Question

I am a breastfeeding mother and i want to know if it is safe to use Tacrolimus (topical use)? Is Tacrolimus (topical use) safe for nursing mother and child? Does Tacrolimus (topical use) extracts into breast milk? Does Tacrolimus (topical use) has any long term or short term side effects on infants? Can Tacrolimus (topical use) influence milk supply or can Tacrolimus (topical use) decrease milk supply in lactating mothers?

Tacrolimus (topical use) lactation summary

Tacrolimus (topical use) is safe in breastfeeding
  • DrLact safety Score for Tacrolimus (topical use) is 1 out of 8 which is considered Safe as per our analyses.
  • A safety Score of 1 indicates that usage of Tacrolimus (topical use) is mostly safe during lactation for breastfed baby.
  • Our study of different scientific research also indicates that Tacrolimus (topical use) does not cause any serious side effects in breastfeeding mothers.
  • Most of scientific studies and research papers declaring usage of Tacrolimus (topical use) safe in breastfeeding are based on normal dosage and may not hold true for higher dosage.
  • Score calculated using the DrLact safety Version 1.2 model, this score ranges from 0 to 8 and measures overall safety of drug in lactation. Scores are primarily calculated using publicly available case studies, research papers, other scientific journals and publically available data.

Answer by Dr. Ru: About Tacrolimus (topical use) usage in lactation

Macrolide immunosuppressant drug that inhibits calcineurin which is used to prevent rejection of transplanted organs (kidney, liver, heart ...) and for treatment of atopic eczema, psoriasis and other autoimmune illnesses (e.g. Arthritis, Lupus, Inflammatory Bowel Disease ...) .Routes of administration: oral for systemic purposes and topical for dermatologic conditions. Systemic administration is approved by various scientific societies and expert panels, (Constantinescu 2014, Götestam-Skorpen 2016, Flint 2016) due to its negligible excretion into breastmilk, the absence of side effects in infants from treated mothers and a low or absent plasma levels in these infants (for details, see info on Tacrolimus). Absorption and bioavailability through skin is even lower than that found by mouth, 30 times lower even after application on 50% of body surface (Draelos 2005 Undre 2009, Gutfreund 2013, EMA2016), therefore milk levels would be expected further lower than after oral ingestion. Do not apply on the breast to prevent ingestion by the infant, otherwise, do it just after a meal and clean the nipple thoroughly with water before the next feed.Local application on the nipple of creams, gels and other products containing paraffin (mineral oil) should better be avoid to keep the infant off from absorption (Noti 2003, Concin 2008).

Alternate Drugs for Other Dermatological preparations. ATC D11

Pimecrolimus(Low Risk)
Aluminium Acetate(Safe)
Intralesional Bleomycin(Unsafe)
Diphencyprone(Safe)
Dihydroxyacetone(Low Risk)
Ellagic Acid(Safe)
Kojic Acid(Low Risk)
Minoxidil Topical Use(Safe)
Finasteride(Low Risk)
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. We do not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.