Research Summary: Safety of Ondansetron (Zofran) in a Hyperemesis Gravidarum (HG) pregnancy.
2021
Dormuth CR, Winquist B, Fisher A, et al.
“This meta-analysis of cohort studies of 456,963 pregnancies in 3 countries published in JAMA, found treatment with ondansetron was not significantly associated with increased risk of fetal death, spontaneous abortion, stillbirth, or major congenital malformations compared with other antiemetics.”
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2019
Kaplan YC, Richardson JL Keskin-Arslan E, Erol-Coskun H, Kennedy D, et al.
This systematic review and meta analysis of published research on ondansetron use in ~3 million pregnancies from Reproductive Toxicology found “no significant increased risk for major malformations, heart defects, orofacial clefts, genitourinary malformations or hypospadias were identified in our primary analysis.”
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2018
Huybrechts KF, Hernández-Díaz S, Straub L, et al.
“This study of 1.8 million pregnancies published in JAMA, first trimester ondansetron use was associated with an increased risk of oral clefts (3 additional cases per 10 000 women treated; adjusted relative risk, 1.24) but not cardiac malformations.”
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2016 – HER Foundation, Fejzo MS, MacGibbon K, Mullin PM.
Ondansetron in pregnancy and risk of adverse fetal outcomes in the United States
“This study of 2,238 pregnancies published in Reproductive Toxicology found fewer reported miscarriages and terminations and a higher live birth rate in women with a history of HG who took ondansetron. Fejzo, et al. also found no evidence to support an increased risk of heart defects or orofacial clefts.”
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