Last update July 31, 2018


Very Low Risk

Safe. Compatible. Minimal risk for breastfeeding and infant.

An immunomodulator and calcineurin inhibitor related to tacrolimus. Used in the treatment of atopic dermatitis.
Used topically as a cream and orally in research studies.

Since the last update we have not found published data on its excretion in breastmilk.

Its pharmacokinetic data (moderately high molecular weight, high percentage of protein binding and very little systemic absorption with topical use (less than 2 micrograms/L in plasma) (AEMPS 2013, FDA 2001) make it unlikely that will be transferred to milk in significant quantities (AEMPS 2013).

Do not apply on the breast in order to prevent the infant from swallowing it (AEMPS 2013, Barret 2013, Butler 2014); if necessary, apply after a feed and clean well with water before the next feed.

It is advisable to avoid the application of creams, gels and other local application products containing paraffin (mineral oil) on the nipple so that the infant does not absorb them (Noti 2003, Concin 2008).


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

Pimecrolimus in other languages or writings:


Pimecrolimus belongs to this group or family:


Main tradenames from several countries containing Pimecrolimus in its composition:


Variable Value Unit
Oral Bioavail. Dermat: baja - poor %
Molecular weight 811 daltons
Protein Binding 74 - 99.6 %
Tmax 2 hours
100 hours


  1. 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
  2. Barrett ME, Heller MM, Fullerton Stone H, Murase JE. Dermatoses of the breast in lactation. Dermatol Ther. 2013 Abstract
  3. AEMPS. Pimecrolimus. Ficha técnica. 2013 Full text (in our servers)
  4. Concin N, Hofstetter G, Plattner B, Tomovski C, Fiselier K, Gerritzen K, Fessler S, Windbichler G, Zeimet A, Ulmer H, Siegl H, Rieger K, Concin H, Grob K. Mineral oil paraffins in human body fat and milk. Food Chem Toxicol. 2008 Abstract
  5. Noti A, Grob K, Biedermann M, Deiss U, Brüschweiler BJ. Exposure of babies to C15-C45 mineral paraffins from human milk and breast salves. Regul Toxicol Pharmacol. 2003 Abstract
  6. Scott G, Osborne SA, Greig G, Hartmann S, Ebelin ME, Burtin P, Rappersberger K, Komar M, Wolff K. Pharmacokinetics of pimecrolimus, a novel nonsteroid anti-inflammatory drug, after single and multiple oral administration. Clin Pharmacokinet. 2003 Abstract
  7. FDA. Pimecrolimus. Drug Summary. 2001 Full text (in our servers)

Total visits


Help us improve this entry

How to cite this entry

Do you need more information or did not found what you were looking for?

   Write us at

e-lactancia is a resource recommended by El Parto Es Nuestro of Spain

Would you like to recommend the use of e-lactancia? Write to us at corporate mail of APILAM