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. This sheet talks about whether exposure to loratadine may increase the risk for birth defects over that background risk. This information should not take the place of medical care and advice from your health care provider.

What is loratadine?

Loratadine (Claritin®) is an over-the-counter medication part of a group called antihistamines (medication used to lessen the effects of histamine production in allergic reactions and colds). Loratadine is used to relieve symptoms of allergies, including sneezing, runny nose, watery eyes, an itchy throat, and an itchy rash or hives.

In the body, loratadine breaks down into another compound called desloratadine (Clarinex®). The similarities between these compounds suggest that the information with loratadine would be helpful in predicting the effects of desloratadine on a pregnancy.

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

You should always speak with your health care provider before making any changes in your medication. It is important to consider the benefits of treating allergy symptoms during pregnancy. Treating allergy symptoms may reduce asthma symptoms and the need for extra asthma medicines. Allergy treatment can also lead to better sleep and emotional well-being.

Can taking loratadine during pregnancy cause birth defects?

It is unlikely that loratadine would cause an increased chance for birth defects. One study with several limitations suggested a small risk for hypospadias (a condition where the opening of the penis is on the underside of the penis instead of at the tip). After collecting more data, this study author published another paper that admitted the increased risk originally seen may have been due to study limitation. In addition, additional studies of pregnant women taking loratadine have not supported an increased risk of any type of birth defect, including hypospadias. Also, studies involving infants with hypospadias did not find that their mothers used loratadine more frequently during pregnancy.

Can taking loratadine cause other pregnancy problems?

Loratadine is not expected to cause other pregnancy problems. A study of 161 women taking loratadine during the first trimester did not show any differences in the rates of miscarriage, delivery age, or birthweight compared to women who did not take loratadine.

Can I take loratadine while I am breastfeeding?

The American Academy of Pediatrics lists loratadine as a medication that is usually compatible with breastfeeding. Studies estimate that a breastfeeding baby whose mother is taking loratadine would get less than 1% of the mother’s dose. This dose of loratadine is thought to be too low to cause problems for the baby. While it is possible that antihistamines could reduce the amount of milk a woman makes, there have been no studies showing that this has actually happened.

Compared to some other antihistamines, loratadine has less chance of causing drowsiness for the mother or the baby. This, along with the low levels in milk, makes loratadine one of the preferred antihistamines for use during breastfeeding. Be sure to talk to your health care provider about all your choices for breastfeeding.

What if the father of the baby takes loratadine?

There are currently no data to suggest that use of loratadine by the father would negatively affect the sperm or increase the risk for birth defects. In general, exposures that fathers have are unlikely to increase risks to a pregnancy. For more information, see the MotherToBaby fact sheet Paternal Exposures and Pregnancy: http://mothertobaby.org/fact-sheets/paternal-exposures-pregnancy/pdf/.

Selected References:

  • Diav-Citrin 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.
  • Gilboa SM, et al. 2014. Antihistamines and birth defects: a systematic review of the literature. Expert Opin Drug Saf 13(12): 1667-98.
  • Hilbert J, et al. 1988. Excretion of loratadine in human breast milk. J Clin Pharamacol 28:234-239.
  • Kallen, B. 2005. Methodologic issues in the epidemiologic study of the teratogenicity of drugs. Congenit Anom (Kyoto) 45: 44-51.
  • Kallen B, Otterblad Olausson P. 2001. Monitoring of maternal drug use and infant congenital malformations. Does loratadine cause hypospadias? Int J Risk Saf Med 14(3-4):115-119.
  • Kallen B, Otterblad Olausson P. 2006. No increased risk of infant hypospadias after maternal use of loratadine in early pregnancy. Int M Med Sci 3(3):106-107.
  • Keles N. 2004. Treatment of allergic rhinitis during pregnancy. Am J Rhinol 18(1)23-28.
  • Li Q, et al. 2013. Assessment of antihistamine use in early pregnancy and birth defects. J Allergy Clin Immunol Pract. 1(6):666-74.e1.
  • Moretti M, et al. 2003. Fetal safety of loratadine use in the first trimester of pregnancy: A multicenter study. J Allergy Clin Immunol. 111(3) 479-83.
  • Pedersen L, et al. 2006b. Maternal use of loratadine during pregnancy and risk of hypospadias in offspring. Int J Med Sci 3(1) 21-25.
  • Schwarz EB et al. 2008. Risk of hypospadias in offspring of women using loratadine during pregnancy: a systematic review and meta-analysis. Drug Saf 31(9):775-88.
  • Werler M, et al. 2004. Evaluation of an association between loratadine and hypospadias – United States, 1997-2001. MMWR 53(10):219-21.