Onzet Use In Pregnancy & Lactation

Pregnancy: Tablet: The safety of Ondansetron for use in human pregnancy has not been established. Evaluation of experimental animal studies does not indicate direct or indirect harmful effects with respect to the development of the embryo, or foetus, the course of gestation pre-and post-natal development. However as animal studies are not always predictive of human response the use of Ondansetron in pregnancy is not recommended.
Injection: Pregnancy Category B. Reproduction studies have been performed in pregnant rats and rabbits at intravenous doses up to 4 mg/kg per day (approximately 1 and 2 times the recommended human intravenous dose of 32 mg/day, respectively, based on body surface area) and have revealed no evidence of impaired fertility or harm to the fetus due to ondansetron. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Lactation: Tablet: Tests have shown that Ondansetron passes into the milk of lactating animals. It is therefore, recommended that mothers receiving Ondansetron should not breastfeed their babies.
Injection: Ondansetron is excreted in the breast milk of rats. It is not known whether ondansetron is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when ondansetron is administered to a nursing woman.
Fertility: Tablet: There is no information on the effects of Ondansetron on human fertility.