FDA label b81ba160-bb0d-4d28-a191-20d2cd646bea

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 0.15mg/kg x 3 N = 419 Ondansetron Injection, USP 32mg 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* 0% 0% 5% 0% *See Neurological 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. Observed During Clinical Practice: In addition to adverse events reported from clinical trials, the following events have been identified during post-approval use of intravenous formulations of ondansetron injection. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to ondansetron injection. Cardiovascular: Arrhythmias (including ventricular and supraventricular tachycardia, premature ventricular contractions, and atrial fibrillation), bradycardia, electrocardiographic alterations (including second-degree heart block, QT interval prolongation and ST segment depression), palpitations, and syncope. General: Flushing. Rare cases of hypersensitivity reactions, sometimes severe (e.g., anaphylaxis/anaphylactoid reactions, angioedema, bronchospasm, cardiopulmonary arrest, hypotension, laryngeal edema, laryngospasm, shock, shortness of breath, stridor) have also been reported. Hepatobiliary: Liver enzyme abnormalities have been reported. Liver failure and death have been reported in patients with cancer receiving concurrent medications including potentially hepatotoxic cytotoxic chemotherapy and antibiotics. The etiology of the liver failure is unclear. Local Reactions: Pain, redness, and burning at site of injection. Lower Respiratory: Hiccups Neurological: Oculogyric crisis, appearing alone, as well as with other dystonic reactions. Skin: Urticaria Special Senses : Transient dizziness during or shortly after I.V. infusion. Eye Disorders: Transient blurred vision, in some cases associated with abnormalities of accommodation. Cases of transient blindness, predominantly during intravenous administration, have been reported. These cases of transient blindness were reported to resolve within a few minutes up to 48 hours.

<table> <caption>Table 7. Principal Adverse Events in Comparative Trials in Adults</caption> <col width="151px"/> <col width="128px"/> <col width="120px"/> <col width="128px"/> <col width="89px"/> <tbody> <tr> <td styleCode=" Toprule Lrule Rrule "> </td> <td align="center" colspan="4" styleCode=" Toprule Lrule Rrule "> <content styleCode="bold">Number of Adult Patients With Event</content> </td> </tr> <tr> <td styleCode=" Toprule Lrule Rrule "> </td> <td align="center" styleCode=" Toprule Lrule Rrule "> <content styleCode="bold">Ondansetron Injection, USP</content> <content styleCode="bold">0.15mg/kg x 3</content> <content styleCode="bold">N = 419</content> </td> <td align="center" styleCode=" Toprule Lrule Rrule "> <paragraph> <content styleCode="bold">Ondansetron Injection, USP </content> <content styleCode="bold"> 32mg x 1</content> <content styleCode="bold">N = 220</content> </paragraph> </td> <td align="center" styleCode=" Toprule Lrule Rrule "> <content styleCode="bold">Metoclopramide</content> <content styleCode="bold">N = 156</content> </td> <td align="center" styleCode=" Toprule Lrule Rrule "> <content styleCode="bold">Placebo</content> <content styleCode="bold">N = 34</content> </td> </tr> <tr> <td styleCode=" Toprule Lrule Rrule "> Diarrhea</td> <td align="center" styleCode=" Toprule Lrule Rrule "> 16%</td> <td align="center" styleCode=" Toprule Lrule Rrule "> 8%</td> <td align="center" styleCode=" Toprule Lrule Rrule "> 44%</td> <td align="center" styleCode=" Toprule Lrule Rrule "> 18%</td> </tr> <tr> <td styleCode=" Toprule Lrule Rrule "> Headache</td> <td align="center" styleCode=" Toprule Lrule Rrule "> 17%</td> <td align="center" styleCode=" Toprule Lrule Rrule "> 25%</td> <td align="center" styleCode=" Toprule Lrule Rrule "> 7%</td> <td align="center" styleCode=" Toprule Lrule Rrule "> 15%</td> </tr> <tr> <td styleCode=" Toprule Lrule Rrule "> Fever</td> <td align="center" styleCode=" Toprule Lrule Rrule "> 8%</td> <td align="center" styleCode=" Toprule Lrule Rrule "> 7%</td> <td align="center" styleCode=" Toprule Lrule Rrule "> 5%</td> <td align="center" styleCode=" Toprule Lrule Rrule "> 3%</td> </tr> <tr> <td styleCode=" Toprule Lrule Rrule "> Akathisia</td> <td align="center" styleCode=" Toprule Lrule Rrule "> 0%</td> <td align="center" styleCode=" Toprule Lrule Rrule "> 0%</td> <td align="center" styleCode=" Toprule Lrule Rrule "> 6%</td> <td align="center" styleCode=" Toprule Lrule Rrule "> 0%</td> </tr> <tr> <td styleCode=" Toprule Lrule Rrule "> Acute dystonic reactions*</td> <td align="center" styleCode=" Toprule Lrule Rrule "> 0%</td> <td align="center" styleCode=" Toprule Lrule Rrule "> 0%</td> <td align="center" styleCode=" Toprule Lrule Rrule "> 5%</td> <td align="center" styleCode=" Toprule Lrule Rrule "> 0%</td> </tr> </tbody> </table>