Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] QT Prolongation [see Warnings and Precautions (5.2 )] Serotonin Syndrome [see Warnings and Precautions ( 5.3 )] Myocardial Ischemia [see Warnings and Precautions ( 5.4 )] Masking of Progressive Ileus and Gastric Distension [see Warnings and Precautions [see Warnings and Precautions ( 5.5 )] The most common adverse reactions in adults for the: prevention of chemotherapy-induced (≥5%) are: headache, malaise/fatigue, constipation, diarrhea ( 6.1 ) prevention of radiation-induced nausea and vomiting (≥2%) are: headache, constipation, and diarrhea ( 6.1 ) prevention of postoperative nausea and vomiting (≥9%) are: headache and hypoxia ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Dr.
Reddy's Laboratories Inc., at 1-888-375-3784 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials 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 with rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The following adverse reactions have been reported in clinical trials of patients treated with ondansetron, the active ingredient of ondansetron.
A causal relationship to therapy with ondansetron was unclear in many cases.
Prevention of Chemotherapy-Induced Nausea and Vomiting The most common adverse reactions reported in greater than or equal to 4% of 300 adults receiving a single 24 mg dose of ondansetron orally in 2 trials for the prevention of nausea and vomiting associated with highly emetogenic chemotherapy (cisplatin greater than or equal to 50 mg/m 2 ) were: headache (11%) and diarrhea (4%).
The most common adverse reactions reported in 4 trials in adults for the prevention of nausea and vomiting associated with moderately emetogenic chemotherapy (primarily cyclophosphamide-based regimens) are shown in Table
Table 3: Most Common Adverse Reactions in Adults a for the Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Chemotherapy [Primarily Cyclophosphamide-based Regimens] Adverse Reaction Ondansetron 8 mg Twice Daily (n = 242) Placebo (n = 262) Headache 58 (24%) 34 (13%) Malaise/Fatigue 32 (13%) 6 (2%) Constipation 22 (9%) 1 (<1%) Diarrhea 15 (6%) 10 (4%) a Reported in greater than or equal to 5% of patients treated with ondansetron and at a rate that exceeded placebo.
Less Common Adverse Reactions Central Nervous System: Extrapyramidal reactions (less than 1% of patients).
Hepatic: Aspartate transaminase (AST) and/or alanine transaminase (ALT) values exceeded twice the upper limit of normal in approximately 1% to 2% of 723 patients receiving ondansetron and cyclophosphamide-based chemotherapy in US clinical trials.
5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions, Including Anaphylaxis and Bronchospasm : Discontinue ondansetron if suspected.
Monitor and treat promptly per standard of care until signs and symptoms resolve ( 5.1 ) QT Interval Prolongation and Torsade de Pointes : Avoid ondansetron tablets in patients with congenital long QT syndrome;
monitor with electrocardiograms (ECGs) if concomitant electrolyte abnormalities, cardiac failure or arrhythmias, or use of other QT prolonging drugs.
( 5.2 ) Serotonin Syndrome : Reported with 5-HT 3 receptor antagonists alone but particularly with concomitant use of serotonergic drugs.
If such symptoms occur, discontinue ondansetron and initiate supportive treatment.
Like all medications, Ondansetron Hydrochloride can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: