There are no controlled data in human pregnancy; however, there is a single case report of a stillborn infant following multiple maternal exposures to this drug during pregnancy. The relationship of the maternal exposures to the fetal outcome is unknown. Animal data suggest this drug may increase the likelihood of neurologic developmental abnormalities, based on findings at systemic exposures close to that expected 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.

This drug should be used during pregnancy only if clearly needed.

US FDA pregnancy category: C

Comments: This drug is lipophilic and may accumulate in the placenta.

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Animal data has revealed reduced pup survival, increased number of stillborn pups, increased pup mortality, decreased pup weight, increased motor activity, and decreased motor activity habituation when this drug was present in the diet from day 6 of gestation through day 10 of lactation.

Use of another agent is preferred during breastfeeding.

Excreted into human milk: Yes

Comments:
-Topical application of this drug can increase drug levels in breastmilk for at least several days.
-An environmental contaminant, this drug is potentially toxic in infants and has possible estrogenic effects that could decrease lactation as well as affect the nursing infant.
-Advise breastfeeding patients to avoid large areas of skin-to-skin contact with their infants while the lotion formulation of this drug is applied, and to interrupt breastfeeding (including expression and discarding of milk) for at least 24 hours following use of this drug.

See references