Use of decongestants during pregnancy and the risk of birth defects

Am J Epidemiol. 2013 Jul 15;178(2):198-208. doi: 10.1093/aje/kws427. Epub 2013 Jul 3.


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.

Keywords: birth defects; decongestants; maternal exposure; pregnancy.

Publication types

  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Abnormalities, Drug-Induced*
  • Administration, Intranasal
  • Administration, Oral
  • Adult
  • Canada
  • Case-Control Studies
  • Female
  • Humans
  • Infant, Newborn
  • Logistic Models
  • Nasal Decongestants / administration & dosage
  • Nasal Decongestants / adverse effects*
  • Nonprescription Drugs / administration & dosage
  • Nonprescription Drugs / adverse effects*
  • Odds Ratio
  • Pregnancy
  • Pregnancy Trimester, First
  • Self Report
  • United States


  • Nasal Decongestants
  • Nonprescription Drugs