{
 "query": "indomethacin",
 "ingredient": "indomethacin",
 "slug": "indomethacin",
 "rxcui": "5781",
 "brands": [
  "Indocin",
  "Tivorbex"
 ],
 "names": [
  "indomethacin",
  "indomethacin sodium",
  "indomethacin sodium trihydrate"
 ],
 "classes": [
  {
   "id": "M01AB",
   "name": "Acetic acid derivatives and related substances"
  },
  {
   "id": "M02AA",
   "name": "Antiinflammatory preparations, non-steroids for topical use"
  },
  {
   "id": "S01BC",
   "name": "Antiinflammatory agents, non-steroids"
  }
 ],
 "alternatives": [
  "aceclofenac",
  "acemetacin",
  "benzydamine",
  "bromfenac",
  "bufexamac",
  "bumadizone",
  "clofezone",
  "dexketoprofen",
  "diclofenac",
  "etodolac",
  "etofenamate",
  "felbinac",
  "feprazone",
  "flurbiprofen",
  "ibuprofen",
  "ketoprofen",
  "ketorolac",
  "lonazolac",
  "loxoprofen",
  "meclofenamic acid",
  "mofebutazone",
  "naproxen",
  "nepafenac",
  "niflumic acid",
  "nimesulide",
  "oxyphenbutazone",
  "phenylbutazone",
  "piketoprofen",
  "piroxicam",
  "proglumetacin",
  "salicylic acid",
  "sulindac",
  "tolmetin",
  "zomepirac"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 64,
   "RECTAL": 7,
   "INTRAVENOUS": 3
  },
  "boxed_warning": "WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS Cardiovascular Thrombotic Events \u2022 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 (5.1) ]. \u2022 Indomethacin extended-release capsules are contraindicated in the setting of coronary artery bypass graft (CABG) surgery [see Contraindications (4) and Warnings and Precautions (5.1) ]. Gastrointestinal Bleeding, Ulceration, and Perforation \u2022 NSAIDs cause an increased risk of serious gastrointestinal (GI) 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 and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events [see Warnings and Precautions (5.2) ]. WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS See full prescribing information for complete boxed warning. ...",
  "indications_and_usage": "Indomethacin extended-release capsules are indicated for: \u2022 Moderate to severe rheumatoid arthritis including acute flares of chronic disease \u2022 Moderate to severe ankylosing spondylitis \u2022 Moderate to severe osteoarthritis \u2022 Acute painful shoulder (bursitis and/or tendinitis) Indomethacin extended-release capsules are a nonsteroidal anti-inflammatory drug indicated for: \u2022 Moderate to severe rheumatoid arthritis including acute flares of chronic disease \u2022 Moderate to severe ankylosing spondylitis \u2022 Moderate to severe osteoarthritis \u2022 Acute painful shoulder (bursitis and/or tendinitis) ( 1 )",
  "contraindications": "Indomethacin extended-release capsules are contraindicated in the following patients: \u2022 Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to indomethacin or any components of the drug product [see Warnings and Precautions (5.7 , 5.9 )] \u2022 History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients [see Warnings and Precautions (5.7 , 5.8) ] \u2022 In the setting of coronary artery bypass graft (CABG) surgery [see Warnings and Precautions (5.1) ] \u2022 Known hypersensitivity to indomethacin or any components of the drug product ( 4 ) \u2022 History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs ( 4 ) \u2022 In the setting of CABG surgery ( 4 )",
  "warnings_and_cautions": "\u2022 Hepatotoxicity : Inform patients of warning signs and symptoms of hepatotoxicity. Discontinue if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop ( 5.3 ) \u2022 Hypertension : Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure ( 5.4 , 7 ) \u2022 Heart Failure and Edema : Avoid use of indomethacin extended-release capsules in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure ( 5.5 ) \u2022 Renal Toxicity : Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid use of indomethacin extended-release capsules in patients with advanced renal disease unless benefits are expected to outweigh risk of worsening renal function ( 5.6 ) \u2022 Anaphylactic Reactions : Seek emergency help if an anaphylactic reaction occurs ( 5.7 ) \u2022 Exacerbation of Asthma Related to Aspirin Sensitivity : Indomethacin extended-release capsules are contraindicated in patients with aspirin-sensitive asthma. Monitor patients with preexisting asthma (without aspirin sensitivity) (...",
  "warnings": "",
  "adverse_reactions": "The following adverse reactions are discussed in greater detail in other sections of the labeling: \u2022 Cardiovascular Thrombotic Events [see Warnings and Precautions (5.1) ] \u2022 GI Bleeding, Ulceration and Perforation [see Warnings and Precautions (5.2) ] \u2022 Hepatotoxicity [see Warnings and Precautions (5.3) ] \u2022 Hypertension [see Warnings and Precautions (5.4) ] \u2022 Heart Failure and Edema [see Warnings and Precautions (5.5) ] \u2022 Renal Toxicity and Hyperkalemia [see Warnings and Precautions (5.6) ] \u2022 Anaphylactic Reactions [see Warnings and Precautions (5.7) ] \u2022 Serious Skin Reactions [see Warnings and Precautions (5.9) ] \u2022 Hematologic Toxicity [see Warnings and Precautions (5.12) ] Most common adverse reactions (incidence \u2265 3%) are headache, dizziness, dyspepsia and nausea. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Hetero Labs Limited at 1-866-495-1995 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience 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...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Warnings and Precautions (5.9) 11/2024",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling (Medication Guide) that accompanies each prescription dispensed. Inform patients, families, or their caregivers of the following information before initiating therapy with indomethacin extended-release capsules and periodically during the course of ongoing therapy. Cardiovascular Thrombotic Events Advise patients to be alert for the symptoms of cardiovascular thrombotic events, including chest pain, shortness of breath, weakness, or slurring of speech, and to report any of these symptoms to their healthcare provider immediately [see Warnings and Precautions (5.1) ]. Gastrointestinal Bleeding, Ulceration, and Perforation Advise patients to report symptoms of ulcerations and bleeding, including epigastric pain, dyspepsia, melena, and hematemesis to their healthcare provider. In the setting of concomitant use of low-dose aspirin for cardiac prophylaxis, inform patients of the increased risk for and the signs and symptoms of GI bleeding [see Warnings and Precautions (5.2) ]. Hepatotoxicity Inform patients of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, pruritus, diarrhea, jaundice, right ...",
  "spl_medguide": "",
  "clinical_studies": "Indomethacin has been shown to be an effective anti-inflammatory agent, appropriate for long-term use in rheumatoid arthritis, ankylosing spondylitis, and osteoarthritis. Indomethacin extended-release capsules affords relief of symptoms; it does not alter the progressive course of the underlying disease. Indomethacin extended-release capsules suppresses inflammation in rheumatoid arthritis as demonstrated by relief of pain, and reduction of fever, swelling and tenderness. Improvement in patients treated with indomethacin for rheumatoid arthritis has been demonstrated by a reduction in joint swelling, average number of joints involved, and morning stiffness; by increased mobility as demonstrated by a decrease in walking time; and by improved functional capability as demonstrated by an increase in grip strength. Indomethacin extended-release capsules may enable the reduction of steroid dosage in patients receiving steroids for the more severe forms of rheumatoid arthritis. In such instances the steroid dosage should be reduced slowly and the patients followed very closely for any possible adverse effects.",
  "brand_name": "Indomethacin",
  "manufacturer": "Sportpharm LLC",
  "application_number": "ANDA201807",
  "pharm_class_epc": [
   "Nonsteroidal Anti-inflammatory Drug [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20260817",
  "set_id": "12821a3a-b5f2-4415-84c9-0a30a4725f1e",
  "has_boxed_warning": true,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 11850,
  "serious": 9568,
  "death": 1214,
  "hospitalization": 3429,
  "primary_suspect": 11789,
  "top_reactions": [
   [
    "Drug Ineffective",
    1790
   ],
   [
    "Fatigue",
    1330
   ],
   [
    "Off Label Use",
    1178
   ],
   [
    "Arthralgia",
    1122
   ],
   [
    "Headache",
    1063
   ],
   [
    "Pain",
    1015
   ],
   [
    "Diarrhoea",
    955
   ],
   [
    "Dizziness",
    909
   ],
   [
    "Nausea",
    881
   ],
   [
    "Vomiting",
    749
   ],
   [
    "Malaise",
    745
   ],
   [
    "Pruritus",
    660
   ],
   [
    "Dyspnoea",
    639
   ],
   [
    "Asthenia",
    631
   ],
   [
    "Drug Intolerance",
    612
   ]
  ],
  "by_year": {
   "2019": 1409,
   "2020": 1232,
   "2021": 1113,
   "2022": 1066,
   "2023": 901,
   "2024": 904,
   "2025": 773,
   "2026": 251
  },
  "by_year_primary": {
   "2019": 1409,
   "2020": 1230,
   "2021": 1110,
   "2022": 1057,
   "2023": 880,
   "2024": 885,
   "2025": 768,
   "2026": 250
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20250515",
   "reason": "cGMP deviations",
   "firm": "Amerisource Health Services LLC",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20250509",
   "reason": "cGMP deviations",
   "firm": "KVK Tech, Inc.",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20250313",
   "reason": "CGMP Deviations",
   "firm": "Glenmark Pharmaceuticals Inc., USA",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20240731",
   "reason": "Failed Dissolution Specifications: below specification results",
   "firm": "Glenmark Pharmaceuticals Inc., USA",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20231107",
   "reason": "Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen",
   "firm": "Glenmark Pharmaceuticals Inc., USA",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20180718",
   "reason": "Failed Tablet/Capsule Specifications: customer complaints of deformed, clumped, misshaped, melted or stuck together capsules.",
   "firm": "Hetero Labs, Ltd. - Unit III",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20180319",
   "reason": "Labeling: Incorrect Instructions: bottles incorrectly labeled with the usual adult dosage of \"One or two capsules 2 or 3 times a day.\" rather than the correct usual adult dosage of \"One capsule 2 or 3 times a day.",
   "firm": "Glenmark Pharmaceuticals Inc., USA",
   "status": "Terminated"
  }
 ],
 "recall_total": 7,
 "drugsfda": {
  "applications": 75,
  "nda": 13,
  "anda": 51,
  "first_approval": "19650610",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 154,
  "labeling_recent": 17,
  "sponsors": [
   "ABLE",
   "AMNEAL",
   "AMNEAL PHARMS",
   "ANI PHARMS",
   "ANNORA PHARMA",
   "AUROBINDO PHARMA",
   "AVANTHI INC",
   "CHARTWELL MOLECULES"
  ],
  "unapproved": false,
  "first_approval_fmt": "06/10/1965"
 },
 "trials": {
  "total": 607,
  "completed": 353,
  "terminated": 87,
  "with_results": 154,
  "industry": 94,
  "phase3": 103,
  "results_share": 0.43626062322946174,
  "terminated_share": 0.14332784184514002
 },
 "pubmed": {
  "rct": 711,
  "meta": 54,
  "recent_rct": 25,
  "cochrane": [
   {
    "pmid": "33448032",
    "title": "Indomethacin for symptomatic patent ductus arteriosus in preterm infants",
    "year": "2021"
   },
   {
    "pmid": "31752052",
    "title": "Indomethacin for intracranial hypertension secondary to severe traumatic brain injury in adults",
    "year": "2019"
   },
   {
    "pmid": "21735414",
    "title": "Fluid restriction and prophylactic indomethacin versus prophylactic indomethacin alone for prevention of morbidity and mortality in extremely low birth weight infants",
    "year": "2011"
   },
   {
    "pmid": "20614421",
    "title": "Prophylactic intravenous indomethacin for preventing mortality and morbidity in preterm infants",
    "year": "2010"
   },
   {
    "pmid": "18254092",
    "title": "Continuous infusion versus intermittent bolus doses of indomethacin for patent ductus arteriosus closure in symptomatic preterm infants",
    "year": "2008"
   },
   {
    "pmid": "17443527",
    "title": "Prolonged versus short course of indomethacin for the treatment of patent ductus arteriosus in preterm infants",
    "year": "2007"
   },
   {
    "pmid": "14974018",
    "title": "Prolonged versus short course of indomethacin for the treatment of patent ductus arteriosus in preterm infants",
    "year": "2004"
   },
   {
    "pmid": "12804488",
    "title": "Indomethacin for asymptomatic patent ductus arteriosus in preterm infants",
    "year": "2003"
   },
   {
    "pmid": "12137683",
    "title": "Dopamine versus no treatment to prevent renal dysfunction in indomethacin-treated preterm newborn infants",
    "year": "2002"
   },
   {
    "pmid": "12137607",
    "title": "Prophylactic intravenous indomethacin for preventing mortality and morbidity in preterm infants",
    "year": "2002"
   },
   {
    "pmid": "12076498",
    "title": "Indomethacin for the treatment of Alzheimer's disease patients",
    "year": "2002"
   },
   {
    "pmid": "11686979",
    "title": "Furosemide for symptomatic patent ductus arteriosus in indomethacin-treated infants",
    "year": "2001"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "indomethacin",
   "Indocin",
   "Tivorbex"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 266083,
  "beneficiaries": 132723,
  "spend": 4712773.29,
  "by_brand": [
   {
    "brand": "Indomethacin",
    "claims": 247264,
    "per_claim": 14.39498904,
    "is_generic": true
   },
   {
    "brand": "Indomethacin ER",
    "claims": 18751,
    "per_claim": 33.420158392,
    "is_generic": false
   },
   {
    "brand": "Indocin",
    "claims": 68,
    "per_claim": 7746.3136765,
    "is_generic": false
   }
  ],
  "per_claim": 17.711666246998117
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "indometacin",
  "matched": "indomethacin",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 1903,
  "fills": 266083,
  "per_million": 7151.903729287478,
  "ratio": 2.5828940086388967,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 57,
   "letter": "D",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "7,152 FDA reports naming it as the suspect drug per million Medicare fills, 2.6x the median drug on this site (-8)",
    "Death share in reports is near or below the FAERS average (1.1x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 73,
   "letter": "C",
   "why": [
    "711 randomized trials and 54 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 44% 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": 81,
   "letter": "B",
   "why": [
    "Recalls since 2016: 0 Class I, 6 Class II, 1 Class III across 51 generic makers (-6)",
    "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": 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": 100,
   "letter": "A",
   "why": [
    "Generic versions approved (51 applications)",
    "34 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 75,
 "grade": "B",
 "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, arthralgia. 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 aceclofenac, acemetacin, 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.)"
 ]
}