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Fludrocortisone Pregnancy and Breastfeeding Warnings

Brand names: Florinef, Florinef Acetate

Medically reviewed by Last updated on Aug 10, 2023.

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

Fludrocortisone Breastfeeding Warnings

Caution is recommended.

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

Comments: Corticosteroids have been found in breast milk of lactating women receiving systemic therapy.

See references

References for pregnancy information

  1. TGA. Therapeutic Goods Administration. Australian Drug Evaluation Committee. Prescribing medicines in pregnancy: an Australian categorisation of risk of drug use in pregancy. 2007.
  2. Product Information. Fludrocortisone Acetate (fludrocortisone). Global Pharmaceutical Corporation. 2018.

References for breastfeeding information

  1. Product Information. Fludrocortisone Acetate (fludrocortisone). Global Pharmaceutical Corporation. 2018.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.