Ondansetron
Ondansetron (ondansetron) is a small molecule pharmaceutical. Ondansetron was first approved as Zofran on 1991-01-04. It is used to treat alcoholism in the USA.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| chemically-induced disorders | D064419 |
| mental disorders | D001523 |
Trade Name
FDA
EMA
Ondansetron (discontinued: Ondansetron, Zofran, Zuplenz)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Ondansetron hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER | GSK | N-020403 DISCN | 1995-01-31 | 1 products, RLD |
| ZOFRAN | Sandoz | N-020007 DISCN | 1991-01-04 | 1 products, RLD |
| ZOFRAN PRESERVATIVE FREE | Sandoz | N-020007 DISCN | 1993-12-10 | 1 products, RLD |
| ZOFRAN | Sandoz | N-020103 DISCN | 1992-12-31 | 3 products, RLD |
| ZOFRAN | Sandoz | N-020605 DISCN | 1997-01-24 | 1 products, RLD |
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Ondansetron
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ZUPLENZ | Aquestive Therapeutics | N-022524 DISCN | 2010-07-02 | 2 products, RLD |
| ZOFRAN ODT | Sandoz | N-020781 DISCN | 1999-01-27 | 2 products, RLD |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| mko melt dose pack | unapproved drug other | 2019-03-04 |
| ondansetron | ANDA | 2025-08-27 |
| ondansetron hcl | ANDA | 2024-12-31 |
| ondansetron hydrochloride | ANDA | 2025-08-21 |
| ondansetron hydrochloride ondansetron hydrochloride | ANDA | 2025-01-27 |
| ondansetron ondansetron hydrochloride | ANDA | 2025-06-12 |
| sumansetron | unapproved drug other | 2023-01-11 |
| zofran | ANDA | 2021-10-01 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| alcoholism | EFO_0003829 | D000437 | F10.1 |
Agency Specific
FDA
EMA
No data
HCPCS
Code | Description |
|---|---|
| J2405 | Injection, ondansetron hydrochloride, per 1 mg |
| Q0162 | Ondansetron 1 mg, oral, fda approved prescription anti-emetic, for use as a complete therapeutic substitute for an iv anti-emetic at the time of chemotherapy treatment, not to exceed a 48 hour dosage regimen |
| S0119 | Ondansetron, oral, 4 mg (for circumstances falling under the medicare statute, use hcpcs q code) |
Clinical
Clinical Trials
608 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Vomiting | D014839 | — | R11.1 | 16 | 41 | 61 | 52 | 56 | 222 |
| Nausea | D009325 | — | R11.0 | 15 | 36 | 38 | 45 | 39 | 170 |
| Postoperative nausea and vomiting | D020250 | EFO_0004888 | — | 5 | 17 | 12 | 37 | 38 | 107 |
| Postoperative pain | D010149 | — | G89.18 | 1 | 2 | 1 | 12 | 33 | 48 |
| Neoplasms | D009369 | — | C80 | 5 | 4 | 9 | 5 | 6 | 29 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 6 | 5 | 3 | 7 | 20 |
| Anesthesia | D000758 | — | — | — | — | 4 | 3 | 10 | 17 |
| Hypotension | D007022 | EFO_0005251 | I95 | 1 | 2 | 6 | 4 | 6 | 17 |
| Gastroenteritis | D005759 | EFO_1001463 | K52.9 | 1 | 1 | 7 | 4 | 4 | 16 |
| Alcoholism | D000437 | EFO_0003829 | F10.1 | 1 | 9 | 4 | 1 | 1 | 15 |
Show 100 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lymphoma | D008223 | — | C85.9 | 4 | 7 | 1 | — | 3 | 13 |
| Syndrome | D013577 | — | — | 1 | 3 | 4 | — | 2 | 9 |
| Multiple myeloma | D009101 | — | C90.0 | 2 | 2 | 2 | — | 2 | 7 |
| Leukemia | D007938 | — | C95 | 2 | 4 | 1 | — | 1 | 6 |
| Myelodysplastic syndromes | D009190 | — | D46 | 2 | 4 | 1 | — | 1 | 6 |
| Schizophrenia | D012559 | EFO_0000692 | F20 | 2 | 1 | 2 | — | 1 | 6 |
| Myeloid leukemia acute | D015470 | — | C92.0 | — | 3 | 1 | — | 1 | 5 |
| Preleukemia | D011289 | — | — | 1 | 3 | 1 | — | 1 | 5 |
| Myeloproliferative disorders | D009196 | — | D47.1 | 1 | 2 | 1 | — | 2 | 5 |
| Laparoscopy | D010535 | — | — | — | — | 2 | — | 3 | 5 |
Show 48 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 2 | 5 | — | — | 2 | 9 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 2 | 2 | — | — | 1 | 5 |
| Cocaine-related disorders | D019970 | — | F14 | — | 3 | — | — | 2 | 5 |
| Glioma | D005910 | EFO_0000520 | — | 1 | 4 | — | — | — | 4 |
| Hodgkin disease | D006689 | — | C81 | 2 | 2 | — | — | 1 | 4 |
| Large b-cell lymphoma diffuse | D016403 | — | C83.3 | — | 3 | — | — | 1 | 4 |
| Bcr-abl positive chronic myelogenous leukemia | D015464 | EFO_0000340 | — | 1 | 3 | — | — | — | 3 |
| Myeloid leukemia | D007951 | — | C92 | — | 3 | — | — | — | 3 |
| Mantle-cell lymphoma | D020522 | — | C83.1 | 1 | 2 | — | — | 1 | 3 |
| Burkitt lymphoma | D002051 | — | C83.7 | — | 2 | — | — | 1 | 3 |
Show 87 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 17 | — | — | — | 2 | 19 |
| Malnutrition | D044342 | EFO_0008572 | E40-E46 | 4 | — | — | — | 1 | 5 |
| Traumatic brain injuries | D000070642 | — | S06 | 2 | — | — | — | 2 | 4 |
| Brain injuries | D001930 | — | S06.9 | 2 | — | — | — | 2 | 4 |
| Brain concussion | D001924 | — | S06.0 | 1 | — | — | — | 2 | 3 |
| Disease | D004194 | EFO_0000408 | R69 | 3 | — | — | — | — | 3 |
| Covid-19 | D000086382 | — | U07.1 | 1 | — | — | — | — | 1 |
| Post-concussion syndrome | D038223 | EFO_1001827 | F07.81 | 1 | — | — | — | — | 1 |
| Fasting | D005215 | EFO_0002756 | — | 1 | — | — | — | — | 1 |
| Dyspnea | D004417 | — | R06.0 | 1 | — | — | — | — | 1 |
Show 3 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Inguinal hernia | D006552 | HP_0000023 | K40 | — | — | — | — | 5 | 5 |
| Hernia | D006547 | — | K40-K46 | — | — | — | — | 3 | 3 |
| Male breast neoplasms | D018567 | — | — | — | — | — | — | 3 | 3 |
| Conduction anesthesia | D000765 | — | — | — | — | — | — | 3 | 3 |
| Coronary artery disease | D003324 | — | I25.1 | — | — | — | — | 2 | 2 |
| Cardiac surgical procedures | D006348 | — | — | — | — | — | — | 2 | 2 |
| Arthritis | D001168 | EFO_0005856 | M05-M14 | — | — | — | — | 2 | 2 |
| Substance withdrawal syndrome | D013375 | EFO_0005800 | — | — | — | — | — | 2 | 2 |
| Postoperative period | D011184 | — | — | — | — | — | — | 2 | 2 |
| Pain management | D059408 | — | — | — | — | — | — | 2 | 2 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Ondansetron |
| INN | ondansetron |
| Description | Ondansetron is a member of carbazoles. |
| Classification | Small molecule |
| Drug class | serotonin 5-HT3 receptor antagonists |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | Cc1nccn1CC1CCc2c(c3ccccc3n2C)C1=O |
Identifiers
| PDB | — |
| CAS-ID | 99614-02-5 |
| RxCUI | — |
| ChEMBL ID | CHEMBL46 |
| ChEBI ID | 7773 |
| PubChem CID | 4595 |
| DrugBank | DB00904 |
| UNII ID | 4AF302ESOS (ChemIDplus, GSRS) |
Target
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Variants
No data
Financial
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Zuplenz – Par Pharmaceutical
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Estimated US medical usage
Ondansetron
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Number of persons purchased
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Number of purchases
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 16,704 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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28,383 adverse events reported
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