Last update March 3, 2022

Montelukast Sodium

Very Low Risk

Safe. Compatible. Minimal risk for breastfeeding and infant.

Montelukast is a selective leukotriene receptor antagonist with actions and uses similar to those of zafirlukast. Used in the management of asthma and allergic rhinitis. Oral administration once daily.

Pharmacokinetic data (moderately high molecular weight, very high protein-binding capacity and low pKa) explain an observed very low excretion into breastmilk. (Datta 2016)

A drug of the same group and similar effect, Zafirlukast, is also excreted into breastmilk in non-significant amounts.

It is a licensed medication to be used in infants from 6 months of age on. Indeed, it has been used as early as 3 months of age with the same tolerance observed in older children.(Kearns 2008, Knorr 2006,  Migoya 2004)

Several medical societies, experts and expert consensus, consider the use of this medication to be safe or very probably safe during breastfeeding. (Chambers 2021, Middleton 2020, Briggs 2015, Nice 2004)

See below the information of this related product:

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


  • Budesonide ( Safe. Compatible. Minimal risk for breastfeeding and infant.)
  • Sodium Cromoglicate ( Safe. Compatible. Minimal risk for breastfeeding and infant.)

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

Montelukast Sodium in other languages or writings:


Montelukast Sodium belongs to this group or family:


Main tradenames from several countries containing Montelukast Sodium in its composition:


Variable Value Unit
Oral Bioavail. 64 - 73 %
Molecular weight 608 daltons
Protein Binding 99 %
VD 0.1 - 0.15 l/Kg
pKa 4.4 -
Tmax 2 - 4 hours
2.7 - 5.5 hours
Theoretical Dose 0.0008 - 0.0015 mg/Kg/d
Relative Dose 0.5 - 0.9 %
Ped.Relat.Dose 0.2 - 0.3 %


  1. Chambers CD, Krishnan JA, Alba L, Albano JD, Bryant AS, Carver M, Cohen LS, Gorodetsky E, Hernandez-Diaz S, Honein MA, Jones BL, Murray RK, Namazy JA, Sahin L, Spong CY, Vasisht KP, Watt K, Wurst KE, Yao L, Schatz M. The safety of asthma medications during pregnancy and lactation: Clinical management and research priorities. J Allergy Clin Immunol. 2021 Jun;147(6):2009-2020. Abstract Full text (link to original source)
  2. Merck. Montelukast. Drug Summary. 2020 Full text (in our servers)
  3. Middleton PG, Gade EJ, Aguilera C, MacKillop L, Button BM, Coleman C, Johnson B, Albrechtsen C, Edenborough F, Rigau D, Gibson PG, Backer V. ERS/TSANZ Task Force Statement on the management of reproduction and pregnancy in women with airways diseases. Eur Respir J. 2020 Feb 6;55(2). pii: 1901208. Abstract Full text (link to original source) Full text (in our servers)
  4. AEMPS. Montelukast. Ficha técnica. 2020 Full text (in our servers)
  5. Datta P, Rewers-Felkins K, Baker T, Hale TW. Transfer of Montelukast into Human Milk During Lactation. Breastfeed Med. 2016 Abstract
  6. Briggs GG, Freeman RK, Towers CV, Forinash AB. Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk. Wolters Kluwer Health. Tenth edition (acces on line) 2015
  7. Kearns GL, Lu S, Maganti L, Li XS, Migoya E, Ahmed T, Knorr B, Reiss TF. Pharmacokinetics and safety of montelukast oral granules in children 1 to 3 months of age with bronchiolitis. J Clin Pharmacol. 2008 Abstract
  8. Knorr B, Maganti L, Ramakrishnan R, Tozzi CA, Migoya E, Kearns G. Pharmacokinetics and safety of montelukast in children aged 3 to 6 months. J Clin Pharmacol. 2006 Abstract
  9. Migoya E, Kearns GL, Hartford A, Zhao J, van Adelsberg J, Tozzi CA, Knorr B, Deutsch P. Pharmacokinetics of montelukast in asthmatic patients 6 to 24 months old. J Clin Pharmacol. 2004 Abstract
  10. Nice FJ, De Eugenio D, Dimino TA, Freeny IC, Rovnack MB, Gromelski JS. Medications and Breast-Feeding: A Guide for Pharmacists, Pharmacy Technicians, and Other Healthcare Professionals. Part I. J Pharm Technol 2004;20:17-27. doi: 10.1177/875512250402000106.

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