Our specialists are fielding a large volume of COVID-19 vaccine inquiries; response times may be delayed. Common questions may be answered by visiting our Fact Sheet or video.

MotherToBaby

Medications and More during pregnancy and breastfeeding

866.626.6847

Ondansetron (Zofran®)

Selected References:

  • Andrade C. 2020. Major Congenital Malformation Risk After First Trimester Gestational Exposure to Oral or Intravenous Ondansetron. J Clin Psychiatry;81(3):20f13472
  • Anderka M, et al. 2012. Medications used to treat nausea and vomiting of pregnancy and the risk of selected birth defects. Birth Defects Res A Clin Mol Teratol; 94(1):22–30.
  • Briggs GG, Freeman RK. 2014. Drugs in Pregnancy and Lactation. 10th edition. Philadelphia, PA: Wolters Kluwer (online version).
  • Kaplan YC, et al. 2019. Use of ondansetron during pregnancy and the risk of major congenital malformations: A systemic review and meta-analysis. Reprod Toxicol; 86 Jun:1-13.
  • Cohen R, et al. 2014. Intestinal obstruction in pregnancy by ondansetron. Reprod Toxicol. 2014 Oct 24;50C:152-153.
  • Colvin L, et al. 2013. Off-label use of ondansetron in pregnancy in Western Australia. Biomed Res Int. 2013:909860.
  • Danielsson B, Wikner BN, Kallen B. 2014. Use of ondansetron during pregnancy and congenital malformations in the infant. Reprod Toxicol 50:134-7.
  • Diav-Citrin O, et al. 2017. Pregnancy outcome following in utero exposure to ondansetron: A prospective comparative, observational cohort study. Reprod Toxicol; 72:203.
  • Einarson AK, et al. 2004. The safety of ondansetron for nausea and vomiting of pregnancy: a prospective comparative study. BJOG;111:940-3.
  • Elkomy MH, et al. 2015. Ondansetron pharmacokinetics in pregnant women and neonates: towards a new treatment for neonatal abstinence syndrome. Clin Pharmacol Ther. 97:167-76.
  • Fejzo MS, et al. 2016. Ondansetron in pregnancy and risk of adverse fetal outcomes in the United States. Reprod Toxicol 62: 87-91.
  • Food and Drug Administration. 2012. FDA Drug Safety Communication: New information regarding QT prolongation with ondansetron (Zofran). https://www.fda.gov/Drugs/DrugSafety/ucm310190.htm. Accessed 7/2018.
  • Larrimer MB, et al. 2014. Antiemetic medications in pregnancy: a prospective investigation of obstetric and neurobehavioral outcomes. Am J Obstet Gynecol 210 (3): 270. e1-7
  • Lavecchia M, et al. 2018. Ondansetron in Pregnancy and the Risk of Congenital Malformations: A Systematic Review. J Obstet Gynaecol Can. 40(7):910-918.
  • Lemon LS, et al. 2020. Ondansetron use in the first trimester of pregnancy and the risk of neonatal ventricular septal defect. Int J Epidemiol;49(2):648-656.
  • Pasternak B. 2013. Ondansetron in pregnancy and risk of adverse fetal outcomes. N Engl J Med 368:814-823.
  • Picot C, et al. 2020. Risk of malformation after ondansetron in pregnancy: An updated systemic review and meta-analysis. Birth Defects Res;112(13):996-1013.