Hepatic reactions during ketoconazole treatment.

Silent and symptomatic hepatic reactions have occurred during ketoconazole treatment. The silent reactions (transient asymptomatic elevations of serum transaminase or alkaline phosphatase levels) may occur at any time during ketoconazole treatment. Asymptomatic increases in liver enzymes may also occur in a sizeable number of patients with fungal disease without any treatment. Symptomatic hepatic reactions have occurred mainly during the first few months of treatment. The estimated incidence of symptomatic reactions is of the order of 1 in 10,000.