Animal studies of topical administration of 0.05% desonide cream during organogenesis led to characteristic corticosteroid malformations as well as maternal weight loss; no malformations were seen at a topical dose of 0.2 g cream/kg/day in rats (0.6 g cream/kg/day in rabbits). A relevant comparison of systemic exposure of animals versus humans is not available. There are no adequate and well-controlled studies in pregnant women on the teratogenic effects from topically applied corticosteroids. The background birth defect and miscarriage risk for the indicated population is not known. In the US general population, the estimated major birth defect risk is 2 to 4% and the miscarriage risk is 15 to 20%.

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.

Safety has not been established during pregnancy.

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

Comments:
-There is no data on use in pregnant women to know this drugs risks, including the risk of fetal harm or reproductive effects.
-Animal reproduction studies showed characteristic corticosteroid malformations.

See references

Safety has not been established.

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

Comments:
-There is no information regarding this drug on the presence in human milk, the effects on a breastfed infant, or effects on milk production.
-It is unknown if topical administration can produce detectable levels in human milk.
-Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for this medication as well as any potential adverse effects from this drug or the underlying maternal condition.
-To minimize infant exposure, use this drug on the smallest area of skin for the shortest possible duration.
-Advise washing nipples and areola prior to breastfeeding if drug was applied in those areas to avoid infant exposure.

See references