FDA label
What is ondansetron used for?
The FDA-approved uses of ondansetron, quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label for ondansetron (injection) lists 2 uses: Prevention of Nausea and Vomiting Associated With Initial and Repeat Courses of Emetogenic Cancer Chemotherapy; Prevention of Postoperative Nausea and/or Vomiting.
Run it in Rivvi
Which 2027 plans near you dropped or restricted ondansetron?
Tier changes and new prior auth, step therapy or quantity limits, plan by plan.
Free to start. Opens Rivvi, the AI workspace for healthcare teams.
Ondansetron Hydrochloride, tablet, film coated
Indications and Usage, quoted from the label by Aurobindo Pharma Limited (ANDA078539). Cross-references to other label sections are left out.
Ondansetron tablets are indicated for the prevention of nausea and vomiting associated with:
- highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2
- initial and repeat courses of moderately emetogenic cancer chemotherapy
- radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen
Ondansetron tablets are also indicated for the prevention of postoperative nausea and/or vomiting.
Source: DailyMed label, set id 57578387-1918-4e56-a564-f14fb22340bf, version 14, effective July 19, 2025. NDC 65862-187, one of 104 listings for this product.
Ondansetron, injection
Indications and Usage, quoted from the label by Hikma Pharmaceuticals USA Inc. (ANDA077541). Cross-references to other label sections are left out.
Prevention of Nausea and Vomiting Associated With Initial and Repeat Courses of Emetogenic Cancer Chemotherapy
Ondansetron Injection is indicated for the prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including high-dose cisplatin.
Ondansetron Injection is approved for patients aged 6 months and older.
Prevention of Postoperative Nausea and/or Vomiting
Ondansetron Injection is indicated for the prevention of postoperative nausea and/or vomiting. As with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients in whom nausea and/or vomiting must be avoided postoperatively, Ondansetron Injection is recommended even when the incidence of postoperative nausea and/or vomiting is low. For patients who do not receive prophylactic Ondansetron Injection and experience nausea and/or vomiting postoperatively, Ondansetron Injection may be given to prevent further episodes.
Ondansetron Injection is approved for patients aged 1 month and older.
Source: DailyMed label, set id c29ca6df-621d-44b6-98fc-b48666573366, version 17, effective April 9, 2026. NDC 0641-6078, one of 34 listings for this product.
Questions
What is ondansetron used for?
The FDA label for ondansetron (injection) lists 2 uses: Prevention of Nausea and Vomiting Associated With Initial and Repeat Courses of Emetogenic Cancer Chemotherapy; Prevention of Postoperative Nausea and/or Vomiting.
What drug class is ondansetron?
FDA lists ondansetron in the Serotonin-3 Receptor Antagonist established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.
More on Ondansetron
- Is Ondansetron a controlled substance?Federal schedule
- Generic for ZofranFDA Orange Book
- Generic for Zofran Preservative FreeFDA Orange Book
- Generic for Zofran ODTFDA Orange Book
- Serotonin-3 Receptor Antagonists listFDA drug class
- NDC 0054-0064Ondansetron NDC record
- NDC 0121-0882Ondansetron NDC record
- NDC 0121-4882Ondansetron NDC record