Ketoconazole Pregnancy and Breastfeeding Warnings
Ketoconazole is also known as: Nizoral
Ketoconazole Pregnancy Warnings
Animal studies revealed evidence of embryotoxicity and teratogenicity. There are no controlled data in human pregnancy. FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
FDA pregnancy category: C Ketoconazole should be used during pregnancy only if the benefit outweighs the risk to the fetus.
Ketoconazole Breastfeeding Warnings
A nursing woman was treated with ketoconazole 200 mg orally once a day. Based on samples measured after the tenth dose, it was estimated that the infant received a maximum daily dosage that was 1.4% of the mother's weight-adjusted dosage. The mother continued to breastfeed the infant during therapy. No adverse effects were reported in the infant.
Breastfeeding is not recommended during use of ketoconazole. Excreted into human milk: Yes Excreted into animal milk: Data not available The effects in the nursing infant are unknown.
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