{
 "query": "sumatriptan",
 "ingredient": "sumatriptan",
 "slug": "sumatriptan",
 "rxcui": "37418",
 "brands": [
  "Tosymra",
  "Imitrex",
  "Onzetra",
  "Zembrace"
 ],
 "names": [
  "sumatriptan",
  "sumatriptan succinate"
 ],
 "classes": [
  {
   "id": "N02CC",
   "name": "Selective serotonin (5HT1) agonists"
  }
 ],
 "alternatives": [
  "almotriptan",
  "eletriptan",
  "frovatriptan",
  "lasmiditan",
  "naratriptan",
  "rizatriptan",
  "zolmitriptan"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 54,
   "SUBCUTANEOUS": 27,
   "NASAL": 9
  },
  "boxed_warning": "",
  "indications_and_usage": "Sumatriptan tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: \u2022 Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with sumatriptan tablets, reconsider the diagnosis of migraine before sumatriptan tablets are administered to treat any subsequent attacks. \u2022 Sumatriptan tablets are not indicated for the prevention of migraine attacks. \u2022 Safety and effectiveness of sumatriptan tablets have not been established for cluster headache. Sumatriptan tablets are a serotonin (5-HT 1B/1D ) receptor agonist (triptan) indicated for acute treatment of migraine with or without aura in adults. ( 1 ) Limitations of Use: \u2022 Use only if a clear diagnosis of migraine headache has been established. ( 1 ) \u2022 Not indicated for the prophylactic therapy of migraine attacks. ( 1 ) \u2022 Not indicated for the treatment of cluster headache. ( 1 )",
  "contraindications": "Sumatriptan tablets are contraindicated in patients with: \u2022 Ischemic coronary artery disease (CAD) (angina pectoris, history of myocardial infarction, or documented silent ischemia) or coronary artery vasospasm, including Prinzmetal\u2019s angina [see Warnings and Precautions (5.1) ] \u2022 Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders [see Warnings and Precautions (5.2) ] \u2022 History of stroke or transient ischemic attack (TIA) or history of hemiplegic or basilar migraine because these patients are at a higher risk of stroke [see Warnings and Precautions (5.4) ] \u2022 Peripheral vascular disease [see Warnings and Precautions (5.5) ] \u2022 Ischemic bowel disease [see Warnings and Precautions (5.5) ] \u2022 Uncontrolled hypertension [see Warnings and Precautions (5.8) ] \u2022 Recent use (i.e., within 24 hours) of ergotamine-containing medication, ergot-type medication (such as dihydroergotamine or methysergide), or another 5-hydroxytryptamine 1 (5-HT 1 ) agonist [see Drug Interactions (7.1 , 7.3) ] \u2022 Concurrent administration of a monoamine oxidase (MAO)-A inhibitor or recent (within 2 weeks) use of an MAO-A inhibitor [ see Drug Interactions (...",
  "warnings_and_cautions": "\u2022 Myocardial ischemia/infarction and Prinzmetal\u2019s angina: Perform cardiac evaluation in patients with multiple cardiovascular risk factors. ( 5.1 ) \u2022 Arrhythmias: Discontinue sumatriptan if occurs. ( 5.2 ) \u2022 Chest/throat/neck/jaw pain, tightness, pressure, or heaviness: Generally not associated with myocardial ischemia; evaluate for coronary artery disease in patients at high risk. ( 5.3 ) \u2022 Cerebral hemorrhage, subarachnoid hemorrhage, and stroke: Discontinue sumatriptan if occurs. ( 5.4 ) \u2022 Gastrointestinal ischemic reactions and peripheral vasospastic reactions: Discontinue sumatriptan if occurs. ( 5.5 ) \u2022 Medication overuse headache: Detoxification may be necessary. ( 5.6 ) \u2022 Serotonin syndrome: Discontinue sumatriptan if occurs. ( 5.7 ) \u2022 Seizures: Use with caution in patients with epilepsy or a lowered seizure threshold. ( 5.10 ) 5.1 Myocardial Ischemia, Myocardial Infarction, and Prinzmetal\u2019s Angina The use of sumatriptan tablets is contraindicated in patients with ischemic or vasospastic CAD. There have been rare reports of serious cardiac adverse reactions, including acute myocardial infarction, occurring within a few hours following administration of sumatriptan tablets. ...",
  "warnings": "",
  "adverse_reactions": "The following adverse reactions are discussed in more detail in other sections of the prescribing information: \u2022 Myocardial ischemia, myocardial infarction, and Prinzmetal\u2019s angina [see Warnings and Precautions (5.1) ] \u2022 Arrhythmias [see Warnings and Precautions (5.2) ] \u2022 Chest, throat, neck, and/or jaw pain/tightness/pressure [see Warnings and Precautions (5.3) ] \u2022 Cerebrovascular events [see Warnings and Precautions (5.4) ] \u2022 Other vasospasm reactions [see Warnings and Precautions (5.5) ] \u2022 Medication overuse headache [see Warnings and Precautions (5.6) ] \u2022 Serotonin syndrome [see Warnings and Precautions (5.7) ] \u2022 Increase in blood pressure [see Warnings and Precautions (5.8) ] \u2022 Hypersensitivity reactions [see Contraindications (4) , Warnings and Precautions (5.9) ] \u2022 Seizures [see Warnings and Precautions (5.10) ] Most common adverse reactions (\u2265 2% and > placebo) were paresthesia, warm/cold sensation, chest pain/tightness/pressure and/or heaviness, neck/throat/jaw pain/tightness/pressure, other sensations of pain/pressure/tightness/heaviness, vertigo, and malaise/fatigue. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Viatris at 1-877-446-3679 (1-877-4-INFO-RX) or FDA...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling (Patient Information) . Risk of Myocardial Ischemia and/or Infarction, Prinzmetal\u2019s Angina, Other Vasospasm-Related Events, Arrhythmias, and Cerebrovascular Events Inform patients that sumatriptan tablets may cause serious cardiovascular side effects such as myocardial infarction or stroke. Although serious cardiovascular events can occur without warning symptoms, patients should be alert for the signs and symptoms of chest pain, shortness of breath, irregular heartbeat, significant rise in blood pressure, weakness, and slurring of speech, and should ask for medical advice if any indicative sign or symptoms are observed. Apprise patients of the importance of this follow-up [see Warnings and Precautions (5.1 , 5.2 , 5.4 , 5.5 , 5.8) ] . Anaphylactic/Anaphylactoid Reactions Inform patients that anaphylactic/anaphylactoid reactions have occurred in patients receiving sumatriptan tablets. Such reactions can be life-threatening or fatal. In general, anaphylactic reactions to drugs are more likely to occur in individuals with a history of sensitivity to multiple allergens [see Contraindications (4) , Warnings and Precautions (5...",
  "spl_medguide": "",
  "clinical_studies": "The efficacy of sumatriptan tablets in the acute treatment of migraine headaches was demonstrated in 3 randomized, double-blind, placebo-controlled trials. Patients enrolled in these 3 trials were predominately female (87%) and Caucasian (97%), with a mean age of 40 years (range: 18 to 65 years). Patients were instructed to treat a moderate to severe headache. Headache response, defined as a reduction in headache severity from moderate or severe pain to mild or no pain, was assessed up to 4 hours after dosing. Associated symptoms such as nausea, photophobia, and phonophobia were also assessed. Maintenance of response was assessed for up to 24 hours postdose. A second dose of sumatriptan tablets or other medication was allowed 4 to 24 hours after the initial treatment for recurrent headache. Acetaminophen was offered to patients in Trials 2 and 3 beginning at 2 hours after initial treatment if the migraine pain had not improved or had worsened. Additional medications were allowed 4 to 24 hours after the initial treatment for recurrent headache or as rescue in all 3 trials. The frequency and time to use of these additional treatments were also determined. In all trials, doses of 25, ...",
  "brand_name": "Sumatriptan Succinate",
  "manufacturer": "Mylan Pharmaceuticals Inc.",
  "application_number": "ANDA077744",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20260826",
  "set_id": "1d2cd01c-05e7-44cf-a71d-0f474e826b7e",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 40144,
  "serious": 18537,
  "death": 816,
  "hospitalization": 6116,
  "primary_suspect": 40074,
  "top_reactions": [
   [
    "Drug Ineffective",
    4672
   ],
   [
    "Headache",
    2998
   ],
   [
    "Migraine",
    2740
   ],
   [
    "Nausea",
    2552
   ],
   [
    "Product Physical Issue",
    2363
   ],
   [
    "Fatigue",
    2129
   ],
   [
    "Application Site Erythema",
    1892
   ],
   [
    "Drug Dose Omission",
    1851
   ],
   [
    "Dizziness",
    1658
   ],
   [
    "Pain",
    1640
   ],
   [
    "Off Label Use",
    1525
   ],
   [
    "Vomiting",
    1411
   ],
   [
    "Product Dose Omission Issue",
    1401
   ],
   [
    "Product Quality Issue",
    1360
   ],
   [
    "Dyspnoea",
    1249
   ]
  ],
  "by_year": {
   "2019": 4144,
   "2020": 3666,
   "2021": 3010,
   "2022": 2705,
   "2023": 2821,
   "2024": 2379,
   "2025": 2450,
   "2026": 1413
  },
  "by_year_primary": {
   "2019": 4143,
   "2020": 3665,
   "2021": 3004,
   "2022": 2691,
   "2023": 2807,
   "2024": 2373,
   "2025": 2436,
   "2026": 1400
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20220413",
   "reason": "cGMP deviations: Temperature abuse",
   "firm": "Mckesson Medical-Surgical Inc. Corporate Office",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20191226",
   "reason": "Failed Impurities/Degradation Specifications; out-of-specification results obtained for related substance.",
   "firm": "Sun Pharmaceutical Industries, Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20131106",
   "reason": "Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which protrude through the needle shield.",
   "firm": "GlaxoSmithKline, LLC.",
   "status": "Terminated"
  }
 ],
 "recall_total": 3,
 "drugsfda": {
  "applications": 53,
  "nda": 9,
  "anda": 40,
  "first_approval": "19921228",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 60,
  "labeling_recent": 6,
  "sponsors": [
   "ALEMBIC",
   "ANTARES PHARMA INC",
   "AUROBINDO PHARMA",
   "AZURITY",
   "BAXTER HLTHCARE CORP",
   "CAPLIN",
   "CHARTWELL MOLECULAR",
   "CIPLA"
  ],
  "unapproved": false,
  "first_approval_fmt": "12/28/1992"
 },
 "trials": {
  "total": 133,
  "completed": 110,
  "terminated": 7,
  "with_results": 49,
  "industry": 90,
  "phase3": 33,
  "results_share": 0.44545454545454544,
  "terminated_share": 0.05263157894736842
 },
 "pubmed": {
  "rct": 284,
  "meta": 21,
  "recent_rct": 8,
  "cochrane": [
   {
    "pmid": "27096438",
    "title": "Sumatriptan plus naproxen for the treatment of acute migraine attacks in adults",
    "year": "2016"
   },
   {
    "pmid": "24865446",
    "title": "Sumatriptan (all routes of administration) for acute migraine attacks in adults - overview of Cochrane reviews",
    "year": "2014"
   },
   {
    "pmid": "24142431",
    "title": "Sumatriptan plus naproxen for acute migraine attacks in adults",
    "year": "2013"
   },
   {
    "pmid": "22336869",
    "title": "Sumatriptan (subcutaneous route of administration) for acute migraine attacks in adults",
    "year": "2012"
   },
   {
    "pmid": "22336868",
    "title": "Sumatriptan (rectal route of administration) for acute migraine attacks in adults",
    "year": "2012"
   },
   {
    "pmid": "22336867",
    "title": "Sumatriptan (intranasal route of administration) for acute migraine attacks in adults",
    "year": "2012"
   },
   {
    "pmid": "22336849",
    "title": "Sumatriptan (oral route of administration) for acute migraine attacks in adults",
    "year": "2012"
   },
   {
    "pmid": "22336784",
    "title": "WITHDRAWN: Oral sumatriptan for acute migraine",
    "year": "2012"
   },
   {
    "pmid": "25267911",
    "title": "Sumatriptan plus naproxen for acute migraine headaches in adults",
    "year": "2010"
   },
   {
    "pmid": "12917936",
    "title": "Oral sumatriptan for acute migraine",
    "year": "2003"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "sumatriptan",
   "Tosymra",
   "Imitrex",
   "Onzetra",
   "Zembrace"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 1923887,
  "beneficiaries": 495442,
  "spend": 55070271.230000004,
  "by_brand": [
   {
    "brand": "Sumatriptan Succinate",
    "claims": 1870066,
    "per_claim": 20.322763496,
    "is_generic": true
   },
   {
    "brand": "Sumatriptan",
    "claims": 48243,
    "per_claim": 177.2010984,
    "is_generic": true
   },
   {
    "brand": "Imitrex",
    "claims": 3210,
    "per_claim": 1599.8727134,
    "is_generic": false
   },
   {
    "brand": "Zembrace Symtouch",
    "claims": 1408,
    "per_claim": 1784.786669,
    "is_generic": false
   },
   {
    "brand": "Tosymra",
    "claims": 473,
    "per_claim": 807.47211416,
    "is_generic": false
   },
   {
    "brand": "Onzetra Xsail",
    "claims": 451,
    "per_claim": 1014.90102,
    "is_generic": false
   },
   {
    "brand": "Imitrex",
    "claims": 36,
    "per_claim": 789.5525,
    "is_generic": false
   }
  ],
  "per_claim": 28.624483262270605
 },
 "mdl": [],
 "dsc": [
  {
   "date": "20160602",
   "title": "FDA evaluating the risk of burns and scars with Zecuity (sumatriptan) migraine patch",
   "url": "https://www.fda.gov/Drugs/DrugSafety/ucm504588.htm",
   "kind": "drug",
   "matched": "sumatriptan"
  }
 ],
 "settlements": [
  {
   "year": 2012,
   "company": "GlaxoSmithKline",
   "amount_usd": 3000000000.0,
   "amount_text": "$3 billion ($1B criminal, $2B civil)",
   "violations": "Criminal: Off-label promotion, failure to disclose safety data. Civil: paying kickbacks to physicians, making false and misleading statements concerning the safety of Avandia, reporting false best prices and underpaying rebates owed under the Medicaid Drug Rebate Program",
   "products": "Avandia (not providing safety data), Wellbutrin, Paxil (promotion of paediatric use), Advair, Lamictal, Zofran, Imitrex, Lotronex, Flovent, Valtrex",
   "laws": "False Claims Act, FDCA",
   "urls": [
    "https://www.justice.gov/opa/pr/2012/July/12-civ-842.html",
    "https://web.archive.org/web/20240714112314/https://www.justice.gov/opa/pr/glaxosmithkline-plead-guilty-and-pay-3-billion-resolve-fraud-allegations-and-failure-report"
   ],
   "matched": "imitrex"
  }
 ],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "sumatriptan",
  "matched": "sumatriptan",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 6209,
  "fills": 1923887,
  "per_million": 3227.32052350268,
  "ratio": 1.1655395765433343,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 92,
   "letter": "A",
   "why": [
    "FDA issued 1 Drug Safety Communication(s) naming this drug since 2010, most recently 2016 (-8)",
    "3,227 FDA reports naming it as the suspect drug per million Medicare fills, 1.2x the median drug on this site",
    "Death share in reports is near or below the FAERS average (0.2x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 60,
   "letter": "D",
   "why": [
    "284 randomized trials and 21 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "10 independent Cochrane review(s) exist",
    "Only 45% of completed registered trials posted results (-8)",
    "'Drug ineffective' is the single most-reported item about this drug in FAERS (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 89,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 2 Class II, 0 Class III across 40 generic makers (-3)",
    "6 label changes approved since 2021: the safety story is still moving (-8)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 65,
   "letter": "C",
   "why": [
    "Maker paid $3 billion ($1B criminal, $2B civil) in 2012 to settle federal allegations naming this drug (Criminal: Off-label promotion, failure to disclose safety data. Civil: paying kickbacks to) (-35)",
    "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 (40 applications)",
    "7 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 80,
 "grade": "B",
 "questions": [
  "In 2016 the FDA issued a safety communication about this drug (FDA evaluating the risk of burns and scars with Zecuity (sumatriptan) migraine patch). Does that risk apply to me?",
  "The maker paid $3 billion in 2012 to settle federal allegations about how this drug was marketed. Is my use one of the uses that was promoted improperly?",
  "The most-reported problems in FDA's adverse event data are headache, migraine, nausea. How would we recognize and handle those?",
  "Why this one over almotriptan, eletriptan, frovatriptan? 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.)"
 ]
}