Ketoconazole (Ketoconazole Topical) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

During clinical trials 45 (5%) of 905 patients treated with ketoconazole cream, 2% and 5 (2.4%) of 208 patients treated with placebo reported side effects consisting mainly of severe irritation, pruritus and stinging. One of the patients treated with ketoconazole cream developed a painful allergic reaction.

In worldwide postmarketing experience, rare reports of contact dermatitis have been associated with ketoconazole cream or one of its excipients, namely sodium sulfite or propylene glycol.

REPORTS OF SUSPECTED KETOCONAZOLE SIDE EFFECTS / ADVERSE REACTIONS

Possible Ketoconazole side effects / adverse reactions in 75 year old male

Reported by a physician from Argentina on 2011-10-04

Patient: 75 year old male

Reactions: Jaundice, Liver Function Test Abnormal, Peripheral Ischaemia, Infected Skin Ulcer

Adverse event resulted in: hospitalization

Suspect drug(s):
Blinded Therapy

Metformin HCL
    Indication: Type 2 Diabetes Mellitus

Blinded Therapy
    Indication: Type 2 Diabetes Mellitus
    Start date: 2010-09-23
    End date: 2011-09-08

Ketoconazole
    Indication: Infected Skin Ulcer

Rifampin
    Indication: Infected Skin Ulcer

Possible Ketoconazole side effects / adverse reactions in 12 year old female

Reported by a health professional (non-physician/pharmacist) from Brazil on 2011-10-14

Patient: 12 year old female weighing 61.0 kg (134.2 pounds)

Reactions: Benign Intracranial Hypertension

Suspect drug(s):
Ketoconazole

Ketoconazole
    Indication: Pituitary-Dependent Cushing's Syndrome

Possible Ketoconazole side effects / adverse reactions in 22 year old female

Reported by a physician from France on 2011-10-14

Patient: 22 year old female weighing 65.0 kg (143.0 pounds)

Reactions: Hypothermia, Intentional Overdose, Coagulopathy, Hepatic Failure, Loss of Consciousness, Renal Failure, Cardiotoxicity, Inhibitory Drug Interaction, Drug Dependence, Cardiac Arrest, Shock

Adverse event resulted in: life threatening event

Suspect drug(s):
Tramadol HCL
    Dosage: up to ten tablets per day
    Indication: Euphoric Mood

Tramadol HCL
    Dosage: intermittent consumption

Ketoconazole
    Dosage: unk
    Indication: Vaginal Infection

Tramadol HCL
    Dosage: took 90 of the 50 mg capsules
    Indication: Dysmenorrhoea