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Index of reports
> Cases with Off Label Use (147)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Zyprexa (Olanzapine) where reactions include off label use. The selected reports were submitted to the FDA during the sample period of about a year. Reports 1 - 30 of 147 Next >>
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 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 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 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 female
Reported by a consumer/non-health professional from France on 2012-08-14
Patient: female
Reactions: Off Label Use, Cytolytic Hepatitis, Urticaria, Cholestasis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Zyprexa
Other drugs received by patient: Taxol; Anafranil; Midodrine Hydrochloride; Nexium; Avastin; Zofran; Corticosteroid NOS; Midodrine Hydrochloride; Chlorpromazine HCL; Anafranil
Possible Zyprexa side effects in 18 year old male
Reported by a physician from Australia on 2012-08-14
Patient: 18 year old male
Reactions: Off Label Use, Rhabdomyolysis, Blood Creatine Phosphokinase Decreased
Drug(s) suspected as cause:
Fluoxetine HCL
Dosage: 60 mg, qd
Administration route: Oral
Indication: Depression
Zyprexa
Dosage: 15 mg, qd
Zyprexa
Dosage: 7.5 mg, qd
Administration route: Oral
Indication: Depression
Start date: 2012-06-01
Other drugs received by patient: Clonazepam
Possible Zyprexa side effects in 74 year old female
Reported by a consumer/non-health professional from China on 2012-08-13
Patient: 74 year old female
Reactions: Off Label Use, Platelet Count Decreased, Purpura
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Zyprexa
Dosage: 10 mg, unk
Indication: Sleep Disorder
Start date: 2012-04-15
End date: 2012-04-30
Zyprexa
Dosage: 5 mg, unk
Start date: 2012-05-01
End date: 2012-06-15
Other drugs received by patient: Calcium
Possible Zyprexa side effects in 50 year old female
Reported by a consumer/non-health professional from United States on 2012-08-13
Patient: 50 year old female
Reactions: Inappropriate Schedule of Drug Administration, Abdominal Discomfort, Off Label Use, Palpitations, Uterine Leiomyoma, Dizziness
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Olanzapine
Dosage: 2.5 mg, qd
Indication: Psychotic Disorder
Zyprexa
Dosage: 2.5 mg, qd
Indication: Anxiety
Zyprexa
Dosage: 2.5 mg, qd
Other drugs received by patient: Xanax
Possible Zyprexa side effects in 47 year old male
Reported by a physician on 2012-08-10
Patient: 47 year old male, weighing 101.0 kg (222.2 pounds)
Reactions: Multi-Organ Failure, Off Label Use, Megacolon, Systemic Candida, Confusional State, Intestinal Infarction, Shock
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Olanzapine
Dosage: (20 mg), oral, (20 mg), oral
Administration route: Oral
Indication: Schizophrenia
Start date: 2011-11-30
Olanzapine
Dosage: (20 mg), oral, (20 mg), oral
Administration route: Oral
Indication: Off Label Use
Start date: 2011-11-30
Olanzapine
Dosage: (20 mg), oral, (20 mg), oral
Administration route: Oral
Indication: Schizophrenia
End date: 2011-11-28
Olanzapine
Dosage: (20 mg), oral, (20 mg), oral
Administration route: Oral
Indication: Off Label Use
End date: 2011-11-28
Zyprexa
Dosage: 10 mg daily as needed up to a maximum dose of 20 mg for two or three days, intramuscular
Indication: Schizophrenia
Other drugs received by patient: Morphine
Possible Zyprexa side effects in female
Reported by a physician from France on 2012-08-08
Patient: female
Reactions: Off Label Use, Cytolytic Hepatitis, Urticaria, Cholestasis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Zyprexa
Other drugs received by patient: Anafranil; Anafranil; Taxol; Corticosteroid NOS; Avastin; Midodrine Hydrochloride; Midodrine Hydrochloride; Chlorpromazine HCL; Nexium; Zofran
Possible Zyprexa side effects in 47 year old male
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-07
Patient: 47 year old male, weighing 101.0 kg (222.2 pounds)
Reactions: Megacolon, Off Label Use, Multi-Organ Failure, Ischaemia, Confusional State, Systemic Candida, Infarction
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Olanzapine
Dosage: 25 mg, oral 20 mg, oral
Administration route: Oral
Indication: Schizophrenia
Start date: 2011-11-30
Olanzapine
Dosage: 25 mg, oral 20 mg, oral
Administration route: Oral
Indication: Schizophrenia
End date: 2011-11-28
Zyprexa
Dosage: 10 mg as needed; a max of 20 mg 2 -3 day, intramuscular
Indication: Schizophrenia
Other drugs received by patient: Morphine
Possible Zyprexa side effects in 27 year old female
Reported by a consumer/non-health professional from Switzerland on 2012-08-07
Patient: 27 year old female
Reactions: Off Label Use, Maternal Exposure During Pregnancy
Drug(s) suspected as cause:
Zyprexa
Other drugs received by patient: Clorazepate Dipotassium; Zolpidem Tartrate
Possible Zyprexa side effects in 47 year old male
Reported by a physician from United Kingdom on 2012-08-07
Patient: 47 year old male, weighing 101.0 kg (222.2 pounds)
Reactions: Off Label Use, Systemic Candida, Confusional State, Multi-Organ Failure, Megacolon, Incorrect Drug Administration Duration
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Olanzapine
Dosage: 25mg, unk
Administration route: Oral
Indication: Schizophrenia
End date: 2011-11-28
Olanzapine
Dosage: 20mg, unk
Administration route: Oral
Start date: 2011-11-30
Zyprexa
Indication: Schizophrenia
Other drugs received by patient: Morphine Sulfate
Possible Zyprexa side effects in male
Reported by a physician from United Kingdom on 2012-08-03
Patient: male, weighing 101.0 kg (222.2 pounds)
Reactions: Off Label Use, Confusional State, Megacolon, Multi-Organ Failure, Systemic Candida, Incorrect Drug Administration Duration
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Olanzapine
Dosage: 20mg, unk
Administration route: Oral
Start date: 2011-11-30
Olanzapine
Dosage: 25mg, unk
Administration route: Oral
Indication: Schizophrenia
End date: 2011-11-28
Zyprexa
Indication: Schizophrenia
Other drugs received by patient: Morphine Sulfate
Possible Zyprexa side effects in 70 year old male
Reported by a consumer/non-health professional from United States on 2012-08-03
Patient: 70 year old male
Reactions: Off Label Use, Self Injurious Behaviour
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Zyprexa
Possible Zyprexa side effects in 33 year old female
Reported by a consumer/non-health professional from United States on 2012-08-02
Patient: 33 year old female
Reactions: LIP Swelling, Body Temperature Fluctuation, Anaphylactic Reaction, Wheezing, Urticaria, Intentional Drug Misuse, Hyperhidrosis, Off Label Use, Thinking Abnormal, Oedema Mouth, Mood Swings, Cold Sweat, Vomiting, Nausea, Swollen Tongue, Tremor, Paraesthesia, Diarrhoea, Presyncope, Withdrawal Syndrome
Drug(s) suspected as cause:
Cymbalta
Dosage: 60 mg, qd
Indication: Depression
End date: 2012-07-15
Zyprexa
Dosage: 10 mg, each evening
Indication: Withdrawal Syndrome
Start date: 2012-06-01
Possible Zyprexa side effects in female
Reported by a physician from Japan on 2012-07-31
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
Dosage: 1550 mg, other
Indication: Gallbladder Cancer non-Resectable
Start date: 2011-08-01
End date: 2011-08-15
Gemzar
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: Azunol; Magmitt; Pursennid / SCH /; Rabeprazole Sodium; Loxonin; Tramal / GFR /; Cisplatin; TS 1
Possible Zyprexa side effects in 85 year old female
Reported by a physician from Japan on 2012-07-31
Patient: 85 year old female
Reactions: Abdominal Pain, Off Label Use, White Blood Cell Count Decreased, Nausea, Hypophagia, Somnolence
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Gemcitabine Hydrochloride
Dosage: 1200 mg, other
Indication: Pancreatic Carcinoma
Zyprexa
Dosage: 2.5 mg, qd
Administration route: Oral
Indication: Nausea
Other drugs received by patient: Omeprazole; Oxycodone HCL; Oxycodone HCL; Loxoprofen; Magnesium Oxide; Prochlorperazine; Oxycodone HCL
Possible Zyprexa side effects in 40 year old male
Reported by a consumer/non-health professional from United States on 2012-07-30
Patient: 40 year old male
Reactions: Off Label Use, Hospitalisation
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Cymbalta
Dosage: 120 mg, qd
Indication: Anxiety
Zyprexa
Dosage: 1 df, unknown
Indication: Anxiety
Zyprexa
Dosage: 10 mg, bid
Possible Zyprexa side effects in male
Reported by a physician from Japan on 2012-07-26
Patient: male, weighing 65.0 kg (143.0 pounds)
Reactions: Off Label Use, Psychomotor Hyperactivity, Neuroleptic Malignant Syndrome
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Zyprexa
Other drugs received by patient: Diazepam; Depakene; Levetiracetam; Silece; Levetiracetam; Tegretol; Lendormin; Valproate Sodium
Possible Zyprexa side effects in 29 year old female
Reported by a physician from Germany on 2012-07-26
Patient: 29 year old female
Reactions: Off Label Use, Abdominal Discomfort, Chills, Irritable Bowel Syndrome
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Zyprexa
Dosage: 15 mg, qd
Administration route: Oral
Start date: 2012-06-01
Zyprexa
Dosage: 15 mg, qd
Administration route: Oral
Indication: Sleep Disorder
Start date: 2004-01-01
Other drugs received by patient: Pantoprazole
Possible Zyprexa side effects in 21 year old male
Reported by a consumer/non-health professional from United States on 2012-07-26
Patient: 21 year old male, weighing 69.4 kg (152.7 pounds)
Reactions: Weight Decreased, Drug Dose Omission, Wrong Drug Administered, Rash, Aggression, Hostility, Off Label Use, Depression
Drug(s) suspected as cause:
Risperdal
Seroquel
Administration route: Oral
Indication: Psychotic Disorder
Start date: 2009-01-01
Seroquel
Administration route: Oral
Indication: Antisocial Behaviour
Start date: 2009-01-01
Seroquel
Administration route: Oral
Start date: 2009-10-01
Seroquel
Administration route: Oral
Start date: 2009-10-01
Zyprexa
Other drugs received by patient: Abilify
Possible Zyprexa side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-23
Patient: female
Reactions: Off Label Use, Insomnia, Depression, Intentional Drug Misuse
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Zyprexa
Dosage: 5 mg, qd
Indication: Sleep Disorder
Zyprexa
Dosage: 2.5 mg, qd
Indication: Bipolar I Disorder
Zyprexa
Dosage: 5 mg, qd
Other drugs received by patient: Miralax; Amitiza; Lorazepam
Possible Zyprexa side effects in 74 year old female
Reported by a consumer/non-health professional from China on 2012-07-20
Patient: 74 year old female
Reactions: Off Label Use, Platelet Count Decreased, Purpura
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Zyprexa
Dosage: 5 mg, unk
Start date: 2012-05-01
End date: 2012-06-15
Zyprexa
Dosage: 10 mg, unk
Indication: Sleep Disorder
Start date: 2012-04-15
End date: 2012-04-30
Other drugs received by patient: Calcium
Possible Zyprexa side effects in 63 year old female
Reported by a consumer/non-health professional from Sweden on 2012-07-18
Patient: 63 year old female
Reactions: Confusional State, Off Label Use, Overdose, Fall
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Zyprexa
Other drugs received by patient: Laktulos; Hydroxocobalamin; Folic Acid; Atenolol; Symbicort; Zopiklon; Aspirin; Spironolactone; Propavan; Ferrous Sulfate TAB; Spiriva; Furosemide
Possible Zyprexa side effects in female
Reported by a physician from Croatia (Local Name: Hrvatska) on 2012-07-11
Patient: female, weighing 100.0 kg (220.0 pounds)
Reactions: Off Label Use, Tachycardia, Pulmonary Oedema, General Physical Health Deterioration, Hypertension, Cardiac Failure Congestive
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Zyprexa
Other drugs received by patient: Equanil; Lanitop; Diazepam; Depakene; Zonadin; Iruzid / 06400701 /
Possible Zyprexa side effects in 29 year old female
Reported by a consumer/non-health professional from Germany on 2012-07-10
Patient: 29 year old female
Reactions: Abdominal Discomfort, Off Label Use, Chills
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Zyprexa
Dosage: 15 mg, qd
Administration route: Oral
Indication: Sleep Disorder
Start date: 2004-01-01
Zyprexa
Dosage: 15 mg, qd
Administration route: Oral
Start date: 2012-06-01
Possible Zyprexa side effects in female
Reported by a consumer/non-health professional from Japan on 2012-07-10
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: Azunol; Rabeprazole Sodium; Magmitt; Pursennid / SCH /; Tramal / GFR /; Loxonin; Cisplatin; TS 1
Possible Zyprexa side effects in 82 year old female
Reported by a physician from Thailand on 2012-07-05
Patient: 82 year old female
Reactions: Off Label Use, Menstrual Disorder, Breast Engorgement
Drug(s) suspected as cause:
Zyprexa
Dosage: 5 mg, unk
Indication: Dementia
Zyprexa
Dosage: 2.5 mg, unk
Other drugs received by patient: Warfarin Sodium
Possible Zyprexa side effects in male
Reported by a consumer/non-health professional from Japan on 2012-06-29
Patient: male, weighing 65.0 kg (143.0 pounds)
Reactions: Off Label Use, Psychomotor Hyperactivity, Dehydration, Neuroleptic Malignant Syndrome
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Zyprexa
Other drugs received by patient: Diazepam; Valproate Sodium; Levetiracetam; Silece; Depakene; Levetiracetam; Tegretol; Lendormin
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