Carcinogenicity/Tumorigenicity: Long-term feeding studies in Swiss albino mice and in Wistar rats have not shown evidence of oncogenesis.
Mutagenicity: Dominant lethal mutation tests have not shown mutation in any stage of germ cell development in male and female mice given single, oral doses of Ketoconazole as high as 80 mg/Kg. In addition, the Ames/salmonella microsomal activator tests have not shown evidence of mutagenicity.
Fertility: Ketoconazole has been shown to decrease or abolish serum testosterone concentrations when used in high doses (e.g., 800 mg to 1.6 g daily). Ketoconazole has also been shown to cause menstrual irregularities, oligospermia, azoospermia, impotence, and decreased male libido.
Use in Children: Several cases of hepatitis have been reported in children who have taken Ketoconazole. Appropriate studies on the relationship of age to the effects of Ketoconazole have not been performed in children up to 2 years of age. However, no pediatrics-specific problems have been documented to date in children over 2 years of age.
Use in Elderly: No information is available on the relationship of age to the effects of azole antifungals in geriatric patients.