Celecoxib is a nonsteroidal anti-inflammatory drug indicated cELEBREX is a nonsteroidal anti-inflammatory drug indicated for osteoarthritis (OA), among other approved uses. It is available as capsules, oral liquid and oral suspension. MedsAcross supplies Celecoxib for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
CELEBREX is indicated CELEBREX is a nonsteroidal anti-inflammatory drug indicated for: • Osteoarthritis (OA). • Rheumatoid Arthritis (RA). • Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older. • Ankylosing Spondylitis (AS). • Acute Pain (AP). • Primary Dysmenorrhea (PD)
Source: US FDA prescribing information
Celecoxib has analgesic, anti-inflammatory, and antipyretic properties. The mechanism of action of CELEBREX is believed to be due to inhibition of prostaglandin synthesis, primarily via inhibition of COX-2. Celecoxib is a potent inhibitor of prostaglandin synthesis in vitro. Celecoxib concentrations reached during therapy have produced in vivo effects. Prostaglandins sensitize afferent nerves and potentiate the action of bradykinin in inducing pain in animal models. Prostaglandins are mediators of inflammation. Since celecoxib is an inhibitor of prostaglandin synthesis, its mode of action may be due to a decrease of prostaglandins in peripheral tissues.
Source: US FDA prescribing information
• Use the lowest effective dosage for shortest duration consistent with individual patient treatment goals. • OA: 200 mg once daily or 100 mg twice daily. • RA: 100 mg to 200 mg twice daily. • JRA: 50 mg twice daily in patients 10 kg to 25 kg. 100 mg twice daily in patients more than 25 kg. • 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. • 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. Hepatic Impairment: Reduce daily dose by 50% in patients with moderate hepatic impairment (Child-Pugh Class B). 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.
Source: US FDA prescribing information
CELEBREX is contraindicated in the following patients: • Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to celecoxib, any components of the drug product. • 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. • In the setting of CABG surgery. • In patients who have demonstrated allergic-type reactions to sulfonamides. • Known hypersensitivity to celecoxib, or any components of the drug product or sulfonamides. • History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs.
Source: US FDA prescribing information
Boxed warning (risk of serious cardiovascular and gastrointestinal 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. • 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. • Hypertension: Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure. • Heart Failure and Edema: Avoid use of CELEBREX in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure.
Source: US FDA prescribing information
The following adverse reactions are discussed in greater detail in other sections of the labeling: • Cardiovascular Thrombotic Events • GI Bleeding, Ulceration and Perforation • Hepatotoxicity • Hypertension • Heart Failure and Edema • Renal Toxicity and Hyperkalemia • Anaphylactic Reactions • Serious Skin Reactions • Hematologic Toxicity 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.
Source: US FDA prescribing information
See Table 3 for clinically significant drug interactions with celecoxib. Table 3: Clinically Significant Drug Interactions with Celecoxib Drugs that Interfere with Hemostasis Clinical Impact: • Celecoxib and anticoagulants such as warfarin have a synergistic effect on bleeding. The concomitant use of Celecoxib and anticoagulants have an increased risk of serious bleeding compared to the use of either drug alone. • Serotonin release by platelets plays an important role in hemostasis. Case-control and cohort epidemiological studies showed that concomitant use of drugs that interfere with serotonin reuptake and an NSAID may potentiate the risk of bleeding more than an NSAID alone. Intervention: Monitor patients with concomitant use of CELEBREX with anticoagulants (e.g., warfarin), antiplatelet drugs (e.g., aspirin), SSRIs, and SNRIs for signs of bleeding.
Source: US FDA prescribing information
Storage Store at room temperature 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (59°F to 86°F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
10 presentations of Celecoxib, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Celecoxib 200 mg capsuleOralGeneric name | — | US FDA | Available on request |
| Celecoxib 100 mg capsuleOralGeneric name | — | US FDA | Available on request |
| Celecoxib 400 mg capsuleOralGeneric name | — | US FDA | Available on request |
| Celecoxib 50 mg capsuleOralGeneric name | — | US FDA | Available on request |
| Celebrex 100 mg capsuleOral | Viatris Specialty | US FDA | Available on request |
| Celebrex 200 mg capsuleOral | Viatris Specialty | US FDA | Available on request |
| Celebrex 400 mg capsuleOral | Viatris Specialty | US FDA | Available on request |
| Celebrex 50 mg capsuleOral | Viatris Specialty | US FDA | Available on request |
| ELYXYB - celecoxib 120 mg/4.8 mL oral liquidOral | Scilex Pharmaceuticals | US FDA | Available on request |
| Vyscoxa 10 mg/mL oral suspensionOral | Carwin Pharmaceutical Associates | US FDA | Available on request |
3 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Conditions linked to Celecoxib in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 10 presentations of Celecoxib and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 3 brand names for Celecoxib, including Celebrex, ELYXYB - celecoxib, Vyscoxa.
Yes. The US FDA first approved Celecoxib on 31 December 1998, according to Drugs@FDA.
No listed presentation of Celecoxib is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Celecoxib is classified under ATC code L01XX33 (Celecoxib).
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