{
 "query": "solifenacin",
 "ingredient": "solifenacin",
 "slug": "solifenacin",
 "rxcui": "322167",
 "brands": [
  "Vesicare"
 ],
 "names": [
  "solifenacin",
  "solifenacin succinate"
 ],
 "classes": [
  {
   "id": "G04BD",
   "name": "Drugs for urinary frequency and incontinence"
  }
 ],
 "alternatives": [
  "darifenacin",
  "emepronium",
  "fesoterodine",
  "flavoxate",
  "mirabegron",
  "oxybutynin",
  "propiverine",
  "terodiline",
  "tolterodine",
  "trospium",
  "vibegron"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 32
  },
  "boxed_warning": "",
  "indications_and_usage": "Solifenacin succinate tablets are indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. Solifenacin succinate tablets are a muscarinic antagonist indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. (1)",
  "contraindications": "Solifenacin succinate tablets are contraindicated in patients: With urinary retention [see Warnings and Precautions (5.2) ] , With gastric retention [see Warnings and Precautions (5.3) ] , With uncontrolled narrow-angle glaucoma [see Warnings and Precautions (5.5) ] , and Who have demonstrated hypersensitivity to solifenacin succinate or the inactive ingredients in solifenacin succinate tablets. Reported adverse reactions have included anaphylaxis and angioedema [see Adverse Reactions (6.2) ] . Urinary retention. ( 4 , 5.2 ) Gastric retention. ( 4 , 5.3 ) Uncontrolled narrow-angle glaucoma. ( 4 , 5.5 ) Hypersensitivity to this product or any of its components. ( 4 , 5.1 , 6.2 )",
  "warnings_and_cautions": "Angioedema and Anaphylactic Reactions : Promptly discontinue solifenacin succinate and provide appropriate therapy. ( 5.1 ) Urinary Retention : Solifenacin succinate is not recommended for use in patients with clinically significant bladder outlet obstruction. ( 5.2 ) Gastrointestinal Disorders : Solifenacin succinate is not recommended for use in patients with decreased gastrointestinal motility. ( 5.3 ) Central Nervous System Effects : Somnolence has been reported with solifenacin succinate. Advise patients not to drive or operate heavy machinery until they know how solifenacin succinate affects them. ( 5.4 ) Controlled Narrow-Angle Glaucoma : Use solifenacin succinate with caution in patients being treated for narrow-angle glaucoma. ( 5.5 ) QT Prolongation in Patients at High Risk of QT Prolongation : Solifenacin succinate is not recommended for use in patients at high risk of QT prolongation, including patients with a known history of QT prolongation and patients taking medications known to prolong the QT interval. ( 5.6 ) 5.1 Angioedema and Anaphylactic Reactions Angioedema of the face, lips, tongue, and/or larynx have been reported with solifenacin succinate. In some cases, a...",
  "warnings": "",
  "adverse_reactions": "The most common adverse reactions (> 4% in solifenacin succinate-treated patients and > placebo-treated patients) were dry mouth and constipation at both 5 mg and 10 mg doses; and urinary tract infection and blurred vision at the 10 mg dose. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 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 practice. Solifenacin succinate has been evaluated for safety in 1811 adult patients in four randomized, placebo-controlled trials (Studies 1 to 4) [see Clinical Studies (14) ] . Expected adverse reactions of antimuscarinic agents are dry mouth, constipation, blurred vision (accommodation abnormalities), urinary retention, and dry eyes. The incidence of dry mouth and constipation in patients treated with solifenacin succinate was higher in the 10 mg dose group compared to the 5 mg dose group. In the four 12-week doub...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling ( Patient Information ). Angioedema and Anaphylactic Reactions Inform patients that angioedema and anaphylactic reactions have been reported in patients treated with solifenacin succinate. Angioedema and anaphylactic reactions may be life-threatening. Advise patients to promptly discontinue solifenacin succinate therapy and seek immediate attention if they experience edema of the tongue or laryngopharynx, or difficulty breathing [see Contraindications (4) and Warnings and Precautions (5.1) ] . Urinary Retention Inform patients that solifenacin succinate may cause urinary retention in patients with conditions associated with bladder outlet obstruction [see Warnings and Precautions (5.2) ] . Gastrointestinal Disorders Inform patients that solifenacin succinate may cause further decrease in gastrointestinal motility in patients with conditions associated with decreased gastrointestinal motility. Solifenacin succinate has been associated with constipation and dry mouth. Advise patients to contact their health care providers if they experience severe abdominal pain or become constipated for 3 or more days [see Warnings and Pre...",
  "spl_medguide": "",
  "clinical_studies": "Solifenacin succinate was evaluated in four twelve-week, double-blind, randomized, placebo-controlled, parallel group, multicenter clinical trials for the treatment of overactive bladder in adult patients having symptoms of urinary frequency, urgency, and/or urge or mixed incontinence (with a predominance of urge). Entry criteria required that patients have symptoms of overactive bladder for \u2265 3 months duration. These studies involved 3027 patients (1811 on solifenacin succinate and 1216 on placebo), and approximately 90% of these patients completed the 12-week studies. Two of the four studies evaluated the 5 and 10 mg solifenacin succinate doses (Studies 1 and 2) and the other two evaluated only the 10 mg dose (Studies 3 and 4). All patients completing the 12-week studies were eligible to enter an open-label, long-term extension study (Study 5) and 81% of patients enrolling completed the additional 40-week treatment period. The majority of patients were Caucasian (93%) and female (80%) with a mean age of 58 years. The primary endpoint in all four trials was the mean change from baseline to 12 weeks in number of micturitions/24 hours. Secondary endpoints included mean change from b...",
  "brand_name": "Solifenacin Succinate",
  "manufacturer": "Aurobindo Pharma Limited",
  "application_number": "ANDA206817",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20240509",
  "set_id": "92b37f2d-b1cf-49e6-a13b-0ead92c0604c",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 22579,
  "serious": 13866,
  "death": 1340,
  "hospitalization": 6442,
  "primary_suspect": 22454,
  "top_reactions": [
   [
    "Drug Ineffective",
    2349
   ],
   [
    "Fatigue",
    1317
   ],
   [
    "Fall",
    1295
   ],
   [
    "Off Label Use",
    1070
   ],
   [
    "Dry Mouth",
    1037
   ],
   [
    "Constipation",
    1021
   ],
   [
    "Dizziness",
    970
   ],
   [
    "Diarrhoea",
    837
   ],
   [
    "Nausea",
    809
   ],
   [
    "Headache",
    793
   ],
   [
    "Urinary Tract Infection",
    772
   ],
   [
    "Malaise",
    726
   ],
   [
    "Asthenia",
    672
   ],
   [
    "Dyspnoea",
    642
   ],
   [
    "Pain",
    629
   ]
  ],
  "by_year": {
   "2019": 2135,
   "2020": 1666,
   "2021": 1231,
   "2022": 1242,
   "2023": 1200,
   "2024": 1137,
   "2025": 1367,
   "2026": 717
  },
  "by_year_primary": {
   "2019": 2130,
   "2020": 1660,
   "2021": 1222,
   "2022": 1214,
   "2023": 1167,
   "2024": 1133,
   "2025": 1345,
   "2026": 700
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20250313",
   "reason": "CGMP Deviations",
   "firm": "Glenmark Pharmaceuticals Inc., USA",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20250313",
   "reason": "CGMP Deviations",
   "firm": "Glenmark Pharmaceuticals Inc., USA",
   "status": "Ongoing"
  }
 ],
 "recall_total": 2,
 "drugsfda": {
  "applications": 28,
  "nda": 2,
  "anda": 26,
  "first_approval": "20041119",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 14,
  "labeling_recent": 0,
  "sponsors": [
   "ACCORD HLTHCARE",
   "AJANTA PHARMA LTD",
   "ALEMBIC",
   "ALKEM LABS LTD",
   "AMNEAL PHARMS CO",
   "ANNORA PHARMA",
   "ASTELLAS",
   "AUROBINDO PHARMA"
  ],
  "unapproved": false,
  "first_approval_fmt": "11/19/2004"
 },
 "trials": {
  "total": 173,
  "completed": 115,
  "terminated": 14,
  "with_results": 43,
  "industry": 94,
  "phase3": 36,
  "results_share": 0.3739130434782609,
  "terminated_share": 0.08092485549132948
 },
 "pubmed": {
  "rct": 136,
  "meta": 16,
  "recent_rct": 25,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 562.64,
  "records": 31,
  "by_name": [
   [
    "Vesicare",
    562.64
   ]
  ],
  "names_checked": [
   "solifenacin",
   "Vesicare"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 1384915,
  "beneficiaries": 393768,
  "spend": 71439375.91000001,
  "by_brand": [
   {
    "brand": "Solifenacin Succinate",
    "claims": 1379426,
    "per_claim": 48.87927741,
    "is_generic": true
   },
   {
    "brand": "Vesicare",
    "claims": 5390,
    "per_claim": 738.46897217,
    "is_generic": false
   },
   {
    "brand": "Vesicare Ls",
    "claims": 99,
    "per_claim": 340.22252525,
    "is_generic": false
   }
  ],
  "per_claim": 51.58394263185828
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 3178,
  "fills": 1384915,
  "per_million": 2294.725669084384,
  "ratio": 0.8287350342645666,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 95,
   "letter": "A",
   "why": [
    "2,295 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 (0.7x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 48,
   "letter": "F",
   "why": [
    "136 randomized trials and 16 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)",
    "Only 37% 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": 97,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 2 Class II, 0 Class III across 26 generic makers (-3)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 100,
   "letter": "A",
   "why": [
    "Pharma paid doctors $563 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 (26 applications)",
    "11 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 85,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are fatigue, fall. 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.)"
 ]
}