TheraRadar
Data updated: May 26, 2026

ONDANSETRON HYDROCHLORIDE

Gastrointestinal Approved 2006-11-22

Ondansetron hydrochloride is indicated for the prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy (including cisplatin $\ge$ 50 mg/m²) and moderately emetogenic chemotherapy. It is also used to prevent nausea and vomiting in patients receiving radiotherapy (total body irradiation or radiation to the abdomen) and in patients during the postoperative period.

Source: FDA Label • Pfizer
Jump to: Indications Approvals Trials Competitors Similar Safety Patents

How ONDANSETRON HYDROCHLORIDE Works

Ondansetron is a selective 5-HT3 receptor antagonist. It works by blocking serotonin receptors located peripherally on vagal nerve terminals and centrally in the chemoreceptor trigger zone of the area postrema. Cytotoxic chemotherapy triggers the release of serotonin from enterochromaffin cells in the small intestine, which stimulates vagal afferents via 5-HT3 receptors to initiate the vomiting reflex; ondansetron inhibits this pathway.

Source: FDA Label
26
Indications
--
Phase 3 Trials
19
Years on Market

Details

Status
Prescription
First Approved
2006-11-22
Routes
INJECTION, ORAL
Dosage Forms
INJECTABLE, TABLET, SOLUTION

Companies

Pfizer ONESOURCE SPECIALTY Aurobindo Pharma CHARTWELL MOLECULAR AVET LIFESCIENCES GLAND PHARMA LTD RISING Dr. Reddy's TARO Hikma Teva PLIVA HRVATSKA DOO Apotex CHARTWELL RX AM REGENT NATCO PHARMA LTD PHARM ASSOC QILU PHARM HAINAN Fresenius Kabi GLENMARK PHARMS LTD LUITPOLD AMNEAL PHARMS Sun Pharma Novartis WOCKHARDT BIO AG SAGENT PHARMS EUGIA PHARMA Baxter LANNETT CO INC ACCORD HLTHCARE CHARTWELL MOLECULES IPCA LABS LTD
Active Ingredient: ONDANSETRON HYDROCHLORIDE

ONDANSETRON HYDROCHLORIDE Approval History

2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
505 FDA actions from 2006 to 2026
Apr 2026 SUPPL
Label · Labeling
Apr 2026 SUPPL
Label · Labeling
Apr 2026 SUPPL
Mfg · Manufacturing (CMC)

What ONDANSETRON HYDROCHLORIDE Treats

4 indications

ONDANSETRON HYDROCHLORIDE is approved for 4 conditions since its original approval in 2006. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Nausea and vomiting from highly emetogenic chemotherapy
  • Nausea and vomiting from moderately emetogenic chemotherapy
  • Nausea and vomiting from radiotherapy
  • Postoperative nausea and vomiting
Source: FDA Label

ONDANSETRON HYDROCHLORIDE Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

Direct competitors

2

Same target(s) AND same indication — head-to-head.

SUSTOL
HERON THERAPS
2016 2 indic.
AKYNZEO
HELSINN HLTHCARE
2014 2 indic.

MoA expansion candidates

1

Same target(s), different indications — where else is this mechanism being explored?

ALOSETRON HYDROCHLORIDE
RISING
2015 2 indic.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

FOCINVEZ
STERISCIENCE
2023 2 indic.
APONVIE
HERON THERAPS
2022 2 indic.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to ONDANSETRON HYDROCHLORIDE

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

BARHEMSYS
AMISULPRIDE
1 shared
ACACIA
Shared indications:
Postoperative Nausea and Vomiting
📋

Clinical Trial Registry

3 trials
Trial Sponsor ID Phase Status Title
NCT03578081 results posted A221602 NCI-2017-02410, UG1CA189823 Ph 3 completed Olanzapine With or Without Fosaprepitant Dimeglumine in Preventing Chemotherapy Induced Nausea and Vomiting in Cancer Patients Receiving Highly Emetogenic Chemotherapy
NCT01578265 Ipca/ARL/127 Ph 1 completed Bioequivalence Study of Ondansetron Tablets USP 8 mg Under Fed Condition
NCT01578252 Ipca/ARL/126 Ph 1 completed Bioequivalence Study of Ondansetron Tablets USP 8 mg Under Fasting Condition
🔬

Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

ONDANSETRON HYDROCHLORIDE FDA Label Details

Indications & Usage

FDA Label (PDF)

ONDANSETRON HYDROCHLORIDE is indicated for the treatment of Nausea and vomiting from highly emetogenic chemotherapy; Nausea and vomiting from moderately emetogenic chemotherapy; Nausea and vomiting from radiotherapy; Postoperative nausea and vomiting.

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Data Sources

FDA Approval: ANDA077473 → Label: DailyMed → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.