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Drugs and Lactation Database (LactMed®) [Internet]. Bethesda (MD): National Institute of Child Health and Human Development; 2006-.

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Drugs and Lactation Database (LactMed®) [Internet].

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Last Revision: December 3, 2018.

Estimated reading time: 1 minute

CASRN: 4759-48-2

Chemical structure

Drug Levels and Effects

Summary of Use during Lactation

No information is available on the use of isotretinoin during breastfeeding. Various topical agents that are less likely to be absorbed by the mother may be preferred during breastfeeding, especially while nursing a newborn or preterm infant.

Drug Levels

Maternal Levels. Relevant published information was not found as of the revision date.

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

Relevant published information was not found as of the revision date.

Effects on Lactation and Breastmilk

A woman who had weaned her infant 18 months previously developed a nipple discharge from her right breast after 5.5 months of therapy with isotretinoin. Microbiological, hormonal (including prolactin), radiologic, and physical examinations were otherwise normal. One month after discontinuing isotretinoin, the discharge ceased. After isotretinoin was reinstituted at the same dose, the discharge reappeared within 10 days.[1] The galactorrhea was probably caused by isotretinoin.

A review of adverse reaction reports on retinoids causing a breast reaction submitted to a French pharmacovigilance center found 22 cases of gynecomastia was associated with isotretinoin use. Fourteen of the cases were gynecomastia, 6 were galactorrhea and 2 were of both gynecomastia and galactorrhea. Gynecomastia and/or galactorrhea was unilateral for almost half of the reported retinoid cases. The median time of onset was 90 days (IQR 39 to 347 days). The outcome was known for 27 of 31 patients and a total recovery after withdrawal of retinoid was observed for 63% of them.[2]

Alternate Drugs to Consider

(Acne) Azelaic Acid, Benzoyl Peroxide, Clindamycin, Erythromycin, Tretinoin


Larsen GK. Iatrogenic breast discharge with isotretinoin. Arch Dermatol. 1985;121:450-1. [PubMed: 3856419]
Atzenhoffer M, Pierre S, Bellet F et al. Gynecomastia and galactorrhea: Unlabeled adverse drug reactions of retinoids used in dermatology. Drug Safety. 2018;41:1198-9. Abstract. DOI: 10.1007/s40264-018-0719-2. [CrossRef]

Substance Identification

Substance Name


CAS Registry Number


Drug Class

  • Breast Feeding
  • Dermatologic Agents
  • Keratolytic Agents
  • Retinoids

Disclaimer: Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.

Copyright Notice

Attribution Statement: LactMed is a registered trademark of the U.S. Department of Health and Human Services.

Bookshelf ID: NBK501634PMID: 30000695


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