Last update Jan. 31, 2018

Fexofenadine Hydrochloride

Very Low Risk

Safe. Compatible. Minimal risk for breastfeeding and infant.

Antihistamine drug of 2nd generation, piperidine derivative, which is an active metabolite of Terfenadine with minimal sedative effect.
Oral administration twice a day.

It is excreted into breast milk in clinically non-significant amount (Butler 2014, So 2010, Leachman 2006, Lucas 1995).

On a telephone interview, 10% of infants whose mothers were on terfenadine, recognized to have experienced colicky pain and hyperexcitability that disappeared without treatment (Ito 1993).

American Academy of Pediatrics: medication usually compatible with breastfeeding (AAP 2001).

See below the information of this related product:

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


Suggestions made at e-lactancia are done by APILAM team, 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.

Other names

Fexofenadine Hydrochloride in other languages or writings:


Fexofenadine Hydrochloride belongs to this group or family:


Main tradenames from several countries containing Fexofenadine Hydrochloride in its composition:


Variable Value Unit
Oral Bioavail. 100 %
Molecular weight 538 daltons
Protein Binding 60 - 70 %
pKa 4,04 -
Tmax 1 - 3 hours
T1/2 11 - 15 hours
M/P ratio 0,21 -
Theoretical Dose 0,006 mg/Kg/d
Relative Dose 0,3 - 0,7 %
Ped.Relat.Dose 0,2 %


  1. Chen YA, Hsu KY. Pharmacokinetics of fexofenadine in healthy Taiwanese volunteers. Pak J Pharm Sci. 2014 Abstract
  2. 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
  3. Fexofenadina. Ficha técnica. 2013 Full text (in our servers)
  4. MHRA. Fexofenadine. Drug Summary. 2011 Full text (in our servers)
  5. So M, Bozzo P, Inoue M, Einarson A. Safety of antihistamines during pregnancy and lactation. Can Fam Physician. 2010 May;56(5):427-9. Abstract Full text (link to original source) Full text (in our servers)
  6. Leachman SA, Reed BR. The use of dermatologic drugs in pregnancy and lactation. Dermatol Clin. 2006 Abstract
  7. del Cuvillo A, Mullol J, Bartra J, Dávila I, Jáuregui I, Montoro J, Sastre J, Valero AL. Comparative pharmacology of the H1 antihistamines. J Investig Allergol Clin Immunol. 2006;16 Suppl 1:3-12. Review. No abstract available. Abstract Full text (link to original source) Full text (in our servers)
  8. Solhaug V, Roland PD. Bruk av antihistaminer under graviditet og amming \ [Use of antihistaminics during pregnancy and breast feeding]. Tidsskr Nor Laegeforen. 2004 Abstract Full text (link to original source) Full text (in our servers)
  9. 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.
  10. AAP - American Academy of Pediatrics Committee on Drugs. Transfer of drugs and other chemicals into human milk. Pediatrics. 2001 Sep;108(3):776-89. Abstract Full text (link to original source) Full text (in our servers)
  11. Lucas BD Jr, Purdy CY, Scarim SK, Benjamin S, Abel SR, Hilleman DE. Terfenadine pharmacokinetics in breast milk in lactating women. Clin Pharmacol Ther. 1995 Abstract
  12. Ito S, Blajchman A, Stephenson M, Eliopoulos C, Koren G. Prospective follow-up of adverse reactions in breast-fed infants exposed to maternal medication. Am J Obstet Gynecol. 1993 May;168(5):1393-9. Abstract

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