Ketoconazole (Nizoral) Adverse Reactions
- dizziness
- drowsiness
- elevated hepatic enzymes
- gynecomastia
- hepatitis
- impotence (erectile dysfunction)
- libido decrease
- nausea/vomiting
- photophobia
- pruritus
Ketoconazole (Nizoral) Adverse Reactions
About 10% of patients receiving ketoconazole experience nausea/vomiting. This usually is transient and may improve when ketoconazole is given with food, which also can increase oral bioavailability.
Elevated hepatic enzymes (AST, ALT) and alkaline phosphatase concentrations can occur during ketoconazole therapy, especially at higher doses. Rarely, hepatocellular, cholestatic, or mixed-pattern hepatotoxicity can occur during therapy. This effect usually is reversible following discontinuation, although recovery can take several months. Death has been reported from ketoconazole hepatotoxicity. Several cases of ketoconazole-related hepatitis have been reported in children. If symptoms of hepatitis occur, or if liver-function test abnormalities persist, ketoconazole should be discontinued.
Ketoconazole can inhibit testosterone secretion at doses of 200 - 400 mg/day and can inhibit cortisol synthesis in doses of 400 - 600 mg/day. Inhibition of testosterone synthesis has led to cases of gynecomastia, libido decrease, and impotence (erectile dysfunction) in men. Serum testosterone concentrations return to baseline and gynecomastia and impotence usually abate after ketoconazole therapy is stopped.
Pruritus can occur in patients taking systemic ketoconazole, and itching, stinging, or irritation can occur in patients receiving topical ketoconazole.
Dizziness or drowsiness occurs in some patients taking ketoconazole. Patients should be careful driving/operating machinery if they have these reactions.
Photophobia occurs in some patients taking ketoconazole. To minimize discomfort, the patient should wear sunglasses while outside and avoid bright light when possible.
[ Last revised: 12/2/2004 11:39:00 AM ]
References
. Sonino N. The use of ketoconazole as an inhibitor of steroid production. N Engl J Med 1987;317:812 - 8.
. Pont A, Williams PL, Loose DS et al. Ketoconazole blocks adrenal steroid synthesis. Ann Intern Med 1982;97:370 - 2.
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