Last update: April 2, 2015


High Risk for breastfeeding

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

At latest update, relevant published data on excretion into breast milk were not found.

Because of a high protein-binding capacity, a significant excretion into breast milk is unlikely.

However, it is one among the Sartan drugs (ARA-II type) with the longest half-life and highest oral bioavailability. The latter properties make it less convenient for use while breastfeeding.

Reportedly, a newborn infant appeared with transient renal failure (kidney malfunction) whose mother had taken this medication during pregnancy.

Until more data on this medication is available safer alternative drugs are preferred especially in premature babies or during the neonatal period.

Should an ARA-II medication (Sartan type) be necessary, the associated risk may be decreased by choosing the one with a favorable pharmacokinetics (shorter half-life elimination time and lower bioavailability) like Eprosartan and Losartan.


Suggestions made at e-lactancia are done by APILAM´s pediatricians and pharmacists, and are based on updated scientific publications.
It is not intended to replace the relationship you have with your doctor but to compound it.

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.


Main tradenames from several countries containing Irbesartan in its composition:


Variable Value Unit
Oral Bioavail. 60 - 80 %
Molecular weight 429 daltons
Protein Binding 96 %
VD 0,7 - 1,3 l/Kg
Tmax 1,5 - 2 hours
T1/2 12 - 17 hours


  1. Rowe H, Baker T, Hale TW. Maternal medication, drug use, and breastfeeding. Pediatr Clin North Am. 2013 Feb;60(1):275-94. Abstract
  2. Sano.Ave. Irbesartan. Drug Summary. 2012 Full text (in our servers)
  3. AEMPS. Irbesartán. Ficha técnica. 2008 Full text (in our servers)
  4. Tamargo j, Caballero R, Gómez R, Núñez L, Vaquero M y Delpón E. Características farmacológicas de los ARA-II. ¿Son todos iguales?. Rev Esp Cardiol Supl. 2006;6:10C-24C. 2006 Full text (in our servers)
  5. Pietrement C, Malot L, Santerne B, Roussel B, Motte J, Morville P. Neonatal acute renal failure secondary to maternal exposure to telmisartan, angiotensin II receptor antagonist. J Perinatol. 2003 Abstract Full text (link to original source) Full text (in our servers)

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