{
 "query": "methadone",
 "ingredient": "methadone",
 "slug": "methadone",
 "rxcui": "6813",
 "brands": [
  "Methadose",
  "Diskets",
  "Dolophine"
 ],
 "names": [
  "methadone",
  "methadone hydrochloride"
 ],
 "classes": [
  {
   "id": "N07BC",
   "name": "Drugs used in opioid dependence"
  }
 ],
 "alternatives": [
  "buprenorphine",
  "heroin",
  "levomethadone",
  "lofexidine"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 31,
   "INTRAVENOUS": 4,
   "INTRAMUSCULAR": 3,
   "SUBCUTANEOUS": 3
  },
  "boxed_warning": "WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF METHADONE HYDROCHLORIDE ORAL SOLUTION Risk of Medication Errors Dosing errors can result in accidental overdose and death. Avoid dosing errors that may result from confusion between mg and mL and confusion with methadone solutions of different concentrations, when prescribing, dispensing, and administering methadone hydrochloride oral solution. Ensure that the dose is communicated clearly and dispensed accurately. Instruct patients and caregivers on how to measure and take or administer the correct dose of methadone hydrochloride oral solution and to use extreme caution when measuring the dose. Strongly advise patients to obtain and always use a graduated device that can measure and deliver the prescribed dose accurately, and to never use household teaspoons or tablespoons to measure a dose because these are not accurate measuring devices. Addiction, Abuse, and Misuse Because the use of methadone hydrochloride oral solution exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, assess each patient\u2019s risk prior to prescribing and reassess all patients regularl...",
  "indications_and_usage": "Methadone hydrochloride oral solution is indicated for the: Management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Limitations of Use: Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration, and persist over the course of therapy [see Warnings and Precautions ( 5.2 )] , reserve opioid analgesics, including methadone hydrochloride oral solution, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Methadone hydrochloride oral solution is not indicated as an as-needed (prn) analgesic. Detoxification treatment of opioid addiction (heroin or other morphine-like drugs). Maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services. Limitations of Use: Methadone products used for the treatment of opioid addiction in detoxification or maintenance programs are subject to the conditions for distribution and use required under ...",
  "contraindications": "Methadone hydrochloride oral solution is contraindicated in patients with: Significant respiratory depression [see Warnings and Precautions ( 5.3 )] Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see Warnings and Precautions ( 5.11 )] Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions ( 5.15 )] Hypersensitivity (e.g., anaphylaxis) to methadone [see Adverse Reactions ( 6 )] Significant respiratory depression ( 4 ) Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment ( 4 ) Known or suspected gastrointestinal obstruction, including paralytic ileus ( 4 ) Hypersensitivity to methadone ( 4 )",
  "warnings_and_cautions": "Opioid-Induced Hyperalgesia (OIH) and Allodynia: Opioid-Induced Hyperalgesia (OIH) occurs when an opioid analgesic paradoxically causes an increase in pain, or an increase in sensitivity to pain. If OIH is suspected, carefully consider appropriately decreasing the dose of the current opioid analgesic, or opioid rotation. ( 5.9 ) Serotonin Syndrome: Potentially life-threatening condition could result from concomitant serotonergic drug administration. Discontinue methadone hydrochloride oral solution if serotonin syndrome is suspected. ( 5.10 ) Risk of Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, Debilitated Patients: Regularly evaluate closely, particularly during initiation and titration. ( 5.11 ) Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid. ( 5.12 ) Severe Hypotension: Regularly evaluate during dose initiation and titration. Avoid use in patients with circulatory shock. ( 5.13 ) Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness: Regularly evaluate for sedation and respira...",
  "warnings": "",
  "adverse_reactions": "The following serious adverse reactions are described, or described in greater detail, in other sections: Addiction, Abuse, and Misuse [see Warnings and Precautions ( 5.2 )] Life-Threatening Respiratory Depression [see Warnings and Precautions ( 5.3 )] QT Prolongation [see Warnings and Precautions ( 5.5 )] Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions ( 5.6 )] Interactions with Benzodiazepines and Other CNS Depressants [see Warnings and Precautions ( 5.4 )] Opioid-Induced Hyperalgesia and Allodynia [see Warnings and Precautions (5.9)] Serotonin Syndrome [see Warnings and Precautions ( 5.10 )] Adrenal Insufficiency [see Warnings and Precautions ( 5.12 )] Severe Hypotension [see Warnings and Precautions ( 5.13 )] Gastrointestinal Adverse Reactions [see Warnings and Precautions ( 5.15 )] Seizures [see Warnings and Precautions ( 5.16 )] Withdrawal [see Warnings and Precautions ( 5.17 )] The following adverse reactions associated with the use of methadone were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequ...",
  "drug_abuse_and_dependence": "9.1 Controlled Substance Methadone hydrochloride oral solution contains methadone, a Schedule II controlled substance. 9.2 Abuse Methadone hydrochloride oral solution contains methadone, a substance with high potential for misuse and abuse, which can lead to the development of substance use disorder, including addiction [see Warnings and Precautions ( 5.2 )] . Misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a healthcare provider or for whom it was not prescribed. Abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence. Misuse and abuse of methadone hydrochloride oral solution increases risk of overdose, which may lead to central nervous system and respiratory depression, hypotension, seizures, and dea...",
  "controlled_substance": "9.1 Controlled Substance Methadone hydrochloride oral solution contains methadone, a Schedule II controlled substance.",
  "recent_major_changes": "Boxed Warning 12/2025 Indications and Usage ( 1 ) 12/2025 Dosage and Administration ( 2.3 , 2.4 , 2.6 ) 12/2025 Warnings and Precautions ( 5.2 , 5.3 , 5.4 , 5.15 , 5.17 ) 12/2025",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling ( Medication Guide ). Storage and Disposal Because of the risks associated with accidental ingestion, misuse, and abuse, advise patients to store methadone hydrochloride oral solution securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home. Inform patients that leaving methadone hydrochloride oral solution unsecured can pose a deadly risk to others in the home [see Warnings and Precautions ( 5.2 , 5.17 ), Abuse ( 9.2 )] . Advise patients and caregivers that when medicines are no longer needed, they should be disposed of promptly. Expired, unwanted, or unused methadone hydrochloride oral solution should be disposed of by flushing the unused medication down the toilet if a drug take-back option is not readily available. Inform patients that they can visit www.fda.gov/drugdisposal for a complete list of medicines recommended for disposal by flushing, as well as additional information on disposal of unused medicines. Medication Errors Strongly advise patients and caregivers to always use a graduated oral syringe or measuring cup, with metric units of measurement...",
  "spl_medguide": "To obtain a printable copy of the Medication Guide, visit www.parhealth.com/products. Medication Guide Methadone Hydrochloride (meth' a done hye\" droe klor' ide) Oral Solution USP, CII Rx only Methadone hydrochloride oral solution is: A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage severe and persistent pain that requires an extended treatment period with a daily opioid pain medicine, when other pain treatments such as non-opioid pain medicines or immediate-release opioid medicines do not treat your pain well enough or you cannot tolerate them. A long-acting opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse than can lead to death. Not to be taken on an \u201cas needed\u201d basis. Also used to manage drug addiction. Important information about methadone hydrochloride oral solution: Get emergency help or call 911 right away if you take too much methadone hydrochloride oral solution (overdose). When you first start taking methadone hydrochloride oral solution, when your dose is changed, or if you take too much (overdose), s...",
  "clinical_studies": "",
  "brand_name": "METHADONE HYDROCHLORIDE",
  "manufacturer": "SpecGx LLC",
  "application_number": "ANDA207537",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20260428",
  "set_id": "5baef1bf-8bf0-429c-a4ce-1c93171f3f15",
  "has_boxed_warning": true,
  "controlled": true,
  "mentions_rems": true
 },
 "faers": {
  "total": 39316,
  "serious": 33907,
  "death": 11792,
  "hospitalization": 10641,
  "primary_suspect": 38949,
  "top_reactions": [
   [
    "Drug Dependence",
    6015
   ],
   [
    "Toxicity To Various Agents",
    4925
   ],
   [
    "Drug Abuse",
    4422
   ],
   [
    "Overdose",
    3802
   ],
   [
    "Pain",
    3604
   ],
   [
    "Death",
    3164
   ],
   [
    "Emotional Distress",
    2475
   ],
   [
    "Drug Withdrawal Syndrome",
    2400
   ],
   [
    "Foetal Exposure During Pregnancy",
    1851
   ],
   [
    "Drug Ineffective",
    1605
   ],
   [
    "Drug Interaction",
    1490
   ],
   [
    "Drug Withdrawal Syndrome Neonatal",
    1477
   ],
   [
    "Nausea",
    1428
   ],
   [
    "Off Label Use",
    1305
   ],
   [
    "Anxiety",
    1290
   ]
  ],
  "by_year": {
   "2019": 3140,
   "2020": 4943,
   "2021": 5930,
   "2022": 3544,
   "2023": 2827,
   "2024": 2502,
   "2025": 2102,
   "2026": 902
  },
  "by_year_primary": {
   "2019": 3137,
   "2020": 4942,
   "2021": 5897,
   "2022": 3491,
   "2023": 2725,
   "2024": 2432,
   "2025": 2039,
   "2026": 870
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class III",
   "date": "20241219",
   "reason": "Failed Tablet/Capsule Specifications: Illegible product identification for the unit dose configuration only.",
   "firm": "West-Ward Columbus Inc",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20170118",
   "reason": "CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.",
   "firm": "VistaPharm, Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20170118",
   "reason": "CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.",
   "firm": "VistaPharm, Inc.",
   "status": "Terminated"
  }
 ],
 "recall_total": 3,
 "drugsfda": {
  "applications": 34,
  "nda": 6,
  "anda": 28,
  "first_approval": "19470813",
  "rems": true,
  "rems_last": "20260618",
  "labeling_supplements": 55,
  "labeling_recent": 12,
  "sponsors": [
   "ASCENT PHARMS INC",
   "AUROLIFE PHARMA LLC",
   "BRECKENRIDGE",
   "ELITE LABS INC",
   "EPIC PHARMA LLC",
   "HIKMA",
   "LANNETT CO INC",
   "LONG GROVE PHARMS"
  ],
  "unapproved": false,
  "first_approval_fmt": "08/13/1947"
 },
 "trials": {
  "total": 578,
  "completed": 366,
  "terminated": 69,
  "with_results": 142,
  "industry": 73,
  "phase3": 78,
  "results_share": 0.3879781420765027,
  "terminated_share": 0.11937716262975778
 },
 "pubmed": {
  "rct": 739,
  "meta": 119,
  "recent_rct": 90,
  "cochrane": [
   {
    "pmid": "28514508",
    "title": "Methadone for neuropathic pain in adults",
    "year": "2017"
   },
   {
    "pmid": "28177515",
    "title": "Methadone for cancer pain",
    "year": "2017"
   },
   {
    "pmid": "24500948",
    "title": "Buprenorphine maintenance versus placebo or methadone maintenance for opioid dependence",
    "year": "2014"
   },
   {
    "pmid": "23787716",
    "title": "QTc interval screening for cardiac risk in methadone treatment of opioid dependence",
    "year": "2013"
   },
   {
    "pmid": "23450540",
    "title": "Methadone at tapered doses for the management of opioid withdrawal",
    "year": "2013"
   },
   {
    "pmid": "23152251",
    "title": "Methadone for chronic non-cancer pain in adults",
    "year": "2012"
   },
   {
    "pmid": "19588333",
    "title": "Methadone maintenance therapy versus no opioid replacement therapy for opioid dependence",
    "year": "2009"
   },
   {
    "pmid": "18425880",
    "title": "Buprenorphine maintenance versus placebo or methadone maintenance for opioid dependence",
    "year": "2008"
   },
   {
    "pmid": "17943808",
    "title": "Methadone for cancer pain",
    "year": "2007"
   },
   {
    "pmid": "16034898",
    "title": "Methadone at tapered doses for the management of opioid withdrawal",
    "year": "2005"
   },
   {
    "pmid": "15495052",
    "title": "Methadone at tapered doses for the management of opioid withdrawal",
    "year": "2004"
   },
   {
    "pmid": "15266465",
    "title": "Buprenorphine maintenance versus placebo or methadone maintenance for opioid dependence",
    "year": "2004"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "methadone",
   "Methadose",
   "Diskets",
   "Dolophine"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 558224,
  "beneficiaries": 66530,
  "spend": 11144007.74,
  "by_brand": [
   {
    "brand": "Methadone HCl",
    "claims": 556775,
    "per_claim": 19.957100355,
    "is_generic": true
   },
   {
    "brand": "Methadone Intensol",
    "claims": 941,
    "per_claim": 25.682624867,
    "is_generic": false
   },
   {
    "brand": "Methadose",
    "claims": 439,
    "per_claim": 17.895444191,
    "is_generic": false
   },
   {
    "brand": "Diskets",
    "claims": 69,
    "per_claim": 5.3585507246,
    "is_generic": false
   }
  ],
  "per_claim": 19.963326084152598
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "methadone",
  "matched": "methadone",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 5341,
  "fills": 558224,
  "per_million": 9567.843732981743,
  "ratio": 3.4554053282780712,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 27,
   "letter": "F",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "9,568 FDA reports naming it as the suspect drug per million Medicare fills, 3.5x the median drug on this site (-11)",
    "Subject to a REMS safety program: FDA requires special controls to use it (-10)",
    "Federally controlled substance: dependence and misuse risk (-10)",
    "Death appears in 3.3x the share of reports seen across all of FAERS (-12)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 83,
   "letter": "B",
   "why": [
    "739 randomized trials and 119 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",
    "Only 39% of completed registered trials posted results (-8)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 74,
   "letter": "C",
   "why": [
    "Recalls since 2016: 0 Class I, 2 Class II, 1 Class III across 28 generic makers (-3)",
    "REMS program in force (-10)",
    "12 label changes approved since 2021: the safety story is still moving (-8)",
    "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 (28 applications)",
    "4 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 66,
 "grade": "C",
 "questions": [
  "This drug carries a boxed warning. Which specific risk does it cover, and does it apply to me?",
  "This is a controlled substance. What is the plan for how long I take it and how I stop?",
  "This drug has a REMS safety program. What monitoring does that require from us?",
  "The most-reported problems in FDA's adverse event data are drug dependence, toxicity to various agents, drug abuse, overdose. How would we recognize and handle those?",
  "Why this one over buprenorphine, heroin, levomethadone? 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.)"
 ]
}