{
 "query": "nabumetone",
 "ingredient": "nabumetone",
 "slug": "nabumetone",
 "rxcui": "31448",
 "brands": [
  "Relafen"
 ],
 "names": [
  "nabumetone"
 ],
 "classes": [],
 "alternatives": [],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 48
  },
  "boxed_warning": "Cardiovascular Risk \u2022 NSAIDs 1 may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk (see WARNINGS ). \u2022 Nabumetone tablets are contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS ). Gastrointestinal Risk \u2022 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 ). 1 Throughout this package insert, the term NSAID refers to a non-aspirin non-steroidal anti-inflammatory drug.",
  "indications_and_usage": "INDICATIONS AND USAGE Carefully consider the potential benefits and risks of nabumetone tablets and other treatment options before deciding to use nabumetone tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Nabumetone tablets are indicated for relief of signs and symptoms of osteoarthritis and rheumatoid arthritis.",
  "contraindications": "CONTRAINDICATIONS Nabumetone tablets are contraindicated in patients with known hypersensitivity to nabumetone or product excipients. Nabumetone 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, General, Preexisting Asthma ). Nabumetone tablets are contraindicated for the treatment of peri-operative pain 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 3 years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, which can be fatal. All NSAIDs, both COX-2 selective and nonselective, may have a similar risk. Patients with known CV disease or risk factors for CV disease may be at greater risk. To minimize the potential risk for an adverse CV event in patients treated with an NSAID, the lowest effective dose should be used for the shortest duration possible. Physicians and patients should remain alert for the development of such events, even in the absence of previous CV symptoms. Patients should be informed about the signs and/or symptoms of serious CV events and the steps to take if they occur. There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrent use of aspirin and an NSAID does increase the risk of serious GI events (see WARNINGS, Gastrointestinal Effects \u2013 Risk of Ulceration, Bleeding, and Perforation ). Two lar...",
  "adverse_reactions": "ADVERSE REACTIONS Adverse reaction information was derived from blinded-controlled and open-labeled clinical trials and from worldwide marketing experience. In the description below, rates of the more common events (greater than 1%) and many of the less common events (less than 1%) represent results of U.S. clinical studies. Of the 1,677 patients who received nabumetone during U.S. clinical trials, 1,524 were treated for at least 1 month, 1,327 for at least 3 months, 929 for at least a year, and 750 for at least 2 years. More than 300 patients have been treated for 5 years or longer. The most frequently reported adverse reactions were related to the gastrointestinal tract and included diarrhea, dyspepsia, and abdominal pain. Incidence \u2265 1% - Probably Causally Related Gastrointestinal Diarrhea (14%), dyspepsia (13%), abdominal pain (12%), constipation* 2 , flatulence* 2 , nausea* 2 , positive stool guaiac* 2 , dry mouth, gastritis, stomatitis, vomiting. Central Nervous System Dizziness* 2 , headache* 2 , fatigue, increased sweating, insomnia, nervousness, somnolence. Dermatologic Pruritus* 2 , rash* 2 . Special Senses Tinnitus* 2 . Miscellaneous Edema* 2 . 2 * Incidence of reported ...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Information for Patients Patients should be informed of the following information before initiating therapy with an NSAID and periodically during the course of ongoing therapy. Patients should also be encouraged to read the NSAID Medication Guide that accompanies each prescription dispensed. \u2022 Nabumetone tablets, like other NSAIDs, may cause serious CV side effects, such as MI or stroke, which may result in hospitalization and even death. Although serious CV events can occur without warning symptoms, patients should be alert for the signs and symptoms of chest pain, shortness of breath, weakness, slurring of speech, and should ask for medical advice when observing any indicative signs or symptoms. Patients should be apprised of the importance of this follow-up (see WARNINGS, Cardiovascular Effects ). \u2022 Nabumetone tablets, like other NSAIDs, can cause GI discomfort and, rarely, serious GI side effects, such as ulcers and bleeding, which may result in hospitalization and even death. Although serious GI tract ulcerations and bleeding can occur without warning symptoms, patients should be alert for the signs and symptoms of ulcerations and bleeding, and should ask for medical advice wh...",
  "spl_medguide": "MEDICATION GUIDE For Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) (See the end of this Medication Guide for a list of prescription NSAID medicines.) What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)? NSAID medicines may increase the chance of a heart attack or stroke that can lead to death. This chance increases: \u2022 with longer use of NSAID medicines \u2022 in people who have heart disease NSAID medicines should never be used right before or after a heart surgery called a \u201ccoronary artery bypass graft (CABG).\u201d NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding: \u2022 can happen without warning symptoms \u2022 may cause death The chance of a person getting an ulcer or bleeding increases with: \u2022 taking medicines called \u201ccorticosteroids\u201d and \u201canticoagulants\u201d \u2022 longer use \u2022 smoking \u2022 drinking alcohol \u2022 older age \u2022 having poor health NSAID medicines should only be used: \u2022 exactly as prescribed \u2022 at the lowest dose possible for your treatment \u2022 for the shortest time needed What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)? NSAID medicines are used t...",
  "clinical_studies": "CLINICAL TRIALS Osteoarthritis The use of nabumetone in relieving the signs and symptoms of osteoarthritis (OA) was assessed in double-blind, controlled trials in which 1,047 patients were treated for 6 weeks to 6 months. In these trials, nabumetone in a dose of 1,000 mg/day administered at night was comparable to naproxen 500 mg/day and to aspirin 3,600 mg/day. Rheumatoid Arthritis The use of nabumetone in relieving the signs and symptoms of rheumatoid arthritis (RA) was assessed in double-blind, randomized, controlled trials in which 770 patients were treated for 3 weeks to 6 months. Nabumetone, in a dose of 1,000 mg/day administered at night, was comparable to naproxen 500 mg/day and to aspirin 3,600 mg/day. In controlled clinical trials of rheumatoid arthritis patients, nabumetone has been used in combination with gold, d-penicillamine, and corticosteroids. Patient Exposure in Clinical Trials of Osteoarthritis and Rheumatoid Arthritis In clinical trials with osteoarthritis and rheumatoid arthritis patients, most patients responded to nabumetone in doses of 1,000 mg/day administered nightly; total daily dosages up to 2,000 mg were used. In open-labeled studies, 1,490 patients we...",
  "brand_name": "Nabumetone",
  "manufacturer": "Proficient Rx LP",
  "application_number": "ANDA091083",
  "pharm_class_epc": [
   "Nonsteroidal Anti-inflammatory Drug [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20200101",
  "set_id": "079a8a9e-6d71-414a-83f3-ef68e323c1fd",
  "has_boxed_warning": true,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 5375,
  "serious": 2744,
  "death": 251,
  "hospitalization": 1122,
  "primary_suspect": 5375,
  "top_reactions": [
   [
    "Drug Ineffective",
    432
   ],
   [
    "Pain",
    374
   ],
   [
    "Fatigue",
    340
   ],
   [
    "Nausea",
    308
   ],
   [
    "Headache",
    278
   ],
   [
    "Chronic Kidney Disease",
    269
   ],
   [
    "Arthralgia",
    266
   ],
   [
    "Drug Hypersensitivity",
    254
   ],
   [
    "Diarrhoea",
    229
   ],
   [
    "Acute Kidney Injury",
    227
   ],
   [
    "Dizziness",
    216
   ],
   [
    "Pain In Extremity",
    193
   ],
   [
    "Fall",
    185
   ],
   [
    "Back Pain",
    184
   ],
   [
    "Malaise",
    181
   ]
  ],
  "by_year": {
   "2019": 591,
   "2020": 537,
   "2021": 322,
   "2022": 277,
   "2023": 225,
   "2024": 179,
   "2025": 188,
   "2026": 77
  },
  "by_year_primary": {
   "2019": 591,
   "2020": 537,
   "2021": 322,
   "2022": 277,
   "2023": 225,
   "2024": 179,
   "2025": 188,
   "2026": 77
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "applications": 15,
  "nda": 1,
  "anda": 14,
  "first_approval": "19911224",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 5,
  "labeling_recent": 0,
  "sponsors": [
   "ANNORA PHARMA",
   "AUROBINDO PHARMA USA",
   "CHARTWELL MOLECULES",
   "CHARTWELL RX",
   "COPLEY PHARM",
   "EPIC PHARMA LLC",
   "IMPAX LABS INC",
   "INVAGEN PHARMS"
  ],
  "unapproved": false,
  "first_approval_fmt": "12/24/1991"
 },
 "trials": {
  "total": 8,
  "completed": 7,
  "terminated": 0,
  "with_results": 0,
  "industry": 5,
  "phase3": 0,
  "results_share": 0.0,
  "terminated_share": 0.0
 },
 "pubmed": {
  "rct": 65,
  "meta": 5,
  "recent_rct": 0,
  "cochrane": [
   {
    "pmid": "19821428",
    "title": "Single dose oral nabumetone for acute postoperative pain in adults",
    "year": "2009"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "nabumetone",
   "Relafen"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 584375,
  "beneficiaries": 213748,
  "spend": 12123385.98,
  "by_brand": [
   {
    "brand": "Nabumetone",
    "claims": 583765,
    "per_claim": 17.09055757,
    "is_generic": true
   },
   {
    "brand": "Relafen Ds",
    "claims": 610,
    "per_claim": 3518.8797377,
    "is_generic": false
   }
  ],
  "per_claim": 20.74590114224599
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 444,
  "fills": 584375,
  "per_million": 759.7860962566845,
  "ratio": 0.2743950464310904,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 70,
   "letter": "C",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "760 FDA reports naming it as the suspect drug per million Medicare fills, 0.3x the median drug on this site",
    "Death share in reports is near or below the FAERS average (0.5x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 49,
   "letter": "F",
   "why": [
    "65 randomized trials and 5 systematic reviews/meta-analyses indexed in PubMed",
    "1 independent Cochrane review(s) exist",
    "'Drug ineffective' is the single most-reported item about this drug in FAERS (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 100,
   "letter": "A",
   "why": [
    "No recalls on record since 2016"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 100,
   "letter": "A",
   "why": [
    "Pharma paid doctors $0 tied to this drug last year: negligible",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 70,
   "letter": "C",
   "why": [
    "Generic versions approved (14 applications)",
    "No same-class alternatives found: little leverage to switch (-30)"
   ],
   "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 pain, fatigue, nausea. How would we recognize and handle those?",
  "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.)"
 ]
}