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Adverse events infrequently reported in all studies included constipation, gastritis, depression, insomnia, tinnitus, menstrual disorder, adrenal insufficiency, gynecomastia, and male breast pain. Carcinogenesis, Mutagenesis, and Impairment of Fertility Itraconazole showed no evidence of carcinogenicity potential in mice treated orally for 23 months at dosage levels up to 80 mg kg day approximately 10x the maximum recommended human dose MRHD. Pharmacokinetic study using single 200-mg dose of kjope sporanox diett pille itraconazole four 50-mg capsules was conducted in three groups of patients with renal impairment uremia: hemodialysis: and continuous ambulatory peritoneal dialysis:. Cases of CHF, peripheral edema, and pulmonary edema have been reported in the post-marketing period among patients being treated for onychomycosis and or systemic fungal infections. The following adverse events led to temporary or permanent discontinuation of therapy.