Animal studies with high-dose oral ketoconazole have revealed evidence of teratogenicity and embryotoxicity; this reproductive toxicity was at doses not relevant to topical use of this drug. Syndactylia and oligodactylia occurred in rats given 80 mg/kg/day of oral ketoconazole (10 times the maximum recommended human oral dose) and embryotoxicity occurred at 160 mg/kg/day; such effects may be due to maternal toxicity, which was observed at these dose levels. There are no controlled data in human pregnancy; limited data indicate no adverse effects of this topical drug on pregnancy or on fetal/neonatal health. There are no known risks associated with use of this drug during pregnancy; no effects on the neonate expected.

This drug has not been detected in plasma after topical application to the skin or chronic shampooing on the scalp of nonpregnant patients; plasma drug levels were detected after the shampoo was applied topically to the entire body.

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 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.

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.

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus; caution is recommended.

AU TGA pregnancy category: B3
US FDA pregnancy category: C
-Foam: Not assigned.

Risk summary (foam): No data available on use of this drug in pregnant women to inform a drug-related risk.

See references

Use is generally considered acceptable; caution is recommended.
-Cream: According to some authorities, a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-Little to no risk to the breastfed infant expected with maternal use (as shampoo or topically on the skin); however, topical application on the breast or nipples should be avoided due to possible ingestion by the infant and availability of safer alternatives.
-Ointments should not be applied to the breast prior to breastfeeding; water miscible cream or gel products should be used if necessary.
miscible cream or gel products should be used if necessary.
-Developmental and health benefits of breastfeeding should be considered as well as the mother's clinical need for this drug.
-The effects in the nursing infant are unknown; potential side effects in the breastfed child due to this drug or the mother's underlying condition should be considered.

There are no known risks associated with use of this drug during lactation; no effects on the nursing infant expected.

It is unknown if there is sufficient systemic absorption with topical use of this drug to have detectable quantities in breast milk.

This drug has not been detected in plasma after topical application to the skin or chronic shampooing on the scalp; plasma drug levels were detected after the shampoo was applied topically to the entire body.

See references