{
 "query": "ondansetron",
 "ingredient": "ondansetron",
 "slug": "ondansetron",
 "rxcui": "26225",
 "brands": [],
 "names": [
  "ondansetron",
  "ondansetron hydrochloride",
  "ondansetron hydrochloride anhydrous"
 ],
 "classes": [
  {
   "id": "A04AA",
   "name": "Serotonin (5HT3) antagonists"
  }
 ],
 "alternatives": [
  "dolasetron",
  "granisetron",
  "palonosetron",
  "tropisetron"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 176,
   "INTRAMUSCULAR": 39,
   "INTRAVENOUS": 39
  },
  "boxed_warning": "",
  "indications_and_usage": "Ondansetron 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 . ( 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 )",
  "contraindications": "Ondansetron is contraindicated in patients: known to have hypersensitivity (e.g., anaphylaxis) to ondansetron or any of the components of the formulation [see Adverse Reactions (6.2) ]. 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. ( 4 ) Concomitant use of apomorphine. ( 4 )",
  "warnings_and_cautions": "Hypersensitivity Reactions Including Anaphylaxis and Bronchospasm: Discontinue ondansetron if suspected. Monitor and treat promptly per standard of care until signs and symptoms resolve. ( 5.1 ) QT Interval Prolongation and Torsade de Pointes: Avoid ondansetron in patients with congenital long QT syndrome; monitor with electrocardiograms (ECGs) if concomitant electrolyte abnormalities, cardiac failure or arrhythmias, or use of other QT prolonging drugs. ( 5.2 ) Serotonin Syndrome: Reported with 5-HT 3 receptor antagonists alone but particularly with concomitant use of serotonergic drugs. If such symptoms occur, discontinue ondansetron and initiate supportive treatment. If concomitant use of ondansetron with other serotonergic drugs is clinically warranted, patients should be made aware of a potential increased risk for serotonin syndrome. ( 5.3 ) Myocardial Ischemia: Monitor or advise patients for signs and symptoms of myocardial ischemia after oral administration. ( 5.4 ) Masking of Progressive Ileus and/or Gastric Distention Following Abdominal Surgery or Chemotherapy-induced Nausea and Vomiting: Monitor for decreased bowel activity, particularly in patients with risk factors for...",
  "warnings": "",
  "adverse_reactions": "The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] QT Prolongation [see Warnings and Precautions (5.2) ] Serotonin Syndrome [see Warnings and Precautions (5.3) ] Myocardial Ischemia [see Warnings and Precautions (5.4) ] Masking of Progressive Ileus and Gastric Distension [see Warnings and Precautions (5.5) ] The most common adverse reactions in adults for the: prevention of chemotherapy-induced (greater than or equal to 5%) are: headache, malaise/fatigue, constipation, diarrhea. ( 6.1 ) prevention of radiation-induced nausea and vomiting (greater than or equal to 2%) are: headache, constipation, and diarrhea. ( 6.1 ) prevention of postoperative nausea and vomiting (greater than or equal to 9%) are: headache and hypoxia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Precision Dose, Inc. at 1-800-397-9228 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the cli...",
  "drug_abuse_and_dependence": "Animal studies have shown that ondansetron is not discriminated as a benzodiazepine nor does it substitute for benzodiazepines in direct addiction studies.",
  "controlled_substance": "",
  "recent_major_changes": "Warnings and Precautions, Myocardial Ischemia ( 5.4 ) 10/2021",
  "information_for_patients": "Hypersensitivity Reactions: Inform patients that ondansetron may cause hypersensitivity reactions, some as severe as anaphylaxis and bronchospasm. Instruct patients to immediately report any signs and symptoms of hypersensitivity reactions, including fever, chills, rash, or breathing problems to their healthcare provider [see Warnings and Precautions (5.1) ]. QT Prolongation: Inform patients that ondansetron may cause serious cardiac arrhythmias, such as QT prolongation. Instruct patients to tell their healthcare provider right away if they perceive a change in their heart rate, if they feel lightheaded, or if they have a syncopal episode [see Warnings and Precautions (5.2) ]. Drug Interactions: Instruct the patient to report the use of all medications, especially apomorphine, to their healthcare provider. Concomitant use of apomorphine and ondansetron may cause a significant drop in blood pressure and loss of consciousness. Advise patients of the possibility of serotonin syndrome with concomitant use of ondansetron and another serotonergic agent, such as medications to treat depression and migraines. Advise patients to seek immediate medical attention if the following symptoms occ...",
  "spl_medguide": "",
  "clinical_studies": "14.1 Prevention of Chemotherapy-Induced Nausea and Vomiting Highly Emetogenic Chemotherapy: In two randomized, double-blind, monotherapy trials, a single 24-mg oral dose of ondansetron was superior to a relevant historical placebo control in the prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m 2 . Steroid administration was excluded from these clinical trials. More than 90% of patients receiving a cisplatin dose greater than or equal to 50 mg/m 2 in the historical-placebo comparator experienced vomiting in the absence of antiemetic therapy. The first trial compared oral doses of ondansetron 24 mg as a single dose, 8 mg every 8 hours for 2 doses, and 32 mg as a single dose in 357 adult cancer patients receiving chemotherapy regimens containing cisplatin greater than or equal to 50 mg/m 2 . The first or single dose was administered 30 minutes prior to chemotherapy. A total of 66% of patients in the ondansetron 24-mg once-a-day group, 55% in the ondansetron 8-mg twice-a-day group, and 55% in the ondansetron 32-mg once-a-day group completed the 24-hour trial period with 0 emetic episodes and no...",
  "brand_name": "Ondansetron Hydrochloride",
  "manufacturer": "Precision Dose Inc.",
  "application_number": "ANDA076960",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20250530",
  "set_id": "04800a86-2391-44e6-8763-d65e8a916c26",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 181672,
  "serious": 134782,
  "death": 21301,
  "hospitalization": 73904,
  "primary_suspect": 181304,
  "top_reactions": [
   [
    "Nausea",
    23252
   ],
   [
    "Fatigue",
    16782
   ],
   [
    "Diarrhoea",
    14744
   ],
   [
    "Vomiting",
    13295
   ],
   [
    "Off Label Use",
    11787
   ],
   [
    "Death",
    9448
   ],
   [
    "Headache",
    8972
   ],
   [
    "Dyspnoea",
    8673
   ],
   [
    "Pain",
    8509
   ],
   [
    "Pyrexia",
    7692
   ],
   [
    "Constipation",
    7573
   ],
   [
    "Asthenia",
    7404
   ],
   [
    "Drug Ineffective",
    6823
   ],
   [
    "Decreased Appetite",
    6786
   ],
   [
    "Pneumonia",
    6334
   ]
  ],
  "by_year": {
   "2019": 18220,
   "2020": 18563,
   "2021": 16726,
   "2022": 15347,
   "2023": 14945,
   "2024": 15091,
   "2025": 15103,
   "2026": 7444
  },
  "by_year_primary": {
   "2019": 18217,
   "2020": 18561,
   "2021": 16702,
   "2022": 15256,
   "2023": 14863,
   "2024": 15033,
   "2025": 15043,
   "2026": 7416
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20251230",
   "reason": "Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged th",
   "firm": "Glenmark Pharmaceuticals Inc., USA",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20231114",
   "reason": "Failed pH Specifications",
   "firm": "Baxter Healthcare Corporation",
   "status": "Completed"
  },
  {
   "class": "Class II",
   "date": "20220413",
   "reason": "cGMP deviations: Temperature abuse",
   "firm": "Mckesson Medical-Surgical Inc. Corporate Office",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20190522",
   "reason": "Failed Impurities/Degradation Specifications.",
   "firm": "Fresenius Kabi USA, LLC",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20130924",
   "reason": "Presence of Particular Matter: Potential vendor glass issue - glass spiticules (glass strands) were identified during site inspection of the vials.",
   "firm": "Hospira Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20130520",
   "reason": "Presence of Particulate; lot being recalled as a precaution due to the discovery of 2 particles found in a lot which preceded the recalled lot",
   "firm": "Hospira, Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20120927",
   "reason": "Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.",
   "firm": "Fresenius Kabi USA, LLC",
   "status": "Terminated"
  }
 ],
 "recall_total": 7,
 "drugsfda": {
  "applications": 85,
  "nda": 6,
  "anda": 76,
  "first_approval": "19910104",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 98,
  "labeling_recent": 13,
  "sponsors": [
   "ACCORD HLTHCARE",
   "AM REGENT",
   "AMNEAL PHARMS",
   "APOTEX",
   "APOTEX INC",
   "AQUESTIVE",
   "AUROBINDO PHARMA",
   "AVET LIFESCIENCES"
  ],
  "unapproved": false,
  "first_approval_fmt": "01/04/1991"
 },
 "trials": {
  "total": 669,
  "completed": 420,
  "terminated": 61,
  "with_results": 142,
  "industry": 141,
  "phase3": 115,
  "results_share": 0.3380952380952381,
  "terminated_share": 0.09118086696562033
 },
 "pubmed": {
  "rct": 850,
  "meta": 63,
  "recent_rct": 58,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "ondansetron"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 9110105,
  "beneficiaries": 5197792,
  "spend": 141815896.12,
  "by_brand": [
   {
    "brand": "Ondansetron ODT",
    "claims": 4929800,
    "per_claim": 14.794311601,
    "is_generic": false
   },
   {
    "brand": "Ondansetron HCl",
    "claims": 4180305,
    "per_claim": 16.477960051,
    "is_generic": true
   }
  ],
  "per_claim": 15.566878331259629
 },
 "mdl": [],
 "dsc": [
  {
   "date": "20121204",
   "title": "Updated information on 32 mg intravenous ondansetron (Zofran) dose and pre-mixed ondansetron products",
   "url": "https://www.fda.gov/Drugs/DrugSafety/ucm330049.htm",
   "kind": "drug",
   "matched": "ondansetron"
  },
  {
   "date": "20120629",
   "title": "New information regarding QT prolongation with ondansetron (Zofran)",
   "url": "https://www.fda.gov/Drugs/DrugSafety/ucm310190.htm",
   "kind": "drug",
   "matched": "ondansetron"
  },
  {
   "date": "20110915",
   "title": "Zofran (ondansetron) - Abnormal heart rhythms may be associated with use of Zofran (ondansetron)",
   "url": "https://www.fda.gov/Drugs/DrugSafety/ucm271913.htm",
   "kind": "drug",
   "matched": "ondansetron"
  }
 ],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "ondansetron",
  "matched": "ondansetron",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 37492,
  "fills": 9110105,
  "per_million": 4115.430063649102,
  "ratio": 1.4862783472381367,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 72,
   "letter": "C",
   "why": [
    "FDA issued 3 Drug Safety Communication(s) naming this drug since 2010, most recently 2012 (-20)",
    "4,115 FDA reports naming it as the suspect drug per million Medicare fills, 1.5x the median drug on this site (-3)",
    "Death share in reports is near or below the FAERS average (1.3x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 68,
   "letter": "C",
   "why": [
    "850 randomized trials and 63 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "No Cochrane review found (-5)",
    "Only 34% of completed registered trials posted results (-15)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 82,
   "letter": "B",
   "why": [
    "Recalls since 2016: 0 Class I, 3 Class II, 1 Class III across 76 generic makers (-5)",
    "13 label changes approved since 2021: the safety story is still moving (-8)",
    "Label lists recent major changes to warnings or indications (-5)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 100,
   "letter": "A",
   "why": [
    "Pharma paid doctors $0 tied to this drug last year: negligible",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 100,
   "letter": "A",
   "why": [
    "Generic versions approved (76 applications)",
    "4 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 80,
 "grade": "B",
 "questions": [
  "In 2012 the FDA issued a safety communication about this drug (Updated information on 32 mg intravenous ondansetron (Zofran) dose and pre-mixed ondansetron products). Does that risk apply to me?",
  "The most-reported problems in FDA's adverse event data are nausea, fatigue, diarrhoea, vomiting. How would we recognize and handle those?",
  "Off-label use is among the most-reported items for this drug. Is my use on-label, and if not, what evidence supports it?",
  "Why this one over dolasetron, granisetron, palonosetron? What would make you pick one of those instead?",
  "What result are we expecting, by when, and what is the plan if it does not happen?",
  "If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)"
 ]
}