Pregnancy: Ketoconazole crosses the placenta. Adequate and well-controlled studies in humans have not been done.
Studies in rats given doses of 80 mg/Kg per day (10 times the MRHD) have shown Ketoconazole to be teratogenic, causing syndactyly and oligodactyly.
Ketoconazole has also been shown to be embryotoxic in rats given doses greater than 80 mg/Kg during the first trimester.
Labor: Ketoconazole has also been shown to cause dystocia in rats given doses greater than 10 mg/Kg (greater than 1.25 times the MRHD) during the third trimester.
Breastfeeding: Ketoconazole is distributed into breast milk.