{
 "query": "epinephrine",
 "ingredient": "epinephrine",
 "slug": "epinephrine",
 "rxcui": "3992",
 "brands": [
  "Auvi-Q",
  "Neffy",
  "Epipen",
  "Primatene Mist Inhaler",
  "Symjepi"
 ],
 "names": [
  "epinephrine",
  "epinephrine bitartrate",
  "epinephrine hydrochloride",
  "epinephrine sulfate"
 ],
 "classes": [
  {
   "id": "B02BC",
   "name": "Local hemostatics"
  },
  {
   "id": "C01CA",
   "name": "Adrenergic and dopaminergic agents"
  },
  {
   "id": "R01AA",
   "name": "Sympathomimetics, plain"
  },
  {
   "id": "R03AA",
   "name": "Alpha- and beta-adrenoreceptor agonists"
  },
  {
   "id": "S01EA",
   "name": "Sympathomimetics in glaucoma therapy"
  }
 ],
 "alternatives": [
  "adrenalone",
  "apraclonidine",
  "arbutamine",
  "brimonidine",
  "cafedrine",
  "calcium alginate",
  "cellulose, oxidized",
  "clonidine",
  "collagen",
  "cyclopentamine",
  "dipivefrin",
  "dobutamine",
  "dopamine",
  "dopexamine",
  "droxidopa",
  "ephedrine",
  "etilefrine",
  "fenoldopam",
  "fenoxazoline",
  "gepefrine",
  "ibopamine",
  "indanazoline",
  "isoproterenol",
  "mephentermine",
  "metaraminol",
  "methoxamine",
  "midodrine",
  "naphazoline",
  "norepinephrine",
  "norfenefrine",
  "octopamine",
  "oxymetazoline",
  "phenylephrine",
  "synephrine",
  "tetrahydrozoline",
  "theodrenaline",
  "thrombin",
  "tramazoline",
  "xylometazoline"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 126,
   "INTRAMUSCULAR": 57,
   "SUBCUTANEOUS": 48,
   "INTRAVENOUS": 42,
   "SUBMUCOSAL": 40,
   "PERINEURAL": 35,
   "INFILTRATION": 34,
   "EPIDURAL": 13,
   "INTRACAUDAL": 13,
   "TOPICAL": 8,
   "INTRAOCULAR": 7,
   "SUBLINGUAL": 6,
   "NASAL": 3,
   "RETROBULBAR": 3,
   "CUTANEOUS": 1,
   "DENTAL": 1,
   "PERIODONTAL": 1,
   "RESPIRATORY (INHALATION)": 1,
   "SUBGINGIVAL": 1
  },
  "boxed_warning": "",
  "indications_and_usage": "Neffy is indicated for emergency treatment of type I allergic reactions, including anaphylaxis, in adult and pediatric patients aged 4 years and older who weigh 15 kg or greater. Neffy is an alpha and beta-adrenergic receptor agonist indicated for emergency treatment of type I allergic reactions, including anaphylaxis, in adult and pediatric patients 4 years of age and older who weigh 15 kg or greater. ( 1 )",
  "contraindications": "None. None ( 4 )",
  "warnings_and_cautions": "Absorption of neffy may be affected by underlying structural and anatomical nasal conditions. ( 5.1 ) Administer with caution in patients with heart disease; may aggravate angina pectoris or produce ventricular arrhythmias. ( 5.2 ) May aggravate certain coexisting conditions. ( 5.2 ) The presence of a sulfite in this product should not deter use. ( 5.3 ) 5.1 Potential Altered Absorption of Neffy in Patients with Underlying Structural or Anatomical Nasal Conditions Clinical pharmacology studies with neffy included subjects with history of allergic rhinitis, but did not include subjects with underlying structural and anatomical nasal conditions (e.g., polyps, history of nasal fractures or injuries, or history of nasal surgery). Absorption of neffy may be affected by underlying structural and anatomical nasal conditions. Consider use of other epinephrine products given by other routes of administration for patients with underlying structural or anatomical nasal conditions. 5.2 Risks Associated with Use of Epinephrine in Certain Coexisting Conditions Some patients may be at greater risk for developing adverse reactions after epinephrine administration. Despite these concerns, it should...",
  "warnings": "",
  "adverse_reactions": "The following clinically significant adverse reactions are described elsewhere in the labeling: Risks Associated with Use of Epinephrine in Certain Coexisting Conditions [see Warnings and Precautions (5.2) ] Allergic Reactions Associated with Sulfite [see Warnings and Precautions (5.3) ] Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Most common adverse reactions are: Adults (incidence \u2265 2%): nasal discomfort, headache, rhinorrhea, dizziness, nausea, vomiting, and throat irritation. ( 6 ) Pediatric patients 4 years of age and older who weigh 15 kg or greater (incidence \u226510%): nasal discomfort, nasal congestion, paresthesia, rhinorrhea, sneezing, upper respiratory tract congestion, epistaxis, rhinalgia, nasal dryness, dry throat, fatigue, and feeling jittery. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact ARS Pharmaceuticals Operations, Inc. at 1-877-MY-NEFFY (877-696-3339) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Adverse Reactions with Neffy in Adult Sub...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Indications ( 1 ) 3/2025 Dosage and Administration ( 2.1 ) 3/2025",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Administration Instructions Advise patients and/or caregivers to store neffy nasal spray in the blister pack until ready to use. Neffy nasal spray is for single use and delivers the entire dose upon activation. Advise patients when to seek emergency medical assistance for close monitoring of the anaphylactic episode and in the event further treatment is required. Instruct patients and/or caregivers in the appropriate use of neffy. Administer neffy into one nostril pointing straight into the naris, press the plunger firmly to activate [see Dosage and Administration (2.2) and Instructions for Use] . If a second dose of neffy is needed, administer a new neffy nasal spray into the same nostril (ipsilateral side) starting 5 minutes after the first dose. Advise patients that improper dosing in the nose may result in some drug dripping out of the nose and not being available for absorption. If symptoms do not improve or worsen, patients and/or caregivers should administer a second dose of neffy in the same nostril starting 5 minutes after the first dose. Risks Associated with Certa...",
  "spl_medguide": "",
  "clinical_studies": "",
  "brand_name": "neffy",
  "manufacturer": "Sportpharm LLC",
  "application_number": "NDA214697",
  "pharm_class_epc": [
   "alpha-Adrenergic Agonist [EPC]",
   "beta-Adrenergic Agonist [EPC]",
   "Catecholamine [EPC]"
  ],
  "route": [
   "NASAL"
  ],
  "effective_time": "20260424",
  "set_id": "2052f9db-7d76-443b-b702-b6b499f9a4b8",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 64110,
  "serious": 35954,
  "death": 3738,
  "hospitalization": 17338,
  "primary_suspect": 64063,
  "top_reactions": [
   [
    "Drug Ineffective",
    6095
   ],
   [
    "Headache",
    4366
   ],
   [
    "Fatigue",
    4003
   ],
   [
    "Sinusitis",
    3997
   ],
   [
    "Dyspnoea",
    3351
   ],
   [
    "Product Dose Omission Issue",
    3245
   ],
   [
    "Nausea",
    3217
   ],
   [
    "Off Label Use",
    3122
   ],
   [
    "Pain",
    2831
   ],
   [
    "Covid-19",
    2718
   ],
   [
    "Pneumonia",
    2621
   ],
   [
    "Pyrexia",
    2258
   ],
   [
    "Cough",
    2222
   ],
   [
    "Nasopharyngitis",
    2204
   ],
   [
    "Rash",
    2201
   ]
  ],
  "by_year": {
   "2019": 4735,
   "2020": 8218,
   "2021": 5661,
   "2022": 5016,
   "2023": 5276,
   "2024": 6163,
   "2025": 6452,
   "2026": 3335
  },
  "by_year_primary": {
   "2019": 4735,
   "2020": 8216,
   "2021": 5654,
   "2022": 5011,
   "2023": 5269,
   "2024": 6149,
   "2025": 6449,
   "2026": 3329
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class I",
   "date": "20260811",
   "reason": "Presence of Particulate Matter and Lack of Assurance of Sterility. Particulate matter identified as nylon, cellulosic, acrylic, polyethylene and glass and broken and leaking vials.",
   "firm": "American Regent, Inc.",
   "status": "Ongoing"
  },
  {
   "class": "Class III",
   "date": "20260514",
   "reason": "Failed Impurities/Degradations Specifications",
   "firm": "Fresenius Kabi USA, LLC",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20260401",
   "reason": "Lack of Assurance of Sterility",
   "firm": "International Medication Systems Ltd.",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20240117",
   "reason": "Labeling: Incorrect or Missing Lot and/or Exp Date. The expiration date listed on the Repack Pouch Label is incorrect.",
   "firm": "Henry Schein Inc. and Glove Club HSI Gloves Inc.",
   "status": "Completed"
  },
  {
   "class": "Class II",
   "date": "20220413",
   "reason": "cGMP deviations: Temperature abuse",
   "firm": "Mckesson Medical-Surgical Inc. Corporate Office",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20220413",
   "reason": "cGMP deviations: Temperature abuse",
   "firm": "Mckesson Medical-Surgical Inc. Corporate Office",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20220413",
   "reason": "cGMP deviations: Temperature abuse",
   "firm": "Mckesson Medical-Surgical Inc. Corporate Office",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20220413",
   "reason": "cGMP deviations: Temperature abuse",
   "firm": "Mckesson Medical-Surgical Inc. Corporate Office",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20220413",
   "reason": "cGMP deviations: Temperature abuse",
   "firm": "Mckesson Medical-Surgical Inc. Corporate Office",
   "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": "20210315",
   "reason": "CGMP Deviations: Intermittent exposure to temperature excursion during storage.",
   "firm": "Cardinal Health Inc.",
   "status": "Terminated"
  }
 ],
 "recall_total": 15,
 "drugsfda": {
  "applications": 34,
  "nda": 19,
  "anda": 14,
  "first_approval": "19510608",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 72,
  "labeling_recent": 17,
  "sponsors": [
   "3M",
   "ADAMIS PHARMS CORP",
   "AM REGENT",
   "AMNEAL",
   "APOTEX",
   "ARMSTRONG PHARMS",
   "ARS PHARMS OPERATION",
   "BAXTER HLTHCARE CORP"
  ],
  "unapproved": false,
  "first_approval_fmt": "06/08/1951"
 },
 "trials": {
  "total": 3621,
  "completed": 1923,
  "terminated": 412,
  "with_results": 654,
  "industry": 599,
  "phase3": 489,
  "results_share": 0.34009360374414976,
  "terminated_share": 0.11378072355702845
 },
 "pubmed": {
  "rct": 727,
  "meta": 73,
  "recent_rct": 72,
  "cochrane": [
   {
    "pmid": "27211231",
    "title": "Epinephrine for transient tachypnea of the newborn",
    "year": "2016"
   },
   {
    "pmid": "25308912",
    "title": "Epinephrine injection versus epinephrine injection and a second endoscopic method in high-risk bleeding ulcers",
    "year": "2014"
   },
   {
    "pmid": "24114291",
    "title": "Nebulized epinephrine for croup in children",
    "year": "2013"
   },
   {
    "pmid": "21678340",
    "title": "Epinephrine for bronchiolitis",
    "year": "2011"
   },
   {
    "pmid": "21328284",
    "title": "Nebulized epinephrine for croup in children",
    "year": "2011"
   },
   {
    "pmid": "18843712",
    "title": "Adrenaline (epinephrine) for the treatment of anaphylaxis with and without shock",
    "year": "2008"
   },
   {
    "pmid": "17443601",
    "title": "Epinephrine injection versus epinephrine injection and a second endoscopic method in high risk bleeding ulcers",
    "year": "2007"
   },
   {
    "pmid": "14974006",
    "title": "Epinephrine for bronchiolitis",
    "year": "2004"
   },
   {
    "pmid": "12804491",
    "title": "Epinephrine for the resuscitation of apparently stillborn or extremely bradycardic newborn infants",
    "year": "2003"
   },
   {
    "pmid": "11869578",
    "title": "Nebulized racemic epinephrine for extubation of newborn infants",
    "year": "2002"
   },
   {
    "pmid": "11279697",
    "title": "Nebulized racemic epinephrine for extubation of newborn infants",
    "year": "2001"
   },
   {
    "pmid": "10796376",
    "title": "Nebulized racemic epinephrine for extubation of newborn infants",
    "year": "2000"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 256523.56,
  "records": 6327,
  "by_name": [
   [
    "Auvi-Q",
    256523.56
   ]
  ],
  "names_checked": [
   "epinephrine",
   "Auvi-Q",
   "Neffy",
   "Epipen",
   "Primatene Mist Inhaler",
   "Symjepi"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 582959,
  "beneficiaries": 462731,
  "spend": 120432005.19999999,
  "by_brand": [
   {
    "brand": "Epinephrine",
    "claims": 578447,
    "per_claim": 206.20770691,
    "is_generic": true
   },
   {
    "brand": "Adrenalin",
    "claims": 2931,
    "per_claim": 20.706963494,
    "is_generic": false
   },
   {
    "brand": "Auvi-Q",
    "claims": 1035,
    "per_claim": 689.20684058,
    "is_generic": false
   },
   {
    "brand": "Epipen 2-Pak",
    "claims": 277,
    "per_claim": 604.41866426,
    "is_generic": false
   },
   {
    "brand": "Neffy",
    "claims": 269,
    "per_claim": 781.89814126,
    "is_generic": false
   }
  ],
  "per_claim": 206.58743616617977
 },
 "mdl": [],
 "dsc": [],
 "settlements": [
  {
   "year": 2006,
   "company": "Mylan",
   "amount_usd": 465000000.0,
   "amount_text": "$465 million",
   "violations": "Misclassification under the Medicaid Drug Rebate Program",
   "products": "EpiPen (epinephrine)",
   "laws": "False Claims Act",
   "urls": [
    "https://arstechnica.com/science/2016/10/for-ripping-off-medicaid-epipen-maker-mylan-pays-feds-465-million/"
   ],
   "matched": "epipen"
  }
 ],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "epinephrine",
  "matched": "epinephrine",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 15927,
  "fills": 582959,
  "per_million": 27320.960822287674,
  "ratio": 9.866903790828186,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 65,
   "letter": "C",
   "why": [
    "27,321 FDA reports naming it as the suspect drug per million Medicare fills, 9.9x the median drug on this site (-15)",
    "Death share in reports is near or below the FAERS average (0.6x)",
    "3 Class I recall(s): reasonable probability of serious harm (-20)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 68,
   "letter": "C",
   "why": [
    "727 randomized trials and 73 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 34% of completed registered trials posted results (-15)",
    "'Drug ineffective' is the single most-reported item about this drug in FAERS (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 57,
   "letter": "D",
   "why": [
    "Recalls since 2016: 3 Class I, 11 Class II, 1 Class III across 14 generic makers (-30)",
    "17 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": 70,
   "letter": "C",
   "why": [
    "Maker paid $465 million in 2006 to settle federal allegations naming this drug (Misclassification under the Medicaid Drug Rebate Program) (-15)",
    "Pharma paid doctors $256,524 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 (14 applications)",
    "39 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 69,
 "grade": "C",
 "questions": [
  "The maker paid $465 million in 2006 to settle federal allegations about how this drug was marketed. Is my use one of the uses that was promoted improperly?",
  "The most-reported problems in FDA's adverse event data are headache, fatigue, sinusitis. How would we recognize and handle those?",
  "Why this one over adrenalone, apraclonidine, arbutamine? 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.)"
 ]
}