2006005309 Age:35 YR Gender:Male I/FU:I Outcome PT Hospitalization - Anxiety Initial or Prolonged Arrhythmia Other Chest Pain Constipation 22-Feb-2006 08:32 AM Page: 886 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dyspnoea Platelet Count Decreased Pulmonary Thrombosis Report Source Product Role Manufacturer Route Dose Duration White Blood Cell Count Consumer Geodon (Ziprasidone) PS 1600 MG (800 Decreased MG, 2 IN 1 D), UNKNOWN Depakote (Valproate Semisodium) C Ativan (Lorazepam) C Lunesta (Eszopiclone) C Date:01/18/06ISR Number: 4887474-7Report Type:Expedited (15-DaCompany Report #2006003505 Age:13 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Foreign Zeldox (Capsules) Mood Altered Health (Ziprasidone) PS ORAL 40 MG (20 MG, Self Mutilation Professional 2 IN 1 D), ORAL Risperidone (Risperidone) C Date:01/18/06ISR Number: 4887480-2Report Type:Expedited (15-DaCompany Report #2006005326 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Heart Rate Increased Foreign Ziprasidone (Caps) Initial or Prolonged Intentional Overdose Literature (Ziprasidone) PS NINE MONTHS Somnolence AGO Suicide Attempt Venlafaxine (Venlafaxine) SS NINE MONTHS AGO Date:01/19/06ISR Number: 4886784-7Report Type:Expedited (15-DaCompany Report #2006007952 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Foreign Ziprasidone (Caps) Initial or Prolonged Suicide Attempt Literature (Ziprasidone) PS UNK (60 MG, Health UNKNOWN), Professional Paracetamol (Paracetamol) SS 15 GRAM (UNKNOWN), Citalopram (Citalopram) SS UNK (20 MG, UNKNOWN), Date:01/19/06ISR Number: 4886785-9Report Type:Expedited (15-DaCompany Report #2006007949 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Suicide Attempt Foreign Ziprasidone (Caps) Literature (Ziprasidone) PS 60 MG, Health UNKNOWN Professional Herbal Preparation (Herbal Preparation) SS 22-Feb-2006 08:32 AM Page: 887 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/19/06ISR Number: 4886788-4Report Type:Expedited (15-DaCompany Report #2005007955 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Suicide Attempt Foreign Ziprasidone (Caps) Literature (Ziprasidone) PS 40 MG, Health UNKNOWN Professional Paracetamol (Paracetamol) SS Citalopram (Citalopram) SS 20 MG, UNKNOWN Alcohol (Ethanol) SS Date:01/19/06ISR Number: 4886790-2Report Type:Expedited (15-DaCompany Report #2006006462 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Ziprasidone (Caps) Initial or Prolonged Lower Respiratory Tract Health (Ziprasidone) PS ORAL 80 MG (80 MG, Inflammation Professional 1 IN 1 D); Company ORAL Representative Date:01/19/06ISR Number: 4886792-6Report Type:Expedited (15-DaCompany Report #2006006481 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Ziprasidone (Caps) Initial or Prolonged Hypomania Health (Ziprasidone) PS ORAL 80 MG (80 MG, Poisoning Professional 1 IN 1 D); Company ORAL Representative Date:01/19/06ISR Number: 4887632-1Report Type:Direct Company Report #CTU 267316 Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Amiodarone PS 200 MG QD Initial or Prolonged Dizziness Metoprolol SS 25 MG QD Dysstasia Ziprasidone 20 Mg Q Heart Rate Decreased Am SS Date:01/23/06ISR Number: 4890795-5Report Type:Expedited (15-DaCompany Report #2006007805 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Consumer Geodon (Ziprasidone) PS (1 IN 1 D) Initial or Prolonged Mania Trazodone Other Road Traffic Accident (Trazodone) SS 50 MG (50 MG, 1 IN 1 D) 22-Feb-2006 08:32 AM Page: 888 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/23/06ISR Number: 4891910-XReport Type:Expedited (15-DaCompany Report #2005166307 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Zeldox (Capsules) Other Condition Aggravated Health (Ziprasidone) PS ORAL 120 MG (60 Insomnia Professional MG, 2 IN 1 Restlessness Company D), ORAL Schizophrenia Representative Diazepam (Diazepam) C Treatment Noncompliance Zyprexa (Olanzapine) C Date:01/23/06ISR Number: 4891912-3Report Type:Expedited (15-DaCompany Report #2006008512 Age:39 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blister Foreign Zeldox (Capsules) Initial or Prolonged Malaise Health (Ziprasidone) PS ORAL ORAL Rash Scarlatiniform Professional Truxal (Chlorprothixene Hydrochloride) C Rivotril (Clonazepam) C Date:01/23/06ISR Number: 4892076-2Report Type:Expedited (15-DaCompany Report #2006008512 Age:39 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Malaise Foreign Zeldox (Capsules) Initial or Prolonged Pruritus Health (Ziprasidone) PS ORAL ORAL Rash Scarlatiniform Professional Truxal (Chlorprothixene Hydrochloride) C Rivotril (Clonazepam) C Date:01/25/06ISR Number: 4892682-5Report Type:Direct Company Report #CTU 267643 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypersomnia Geodon (Pfizer) PS Pfizer ORAL SEE SECTION B Road Traffic Accident # 5 DAILY ORAL Date:01/26/06ISR Number: 4896773-4Report Type:Expedited (15-DaCompany Report #2005134380 Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arrhythmia Foreign Ziprasidone (Caps) Initial or Prolonged Extrapyramidal Disorder Consumer (Ziprasidone) PS ORAL 160 MG (80 Other Hypotension Health MG, 2 IN 1 Quadriparesis Professional D), ORAL Risperidone (Risperidone) SS Biperiden (Biperiden) C Diazepam (Diazepam) C Valproate Sodium (Valproate Sodium) C 22-Feb-2006 08:32 AM Page: 889 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/27/06ISR Number: 4896935-6Report Type:Expedited (15-DaCompany Report #2005161761 Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Drooling Foreign Zeldox (Capsules) Grimacing Health (Ziprasidone) PS ORAL 80 MG (40 MG, Musculoskeletal Stiffness Professional 2 IN 1 D), Speech Disorder Other ORAL Tension Escitalopram Tic (Escitalopram) C Date:01/27/06ISR Number: 4898457-5Report Type:Expedited (15-DaCompany Report #2006003122 Age:61 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Health Geodon (Im) Cardio-Respiratory Arrest Professional (Ziprasidone) PS INTRAMUSCULAR (20 MG/KG,), Moaning Company INTRAMUSCULAR Representative Thorazine (Chlorpromazine Hydrochloride) C Lithium (Lithium) C Date:01/27/06ISR Number: 4898721-XReport Type:Expedited (15-DaCompany Report #2006009305 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Geodon (Ziprasidone) PS ORAL 80 MG (40 MG, Condition Aggravated Professional 2 IN 1 D), Gastrointestinal Injury ORAL Hallucination, Auditory Paranoia Skin Laceration Date:01/27/06ISR Number: 4898944-XReport Type:Expedited (15-DaCompany Report #2006010994 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Bipolar Disorder Consumer Geodon (Ziprasidone) PS Zoloft (Sertraline) SS Alprazolam (Alprazolam) SS Wellbutrin (Bupropion Hydrochloride) C Date:01/30/06ISR Number: 4897422-1Report Type:Direct Company Report #CTU 268154 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Torsade De Pointes Geodon 60mg Hospitalization - Ventricular Tachycardia Pfizer PS Pfizer ORAL 60MG DAILY Initial or Prolonged IN AM PO Disability Geodon 80mg Pfizer SS Pfizer ORAL 80MG DAILY IN PM PO Synthroid C Depakote C Premarin C 22-Feb-2006 08:32 AM Page: 890 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/31/06ISR Number: 4898526-XReport Type:Direct Company Report #CTU 268351 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Geodon 80 Mg Bid PS OPHTHALMIC PO 80 MG BID Oculogyration Paranoia Date:01/31/06ISR Number: 4898736-1Report Type:Expedited (15-DaCompany Report #2006012140 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Serotonin Syndrome Health Geodon (Ziprasidone) PS 160 MG Professional Mao Inhibitors (Mao Company Inhibitors) C Representative Date:01/31/06ISR Number: 4899302-4Report Type:Expedited (15-DaCompany Report #2004008864 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Toxicity Foreign Ziprasidone (Caps) Initial or Prolonged Intentional Overdose Literature (Ziprasidone) PS ORAL 180 MG (60 Other Somnolence Consumer MG), ORAL Suicide Attempt Health Venlafaxine Professional (Venlafaxine) C Date:01/31/06ISR Number: 4899364-4Report Type:Expedited (15-DaCompany Report #2006011948 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Suicide Attempt Foreign Ziprasidone (Caps) Health (Ziprasidone) PS ORAL 100 MG (2 IN Professional 1 D), ORAL Company Representative Date:02/01/06ISR Number: 4901770-6Report Type:Direct Company Report #CTU 268389 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Priapism Geodon (Ziprasidone) PS ORAL 80MG PO BID Initial or Prolonged Fluoxetine C Trazodone C Date:02/02/06ISR Number: 4901196-5Report Type:Expedited (15-DaCompany Report #2006014204 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Geodon (Ziprasidone) PS Professional Company Representative 22-Feb-2006 08:32 AM Page: 891 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/02/06ISR Number: 4901300-9Report Type:Expedited (15-DaCompany Report #2005173468 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alcoholic Liver Disease Health Geodon (Im) Cardiac Death Professional (Ziprasidone) PS INTRAMUSCULAR 20 MG (20 MG, Cardio-Respiratory Arrest ONE TIME Cholelithiasis DOSE), Gastritis INTRAMUSCULAR Mitral Valve Prolapse Protonix Pneumonia Aspiration (Pantoprazole) C Renal Disorder Electrolyte Respiratory Failure Solutions Spleen Congestion (Electrolyte Ventricular Hypertrophy Solutions) C Minerals Nos (Minerals Nos) C Clonidine (Clonidine) C Clonidine (Clonidine) C Haloperidol (Haloperidol) C All Other Therapeutic Products (All Other Therapeutic Products) C Thiamine (Thiamine) C Multivitamins (Multivitamins) C Lactulose (Lactulose) C Heparin (Heparin) C Multivitamins (Multivitamins) C Folic Acid (Folic Acid) C Thaimine (Thiamine) C Insulin, Regular (Insulin) C Potassium Phosphate (Potassium Phosphate) C Calcium Chloride (Calcium Chloride Anhydrous) C Duoneb (Ipratropium Bromide, Salbutamol Sulfate) C Lactulose (Lactulose) C Lorazepam (Lorazepam) C Pepcid (Famotidine) C All Other Therapeutic Products (All Other Therapeutic Products) C 22-Feb-2006 08:32 AM Page: 892 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/06/06ISR Number: 4903512-7Report Type:Direct Company Report #CTU 268712 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dyspnoea Geodon 60mg Bid PS ORAL 60MG BID ORAL Eye Swelling Local Swelling Nausea Rash Rash Generalised Urticaria Vomiting 22-Feb-2006 08:32 AM Page: 893 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Summary report for FOI selections: Selection by inexact search of active ingredient: ZIPRASIDONE% Selection by inexact search of Tradename/Verbatim: GEODON% Total number of reports: 3,700 From: 01-NOV-1997 To: Present 22-Feb-2006 08:32 AM Page: 894