This drug should only be used during pregnancy if the benefit outweighs the potential risk to the fetus

AU TGA pregnancy category: A
AU TGA pregnancy category: C (acetate suspension)
US FDA pregnancy category: C

Comments:
-Observe for signs and symptoms of hypoadrenalism in infants exposed to this drug in utero.
-Women who become pregnant while using this drug should be apprised of the potential fetal risks.
-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.

Teratogenicity including increased incidence of cleft palate have occurred in animal studies. A number of cohort and case controlled studies in humans suggest maternal corticosteroid use in the first trimester produces a slight increased risk of cleft lip with or without cleft palate (increased from 1 out of 1000 to 3 to 5 out of 1000 infants). 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. Cataracts have been observed rarely in infants born to mothers receiving long-term corticosteroid therapy during pregnancy. 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.

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.

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Benefit should outweigh risk

Excreted into human milk: Yes

This drug is present in breastmilk in very low amounts. Fully breastfed infants of mothers receiving 1 g IV over 3 days to treat multiple sclerosis have received doses nearing their daily cortisol output, but less than a therapeutic dose. If possible, breastfeeding should be avoided for 2 to 8 hours after a 1 g IV infusion. Local injections for tendinitis are not expected to cause adverse effects in infants, but may cause a temporary loss of milk supply in the mothers. Maternal oral doses up to 40 mg/day are not likely to cause systemic effects in infants, however, doses higher than that may cause a degree of adrenal suppression.

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