Last update Feb. 9, 2023


High Risk

Poorly safe. Evaluate carefully. Use safer alternative or interrupt breastfeeding 3 to 7 T ½ (elimination half-lives). Read the Comment.

Retinoid which is a synthetic derivative of vitamin A. It is a cis-configuration of Tretinoin, an acid form of vitamin A. Indicated in the treatment of severe forms of acne. Oral and/or topical dermatological administration.

At latest update no published data on excretion into breast milk were found.

Despite of a high plasma protein-binding capacity, it is a highly lipophilic substance, hence, it is presumed to accumulate in breastmilk. The natural form of vitamin A is readily excreted into breastmilk.

In addition to being a potent teratogen (Shirazi 2015), which affects pregnancy, it has been shown to decrease all pituitary hormones levels (Karadag 2011 and 2015) along with other potential serious side effects associated to the use of Isotretinoin.

It can produce galactorrhea and/or gynecomastia. (Atzenhoffer 2018, Larsen 1985)

A safer alternative should be preferred until more published data on this drug related to breastfeeding is available, especially during the neonatal period and in case of prematurity.

Topical administration would be compatible with lactation due to its low absorption through the skin. Do not apply on the chest.


Suggestions made at e-lactancia are done by APILAM team of health professionals, and are based on updated scientific publications. It is not intended to replace the relationship you have with your doctor but to compound it. The pharmaceutical industry contraindicates breastfeeding, mistakenly and without scientific reasons, in most of the drug data sheets.

Jose Maria Paricio, Founder & President of APILAM/e-Lactancia

Your contribution is essential for this service to continue to exist. We need the generosity of people like you who believe in the benefits of breastfeeding.

Thank you for helping to protect and promote breastfeeding.

José María Paricio, founder of e-lactancia.

Other names

Isotretinoin is also known as

Isotretinoin in other languages or writings:


Isotretinoin belongs to this group or family:


Main tradenames from several countries containing Isotretinoin in its composition:


Variable Value Unit
Oral Bioavail. 25 - 60 %
Molecular weight 300 daltons
Protein Binding 100 %
Tmax 3 - 4 hours
19 - 29 hours


  1. Atzenhoffer M, Pierre S, Bellet F, Pinel S, Javot L, Vial T, Kassai B, Auffret M.1 Gynecomastia and galactorrhea: Unlabeled adverse drug reactions of retinoids used in dermatology. Drug Safety. 2018;41:1198–9. Poster 1274. Abstract Full text (link to original source) Full text (in our servers)
  2. Karadag AS, Takci Z, Ertugrul DT, Bilgili SG, Balahoroglu R, Takir M. The effect of different doses of isotretinoin on pituitary hormones. Dermatology. 2015 Abstract
  3. Shirazi M, Abbariki E, Pirjani R, Akhavan S, Dastgerdy E. Congenital microtia in a neonate due to maternal isotretinoin exposure 1 month before pregnancy: Case Report. J Obstet Gynaecol Res. 2015 Abstract
  4. Butler DC, Heller MM, Murase JE. Safety of dermatologic medications in pregnancy and lactation: Part II. Lactation. J Am Acad Dermatol. 2014 Mar;70(3):417.e1-10; quiz 427. Abstract
  5. Bayerl C. [Acne therapy in pregnancy]. Hautarzt. 2013 Abstract
  6. Karadag AS, Ertugrul DT, Tutal E, Akin KO. Isotretinoin influences pituitary hormone levels in acne patients. Acta Derm Venereol. 2011 Abstract
  7. Larsen GK. Iatrogenic breast discharge with isotretinoin. Arch Dermatol. 1985 Abstract

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