Ketoconazole Pregnancy and Breastfeeding Warnings

Brand names: Nizoral

Medically reviewed by Drugs.com. Last updated on Feb 14, 2025.

Ketoconazole Pregnancy Warnings

This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus.
-According to some authorities: Use is contraindicated.
-According to some authorities: Use is contraindicated. Use is not recommended unless clearly needed and the benefit outweighs the risk.

AU TGA pregnancy category: B3
US FDA pregnancy category: Not Assigned

Risk summary: Inadequate data available on the use of this drug in pregnant women to inform a drug-related risk.

Animal studies revealed evidence of embryotoxicity and teratogenicity. There are no controlled data in human pregnancy.

AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Ketoconazole Breastfeeding Warnings

Breastfeeding is not recommended during use of ketoconazole.

Excreted into human milk: Yes

The effects in the nursing infant are unknown.

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.

See references

Further information

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