{
 "query": "rimegepant",
 "ingredient": "rimegepant",
 "slug": "rimegepant",
 "rxcui": "2282307",
 "brands": [
  "Nurtec"
 ],
 "names": [
  "rimegepant",
  "rimegepant sulfate"
 ],
 "classes": [
  {
   "id": "N02CD",
   "name": "Calcitonin gene-related peptide (CGRP) antagonists"
  }
 ],
 "alternatives": [
  "atogepant",
  "eptinezumab",
  "erenumab",
  "fremanezumab",
  "galcanezumab",
  "ubrogepant",
  "zavegepant"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 2
  },
  "boxed_warning": "",
  "indications_and_usage": "is a calcitonin gene-related peptide receptor antagonist indicated for the: \u2022 acute treatment of migraine with or without aura in adults ( 1.1 ) \u2022 preventive treatment of episodic migraine in adults ( 1.2 ) 1.1 Acute Treatment of Migraine NURTEC ODT is indicated for the acute treatment of migraine with or without aura in adults . 1.2 Preventive Treatment of Episodic Migraine NURTEC ODT is indicated for the preventive treatment of episodic migraine in adults.",
  "contraindications": "is contraindicated in patients with a history of hypersensitivity reaction to rimegepant, NURTEC ODT, or any of its components. Reactions have included anaphylaxis and delayed serious hypersensitivity [see Warnings and Precautions (5.1) ] . Patients with a history of hypersensitivity reaction to rimegepant, NURTEC ODT, or to any of its components. ( 4 )",
  "warnings_and_cautions": "\u2022 Hypersensitivity Reactions: If a serious hypersensitivity reaction occurs, discontinue NURTEC ODT and initiate appropriate therapy. Severe hypersensitivity reactions have included anaphylaxis, dyspnea, and rash, and can occur days after administration. ( 5.1 ) \u2022 Hypertension: New-onset or worsening of pre-existing hypertension may occur. ( 5.2 ) \u2022 Raynaud\u2019s Phenomenon: New-onset or worsening of pre-existing Raynaud\u2019s phenomenon may occur. ( 5.3 ) 5.1 Hypersensitivity Reactions Serious hypersensitivity reactions, including anaphylaxis, dyspnea , and rash, have occurred in patients treated with NURTEC ODT . Hypersensitivity reactions can occur days after administration, and delayed serious hypersensitivity has occurred. If a hypersensitivity reaction occurs, discontinue NURTEC ODT and initiate appropriate therapy [see Contraindications (4) and Adverse Reactions (6.1 , 6.2) ] . 5.2 Hypertension Development of hypertension and worsening of pre-existing hypertension have been reported following the use of CGRP antagonists, including NURTEC ODT, in the postmarketing setting. Some of the patients who developed new-onset hypertension had risk factors for hypertension. There were cases re...",
  "warnings": "",
  "adverse_reactions": "The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: \u2022 Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] \u2022 Hypertension [see Warnings and Precautions (5.2) ] \u2022 Raynaud\u2019s Phenomenon [see Warnings and Precautions (5.3) ] \u2022 Acute treatment of migraine: the adverse reaction reported in \u22651% of patients treated with NURTEC ODT is nausea. ( 6.1 ) \u2022 Preventive treatment of episodic migraine: adverse reactions reported in \u22652% for rimegepant and \u22651% higher than placebo are nausea and abdominal pain/dyspepsia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 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 to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Acute Treatment of Migraine The safety of NURTEC ODT for the acute treatment of migraine in adults has been evaluated in a randomized, double-blind, placebo-controlled tri...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Dosage and Administration ( 2.1 , 2.2 ) 3/2026 Contraindications ( 4 ) 8/2025 Warnings and Precautions ( 5.1 ) 8/2025",
  "information_for_patients": "Advise patients to read the FDA-approved patient labeling (Patient Information). Handling of Orally Disintegrating Tablets Packaging Instruct patients not to remove the blister from the outer aluminum pouch until ready to use the orally disintegrating tablet inside [see Dosage and Administration (2.3) ] . Hypersensitivity Reactions Inform patients about the signs and symptoms of hypersensitivity reactions and that these reactions can occur days after administration of NURTEC ODT. Advise patients to contact their healthcare provider immediately if signs or symptoms of hypersensitivity reactions occur [see Warnings and Precautions (5.1) ]. Hypertension Inform patients that hypertension can develop or pre-existing hypertension can worsen with NURTEC ODT, and that they should contact their healthcare provider if they experience elevation in their blood pressure [see Warnings and Precautions (5.2) ] . Raynaud\u2019s Phenomenon Inform patients that Raynaud\u2019s phenomenon can develop or worsen with NURTEC ODT. Advise patients to discontinue NURTEC ODT and contact their healthcare provider if they experience signs or symptoms of Raynaud\u2019s phenomenon [see Warnings and Precautions (5.3) ] . Pregnan...",
  "spl_medguide": "",
  "clinical_studies": "14.1 Acute Treatment of Migraine The efficacy of NURTEC ODT for the acute treatment of migraine with and without aura in adults was demonstrated in a randomized, double-blind, placebo-controlled trial: Study 1 (NCT03461757). Patients in the study were randomized to receive 75 mg of NURTEC ODT (N=732) or placebo (N=734). Patients were instructed to treat a migraine of moderate to severe headache pain intensity. Rescue medication (i.e., NSAIDs, acetaminophen, and/or an antiemetic) was allowed 2 hours after the initial treatment. Other forms of rescue medication such as triptans were not allowed within 48 hours of initial treatment. Approximately 14% of patients were taking preventive medications for migraine at baseline. None of the patients in Study 1 were on concomitant preventive medication that act on the CGRP pathway. The primary efficacy analyses were conducted in patients who treated a migraine with moderate to severe pain. NURTEC ODT 75 mg demonstrated an effect on pain freedom and most bothersome symptom (MBS) freedom at two hours after dosing, compared to placebo. Pain freedom was defined as a reduction of moderate or severe headache pain to no headache pain, and MBS freedo...",
  "brand_name": "NURTEC ODT",
  "manufacturer": "Pfizer Laboratories Div Pfizer Inc",
  "application_number": "NDA212728",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20260604",
  "set_id": "9ef08e09-1098-35cc-e053-2a95a90a3e1d",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 13083,
  "serious": 2756,
  "death": 111,
  "hospitalization": 822,
  "primary_suspect": 13048,
  "top_reactions": [
   [
    "Drug Ineffective",
    4095
   ],
   [
    "Nausea",
    1222
   ],
   [
    "Migraine",
    895
   ],
   [
    "Headache",
    800
   ],
   [
    "Therapeutic Product Effect Incomplete",
    656
   ],
   [
    "Off Label Use",
    534
   ],
   [
    "Dizziness",
    480
   ],
   [
    "Fatigue",
    476
   ],
   [
    "Vomiting",
    406
   ],
   [
    "Feeling Abnormal",
    327
   ],
   [
    "Somnolence",
    301
   ],
   [
    "Product Dose Omission Issue",
    300
   ],
   [
    "Pain",
    297
   ],
   [
    "Rash",
    285
   ],
   [
    "Pruritus",
    265
   ]
  ],
  "by_year": {
   "2019": 12,
   "2020": 688,
   "2021": 2009,
   "2022": 3601,
   "2023": 2134,
   "2024": 2037,
   "2025": 1876,
   "2026": 710
  },
  "by_year_primary": {
   "2019": 12,
   "2020": 688,
   "2021": 2009,
   "2022": 3596,
   "2023": 2125,
   "2024": 2025,
   "2025": 1868,
   "2026": 709
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20210315",
   "reason": "CGMP Deviations: Intermittent exposure to temperature excursion during storage.",
   "firm": "Cardinal Health Inc.",
   "status": "Terminated"
  }
 ],
 "recall_total": 1,
 "drugsfda": {
  "applications": 2,
  "nda": 1,
  "anda": 0,
  "first_approval": "20200227",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 7,
  "labeling_recent": 6,
  "sponsors": [
   "APOTEX CORP",
   "PFIZER"
  ],
  "unapproved": false,
  "first_approval_fmt": "02/27/2020"
 },
 "trials": {
  "total": 69,
  "completed": 28,
  "terminated": 4,
  "with_results": 25,
  "industry": 43,
  "phase3": 19,
  "results_share": 0.8928571428571429,
  "terminated_share": 0.057971014492753624
 },
 "pubmed": {
  "rct": 24,
  "meta": 15,
  "recent_rct": 22,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "rimegepant",
   "Nurtec"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 426648,
  "beneficiaries": 105323,
  "spend": 625230826.2,
  "by_brand": [
   {
    "brand": "Nurtec ODT",
    "claims": 426648,
    "per_claim": 1465.4488623,
    "is_generic": false
   }
  ],
  "per_claim": 1465.4488622939755
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 4602,
  "fills": 426648,
  "per_million": 10786.409405411487,
  "ratio": 3.8954875907899273,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 88,
   "letter": "A",
   "why": [
    "10,786 FDA reports naming it as the suspect drug per million Medicare fills, 3.9x the median drug on this site (-12)",
    "Death share in reports is near or below the FAERS average (0.1x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 42,
   "letter": "F",
   "why": [
    "24 randomized trials and 15 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)",
    "'Drug ineffective' is the single most-reported item about this drug in FAERS (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 84,
   "letter": "B",
   "why": [
    "Recalls since 2016: 0 Class I, 1 Class II, 0 Class III (-3)",
    "6 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": 70,
   "letter": "C",
   "why": [
    "No generic version approved: brand-only pricing (-30)",
    "7 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 76,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are nausea, migraine, headache. 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 atogepant, eptinezumab, erenumab? What would make you pick one of those instead?",
  "There is no generic. Is there an older generic in the same class that works as well for my situation?",
  "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.)"
 ]
}