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Pregnant Women: The safety of ondansetron for use in human pregnancy has not been established. Ondansetron is not teratogenic in animals. However, as animal studies are not always predictive of human response, the use of ondansetron in pregnancy is not recommended.
Safety data of ondansetron in pregnancy are limited and findings from available pharmacoepidemiologic studies are inconsistent.
Post-marketing reports describe cases of congenital malformations with use of ondansetron during pregnancy; however, the reports are insufficient to establish causal relationship.
Nursing Women: Ondansetron is excreted in the milk of lactating rats. It is not known if it is excreted in human milk, however, nursing is not recommended during treatment with ondansetron.
