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Hypersensitivity reactionsincluding anaphylaxis and bronchospasmhave been reported in patients who have exhibited hypersensitivity to other selective 5-HT 3 receptor antagonistsIf hypersensitivity reactions occurdiscontinue use of ZOFRANtreat promptly per standard of care and monitor until signs and symptoms resolvesee CONTRAINDICATIONS

Methodological limitations of the epidemiology studies preclude a reliable evaluation of the potential risk of adverse fetal outcomes with the use of ondansetron in pregnancy.

Pediatric cases consistent with serotonin syndrome have been reported after inadvertent oral overdoses of ondansetronexceeding estimated ingestion of 5 mg per kgin young childrenReported symptoms included somnolenceagitationtachycardiatachypneahypertensionflushingmydriasisdiaphoresismyoclonic movementshorizontal nystagmushyperreflexiaand seizurePatients required supportive careincluding intubation in some caseswith complete recovery without sequelae within 1 to 2 days.

The following adverse reactions have been identified during post-approval use of ondansetronBecause these reactions are reported voluntarily from a population of uncertain sizeit is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy prevention of nausea and vomiting associated with radiotherapy prevention of postoperative nausea and/or vomiting.

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