{
 "query": "ropinirole",
 "ingredient": "ropinirole",
 "slug": "ropinirole",
 "rxcui": "72302",
 "brands": [],
 "names": [
  "ropinirole",
  "ropinirole hydrochloride"
 ],
 "classes": [
  {
   "id": "N04BC",
   "name": "Dopamine agonists"
  }
 ],
 "alternatives": [
  "apomorphine",
  "bromocriptine",
  "cabergoline",
  "dihydroergocryptine mesylate",
  "pergolide",
  "piribedil",
  "pramipexole",
  "rotigotine"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 58
  },
  "boxed_warning": "",
  "indications_and_usage": "Ropinirole tablets are a non-ergoline dopamine agonist indicated for the treatment of Parkinson\u2019s disease (PD) and moderate-to-severe primary Restless Legs Syndrome (RLS). ( 1.1, 1.2 ) 1.1 Parkinson\u2019s Disease Ropinirole tablets are indicated for the treatment of Parkinson\u2019s disease. 1.2 Restless Legs Syndrome Ropinirole tablets are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS).",
  "contraindications": "Ropinirole tablets are contraindicated in patients known to have a hypersensitivity/allergic reaction (including urticaria, angioedema, rash, pruritus) to ropinirole or to any of the excipients. History of hypersensitivity/allergic reaction (including urticaria, angioedema, rash, pruritus) to ropinirole or to any of the excipients. (4)",
  "warnings_and_cautions": "Sudden onset of sleep and somnolence may occur (5.1) Syncope may occur (5.2) Hypotension, including orthostatic hypotension may occur (5.3) May cause hallucinations and psychotic-like behaviors (5.4) May cause or exacerbate dyskinesia (5.5) May cause problems with impulse control or compulsive behaviors (5.6) 5.1 Falling Asleep during Activities of Daily Living and Somnolence Patients treated with ropinirole hydrochloride have reported falling asleep while engaged in activities of daily living, including driving or operating machinery, which sometimes resulted in accidents. Although many of these patients reported somnolence while on ropinirole hydrochloride, some perceived that they had no warning signs, such as excessive drowsiness, and believed that they were alert immediately prior to the event. Some have reported these events more than 1 year after initiation of treatment. In controlled clinical trials, somnolence was commonly reported in patients receiving ropinirole hydrochloride and was more frequent in Parkinson's disease (up to 40% ropinirole hydrochloride, 6% placebo) than in RLS (12% ropinirole hydrochloride, 6% placebo) [see Adverse Reactions (6.1) ] . It has been repo...",
  "warnings": "",
  "adverse_reactions": "The following adverse reactions are described in more detail in other sections of the label: Hypersensitivity [see Contraindications (4) ] Falling asleep during activities of daily living and somnolence [see Warnings and Precautions (5.1) ] Syncope [see Warnings and Precautions (5.2) ] Hypotension/orthostatic hypotension [see Warnings and Precautions (5.3) ] Hallucinations/psychotic-like behavior [see Warnings and Precautions (5.4) ] Dyskinesia [see Warnings and Precautions (5.5) ] Impulse control/compulsive behaviors [see Warnings and Precautions (5.6) ] Withdrawal-emergent hyperpyrexia and confusion [see Warnings and Precautions (5.7) ] Withdrawal Symptoms [see Warnings and Precautions (5.8) ] Augmentation and early-morning rebound in RLS [see Warnings and Precautions (5.9) ] Fibrotic complications [see Warnings and Precautions (5.10) ] Retinal pathology [see Warnings and Precautions (5.11) ] Most common adverse reactions (incidence with ropinirole hydrochloride at least 5% greater than placebo) in the respective indications were: Early PD: Nausea, somnolence, dizziness, syncope, asthenic condition, viral infection, leg edema, vomiting, and dyspepsia. (6.1) Advanced PD: Dyskinesi...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Warnings and Precautions, Withdrawal Symptoms ( 5.8 ) 7/2021 Melanoma-removal ( 5.9 ) 7/2021",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling (Patient Information). Dosing Instructions Instruct patients to take ropinirole hydrochloride only as prescribed. If a dose is missed, advise patients not to double their next dose. Ropinirole tablets can be taken with or without food [see Dosage and Administration (2.1) ] . Ropinirole is the active ingredient in ropinirole tablets (the immediate\u2011release formulation). Ask your patients if they are taking another medication containing ropinirole. Hypersensitivity/Allergic Reactions Advise patients about the potential for developing a hypersensitivity/allergic reaction including manifestations such as urticaria, angioedema, rash, and pruritus when taking any ropinirole product. Inform patients who experience these or similar reactions to immediately contact their healthcare professional [see Contraindications (4) ] . Falling Asleep during Activities of Daily Living and Somnolence Alert patients to the potential sedating effects caused by ropinirole hydrochloride, including somnolence and the possibility of falling asleep while engaged in activities of daily living. Because somnolence is a frequent adverse reaction with pote...",
  "spl_medguide": "",
  "clinical_studies": "14.1 Parkinson\u2019s Disease The effectiveness of ropinirole hydrochloride in the treatment of Parkinson\u2019s disease was evaluated in a multinational drug development program consisting of 11 randomized, controlled trials. Four trials were conducted in patients with early Parkinson\u2019s disease and no concomitant L-dopa and 7 trials were conducted in patients with advanced Parkinson\u2019s disease with concomitant L-dopa. Three placebo-controlled trials provide evidence of effectiveness of ropinirole hydrochloride in the management of patients with Parkinson\u2019s disease who were and were not receiving concomitant L-dopa. Two of these 3 trials enrolled patients with early Parkinson\u2019s disease (without L-dopa) and 1 enrolled patients receiving L-dopa. In these trials a variety of measures were used to assess the effects of treatment (e.g., Unified Parkinson\u2019s Disease Rating Scale [UPDRS], Clinical Global Impression [CGI] scores, patient diaries recording time \u201con\u201d and \u201coff,\u201d tolerability of L-dopa dose reductions). In both trials of patients with early Parkinson\u2019s disease (without L-dopa), the motor component (Part III) of the UPDRS was the primary outcome assessment. The UPDRS is a multi-item rating...",
  "brand_name": "ropinirole",
  "manufacturer": "Accord Healthcare Inc.",
  "application_number": "ANDA204022",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20241003",
  "set_id": "4a2a5b63-5b14-6975-e054-00144ff8d46c",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 25971,
  "serious": 16297,
  "death": 2175,
  "hospitalization": 7894,
  "primary_suspect": 25936,
  "top_reactions": [
   [
    "Drug Ineffective",
    1869
   ],
   [
    "Fall",
    1811
   ],
   [
    "Fatigue",
    1651
   ],
   [
    "Nausea",
    1600
   ],
   [
    "Dizziness",
    1216
   ],
   [
    "Pain",
    1105
   ],
   [
    "Hallucination",
    1098
   ],
   [
    "Dyspnoea",
    1072
   ],
   [
    "Death",
    1035
   ],
   [
    "Diarrhoea",
    1020
   ],
   [
    "Headache",
    986
   ],
   [
    "Asthenia",
    948
   ],
   [
    "Off Label Use",
    938
   ],
   [
    "Gait Disturbance",
    870
   ],
   [
    "Insomnia",
    865
   ]
  ],
  "by_year": {
   "2019": 2595,
   "2020": 2491,
   "2021": 2005,
   "2022": 1813,
   "2023": 1439,
   "2024": 1679,
   "2025": 1790,
   "2026": 848
  },
  "by_year_primary": {
   "2019": 2595,
   "2020": 2491,
   "2021": 2004,
   "2022": 1797,
   "2023": 1434,
   "2024": 1674,
   "2025": 1785,
   "2026": 847
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20230207",
   "reason": "CGMP Deviations: recalling drug products following an FDA inspection.",
   "firm": "Accord Healthcare, Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20230207",
   "reason": "CGMP Deviations: recalling drug products following an FDA inspection.",
   "firm": "Accord Healthcare, Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20230207",
   "reason": "CGMP Deviations: recalling drug products following an FDA inspection.",
   "firm": "Accord Healthcare, Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20230207",
   "reason": "CGMP Deviations: recalling drug products following an FDA inspection.",
   "firm": "Accord Healthcare, Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20230207",
   "reason": "CGMP Deviations: recalling drug products following an FDA inspection.",
   "firm": "Accord Healthcare, Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20230207",
   "reason": "CGMP Deviations: recalling drug products following an FDA inspection.",
   "firm": "Accord Healthcare, Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20230207",
   "reason": "CGMP Deviations: recalling drug products following an FDA inspection.",
   "firm": "Accord Healthcare, Inc.",
   "status": "Terminated"
  }
 ],
 "recall_total": 7,
 "drugsfda": {
  "applications": 23,
  "nda": 2,
  "anda": 21,
  "first_approval": "19970919",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 22,
  "labeling_recent": 3,
  "sponsors": [
   "ACCORD HLTHCARE",
   "ACTAVIS ELIZABETH",
   "ALEMBIC",
   "ALEMBIC LTD",
   "AUROBINDO PHARMA USA",
   "CHARTWELL RX",
   "COSETTE PHARMS NC",
   "DR REDDYS LABS LTD"
  ],
  "unapproved": false,
  "first_approval_fmt": "09/19/1997"
 },
 "trials": {
  "total": 80,
  "completed": 68,
  "terminated": 6,
  "with_results": 33,
  "industry": 63,
  "phase3": 30,
  "results_share": 0.4852941176470588,
  "terminated_share": 0.075
 },
 "pubmed": {
  "rct": 73,
  "meta": 11,
  "recent_rct": 2,
  "cochrane": [
   {
    "pmid": "11279719",
    "title": "Ropinirole versus bromocriptine for levodopa-induced complications in Parkinson's disease",
    "year": "2001"
   },
   {
    "pmid": "11279718",
    "title": "Ropinirole for levodopa-induced complications in Parkinson's disease",
    "year": "2001"
   },
   {
    "pmid": "10908504",
    "title": "Ropinirole versus bromocriptine for levodopa-induced complications in Parkinson's disease",
    "year": "2000"
   },
   {
    "pmid": "10908503",
    "title": "Ropinirole for levodopa-induced complications in Parkinson's disease",
    "year": "2000"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "ropinirole"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 3480847,
  "beneficiaries": 704591,
  "spend": 64771569.82,
  "by_brand": [
   {
    "brand": "Ropinirole HCl",
    "claims": 3405431,
    "per_claim": 16.116654086,
    "is_generic": true
   },
   {
    "brand": "Ropinirole ER",
    "claims": 75416,
    "per_claim": 131.10502254,
    "is_generic": false
   }
  ],
  "per_claim": 18.607991049304953
 },
 "mdl": [],
 "dsc": [
  {
   "date": "20110613",
   "title": "Risperdal and Requip - Medication errors resulting from confusion between risperidone (Risperdal) and ropinirole (Requip)",
   "url": "https://www.fda.gov/Drugs/DrugSafety/ucm258805.htm",
   "kind": "drug",
   "matched": "ropinirole"
  }
 ],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "ApplicationRejected",
  "name": "ropinirole",
  "matched": "ropinirole",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 4306,
  "fills": 3480847,
  "per_million": 1237.0552339703527,
  "ratio": 0.446759726238057,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 92,
   "letter": "A",
   "why": [
    "FDA issued 1 Drug Safety Communication(s) naming this drug since 2010, most recently 2011 (-8)",
    "1,237 FDA reports naming it as the suspect drug per million Medicare fills, 0.4x the median drug on this site",
    "Death share in reports is near or below the FAERS average (0.9x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 46,
   "letter": "F",
   "why": [
    "73 randomized trials and 11 systematic reviews/meta-analyses indexed in PubMed",
    "4 independent Cochrane review(s) exist",
    "Only 49% 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": 85,
   "letter": "B",
   "why": [
    "Recalls since 2016: 0 Class I, 7 Class II, 0 Class III across 21 generic makers (-6)",
    "3 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 (21 applications)",
    "8 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 81,
 "grade": "B",
 "questions": [
  "In 2011 the FDA issued a safety communication about this drug (Risperdal and Requip - Medication errors resulting from confusion between risperidone (Risperdal) and ropiniro). Does that risk apply to me?",
  "The most-reported problems in FDA's adverse event data are fall, fatigue, nausea. How would we recognize and handle those?",
  "Why this one over apomorphine, bromocriptine, cabergoline? 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.)"
 ]
}