Adapalene / benzoyl peroxide topical Pregnancy and Breastfeeding Warnings
Medically reviewed by Drugs.com. Last updated on May 19, 2022.
Adapalene / benzoyl peroxide topical is also known as: Epiduo, Epiduo Forte
Adapalene / benzoyl peroxide topical Pregnancy Warnings
Animal studies have not been reported. 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.
This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus.
AU TGA pregnancy category: D
US FDA pregnancy category: C
Comment:
-Patients who become pregnant during treatment should consider discontinuation of this drug.
Adapalene / benzoyl peroxide topical Breastfeeding Warnings
Caution is recommended.
Excreted into human milk: Unknown
Excreted into animal milk: Yes (adapalene); Unknown (benzoyl peroxide)
Comment:
-This drug should be used in areas away from the chest to prevent accidental contact with the infant's skin.
Risk to the nursing infant is considered low, as only a negligible amount is absorbed after topical application.
See also
References for pregnancy information
- Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
- Cerner Multum, Inc. "Australian Product Information." O 0
- "Product Information. Epiduo (adapalene-benzoyl peroxide topical)." Galderma Laboratories Inc (2009):
References for breastfeeding information
- Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
- Cerner Multum, Inc. "Australian Product Information." O 0
- "Product Information. Epiduo (adapalene-benzoyl peroxide topical)." Galderma Laboratories Inc (2009):
- United States National Library of Medicine "Toxnet. Toxicology Data Network. http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT" (2013):
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.