Last update Dec. 4, 2020


Low Risk

Moderately safe. Probably compatible. Mild risk possible. Follow up recommended. Read the Comment.

An antimicrobial indicated in the treatment of leprosy.
Daily oral administration over several months.

It is excreted in breastmilk in an amount that could be significant (Venkatesan 1997), but no adverse effects have been observed in infants whose mothers were taking it, with the exception of being able to cause a reddish discoloration of the skin of infants, reversible at the end of treatment. (Ozturk 2017, WHO 2002).

May turn milk bright pink (Waters 1969).

Known alternatives with faster elimination and less excretion in breastmilk should be considered, especially during the neonatal period and in cases of prematurity.


  • Dapsone (Moderately safe. Probably compatible. Mild risk possible. Follow up recommended. Read the Comment.)

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

Clofazimine is also known as

Clofazimine in other languages or writings:


Clofazimine belongs to this group or family:


Main tradenames from several countries containing Clofazimine in its composition:


Variable Value Unit
Oral Bioavail. 45 - 70 %
Molecular weight 473 daltons
pKa 8.51 -
Tmax 4 - 12 hours
1680 (600 - 2160) hours
M/P ratio 1.5 (1 - 1.7) -
Theoretical Dose 0.12 - 0.26 mg/Kg/d
Relative Dose 22 (14 - 30) %
Ped.Relat.Dose 20 %


  1. Ozturk Z, Tatliparmak A. Leprosy treatment during pregnancy and breastfeeding: A case report and brief review of literature. Dermatol Ther. 2017 Jan;30(1). Abstract
  2. WHO / UNICEF. BREASTFEEDING AND MATERNAL MEDICATION Recommendations for Drugs in the Eleventh WHO Model List of Essential Drugs. Department of Child and Adolescent Health and Development (WHO/UNICEF) 2002 Full text (link to original source) Full text (in our servers)
  3. Venkatesan K, Mathur A, Girdhar A, Girdhar BK. Excretion of clofazimine in human milk in leprosy patients. Lepr Rev. 1997 Sep;68(3):242-6. Abstract
  4. Waters MF. G 30 320 or B 663--lampren (Geigy). Lepr Rev. 1969 Jan;40(1):21-47. No abstract available. Abstract

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