Index of reports
> Cases with Hepatitis (4)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Nizoral (Ketoconazole) where reactions include hepatitis. The selected reports were submitted to the FDA during the sample period of about a year.
Possible Nizoral side effects in female
Reported by a consumer/non-health professional from China on 2012-05-03
Patient: female, weighing 60.0 kg (132.0 pounds)
Reactions: Subacute Hepatic Failure, Hepatic Encephalopathy, Disseminated Intravascular Coagulation, Dizziness, Hepatitis, Abdominal Pain Upper
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Nizoral
Other drugs received by patient: Unknown Medication; Unknown Medication; Methylprednisolone; Alprostadil; Glutathione; Methylprednisolone; Unknown Medication; Alprostadil; Glycyrrhizic Acid, Ammonium Salt; Glutathione; Glycyrrhizic Acid, Ammonium Salt; Unknown Medication; Unknown Medication
Possible Nizoral side effects in female
Reported by a pharmacist from China on 2012-05-02
Patient: female, weighing 60.0 kg (132.0 pounds)
Reactions: Cholecystitis, Intentional Drug Misuse, Hepatitis, Gastritis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Nizoral
Dosage: 26-jul, first box
Administration route: Oral
Indication: Onychomycosis
Start date: 2011-07-26
Nizoral
Dosage: 2 boxes in aug (year unspecified)
Administration route: Oral
End date: 2011-09-06
Possible Nizoral side effects in female
Reported by a health professional (non-physician/pharmacist) from China on 2012-04-30
Patient: female, weighing 60.0 kg (132.0 pounds)
Reactions: Subacute Hepatic Failure, Hepatic Encephalopathy, Disseminated Intravascular Coagulation, Dizziness, Hepatitis, Abdominal Pain Upper
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Nizoral
Dosage: possibly for 10 days and taken about 10 tablets
Administration route: Oral
Indication: Onychomycosis
Start date: 2011-03-17
Nizoral
Dosage: approximately 10 days
Administration route: Oral
Start date: 2011-06-17
Other drugs received by patient: Unknown Medication; Methylprednisolone; Glycyrrhizic Acid, Ammonium Salt; Alprostadil; Alprostadil; Glutathione; Glutathione; Glycyrrhizic Acid, Ammonium Salt; Unknown Medication; Unknown Medication; Methylprednisolone; Unknown Medication; Unknown Medication
Possible Nizoral side effects in 52 year old female
Reported by a pharmacist from China on 2011-10-17
Patient: 52 year old female
Reactions: Cholecystitis, Intentional Drug Misuse, Hepatitis, Gastritis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Nizoral
Dosage: 26-jul, first box
Administration route: Oral
Nizoral
Dosage: 2 boxes in aug (year unspecified)
Administration route: Oral
Indication: Onychomycosis
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