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adverse reactions
6 ADVERSE REACTIONS The most common adverse events reported (≥7%) in the clinical trials were headache, diarrhea, and pyrexia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Baxter Healthcare Corporation at 1-866-888-2472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Chemotherapy-Induced Nausea and Vomiting The adverse events in Table 1 have been reported in individuals 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 intravenous fluids. Most were receiving a diuretic. Table 1. Principal Adverse Events in Comparative Trials (0.15 mg/kg x 3 and 32 mg x 1) Number of Patients With Event Ondansetron Injection 0.15 mg/kg x 3 n = 419 Ondansetron Injection 32 mg x 1 n = 220 Metoclopramide 2 mg/kg x 6 n = 156 Placebo n = 34 Headache 17% 25% 7% 15% Diarrhea 16% 8% 44% 18% Pyrexia 8% 7% 5% 3% Akathisia 0% 0% 6% 0% Acute dystonic reactions See Adverse Reactions (6.2). 0% 0% 5% 0% 6.2 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Cardiac Disorders Rare cases of angina pectoris (chest pain), hypotension, tachycardia, and electrocardiogram abnormalities have been reported. In many cases, the relationship to ondansetron injection was unclear. Gastrointestinal Disorders Constipation has been reported in 11% of chemotherapy patients receiving multiday ondansetron. Hepatobiliary Disorders In comparative trials in cisplatin chemotherapy patients with normal baseline values of aspartate aminotransferase (AST) and alanine aminotransferase (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 aminotransferase values occurred in some courses, but symptomatic hepatic disease did not occur. Skin and Subcutaneous Tissue Disorders Rash has occurred in approximately 1% of patients receiving ondansetron. Nervous System Disorders There have been rare cases of grand mal convulsion and rare reports consistent with, but not diagnostic of, extrapyramidal disorders in patients receiving ondansetron injection. The relationship to ondansetron injection was unclear. Metabolism and Nutrition Disorders Rare cases of hypokalemia have been reported. The relationship to ondansetron injection was unclear. 6.3 Postmarketing Experience 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. Cardiac Disorders Arrhythmias (including ventricular fibrillation, ventricular tachycardia, torsade de pointes, atrial fibrillation, supraventricular tachycardia, and premature ventricular contractions), electrocardiogram abnormalities (including QT prolonged, ST segment depression, and second degree atrioventricular block), syncope, chest discomfort, bradycardia, and palpitations have been reported. Immune System Disorders Rare cases of hypersensitivity reactions, sometimes severe (e.g., cardiopulmonary arrest, anaphylactic and anaphylactoid reactions, shock, laryngospasm, stridor, hypotension, bronchospasm, angioedema, laryngeal edema, dyspnea) have been reported. Gastrointestinal Disorders Nausea and vomiting have been reported. Hepatobiliary Disorders Hepatic necrosis, hepatitis, jaundice, hepatic enzyme abnormalities [including increased aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), gamma-glutamyl transferase (GGT), and bilirubin], and hepatic function abnormal have been reported. Hepatic failure and death have been reported in patients with cancer receiving concurrent medications including potentially hepatotoxic cytotoxic chemotherapy and antibiotics. The etiology of the hepatic failure is unclear. General Disorders and Administrative Site Conditions Pain, erythema, and irritation at site of injection have been reported. Chills and lethargy have also been reported. Respiratory, Thoracic, and Mediastinal Disorders Hiccups have been reported. Nervous System Disorders Oculogyric crisis appearing alone, as well as with other dystonic reactions have been reported. Skin and Subcutaneous Tissue Disorders Urticaria, pruritus, flushing, and hyperhidrosis have been reported. Musculoskeletal and Connective Tissue Disorders Arthralgia has been reported. Special Senses Transient dizziness during or shortly after intravenous infusion has been reported. Eye Disorders Transient blurred vision, in some cases associated with accommodation disorder. Rare 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.