Animal models have revealed evidence of teratogenicity and fetotoxicity. Some species have shown delayed ossification, supernumerary ribs, hydrocephaly, domed heads, increased fetal resorption, and/or increased intrauterine death at doses of at least 4 times the maximum human dose. There are no controlled data in human pregnancy.

There are approximately 30 human case reports with evidence of congenital malformations, including holoprosencephaly. The significance of these malformations to the fetus is unknown.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

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.

This drug should not be used during pregnancy unless clearly needed and the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: D
US FDA pregnancy category: C

Comment: Use of adequate methods of contraception should be encouraged.

See references

Some experts state that risk to the nursing infant is considered low as this drug is poorly absorbed after application.

Use is not recommended and 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: Unknown

Comments:
-The effects in the nursing infant are unknown.
-If this drug is used during breastfeeding, patients should ensure that infants do not come into contact with treated areas.
-Ointments should not be applied to the breast prior to breastfeeding; if necessary, water-miscible cream or gel products should be used.

See references