{
 "query": "rizatriptan",
 "ingredient": "rizatriptan",
 "slug": "rizatriptan",
 "rxcui": "88014",
 "brands": [
  "Maxalt",
  "Rizafilm"
 ],
 "names": [
  "rizatriptan",
  "rizatriptan benzoate"
 ],
 "classes": [
  {
   "id": "N02CC",
   "name": "Selective serotonin (5HT1) agonists"
  }
 ],
 "alternatives": [
  "almotriptan",
  "eletriptan",
  "frovatriptan",
  "lasmiditan",
  "naratriptan",
  "sumatriptan",
  "zolmitriptan"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 46
  },
  "boxed_warning": "",
  "indications_and_usage": "\u00ae and MAXALT-MLT \u00ae are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. Limitations of Use MAXALT should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with MAXALT, the diagnosis of migraine should be reconsidered before MAXALT is administered to treat any subsequent attacks. MAXALT is not indicated for use in the management of hemiplegic or basilar migraine [see Contraindications (4) ] . MAXALT is not indicated for the prevention of migraine attacks. Safety and effectiveness of MAXALT have not been established for cluster headache. MAXALT is a serotonin (5-HT) 1B/1D receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years of age ( 1 ) Limitations of Use : Use only after clear diagnosis of migraine has been established ( 1 ) Not indicated for the prophylactic therapy of migraine ( 1 ) Not indicated for the treatment of cluster headache ( 1 )",
  "contraindications": "is contraindicated in patients with: Ischemic coronary artery disease (angina pectoris, history of myocardial infarction, or documented silent ischemia), or other significant underlying cardiovascular disease [see Warnings and Precautions (5.1) ] . Coronary artery vasospasm including Prinzmetal's angina [see Warnings and Precautions (5.1) ] . History of stroke or transient ischemic attack (TIA) [see Warnings and Precautions (5.4) ] . Peripheral vascular disease (PVD) [see Warnings and Precautions (5.5) ] . Ischemic bowel disease [see Warnings and Precautions (5.5) ] . Uncontrolled hypertension [see Warnings and Precautions (5.8) ] . Recent use (i.e., within 24 hours) of another 5-HT 1 agonist, ergotamine-containing medication, or ergot-type medication (such as dihydroergotamine or methysergide) [see Drug Interactions (7.2 and 7.3) ] . Hemiplegic or basilar migraine [see Indications and Usage (1) ] . Concurrent administration or recent discontinuation (i.e., within 2 weeks) of a MAO-A inhibitor [see Drug Interactions (7.5) and Clinical Pharmacology (12.3) ] . Hypersensitivity to rizatriptan or any of the excipients (angioedema and anaphylaxis seen) [see Adverse Reactions (6.2) ] . H...",
  "warnings_and_cautions": "Myocardial ischemia, myocardial infarction, and Prinzmetal's angina: Perform cardiac evaluation in patients with multiple cardiovascular risk factors ( 5.1 ) Arrhythmias: Discontinue dosing if occurs ( 5.2 ) Chest/throat/neck/jaw pain, tightness, pressure, or heaviness; Generally not associated with myocardial ischemia; Evaluate patients at high risk ( 5.3 ) Cerebral hemorrhage, subarachnoid hemorrhage, and stroke: Discontinue dosing if occurs ( 5.4 ) Gastrointestinal ischemic events, peripheral vasospastic reactions: Discontinue dosing if occurs ( 5.5 ) Medication overuse headache: Detoxification may be necessary ( 5.6 ) Serotonin syndrome: Discontinue dosing if occurs ( 5.7 ) 5.1 Myocardial Ischemia, Myocardial Infarction, and Prinzmetal's Angina MAXALT should not be given to patients with ischemic or vasospastic coronary artery disease. There have been rare reports of serious cardiac adverse reactions, including acute myocardial infarction, occurring within a few hours following administration of MAXALT. Some of these reactions occurred in patients without known coronary artery disease (CAD). 5-HT 1 agonists, including MAXALT may cause coronary artery vasospasm (Prinzmetal's Ang...",
  "warnings": "",
  "adverse_reactions": "The following adverse reactions are discussed in more detail in other sections of the labeling: Myocardial Ischemia, Myocardial Infarction, and Prinzmetal's Angina [see Warnings and Precautions (5.1) ] . Arrhythmias [see Warnings and Precautions (5.2) ]. Chest, Throat, Neck and/or Jaw Pain/Tightness/Pressure [see Warnings and Precautions (5.3) ] . Cerebrovascular Events [see Warnings and Precautions (5.4) ] . Other Vasospasm Reactions [see Warnings and Precautions (5.5) ] . Medication Overuse Headache [see Warnings and Precautions (5.6) ] . Serotonin Syndrome [see Warnings and Precautions (5.7) ] . Increase in Blood Pressure [see Warnings and Precautions (5.8) ] . The most common adverse reactions in adults were (incidence \u22655% and greater than placebo): asthenia/fatigue, somnolence, pain/pressure sensation and dizziness ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Organon LLC, a subsidiary of Organon & Co., at 1-844-674-3200 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to ...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Dosage and Administration ( 2 ) 09/2020",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling (Patient Information). Risk of Myocardial Ischemia and/or Infarction, Prinzmetal's Angina, Other Vasospasm-Related Events, and Cerebrovascular Events Inform patients that MAXALT 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, weakness, slurring of speech, and should ask for medical advice when observing any indicative sign or symptoms. Patients should be apprised of the importance of this follow-up [see Warnings and Precautions (5.1 , 5.2 , 5.4 , 5.5) ] . Serotonin Syndrome Patients should be cautioned about the risk of serotonin syndrome with the use of MAXALT or other triptans, particularly during combined use with selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs) [see Warnings and Precautions (5.7) , Drug Interactions (7.4) , and Clinical Pharmacology (12.3) ] . Pregnancy Inform patients that MAXALT should not be used during pregnancy unless the potential benefit just...",
  "spl_medguide": "",
  "clinical_studies": "14.1 Adults The efficacy of MAXALT Tablets was established in four multicenter, randomized, placebo-controlled trials. Patients enrolled in these studies were primarily female (84%) and Caucasian (88%), with a mean age of 40 years (range of 18 to 71). Patients were instructed to treat a moderate to severe headache. Headache response, defined as a reduction of moderate or severe headache pain to no or mild headache pain, was assessed for up to 2 hours (Study 1) or up to 4 hours after dosing (Studies 2, 3 and 4). Associated symptoms of nausea, photophobia, and phonophobia and maintenance of response up to 24 hours post-dose were evaluated. A second dose of MAXALT Tablets was allowed 2 to 24 hours after dosing for treatment of recurrent headache in Studies 1 and 2. Additional analgesics and/or antiemetics were allowed 2 hours after initial treatment for rescue in all four studies. In all studies, the percentage of patients achieving headache response 2 hours after treatment was significantly greater in patients who received either MAXALT 5 or 10 mg compared to those who received placebo. In a separate study, doses of 2.5 mg were not different from placebo. Doses greater than 10 mg wer...",
  "brand_name": "MAXALT",
  "manufacturer": "Organon LLC",
  "application_number": "NDA020864",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20260129",
  "set_id": "007b4644-e0e7-4863-9ae3-fe09676b3f5f",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 13932,
  "serious": 7773,
  "death": 249,
  "hospitalization": 2487,
  "primary_suspect": 13908,
  "top_reactions": [
   [
    "Drug Ineffective",
    2009
   ],
   [
    "Nausea",
    1580
   ],
   [
    "Headache",
    1410
   ],
   [
    "Migraine",
    1298
   ],
   [
    "Off Label Use",
    1216
   ],
   [
    "Fatigue",
    950
   ],
   [
    "Product Use In Unapproved Indication",
    743
   ],
   [
    "Pain",
    705
   ],
   [
    "Diarrhoea",
    616
   ],
   [
    "Dizziness",
    612
   ],
   [
    "Vomiting",
    605
   ],
   [
    "Hyperhidrosis",
    559
   ],
   [
    "Dyspnoea",
    521
   ],
   [
    "Arthralgia",
    518
   ],
   [
    "Hypersensitivity",
    476
   ]
  ],
  "by_year": {
   "2019": 1421,
   "2020": 1304,
   "2021": 1167,
   "2022": 1283,
   "2023": 1171,
   "2024": 1277,
   "2025": 1233,
   "2026": 656
  },
  "by_year_primary": {
   "2019": 1420,
   "2020": 1304,
   "2021": 1166,
   "2022": 1274,
   "2023": 1168,
   "2024": 1269,
   "2025": 1231,
   "2026": 656
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20250709",
   "reason": "CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.",
   "firm": "Ascend Laboratories, LLC",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20250709",
   "reason": "CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.",
   "firm": "Ascend Laboratories, LLC",
   "status": "Ongoing"
  },
  {
   "class": "Class III",
   "date": "20211018",
   "reason": "Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.",
   "firm": "MACLEODS PHARMA USA, INC",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20211018",
   "reason": "Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.",
   "firm": "MACLEODS PHARMA USA, INC",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20211018",
   "reason": "Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.",
   "firm": "MACLEODS PHARMA USA, INC",
   "status": "Terminated"
  }
 ],
 "recall_total": 5,
 "drugsfda": {
  "applications": 28,
  "nda": 3,
  "anda": 25,
  "first_approval": "19980629",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 20,
  "labeling_recent": 2,
  "sponsors": [
   "ALKEM LABS LTD",
   "APOTEX INC",
   "AUROBINDO PHARMA LTD",
   "AVET LIFESCIENCES",
   "CHARTWELL RX",
   "GENSCO",
   "GLENMARK PHARMS LTD",
   "INVAGEN PHARMS"
  ],
  "unapproved": false,
  "first_approval_fmt": "06/29/1998"
 },
 "trials": {
  "total": 42,
  "completed": 39,
  "terminated": 1,
  "with_results": 24,
  "industry": 37,
  "phase3": 24,
  "results_share": 0.6153846153846154,
  "terminated_share": 0.023809523809523808
 },
 "pubmed": {
  "rct": 71,
  "meta": 7,
  "recent_rct": 2,
  "cochrane": [
   {
    "pmid": "25408622",
    "title": "Rizatriptan for acute migraine headaches in adults",
    "year": "2010"
   },
   {
    "pmid": "17636717",
    "title": "WITHDRAWN: Rizatriptan for acute migraine",
    "year": "2007"
   },
   {
    "pmid": "11687054",
    "title": "Rizatriptan for acute migraine",
    "year": "2001"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "rizatriptan",
   "Maxalt",
   "Rizafilm"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 739330,
  "beneficiaries": 199485,
  "spend": 16779337.16,
  "by_brand": [
   {
    "brand": "Rizatriptan",
    "claims": 736383,
    "per_claim": 19.739707747,
    "is_generic": false
   },
   {
    "brand": "Maxalt Mlt",
    "claims": 1520,
    "per_claim": 721.02270395,
    "is_generic": false
   },
   {
    "brand": "Maxalt",
    "claims": 1427,
    "per_claim": 804.06267694,
    "is_generic": false
   }
  ],
  "per_claim": 22.695328418973936
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 3156,
  "fills": 739330,
  "per_million": 4268.7297958962845,
  "ratio": 1.5416422020850256,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 91,
   "letter": "A",
   "why": [
    "4,269 FDA reports naming it as the suspect drug per million Medicare fills, 1.5x the median drug on this site (-4)",
    "Death share in reports is near or below the FAERS average (0.2x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 51,
   "letter": "D",
   "why": [
    "71 randomized trials and 7 systematic reviews/meta-analyses indexed in PubMed",
    "3 independent Cochrane review(s) exist",
    "'Drug ineffective' is the single most-reported item about this drug in FAERS (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 87,
   "letter": "B",
   "why": [
    "Recalls since 2016: 0 Class I, 2 Class II, 3 Class III across 25 generic makers (-4)",
    "2 label changes approved since 2021 (-4)",
    "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 (25 applications)",
    "7 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 83,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are nausea, headache, migraine. 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 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.)"
 ]
}