pharmacopeia
GET
/api/v1/drug/celecoxib

Boxed warning

RISK OF SERIOUS CARDIOVASCULAR AND GASTRO-INTESTINAL EVENTS 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 the treatment and may increase with duration of use [ see Warnings and Precautions (5.1) ]. Celecoxib is 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 NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which c an 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. Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal.

2D structure
4-[5-(4-methylphenyl)-3-(trifluoromethyl)pyrazol-1-yl]benzenesulfonamide
SMILES CC1=CC=C(C=C1)C2=CC(=NN2C3=CC=C(C=C3)S(=O)(=O)N)C(F)(F)F
InChIKey RZEKVGVHFLEQIL-UHFFFAOYSA-N

Mechanism of action

Sourced from openFDA

Celecoxib has analgesic, anti-inflammatory, and antipyretic properties. The mechanism of action of celecoxib is believed to be due to inhibition of prostaglandin synthesis, primarily via inhibition of COX-2.

CyclooxygenaseCyclooxygenase 2

Indications

Sourced from openFDA
  • 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 For the management of the signs and symptoms of OA [ see Clinical Studies (14.1) ].ICD-10: M06.9, M19.90

Contraindications

Sourced from openFDA
  • 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) ].contraindicated

Dosage & administration

Sourced from openFDA

2. DOSAGE AND ADMINISTRATION Use the lowest effective dosage for shortest duration consistent with individual patient treatment goals. ( 2.1 ) OA: 200 mg once daily or 100 mg twice daily. ( 2.2 , 14.1 ) RA: 100 mg to 200 mg twice daily. ( 2.3 , 14.2 ) JRA: 50 mg twice daily in patients 10 kg to 25 kg. 100 mg twice daily in patients more than 25 kg. ( 2.4 , 14.3 ) AS: 200 mg once daily single dose or 100 mg twice daily. If no effect is observed after 6 weeks, a trial of 400 mg (single or divided doses) may be of benefit. ( 2.5 , 14.4 ) AP and PD: 400 mg initially, followed by 200 mg dose if needed on first day. On subsequent days, 200 mg twice daily as needed. ( 2.6 , 14.5 ) Hepatic Impairment: Reduce daily dose by 50% in patients with moderate hepatic impairment (Child-Pugh Class B). ( 2.7 , 8.6 , 12.3 ) Poor Metabolizers of CYP2C9 Substrates: Consider a dose reduction by 50% (or alternative management for JRA) in patients who are known or suspected to be CYP2C9 poor metabolizers. ( 2.7 , 8.8 , 12.3 ). 2.1 General Dosing Instructions Carefully consider the potential benefits and risks of celecoxib and other treatment options before deciding to use celecoxib. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [ see Warnings and Precautions (5) ]. These doses can be given without regard to timing of meals. 2.2 Osteoarthritis For OA, the dosage is 200 mg per day administered as a single dose or as 100 mg twice daily. 2.3 Rheumatoid Arthritis For RA, the dosage is 100 mg to 200 mg twice daily.

Warnings & precautions

Sourced from openFDA

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 appearance of skin rash or other signs of hypersensitivity. ( 5.9 ) Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): Discontinue and evaluate clinically. ( 5.10 ) Fetal Toxicity: Limit use of NSAIDs, including celecoxib, between about 20 to 30 weeks in pregnancy due to the risk of oligohydramnios/fetal renal dysfunction.

Adverse reactions

Sourced from openFDA

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 Micro Labs USA, Inc. at 1-855-839-8195 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 in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.

Use in specific populations

Sourced from openFDA

8. USE IN SPECIFIC POPULATIONS Infertility: NSAIDs are associated with reversible infertility. Consider withdrawal of celecoxib in women who have difficulties conceiving. ( 8.3 ) 8.1 Pregnancy Risk Summary Use of NSAIDs, including celecoxib, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. Because of these risks, limit dose and duration of celecoxib use between about 20 and 30 weeks of gestation and avoid celecoxib use at about 30 weeks of gestation and later in pregnancy ( see Clinical Considerations, Data ). Premature Closure of Fetal Ductus Arteriosus Use of NSAIDs, including celecoxib, at about 30 weeks gestation or later in pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Oligohydramnios/Neonatal Renal Impairment Use of NSAIDs at about 20 weeks gestation or later in pregnancy has been associated with cases of fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment. Data from observational studies regarding other potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive.

Pharmacokinetics

Sourced from openFDA
Metabolism
Celecoxib exhibits dose-proportional increase in exposure after oral administration up to 200 mg twice daily and less than proportional increase at higher doses. It has extensive distribution and high protein binding.

Overdosage

Sourced from openFDA

10. OVERDOSAGE Symptoms following acute NSAID overdosages have been typically limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which have been generally reversible with supportive care. Gastrointestinal bleeding has occurred. Hypertension, acute renal failure, respiratory depression, and coma have occurred, but were rare [see Warnings and Precautions (5.2 , 5.4 , 5.6) ]. No overdoses of celecoxib were reported during clinical trials. Doses up to 2400 mg/day for up to 10 days in 12 patients did not result in serious toxicity. No information is available regarding the removal of celecoxib by hemodialysis, but based on its high degree of plasma protein binding (>97%) dialysis is unlikely to be useful in overdose. Manage patients with symptomatic and supportive care following an NSAID overdosage. There are no specific antidotes. Consider emesis and/or activated charcoal (60 to 100 grams in adults, 1 to 2 grams per kg of body weight in pediatric patients) and/or osmotic cathartic in symptomatic patients seen within four hours of ingestion or in patients with a large overdosage (5 to 10 times the recommended dosage).

Approval history

Sourced from openFDA
  • Dec 31, 1998NDANDA020998Upjohn
  • Oct 29, 2014ANDAANDA202240Lupin
  • Feb 11, 2015ANDAANDA200562Watson Labs Inc
  • Jun 2, 2015ANDAANDA204197Apotex
  • Aug 21, 2015ANDAANDA204519Alembic
  • Sep 23, 2015ANDAANDA207446Cipla
  • May 5, 2020NDANDA212157Scilex Pharms
  • Jul 29, 2025NDANDA211759Carwin Pharm Assoc

FDA shortages

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Reference statistics from the openFDA drug-shortage dataset. For a live view, consult the FDA database directly. Not clinical guidance.

  • Celecoxib, Capsule, 100 mg (NDC 0591-3983-01)To be discontinued
    Sponsor: Teva Pharmaceuticals USA, Inc.
    Updated
  • Celecoxib, Capsule, 100 mg (NDC 0591-3983-05)To be discontinued
    Sponsor: Teva Pharmaceuticals USA, Inc.
    Updated
  • Celecoxib, Capsule, 200 mg (NDC 0591-3984-01)To be discontinued
    Sponsor: Teva Pharmaceuticals USA, Inc.
    Updated
  • Celecoxib, Capsule, 200 mg (NDC 0591-3984-05)To be discontinued
    Sponsor: Teva Pharmaceuticals USA, Inc.
    Updated
  • Celecoxib, Capsule, 400 mg (NDC 0591-3985-60)To be discontinued
    Sponsor: Teva Pharmaceuticals USA, Inc.
    Updated
  • Celecoxib, Capsule, 50 mg (NDC 0591-3982-60)To be discontinued
    Sponsor: Teva Pharmaceuticals USA, Inc.
    Updated

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
129,443 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Drug Ineffective17,85914%
  2. 2Pain12,4539.6%
  3. 3Arthralgia11,0858.6%
  4. 4Fatigue9,8897.6%
  5. 5Nausea9,5687.4%
  6. 6Off Label Use7,8996.1%
  7. 7Drug Hypersensitivity7,8376.1%
  8. 8Diarrhoea7,4455.8%
  9. 9Headache7,3765.7%
  10. 10Rheumatoid Arthritis7,3155.7%
  11. 11Myocardial Infarction7,0455.4%
  12. 12Rash6,3844.9%
  13. 13Malaise6,3794.9%
  14. 14Dizziness6,3194.9%
  15. 15Condition Aggravated6,3054.9%

Literature

View JSON

Recent PubMed references pinned to Celecoxib as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 679 ClinicalTrials.gov registrations naming Celecoxib as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Pharmacogenomics

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CPIC-curated drug–gene pairs for Celecoxib. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

Frequently asked questions

How does Celecoxib work?
Celecoxib has analgesic, anti-inflammatory, and antipyretic properties. The mechanism of action of celecoxib is believed to be due to inhibition of prostaglandin synthesis, primarily via inhibition of COX-2.
What is Celecoxib used for?
According to FDA labeling, Celecoxib carries indications including: 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 For the management of the signs and symptoms of OA [ see Clinical Studies (14.1) ].. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Celecoxib?
Celecoxib is classified as Coxibs, Other antineoplastic agents, Nonsteroidal Anti-inflammatory Drug, Cyclooxygenase 2 Inhibitors, Cyclooxygenase Inhibitors, Decreased Prostaglandin Production.
What are the brand names for Celecoxib?
Celecoxib is marketed under brand names including Celebrex, Consensi, Elyxyb, Seglentis, Vyscoxa.
What are the contraindications for Celecoxib?
Celecoxib labeling lists contraindications including: 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) ].. Always consult the full prescribing information and a clinician.
Note. Data for celecoxib is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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