{
 "query": "celecoxib",
 "ingredient": "celecoxib",
 "slug": "celecoxib",
 "rxcui": "140587",
 "brands": [
  "Celebrex",
  "Elyxyb",
  "Vyscoxa"
 ],
 "names": [
  "celecoxib"
 ],
 "classes": [
  {
   "id": "M01AH",
   "name": "Coxibs"
  }
 ],
 "alternatives": [
  "etoricoxib",
  "parecoxib",
  "rofecoxib",
  "valdecoxib"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 129
  },
  "boxed_warning": "WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS See full prescribing information for complete boxed warning. 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 the treatment and may increase with duration of use. ( 5.1 ) Celecoxib is contraindicated in the setting of coronary artery bypass graft (CABG) surgery. ( 4 , 5.1 ) 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. ( 5.2 ) 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...",
  "indications_and_usage": "1. INDICATIONS AND USAGE Celecoxib is indicated Celecoxib is a nonsteroidal anti-inflammatory drug indicated for: Osteoarthritis (OA) ( 1.1 ) Rheumatoid Arthritis (RA) ( 1.2 ) Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older ( 1.3 ) Ankylosing Spondylitis (AS) ( 1.4 ) Acute Pain (AP) ( 1.5 ) Primary Dysmenorrhea (PD) ( 1.6 ) 1.1 Osteoarthritis (OA) For the management of the signs and symptoms of OA [ see Clinical Studies (14.1) ]. 1.2 Rheumatoid Arthritis (RA) For the management of the signs and symptoms of RA [ see Clinical Studies (14.2) ]. 1.3 Juvenile Rheumatoid Arthritis (JRA) For the management of the signs and symptoms of JRA in patients 2 years and older [ see Clinical Studies (14.3) ]. 1.4 Ankylosing Spondylitis (AS) For the management of the signs and symptoms of AS [ see Clinical Studies (14.4) ]. 1.5 Acute Pain For the management of acute pain in adults [ see Clinical Studies (14.5) ]. 1.6 Primary Dysmenorrhea For the management of primary dysmenorrhea [ see Clinical Studies (14.5) ].",
  "contraindications": "4. CONTRAINDICATIONS Celecoxib is contraindicated in the following patients: Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to celecoxib, any components of the drug product [ see Warnings and Precautions (5.7 , 5.9) ]. 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) ]. In the setting of CABG surgery [ see Warnings and Precautions (5.1) ]. In patients who have demonstrated allergic-type reactions to sulfonamides [ see Warnings and Precautions (5.7) ]. Known hypersensitivity to celecoxib, or any components of the drug product or sulfonamides. ( 4 ) History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. ( 4 ) In the setting of CABG surgery. ( 4 )",
  "warnings_and_cautions": "5. WARNINGS AND PRECAUTIONS 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 ) Hypertension: Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure. ( 5.4 , 7 ) Heart Failure and Edema : Avoid use of celecoxib in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure. ( 5.5 ) Renal Toxicity : Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid use of celecoxib in patients with advanced renal disease unless benefits are expected to outweigh risk of worsening renal function. ( 5.6 ) Anaphylactic Reactions : Seek emergency help if an anaphylactic reaction occurs. ( 5.7 ) Exacerbation of Asthma Related to Aspirin Sensitivity : Celecoxib is contraindicated in patients with aspirin-sensitive asthma. Monitor patients with preexisting asthma (without aspirin sensitivity). ( 5.8 ) Serious Skin Reactions : Discontinue celecoxib at first appe...",
  "warnings": "",
  "adverse_reactions": "6. ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: Cardiovascular Thrombotic Events [ see Warnings and Precautions (5.1) ] GI Bleeding, Ulceration and Perforation [ see Warnings and Precautions (5.2) ] Hepatotoxicity [ see Warnings and Precautions (5.3) ] Hypertension [ see Warnings and Precautions (5.4) ] Heart Failure and Edema [ see Warnings and Precautions (5.5) ] Renal Toxicity and Hyperkalemia [ see Warnings and Precautions (5.6) ] Anaphylactic Reactions [ see Warnings and Precautions (5.7) ] Serious Skin Reactions [ see Warnings and Precautions (5.9) ] Hematologic Toxicity [ see Warnings and Precautions (5.12) ] Most common adverse reactions in arthritis trials (> 2% and > placebo) are: abdominal pain, diarrhea, dyspepsia, flatulence, peripheral edema, accidental injury, dizziness, pharyngitis, rhinitis, sinusitis, upper respiratory tract infection, rash. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Westminster Pharmaceuticals, LLC at 1-844-221-7294 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 condition...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Warnings and Precautions ( 5.10 ) 04/2021 Warnings and Precautions ( 5.11 ) 04/2021",
  "information_for_patients": "17. PATIENT COUNSELING INFORMATION 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 celecoxib 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 health care 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 health care 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 jaundic...",
  "spl_medguide": "Medication Guide for Nonsteroidal Anti-inflammatory Drugs (NSAIDs) What is the most important information I should know about medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)? NSAIDs can cause serious side effects, including: Increased risk of a heart attack or stroke that can lead to death. This risk may happen early in treatment and may increase: with increasing doses of NSAIDs with longer use of NSAIDs Do not take NSAIDs right before or after a heart surgery called a \"coronary artery bypass graft (CABG).\" Avoid taking NSAIDs after a recent heart attack, unless your healthcare provider tells you to. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack. Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach and intestines: anytime during use without warning symptoms that may cause death The risk of getting an ulcer or bleeding increases with: past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs taking medicines called \"corticosteroids\", \"antiplatelet drugs\", \"anticoagulants\", \"SSRIs\" or \"SNRIs\" increasing doses o...",
  "clinical_studies": "14.1 Osteoarthritis Celecoxib has demonstrated significant reduction in joint pain compared to placebo. Celecoxib was evaluated for treatment of the signs and the symptoms of OA of the knee and hip in placebo- and active-controlled clinical trials of up to 12 weeks duration. In patients with OA, treatment with celecoxib 100 mg twice daily or 200 mg once daily resulted in improvement in WOMAC (Western Ontario and McMaster Universities) osteoarthritis index, a composite of pain, stiffness, and functional measures in OA. In three 12-week studies of pain accompanying OA flare, celecoxib doses of 100 mg twice daily and 200 mg twice daily provided significant reduction of pain within 24 to 48 hours of initiation of dosing. At doses of 100 mg twice daily or 200 mg twice daily the effectiveness of celecoxib was shown to be similar to that of naproxen 500 mg twice daily. Doses of 200 mg twice daily provided no additional benefit above that seen with 100 mg twice daily. A total daily dose of 200 mg has been shown to be equally effective whether administered as 100 mg twice daily or 200 mg once daily. 14.2 Rheumatoid Arthritis Celecoxib has demonstrated significant reduction in joint tenderne...",
  "brand_name": "Celecoxib",
  "manufacturer": "Northwind Health Company, LLC",
  "application_number": "ANDA210071",
  "pharm_class_epc": [
   "Nonsteroidal Anti-inflammatory Drug [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20260416",
  "set_id": "0de7a6f8-baba-1fd0-e063-6394a90ad434",
  "has_boxed_warning": true,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 87059,
  "serious": 61204,
  "death": 8863,
  "hospitalization": 25515,
  "primary_suspect": 86880,
  "top_reactions": [
   [
    "Drug Ineffective",
    15157
   ],
   [
    "Pain",
    9892
   ],
   [
    "Arthralgia",
    9489
   ],
   [
    "Fatigue",
    8593
   ],
   [
    "Off Label Use",
    7932
   ],
   [
    "Nausea",
    7869
   ],
   [
    "Drug Hypersensitivity",
    6994
   ],
   [
    "Rheumatoid Arthritis",
    6939
   ],
   [
    "Diarrhoea",
    6392
   ],
   [
    "Headache",
    6076
   ],
   [
    "Condition Aggravated",
    5841
   ],
   [
    "Malaise",
    5560
   ],
   [
    "Rash",
    5401
   ],
   [
    "Joint Swelling",
    5216
   ],
   [
    "Pain In Extremity",
    5011
   ]
  ],
  "by_year": {
   "2019": 8744,
   "2020": 9146,
   "2021": 6486,
   "2022": 6505,
   "2023": 5724,
   "2024": 6609,
   "2025": 6708,
   "2026": 2569
  },
  "by_year_primary": {
   "2019": 8738,
   "2020": 9139,
   "2021": 6464,
   "2022": 6461,
   "2023": 5694,
   "2024": 6587,
   "2025": 6681,
   "2026": 2555
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20250513",
   "reason": "Presence of Foreign Tablets/Capsules: manufacturer recalled because one tadalafil 5mg tablet was found in 500 count bottle of Celecoxib 200 mg capsules",
   "firm": "AvKARE",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20250509",
   "reason": "Presence of Foreign Tablets/Capsules; customer complaint found one Tadalafil 5mg tablet inside a sealed 500-count bottle of Celecoxib 200mg capsule",
   "firm": "Alembic Pharmaceuticals Limited",
   "status": "Ongoing"
  }
 ],
 "recall_total": 2,
 "drugsfda": {
  "applications": 30,
  "nda": 4,
  "anda": 26,
  "first_approval": "19981231",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 17,
  "labeling_recent": 4,
  "sponsors": [
   "ALEMBIC",
   "AMNEAL PHARMS",
   "APOTEX",
   "AUROBINDO PHARMA",
   "CADILA PHARMS LTD",
   "CARWIN PHARM ASSOC",
   "CIPLA",
   "CSPC OUYI"
  ],
  "unapproved": false,
  "first_approval_fmt": "12/31/1998"
 },
 "trials": {
  "total": 693,
  "completed": 413,
  "terminated": 119,
  "with_results": 168,
  "industry": 230,
  "phase3": 125,
  "results_share": 0.4067796610169492,
  "terminated_share": 0.1717171717171717
 },
 "pubmed": {
  "rct": 466,
  "meta": 56,
  "recent_rct": 61,
  "cochrane": [
   {
    "pmid": "28598564",
    "title": "WITHDRAWN: Celecoxib for rheumatoid arthritis",
    "year": "2017"
   },
   {
    "pmid": "28597983",
    "title": "Celecoxib for rheumatoid arthritis",
    "year": "2017"
   },
   {
    "pmid": "28530031",
    "title": "Celecoxib for osteoarthritis",
    "year": "2017"
   },
   {
    "pmid": "24150982",
    "title": "Single dose oral celecoxib for acute postoperative pain in adults",
    "year": "2013"
   },
   {
    "pmid": "22419293",
    "title": "Single dose oral celecoxib for acute postoperative pain in adults",
    "year": "2012"
   },
   {
    "pmid": "18843655",
    "title": "Single dose oral celecoxib for acute postoperative pain in adults",
    "year": "2008"
   },
   {
    "pmid": "12804506",
    "title": "Single dose oral celecoxib for postoperative pain",
    "year": "2003"
   },
   {
    "pmid": "12519610",
    "title": "Celecoxib for rheumatoid arthritis",
    "year": "2002"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "celecoxib",
   "Celebrex",
   "Elyxyb",
   "Vyscoxa"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 5714441,
  "beneficiaries": 1863495,
  "spend": 180178984.34,
  "by_brand": [
   {
    "brand": "Celecoxib",
    "claims": 5701064,
    "per_claim": 28.891075245,
    "is_generic": true
   },
   {
    "brand": "Celebrex",
    "claims": 11915,
    "per_claim": 1154.5166169,
    "is_generic": false
   },
   {
    "brand": "Elyxyb",
    "claims": 1462,
    "per_claim": 1171.7167237,
    "is_generic": false
   }
  ],
  "per_claim": 31.530465419102235
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": {
  "section": "Haematology",
  "names": [
   "celecoxib",
   "etoricoxib",
   "parecoxib"
  ],
  "reason": "Cox-2 inhibitors (coxibs), i.e. celecoxib, etoricoxib and parecoxib, have been linked to an excess of cardiovascular events (including myocardial infarction and thrombosis) and skin reactions compared with other equally effective NSAIDs (Prescrire Int n\u00b0 167; Rev Prescrire n\u00b0 344, 361, 374, 409).",
  "edition": "2026",
  "qualifier": null,
  "qualified": false,
  "matched": "celecoxib"
 },
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 15823,
  "fills": 5714441,
  "per_million": 2768.949753790441,
  "ratio": 1.0,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 55,
   "letter": "D",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "Listed by the independent review Prescrire as a drug to avoid (2026 edition) (-10)",
    "2,769 FDA reports naming it as the suspect drug per million Medicare fills, 1.0x the median drug on this site",
    "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": 60,
   "letter": "D",
   "why": [
    "466 randomized trials and 56 systematic reviews/meta-analyses indexed in PubMed",
    "Prescrire's independent reviewers find its harm-benefit balance unfavourable versus alternatives (-10)",
    "8 independent Cochrane review(s) exist",
    "Only 41% 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": 88,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 2 Class II, 0 Class III across 26 generic makers (-3)",
    "4 label changes approved since 2021 (-4)",
    "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 (26 applications)",
    "4 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 72,
 "grade": "C",
 "questions": [
  "An independent reviewer (Prescrire) lists this as a drug to avoid because the harms outweigh the benefits versus alternatives. What is your view on that?",
  "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, arthralgia, fatigue. 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 etoricoxib, parecoxib, rofecoxib? 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.)"
 ]
}