Fluconazole and Risk for Birth Defects

Fluconazole (Diflucan) is used to treat fungal infections (including some that are life-threatening) and vaginal candidiasis. Chronic high-dose fluconazole (400–800 mg daily) during the first trimester of pregnancy has been associated with an uncommon set of skeletal abnormalities and congenital heart defects in offspring. Accordingly, the FDA has changed fluconazole's pregnancy risk category from C to D (positive evidence of human fetal risk) for indications other than vaginal candidiasis. This warning does not affect the 150-mg single dose for vaginal candidiasis, which remains category C (available data in humans do not suggest excess risk for congenital anomalies).