Animal studies have not been reported and there is limited amount of data in the use of this drug in human pregnancy. Australian labeling reports cases of miscarriage or fetal malformation occurring in pregnant women treated with this drug; specifics were not provided. The mechanism of action of this drug can be considered when evaluating risk and benefits. There are no controlled data in human pregnancy.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. 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: D
US FDA pregnancy category: C

Comments:
-Consider mechanism of action; this drug stimulates the release of endogenous corticosteroids.

See references

Benefit should outweigh risk

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

Comments:
-If possible, mothers may want to avoid breastfeeding during period of use as there are no reports describing use during lactation.

See references