This drug readily crosses the placenta. Teratogenicity including increased incidence of cleft palate have occurred in animal studies, however, the relevance to humans has been questioned. This drug has been used without reports of adverse outcomes in women with adrenal insufficiency. Untreated adrenal insufficiency during pregnancy has been associated with poor outcomes in both mothers and infants. There is the possibility of adrenal cortex suppression in newborns with maternal long term use at higher doses; however, the short term use of corticosteroids antepartum for the prevention of respiratory distress syndrome does not seem to pose a risk. Maternal pulmonary edema has been reported with inhibition of uterine contractions and fluid overload. There are no adequate and well controlled studies in pregnant women.

Corticosteroids have been shown to impair fertility in male rats.

AU TGA pregnancy category A: Drugs which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed.

AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. 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.

Benefit should outweigh risk

AU TGA pregnancy category: A (oral, rectal foam); C (parenteral)
US FDA pregnancy category: C

Comments:
-Women receiving this drug for adrenal insufficiency should be carefully monitored; dosing during pregnancy should be individualized to clinical response.
-Infants exposed to higher doses in utero should be observed for signs and symptoms of hypoadrenalism.
-The short-term use of corticosteroids antepartum for the prevention of respiratory distress syndrome does not seem to pose a risk to the fetus or newborn infant.

See references

Benefit should outweigh risk

Excreted into human milk: Unknown

Comments: Single doses, local use, and maternal doses up to 160 mg per day are generally compatible with breastfeeding as it is unlikely to cause systemic effects in the infant; higher doses may cause a degree of adrenal suppression.

Endogenous hydrocortisone (cortisol) is present in the breast milk. Corticosteroids (i.e. prednisone) have been detected in breast milk in low amounts, however, specific information on this drug in breast milk is not known. Theoretically, the presence of exogenous corticosteroids in breast milk could suppress growth, interfere with endogenous corticosteroid production, or cause other unwanted effects in breast fed babies. The use of this drug for replacement therapy is unlikely to have any clinically significant impact, however, it is presumed that breastfed infants of mothers taking high doses of systemic corticosteroids for prolonged periods of time may be at risk of adrenal suppression.

See references