Ondansetron 4 mg Tablets — Generic For Zofran — Rising Pharma

These highlights do not include all the information needed to use ONDANSETRON TABLETS safely and effectively. See full prescribing information for ONDANSETRON TABLETS.

ONDANSETRON tablets, for oral use

Initial U.S. Approval: 1991

Indications And Usage

Ondansetron tablets are a 5-HT3 receptor antagonist indicated for the prevention of:

nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2. (1)

nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy. (1)

nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen. (1)

postoperative nausea and/or vomiting. (1)

Dosage And Administration

See full prescribing information for the recommended dosage in adults and pediatrics. (2)

Patients with severe hepatic impairment: do not exceed a total daily dose of 8 mg. (2.2, 8.6)

Dosage Forms And Strengths

Tablets: 4 mg and 8 mg. (3)

Contraindications

Patients known to have hypersensitivity (e.g., anaphylaxis) to ondansetron or any components of the formulation. (4)

Concomitant use of apomorphine. (4)

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 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-HT3 receptor antagonists alone but particularly with concomitant use of serotonergic drugs. If such symptoms occur, discontinue ondansetron and initiate supportive treatment. If concomitant use of ondansetron with other serotonergic drugs is clinically warranted, patients should be made aware of a potential increased risk for serotonin syndrome. (5.3)
• Myocardial Ischemia: Monitor or advise patients for signs and symptoms of myocardial ischemia after oral administration. (5.4)
• Masking of Progressive Ileus and/or Gastric Distension Following Abdominal Surgery or Chemotherapy-Induced Nausea and Vomiting: Monitor for decreased bowel activity, particularly in patients with risk factors for gastrointestinal obstruction. (5.5)

• 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 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-HT3 receptor antagonists alone but particularly with concomitant use of serotonergic drugs. If such symptoms occur, discontinue ondansetron and initiate supportive treatment. If concomitant use of ondansetron with other serotonergic drugs is clinically warranted, patients should be made aware of a potential increased risk for serotonin syndrome. (5.3)
• Myocardial Ischemia: Monitor or advise patients for signs and symptoms of myocardial ischemia after oral administration. (5.4)
• Masking of Progressive Ileus and/or Gastric Distension Following Abdominal Surgery or Chemotherapy-Induced Nausea and Vomiting: Monitor for decreased bowel activity, particularly in patients with risk factors for gastrointestinal obstruction. (5.5)

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 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-HT3 receptor antagonists alone but particularly with concomitant use of serotonergic drugs. If such symptoms occur, discontinue ondansetron and initiate supportive treatment. If concomitant use of ondansetron with other serotonergic drugs is clinically warranted, patients should be made aware of a potential increased risk for serotonin syndrome. (5.3)

Myocardial Ischemia: Monitor or advise patients for signs and symptoms of myocardial ischemia after oral administration. (5.4)

Masking of Progressive Ileus and/or Gastric Distension Following Abdominal Surgery or Chemotherapy-Induced Nausea and Vomiting: Monitor for decreased bowel activity, particularly in patients with risk factors for gastrointestinal obstruction. (5.5)

Adverse Reactions

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 Rising Pharma Holdings, Inc. at 1-844-874-7464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 9/2025