This sheet talks about exposure to fexofenadine in pregnancy or breastfeeding. This information should not take the place of medical care and advice from your healthcare provider.

What is fexofenadine?

Fexofenadine is an over-the-counter antihistamine. Antihistamines are used to reduce the symptoms of allergic reactions and colds, including sneezing, runny nose, watery eyes and itchy throat. Fexofenadine has been sold under brand names such as Allegra® and Aller-Ease®.

The medicine terfenadine changes into fexofenadine in the body, so information on terfenadine may also be helpful for predicting the effects of fexofenadine on pregnancy and breastfeeding.

I take fexofenadine. Can it make it harder for me to get pregnant?

Studies on women have not been done to see if fexofenadine could make it harder for a woman to get pregnant. In animal studies, there was no evidence that suggested taking fexofenadine will make it harder to become pregnant.

I just found out I am pregnant. Should I stop taking fexofenadine?

Talk with your healthcare providers before making any changes to this medication. It is important to consider the benefits of treating allergy symptoms and other conditions during pregnancy. Treating allergy symptoms may reduce asthma symptoms and the need for additional asthma medications.

Does taking fexofenadine increase the chance for miscarriage?

Miscarriage can occur in any pregnancy. Studies have not been done to see if fexofenadine increases the chance for miscarriage.

Does taking fexofenadine increase the chance of birth defects?

In every pregnancy, a woman starts out with a 3-5% chance of having a baby with a birth defect. This is called her background risk. Studies on both fexofenadine and terfenadine have not found an increase chance of birth defects with the use of these medications during pregnancy.

Does taking fexofenadine in pregnancy cause other pregnancy complications or long-term problems in behavior or learning for the baby?  

There are no studies that have looked at whether fexofenadine causes other pregnancy complications or long-term problems for the baby. A study on terfenadine found no increase in premature delivery or low birth weight when used during pregnancy.

Can I breastfeed while taking fexofenadine?

Fexofenadine is less likely to cause sleepiness in adults than some other antihistamines. For this reason, fexofenadine may be preferred for breastfeeding over antihistamines that do cause sleepiness. Information from terfenadine suggests that the amount of fexofenadine in the breastmilk is small. Studies have shown that only a small amount (less than 1%) of the mother’s dose of fexofenadine reached the baby through the mother’s breast milk. This dose would be too low to cause problems for the baby.

It is possible that antihistamines may lower the amount of milk a woman makes. This might be more likely to happen if antihistamines are used in combination with an oral decongestant like pseudoephedrine or phenylephrine, or if used before beginning to breastfeed or with a newborn baby.

Talk to your healthcare provider about all of your breastfeeding questions.

If a man takes fexofenadine, could it affect his fertility (ability to get partner pregnant) or increase the chance of birth defects?

There is no evidence that suggests that fexofenadine would affect a man’s ability to conceive or increase risk to a pregnancy. In general, exposures that fathers have are unlikely to increase risks to a pregnancy. For more information, please see the MotherToBaby fact sheet Paternal Exposures at https://mothertobaby.org/fact-sheets/paternal-exposures-pregnancy/pdf/.

Selected References

  • Craig-McFeely PM, et al. 2001. Evaluation of the safety of fexofenadine from experience gained in general practice use in England in 1997. Eur J Clin Pharmacol 57(4):313-320.
  • Diav-Citrin O, et al. 2003. Pregnancy outcome after gestational exposure to loratadine or antihistamines: a prospective controlled cohort study. J Allergy Clin Immunol 111(6):1239-1243.
  • Gilboa SM, et al. 2009. National Birth Defects Prevention Study: Use of antihistamine medications during early pregnancy and isolated major malformations. Birth Defects Res A Clin Mol Teratol 85(2):137-150.
  • Ito S, et al. 1993. Prospective follow-up of adverse reactions in breast-fed infants exposed to maternal medication. Am J Obstet Gynecol. 168:1393-9.
  • Kallen B. 2002. Use of antihistamine drugs in early pregnancy and delivery outcome. J Matern Fetal Neonatal Med 11:146-152.
  • Loebstein R, et al. 2000. Pregnancy outcome after gestational exposure to terfenadine: A multicenter, prospective controlled study. Immunology and Allergy Clinics of North America 20(4):807-30.
  • Lucas BD Jr, et al: 1995. Terfenadine pharmacokinetics in breast milk in lactating women. Clin Pharmacol Ther. Apr; 57(4):398-402.
  • Schatz M, Petitti D. 1997. Antihistamines and pregnancy. Ann Allergy Asthma Immunol 78:157-159.