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The safety and effectiveness of orally administered ZOFRAN have not been established in pediatric patients for:

Because clinical trials are conducted under widely varying conditionsadverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The FDA had previously noted that ondansetron could increase the risk of developing QT interval prolongationThe agency also pointed to articles published in the medical literature that describe QT interval prolongation with ondansetron.

This list is not complete and other drugs may interact with ondansetronTell your doctor about all medications you useThis includes prescriptionover-the-countervitaminand herbal productsDo not start a new medication without telling your doctor.

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zofran during pregnancy increases the risk of multiple birth defects including heart defects, septal valve defects, cleft palate and cleft lip, and kidney defects.