Nizoral (Ketoconazole) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

In rare cases, anaphylaxis has been reported after the first dose. Several cases of hypersensitivity reactions including urticaria have also been reported. However, the most frequent adverse reactions were nausea and/or vomiting in approximately 3%, abdominal pain in 1.2%, pruritus in 1.5%, and the following in less than 1% of the patients: headache, dizziness, somnolence, fever and chills, photophobia, diarrhea, gynecomastia, impotence, thrombocytopenia, leukopenia, hemolytic anemia, and bulging fontanelles. Oligospermia has been reported in investigational studies with the drug at dosages above those currently approved. Oligospermia has not been reported at dosages up to 400 mg daily, however sperm counts have been obtained infrequently in patients treated with these dosages. Most of these reactions were mild and transient and rarely required discontinuation of NIZORAL^® (ketoconazole) Tablets. In contrast, the rare occurrences of hepatic dysfunction require special attention (see WARNINGS section).

In worldwide postmarketing experience with NIZORAL^® Tablets there have been rare reports of alopecia, paresthesia, and signs of increased intracranial pressure including bulging fontanelles and papilledema. Hypertriglyceridemia has also been reported but a causal association with NIZORAL^® Tablets is uncertain.

Neuropsychiatric disturbances, including suicidal tendencies and severe depression, have occurred rarely in patients using NIZORAL^® Tablets.

Ventricular dysrhythmias (prolonged QT intervals) have occurred with the concomitant use of terfenadine with ketoconazole tablets. (See BOX WARNING, CONTRAINDICATIONS, and WARNINGS sections.) Data suggest that coadministration of ketoconazole tablets and cisapride can result in prolongation of the QT interval and has rarely been associated with ventricular arrhythmias. (See CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS sections.)

REPORTS OF SUSPECTED NIZORAL SIDE EFFECTS / ADVERSE REACTIONS

Possible Nizoral side effects / adverse reactions 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

Suspect drug(s):
Nizoral
    Dosage: 26-jul, first box
    Administration route: Oral

Nizoral
    Dosage: 2 boxes in aug (year unspecified)
    Administration route: Oral
    Indication: Onychomycosis

Possible Nizoral side effects / adverse reactions in 59 year old male

Reported by a consumer/non-health professional from Korea, Republic of on 2011-11-21

Patient: 59 year old male

Reactions: Hypokinesia, Skin Exfoliation, Pyrexia, Rash

Suspect drug(s):
Nizoral

Possible Nizoral side effects / adverse reactions in 41 year old female

Reported by a consumer/non-health professional from United States on 2012-01-24

Patient: 41 year old female

Reactions: Cellulitis, Drug Ineffective

Suspect drug(s):
Armodafinil
    Indication: Product Used FOR Unknown Indication

Nizoral
    Indication: Product Used FOR Unknown Indication