{
 "query": "ibuprofen",
 "ingredient": "ibuprofen",
 "slug": "ibuprofen",
 "rxcui": "5640",
 "brands": [
  "Ibu",
  "Caldolor",
  "Addaprin",
  "Advil",
  "Genpril",
  "Ibuprohm",
  "Motrin",
  "Proprinal",
  "Samson 8",
  "Wal-Profen"
 ],
 "names": [
  "ibuprofen",
  "ibuprofen lysine"
 ],
 "classes": [
  {
   "id": "G02CC",
   "name": "Antiinflammatory products for vaginal administration"
  },
  {
   "id": "M01AE",
   "name": "Propionic acid derivatives"
  },
  {
   "id": "M02AA",
   "name": "Antiinflammatory preparations, non-steroids for topical use"
  }
 ],
 "alternatives": [
  "aceclofenac",
  "alminoprofen",
  "benzydamine",
  "bufexamac",
  "clofezone",
  "dexketoprofen",
  "diclofenac",
  "etofenamate",
  "felbinac",
  "fenbufen",
  "fenoprofen",
  "feprazone",
  "flurbiprofen",
  "indomethacin",
  "ketoprofen",
  "loxoprofen",
  "meclofenamic acid",
  "mofebutazone",
  "naproxen",
  "niflumic acid",
  "nimesulide",
  "oxaprozin",
  "oxyphenbutazone",
  "phenylbutazone",
  "piketoprofen",
  "piroxicam",
  "suprofen",
  "tiaprofenic acid",
  "tolmetin"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 1119,
   "INTRAVENOUS": 5
  },
  "boxed_warning": "Cardiovascular Thrombotic Events Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use [see Warnings and Precautions ]. Ibuprofen tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery [see Contraindications and Warnings ]. Gastrointestinal Risk NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events (see WARNINGS ).",
  "indications_and_usage": "INDICATIONS AND USAGE Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen tablets are indicated for relief of mild to moderate pain. Ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of ibuprofen tablets in children have not been conducted.",
  "contraindications": "CONTRAINDICATIONS Ibuprofen tablets are contraindicated in patients with known hypersensitivity to Ibuprofen. Ibuprofen tablets should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see WARNINGS , Anaphylactoid Reactions , and PRECAUTIONS , Preexisting Asthma ). In the setting of coronary artery bypass graft (CABG) surgery [see Warnings ]",
  "warnings_and_cautions": "",
  "warnings": "WARNINGS Cardiovascular Effects Cardiovascular Thrombotic Events Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction (MI) and stroke, which can be fatal. Based on available data, it is unclear that the risk for CV thrombotic events is similar for all NSAIDs. The relative increase in serious CV thrombotic events over baseline conferred by NSAID use appears to be similar in those with and without known CV disease or risk factors for CV disease. However, patients with known CV disease or risk factors had a higher absolute incidence of excess serious CV thrombotic events, due to their increased baseline rate. Some observational studies found that this increased risk of serious CV thrombotic events began as early as the first weeks of treatment. The increase in CV thrombotic risk has been observed most consistently at higher doses. To minimize the potential risk for an adverse CV event in NSAID-treated patients, use the lowest effective dose for the shortest duration possible. Physicians and patients should remain alert for the devel...",
  "adverse_reactions": "ADVERSE REACTIONS The most frequent type of adverse reaction occurring with ibuprofen tablets is gastrointestinal. In controlled clinical trials the percentage of patients reporting one or more gastrointestinal complaints ranged from 4% to 16%. In controlled studies when ibuprofen tablets were compared to aspirin and indomethacin in equally effective doses, the overall incidence of gastrointestinal complaints was about half that seen in either the aspirin- or indomethacin-treated patients. Adverse reactions observed during controlled clinical trials at an incidence greater than 1% are listed in the table. Those reactions listed in Column one encompass observations in approximately 3,000 patients. More than 500 of these patients were treated for periods of at least 54 weeks. Still other reactions occurring less frequently than 1 in 100 were reported in controlled clinical trials and from marketing experience. These reactions have been divided into two categories: Column two of the table lists reactions with therapy with ibuprofen tablets where the probability of a causal relationship exists: for the reactions in Column three, a causal relationship with ibuprofen tablets has not been...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Hepatic effects Borderline elevations of one or more liver tests may occur in up to 15% of patients taking NSAIDs, including ibuprofen tablets. These laboratory abnormalities may progress, may remain unchanged, or may be transient with continuing therapy. Notable elevations of ALT or AST (approximately three or more times the upper limit of normal) have been reported in approximately 1% of patients in clinical trials with NSAIDs. In addition, rare cases of severe hepatic reactions, including jaundice, fulminant hepatitis, liver necrosis, and hepatic failure, some of them with fatal outcomes have been reported. A patient with symptoms and/or signs suggesting liver dysfunction, or with abnormal liver test values, should be evaluated for evidence of the development of a more severe hepatic reaction while on therapy with ibuprofen tablets. If clinical signs and symptoms consistent with liver disease develop, or if systemic manifestations occur (e.g., eosinophilia, rash, etc.), ibuprofen tablets should be discontinued.",
  "spl_medguide": "",
  "clinical_studies": "",
  "brand_name": "Ibuprofen",
  "manufacturer": "Aurobindo Pharma Limited",
  "application_number": "ANDA213794",
  "pharm_class_epc": [
   "Nonsteroidal Anti-inflammatory Drug [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20250214",
  "set_id": "00872852-680a-41b3-901b-b991b12a176d",
  "has_boxed_warning": true,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 222353,
  "serious": 144405,
  "death": 14602,
  "hospitalization": 67172,
  "primary_suspect": 221679,
  "top_reactions": [
   [
    "Drug Ineffective",
    21264
   ],
   [
    "Fatigue",
    16243
   ],
   [
    "Pain",
    15188
   ],
   [
    "Nausea",
    14763
   ],
   [
    "Headache",
    13713
   ],
   [
    "Arthralgia",
    11834
   ],
   [
    "Diarrhoea",
    10775
   ],
   [
    "Off Label Use",
    10684
   ],
   [
    "Dyspnoea",
    10549
   ],
   [
    "Vomiting",
    10514
   ],
   [
    "Rash",
    9816
   ],
   [
    "Dizziness",
    8970
   ],
   [
    "Pruritus",
    8692
   ],
   [
    "Pyrexia",
    8072
   ],
   [
    "Drug Hypersensitivity",
    7676
   ]
  ],
  "by_year": {
   "2019": 22904,
   "2020": 20822,
   "2021": 21095,
   "2022": 18016,
   "2023": 16626,
   "2024": 15056,
   "2025": 15361,
   "2026": 7206
  },
  "by_year_primary": {
   "2019": 22880,
   "2020": 20804,
   "2021": 21044,
   "2022": 17882,
   "2023": 16499,
   "2024": 14968,
   "2025": 15266,
   "2026": 7094
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20260302",
   "reason": "Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product.",
   "firm": "STRIDES PHARMA INC",
   "status": "Ongoing"
  },
  {
   "class": "Class III",
   "date": "20241029",
   "reason": "Failed Tablet/Capsule Specifications",
   "firm": "Dr. Reddy's Laboratories, Inc.",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20240806",
   "reason": "Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.",
   "firm": "Dr. Reddy's Laboratories, Inc.",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20240806",
   "reason": "Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.",
   "firm": "Dr. Reddy's Laboratories, Inc.",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20240806",
   "reason": "Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.",
   "firm": "Dr. Reddy's Laboratories, Inc.",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20220413",
   "reason": "cGMP deviations: Temperature abuse",
   "firm": "Mckesson Medical-Surgical Inc. Corporate Office",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20201022",
   "reason": "Labeling Not Elsewhere Classified: Ibuprofen Oral Suspension  is missing dosing cups.",
   "firm": "Aurobindo Pharma USA Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20200316",
   "reason": "Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.",
   "firm": "Glaxosmithkline Consumer Healthcare Holdings",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20200316",
   "reason": "Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.",
   "firm": "Glaxosmithkline Consumer Healthcare Holdings",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20190927",
   "reason": "Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.",
   "firm": "Taro Pharmaceuticals U.S.A., Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20190927",
   "reason": "Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.",
   "firm": "Taro Pharmaceuticals U.S.A., Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20190927",
   "reason": "Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.",
   "firm": "Taro Pharmaceuticals U.S.A., Inc.",
   "status": "Terminated"
  }
 ],
 "recall_total": 27,
 "drugsfda": {
  "applications": 156,
  "nda": 16,
  "anda": 120,
  "first_approval": "19740919",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 123,
  "labeling_recent": 8,
  "sponsors": [
   "ABBOTT",
   "ACTAVIS MID ATLANTIC",
   "ALRA",
   "AMNEAL PHARMS",
   "AMNEAL PHARMS NY",
   "ANI PHARMS",
   "ANNORA PHARMA",
   "ARISE"
  ],
  "unapproved": false,
  "first_approval_fmt": "09/19/1974"
 },
 "trials": {
  "total": 1119,
  "completed": 696,
  "terminated": 136,
  "with_results": 248,
  "industry": 279,
  "phase3": 165,
  "results_share": 0.3563218390804598,
  "terminated_share": 0.12153708668453976
 },
 "pubmed": {
  "rct": 1045,
  "meta": 113,
  "recent_rct": 144,
  "cochrane": [
   {
    "pmid": "38180091",
    "title": "Ibuprofen for acute postoperative pain in children",
    "year": "2024"
   },
   {
    "pmid": "34499349",
    "title": "Single-dose intravenous ibuprofen for acute postoperative pain in adults",
    "year": "2021"
   },
   {
    "pmid": "32045960",
    "title": "Ibuprofen for the treatment of patent ductus arteriosus in preterm or low birth weight (or both) infants",
    "year": "2020"
   },
   {
    "pmid": "31985838",
    "title": "Ibuprofen for the prevention of patent ductus arteriosus in preterm and/or low birth weight infants",
    "year": "2020"
   },
   {
    "pmid": "31222841",
    "title": "Ibuprofen for the prevention of patent ductus arteriosus in preterm and/or low birth weight infants",
    "year": "2019"
   },
   {
    "pmid": "30264852",
    "title": "Ibuprofen for the treatment of patent ductus arteriosus in preterm or low birth weight (or both) infants",
    "year": "2018"
   },
   {
    "pmid": "26230487",
    "title": "Ibuprofen for acute treatment of episodic tension-type headache in adults",
    "year": "2015"
   },
   {
    "pmid": "26171993",
    "title": "Single dose oral ibuprofen plus caffeine for acute postoperative pain in adults",
    "year": "2015"
   },
   {
    "pmid": "25692606",
    "title": "Ibuprofen for the treatment of patent ductus arteriosus in preterm or low birth weight (or both) infants",
    "year": "2015"
   },
   {
    "pmid": "25927097",
    "title": "Single dose oral ibuprofen plus codeine for acute postoperative pain in adults",
    "year": "2015"
   },
   {
    "pmid": "24338830",
    "title": "Ibuprofen and/or paracetamol (acetaminophen) for pain relief after surgical removal of lower wisdom teeth",
    "year": "2013"
   },
   {
    "pmid": "24174375",
    "title": "Combined and alternating paracetamol and ibuprofen therapy for febrile children",
    "year": "2013"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 65035.66,
  "records": 1319,
  "by_name": [
   [
    "Caldolor",
    65035.66
   ]
  ],
  "names_checked": [
   "ibuprofen",
   "Ibu",
   "Caldolor",
   "Addaprin",
   "Advil",
   "Genpril",
   "Ibuprohm",
   "Motrin",
   "Proprinal",
   "Samson 8",
   "Wal-Profen"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 7574127,
  "beneficiaries": 3827890,
  "spend": 54047564.83,
  "by_brand": [
   {
    "brand": "Ibuprofen",
    "claims": 7174958,
    "per_claim": 7.2676930499,
    "is_generic": true
   },
   {
    "brand": "Ibu",
    "claims": 399096,
    "per_claim": 4.7418364003,
    "is_generic": false
   },
   {
    "brand": "Caldolor",
    "claims": 73,
    "per_claim": 133.21232877,
    "is_generic": false
   }
  ],
  "per_claim": 7.135814441717177
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "ibuprofen",
  "matched": "ibuprofen",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 37328,
  "fills": 7574127,
  "per_million": 4928.356759795552,
  "ratio": 1.7798650022627094,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 55,
   "letter": "D",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "4,928 FDA reports naming it as the suspect drug per million Medicare fills, 1.8x the median drug on this site (-5)",
    "Death share in reports is near or below the FAERS average (0.7x)",
    "1 Class I recall(s): reasonable probability of serious harm (-10)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 80,
   "letter": "B",
   "why": [
    "1045 randomized trials and 113 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 36% of completed registered trials posted results (-8)",
    "'Drug ineffective' is the single most-reported item about this drug in FAERS (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 63,
   "letter": "C",
   "why": [
    "Recalls since 2016: 1 Class I, 23 Class II, 2 Class III across 120 generic makers (-29)",
    "8 label changes approved since 2021: the safety story is still moving (-8)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 100,
   "letter": "A",
   "why": [
    "Pharma paid doctors $65,036 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 (120 applications)",
    "29 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 74,
 "grade": "C",
 "questions": [
  "This drug carries a boxed warning. Which specific risk does it cover, and does it apply to me?",
  "The most-reported problems in FDA's adverse event data are fatigue, pain, nausea. How would we recognize and handle those?",
  "Why this one over aceclofenac, alminoprofen, benzydamine? 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.)"
 ]
}