First-trimester antihistamine exposure and risk of spontaneous abortion or preterm birth

Pharmacoepidemiol Drug Saf. 2014 Oct;23(10):1043-50. doi: 10.1002/pds.3637. Epub 2014 May 1.


Purpose: We tested whether antihistamine exposure during early pregnancy is associated with spontaneous abortion (SAB) or preterm birth (PTB).

Methods: Women were enrolled in Right from the Start (2004-2010), a prospective pregnancy cohort. Data about first-trimester antihistamine use were obtained from screening and first-trimester interviews. Self-reported outcomes included SAB and PTB and were verified by medical records. Cox proportional hazards models were used to test for an association between antihistamine use and each outcome, both performed adjusting for confounders.

Results: Among the 2685 pregnancies analyzed, 14% (n = 377) reported use of antihistamines. Among antihistamine users, 12% (n = 44) experienced SABs, and 6% (n = 21) had PTBs. Antihistamine exposure was not associated with SAB (adjusted hazard ratio [aHR] = 0.88, 95% confidence interval [CI] 0.64, 1.21) or PTB, which was modified by maternal race (aHR = 1.03, 95%CI 0.61, 1.72 among White women and aHR = 0.43, 95%CI 0.14, 1.34 among Black women).

Conclusions: Despite the biologic plausibility that antihistamine use may influence pregnancy outcomes, we did not detect evidence of an association with SAB or PTB. These data demonstrate the utility of large prospective cohorts for evaluating drug safety in pregnancy when concerns are raised from animal models.

Keywords: histamine antagonists; pharmacoepidemiology; pregnancy; prospective studies.

Publication types

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

MeSH terms

  • Abortion, Spontaneous / chemically induced*
  • Abortion, Spontaneous / epidemiology*
  • Adolescent
  • Adult
  • Female
  • Histamine Antagonists / administration & dosage
  • Histamine Antagonists / adverse effects*
  • Histamine Antagonists / therapeutic use
  • Humans
  • Maternal Exposure / adverse effects*
  • Pregnancy
  • Pregnancy Trimester, First
  • Prospective Studies
  • Risk
  • United States / epidemiology
  • Young Adult


  • Histamine Antagonists