Drug Levels and Effects:

Summary of Use during Lactation:

Limited information indicates that maternal doses of acitretin of0.65 mg/kg daily produce low levels in milk. Because there is no published experience with acitretin during breastfeeding, opinions vary on the advisability of breastfeeding during acitretin therapy.[1][2] Varioustopicalagents that are less likely to be absorbed by the mother may be preferred during breastfeeding, especially while nursing a newborn or preterm infant. Only water-misciblecreamor gel products should be applied to the breast because ointments may expose the infant to high levels of mineral paraffins via licking.[3]

Drug Levels:

Maternal Levels.

A woman who was 8 months postpartum discontinued breastfeeding and began acitretin 40 mg (</span>0.65 mg/kg) once daily by mouth after breakfast. Milk was collected before starting the drug and then twice daily for 9 days. Acitretin and its 13-cis-metabolite were detected in milk 12 hours after the first dose and levels gradually increased over 4 to 5 days to steady-state levels between 30 and 40 mcg/L that did not fluctuate markedly during the day. Acitretin was the main component found in milk 10 to 12 hours after a dose while the metabolite was the primary component in milk 22 to 24 hours after the previous dose.[1] Assuming an average milk level of 35 mcg/L, an exclusively breastfed infant would receive an estimated0.8% of the maternal weight-adjusted dosage as acitretin and its metabolite.

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.

Possible Effects on Lactation:

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


1. Rollman O, Pihl-Lundin I. Acitretin excretion into human breast milk. Acta Derm Venereol. 1990;70:487-90. PMID:1981420
2. American Academy of Pediatrics Committee on Drugs. The transfer of drugs and other chemicals into human milk. Pediatrics. 2001;108:776-89. PMID:11533352
3. Noti A, Grob K, Biedermann M et al. Exposure of babies to C(15)-C(45) mineral paraffins from human milk and breast salves. Regul Toxicol Pharmacol. 2003;38:317-25. PMID:14623482

Substance Identification:

Substance Name:


CAS Registry Number:


Drug Class:

  • Keratolytic Agents

  • Retinoids

  • Administrative Information:

    LactMed Record Number:


    Last Revision Date:

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