{
 "query": "fentanyl",
 "ingredient": "fentanyl",
 "slug": "fentanyl",
 "rxcui": "4337",
 "brands": [
  "Fentora",
  "Abstral",
  "Actiq",
  "Ionsys"
 ],
 "names": [
  "fentanyl",
  "fentanyl citrate",
  "fentanyl hydrochloride"
 ],
 "classes": [
  {
   "id": "N01AH",
   "name": "Opioid anesthetics"
  },
  {
   "id": "N02AB",
   "name": "Phenylpiperidine derivatives"
  }
 ],
 "alternatives": [
  "alfentanil",
  "anileridine",
  "meperidine",
  "phenoperidine",
  "remifentanil",
  "sufentanil"
 ],
 "label": {
  "route_mode": "INTRAMUSCULAR",
  "route_counts": {
   "INTRAMUSCULAR": 6,
   "INTRAVENOUS": 6,
   "TRANSDERMAL": 5
  },
  "boxed_warning": "WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF FENTANYL \u200eCITRATE INJECTION WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF FENTANYL \u200eCITRATE INJECTION See full prescribing information for complete boxed warning. \u2022 Fentanyl Citrate Injection exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess patient's risk before prescribing and reassess regularly for these behaviors and conditions. ( 5.1 ) \u2022 Serious, life-threatening, or fatal respiratory depression may occur with use Fentanyl Citrate Injection, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of \u200eFentanyl Citrate Injection are essential.\u200e ( 5.2 ) \u2022 Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate. ( 5.3 , 7 ) \u2022 Concomitant use with CYP3A4 inhibitors (or discontinuation of CYP3A4 inducers) can result in a fatal overdose of fentanyl. ( 5....",
  "indications_and_usage": "Fentanyl Citrate Injection is indicated for: \u2022 analgesic action of short duration during the anesthetic periods, premedication, induction and maintenance, and in the immediate postoperative period (recovery room) as the need arises. \u2022 use as an opioid analgesic supplement in general or regional anesthesia. \u2022 administration with a neuroleptic as an anesthetic premedication, for the induction of anesthesia and as an adjunct in the maintenance of general and regional anesthesia. \u2022 use as an anesthetic agent with oxygen in selected high-risk patients, such as those undergoing open heart surgery or certain complicated neurological or orthopedic procedures. Fentanyl Citrate Injection is an opioid agonist indicated for ( 1 ): \u2022 analgesic action of short duration during the anesthetic periods, premedication, induction and maintenance, and in the immediate postoperative period (recovery room) as the need arises. \u2022 use as an opioid analgesic supplement in general or regional anesthesia. \u2022 administration with a neuroleptic as an anesthetic premedication, for the induction of anesthesia and as an adjunct in the maintenance of general and regional anesthesia. \u2022 use as an anesthetic agent with o...",
  "contraindications": "Fentanyl Citrate Injection is contraindicated in patients with: \u2022 Hypersensitivity to fentanyl (e.g., anaphylaxis) [see Adverse Reactions (6) ]. \u2022 Hypersensitivity to fentanyl. ( 4 )",
  "warnings_and_cautions": "\u2022 Risks of Skeletal Muscle Rigidity and Skeletal Muscle Movement : Manage with neuromuscular blocking agent. See full prescribing information for more detail on managing these risks. ( 5.5 ) \u2022 Severe Cardiovascular Depression : Monitor during dosage initiation and titration. ( 5.6 ) \u2022 Opioid-Induced Hyperalgesia and Allodynia : Opioid-Induced \u200eHyperalgesia (OIH) occurs when an opioid analgesic \u200eparadoxically causes an increase in pain, or an increase in \u200esensitivity to pain. If OIH is suspected, carefully consider appropriately \u200edecreasing the dose of the current opioid analgesic or \u200eopioid rotation. ( 5.7 ) \u2022 Serotonin Syndrome : Potentially life-threatening condition could result from concomitant serotonergic drug administration. Discontinue Fentanyl Citrate Injection if serotonin syndrome is suspected. ( 5.8 ) \u2022 Adrenal Insufficiency : If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid. ( 5.9 ) \u2022 Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness : Monitor for sedation and respiratory depression. ( 5.10 ) 5.1 Addiction, Abuse, and Misuse Fentanyl Citrate Injectio...",
  "warnings": "",
  "adverse_reactions": "The following serious adverse reactions are described, or described in greater detail, in other sections: \u2022 Addiction, Abuse, and Misuse [see Warnings and Precautions (5.1) ] \u2022 Life-Threatening Respiratory Depression [see Warnings and Precautions (5.2) ] \u2022 Interactions with Benzodiazepines or Other CNS Depressants [see Warnings and Precautions (5.3) ] \u2022 Severe Cardiovascular Depression [see Warnings and Precautions (5.6) ] \u2022 Opioid-Induced Hyperalgesia and Allodynia [see Warnings and Precautions (5.7) ]\u200e \u2022 Serotonin Syndrome [see Warnings and Precautions (5.8) ] \u2022 Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.11) ] \u2022 Seizures [see Warnings and Precautions (5.12) ] The following adverse reactions associated with the use of fentanyl 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 frequency or establish a causal relationship to drug exposure. As with other opioid agonists, the most common serious adverse reactions reported to occur with fentanyl are respiratory depression, apnea, rigidity, and bradycardi...",
  "drug_abuse_and_dependence": "9.1 Controlled Substance Fentanyl Citrate Injection contains fentanyl, a Schedule II controlled substance. 9.2 Abuse Fentanyl Citrate Injection contains fentanyl, a substance with high potential for misuse and abuse, which can lead to the development of \u200esubstance use disorder, including addiction [see Warnings and Precautions (5.1) ]. Misuse is the intentional use, for therapeutic purposes, of a drug by an \u200eindividual in a way other than prescribed by a healthcare provider or for \u200ewhom it was not prescribed.\u200e 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 \u200econsequences, giving a higher priority to drug use than other activities and \u200eobligations), and possible tolerance or physical dependence.\u200e Misuse and abuse of Fentanyl Citrate Injection increases risk of \u200eoverdose, which may lead to central nervous system and respiratory \u200edepression, hypotension, seizures, and death. The risk is increased wi...",
  "controlled_substance": "9.1 Controlled Substance Fentanyl Citrate Injection contains fentanyl, a Schedule II controlled substance.",
  "recent_major_changes": "Dosage and Administration ( 2.1 ) 12/2025 Warnings and Precautions ( 5.2 , 5.3 , 5.11 ) 12/2025",
  "information_for_patients": "Addiction, Abuse, and Misuse \u200e Inform patients that the use of Fentanyl Citrate Injection, even when taken as recommended, can result in \u200eaddiction, abuse, and misuse, which can lead to overdose and death [see Warnings and Precautions (5.1) ] . Life-Threatening Respiratory Depression Inform patients of the risk of life-threatening respiratory depression, including information that the risk is \u200egreatest when starting Fentanyl Citrate Injection or when the dosage is increased, and that it can occur \u200eeven at recommended dosages \u200e[see Warnings and Precautions (5.2) ]\u200e. \u200e Hyperalgesia and Allodynia Advise \u200epatients to inform their healthcare provider if they \u200eexperience symptoms of hyperalgesia, including worsening \u200epain, increased \u200esensitivity to pain, or new pain [see Warnings and Precautions (5.7) , \u200e Adverse Reactions (6) ].\u200e Serotonin Syndrome Inform patients that opioids could cause a rare but potentially life-threatening condition called serotonin syndrome resulting from concomitant administration of serotonergic drugs. Warn patients of the symptoms of serotonin syndrome and to seek medical attention right away if \u200esymptoms develop after discharge from the hospital.\u200e Instruct pat...",
  "spl_medguide": "",
  "clinical_studies": "",
  "brand_name": "FENTANYL CITRATE",
  "manufacturer": "Hospira, Inc.",
  "application_number": "NDA019115",
  "pharm_class_epc": [],
  "route": [
   "INTRAMUSCULAR",
   "INTRAVENOUS"
  ],
  "effective_time": "20260407",
  "set_id": "1ed25b2c-334e-4021-ada1-3396f07630dc",
  "has_boxed_warning": true,
  "controlled": true,
  "mentions_rems": false
 },
 "faers": {
  "total": 137592,
  "serious": 111931,
  "death": 50018,
  "hospitalization": 35024,
  "primary_suspect": 137081,
  "top_reactions": [
   [
    "Death",
    18618
   ],
   [
    "Toxicity To Various Agents",
    16256
   ],
   [
    "Overdose",
    13326
   ],
   [
    "Drug Abuse",
    12612
   ],
   [
    "Drug Ineffective",
    8558
   ],
   [
    "Drug Dependence",
    8211
   ],
   [
    "Pain",
    7884
   ],
   [
    "Nausea",
    5366
   ],
   [
    "Product Adhesion Issue",
    4585
   ],
   [
    "Dependence",
    4378
   ],
   [
    "Off Label Use",
    4103
   ],
   [
    "Vomiting",
    3798
   ],
   [
    "Fatigue",
    3625
   ],
   [
    "Drug Withdrawal Syndrome",
    3473
   ],
   [
    "Diarrhoea",
    3153
   ]
  ],
  "by_year": {
   "2019": 10605,
   "2020": 12805,
   "2021": 9889,
   "2022": 9623,
   "2023": 10073,
   "2024": 3063,
   "2025": 6860,
   "2026": 2778
  },
  "by_year_primary": {
   "2019": 10593,
   "2020": 12786,
   "2021": 9854,
   "2022": 9507,
   "2023": 9995,
   "2024": 2999,
   "2025": 6733,
   "2026": 2736
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class I",
   "date": "20250131",
   "reason": "Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.",
   "firm": "Alvogen, Inc",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20200720",
   "reason": "Lack of Assurance of Sterility; potential loose metal overseal crimp defects.",
   "firm": "Pfizer Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class I",
   "date": "20190419",
   "reason": "Product Mix-Up: Customer complaint that their carton labeled as Fentanyl Transdermal Systems, 12 mcg/h contained five patches labeled and containing 50 mcg/h.",
   "firm": "Alvogen, Inc",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20150513",
   "reason": "Failed Impurities/Degradation Specifications; 12 month stability testing (Expansion of RES #70548).",
   "firm": "West-Ward Pharmaceutical Corp.",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20150216",
   "reason": "Failed Impurities/Degradation Specifications; 12 month stability testing.",
   "firm": "West-Ward Pharmaceutical Corporation",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20141203",
   "reason": "Lack of Assurance of Sterility; improperly crimped fliptop vials",
   "firm": "Hospira Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20140627",
   "reason": "Lack of Assurance of Sterility: Fliptop vial crimps are loose or missing.",
   "firm": "Hospira Inc.",
   "status": "Terminated"
  }
 ],
 "recall_total": 7,
 "drugsfda": {
  "applications": 35,
  "nda": 13,
  "anda": 20,
  "first_approval": "19680219",
  "rems": true,
  "rems_last": "20260618",
  "labeling_supplements": 115,
  "labeling_recent": 21,
  "sponsors": [
   "ABBOTT",
   "ACTAVIS LABS FL INC",
   "ACTAVIS LABS UT INC",
   "ADALVO",
   "BTCP PHARMA",
   "CEPHALON",
   "DIFGEN PHARMS",
   "DR REDDYS"
  ],
  "unapproved": false,
  "first_approval_fmt": "02/19/1968"
 },
 "trials": {
  "total": 2436,
  "completed": 1449,
  "terminated": 203,
  "with_results": 300,
  "industry": 229,
  "phase3": 253,
  "results_share": 0.2070393374741201,
  "terminated_share": 0.08333333333333333
 },
 "pubmed": {
  "rct": 2129,
  "meta": 76,
  "recent_rct": 180,
  "cochrane": [
   {
    "pmid": "27727431",
    "title": "Fentanyl for neuropathic pain in adults",
    "year": "2016"
   },
   {
    "pmid": "25300594",
    "title": "Intranasal fentanyl for the management of acute pain in children",
    "year": "2014"
   },
   {
    "pmid": "24874470",
    "title": "Impact of morphine, fentanyl, oxycodone or codeine on patient consciousness, appetite and thirst when used to treat cancer pain",
    "year": "2014"
   },
   {
    "pmid": "24096644",
    "title": "Transdermal fentanyl for cancer pain",
    "year": "2013"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "fentanyl",
   "Fentora",
   "Abstral",
   "Actiq",
   "Ionsys"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 821674,
  "beneficiaries": 116881,
  "spend": 93934756.87,
  "by_brand": [
   {
    "brand": "Fentanyl",
    "claims": 821141,
    "per_claim": 112.51181913,
    "is_generic": true
   },
   {
    "brand": "Fentanyl Citrate",
    "claims": 510,
    "per_claim": 1737.2020588,
    "is_generic": true
   },
   {
    "brand": "Fentora",
    "claims": 23,
    "per_claim": 28726.78913,
    "is_generic": false
   }
  ],
  "per_claim": 114.32119900349774
 },
 "mdl": [],
 "dsc": [
  {
   "date": "20130923",
   "title": "FDA requiring color changes to Duragesic (fentanyl) pain patches to aid safety\u00e2\u0080\u0095emphasizing that accidental exposure to used patches can cause death",
   "url": "https://www.fda.gov/Drugs/DrugSafety/ucm368902.htm",
   "kind": "drug",
   "matched": "fentanyl"
  }
 ],
 "settlements": [
  {
   "year": 2008,
   "company": "Cephalon",
   "amount_usd": 425000000.0,
   "amount_text": "$425 million",
   "violations": "Off-label promotion",
   "products": "Actiq, Gabitril, Provigil",
   "laws": "False Claims Act, FDCA",
   "urls": [
    "https://www.justice.gov/archive/opa/pr/2008/September/08-civ-860.html"
   ],
   "matched": "actiq"
  }
 ],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "fentanyl",
  "matched": "fentanyl",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 12468,
  "fills": 821674,
  "per_million": 15173.901084858471,
  "ratio": 5.480020381044032,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 0,
   "letter": "F",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "FDA issued 1 Drug Safety Communication(s) naming this drug since 2010, most recently 2013 (-8)",
    "15,174 FDA reports naming it as the suspect drug per million Medicare fills, 5.5x the median drug on this site (-15)",
    "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 4.0x the share of reports seen across all of FAERS (-12)",
    "2 Class I recall(s): reasonable probability of serious harm (-20)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 75,
   "letter": "B",
   "why": [
    "2129 randomized trials and 76 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "4 independent Cochrane review(s) exist",
    "Only 21% of completed registered trials posted results (-15)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 47,
   "letter": "F",
   "why": [
    "Recalls since 2016: 2 Class I, 1 Class II, 0 Class III across 20 generic makers (-30)",
    "REMS program in force (-10)",
    "21 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": 85,
   "letter": "B",
   "why": [
    "Maker paid $425 million in 2008 to settle federal allegations naming this drug (Off-label promotion) (-15)",
    "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 (20 applications)",
    "6 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 49,
 "grade": "F",
 "questions": [
  "In 2013 the FDA issued a safety communication about this drug (FDA requiring color changes to Duragesic (fentanyl) pain patches to aid safety\u00e2\u0080\u0095emphasizing that accidental e). Does that risk apply to me?",
  "The maker paid $425 million in 2008 to settle federal allegations about how this drug was marketed. Is my use one of the uses that was promoted improperly?",
  "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 death, toxicity to various agents, overdose, drug abuse. How would we recognize and handle those?",
  "Why this one over alfentanil, anileridine, meperidine? 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.)"
 ]
}