No evidence of adverse pregnancy outcome after exposure to ibuprofen in the first trimester - Evaluation of the national Embryotox cohort

Reprod Toxicol. 2018 Aug;79:32-38. doi: 10.1016/j.reprotox.2018.05.003. Epub 2018 May 12.


Ibuprofen is an analgesic frequently used in the 1st and 2nd trimester of pregnancy. Most relevant studies deal with NSAID as a group and do not specifically focus on ibuprofen. In this study, 1117 women exposed to ibuprofen in the 1st trimester were compared to 2229 non-exposed women. Data were retrieved from the German Embryotox database. No significantly increased risk of major birth defects (4.8% vs. 4.1%; OR adjusted 1.11, 95% CI 0.75-1.64) or a distinct pattern of birth defects were found. The cumulative incidences of spontaneous abortions were similar across cohorts (15.5% vs. 16.6%; HR adjusted 0.85; 95% CI, 0.65-1.11). Subgroup analyses of pregnancies exposed for ≥7 (n = 223) and ≥30 days (n = 72) did not reveal a higher risk with increasing treatment duration. Ibuprofen does not seem to carry a substantial embryotoxic risk regarding the investigated endpoints.

Keywords: Abortions; Anti-inflammatory agents; Congenital abnormalities [MeSH]; Ibuprofen [MeSH]; Non-Steroidal [MesH]; Pharmacovigilance [MeSH]; Pregnancy outcome [MeSH]; Spontaneous [MeSH].

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Abnormalities, Drug-Induced / epidemiology
  • Abortion, Spontaneous / epidemiology
  • Analgesics / therapeutic use*
  • Anti-Inflammatory Agents, Non-Steroidal / therapeutic use*
  • Antipyretics / therapeutic use*
  • Cohort Studies
  • Female
  • Germany / epidemiology
  • Humans
  • Ibuprofen / therapeutic use*
  • Incidence
  • Maternal-Fetal Exchange
  • Pregnancy
  • Pregnancy Outcome
  • Pregnancy Trimester, First*


  • Analgesics
  • Anti-Inflammatory Agents, Non-Steroidal
  • Antipyretics
  • Ibuprofen