Fludrocortisone Pregnancy Warnings
Animal studies have not been reported. Corticosteroids have been shown to be teratogenic in animals at low doses. It is unknown whether this drug can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. There are no controlled data in human pregnancy.
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.
Use is recommended only if clearly needed.
AU TGA pregnancy category: C
US FDA pregnancy category: C
Comments: Observe infants born to mothers who received substantial doses of this drug during pregnancy for signs of hypoadrenalism.
See references