Ondansetron
Serotonin (5ht3) Antagonists
Sold as ZOFRAN ODT · ONDISSOLVE ODF
- Drug class
- Serotonin (5ht3) Antagonists
- Availability
- Prescription only
- Routes
- Oral, Intravenous
- Markets covered
- 3
- Products on record
- 153
- FDA reports (12 mo)
- 9,947
Overview
Plain-language summary, compiled from the cited regulatory records
Ondansetron is a medication classified as a Serotonin (5ht3) Antagonist [1]. It is approved for the prevention of nausea and vomiting associated with certain medical treatments [1]. This includes highly emetogenic cancer chemotherapy, such as cisplatin at doses greater than or equal to 50 mg/m², and initial and repeat courses of moderately emetogenic cancer chemotherapy [1]. Ondansetron is also indicated for preventing nausea and vomiting associated with radiotherapy, including total body irradiation, single high-dose fractions to the abdomen, or daily fractions to the abdomen [1]. Additionally, it is approved for the prevention of postoperative nausea and vomiting [1].
In the past 12 months, there have been 9,947 adverse event reports associated with ondansetron [2]. Common adverse events reported include nausea, fatigue, off-label use, diarrhea, and vomiting [2]. Ondansetron is available under various brand names in this market [1].
This is not medical advice. Consult a qualified healthcare professional.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| CA Canada | Health Canada | 79 | February 4, 2026 |
| GB United Kingdom | MHRA | 60 | April 24, 2026 |
| US United States | FDA | 14 | January 26, 2026 |
CACanada· Health Canada
79 products
Uses
5 Missed Dose 09/2024 7 WARNINGS AND PRECAUTIONS, Serotonin Toxicity/Neuroleptic Malignant Syndrome 09/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ..............................................................................................
2 TABLE OF CONTENTS ................................................................................................................ 2 PART I: HEALTH PROFESSIONAL INFORMATION........................................................................
4 1 INDICATIONS ................................................................................................................. 1 Pediatrics (<18 years of age) .....................................................................................
2 Geriatrics .................................................................................................................. 4 2 CONTRAINDICATIONS ...................................................................................................
GBUnited Kingdom· MHRA
60 products
Uses
Adults:
Ondansetron is indicated for the management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy. Ondansetron is indicated for the prevention of post-operative nausea and vomiting (PONV). For treatment of established PONV, administration by injection is recommended.
Paediatric Population:
Ondansetron is indicated for the management of chemotherapy-induced nausea and vomiting (CINV) in children aged ≥6 months No studies have been conducted on the use of orally administered ondansetron in the prevention and treatment of PONV in children aged ≥1 month, administration by IV injection is recommended for this purpose.
USUnited States· FDA
14 products
Uses
1 INDICATIONS AND USAGE 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/m 2 . 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.
Ondansetron tablets are 5-HT 3 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/m 2 (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)
Drug interactions
Known interactions involving Ondansetron. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 600. Type above to find a specific drug.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]Health Canada (DPD) · 02258188 · revised March 22, 2025
- [2]MHRA (UK) · PL393070109 · revised October 31, 2025
- [3]FDA DailyMed · 00327696-c496-4c… · revised April 24, 2024 [PDF]
- [4]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.