Celecoxib is a nonsteroidal anti-inflammatory drug sold in the U.S. under 4 brand and generic names, for rheumatoid arthritis, dysmenorrhea and osteoarthritis. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Celecoxib (application ANDA202240). Other celecoxib products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
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 capsules and other treatment options before deciding to use celecoxib capsules. 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,…
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 Lupin Pharmaceuticals, Inc at 1-800-399-2561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 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 )] 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…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
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Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| APO;C100 | 100 mg | white | capsule | — |
| SG;158 | 200 mg | white | capsule | — |
| C6;200mg | 200 mg | white | capsule | — |
| OE;100 | 100 mg | white | capsule | — |
| Cipla;421;200 | 200 mg | white | capsule | — |
A combination is a different drug — different dosing, different warnings. It is listed here so you can find it, not so you can substitute it.
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
Celecoxib Capsules
Presence of Foreign Tablets/Capsules: manufacturer recalled because one tadalafil 5mg tablet was found in 500 count bottle of Celecoxib 200 mg capsules
AvKARE · May 13, 2025
Celecoxib Capsules
Presence of Foreign Tablets/Capsules; customer complaint found one Tadalafil 5mg tablet inside a sealed 500-count bottle of Celecoxib 200mg capsule
Alembic Pharmaceuticals Limited · May 9, 2025
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
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 ) 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) ].
Drugs that Interfere with Hemostasis (e.g. warfarin, aspirin, selective serotonin reuptake inhibitors [SSRIs]/ serotonin norepinephrine reuptake inhibitors [SNRIs]) : Monitor patients for bleeding who are concomitantly taking celecoxib with drugs that interfere with hemostasis. Concomitant use of celecoxib and analgesic doses of aspirin is not generally recommended. ( 7 ) Angiotensin Converting Enzyme (ACE) Inhibitors, Angiotensin Receptor Blockers (ARB), or Beta-Blockers : Concomitant use with celecoxib may diminish the antihypertensive effect of these drugs. Monitor blood pressure. ( 7 ) ACE Inhibitors and ARBs : Concomitant use with celecoxib in elderly, volume depleted, or those with renal impairment may result in deterioration of renal function. In such high risk patients, monitor for signs of worsening renal function. ( 7 ) Diuretics : NSAIDs can reduce natriuretic effect of furosemide and thiazide diuretics. Monitor patients to assure diuretic efficacy including antihypertensive effects. ( 7 ) Digoxin : Concomitant use with celecoxib can increase serum concentration and prolong half-life of digoxin. Monitor serum digoxin levels. ( 7 ) 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…
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| 3 | Not yet rated | Prescription | Liquid | Generic | $3 | View → |
| 4 | Not yet rated | Prescription | Suspension | Generic | $3 | View → |