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Nizoral (Ketoconazole) - Hepatitis - Suspected Cause - Side Effect Reports

 
 



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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