This drug readily crosses the placenta. Teratogenicity including increased incidence of cleft palate have occurred in animal studies, however, the relevance to human has been questioned. Reduced placental and birth weight have been recorded in animals and humans after long term treatment. There is the possibility of adrenal cortex suppression in the newborn with long term use in the mother; however, 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 the newborn infant. 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.

Increases and decreases in sperm motility and number of sperm have been observed in some patients.

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); C (parenteral)
US FDA pregnancy category: C

Comments:
-Observe for signs and symptoms of hypoadrenalism in infants exposed in utero.
-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

Corticosteroids appear in breast milk in low amounts; specific information on this drug is unknown. Theoretically, its presence in breast milk could suppress growth, interfere with endogenous corticosteroid production, or cause other unwanted effects in breast fed babies. It is presumed that breastfed infants of mothers taking high doses of systemic corticosteroids for prolonged periods of time may have some degree of adrenal suppression.

Benefit should outweigh risk

Excreted into human milk: Unknown

Comments: Mothers receiving pharmacologic doses should generally avoid breastfeeding; single doses and local use are generally compatible with breastfeeding.

See references