FDA label d8c39b02-415c-4de1-9f9b-2f2736a79f4e

WARNINGS Hypersensitivity reactions have been reported in patients who have exhibited hypersensitivity to other selective 5-HT 3 receptor antagonists.

ADVERSE REACTIONS Chemotherapy-Induced Nausea and Vomiting: The adverse events in Table 7 have been reported in adults receiving ondansetron at a dosage of three 0.15-mg/kg doses or as a single 32-mg dose in clinical trials. These patients were receiving concomitant chemotherapy, primarily cisplatin, and I.V. fluids. Most were receiving a diuretic. Table 7. Principal Adverse Events in Comparative Trials in Adults Number of Adult Patients With Event Ondansetron Injection, USP 0.15 mg/kg x 3 n = 419 Ondansetron Injection, USP 32 mg x 1 n = 220 Metoclopramide n=156 Placebo n=34 Diarrhea 16% 8% 44% 18% Headache 17% 25% 7% 15% Fever 8% 7% 5% 3% Akathisia 0% 0% 6% 0% Acute dystonic reactions See Neurological . 0% 0% 5% 0% The following have been reported during controlled clinical trials: Cardiovascular: Rare cases of angina (chest pain), electrocardiographic alterations, hypotension, and tachycardia have been reported. In many cases, the relationship to ondansetron injection was unclear. Gastrointestinal: Constipation has been reported in 11% of chemotherapy patients receiving multiday ondansetron. Hepatic: In comparative trials in cisplatin chemotherapy patients with normal baseline values of aspartate transaminase (AST) and alanine transaminase (ALT), these enzymes have been reported to exceed twice the upper limit of normal in approximately 5% of patients. The increases were transient and did not appear to be related to dose or duration of therapy. On repeat exposure, similar transient elevations in transaminase values occurred in some courses, but symptomatic hepatic disease did not occur. Integumentary: Rash has occurred in approximately 1% of patients receiving ondansetron. Neurological: There have been rare reports consistent with, but not diagnostic of, extrapyramidal reactions in patients receiving ondansetron injection, and rare cases of grand mal seizure. The relationship to ondansetron injection was unclear. Other: Rare cases of hypokalemia have been reported. The relationship to ondansetron injection was unclear.

<table width="90%" ID="table7"> <caption>Table 7. Principal Adverse Events in Comparative Trials in Adults</caption> <col width="20%" align="left" valign="bottom"/> <col width="20%" align="center" valign="bottom"/> <col width="20%" align="center" valign="bottom"/> <col width="20%" align="center" valign="bottom"/> <col width="20%" align="center" valign="bottom"/> <thead> <tr styleCode="Botrule"> <th styleCode="Lrule Rrule"/> <th styleCode="Rrule" colspan="4">Number of Adult Patients With Event</th> </tr> <tr> <th styleCode="Lrule Rrule"/> <th styleCode="Rrule">Ondansetron Injection, USP 0.15 mg/kg x 3 n = 419</th> <th styleCode="Rrule">Ondansetron Injection, USP 32 mg x 1 n = 220</th> <th styleCode="Rrule"> Metoclopramide n=156</th> <th styleCode="Rrule">Placebo n=34</th> </tr> </thead> <tbody> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule">Diarrhea</td> <td styleCode="Rrule">16%</td> <td styleCode="Rrule">8%</td> <td styleCode="Rrule">44%</td> <td styleCode="Rrule">18%</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule">Headache</td> <td styleCode="Rrule">17%</td> <td styleCode="Rrule">25%</td> <td styleCode="Rrule">7%</td> <td styleCode="Rrule">15%</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule">Fever</td> <td styleCode="Rrule">8%</td> <td styleCode="Rrule">7%</td> <td styleCode="Rrule">5%</td> <td styleCode="Rrule">3%</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule">Akathisia</td> <td styleCode="Rrule">0%</td> <td styleCode="Rrule">0%</td> <td styleCode="Rrule">6%</td> <td styleCode="Rrule">0%</td> </tr> <tr> <td styleCode="Lrule Rrule">Acute dystonic reactions<footnote>See <linkHtml href="#Neurological">Neurological</linkHtml>.</footnote> </td> <td styleCode="Rrule">0%</td> <td styleCode="Rrule">0%</td> <td styleCode="Rrule">5%</td> <td styleCode="Rrule">0%</td> </tr> </tbody> </table>