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There are no adequate and controlled studies to date using Ondansetron in pregnant women. Reproduction studies have been performed in pregnant rats and rabbits at I.V. doses up to 4 mg/kg per day and have revealed no evidence of impaired fertility or harm to the fetus due to Ondansetron. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Animal tests (with rats) have shown that Ondansetron is excreted in the breast milk. It is therefore recommended that mothers receiving this drug should not breast-feed their babies.
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