{
 "query": "naloxone",
 "ingredient": "naloxone",
 "slug": "naloxone",
 "rxcui": "7242",
 "brands": [
  "Narcan",
  "Kloxxado",
  "Zimhi",
  "Rextovy",
  "Rezenopy"
 ],
 "names": [
  "naloxone",
  "naloxone hydrochloride",
  "naloxone hydrochloride dihydrate"
 ],
 "classes": [
  {
   "id": "A06AH",
   "name": "Peripheral opioid receptor antagonists"
  },
  {
   "id": "V03AB",
   "name": "Antidotes"
  }
 ],
 "alternatives": [
  "4-dimethylaminophenol",
  "acetylcysteine",
  "alvimopan",
  "amyl nitrite",
  "andexanet alfa",
  "copper sulfate",
  "dimercaprol",
  "ethanol",
  "flumazenil",
  "fomepizole",
  "glutathione",
  "hydroxocobalamin",
  "idarucizumab",
  "ipecac",
  "methionine",
  "methylene blue",
  "methylnaltrexone bromide",
  "naldemedine",
  "naloxegol",
  "obidoxime",
  "phentolamine",
  "physostigmine",
  "potassium iodide",
  "potassium permanganate",
  "pralidoxime",
  "protamines",
  "prussian blue insoluble",
  "sodium nitrite",
  "sugammadex",
  "thiosulfate"
 ],
 "label": {
  "route_mode": "SUBLINGUAL",
  "route_counts": {
   "SUBLINGUAL": 53,
   "INTRAMUSCULAR": 49,
   "SUBCUTANEOUS": 49,
   "INTRAVENOUS": 47,
   "NASAL": 31,
   "BUCCAL": 13,
   "PARENTERAL": 7,
   "ORAL": 3
  },
  "boxed_warning": "",
  "indications_and_usage": "Nasal Spray is indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression. NARCAN Nasal Spray is intended for immediate administration as emergency therapy in settings where opioids may be present. NARCAN Nasal Spray is not a substitute for emergency medical care. NARCAN Nasal Spray is an opioid antagonist indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression. ( 1 ) NARCAN Nasal Spray is intended for immediate administration as emergency therapy in settings where opioids may be present. ( 1 ) NARCAN Nasal Spray is not a substitute for emergency medical care. ( 1 )",
  "contraindications": "Nasal Spray is contraindicated in patients known to be hypersensitive to naloxone hydrochloride or to any of the other ingredients. Hypersensitivity to naloxone hydrochloride. ( 4 )",
  "warnings_and_cautions": "Risk of Recurrent Respiratory and CNS Depression : Due to the duration of action of naloxone relative to the opioid, keep patient under continued surveillance and administer repeat doses of naloxone using a new nasal spray with each dose, as necessary, while awaiting emergency medical assistance. ( 5.1 ) Risk of Limited Efficacy with Partial Agonists or Mixed Agonists/Antagonists : Reversal of respiratory depression caused by partial agonists or mixed agonists/antagonists, such as buprenorphine and pentazocine, may be incomplete. Larger or repeat doses may be required. ( 5.2 ) Precipitation of Severe Opioid Withdrawal : Use in patients who are opioid dependent may precipitate opioid withdrawal. In neonates, opioid withdrawal may be life-threatening if not recognized and properly treated. Monitor for the development of opioid withdrawal. ( 5.3 ) Risk of Cardiovascular (CV) Effects: Abrupt postoperative reversal of opioid depression may result in adverse CV effects. These events have primarily occurred in patients who had pre-existing CV disorders or received other drugs that may have similar adverse CV effects. Monitor these patients closely in an appropriate healthcare setting afte...",
  "warnings": "",
  "adverse_reactions": "The following serious adverse reactions are discussed elsewhere in the labeling: Precipitation of Severe Opioid Withdrawal [see Warnings and Precautions (5.3) ] Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to the rates in the clinical studies of another drug and may not reflect the rates observed in practice. The following adverse reactions were observed in a NARCAN Nasal Spray clinical study. In a pharmacokinetic study of 30 healthy adult volunteers exposed to one spray of NARCAN Nasal Spray in one nostril or two sprays of NARCAN Nasal Spray, one in each nostril, the most common adverse reactions were: increased blood pressure, constipation, toothache, muscle spasms, musculoskeletal pain, headache, nasal dryness, nasal edema, nasal congestion, nasal inflammation, rhinalgia, and xeroderma. The following adverse reactions have been identified primarily during post-approval use of naloxone hydrochloride in the post-operative setting. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate ...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Advise the patient and family members or caregivers to read the FDA-approved patient labeling ( Patient Information and Instructions for Use ). Recognition of Opioid Overdose Inform patients and their family members or caregivers about how to recognize the signs and symptoms of an opioid overdose such as the following: Extreme somnolence - inability to awaken a patient verbally or upon a firm sternal rub. Respiratory depression - this can range from slow or shallow respiration to no respiration in a patient who is unarousable. Other signs and symptoms that may accompany somnolence and respiratory depression include the following: Miosis. Bradycardia and/or hypotension. Risk of Recurrent Respiratory and Central Nervous System Depression Instruct patients and their family members or caregivers that, since the duration of action of most opioids may exceed that of NARCAN Nasal Spray, they must seek immediate emergency medical assistance after the first dose of NARCAN Nasal Spray and keep the patient under continued surveillance [see Dosage and Administration (2.2) , Warnings and Precautions (5.3) ] . Limited Efficacy for/with Partial Agonists or Mixed Agonist/Antagonists Instruct patie...",
  "spl_medguide": "",
  "clinical_studies": "",
  "brand_name": "Narcan",
  "manufacturer": "Emergent Devices Inc.",
  "application_number": "NDA208411",
  "pharm_class_epc": [],
  "route": [
   "NASAL"
  ],
  "effective_time": "20251205",
  "set_id": "724df050-5332-4d0a-9a5f-17bf08a547e1",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 9603,
  "serious": 7420,
  "death": 1817,
  "hospitalization": 4152,
  "primary_suspect": 9541,
  "top_reactions": [
   [
    "Toxicity To Various Agents",
    903
   ],
   [
    "Drug Ineffective",
    740
   ],
   [
    "Nausea",
    670
   ],
   [
    "Overdose",
    587
   ],
   [
    "Fatigue",
    578
   ],
   [
    "Off Label Use",
    566
   ],
   [
    "Death",
    530
   ],
   [
    "Pain",
    526
   ],
   [
    "Vomiting",
    472
   ],
   [
    "Diarrhoea",
    459
   ],
   [
    "Dyspnoea",
    397
   ],
   [
    "Acute Kidney Injury",
    360
   ],
   [
    "Headache",
    356
   ],
   [
    "Pneumonia",
    311
   ],
   [
    "Fall",
    310
   ]
  ],
  "by_year": {
   "2019": 678,
   "2020": 1186,
   "2021": 978,
   "2022": 983,
   "2023": 1119,
   "2024": 1326,
   "2025": 1292,
   "2026": 552
  },
  "by_year_primary": {
   "2019": 677,
   "2020": 1185,
   "2021": 972,
   "2022": 970,
   "2023": 1097,
   "2024": 1317,
   "2025": 1287,
   "2026": 550
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20210315",
   "reason": "CGMP Deviations: Intermittent exposure to temperature excursion during storage.",
   "firm": "Cardinal Health Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class I",
   "date": "20180604",
   "reason": "Presence of Particulate Matter; Potential for particulate matter on the syringe plunger.",
   "firm": "HOSPIRA INC, LAKE FOREST",
   "status": "Terminated"
  }
 ],
 "recall_total": 2,
 "drugsfda": {
  "applications": 90,
  "nda": 10,
  "anda": 53,
  "first_approval": "19710413",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 20,
  "labeling_recent": 6,
  "sponsors": [
   "ABRAXIS PHARM",
   "ACCORD HLTHCARE",
   "ADAPT",
   "AMNEAL",
   "AMPHASTAR PHARMS INC",
   "ASTRAZENECA",
   "BAXTER HLTHCARE CORP",
   "BPI LABS"
  ],
  "unapproved": false,
  "first_approval_fmt": "04/13/1971"
 },
 "trials": {
  "total": 858,
  "completed": 586,
  "terminated": 110,
  "with_results": 287,
  "industry": 213,
  "phase3": 129,
  "results_share": 0.48976109215017066,
  "terminated_share": 0.1282051282051282
 },
 "pubmed": {
  "rct": 545,
  "meta": 57,
  "recent_rct": 78,
  "cochrane": [
   {
    "pmid": "30311212",
    "title": "Naloxone for opioid-exposed newborn infants",
    "year": "2018"
   },
   {
    "pmid": "23450541",
    "title": "Naloxone for opiate-exposed newborn infants",
    "year": "2013"
   },
   {
    "pmid": "14974047",
    "title": "Naloxone for preventing morbidity and mortality in newborn infants of greater than 34 weeks' gestation with suspected perinatal asphyxia",
    "year": "2004"
   },
   {
    "pmid": "14584016",
    "title": "Naloxone for shock",
    "year": "2003"
   },
   {
    "pmid": "12519598",
    "title": "Naloxone for narcotic-exposed newborn infants",
    "year": "2002"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 18329.8,
  "records": 377,
  "by_name": [
   [
    "Kloxxado",
    18329.8
   ]
  ],
  "names_checked": [
   "naloxone",
   "Narcan",
   "Kloxxado",
   "Zimhi",
   "Rextovy",
   "Rezenopy"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 727870,
  "beneficiaries": 614630,
  "spend": 46003054.01,
  "by_brand": [
   {
    "brand": "Naloxone HCl",
    "claims": 715410,
    "per_claim": 62.315196698,
    "is_generic": true
   },
   {
    "brand": "Narcan",
    "claims": 9543,
    "per_claim": 110.42544273,
    "is_generic": false
   },
   {
    "brand": "Kloxxado",
    "claims": 2886,
    "per_claim": 126.05214484,
    "is_generic": false
   },
   {
    "brand": "Zimhi",
    "claims": 31,
    "per_claim": 147.18225806,
    "is_generic": false
   }
  ],
  "per_claim": 63.20229437949084
 },
 "mdl": [
  {
   "number": "3092",
   "title": "Suboxone (Buprenorphine/Naloxone) Film Products Liability Litigation",
   "judge": "Calabrese, J. Philip",
   "court": "OHN",
   "docket": "1:24-md-3092",
   "actions": "",
   "matched": "naloxone"
  }
 ],
 "dsc": [
  {
   "date": "20220630",
   "title": "FDA recommends health care professionals discuss naloxone with all patients when prescribing opioid pain relievers or medicines to treat opioid use disorder",
   "url": "https://www.fda.gov/drugs/drug-safety-communications/fda-recommends-health-care-professionals-discuss-naloxone-all-patients-when-prescribing-opioid-pain",
   "kind": "drug",
   "matched": "naloxone"
  }
 ],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "naloxone",
  "matched": "naloxone",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 3154,
  "fills": 727870,
  "per_million": 4333.191366590188,
  "ratio": 1.5649223539208117,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 71,
   "letter": "C",
   "why": [
    "FDA issued 1 Drug Safety Communication(s) naming this drug since 2010, most recently 2022 (-8)",
    "4,333 FDA reports naming it as the suspect drug per million Medicare fills, 1.6x the median drug on this site (-4)",
    "Death appears in 2.1x the share of reports seen across all of FAERS (-7)",
    "1 Class I recall(s): reasonable probability of serious harm (-10)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 76,
   "letter": "B",
   "why": [
    "545 randomized trials and 57 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "5 independent Cochrane review(s) exist",
    "Only 49% of completed registered trials posted results (-8)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 74,
   "letter": "C",
   "why": [
    "Recalls since 2016: 1 Class I, 1 Class II, 0 Class III across 53 generic makers (-18)",
    "6 label changes approved since 2021: the safety story is still moving (-8)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 60,
   "letter": "D",
   "why": [
    "Pharma paid doctors $18,330 tied to this drug last year: negligible",
    "Named in 1 active federal multidistrict litigation(s) (-40)"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 100,
   "letter": "A",
   "why": [
    "Generic versions approved (53 applications)",
    "30 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 74,
 "grade": "C",
 "questions": [
  "In 2022 the FDA issued a safety communication about this drug (FDA recommends health care professionals discuss naloxone with all patients when prescribing opioid pain relie). Does that risk apply to me?",
  "The most-reported problems in FDA's adverse event data are toxicity to various agents, nausea, overdose. How would we recognize and handle those?",
  "Off-label use is among the most-reported items for this drug. Is my use on-label, and if not, what evidence supports it?",
  "Why this one over 4-dimethylaminophenol, acetylcysteine, alvimopan? What would make you pick one of those instead?",
  "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.)"
 ]
}