FDA label 417468df-53c1-484b-e054-00144ff88e88

WARNINGS Hypersensitivity reactions have been reported in patients who have exhibited hyper-sensitivity to other selective 5-HT3 receptor antagonists.

ADVERSE REACTIONS The following have been reported as adverse events in clinical trials of patients treated with ondansetron, the active ingredient of ondansetron hydrochloride tablets. A causal relationship to therapy with ondansetron hydrochloride tablets has been unclear in many cases. Chemotherapy-Induced Nausea and Vomiting: The adverse events in Table 5 have been reported inof adult patients receiving a single 24-mg ondansetron hydrochloride tablet in 2 trials. These patients were receiving concurrent highly emetogenic cisplatin-based chemotherapy regimens (cisplatin dosemg/m2). Table 5. Principal Adverse Events in US Trials: Single Day Therapy With 24-mg Ondansetron Hydrochloride Tablets (Highly Emetogenic Chemotherapy) EventOndansetron 24 mg q.d n = 300Ondansetron 8 mg b.i.d. n = 124Ondansetron 32 mg q.d. n = 117 Headache33 (11%)16 (13%)17 (15%)Diarrhea13 (4%)9 (7%)3 (3%) The adverse events in Table 6 have been reported inof adults receiving either 8 mg of ondansetron hydrochloride tablets 2 or 3 times a day for 3 days or placebo in 4 trials. These patients were receiving concurrent moderately emetogenic chemotherapy, primarily cyclophosphamide-based regimens. Table 6. Principal Adverse Events in US Trials: 3 Days of Therapy With 8-mg Ondansetron Hydrochloride Tablets (Moderately Emetogenic therapy) EventOndansetron 8 mg b.i.d. n = 242Ondansetron 8 mg t.i.d. n = 415Placebo n = 262 Headache58 (24%)113 (27%)34 (13%)Malaise/fatigue32 (13%)37 (9%)6 (2%)Constipation22 (9%)26 (6%)1 (<1%)Diarrhea15 (6%)16 (4%)10 (4%)Dizziness13 (5%)18 (4%)12 (5%)Central Nervous System: There have been rare reports consistent with, but not diagnostic of, extrapyramidal reactions in patients receiving ondansetron. Hepatic:In 723 patients receiving cyclophosphamide-based chemotherapy in US clinical trials, AST and/or ALT values have been reported to exceed twice the upper limit of normal in approximately 1% to 2% of patients receiving ondansetron hydrochloride tablets. 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. The role of cancer chemotherapy in these biochemical changes cannot be clearly determined. There have been reports of liver failure and death in patients with cancer receiving concurrent medications including potentially hepatotoxic cytotoxic chemotherapy and antibiotics. The etiology of the liver failure is unclear. Integumentary:Rash has occurred in approximately 1% of patients receiving ondansetron. Other:Rare cases of anaphylaxis, bronchospasm, tachycardia, angina (chest pain), hypokalemia, electrocardiographic alterations, vascular occlusive events, and grand mal seizures have been reported. Except for bronchospasm and anaphylaxis, the relationship to ondansetron hydrochloride was unclear. Radiation-Induced Nausea and Vomiting: The adverse events reported in patients receiving ondansetron hydrochloride tablets and concurrent radiotherapy were similar to those reported in patients receiving ondansetron hydrochloride tablets and concurrent chemotherapy. The most frequently reported adverse events were headache, constipation, and diarrhea. Postoperative Nausea and Vomiting: The adverse events in Table 7 have been reported inof patients receiving ondansetron hydrochloride tablets at a dosage of 16 mg orally in clinical trials. With the exception of headache, rates of these events were not significantly different in the ondansetron and placebo groups. These patients were receiving multiple concomitant preoperative and postoperative medications. Table 7. Frequency of Adverse Events From Controlled Studies With Ondansetron Hydrochloride Tablets (Postoperative Nausea and Vomiting) Adverse EventOndansetron 16 mg (n = 550)Placebo (n = 531) Wound problem152 (28%)162 (31%)Drowsiness/sedation112 (20%)122 (23%)Headache49 (9%)27 (5%)Hypoxia49 (9%)35 (7%)Pyrexia45 (8%)34 (6%)Dizziness36 (7%)34 (6%)Gynecological disorder36 (7%)33 (6%)Anxiety/agitation33 (6%)29 (5%)Bradycardia32 (6%)30 (6%)Shiver(s)28 (5%)30 (6%)Urinary retention28 (5%)18 (3%)Hypotension27 (5%)32 (6%)Pruritus27 (5%)20 (4%)Observed During Clinical Practice: In addition to adverse events reported from clinical trials, the following events have been identified during post-approval use of oral formulations of ondansetron hydrochloride. 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 hydrochloride. General:Flushing. Rare cases of hypersensitivity reactions, sometimes severe (e.g., anaphylaxis/anaphylactoid reactions, angioedema, bronchospasm, shortness of breath, hypotension, laryngeal edema, stridor) have also been reported. Laryngospasm, shock, and cardiopulmonary arrest have occurred during allergic reactions in patients receiving injectable ondansetron. Hepatobiliary:Liver enzyme abnormalities Lower Respiratory:Hiccups Neurology:Oculogyric crisis, appearing alone, as well as with other dystonic reactions Skin:Urticaria Special Senses: Eye Disorders: 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