{
 "query": "pramipexole",
 "ingredient": "pramipexole",
 "slug": "pramipexole",
 "rxcui": "746741",
 "brands": [
  "Mirapex"
 ],
 "names": [
  "pramipexole",
  "pramipexole dihydrochloride"
 ],
 "classes": [
  {
   "id": "N04BC",
   "name": "Dopamine agonists"
  }
 ],
 "alternatives": [
  "apomorphine",
  "bromocriptine",
  "cabergoline",
  "dihydroergocryptine mesylate",
  "pergolide",
  "piribedil",
  "ropinirole",
  "rotigotine"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 37
  },
  "boxed_warning": "",
  "indications_and_usage": "tablets are a non-ergot dopamine agonist indicated for the treatment of: Parkinson\u2019s disease (PD) ( 1.1 ) Moderate-to-severe primary Restless Legs Syndrome (RLS) ( 1.2 ) 1.1 Parkinson\u2019s Disease Pramipexole dihydrochloride tablets are indicated for the treatment of Parkinson\u2019s disease. 1.2 Restless Legs Syndrome Pramipexole dihydrochloride tablets are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS).",
  "contraindications": "None. None ( 4 )",
  "warnings_and_cautions": "Falling Asleep During Activities of Daily Living: Sudden onset of sleep may occur without warning; advise patients to report symptoms ( 5.1 ) Symptomatic Orthostatic Hypotension: Monitor during dose escalation ( 5.2 ) Impulse Control/Compulsive Behaviors: Patients may experience compulsive behaviors and other intense urges ( 5.3 ) Hallucinations and Psychotic-like Behavior: May occur; risk increases with age. ( 5.4 ) Dyskinesia: May be caused or exacerbated by PRAMIPEXOLE DIHYDROCHLORIDE tablets ( 5.5 ) Postural Deformity: Consider reducing the dose or discontinuing PRAMIPEXOLE DIHYDROCHLORIDE tablets if postural deformity occurs ( 5.6 ) 5.1 Falling Asleep During Activities of Daily Living and Somnolence Patients treated with pramipexole have reported falling asleep while engaged in activities of daily living, including the operation of motor vehicles which sometimes resulted in accidents. Although many of these patients reported somnolence while on pramipexole tablets, some perceived that they had no warning signs (sleep attack) such as excessive drowsiness, and believed that they were alert immediately prior to the event. Some of these events had been reported as late as one year...",
  "warnings": "",
  "adverse_reactions": "The following adverse reactions are discussed in greater detail in other sections of the labeling: Falling Asleep During Activities of Daily Living and Somnolence [ see Warnings and Precautions ( 5.1 ) ]. Symptomatic Orthostatic Hypotension [ see Warnings and Precautions ( 5.2 ) ]. Impulse Control/Compulsive Behaviors [ see Warnings and Precautions ( 5.3 ) ]. Hallucinations and Psychotic-like Behavior [ see Warnings and Precautions ( 5.4 ) ]. Dyskinesia [ see Warnings and Precautions ( 5.5 ) ]. Postural Deformity [ see Warnings and Precautions ( 5.6 ) ]. Rhabdomyolysis [ see Warnings and Precautions ( 5.8 ) ]. Retinal Pathology [ see Warnings and Precautions ( 5.9 ) ]. Events Reported with Dopaminergic Therapy [ see Warnings and Precautions ( 5.10 ) ]. Withdrawal Symptoms [ see Warnings and Precautions ( 5.11 ) ] Most common adverse reactions (incidence >5% and greater than placebo): Early PD without levodopa: nausea, dizziness, somnolence, insomnia, constipation, asthenia, and hallucinations ( 6.1 ) Advanced PD with levodopa: postural (orthostatic) hypotension, dyskinesia, extrapyramidal syndrome, insomnia, dizziness, hallucinations, accidental injury, dream abnormalities, confusi...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Warnings and Precautions, Withdrawal Symptoms ( 5.11 ) 7/2021",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling (Patient Information). Dosing Instructions Instruct patients to take pramipexole dihydrochloride tablets only as prescribed. If a dose is missed, advise patients not to double their next dose. Pramipexole dihydrochloride tablets can be taken with or without food. If patients develop nausea, advise that taking pramipexole dihydrochloride tablets with food may reduce the occurrence of nausea. Pramipexole is the active ingredient that is in both pramipexole dihydrochloride tablets and extended-release pramipexole tablets. Ensure that patients do not take both extended-release pramipexole and pramipexole dihydrochloride tablets. Sedating Effects Alert patients to the potential sedating effects associated with pramipexole dihydrochloride tablets, including somnolence and the possibility of falling asleep while engaged in activities of daily living. Since somnolence is a frequent adverse reaction with potentially serious consequences, patients should neither drive a car nor engage in other potentially dangerous activities until they have gained sufficient experience with pramipexole dihydrochloride tablets to gauge whether or n...",
  "spl_medguide": "",
  "clinical_studies": "14.1 Parkinson\u2019s Disease The effectiveness of pramipexole dihydrochloride tablets in the treatment of Parkinson's disease was evaluated in a multinational drug development program consisting of seven randomized, controlled trials. Three were conducted in patients with early Parkinson\u2019s disease who were not receiving concomitant levodopa, and four were conducted in patients with advanced Parkinson\u2019s disease who were receiving concomitant levodopa. Among these seven studies, three studies provide the most persuasive evidence of pramipexole\u2019s effectiveness in the management of patients with Parkinson's disease who were and were not receiving concomitant levodopa. Two of these three trials enrolled patients with early Parkinson\u2019s disease (not receiving levodopa), and one enrolled patients with advanced Parkinson's disease who were receiving maximally tolerated doses of levodopa. In all studies, the Unified Parkinson\u2019s Disease Rating Scale (UPDRS), or one or more of its subparts, served as the primary outcome assessment measure. The UPDRS is a four-part multi-item rating scale intended to evaluate mentation (part I), Activities of Daily Living (ADL) (part II), motor performance (part II...",
  "brand_name": "Pramipexole Dihydrochloride",
  "manufacturer": "ScieGen Pharmaceuticals Inc",
  "application_number": "ANDA203855",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20251224",
  "set_id": "395fee34-43dc-4840-a6b8-70d5736f9c8b",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 26326,
  "serious": 18477,
  "death": 2086,
  "hospitalization": 9133,
  "primary_suspect": 26236,
  "top_reactions": [
   [
    "Drug Ineffective",
    2250
   ],
   [
    "Fall",
    1885
   ],
   [
    "Fatigue",
    1809
   ],
   [
    "Nausea",
    1529
   ],
   [
    "Dizziness",
    1330
   ],
   [
    "Pain",
    1316
   ],
   [
    "Dyspnoea",
    1259
   ],
   [
    "Off Label Use",
    1245
   ],
   [
    "Hallucination",
    1219
   ],
   [
    "Condition Aggravated",
    1194
   ],
   [
    "Headache",
    1091
   ],
   [
    "Insomnia",
    1080
   ],
   [
    "Gait Disturbance",
    1037
   ],
   [
    "Death",
    982
   ],
   [
    "Dyskinesia",
    959
   ]
  ],
  "by_year": {
   "2019": 2621,
   "2020": 2598,
   "2021": 2289,
   "2022": 2065,
   "2023": 1773,
   "2024": 860,
   "2025": 2032,
   "2026": 1089
  },
  "by_year_primary": {
   "2019": 2618,
   "2020": 2595,
   "2021": 2285,
   "2022": 2048,
   "2023": 1734,
   "2024": 859,
   "2025": 2020,
   "2026": 1082
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class III",
   "date": "20190821",
   "reason": "Subpotent Drug: Out of specification result during stability study in Pramipexole Dihydrochloride Tablets 0.125 mg",
   "firm": "Macleods Pharma Usa Inc",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20151224",
   "reason": "Presence of Foreign Tablets/Capsules:  Presence of a comingled Carbimazole 5 mg tablet.",
   "firm": "Macleods Pharma Usa Inc",
   "status": "Terminated"
  }
 ],
 "recall_total": 2,
 "drugsfda": {
  "applications": 33,
  "nda": 3,
  "anda": 30,
  "first_approval": "19970701",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 29,
  "labeling_recent": 3,
  "sponsors": [
   "ACTAVIS ELIZABETH",
   "ALEMBIC",
   "AUROBINDO PHARMA LTD",
   "BOEHRINGER INGELHEIM",
   "CHARTWELL RX",
   "DR REDDYS",
   "GLENMARK PHARMS LTD",
   "HERITAGE PHARMA AVET"
  ],
  "unapproved": false,
  "first_approval_fmt": "07/01/1997"
 },
 "trials": {
  "total": 180,
  "completed": 135,
  "terminated": 21,
  "with_results": 68,
  "industry": 128,
  "phase3": 44,
  "results_share": 0.5037037037037037,
  "terminated_share": 0.11666666666666667
 },
 "pubmed": {
  "rct": 114,
  "meta": 18,
  "recent_rct": 19,
  "cochrane": [
   {
    "pmid": "10908540",
    "title": "Pramipexole for levodopa-induced complications in Parkinson's disease",
    "year": "2000"
   },
   {
    "pmid": "10908539",
    "title": "Pramipexole versus bromocriptine for levodopa-induced complications in Parkinson's disease",
    "year": "2000"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "pramipexole",
   "Mirapex"
  ],
  "source": "bulk-index"
 },
 "partd": null,
 "mdl": [],
 "dsc": [
  {
   "date": "20120919",
   "title": "Ongoing safety review of Parkinson\u00e2\u0080\u0099s drug Mirapex (pramipexole) and possible risk of heart failure",
   "url": "https://www.fda.gov/Drugs/DrugSafety/ucm319779.htm",
   "kind": "drug",
   "matched": "pramipexole"
  }
 ],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "ApplicationRejected",
  "name": "pramipexole",
  "matched": "pramipexole",
  "stewardship": []
 },
 "exposure": null,
 "scores": {
  "safety": {
   "score": 92,
   "letter": "A",
   "why": [
    "FDA issued 1 Drug Safety Communication(s) naming this drug since 2010, most recently 2012 (-8)",
    "Death share in reports is near or below the FAERS average (0.9x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 60,
   "letter": "D",
   "why": [
    "114 randomized trials and 18 systematic reviews/meta-analyses indexed in PubMed",
    "2 independent Cochrane review(s) exist",
    "'Drug ineffective' is the single most-reported item about this drug in FAERS (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 91,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 0 Class II, 1 Class III across 30 generic makers (-0)",
    "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 (30 applications)",
    "8 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 86,
 "grade": "B",
 "questions": [
  "In 2012 the FDA issued a safety communication about this drug (Ongoing safety review of Parkinson\u00e2\u0080\u0099s drug Mirapex (pramipexole) and possible risk of heart failure). 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.)"
 ]
}