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Zyprexa (Olanzapine) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Zyprexa (Olanzapine) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (1480)
Death (208)
Life Threatening Events (128)
Disability (43)

Reports by Reaction Type

Weight Increased (199)Off Label Use (147)Overdose (142)Diabetes Mellitus (117)Hospitalisation (77)Confusional State (68)Hypertension (68)Death (67)Somnolence (66)Pneumonia (61)Tremor (59)Drug Ineffective (58)

Below are a few examples of reports where side effects / adverse reactions may be related to Zyprexa (Olanzapine). For a complete list or a specific selection of reports, please use the links above.

Possible Zyprexa side effects in 63 year old male

Reported by a consumer/non-health professional from Germany on 2012-08-27

Patient: 63 year old male

Reactions: Drug Level Increased

Drug(s) suspected as cause:
Abilify
    Dosage: dose increased to 30 mg

Zyprexa



Possible Zyprexa side effects in female

Reported by a consumer/non-health professional from Japan on 2012-08-27

Patient: female, weighing 55.8 kg (122.8 pounds)

Reactions: Off Label Use, Dysgeusia, Vomiting, Fatigue, Nausea, Platelet Count Decreased, Decreased Appetite

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Gemzar

Gemzar
    Dosage: 1550 mg, other
    Indication: Gallbladder Cancer non-Resectable
    Start date: 2011-08-01
    End date: 2011-08-15

Zyprexa
    Dosage: 5 mg, qd
    Administration route: Oral
    Indication: Nausea
    Start date: 2011-08-04
    End date: 2011-08-10

Other drugs received by patient: Pursennid / SCH /; Loxonin; Tramal / GFR /; Rabeprazole Sodium; Cisplatin; TS 1; Azunol; Magmitt



Possible Zyprexa side effects in female

Reported by a consumer/non-health professional from Canada on 2012-08-27

Patient: female

Reactions: Renal Failure, Diabetes Mellitus

Drug(s) suspected as cause:
Zyprexa



Possible Zyprexa side effects in male

Reported by a health professional (non-physician/pharmacist) from Italy on 2012-08-27

Patient: male

Reactions: Jaundice Cholestatic

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Akineton
    Administration route: Oral
    Indication: Tremor
    Start date: 2011-01-01
    End date: 2012-08-03

Chlorpromazine HCL
    Administration route: Oral
    Indication: Abnormal Behaviour
    Start date: 2011-08-03
    End date: 2012-08-03

Zyprexa
    Administration route: Oral
    Indication: Abnormal Behaviour
    Start date: 2010-08-03
    End date: 2012-08-03



Possible Zyprexa side effects in male

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-27

Patient: male

Reactions: Sudden Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Loxapine HCL
    Dosage: 100/50/50/100
    Administration route: Oral
    Start date: 2012-07-16

Loxapine HCL
    Administration route: Oral
    Indication: Psychotic Disorder
    Start date: 2012-07-15

Loxapine HCL
    Administration route: Oral
    Start date: 2012-07-23
    End date: 2012-07-23

Loxapine HCL
    Administration route: Oral

Risperdal Consta
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-01-01
    End date: 2012-07-02

Zyprexa
    Dosage: 10/20
    Administration route: Oral
    Indication: Psychotic Disorder
    Start date: 2012-07-17

Zyprexa
    Administration route: Oral
    Start date: 2012-07-16

Zyprexa
    Administration route: Oral
    End date: 2012-07-23

Other drugs received by patient: Risperdal; Valium; Trimeprazine Tartrate; Valium; Valium; Valium; Valium; Akineton; Tranxene; Valium; Imovane



Possible Zyprexa side effects in 70 year old male

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 70 year old male

Reactions: Off Label Use, Psychotic Disorder, Head Injury, Self Injurious Behaviour

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zyprexa

Other drugs received by patient: Haloperidol Lactate



Possible Zyprexa side effects in 63 year old male

Reported by a consumer/non-health professional from Germany on 2012-08-27

Patient: 63 year old male

Reactions: Drug Level Increased

Drug(s) suspected as cause:
Abilify
    Dosage: dose increased to 30 mg

Zyprexa



Possible Zyprexa side effects in 57 year old female

Reported by a consumer/non-health professional from Mexico on 2012-08-24

Patient: 57 year old female, weighing 135.0 kg (296.9 pounds)

Reactions: Weight Increased, Hospitalisation, Wrong Technique in Drug Usage Process, Restlessness, Drug Dependence

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zyprexa
    Dosage: unk, unknown
    Start date: 2010-01-01

Zyprexa
    Dosage: 10 mg, unk

Zyprexa
    Dosage: 2.5 mg, qd
    Administration route: Oral
    Indication: Schizophrenia
    Start date: 1997-01-01
    End date: 2004-01-01

Other drugs received by patient: Acetylsalicylic Acid W / Caffeine; Akineton; Risperdal; Tramadol HCL; Acetaminophen; Pradaxa; Omeprazole



Possible Zyprexa side effects in male

Reported by a physician from United States on 2012-08-24

Patient: male

Reactions: Rhabdomyolysis, Urinary Incontinence, Mental Status Changes, Hemiparesis, Muscle Rigidity, Weight Increased, Paraplegia, Overdose, Decubitus Ulcer, Transient Ischaemic Attack, White Blood Cell Count Increased, Urinary Tract Infection, Haemorrhoids, Alanine Aminotransferase Increased, Myopathy, Convulsion, Haematochezia, Oliguria, Aspartate Aminotransferase Increased, Complex Partial Seizures

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zyprexa
    Dosage: 10 mg, bid

Zyprexa
    Dosage: 15 mg, qd
    Administration route: Oral
    Indication: Psychotic Disorder
    Start date: 2003-04-22

Zyprexa
    Dosage: 12.5 mg, qd

Zyprexa
    Dosage: 5 mg, bid

Zyprexa
    Dosage: 20 mg, qd

Zyprexa
    Dosage: 10 mg, qd

Zyprexa
    Dosage: 25 mg, qd
    End date: 2010-03-04

Other drugs received by patient: Xanax; Amlodipine; Abilify; Lorazepam; Lotrel; Enablex; Ditropan; Topamax; Toprol-XL; Valium; Clonazepam; Lamictal; Ativan; Lexapro; Imipramine HCL; Lisinopril



Possible Zyprexa side effects in 15 year old female

Reported by a consumer/non-health professional from Mexico on 2012-08-24

Patient: 15 year old female, weighing 68.0 kg (149.6 pounds)

Reactions: Drug Dose Omission, Wrong Technique in Drug Usage Process, Headache, Off Label Use, Thrombocytopenic Purpura, Nasal Turbinate Abnormality, Dyspnoea, Abnormal Behaviour, Condition Aggravated, Stress, Joint Injury, Arthralgia, Visual Impairment, Heart Rate Increased, Platelet Count Decreased, Eye Swelling, Hypothyroidism, Vision Blurred, Memory Impairment, Hyperthyroidism

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zyprexa
    Dosage: 10 mg, qd
    Administration route: Oral
    Start date: 2011-04-02

Zyprexa
    Dosage: 15 mg, qd
    Administration route: Oral
    Indication: Bipolar Disorder

Other drugs received by patient: Omeprazole; Amoxicillin and Clavulanate Potassium; Clonazepam; Lamotrigine; Lamotrigine; Tapazol; Tapazol



Possible Zyprexa side effects in 70 year old male

Reported by a physician from United Kingdom on 2012-08-24

Patient: 70 year old male

Reactions: Syncope

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cymbalta

Zyprexa



Possible Zyprexa side effects in 82 year old female

Reported by a physician from Australia on 2012-08-24

Patient: 82 year old female

Reactions: Electrocardiogram QT Prolonged, Atrial Fibrillation, Ventricular Fibrillation

Drug(s) suspected as cause:
Zyprexa

Other drugs received by patient: Dothiepin Hydrochloride



Possible Zyprexa side effects in male

Reported by a physician from Italy on 2012-08-23

Patient: male

Reactions: Dysarthria, Tachycardia, Snoring, Sopor, Drug Abuse

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zyprexa

Other drugs received by patient: Valproate Sodium; Lansoprazole; Trazodone HCL; Clonazepam; Anafranil; Haloperidol Lactate



Possible Zyprexa side effects in 25 year old female

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient: 25 year old female

Reactions: Weight Increased

Drug(s) suspected as cause:
Zyprexa
    Dosage: 2.5 mg, bid

Zyprexa
    Dosage: 2.5 mg, qd
    Indication: Schizophrenia

Other drugs received by patient: Fluoxetine Hydrochloride; Clozapine; Topamax; Buspar



Possible Zyprexa side effects in 80 year old male

Reported by a physician from United States on 2012-08-23

Patient: 80 year old male

Reactions: Off Label Use, Wrong Technique in Drug Usage Process, Depression

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zyprexa
    Dosage: unk, unknown
    Administration route: Oral
    Indication: Depression

Zyprexa Zydis
    Dosage: unk, unknown
    Indication: Depression



Possible Zyprexa side effects in male

Reported by a physician from Ireland on 2012-08-23

Patient: male

Reactions: Overdose, Swelling, Dermatitis Bullous

Drug(s) suspected as cause:
Zyprexa
    Dosage: 385 mg, unknown
    Administration route: Oral

Zyprexa
    Dosage: 1 df, unknown
    Administration route: Oral



Possible Zyprexa side effects in female

Reported by a health professional (non-physician/pharmacist) from Denmark on 2012-08-22

Patient: female

Reactions: Encephalopathy, Extrapyramidal Disorder, Tardive Dyskinesia, Delirium, Hyperkinesia, Tremor

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Escitalopram
    Dosage: 10 mg
    Start date: 2012-04-11

Escitalopram
    Dosage: 10 mg
    Administration route: Oral
    Indication: Depression
    Start date: 2002-01-01
    End date: 2012-04-05

Zolpidem
    Dosage: 10 mg
    Administration route: Oral
    Indication: Insomnia
    Start date: 2002-01-01
    End date: 2012-04-05

Zyprexa
    Dosage: 2.5 mg
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2002-01-01
    End date: 2012-04-05

Other drugs received by patient: Sintrom; Cordarone; Tenormin; Pamidronate Disodium; Levofloxacin; Sintrom; Cordarone; Nitroglycerin; Levothyroxine Sodium; Rocephin; Acetaminophen; Piperacillin and Tazobactam



Possible Zyprexa side effects in male

Reported by a physician from France on 2012-08-22

Patient: male

Reactions: Electrocardiogram QT Prolonged

Drug(s) suspected as cause:
Zyprexa
    Dosage: 10 mg, qd
    Indication: Schizophrenia

Zyprexa
    Dosage: 7.5 mg, qd



Possible Zyprexa side effects in male

Reported by a health professional (non-physician/pharmacist) from Italy on 2012-08-22

Patient: male

Reactions: Blood Creatine Phosphokinase Increased, Blood Chloride Decreased, Alanine Aminotransferase Increased, Blood Cholinesterase Decreased, Aggression, Gamma-Glutamyltransferase Increased, Presyncope, Aspartate Aminotransferase Increased, Multiple Drug Overdose Intentional, Suicide Attempt, Blood Sodium Decreased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Oxcarbazepine
    Dosage: 7 df, unk
    Administration route: Oral
    Start date: 2012-04-22
    End date: 2012-04-22

Zyprexa
    Dosage: 4 df, unk
    Administration route: Oral
    Start date: 2012-04-22
    End date: 2012-04-22



Possible Zyprexa side effects in 35 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-22

Patient: 35 year old female

Reactions: Pruritus, Cytolytic Hepatitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Effexor XR
    Dosage: 75 mg, 2x/day
    Administration route: Oral
    Start date: 2011-12-10
    End date: 2011-12-23

Hydroxyzine HCL
    Dosage: 300 mg, until 300 mg daily
    Administration route: Oral
    Start date: 2011-12-21

Tercian
    Dosage: 30 drops
    Administration route: Oral
    Start date: 2011-12-06
    End date: 2011-12-06

Tercian
    Dosage: 15 drops
    Administration route: Oral
    Start date: 2011-12-07
    End date: 2011-12-12

Tercian
    Dosage: 100 drops (=100 mg) daily
    Administration route: Oral
    Indication: Anxiolytic Therapy
    Start date: 2011-12-01
    End date: 2011-12-03

Tercian
    Dosage: 95 drops daily
    Administration route: Oral
    Start date: 2011-12-04
    End date: 2011-12-05

Tercian
    Dosage: 5 drops
    Administration route: Oral
    Start date: 2011-12-13

Venlafaxine HCL
    Dosage: 50 mg, 1x/day
    Administration route: Oral
    Start date: 2011-12-07
    End date: 2011-12-09

Zyprexa
    Dosage: 10 mg daily
    Administration route: Oral
    Indication: Major Depression
    Start date: 2011-12-01
    End date: 2011-12-05

Zyprexa
    Dosage: 10 mg, 2x/day
    Administration route: Oral
    Start date: 2011-12-06
    End date: 2011-12-23



Possible Zyprexa side effects in 62 year old male

Reported by a individual with unspecified qualification from United States on 2012-08-22

Patient: 62 year old male, weighing 93.4 kg (205.6 pounds)

Reactions: Sedation, Fall, Somnolence, Asthenia

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Zyprexa



Possible Zyprexa side effects in 27 year old female

Reported by a physician from Japan on 2012-08-22

Patient: 27 year old female

Reactions: Pneumonia, Cough Decreased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zyprexa



Possible Zyprexa side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-21

Patient: male, weighing 94.3 kg (207.5 pounds)

Reactions: Tooth Loss, Drug Ineffective, Increased Appetite, Restless Legs Syndrome, Pain, Blood Triglycerides Increased, Erectile Dysfunction, Weight Increased, Neuropathy Peripheral, Adverse Event, Blood Cholesterol Increased, Blood Glucose Increased, Scoliosis, Glucose Tolerance Impaired, Mental Disorder, Gait Disturbance, Diabetic Ketoacidosis, Feeling Abnormal

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Zyprexa
    Dosage: 10 mg, each evening
    Indication: Schizophrenia
    Start date: 1999-04-01

Zyprexa
    Dosage: 5 mg, unk

Other drugs received by patient: Tranxene



Possible Zyprexa side effects in 65 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-21

Patient: 65 year old female

Reactions: Urticaria, Hepatocellular Injury, Cholestasis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Anafranil
    Dosage: 150 mg, 1x/day
    Administration route: Oral
    Indication: Major Depression
    Start date: 2012-06-22

Avastin
    Dosage: unk
    Indication: Breast Cancer
    Start date: 2012-02-01
    End date: 2012-07-16

Chlorpromazine HCL
    Dosage: 200 drop(s)
    Administration route: Oral
    Indication: Major Depression
    Start date: 2012-06-20
    End date: 2012-06-28

Midodrine Hydrochloride
    Dosage: unk
    Administration route: Oral
    Indication: Orthostatic Hypotension
    Start date: 2012-06-22
    End date: 2012-07-16

Paclitaxel
    Dosage: unk
    Indication: Breast Cancer Recurrent
    Start date: 2012-02-01
    End date: 2012-07-16

Zofran
    Dosage: 8 mg, weekly
    Administration route: Oral
    Indication: Vomiting
    Start date: 2012-02-01
    End date: 2012-07-16

Zyprexa
    Dosage: 10 mg, 1x/day
    Administration route: Oral
    Indication: Major Depression
    Start date: 2012-06-28
    End date: 2012-07-16

Other drugs received by patient: Nexium



Possible Zyprexa side effects in 36 year old female

Reported by a physician from Japan on 2012-08-20

Patient: 36 year old female

Reactions: Pancytopenia

Drug(s) suspected as cause:
Zyprexa

Other drugs received by patient: Seroquel; Valproate Sodium



Possible Zyprexa side effects in 57 year old female

Reported by a physician from United States on 2012-08-20

Patient: 57 year old female

Reactions: Chest Pain, Drug Hypersensitivity

Drug(s) suspected as cause:
Celexa
    Dosage: unk

Ciprofloxacin HCL
    Dosage: unk

Gabapentin
    Dosage: unk

Hydrocodone Bitartrate + Acetaminophen
    Dosage: unk

Iodine
    Dosage: unk

Morphine Sulfate
    Dosage: unk

Oxycontin
    Dosage: unk

Povidone-Iodine (Formula 47)
    Dosage: unk

Prozac
    Dosage: unk

Secretin INJ
    Dosage: unk

Seroquel
    Dosage: unk

Titanium Dioxide
    Dosage: unk

Zyprexa
    Dosage: unk



Possible Zyprexa side effects in 33 year old male

Reported by a consumer/non-health professional from United States on 2012-08-17

Patient: 33 year old male, weighing 86.6 kg (190.6 pounds)

Reactions: Weight Decreased, Muscle Atrophy, Pain, Urinary Incontinence, Erectile Dysfunction, Suicidal Ideation, Blood Glucose Abnormal, Fatigue, Chest Pain, Blindness Unilateral, Unevaluable Event, Crying, Muscle Spasms, Type 2 Diabetes Mellitus, Libido Decreased, Rash, Dysstasia, Renal Failure, Visual Impairment, Alopecia, Hearing Disability, Bradyphrenia

Drug(s) suspected as cause:
Zyprexa
    Dosage: 20 mg, qd
    Start date: 2004-01-01

Zyprexa
    Dosage: 10 mg, bid
    Indication: Bipolar Disorder

Other drugs received by patient: Gemfibrozil; Enalapril Maleate; Lortab; Xanax; Lovaza; Glyburide; Metformin HCL; Aspirin



Possible Zyprexa side effects in 50 year old male

Reported by a consumer/non-health professional from United Kingdom on 2012-08-17

Patient: 50 year old male

Reactions: Blood Prolactin Increased, Pituitary Tumour Benign

Drug(s) suspected as cause:
Zyprexa

Other drugs received by patient: Fluticasone Propionate / Salmeterol; Carbamazepine; Dihydrocodeine Bitartrate INJ



Possible Zyprexa side effects in 16 year old male

Reported by a physician from United Kingdom on 2012-08-17

Patient: 16 year old male, weighing 56.4 kg (124.1 pounds)

Reactions: Psychotic Disorder, Pericarditis, Blood Thrombin Increased, Myocarditis

Drug(s) suspected as cause:
Olanzapine
    Dosage: 5 mg, qd
    Administration route: Oral
    Indication: Psychotic Disorder
    Start date: 2012-05-24
    End date: 2012-05-24

Zyprexa
    Dosage: 2.5 mg, prn
    Start date: 2012-05-21
    End date: 2012-05-23

Zyprexa
    Dosage: 15 mg, qd
    Indication: Psychotic Disorder
    Start date: 2012-05-22

Zyprexa
    Dosage: 5 mg, prn
    Start date: 2012-05-21
    End date: 2012-05-23

Other drugs received by patient: Zuclopenthixol; Lorazepam



Possible Zyprexa side effects in female

Reported by a consumer/non-health professional from Australia on 2012-08-17

Patient: female

Reactions: Electrocardiogram QT Prolonged

Drug(s) suspected as cause:
Zyprexa
    Dosage: 7.5 mg, unk

Zyprexa
    Dosage: 5 mg, unk
    Indication: Schizophrenia

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