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Medications and More during pregnancy and breastfeeding

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). 
  • Cao X, et al. 2022. Risk of abnormal pregnancy outcomes after using ondansetron during pregnancy: A systematic review and meta-analysis. Front Pharmacol, 13(951072). 
  • Cohen R, et al. 2014. Intestinal obstruction in pregnancy by ondansetron. Reprod Toxicol. 2014 Oct 24;50C:152-153. 
  • Cho Y,et al. 2025. Antiemetic use during pregnancy and child neurodevelopment: population-based birth cohort study. BMC medicine, 23(1), 667.  
  • 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. 
  • Dormuth CR, et al; Canadian Network for Observational Drug Effect Studies (CNODES) Investigators. 2021. Comparison of Pregnancy Outcomes of Patients Treated with Ondansetron vs Alternative Antiemetic Medications in a Multinational, Population-Based Cohort. JAMA Netw Open; 4(4):e215329. 
  • 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://downloads.regulations.gov › FDA-2016-N-2462-0013 › content.pdf. Accessed 2018, 2022, and 2026.  
  • Huybrechts KF, et al. 2018. Association of Maternal First-Trimester Ondansetron Use With Cardiac Malformations and Oral Clefts in Offspring. JAMA, 320(23), 2429–2437.  
  • Jelting Y, et al. 2017. Preventing nausea and vomiting in women undergoing regional anesthesia for cesarean section: Challenges and solutions. Local Reg Anesth, 10:83–90. 
  • 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. 
  • 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 
  • Laspro M, et al. 2025. Association of Commonly Prescribed Antepartum Medications and Incidence of Orofacial Clefting. The Cleft palate-craniofacial journal : official publication of the American Cleft Palate-Craniofacial Association, 62(7), 1164–1174 
  • 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. 
  • Masarwe S, et al. 2023. Ondansetron use during pregnancy: Birth defects and obstetric outcomes. Clin Nurs Res, 32(4):705-711. 
  • 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. 
  • Reis ACC, et al. 2023. Safety evaluation of ondanstron after gestational exposure on male reproductive parameters in rats. Regul Toxicol Pharmacol, 137:105302. 
  • Sakran R, et al. 2021. Pregnancy outcome following in-utero exposure to ondansetron: A prospective comparative observational study. Reprod Toxicol; 99:9-14. 
  • Schrager NL, et al. 2023. The association of nausea and vomiting of pregnancy, its treatments, and select birth defects: Findings from the National Birth Defect Prevention Study. Birth Defects Res, 115(3):275-289. 
  • Sillis L, et al.2026. Medications for Nausea and Vomiting of Pregnancy and the Risks for Adverse Birth Outcomes. Pharmacoepidemiology and drug safety, 35(4), e70367.  
  • Suarez EA, et al. 2021. Ondansetron use in early pregnancy and the risk of late pregnancy outcomes. Pharmacoepidemiol Drug Saf; 30(2):114-125.  
  • Suarez EA, et al. 2021. Ondansetron use in early pregnancy and the risk of miscarriage. Pharmacoepidemiol Drug Saf; 30(2):103-113.  
  • Tolchinsky I, et al. 2026 Another prospective study on the safety of ondansetron for nausea and vomiting of pregnancy: addressing ongoing concerns. Front. Pharmacol. 17:1783632.  
  • Yang J, 2026. Ondansetron Use for Women With Hyperemesis Gravidarum and Risks of Spontaneous Abortion and Stillbirth: A Retrospective Cohort Study. Pharmacoepidemiology and drug safety, 35(2), e70335.  
  • Zhao W, et al. 2020. Retrospective comparison of the safety and effectiveness of dexmedetomidine versus standard of care before and during cesarean delivery in a maternity unit in Zhengzhou, China. Med Sci Monit, 26:e925709. 

MotherToBaby cuenta con el apoyo de la Administración de Recursos y Servicios de Salud (HRSA) del Departamento de Salud y Servicios Humanos de los Estados Unidos (HHS) como parte de una adjudicación por un total de $6,000,000 con cero porcentaje financiado con fuentes no gubernamentales. Los contenidos son los del autor/es y no representan necesariamente los puntos de vista oficiales de, ni un respaldo, por HRSA, HHS o el Gobierno de los Estados Unidos.