{
 "query": "mirabegron",
 "ingredient": "mirabegron",
 "slug": "mirabegron",
 "rxcui": "1300786",
 "brands": [
  "Myrbetriq"
 ],
 "names": [
  "mirabegron"
 ],
 "classes": [
  {
   "id": "G04BD",
   "name": "Drugs for urinary frequency and incontinence"
  }
 ],
 "alternatives": [
  "darifenacin",
  "emepronium",
  "fesoterodine",
  "flavoxate",
  "oxybutynin",
  "propiverine",
  "solifenacin",
  "terodiline",
  "tolterodine",
  "trospium",
  "vibegron"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 14
  },
  "boxed_warning": "",
  "indications_and_usage": "is a beta-3 adrenergic agonist indicated for the treatment of: \u2022 Overactive bladder (OAB) in adult patients with symptoms of urge urinary incontinence, urgency, and urinary frequency, either alone or in combination with the muscarinic antagonist solifenacin succinate. ( 1.1 ) \u2022 Neurogenic detrusor overactivity (NDO) in pediatric patients aged 3 years and older and weighing 35 kg or more. ( 1.2 ) MYRBETRIQ Granules is a beta-3 adrenergic agonist indicated for the treatment of NDO in pediatric patients aged 3 years and older. ( 1.2 ) 1.1 Adult Overactive Bladder (OAB) MYRBETRIQ Monotherapy MYRBETRIQ \u00ae is indicated for the treatment of OAB in adult patients with symptoms of urge urinary incontinence, urgency, and urinary frequency. MYRBETRIQ Combination Therapy with Solifenacin Succinate MYRBETRIQ, in combination with the muscarinic antagonist solifenacin succinate, is indicated for the treatment of OAB in adult patients with symptoms of urge urinary incontinence, urgency, and urinary frequency. 1.2 Pediatric Neurogenic Detrusor Overactivity (NDO) MYRBETRIQ Granules MYRBETRIQ \u00ae Granules is indicated for the treatment of NDO in pediatric patients aged 3 years and older. MYRBETRIQ MYRBE...",
  "contraindications": "Granules is contraindicated in patients with known hypersensitivity reactions to mirabegron or any inactive ingredients of the tablet or oral suspension [see Adverse Reactions ( 6.1 , 6.2 )] . Hypersensitivity to mirabegron or any inactive ingredients. ( 4 )",
  "warnings_and_cautions": "\u2022 Increases in Blood Pressure : Can increase blood pressure in adult or pediatric patients. Periodically monitor blood pressure, especially in hypertensive patients. MYRBETRIQ/MYRBETRIQ Granules are not recommended in patients with severe uncontrolled hypertension. ( 5.1 ) \u2022 Urinary Retention in Patients With Bladder Outlet Obstruction and in Patients Taking Muscarinic Antagonist Drugs for Overactive Bladder : Administer with caution in these patients because of risk of urinary retention. ( 5.2 ) \u2022 Angioedema : Angioedema of the face, lips, tongue, and/or larynx has been reported with mirabegron. ( 5.3 , 6.2 ) 5.1 Increases in Blood Pressure Increases in Blood Pressure in Adults MYRBETRIQ/MYRBETRIQ Granules can increase blood pressure. Periodic blood pressure determinations are recommended, especially in hypertensive patients. MYRBETRIQ/MYRBETRIQ Granules is not recommended for use in patients with severe uncontrolled hypertension (defined as systolic blood pressure greater than or equal to 180 mm Hg and/or diastolic blood pressure greater than or equal to 110 mm Hg) [see Clinical Pharmacology ( 12.2 )] . In two, randomized, placebo-controlled, healthy adult volunteer studies, MYRB...",
  "warnings": "",
  "adverse_reactions": "The following adverse reactions are discussed in more detail in other sections of the labeling. \u2022 Hypertension [see Warnings and Precautions ( 5.1 )] \u2022 Urinary Retention [see Warnings and Precautions ( 5.2 )] \u2022 Angioedema [see Warnings and Precautions ( 5.3 )] \u2022 Most commonly reported adverse reactions with MYRBETRIQ monotherapy in adult patients with OAB (> 2% and > placebo) were hypertension, nasopharyngitis, urinary tract infection, and headache. ( 6.1 ) \u2022 Most commonly reported adverse reactions with MYRBETRIQ, in combination with solifenacin succinate in adult patients with OAB (> 2% and > placebo and > comparator), were dry mouth, urinary tract infection, constipation, and tachycardia. ( 6.1 ) \u2022 Most commonly reported adverse reactions with MYRBETRIQ/MYRBETRIQ Granules in pediatric patients with NDO (\u2265 3%) were UTI, nasopharyngitis, constipation, and headache. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Astellas Pharma US, Inc. at 1-800-727-7003 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...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Indications and Usage ( 1.2 ) 3/2021 Dosage and Administration ( 2 ) 3/2021 Warnings and Precautions, Increase in Blood Pressure ( 5.1 ) 3/2021",
  "information_for_patients": "Advise the patient and/or caregiver to read the FDA-approved patient labeling (Patient Information). Increases in Blood Pressure Inform patients and/or their caregivers that MYRBETRIQ/MYRBETRIQ Granules may increase blood pressure. Advise patients, especially patients with hypertension, to periodically monitor their blood pressure and report increased measurement to their health care provider [see Warnings and Precautions ( 5.1 )] . Urinary Retention Inform patients and/or their caregivers that MYRBETRIQ may cause urinary retention in adult patients with bladder outlet obstruction and in patients taking muscarinic antagonist medications for the treatment of OAB. Advise patients to contact their physician if they experience these effects while taking MYRBETRIQ [see Warnings and Precautions ( 5.2 )] . Angioedema Inform patients and/or their caregivers that MYRBETRIQ/MYRBETRIQ Granules may cause angioedema. Advise patients and/or their caregivers to promptly discontinue MYRBETRIQ/MYRBETRIQ Granules and seek medical attention if angioedema associated with the upper airway swelling occurs as this may be life-threatening [see Warnings and Precautions ( 5.3 )] . Drug Interactions Advise p...",
  "spl_medguide": "",
  "clinical_studies": "14.1 MYRBETRIQ Monotherapy for Adult OAB MYRBETRIQ was evaluated in three, 12-week, double-blind, randomized, placebo-controlled, parallel group, multicenter clinical trials in patients with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency (Studies 1, 2, and 3). Entry criteria required that patients had symptoms of overactive bladder for at least 3 months duration, at least 8 micturitions per day, and at least 3 episodes of urgency with or without incontinence over a 3-day period. The majority of patients were Caucasian (94%) and female (72%) with a mean age of 59 years (range 18 \u2013 95 years). The population included both na\u00efve patients who had not received prior muscarinic antagonist pharmacotherapy for overactive bladder (48%) and those who had received prior muscarinic antagonist pharmacotherapy for OAB (52%). In Study 1 (NCT00689104), patients were randomized to placebo, MYRBETRIQ 50 mg, MYRBETRIQ 100 mg, or an active control once daily. In Study 2 (NCT00662909), patients were randomized to placebo, MYRBETRIQ 50 mg or MYRBETRIQ 100 mg once daily. In Study 3 (NCT00912964), patients were randomized to placebo, MYRBETRIQ 25 mg or MYRBETR...",
  "brand_name": "Myrbetriq",
  "manufacturer": "Astellas Pharma US, Inc.",
  "application_number": "NDA202611",
  "pharm_class_epc": [
   "beta3-Adrenergic Agonist [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20240801",
  "set_id": "ba9e9e15-e666-4c56-9271-2e24739cfa2d",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 39207,
  "serious": 20521,
  "death": 3387,
  "hospitalization": 8875,
  "primary_suspect": 39110,
  "top_reactions": [
   [
    "Drug Ineffective",
    5430
   ],
   [
    "Off Label Use",
    2816
   ],
   [
    "Fatigue",
    2342
   ],
   [
    "Dizziness",
    2273
   ],
   [
    "Headache",
    2209
   ],
   [
    "Fall",
    2134
   ],
   [
    "Diarrhoea",
    2039
   ],
   [
    "Pain",
    1914
   ],
   [
    "Nausea",
    1835
   ],
   [
    "Asthenia",
    1604
   ],
   [
    "Hypertension",
    1556
   ],
   [
    "Arthralgia",
    1530
   ],
   [
    "Intentional Product Misuse",
    1507
   ],
   [
    "Confusional State",
    1461
   ],
   [
    "Rash",
    1445
   ]
  ],
  "by_year": {
   "2019": 3742,
   "2020": 3406,
   "2021": 3118,
   "2022": 2794,
   "2023": 2840,
   "2024": 3145,
   "2025": 3288,
   "2026": 1425
  },
  "by_year_primary": {
   "2019": 3740,
   "2020": 3403,
   "2021": 3109,
   "2022": 2781,
   "2023": 2830,
   "2024": 3136,
   "2025": 3269,
   "2026": 1397
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20260805",
   "reason": "CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.",
   "firm": "Zydus Pharmaceuticals (USA) Inc",
   "status": "Ongoing"
  }
 ],
 "recall_total": 1,
 "drugsfda": {
  "applications": 15,
  "nda": 2,
  "anda": 11,
  "first_approval": "20120628",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 4,
  "labeling_recent": 0,
  "sponsors": [
   "ALKEM LABS LTD",
   "APGDI",
   "APOTEX",
   "AUROBINDO PHARMA LTD",
   "CREEKWOOD PHARMS",
   "DEVA HOLDING AS",
   "LUPIN",
   "MSN"
  ],
  "unapproved": false,
  "first_approval_fmt": "06/28/2012"
 },
 "trials": {
  "total": 195,
  "completed": 121,
  "terminated": 9,
  "with_results": 40,
  "industry": 83,
  "phase3": 33,
  "results_share": 0.3305785123966942,
  "terminated_share": 0.046153846153846156
 },
 "pubmed": {
  "rct": 118,
  "meta": 49,
  "recent_rct": 48,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 98949.29,
  "records": 2675,
  "by_name": [
   [
    "Myrbetriq",
    98949.29
   ]
  ],
  "names_checked": [
   "mirabegron",
   "Myrbetriq"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 3722825,
  "beneficiaries": 881635,
  "spend": 2431374764.33,
  "by_brand": [
   {
    "brand": "Myrbetriq",
    "claims": 3453189,
    "per_claim": 665.20188542,
    "is_generic": false
   },
   {
    "brand": "Mirabegron ER",
    "claims": 269636,
    "per_claim": 498.10459594,
    "is_generic": false
   }
  ],
  "per_claim": 653.0993974548898
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 7802,
  "fills": 3722825,
  "per_million": 2095.7203199183414,
  "ratio": 0.7568646982667311,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 95,
   "letter": "A",
   "why": [
    "2,096 FDA reports naming it as the suspect drug per million Medicare fills, 0.8x the median drug on this site",
    "Death share in reports is near or below the FAERS average (0.9x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 46,
   "letter": "F",
   "why": [
    "118 randomized trials and 49 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)",
    "Only 33% of completed registered trials posted results (-15)",
    "'Drug ineffective' is the single most-reported item about this drug in FAERS (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 94,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 1 Class II, 0 Class III across 11 generic makers (-1)",
    "Label lists recent major changes to warnings or indications (-5)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 100,
   "letter": "A",
   "why": [
    "Pharma paid doctors $98,949 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 (11 applications)",
    "11 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 84,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are fatigue, dizziness. 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 darifenacin, emepronium, fesoterodine? 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.)"
 ]
}