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.)
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REPORTS OF SIDE EFFECTS / ADVERSE REACTIONS RELATED TO NIZORAL
Below is a sample of reports where side effects / adverse reactions may be related to Nizoral. The information is not vetted and should not be cosidered as verified clinical evidence.
Possible Nizoral side effects / adverse reactions in 47 year old female
Reported by a health professional (non-physician/pharmacist) from Taiwan, Province of China on 2007-04-05
Patient: 47 year old female
Reactions: Jaundice, Fatigue
Adverse event resulted in: life threatening event
Suspect drug(s):
Nizoral
Possible Nizoral side effects / adverse reactions in 73 year old female
Reported by a health professional (non-physician/pharmacist) from Taiwan, Province of China on 2007-04-05
Patient: 73 year old female
Reactions: Jaundice
Suspect drug(s):
Nizoral
Other drugs received by patient: Cetirizine HCL
Possible Nizoral side effects / adverse reactions in 73 year old female
Reported by a health professional (non-physician/pharmacist) from Taiwan, Province of China on 2007-05-03
Patient: 73 year old female
Reactions: Jaundice
Suspect drug(s):
Nizoral
Other drugs received by patient: Cetirizine HCL
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