Adapalene topical Pregnancy and Breastfeeding Warnings

Brand names: Differin, Plixda

Medically reviewed by Drugs.com. Last updated on Jul 24, 2023.

Adapalene topical Pregnancy Warnings

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

AU TGA pregnancy category: D
US FDA pregnancy category: C

Comment:
-Some experts recommend treatment discontinuation during pregnancy, while other experts recommend avoiding use during the first trimester.

Animal data have revealed evidence of fetal skeletal malformations, including supernumerary ribs, at high topical doses. Teratogenic effects were observed in animal models given large oral doses. 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.

See references

Adapalene topical Breastfeeding Warnings

Caution is recommended; use considered a low risk to the nursing infant.

Excreted into human milk: Unknown
Excreted into animal milk: Unknown

Comments:
-This drug should be used in areas away from the chest to prevent accidental contact with the infant's skin.
-Ointments should not be applied to the breast prior to breastfeeding; if necessary, water-miscible cream or gel products may be used, but the products should not be applied to the nipple area.

Risk to the nursing infant is considered low, as only a negligible amount is absorbed after topical application.

See references

Further information

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

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