Use of Decongestants During Pregnancy and the Risk of Birth Defects

Wai-Ping Yau; Allen A. Mitchell; Kueiyu Joshua Lin; Martha M. Werler; Sonia Hernández-Díaz


Am J Epidemiol. 2013;178(2):198-208. 

In This Article

Abstract and Introduction


Previous studies suggested that early pregnancy exposure to specific oral decongestants increases the risks of several birth defects. Using January 1993–January 2010 data from the Slone Epidemiology Center Birth Defects Study, we tested those hypotheses among 12,734 infants with malformations (cases) and 7,606 nonmalformed control infants in the United States and Canada. Adjusted odds ratios and 95% confidence intervals were estimated for specific birth defects, with controlling for potential confounders. Findings did not replicate several hypotheses but did support 3 previously reported associations: phenylephrine and endocardial cushion defect (odds ratio = 8.0; 95% confidence interval: 2.5, 25.3; 4 exposed cases), phenylpropanolamine and ear defects (odds ratio = 7.8; 95% confidence interval: 2.2, 27.2; 4 exposed cases), and phenylpropanolamine and pyloric stenosis (odds ratio = 3.2; 95% confidence interval: 1.1, 8.8; 6 exposed cases). Hypothesis-generating analyses involving multiple comparisons identified a small number of associations with oral and intranasal decongestants. Accumulating evidence supports associations between first-trimester use of specific oral and possibly intranasal decongestants and the risk of some infrequent specific birth defects.


Decongestants, particularly pseudoephedrine, are among the over-the-counter (OTC) medications most commonly used during pregnancy.[1] Because they are available without prescription, they are widely perceived as safe by healthcare providers and pregnant women, yet the safety of prenatal exposure with regard to specific birth defects remains unclear. Given their extensive use, even a small increase in the risk of birth defects would have considerable public health implications.

All decongestants are vasoconstrictive and could share class-related effects. On the other hand, teratogenicity can vary within a given class,[2] which makes it necessary that consideration also be given to specific decongestants. Epidemiologic studies of specific decongestants have identified elevated risks of specific birth defects, including defects of the heart, eyes and ears, gut, abdominal wall, and feet (Web Table 1, available at[3–16]

Using data from the Slone Epidemiology Center Birth Defects Study (BDS), we tested the previously reported associations between specific birth defects and first-trimester exposure to oral decongestants and, in hypothesis-generation analyses, explored the risks of other common major congenital malformations. In addition, we explored the risk of specific birth defects in relation to first-trimester use of intranasal decongestants.