{
 "query": "amantadine",
 "ingredient": "amantadine",
 "slug": "amantadine",
 "rxcui": "620",
 "brands": [
  "Gocovri",
  "Osmolex"
 ],
 "names": [
  "amantadine",
  "amantadine hydrochloride",
  "amantadine sulfate"
 ],
 "classes": [
  {
   "id": "N04BB",
   "name": "Adamantane derivatives"
  }
 ],
 "alternatives": [],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 54
  },
  "boxed_warning": "",
  "indications_and_usage": "INDICATIONS AND USAGE Amantadine hydrochloride capsules are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine hydrochloride capsules are also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions. Influenza A Prophylaxis: Amantadine hydrochloride capsules are indicated for chemoprophylaxis against signs and symptoms of influenza A virus infection. Because amantadine hydrochloride capsules do not completely prevent the host immune response to influenza A infection, individuals who take this drug may still develop immune responses to natural disease or vaccination and may be protected when later exposed to antigenically related viruses. Following vaccination during an influenza A outbreak, amantadine hydrochloride capsules prophylaxis should be considered for the 2- to 4-week time period required to develop an antibody response. Influenza A Treatment: Amantadine hydrochloride capsules are also indicated in the treatment of uncomplicated respiratory tract illness caused by influenza A virus strains especially when administered early in the course of illness. There are...",
  "contraindications": "CONTRAINDICATIONS Amantadine hydrochloride is contraindicated in patients with known hypersensitivity to amantadine hydrochloride or to any of the other ingredients in Amantadine hydrochloride.",
  "warnings_and_cautions": "",
  "warnings": "WARNINGS Deaths: Deaths have been reported from overdose with amantadine hydrochloride. The lowest reported acute lethal dose was 1 gram. Acute toxicity may be attributable to the anticholinergic effects of amantadine. Drug overdose has resulted in cardiac, respiratory, renal or central nervous system toxicity. Cardiac dysfunction includes arrhythmia, tachycardia and hypertension (see OVERDOSAGE ). Deaths due to drug accumulation (overdose) have been reported in patients with renal impairment, who were prescribed higher than recommended dose of amantadine hydrochloride for their level of renal function [see Dosage and Administration: Dosage for Impairment Renal Function and Overdosage ] . Suicide Attempts: Suicide attempts, some of which have been fatal, have been reported in patients treated with amantadine hydrochloride, many of whom received short courses for influenza treatment or prophylaxis. The incidence of suicide attempts is not known and the pathophysiologic mechanism is not understood. Suicide attempts and suicidal ideation have been reported in patients with and without prior history of psychiatric illness. Amantadine hydrochloride can exacerbate mental problems in pati...",
  "adverse_reactions": "ADVERSE REACTIONS The adverse reactions reported most frequently at the recommended dose of amantadine hydrochloride (5% to 10%) are: nausea, dizziness (lightheadedness), and insomnia. Less frequently (1% to 5%) reported adverse reactions are: depression, anxiety and irritability, hallucinations, confusion, anorexia, dry mouth, constipation, ataxia, livedo reticularis, peripheral edema, orthostatic hypotension, headache, somnolence, nervousness, dream abnormality, agitation, dry nose, diarrhea and fatigue. Infrequently (0.1% to 1%) occurring adverse reactions are: congestive heart failure, psychosis, urinary retention, dyspnea, skin rash, vomiting, weakness, slurred speech, euphoria, thinking abnormality, amnesia, hyperkinesia, hypertension, decreased libido, and visual disturbance, including punctate subepithelial or other corneal opacity, corneal edema, decreased visual acuity, sensitivity to light, and optic nerve palsy. Rare (less than 0.1%) occurring adverse reactions are: instances of convulsion, leukopenia, neutropenia, eczematoid dermatitis, oculogyric episodes, suicidal attempt, suicide, and suicidal ideation (see WARNINGS ). Other adverse reactions reported during postmar...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Information for Patients: Patients should be advised of the following information: Blurry vision and/or impaired mental acuity may occur. Gradually increase physical activity as the symptoms of Parkinson's disease improve. Avoid excessive alcohol usage, since it may increase the potential for CNS effects such as dizziness, confusion, light-headedness and orthostatic hypotension. Avoid getting up suddenly from a sitting or lying position. If dizziness or lightheadedness occurs, notify physician. Notify physician if mood/mental changes, swelling of extremities, difficulty urinating and/or shortness of breath occur. Do not take more medication than prescribed because of the risk of overdose. If there is no improvement in a few days, or if medication appears less effective after a few weeks, discuss with a physician. Consult physician before discontinuing medication. Seek medical attention immediately if it is suspected that an overdose of medication has been taken. Drug Interactions Careful observation is required when amantadine hydrochloride is administered concurrently with central nervous system stimulants. Agents with anticholinergic properties may potentiate the anticholinergic-...",
  "spl_medguide": "",
  "clinical_studies": "",
  "brand_name": "Amantadine Hydrochloride",
  "manufacturer": "Upsher-Smith Laboratories, LLC",
  "application_number": "ANDA070589",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20250709",
  "set_id": "5232b933-1df9-43b4-8ac2-61bfa4855e68",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 19884,
  "serious": 12498,
  "death": 2238,
  "hospitalization": 6480,
  "primary_suspect": 19814,
  "top_reactions": [
   [
    "Fall",
    2244
   ],
   [
    "Hallucination",
    1667
   ],
   [
    "Drug Ineffective",
    1593
   ],
   [
    "Dyskinesia",
    1413
   ],
   [
    "Fatigue",
    1364
   ],
   [
    "Gait Disturbance",
    1216
   ],
   [
    "Dizziness",
    1154
   ],
   [
    "Death",
    1133
   ],
   [
    "Tremor",
    1014
   ],
   [
    "Parkinson^S Disease",
    869
   ],
   [
    "Nausea",
    835
   ],
   [
    "Asthenia",
    820
   ],
   [
    "Balance Disorder",
    784
   ],
   [
    "Off Label Use",
    775
   ],
   [
    "Somnolence",
    763
   ]
  ],
  "by_year": {
   "2019": 2122,
   "2020": 2338,
   "2021": 2077,
   "2022": 1907,
   "2023": 1335,
   "2024": 1381,
   "2025": 1524,
   "2026": 744
  },
  "by_year_primary": {
   "2019": 2122,
   "2020": 2338,
   "2021": 2075,
   "2022": 1899,
   "2023": 1314,
   "2024": 1372,
   "2025": 1517,
   "2026": 724
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20260213",
   "reason": "Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.",
   "firm": "AvKARE",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20210315",
   "reason": "CGMP Deviations: Intermittent exposure to temperature excursion during storage.",
   "firm": "Cardinal Health Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20180330",
   "reason": "Failed Dissolution Specifications",
   "firm": "AVKARE Inc.",
   "status": "Terminated"
  }
 ],
 "recall_total": 3,
 "drugsfda": {
  "applications": 43,
  "nda": 6,
  "anda": 35,
  "first_approval": "19680214",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 19,
  "labeling_recent": 2,
  "sponsors": [
   "ACTAVIS ELIZABETH",
   "ADAPTIS",
   "ALEMBIC",
   "AUROBINDO PHARMA USA",
   "BIONPHARMA",
   "CHARTWELL MOLECULAR",
   "CHARTWELL RX",
   "ENDO PHARMS"
  ],
  "unapproved": false,
  "first_approval_fmt": "02/14/1968"
 },
 "trials": {
  "total": 339,
  "completed": 198,
  "terminated": 43,
  "with_results": 104,
  "industry": 107,
  "phase3": 86,
  "results_share": 0.5252525252525253,
  "terminated_share": 0.12684365781710916
 },
 "pubmed": {
  "rct": 206,
  "meta": 34,
  "recent_rct": 18,
  "cochrane": [
   {
    "pmid": "25415374",
    "title": "Amantadine and rimantadine for influenza A in children and the elderly",
    "year": "2014"
   },
   {
    "pmid": "22258950",
    "title": "Amantadine and rimantadine for influenza A in children and the elderly",
    "year": "2012"
   },
   {
    "pmid": "18254006",
    "title": "Amantadine and rimantadine for influenza A in children and the elderly",
    "year": "2008"
   },
   {
    "pmid": "17253480",
    "title": "Amantadine for fatigue in multiple sclerosis",
    "year": "2007"
   },
   {
    "pmid": "16625539",
    "title": "Amantadine and rimantadine for influenza A in adults",
    "year": "2006"
   },
   {
    "pmid": "15266442",
    "title": "Amantadine and rimantadine for preventing and treating influenza A in adults",
    "year": "2004"
   },
   {
    "pmid": "12804468",
    "title": "Amantadine for dyskinesia in Parkinson's disease",
    "year": "2003"
   },
   {
    "pmid": "12804439",
    "title": "Amantadine for fatigue in multiple sclerosis",
    "year": "2003"
   },
   {
    "pmid": "12535476",
    "title": "Amantadine in Parkinson's disease",
    "year": "2003"
   },
   {
    "pmid": "12137620",
    "title": "Amantadine and rimantadine for preventing and treating influenza A in adults",
    "year": "2002"
   },
   {
    "pmid": "11405978",
    "title": "Amantadine and rimantadine for preventing and treating influenza A in adults",
    "year": "2001"
   },
   {
    "pmid": "10796612",
    "title": "Amantadine and rimantadine for preventing and treating influenza A in adults",
    "year": "2000"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 1181132.86,
  "records": 7794,
  "by_name": [
   [
    "Gocovri",
    1181132.86
   ]
  ],
  "names_checked": [
   "amantadine",
   "Gocovri",
   "Osmolex"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 557873,
  "beneficiaries": 109379,
  "spend": 123470222.11,
  "by_brand": [
   {
    "brand": "Amantadine",
    "claims": 526882,
    "per_claim": 44.221170395,
    "is_generic": false
   },
   {
    "brand": "Gocovri",
    "claims": 30705,
    "per_claim": 3251.6782833,
    "is_generic": false
   },
   {
    "brand": "Osmolex ER",
    "claims": 286,
    "per_claim": 1147.2088112,
    "is_generic": false
   }
  ],
  "per_claim": 221.32317231699687
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 3613,
  "fills": 557873,
  "per_million": 6476.384410071826,
  "ratio": 2.338931719944085,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 93,
   "letter": "A",
   "why": [
    "6,476 FDA reports naming it as the suspect drug per million Medicare fills, 2.3x the median drug on this site (-7)",
    "Death share in reports is near or below the FAERS average (1.2x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 73,
   "letter": "C",
   "why": [
    "206 randomized trials and 34 systematic reviews/meta-analyses indexed in PubMed",
    "12 independent Cochrane review(s) exist"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 92,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 3 Class II, 0 Class III across 35 generic makers (-4)",
    "2 label changes approved since 2021 (-4)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 70,
   "letter": "C",
   "why": [
    "Pharma paid doctors $1,181,133 tied to this drug last year (-30)",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 70,
   "letter": "C",
   "why": [
    "Generic versions approved (35 applications)",
    "No same-class alternatives found: little leverage to switch (-30)"
   ],
   "weight": 0.1
  }
 },
 "total": 82,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are fall, hallucination, dyskinesia. How would we recognize and handle those?",
  "The manufacturer pays physicians heavily to promote this drug. Have you received anything from them?",
  "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.)"
 ]
}