Last update Sept. 5, 2022

Fexofenadine Hydrochloride


Safe substance and/or breastfeeding is the best option.

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. (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)

Experts authors consider the use of this medication to be safe or very probably safe during breastfeeding (Hale, Briggs 2015, Butler 2014, So 2010, Leachman 2006). American Academy of Pediatrics: medication usually compatible with breastfeeding. (AAP 2001)


Until more published data is known about this drug in relation to breastfeeding, known safer alternatives are preferable, especially during the neonatal period and in the event of prematurity.

See below the information of this related product:

  • Terfenadine (Fairly safe. Mild or unlikely adverse effects. Compatible under certain circumstances. Follow-up recommended. Read Commentary.)


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

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
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. Hale TW. Medications & Mothers' Milk. 1991- . Springer Publishing Company. Available from Consulted on April 10, 2024 Full text (link to original source)
  2. 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
  3. 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
  4. Chen YA, Hsu KY. Pharmacokinetics of fexofenadine in healthy Taiwanese volunteers. Pak J Pharm Sci. 2014 Abstract
  5. Fexofenadina. Ficha técnica. 2013 Full text (in our servers)
  6. MHRA. Fexofenadine. Drug Summary. 2011 Full text (in our servers)
  7. 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)
  8. 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)
  9. Leachman SA, Reed BR. The use of dermatologic drugs in pregnancy and lactation. Dermatol Clin. 2006 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.
  11. 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)
  12. 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)
  13. 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
  14. 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

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