Prescription medicine
Ondansetron First approved as Zofran
Ondansetron (Zofran) is a prescription medicine with an FDA approval on record since 1991. FDA's NDC Directory lists it from 77 generic labelers, and pharmacies paid $0.0582 per ondansetron HCl 4 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the ondansetron FDA label on DailyMed (effective January 8, 2026, Glenmark Pharmaceuticals Inc., USA); the NDA 20007 record on Drugs@FDA; every ondansetron label on DailyMed.
Highlights of the record
FDA label of January 8, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageOndansetron is 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 is also in
Forms and strengths
- 4 mg
- 8 mg
- 16 mg
- 24 mg
- 2 mg/ml
- 4 mg/5ml
- 4 mg/2ml
Film-coated tablet; orally disintegrating tablet; injection; solution; injection (solution).
On the market
- Earliest approval on file
- January 4, 1991 Zofran, Sandoz; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 76 first November 22, 2006; 36 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 77 of which 77 under generic applications, 0 under brand applications, repackagers included
- Last listed patent
- July 13, 2030 Zuplenz film; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.0582 per tablet Ondansetron HCl 4 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 15 since 2012 0 Class I among all firms' recalls; latest December 30, 2025; 6 more by firms not listed as its makers
- FAERS reports
- 121,842 through July 30, 2026
What is ondansetron used for?
From the label: indications and usageOndansetron is 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 is also indicated for the prevention of postoperative nausea and/or vomiting. Ondansetron is a 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 . […]
Conditions named in the indications of ondansetron's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Serotonin-3 Receptor Antagonist.
Source: FDA drug label (Ondansetron), Glenmark Pharmaceuticals Inc., USA, effective January 8, 2026 (SPL set eee5217a-eba8-463a-812d-bf3c66f0934f), via openFDA; the full label on DailyMed
Is there a generic for ondansetron (Zofran)?
The FDA approved the first generic ondansetron on November 22, 2006. 76 generic applications are approved; 36 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 2 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists ondansetron from 77 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Zofran injection; a patent listed only for Zuplenz film runs to July 13, 2030. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1991 earliest approval on file
- 2006 first generic approved
- 2030 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for ondansetron (Zofran)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0582 per Ondansetron HCl 4 mg tablet, down 14% from $0.0676 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Ondansetron HCl 4 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Ondansetron 4 mg/5 mL solution | Generic | $0.286 per mL | n/a | +1% |
| Ondansetron 40 mg/20 mL vial | Generic | $0.173 per mL | $3.46 per vial | +3% |
| Ondansetron HCl 4 mg tablet | Generic | $0.0582 per tablet | $1.75 | -14% |
| Ondansetron HCl 4 mg/2 mL vial | Generic | $0.176 per mL | $0.352 per vial | -17% |
| Ondansetron HCl 8 mg tablet | Generic | $0.0781 per tablet | $2.34 | -15% |
| Ondansetron ODT 4 mg tablet | Generic | $0.120 per tablet | $3.60 | -26% |
| Ondansetron ODT 8 mg tablet | Generic | $0.169 per tablet | $5.06 | -8% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has ondansetron been recalled?
The FDA's Enforcement Report lists 21 recalls naming ondansetron since 2012: 0 Class I (the most serious), 20 Class II, 1 Class III; 2 still ongoing. 6 of them are by firms that FDA's NDC Directory does not list as a maker of ondansetron and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| December 30, 2025 | Class II | Glenmark Pharmaceuticals Inc., USA | Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets … |
| November 17, 2025 | Class II | Preferred Pharmaceuticals, Inc. | Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets … |
| November 14, 2023 | Class II | Baxter Healthcare Corporation | Failed pH Specifications |
| December 27, 2022 | Class II | Sentara Infusion Services not a listed maker | Lack of sterility assurance |
| May 9, 2022 | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy | Lack of assurance of sterility. |
| April 13, 2022 | Class II | Mckesson Medical-Surgical Inc. Corporate Office | cGMP deviations: Temperature abuse |
| March 15, 2021 | Class II | Cardinal Health Inc. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. |
| June 19, 2019 | Class II | RXQ Compounding LLC not a listed maker | Lack of Assurance of Sterility |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the ondansetron label say about other medicines?
The ondansetron label names 14 other medicines in its interaction, contraindication or warning sections. The labels of 7 other medicines name ondansetron. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Apomorphine | contraindications | receiving concomitant apomorphine due to the risk of profound hypotension and loss of consciousness Patients known to have hypersensitivity (e.g., anaphylaxis) to ondansetron or any components of the formulation. |
| Atracurium | drug interactions | Ondansetron does not alter the respiratory depressant effects produced by alfentanil or the degree of neuromuscular blockade produced by atracurium. |
| Carbamazepine | drug interactions | In patients treated with potent inducers of CYP3A4 (i.e., phenytoin, carbamazepine, and rifampin), the clearance of ondansetron was significantly increased and ondansetron blood concentrations were decreased. |
| Carmustine | drug interactions | Chemotherapy Carmustine, etoposide, and cisplatin do not affect the pharmacokinetics of ondansetron. |
| Cisplatin | drug interactions | Chemotherapy Carmustine, etoposide, and cisplatin do not affect the pharmacokinetics of ondansetron. |
| Etoposide | drug interactions | Chemotherapy Carmustine, etoposide, and cisplatin do not affect the pharmacokinetics of ondansetron. |
| Fentanyl | warnings and precautions | Most reports have been associated with concomitant use of serotonergic drugs (e.g., selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors, mirtazapine, fentanyl, lithium, tramadol, and intravenous methylene blue). |
| Lithium | warnings and precautions | Most reports have been associated with concomitant use of serotonergic drugs (e.g., selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors, mirtazapine, fentanyl, lithium, tramadol, and intravenous methylene blue). |
| Methotrexate | drug interactions | In a crossover trial in 76 pediatric patients, intravenous ondansetron did not increase systemic concentrations of high-dose methotrexate. |
| Methylene blue | warnings and precautions | Most reports have been associated with concomitant use of serotonergic drugs (e.g., selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors, mirtazapine, fentanyl, lithium, tramadol, and intravenous methylene blue). |
| Mirtazapine | warnings and precautions | Most reports have been associated with concomitant use of serotonergic drugs (e.g., selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors, mirtazapine, fentanyl, lithium, tramadol, and intravenous methylene blue). |
| Phenytoin | drug interactions | In patients treated with potent inducers of CYP3A4 (i.e., phenytoin, carbamazepine, and rifampin), the clearance of ondansetron was significantly increased and ondansetron blood concentrations were decreased. |
| Rifampin | drug interactions | In patients treated with potent inducers of CYP3A4 (i.e., phenytoin, carbamazepine, and rifampin), the clearance of ondansetron was significantly increased and ondansetron blood concentrations were decreased. |
| Tramadol | drug interactions | Although no pharmacokinetic drug interaction between ondansetron and tramadol has been observed, data from 2 small trials indicate that when used together, ondansetron may increase patient-controlled administration of tramadol. |
Other labels that name ondansetron
Source: FDA drug label (Ondansetron), Glenmark Pharmaceuticals Inc., USA, effective January 8, 2026 (SPL set eee5217a-eba8-463a-812d-bf3c66f0934f), via openFDA; the full label on DailyMed
What do FAERS reports show for ondansetron?
The FDA Adverse Event Reporting System holds 121,842 reports that list ondansetron among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 15,159 are coded as a death and 53,916 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as ondansetron?
7 other medicines are given the same way (oral) and in the same FDA class as ondansetron or labeled mainly for the same use (nausea and vomiting), the same class first. Nausea and vomiting lists all 16 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Meclizine | Nausea and vomiting | 24 labelers | $0.0442 per tablet 12.5 mg tablet | No current entry |
| Prochlorperazine | Nausea and vomiting | 29 labelers | $0.162 per tablet 10 mg tablet | No current entry |
| Dimenhydrinate | Nausea and vomiting | none listed | $0.0575 per tablet 50 mg tablet | No current entry |
| Aprepitant | Nausea and vomiting | 5 labelers | $46.42 per capsule 40 mg capsule | A presentation being discontinued |
| Doxylamine and pyridoxine | Nausea and vomiting | 4 labelers | $1.09 per unit 10-10 mg | No current entry |
| Trimethobenzamide | Nausea and vomiting | 4 labelers | n/a | No current entry |
| Tradipitant | Nausea and vomiting | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as ondansetron
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does ondansetron compare with medicines for the same use?
6 side-by-side pages set ondansetron beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to ondansetron
- 7 medicines for the same use
- Other serotonin-3 receptor antagonists
- the pharmacologic class, with prices and generics
- Ondansetron side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other