{
 "query": "naltrexone",
 "ingredient": "naltrexone",
 "slug": "naltrexone",
 "rxcui": "7243",
 "brands": [
  "ReVia",
  "Vivitrol"
 ],
 "names": [
  "naltrexone",
  "naltrexone hydrochloride"
 ],
 "classes": [
  {
   "id": "N07BB",
   "name": "Drugs used in alcohol dependence"
  }
 ],
 "alternatives": [
  "acamprosate",
  "calcium carbimide",
  "disulfiram",
  "nalmefene"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 44
  },
  "boxed_warning": "",
  "indications_and_usage": "INDICATIONS AND USAGE Naltrexone hydrochloride tablets USP 50 mg is indicated in the treatment of alcohol dependence and for the blockade of the effects of exogenously administered opioids. Naltrexone hydrochloride tablets USP 50 mg has not been shown to provide any therapeutic benefit except as part of an appropriate plan of management for the addictions.",
  "contraindications": "CONTRAINDICATIONS Naltrexone hydrochloride is contraindicated in Patients receiving opioid analgesics. Patients currently dependent on opioids, including those currently maintained on opiate agonists (e.g., methadone ) or partial agonists (e.g., buprenorphine) Patients in acute opioid withdrawal (see WARNINGS ). Any individual who has failed the naloxone challenge test or who has a positive urine screen for opioids. Any individual with a history of sensitivity to naltrexone hydrochloride or any other components of this product.It is not known if there is any cross-sensitivity with naloxone or the phenanthrene containing opioids.",
  "warnings_and_cautions": "",
  "warnings": "WARNINGS Vulnerability to Opioid Overdose After opioid detoxification, patients are likely to have reduced tolerance to opioids. As the blockade of exogenous opioids provided by naltrexone hydrochloride wanes and eventually dissipates completely, patients who have been treated with naltrexone hydrochloride may respond to lower doses of opioids than previously used, just as they would shortly after completing detoxification. This could result in potentially life-threatening opioid intoxication (respiratory compromise or arrest, circulatory collapse, etc.) if the patient uses previously tolerated doses of opioids. Cases of opioid overdose with fatal outcomes have been reported in patients after discontinuing treatment. Patients should be alerted that they may be more sensitive to opioids, even at lower doses, after naltrexone hydrochloride treatment is discontinued. It is important that patients inform family members, and the people closest to the patient of this increased sensitivity to opioids and the risk of overdose. (see PRECAUTIONS, Information for Patients ). There is also the possibility that a patient who is treated with naltrexone hydrochloride could overcome the opioid blo...",
  "adverse_reactions": "ADVERSE REACTIONS During two randomized, double-blind placebo-controlled 12 week trials to evaluate the efficacy of naltrexone hydrochloride as an adjunctive treatment of alcohol dependence, most patients tolerated naltrexone hydrochloride well. In these studies, a total of 93 patients received naltrexone hydrochloride at a dose of 50 mg once daily. Five of these patients discontinued naltrexone hydrochloride because of nausea. No serious adverse events were reported during these two trials. While extensive clinical studies evaluating the use of naltrexone hydrochloride in detoxified, formerly opioid-dependent individuals failed to identify any single, serious untoward risk of naltrexone hydrochloride use, placebo-controlled studies employing up to five-fold higher doses of naltrexone hydrochloride (up to 300 mg per day) than that recommended for use in opiate receptor blockade have shown that naltrexone hydrochloride causes hepatocellular injury in a substantial proportion of patients exposed at higher doses (see WARNINGS and PRECAUTIONS: Laboratory Tests ). Aside from this finding, and the risk of precipitated opioid withdrawal, available evidence does not incriminate naltrexone ...",
  "drug_abuse_and_dependence": "DRUG ABUSE AND DEPENDENCE Naltrexone hydrochloride is a pure opioid antagonist. It does not lead to physical or psychological dependence. Tolerance to the opioid antagonist effect is not known to occur.",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Information for Patients It is recommended that the prescribing physician relate the following information to patients being treated with naltrexone hydrochloride: You have been prescribed naltrexone hydrochloride as part of the comprehensive treatment for your alcoholism or drug dependence. You should carry identification to alert medical personnel to the fact that you are taking naltrexone hydrochloride. A naltrexone hydrochloride medication card may be obtained from your physician and can be used for this purpose. Carrying the identification card should help to ensure that you can obtain adequate treatment in an emergency. If you require medical treatment, be sure to tell the treating physician that you are receiving naltrexone hydrochloride therapy.You should take naltrexone hydrochloride as directed by your physician. Advise patients that if they previously used opioids, they may be more sensitive to lower doses of opioids and at risk of accidental overdose should they use opioids after naltrexone hydrochloride treatment is discontinued or temporarily interrupted. It is important that patients inform family members and the people closest to the patient of this increased sensit...",
  "spl_medguide": "",
  "clinical_studies": "Clinical Trials Alcoholism: The efficacy of naltrexone hydrochloride as an aid to the treatment of alcoholism was tested in placebo-controlled, outpatient, double blind trials. These studies used a dose of naltrexone hydrochloride tablets 50 mg once daily for 12 weeks as an adjunct to social and psychotherapeutic methods when given under conditions that enhanced patient compliance. Patients with psychosis, dementia, and secondary psychiatric diagnoses were excluded from these studies. In one of these studies, 104 alcohol-dependent patients were randomized to receive either naltrexone hydrochloride tablets 50 mg once daily or placebo. In this study, naltrexone hydrochloride proved superior to placebo in measures of drinking including abstention rates (51% vs. 23%), number of drinking days, and relapse (31% vs. 60%). In a second study with 82 alcohol-dependent patients, the group of patients receiving naltrexone hydrochloride were shown to have lower relapse rates (21% vs. 41%), less alcohol craving, and fewer drinking days compared with patients who received placebo, but these results depended on the specific analysis used. The clinical use of naltrexone hydrochloride as adjunctive ...",
  "brand_name": "Naltrexone Hydrochloride",
  "manufacturer": "A-S Medication Solutions",
  "application_number": "ANDA091205",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20231215",
  "set_id": "00c04ff4-b6f2-466c-9ab9-813a60577db0",
  "has_boxed_warning": false,
  "boxed_labels": "0 of 43",
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 31707,
  "serious": 9227,
  "death": 1235,
  "hospitalization": 4143,
  "primary_suspect": 31668,
  "top_reactions": [
   [
    "Injection Site Reaction",
    4388
   ],
   [
    "Injection Site Pain",
    3149
   ],
   [
    "Nausea",
    2219
   ],
   [
    "Fatigue",
    1991
   ],
   [
    "Alcoholism",
    1949
   ],
   [
    "Injection Site Mass",
    1911
   ],
   [
    "Pain",
    1724
   ],
   [
    "Drug Ineffective",
    1667
   ],
   [
    "Headache",
    1585
   ],
   [
    "Off Label Use",
    1563
   ],
   [
    "Feeling Abnormal",
    1453
   ],
   [
    "Drug Dependence",
    1376
   ],
   [
    "Malaise",
    1330
   ],
   [
    "Insomnia",
    1251
   ],
   [
    "Anxiety",
    1144
   ]
  ],
  "by_year": {
   "2019": 3488,
   "2020": 3888,
   "2021": 2914,
   "2022": 2736,
   "2023": 2127,
   "2024": 1657,
   "2025": 1637,
   "2026": 897
  },
  "by_year_primary": {
   "2019": 3487,
   "2020": 3888,
   "2021": 2912,
   "2022": 2732,
   "2023": 2118,
   "2024": 1647,
   "2025": 1634,
   "2026": 887
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20220413",
   "reason": "cGMP deviations: Temperature abuse",
   "firm": "Mckesson Medical-Surgical Inc. Corporate Office",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20190926",
   "reason": "Labeling: Not Elsewhere Classified. Drug product kit recalled due to 1 inch needles being placed in the 1 1/2 inch needle cardboard sleeve labelled as administration needles. The product vial is not impacted.",
   "firm": "Alkermes, Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20190808",
   "reason": "Labeling: Not  Elsewhere Classified. Drug product kit recalled due to 1 inch needles being placed in the 1 1/2 inch needle cardboard sleeve labelled as administration needles. The product vial is not impacted.",
   "firm": "Alkermes Inc",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20140304",
   "reason": "Customer complaints for failure to deliver the dose.",
   "firm": "Alkermes, Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20121106",
   "reason": "Lack of Assurance of Sterility: Product did not meet the criteria for container closure integrity testing during routine 24 month stability testing.",
   "firm": "Alkermes, Inc.",
   "status": "Terminated"
  }
 ],
 "recall_total": 5,
 "drugsfda": {
  "applications": 10,
  "nda": 2,
  "anda": 8,
  "first_approval": "19841120",
  "rems": false,
  "rems_last": "20210506",
  "labeling_supplements": 17,
  "labeling_recent": 3,
  "sponsors": [
   "ACCORD HLTHCARE",
   "ALKERMES",
   "BARR",
   "CHARTWELL",
   "ELITE LABS",
   "NOVITIUM PHARMA",
   "SPECGX LLC",
   "SUN PHARM"
  ],
  "unapproved": false,
  "first_approval_fmt": "11/20/1984"
 },
 "trials": {
  "total": 537,
  "completed": 381,
  "terminated": 63,
  "with_results": 210,
  "industry": 159,
  "phase3": 102,
  "results_share": 0.5511811023622047,
  "terminated_share": 0.11731843575418995
 },
 "pubmed": {
  "rct": 621,
  "meta": 87,
  "recent_rct": 105,
  "cochrane": [
   {
    "pmid": "40342086",
    "title": "Sustained-release naltrexone for opioid dependence",
    "year": "2025"
   },
   {
    "pmid": "29607497",
    "title": "Low dose naltrexone for induction of remission in Crohn's disease",
    "year": "2018"
   },
   {
    "pmid": "24558033",
    "title": "Low dose naltrexone for induction of remission in Crohn's disease",
    "year": "2014"
   },
   {
    "pmid": "21491383",
    "title": "Oral naltrexone maintenance treatment for opioid dependence",
    "year": "2011"
   },
   {
    "pmid": "21328250",
    "title": "Oral naltrexone maintenance treatment for opioid dependence",
    "year": "2011"
   },
   {
    "pmid": "18425938",
    "title": "Sustained-release naltrexone for opioid dependence",
    "year": "2008"
   },
   {
    "pmid": "16437431",
    "title": "Oral naltrexone maintenance treatment for opioid dependence",
    "year": "2006"
   },
   {
    "pmid": "12804405",
    "title": "Naltrexone maintenance treatment for opioid dependence",
    "year": "2003"
   },
   {
    "pmid": "12076406",
    "title": "Naltrexone maintenance treatment for opioid dependence",
    "year": "2002"
   },
   {
    "pmid": "11687108",
    "title": "Naltrexone maintenance treatment for opioid dependence",
    "year": "2001"
   },
   {
    "pmid": "11034715",
    "title": "Naltrexone maintenance treatment for opioid dependence",
    "year": "2000"
   },
   {
    "pmid": "10796779",
    "title": "Naltrexone maintenance treatment for opioid dependence",
    "year": "2000"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 626735.56,
  "records": 9491,
  "by_name": [
   [
    "Vivitrol",
    626735.56
   ]
  ],
  "names_checked": [
   "naltrexone",
   "ReVia",
   "Vivitrol"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 466006,
  "beneficiaries": 139452,
  "spend": 23023694.98,
  "by_brand": [
   {
    "brand": "Naltrexone HCl",
    "claims": 466006,
    "per_claim": 49.406434638,
    "is_generic": true
   }
  ],
  "per_claim": 49.40643463818063
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "naltrexone",
  "matched": "naltrexone",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 4168,
  "fills": 466006,
  "per_million": 8944.090848615682,
  "ratio": 3.2301383715511753,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 90,
   "letter": "A",
   "why": [
    "8,944 FDA reports naming it as the suspect drug per million Medicare fills, 3.2x the median drug on this site (-10)",
    "Death share in reports is near or below the FAERS average (0.4x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 88,
   "letter": "A",
   "why": [
    "621 randomized trials and 87 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "12 independent Cochrane review(s) exist"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 87,
   "letter": "B",
   "why": [
    "Recalls since 2016: 0 Class I, 3 Class II, 0 Class III (-9)",
    "3 label changes approved since 2021 (-4)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 85,
   "letter": "B",
   "why": [
    "Pharma paid doctors $626,736 tied to this drug last year (-15)",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 100,
   "letter": "A",
   "why": [
    "Generic versions approved (8 applications)",
    "4 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 89,
 "grade": "A",
 "questions": [
  "The most-reported problems in FDA's adverse event data are injection site reaction, injection site pain, nausea, fatigue. How would we recognize and handle those?",
  "Why this one over acamprosate, calcium carbimide, disulfiram? 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.)"
 ]
}