{
 "query": "acetaminophen",
 "ingredient": "acetaminophen",
 "slug": "acetaminophen",
 "rxcui": "161",
 "brands": [
  "Acephen",
  "Anacin AF",
  "Cetafen",
  "Feverall",
  "Mapap",
  "Panadol",
  "Pharbetol",
  "Redutemp",
  "Tactinal",
  "Tempra Quicklets",
  "Tycolene",
  "Tylenol"
 ],
 "names": [
  "acetaminophen"
 ],
 "classes": [
  {
   "id": "N02BE",
   "name": "Anilides"
  }
 ],
 "alternatives": [
  "phenacetin"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 2954,
   "INTRAVENOUS": 22,
   "RECTAL": 11
  },
  "boxed_warning": "",
  "indications_and_usage": "Uses temporarily relieves minor aches and pains due to: minor pain of arthritis muscular aches backache premenstrual and menstrual cramps the common cold headache toothache temporarily reduces fever",
  "contraindications": "",
  "warnings_and_cautions": "",
  "warnings": "Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if you take more than 6 caplets in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away. Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are allergic to acetaminophen or any of the inactive ingredients in this product Ask a doctor before use if you have liver disease Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin Stop use and ask a doctor if pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning In case of o...",
  "adverse_reactions": "",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "",
  "spl_medguide": "",
  "clinical_studies": "",
  "brand_name": "Tylenol 8 HR Arthritis Pain",
  "manufacturer": "Kenvue Brands LLC",
  "application_number": "NDA019872",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20241113",
  "set_id": "3af22fc8-e4e0-4863-8696-6bc1257047cb",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 493018,
  "serious": 377742,
  "death": 65044,
  "hospitalization": 194570,
  "primary_suspect": 491121,
  "top_reactions": [
   [
    "Off Label Use",
    37679
   ],
   [
    "Fatigue",
    37430
   ],
   [
    "Drug Ineffective",
    36576
   ],
   [
    "Nausea",
    32779
   ],
   [
    "Headache",
    30842
   ],
   [
    "Pain",
    29414
   ],
   [
    "Diarrhoea",
    26786
   ],
   [
    "Dyspnoea",
    24954
   ],
   [
    "Vomiting",
    24309
   ],
   [
    "Arthralgia",
    23803
   ],
   [
    "Pyrexia",
    22338
   ],
   [
    "Toxicity To Various Agents",
    20393
   ],
   [
    "Rash",
    19458
   ],
   [
    "Dizziness",
    18731
   ],
   [
    "Malaise",
    18394
   ]
  ],
  "by_year": {
   "2019": 46969,
   "2020": 51183,
   "2021": 45546,
   "2022": 42739,
   "2023": 42966,
   "2024": 43984,
   "2025": 47251,
   "2026": 20645
  },
  "by_year_primary": {
   "2019": 46931,
   "2020": 51133,
   "2021": 45427,
   "2022": 42424,
   "2023": 42637,
   "2024": 43579,
   "2025": 46893,
   "2026": 20422
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Not Yet Classified",
   "date": "20260918",
   "reason": "Discoloration: consumer complaints received for discolored tablets",
   "firm": "Aurobindo Pharma USA Inc",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20251021",
   "reason": "Defective Container",
   "firm": "Kenvue Brands LLC",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20250820",
   "reason": "Discoloration",
   "firm": "Baxter Healthcare Corporation",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20250522",
   "reason": "cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets).",
   "firm": "Aurobindo Pharma USA Inc",
   "status": "Ongoing"
  },
  {
   "class": "Class I",
   "date": "20240708",
   "reason": "Labeling: Label Mix-up: a bag of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection was found inside an overwrap labeled Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL)",
   "firm": "Hikma Pharmaceuticals USA Inc.",
   "status": "Ongoing"
  },
  {
   "class": "Class I",
   "date": "20240621",
   "reason": "Labeling: Label Mix-Up: Some bottles of Acetaminophen Extra Strength 500 mg tablets were incorrectly labeled with the drug facts label for Aspirin 81 mg tablets.",
   "firm": "A-S Medication Solutions LLC",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20230522",
   "reason": "Failed Impurities/Degradation Specifications: firm's investigation due to customer complaints for discoloration found that the product was out of specification for an impurity.",
   "firm": "Aurobindo Pharma USA Inc.",
   "status": "Completed"
  },
  {
   "class": "Class II",
   "date": "20220804",
   "reason": "Temperature Abuse: Product distributed in refrigerated trucks with labels attached to pallets indicating \"Refrigerate Upon Arrival\", however product is labeled to be stored in a controlled room temperature environment.",
   "firm": "Baxter Healthcare Corporation",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20211101",
   "reason": "cGMP Deviations: Product manufactured with contaminated raw ingredient.",
   "firm": "Precision Dose Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20211101",
   "reason": "cGMP Deviations: Product manufactured with contaminated raw ingredient.",
   "firm": "Precision Dose Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20211026",
   "reason": "CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.",
   "firm": "Perrigo Company PLC",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20211026",
   "reason": "CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.",
   "firm": "Perrigo Company PLC",
   "status": "Terminated"
  }
 ],
 "recall_total": 33,
 "drugsfda": {
  "applications": 16,
  "nda": 4,
  "anda": 12,
  "first_approval": "19681107",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 4,
  "labeling_recent": 0,
  "sponsors": [
   "ACINO PRODS",
   "APOTEX",
   "AUROBINDO PHARMA",
   "B BRAUN MEDICAL",
   "CAPLIN",
   "GLAND",
   "GRANULES",
   "HIKMA"
  ],
  "unapproved": false,
  "first_approval_fmt": "11/07/1968"
 },
 "trials": {
  "total": 2133,
  "completed": 1244,
  "terminated": 261,
  "with_results": 511,
  "industry": 527,
  "phase3": 330,
  "results_share": 0.4107717041800643,
  "terminated_share": 0.12236286919831224
 },
 "pubmed": {
  "rct": 720,
  "meta": 158,
  "recent_rct": 96,
  "cochrane": [
   {
    "pmid": "37594020",
    "title": "Paracetamol (acetaminophen) or non-steroidal anti-inflammatory drugs, alone or combined, for pain relief in acute otitis media in children",
    "year": "2023"
   },
   {
    "pmid": "36519620",
    "title": "Paracetamol (acetaminophen) for patent ductus arteriosus in preterm or low birth weight infants",
    "year": "2022"
   },
   {
    "pmid": "34559424",
    "title": "Paracetamol/acetaminophen (single administration) for perineal pain in the early postpartum period",
    "year": "2021"
   },
   {
    "pmid": "33294991",
    "title": "N-acetylcysteine for non-paracetamol (acetaminophen)-related acute liver failure",
    "year": "2020"
   },
   {
    "pmid": "31985831",
    "title": "Paracetamol (acetaminophen) for patent ductus arteriosus in preterm or low birth weight infants",
    "year": "2020"
   },
   {
    "pmid": "31985830",
    "title": "Paracetamol (acetaminophen) for prevention or treatment of pain in newborns",
    "year": "2020"
   },
   {
    "pmid": "29624206",
    "title": "Paracetamol (acetaminophen) for patent ductus arteriosus in preterm or low birth weight infants",
    "year": "2018"
   },
   {
    "pmid": "29473717",
    "title": "Interventions for paracetamol (acetaminophen) overdose",
    "year": "2018"
   },
   {
    "pmid": "28770975",
    "title": "Paracetamol (acetaminophen) for chronic non-cancer pain in children and adolescents",
    "year": "2017"
   },
   {
    "pmid": "28700092",
    "title": "Oral paracetamol (acetaminophen) for cancer pain",
    "year": "2017"
   },
   {
    "pmid": "28510996",
    "title": "Tramadol with or without paracetamol (acetaminophen) for cancer pain",
    "year": "2017"
   },
   {
    "pmid": "28027389",
    "title": "Paracetamol (acetaminophen) with or without codeine or dihydrocodeine for neuropathic pain in adults",
    "year": "2016"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "acetaminophen",
   "Acephen",
   "Anacin AF",
   "Cetafen",
   "Feverall",
   "Mapap",
   "Panadol",
   "Pharbetol",
   "Redutemp",
   "Tactinal",
   "Tempra Quicklets",
   "Tycolene",
   "Tylenol"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 734,
  "beneficiaries": 305,
  "spend": 125890.89,
  "by_brand": [
   {
    "brand": "Acetaminophen",
    "claims": 734,
    "per_claim": 171.51347411,
    "is_generic": true
   }
  ],
  "per_claim": 171.5134741144414
 },
 "mdl": [
  {
   "number": "3043",
   "title": "Acetaminophen - ASD/ADHD Products Liability Litigation",
   "judge": "Cote, Denise L.",
   "court": "NYS",
   "docket": "1:22-md-3043",
   "actions": "",
   "matched": "acetaminophen"
  }
 ],
 "dsc": [
  {
   "date": "20130801",
   "title": "FDA warns of rare but serious skin reactions with the pain reliever/fever reducer acetaminophen",
   "url": "https://www.fda.gov/Drugs/DrugSafety/ucm363041.htm",
   "kind": "drug",
   "matched": "acetaminophen"
  },
  {
   "date": "20111222",
   "title": "Acetaminophen - Addition of another concentration of liquid acetaminophen marketed for infants",
   "url": "https://www.fda.gov/Drugs/DrugSafety/ucm284741.htm",
   "kind": "drug",
   "matched": "acetaminophen"
  },
  {
   "date": "20110113",
   "title": "Acetaminophen - Prescription Acetaminophen Products to be Limited to 325 mg Per Dosage Unit; Boxed Warning Will Highlight Potential for Severe Liver Failure",
   "url": "https://www.fda.gov/Drugs/DrugSafety/ucm239821.htm",
   "kind": "drug",
   "matched": "acetaminophen"
  }
 ],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": null,
 "scores": {
  "safety": {
   "score": 55,
   "letter": "D",
   "why": [
    "FDA issued 3 Drug Safety Communication(s) naming this drug since 2010, most recently 2013 (-20)",
    "Death share in reports is near or below the FAERS average (1.4x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)",
    "3 Class I recall(s): reasonable probability of serious harm (-20)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 84,
   "letter": "B",
   "why": [
    "720 randomized trials and 158 systematic reviews/meta-analyses indexed in PubMed",
    "12 independent Cochrane review(s) exist",
    "Only 41% of completed registered trials posted results (-8)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 70,
   "letter": "C",
   "why": [
    "Recalls since 2016: 3 Class I, 25 Class II, 0 Class III across 12 generic makers (-30)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 60,
   "letter": "D",
   "why": [
    "Pharma paid doctors $0 tied to this drug last year: negligible",
    "Named in 1 active federal multidistrict litigation(s) (-40)"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 90,
   "letter": "A",
   "why": [
    "Generic versions approved (12 applications)",
    "1 same-class alternative(s) (-10)"
   ],
   "weight": 0.1
  }
 },
 "total": 69,
 "grade": "C",
 "questions": [
  "In 2013 the FDA issued a safety communication about this drug (FDA warns of rare but serious skin reactions with the pain reliever/fever reducer acetaminophen). Does that risk apply to me?",
  "The most-reported problems in FDA's adverse event data are fatigue, nausea. 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 phenacetin? 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.)"
 ]
}