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Adapalene / benzoyl peroxide topical Pregnancy and Breastfeeding Warnings

Adapalene / benzoyl peroxide topical is also known as: Epiduo, Epiduo Forte

Medically reviewed on Sep 11, 2018

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.

See references

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 references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Epiduo (adapalene-benzoyl peroxide topical)." Galderma Laboratories Inc, Cranbury, NJ.

References for breastfeeding information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. "Product Information. Epiduo (adapalene-benzoyl peroxide topical)." Galderma Laboratories Inc, Cranbury, NJ.
  4. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):

Further information

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

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