{
 "query": "buprenorphine",
 "ingredient": "buprenorphine",
 "slug": "buprenorphine",
 "rxcui": "1819",
 "brands": [
  "Belbuca",
  "BuTrans",
  "Sublocade",
  "Brixadi",
  "Buprenex"
 ],
 "names": [
  "buprenorphine",
  "buprenorphine hydrochloride"
 ],
 "classes": [
  {
   "id": "N02AE",
   "name": "Oripavine derivatives"
  },
  {
   "id": "N07BC",
   "name": "Drugs used in opioid dependence"
  }
 ],
 "alternatives": [
  "heroin",
  "levomethadone",
  "lofexidine",
  "methadone"
 ],
 "label": {
  "route_mode": "SUBLINGUAL",
  "route_counts": {
   "SUBLINGUAL": 89,
   "BUCCAL": 14,
   "TRANSDERMAL": 7,
   "INTRAMUSCULAR": 4,
   "INTRAVENOUS": 4,
   "SUBCUTANEOUS": 2
  },
  "boxed_warning": "",
  "indications_and_usage": "Buprenorphine Sublingual Tablets are indicated for the treatment of opioid dependence and are preferred for induction. Buprenorphine sublingual tablets should be used as part of a complete treatment plan to include counseling and psychosocial support. Buprenorphine sublingual tablets contain buprenorphine, a partial opioid agonist, and are indicated for the treatment of opioid dependence and are preferred for induction. ( 1 ) Buprenorphine sublingual tablets should be used as part of a complete treatment plan that includes counseling and psychosocial support. ( 1 )",
  "contraindications": "Buprenorphine sublingual tablets are contraindicated in patients with a history of hypersensitivity to buprenorphine, as serious adverse reactions, including anaphylactic shock, have been reported [see Warnings and Precautions (5.9) ]. Hypersensitivity to buprenorphine. ( 4 )",
  "warnings_and_cautions": "Addiction, Abuse, and Misuse : Buprenorphine can be abused in a similar manner to other opioids. Monitor patients for conditions indicative of diversion or progression of opioid dependence and addictive behaviors. Multiple refills should not be prescribed early in treatment or without appropriate patient follow-up visits. ( 5.1 ) Respiratory Depression : Life-threatening respiratory depression and death have occurred in association with buprenorphine use. Warn patients of the potential danger of self-administration of benzodiazepines or other CNS depressants while under treatment with buprenorphine sublingual tablets ( 5.2 , 5.3 ) Unintentional Pediatric Exposure : Store buprenorphine sublingual tablets safely out of the sight and reach of children. Buprenorphine can cause severe, possibly fatal, respiratory depression in children. ( 5.4 ) Neonatal Opioid Withdrawal Syndrome : Neonatal opioid withdrawal syndrome (NOWS) is an expected and treatable outcome of prolonged use of opioids during pregnancy. ( 5.5 ) Adrenal Insufficiency : If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid. ( 5.6 ) Risk of Opioid Withdrawal with Abrupt D...",
  "warnings": "",
  "adverse_reactions": "The following serious adverse reactions are described elsewhere in the labeling: Addiction, Abuse, and Misuse [see Warnings and Precautions (5.1) ] Respiratory and CNS Depression [see Warnings and Precautions (5.2 , 5.3) ] Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions (5.5) ] Adrenal Insufficiency [see Warnings and Precautions (5.6) ] Opioid Withdrawal [see Warnings and Precautions (5.7 , 5.10) ] Hepatitis, Hepatic Events [see Warnings and Precautions (5.8) ] Hypersensitivity Reactions [see Warnings and Precautions (5.9) ] Orthostatic Hypotension [see Warnings and Precautions (5.16) ] Elevation of Cerebrospinal Fluid Pressure [see Warnings and Precautions (5.17) ] Elevation of Intracholedochal Pressure [see Warnings and Precautions (5.18) ] Adverse events commonly observed with administration of buprenorphine are oral hypoesthesia, glossodynia, oral mucosal erythema, headache, nausea, vomiting, hyperhidrosis, constipation, signs and symptoms of withdrawal, insomnia, pain, and peripheral edema. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Rhodes Pharmaceuticals L.P. at 1-888-827-0616 or FDA at 1-800-FDA-1088, or www.fda.gov/medwatch 6.1 Clinical Trials Ex...",
  "drug_abuse_and_dependence": "9.1 Controlled Substance Buprenorphine sublingual tablets contain buprenorphine, a Schedule III controlled substance under the Controlled Substances Act. Under the Drug Addiction Treatment Act (DATA) codified at 21 U.S.C. 823(g), prescription use of this product in the treatment of opioid dependence is limited to healthcare providers who meet certain qualifying requirements, and who have notified the Secretary of Health and Human Services (HHS) of their intent to prescribe this product for the treatment of opioid dependence and have been assigned a unique identification number that must be included on every prescription. 9.2 Abuse Buprenorphine, like morphine and other opioids, has the potential for being abused and is subject to criminal diversion. This should be considered when prescribing or dispensing buprenorphine in situations when the clinician is concerned about an increased risk of misuse, abuse, or diversion. Healthcare professionals should contact their state professional licensing board or state-controlled substances authority for information on how to prevent and detect abuse or diversion of this product. Patients who continue to misuse, abuse, or divert, buprenorphine...",
  "controlled_substance": "9.1 Controlled Substance Buprenorphine sublingual tablets contain buprenorphine, a Schedule III controlled substance under the Controlled Substances Act. Under the Drug Addiction Treatment Act (DATA) codified at 21 U.S.C. 823(g), prescription use of this product in the treatment of opioid dependence is limited to healthcare providers who meet certain qualifying requirements, and who have notified the Secretary of Health and Human Services (HHS) of their intent to prescribe this product for the treatment of opioid dependence and have been assigned a unique identification number that must be included on every prescription.",
  "recent_major_changes": "Dosage and Administration ( 2.6 ) 06/2022 Warnings and Precautions ( 5.13 , 5.14 ) 06/2022",
  "information_for_patients": "Advise patients 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 buprenorphine sublingual tablets securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home [see Warnings and Precautions (5.1 , 5.4) , Drug Abuse and Dependence (9.2) ] . Inform patients that leaving buprenorphine sublingual tablets unsecured can pose a deadly risk to others in the home. Advise patients and caregivers that when medicines are no longer needed, they should be disposed of promptly. Expired, unwanted, or unused buprenorphine sublingual tablets 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. Safe Use Before initiating treatment with buprenorphine sublingual tablets, explain the points listed below to caregivers and patients. Instruct patie...",
  "spl_medguide": "MEDICATION GUIDE Buprenorphine (byoo-pre-NOR-feen) Sublingual Tablets, CIII IMPORTANT: Keep buprenorphine sublingual tablets in a secure place away from children. Accidental use by a child is a medical emergency and can result in death. If a child accidentally takes buprenorphine sublingual tablets, get emergency help or call 911 right away. Tell your healthcare provider if you are living in a household where there are small children. What is the most important information I should know about buprenorphine sublingual tablets? Buprenorphine sublingual tablets contain a medicine called buprenorphine. Buprenorphine is an opioid that can cause serious and life-threatening breathing problems, especially if you take or use certain other medicines or drugs. Talk to your healthcare provider about naloxone. Naloxone is a medicine that is available to patients for the emergency treatment of an opioid overdose, including accidental use of buprenorphine sublingual tablets by a child. If naloxone is given, you must call 911 or get emergency medical help right away to treat an overdose or accidental use of an opioid. Buprenorphine sublingual tablets may cause serious and life-threatening breathi...",
  "clinical_studies": "Clinical data on the safety and efficacy of buprenorphine sublingual tablets were derived from studies of buprenorphine sublingual tablet formulations, with and without naloxone, and from studies of sublingual administration of a more bioavailable ethanolic solution of buprenorphine. Buprenorphine sublingual tablets were studied in 1834 patients; buprenorphine and naloxone sublingual tablets in 575 patients, and buprenorphine sublingual solutions in 2470 patients. A total of 1270 women received buprenorphine in those clinical trials. Dosing recommendations are based on data from one trial of both tablet formulations and two trials of the ethanolic solution. All trials used buprenorphine in conjunction with psychosocial counseling as part of a comprehensive addiction treatment program. There were no clinical studies conducted to assess the efficacy of buprenorphine as the only component of treatment. In a double-blind placebo- and active-controlled study, 326 heroin-addicted subjects were randomly assigned to either buprenorphine and naloxone sublingual tablets, 16/4 mg per day; buprenorphine sublingual tablets, 16 mg per day; or placebo sublingual tablets. For subjects randomized t...",
  "brand_name": "BUPRENORPHINE",
  "manufacturer": "Clinical Solutions Wholesale, LLC",
  "application_number": "ANDA207276",
  "pharm_class_epc": [],
  "route": [
   "SUBLINGUAL"
  ],
  "effective_time": "20240109",
  "set_id": "2181e700-caa1-48c4-90ce-60fec053ba6a",
  "has_boxed_warning": false,
  "controlled": true,
  "mentions_rems": false
 },
 "faers": {
  "total": 94846,
  "serious": 66850,
  "death": 27682,
  "hospitalization": 14143,
  "primary_suspect": 94589,
  "top_reactions": [
   [
    "Drug Dependence",
    16962
   ],
   [
    "Overdose",
    14257
   ],
   [
    "Death",
    14063
   ],
   [
    "Toxicity To Various Agents",
    11227
   ],
   [
    "Pain",
    9122
   ],
   [
    "Drug Withdrawal Syndrome",
    7502
   ],
   [
    "Emotional Distress",
    6240
   ],
   [
    "Drug Ineffective",
    5067
   ],
   [
    "Drug Abuse",
    4741
   ],
   [
    "Nausea",
    3904
   ],
   [
    "Product Adhesion Issue",
    3362
   ],
   [
    "Dependence",
    3197
   ],
   [
    "Drug Withdrawal Syndrome Neonatal",
    3010
   ],
   [
    "Foetal Exposure During Pregnancy",
    2685
   ],
   [
    "Off Label Use",
    2632
   ]
  ],
  "by_year": {
   "2019": 5160,
   "2020": 7426,
   "2021": 12038,
   "2022": 6608,
   "2023": 6322,
   "2024": 5283,
   "2025": 5494,
   "2026": 2006
  },
  "by_year_primary": {
   "2019": 5156,
   "2020": 7418,
   "2021": 12019,
   "2022": 6572,
   "2023": 6194,
   "2024": 5267,
   "2025": 5469,
   "2026": 1988
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20260908",
   "reason": "Crystallization",
   "firm": "Par Health USA, LLC",
   "status": "Ongoing"
  },
  {
   "class": "Class III",
   "date": "20260819",
   "reason": "Labeling: Label Mix-up",
   "firm": "American Health Packaging",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20260612",
   "reason": "Crystallization; identified as Buprenorphine free base",
   "firm": "Par Health USA, LLC",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20260313",
   "reason": "Crystallization; identified as Buprenorphine free base",
   "firm": "ENDO USA, Inc.",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20240520",
   "reason": "Lack of Assurance of Sterility-The potential for incomplete crimp seals.",
   "firm": "Pfizer Inc.",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20230503",
   "reason": "CGMP Deviations",
   "firm": "SUN PHARMACEUTICAL INDUSTRIES INC",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20211109",
   "reason": "Crystallization; identified as Buprenorphine free base",
   "firm": "PAR Sterile Products LLC",
   "status": "Terminated"
  },
  {
   "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": "20210315",
   "reason": "CGMP Deviations: Intermittent exposure to temperature excursion during storage.",
   "firm": "Cardinal Health Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20200904",
   "reason": "Failed Stability Specifications: Below specification result for buprenorphine release rate.",
   "firm": "Teva Pharmaceuticals USA",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20200814",
   "reason": "Sub-potent Drug: Out-of-Specification assay results found at 3 month stability testing.",
   "firm": "Hikma Pharmaceuticals USA Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20170428",
   "reason": "Crystallization: due to the presence of white, crystalline particulates, adhered to the side and bottom of the glass vials, which are comprised of principally dextrose and the buprenorphine active component.",
   "firm": "PAR Sterile Products LLC",
   "status": "Terminated"
  }
 ],
 "recall_total": 13,
 "drugsfda": {
  "applications": 28,
  "nda": 7,
  "anda": 21,
  "first_approval": "19811229",
  "rems": true,
  "rems_last": "20260814",
  "labeling_supplements": 64,
  "labeling_recent": 29,
  "sponsors": [
   "ACTAVIS ELIZABETH",
   "AM REGENT",
   "AMNEAL",
   "ASCENT PHARMS INC",
   "BARR",
   "BDSI",
   "BRAEBURN",
   "DIFGEN PHARMS"
  ],
  "unapproved": false,
  "first_approval_fmt": "12/29/1981"
 },
 "trials": {
  "total": 778,
  "completed": 481,
  "terminated": 104,
  "with_results": 225,
  "industry": 225,
  "phase3": 132,
  "results_share": 0.4677754677754678,
  "terminated_share": 0.13367609254498714
 },
 "pubmed": {
  "rct": 798,
  "meta": 106,
  "recent_rct": 131,
  "cochrane": [
   {
    "pmid": "28220474",
    "title": "Buprenorphine for managing opioid withdrawal",
    "year": "2017"
   },
   {
    "pmid": "26421677",
    "title": "Buprenorphine for neuropathic pain in adults",
    "year": "2015"
   },
   {
    "pmid": "25826743",
    "title": "Buprenorphine for treating cancer pain",
    "year": "2015"
   },
   {
    "pmid": "24500948",
    "title": "Buprenorphine maintenance versus placebo or methadone maintenance for opioid dependence",
    "year": "2014"
   },
   {
    "pmid": "19588330",
    "title": "Buprenorphine for the management of opioid withdrawal",
    "year": "2009"
   },
   {
    "pmid": "18425880",
    "title": "Buprenorphine maintenance versus placebo or methadone maintenance for opioid dependence",
    "year": "2008"
   },
   {
    "pmid": "16625553",
    "title": "Buprenorphine for the management of opioid withdrawal",
    "year": "2006"
   },
   {
    "pmid": "15495026",
    "title": "Buprenorphine for the management of opioid withdrawal",
    "year": "2004"
   },
   {
    "pmid": "15266465",
    "title": "Buprenorphine maintenance versus placebo or methadone maintenance for opioid dependence",
    "year": "2004"
   },
   {
    "pmid": "12804429",
    "title": "Buprenorphine maintenance versus placebo or methadone maintenance for opioid dependence",
    "year": "2003"
   },
   {
    "pmid": "12519569",
    "title": "Buprenorphine maintenance versus placebo or methadone maintenance for opioid dependence",
    "year": "2002"
   },
   {
    "pmid": "12076434",
    "title": "Buprenorphine for the management of opioid withdrawal",
    "year": "2002"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 2105781.91,
  "records": 48220,
  "by_name": [
   [
    "Brixadi",
    1220193.6
   ],
   [
    "Sublocade",
    580115.48
   ],
   [
    "Belbuca",
    305472.83
   ]
  ],
  "names_checked": [
   "buprenorphine",
   "Belbuca",
   "BuTrans",
   "Sublocade",
   "Brixadi",
   "Buprenex"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 1096856,
  "beneficiaries": 192411,
  "spend": 359641018.3600001,
  "by_brand": [
   {
    "brand": "Buprenorphine",
    "claims": 455308,
    "per_claim": 246.56572011,
    "is_generic": true
   },
   {
    "brand": "Buprenorphine HCl",
    "claims": 365646,
    "per_claim": 40.337641243,
    "is_generic": true
   },
   {
    "brand": "Belbuca",
    "claims": 217647,
    "per_claim": 735.76018659,
    "is_generic": false
   },
   {
    "brand": "Butrans",
    "claims": 25786,
    "per_claim": 418.86505507,
    "is_generic": false
   },
   {
    "brand": "Sublocade",
    "claims": 24923,
    "per_claim": 2025.6913734,
    "is_generic": false
   },
   {
    "brand": "Brixadi",
    "claims": 7546,
    "per_claim": 1484.9216221,
    "is_generic": false
   }
  ],
  "per_claim": 327.88353107427054
 },
 "mdl": [
  {
   "number": "3092",
   "title": "Suboxone (Buprenorphine/Naloxone) Film Products Liability Litigation",
   "judge": "Calabrese, J. Philip",
   "court": "OHN",
   "docket": "1:24-md-3092",
   "actions": "",
   "matched": "buprenorphine"
  }
 ],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "buprenorphine",
  "matched": "buprenorphine",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 12724,
  "fills": 1096856,
  "per_million": 11600.428862129576,
  "ratio": 4.189468893846716,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 56,
   "letter": "D",
   "why": [
    "11,600 FDA reports naming it as the suspect drug per million Medicare fills, 4.2x the median drug on this site (-12)",
    "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 3.2x the share of reports seen across all of FAERS (-12)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 83,
   "letter": "B",
   "why": [
    "798 randomized trials and 106 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 47% of completed registered trials posted results (-8)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 71,
   "letter": "C",
   "why": [
    "Recalls since 2016: 0 Class I, 11 Class II, 1 Class III across 21 generic makers (-6)",
    "REMS program in force (-10)",
    "29 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": 30,
   "letter": "F",
   "why": [
    "Pharma paid doctors $2,105,782 tied to this drug last year (-30)",
    "Named in 1 active federal multidistrict litigation(s) (-40)"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 100,
   "letter": "A",
   "why": [
    "Generic versions approved (21 applications)",
    "4 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 66,
 "grade": "C",
 "questions": [
  "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, overdose, death, toxicity to various agents. How would we recognize and handle those?",
  "Why this one over heroin, levomethadone, lofexidine? What would make you pick one of those instead?",
  "The manufacturer pays physicians heavily to promote this drug. Have you received anything from them?",
  "This drug is in active federal litigation. What is the claim, and does it affect my risk?",
  "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.)"
 ]
}