Ondansetron in pregnancy and risk of adverse fetal outcomes in the United States

Reprod Toxicol. 2016 Jul:62:87-91. doi: 10.1016/j.reprotox.2016.04.027. Epub 2016 May 2.


This is an analysis of fetal outcome in pregnancies exposed to ondansetron to treat Hyperemesis Gravidarum (HG). In this retrospective cohort study, U.S. data on outcome were collected on 1070 pregnancies exposed to ondansetron and compared to outcomes in two control groups: 771 pregnancies in women with a history of HG with no ondansetron exposure and 1555 pregnancies with neither a history of HG nor ondansetron exposure. Ventricular septal defects were reported in 2/952 of infants in the HG/Ondansetron-exposure group and 4/1286 in the No HG/No Ondansetron-exposure group. Cleft palate was reported in 1/952 live births in the HG/Ondansetron and 2/1286 in the No HG/No Ondansetron-exposure groups. Women with a history of HG who took ondansetron reported less miscarriages and terminations, and higher live birth rates. The overall results do not support evidence of teratogenicity of ondansetron.

Keywords: Birth defect; Cleft; Heart defect; Hyperemesis gravidarum; Morning sickness; Nausea; Ondansetron; Pregnancy.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Abortion, Spontaneous / epidemiology
  • Adolescent
  • Adult
  • Antiemetics / therapeutic use*
  • Child
  • Congenital Abnormalities / epidemiology
  • Female
  • Humans
  • Hyperemesis Gravidarum / drug therapy*
  • Male
  • Middle Aged
  • Ondansetron / therapeutic use*
  • Pregnancy
  • Pregnancy Outcome
  • Pregnancy Rate
  • Retrospective Studies
  • Risk
  • United States / epidemiology
  • Young Adult


  • Antiemetics
  • Ondansetron