Prescription medicine
Celecoxib Brand names: Celebrex, Vyscoxa
Celecoxib (Celebrex) is a prescription medicine with an FDA approval on record since 1998. FDA's NDC Directory lists it from 63 generic labelers, and pharmacies paid $0.0762 per celecoxib 200 mg capsule in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the celecoxib FDA label on DailyMed (effective November 22, 2024, Viatris Specialty LLC); the NDA 20998 record on Drugs@FDA; every celecoxib label on DailyMed.
Highlights of the record
FDA label of November 22, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
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 [see Warnings and Precautions (5.1) ].
CELEBREX 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 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.
Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. […]
Used for
From the label: indications and usageCELEBREX 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) ].
Forms and strengths
- 50 mg
- 100 mg
- 200 mg
- 400 mg
- 10 mg/ml
- 120 mg/4.8ml
Capsule; suspension; liquid.
On the market
- Earliest approval on file
- December 31, 1998 Celebrex, Upjohn; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 26 first May 30, 2014; 18 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 66 of which 63 under generic applications, 3 under brand applications, repackagers included
- Last listed patent
- September 17, 2045 Vyscoxa oral suspension; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.0762 per capsule Celecoxib 200 mg capsule
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 2 since 2025 0 Class I among all firms' recalls; latest May 13, 2025
- FAERS reports
- 130,882 through July 30, 2026
What is celecoxib used for?
From the label: indications and usageCELEBREX 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 […]
Conditions named in the indications of celecoxib's FDA labels, with every medicine labeled for each:
From other celecoxib labelsMigraine: ELYXYB is indicated for the acute treatment of migraine with or without aura in adults.
FDA pharmacologic class: Nonsteroidal Anti-inflammatory Drug.
Source: FDA drug label (CELEBREX), NDA020998 (Upjohn), as published by Viatris Specialty LLC, effective November 22, 2024 (SPL set 2d6675e4-5859-4be2-8037-a20ce9f707aa), via openFDA; the full label on DailyMed
What does the patient leaflet for celecoxib say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: 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: o with increasing doses of NSAIDs o 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: o anytime during use o without warning symptoms o that may cause death • The risk of getting an ulcer or bleeding increases with: o past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs o taking medicines called “corticosteroids”, “antiplatelet drugs”, “anticoagulants”, “SSRIs” or “SNRIs” o increasing doses of NSAIDs o longer use of NSAIDs o smoking o drinking alcohol o older age o poor health o advanced liver disease o bleeding problems • NSAIDs should only be used: o exactly as prescribed o at the lowest dose possible for your treatment o for the shortest time needed
Source: FDA drug label (CELEBREX), NDA020998 (Upjohn), as published by Viatris Specialty LLC, effective November 22, 2024 (SPL set 2d6675e4-5859-4be2-8037-a20ce9f707aa), via openFDA; the full label on DailyMed
Is there a generic for celecoxib (Celebrex)?
The FDA approved the first generic celecoxib on May 30, 2014. 26 generic applications are approved; 18 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists celecoxib from 63 labelers under a generic (ANDA) application and from 3 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Celebrex capsules; a patent listed only for Vyscoxa oral suspension runs to September 17, 2045. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1998 earliest approval on file
- 2014 first generic approved
- 2045 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for celecoxib (Celebrex)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0762 per Celecoxib 200 mg capsule, down 13% from $0.088 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Celecoxib 200 mg capsule (generic)
- Celebrex 100 mg capsule (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Celecoxib 100 mg capsule | Generic | $0.0614 per capsule | $1.84 | -16% |
| Celecoxib 200 mg capsule | Generic | $0.0762 per capsule | $2.29 | -13% |
| Celecoxib 400 mg capsule | Generic | $0.248 per capsule | $7.44 | -24% |
| Celecoxib 50 mg capsule | Generic | $0.0914 per capsule | $2.74 | +9% |
| Celebrex 100 mg capsule | Brand | $9.53 per capsule many times the lowest per-tablet cost; NADAC records the price, not why | $286.02 | -0.2% |
| Celebrex 200 mg capsule | Brand | $15.65 per capsule many times the lowest per-tablet cost; NADAC records the price, not why | $469.40 | -0.5% |
| Celebrex 400 mg capsule | Brand | $23.50 per capsule many times the lowest per-tablet cost; NADAC records the price, not why | $704.92 | n/a |
| Elyxyb 120 mg/4.8 mL solution | Brand | $30.54 per mL | n/a | +5% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has celecoxib been recalled?
The FDA's Enforcement Report lists 2 recalls naming celecoxib since 2025: 0 Class I (the most serious), 2 Class II, 0 Class III; 2 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| May 13, 2025 | Class II | AvKARE | Presence of Foreign Tablets/Capsules: manufacturer recalled because one tadalafil 5mg tablet was found in 500 count bottle of Celecoxib 200 mg capsules |
| May 9, 2025 | Class II | Alembic Pharmaceuticals Limited | Presence of Foreign Tablets/Capsules; customer complaint found one Tadalafil 5mg tablet inside a sealed 500-count bottle of Celecoxib 200mg capsule |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the celecoxib label say about other medicines?
The celecoxib label names 20 other medicines in its interaction, contraindication or warning sections. The labels of 6 other medicines name celecoxib. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Aspirin | contraindications | History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. |
| Atomoxetine | drug interactions | CYP2D6 substrates Clinical Impact: In vitro studies indicate that celecoxib, although not a substrate, is an inhibitor of CYP2D6. Therefore, there is a potential for an in vivo drug interaction with drugs that are metabolized by CYP2D6 (e.g., atomoxetine), and celecoxib may … Intervention: Evaluate each patient’s medical history when consideration is given to prescribing celecoxib. A dosage adjustment may be warranted when celecoxib is administered with CYP2D6 substrates [see ]. |
| Cyclosporine | drug interactions | Clinical Impact: Concomitant use of CELEBREX and cyclosporine may increase cyclosporine’s nephrotoxicity. Intervention: During concomitant use of CELEBREX and cyclosporine, monitor patients for signs of worsening renal function. NSAIDs and Salicylates |
| Diclofenac | drug interactions | NSAIDs with short elimination half-lives (e.g., diclofenac, indomethacin) should be avoided for a period of two days before, the day of, and two days following administration of pemetrexed. |
| Diflunisal | drug interactions | NSAIDs and Salicylates Clinical Impact: Concomitant use of Celecoxib with other NSAIDs or salicylates (…) increases the risk of GI toxicity, with little or no increase in efficacy. Intervention: The concomitant use of Celecoxib with other NSAIDs or salicylates is not recommended. |
| Digoxin | drug interactions | Clinical Impact: The concomitant use of Celecoxib with digoxin has been reported to increase the serum concentration and prolong the half-life of digoxin. Intervention: During concomitant use of CELEBREX and digoxin, monitor serum digoxin levels. |
| Ergotamine | warnings and precautions | Overuse of acute migraine drugs (e.g., ergotamine, triptans, opioids, nonsteroidal anti- inflammatory drugs or combination of these drugs for 10 or more days per month), including ELYXYB, may lead to exacerbation of headache (medication overuse headache). |
| Fluconazole | drug interactions | Clinical Impact: Celecoxib metabolism is predominantly mediated via cytochrome P450 (CYP) 2C9 in the liver. Co-administration of celecoxib with drugs that are known to inhibit CYP2C9 (e.g., fluconazole) may enhance the exposure and toxicity of celecoxib … Intervention: Evaluate each patient’s medical history when consideration is given to prescribing celecoxib. A dosage adjustment may be warranted when celecoxib is administered with CYP2C9 inhibitors or inducers [see … |
| Furosemide | drug interactions | Diuretics Clinical Impact: Clinical studies, as well as post-marketing observations, showed that NSAIDs reduced the natriuretic effect of loop diuretics (e.g., furosemide) and thiazide diuretics in some patients. … Intervention: During concomitant use of CELEBREX with diuretics, observe patients for signs of worsening renal function, in addition to assuring diuretic efficacy including antihypertensive effects [see ]. |
| Ibuprofen | warnings and precautions | A randomized controlled trial entitled the Prospective Randomized Evaluation of Celecoxib Integrated Safety vs. Ibuprofen Or Naproxen (PRECISION) was conducted to assess the relative cardiovascular thrombotic risk of a COX-2 inhibitor, celecoxib, compared to the non-selective NSAIDs naproxen and ibuprofen. |
| Indomethacin | drug interactions | NSAIDs with short elimination half-lives (e.g., diclofenac, indomethacin) should be avoided for a period of two days before, the day of, and two days following administration of pemetrexed. |
| Lithium | drug interactions | Clinical Impact: NSAIDs have produced elevations in plasma lithium levels and reductions in renal lithium clearance. The mean minimum lithium concentration increased 15%, and the renal clearance decreased by approximately 20%. … Intervention: During concomitant use of CELEBREX and lithium, monitor patients for signs of lithium toxicity. |
| Meloxicam | drug interactions | Pemetrexed Clinical Impact: Concomitant use of CELEBREX and pemetrexed may increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity (…). … potential interaction between pemetrexed and NSAIDs with longer half-lives (e.g., meloxicam, nabumetone), patients taking these NSAIDs should interrupt dosing for at least five days before, the day of, and two days … |
| Methotrexate | drug interactions | Methotrexate Clinical Impact: Concomitant use of NSAIDs and methotrexate may increase the risk for methotrexate toxicity (…). CELEBREX has no effect on methotrexate pharmacokinetics. Intervention: During concomitant use of CELEBREX and methotrexate, monitor patients for methotrexate toxicity. |
Every other medicine the celecoxib label names
| Medicine named | Section | What the label says |
|---|---|---|
| Nabumetone | drug interactions | Pemetrexed Clinical Impact: Concomitant use of CELEBREX and pemetrexed may increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity (…). … interaction between pemetrexed and NSAIDs with longer half-lives (e.g., meloxicam, nabumetone), patients taking these NSAIDs should interrupt dosing for at least five days before, the day of, and two days following … |
| Naproxen | warnings and precautions | A randomized controlled trial entitled the Prospective Randomized Evaluation of Celecoxib Integrated Safety vs. Ibuprofen Or Naproxen (PRECISION) was conducted to assess the relative cardiovascular … |
| Pemetrexed | drug interactions | Pemetrexed Clinical Impact: Concomitant use of CELEBREX and pemetrexed may increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity (…). Intervention: During concomitant use of CELEBREX and pemetrexed, in patients with renal impairment whose creatinine clearance ranges from 45 to 79 mL/min, monitor for myelosuppression, renal and GI toxicity. … |
| Propranolol | drug interactions | Clinical Impact: NSAIDs may diminish the antihypertensive effect of ACE inhibitors, ARBs, or beta-blockers (including propranolol). In patients who are elderly, volume-depleted (…), or have renal impairment, co-administration of an NSAID with ACE inhibitors … Intervention: During concomitant use of CELEBREX and ACE inhibitors, ARBs, or beta-blockers, monitor blood pressure to ensure that the desired blood pressure is obtained. … |
| Rifampin | drug interactions | Clinical Impact: Celecoxib metabolism is predominantly mediated via cytochrome P450 (CYP) 2C9 in the liver. Co-administration of celecoxib with drugs that are known to inhibit CYP2C9 (e.g., fluconazole) may enhance the exposure and toxicity of celecoxib … Intervention: Evaluate each patient’s medical history when consideration is given to prescribing celecoxib. A dosage adjustment may be warranted when celecoxib is administered with CYP2C9 inhibitors or inducers [see … |
| Warfarin | drug interactions | 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. … 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 [see ]. |
Other labels that name celecoxib
Source: FDA drug label (CELEBREX), NDA020998 (Upjohn), as published by Viatris Specialty LLC, effective November 22, 2024 (SPL set 2d6675e4-5859-4be2-8037-a20ce9f707aa), via openFDA; the full label on DailyMed
What do FAERS reports show for celecoxib?
The FDA Adverse Event Reporting System holds 130,882 reports that list celecoxib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 12,399 are coded as a death and 40,397 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as celecoxib?
31 other medicines are given the same way (oral) and in the same FDA class as celecoxib or labeled mainly for the same use (osteoarthritis), the same class first. Osteoarthritis lists all 27 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Ibuprofen | Pain, Osteoarthritis, Rheumatoid arthritis | 273 labelers | $0.0573 per tablet 800 mg tablet | No current entry |
| Naproxen | Pain, Osteoarthritis, Rheumatoid arthritis | 146 labelers | $0.0565 per tablet 500 mg tablet | No current entry |
| Diclofenac | Migraine, Pain, Osteoarthritis, Rheumatoid arthritis | 67 labelers | $0.0619 per tablet 75 mg tablet | A presentation being discontinued |
| Acetaminophen and aspirin and caffeine | Pain | 39 labelers | $0.0648 per unit 250-250-65 mg cplt | No current entry |
| Meloxicam | Pain, Osteoarthritis, Rheumatoid arthritis | 43 labelers | $0.0166 per tablet 7.5 mg tablet | No current entry |
| Etodolac | Pain, Osteoarthritis, Rheumatoid arthritis | 30 labelers | $0.262 per tablet 400 mg tablet | No current entry |
| Acetaminophen and ibuprofen | Pain | 51 labelers | $0.107 per unit 250-125 mg | No current entry |
| Indomethacin | Osteoarthritis, Rheumatoid arthritis | 25 labelers | $0.210 per capsule 75 mg capsule | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does celecoxib compare with medicines for the same use?
14 side-by-side pages set celecoxib beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to celecoxib
- 31 medicines for the same use
- Other NSAIDs
- the pharmacologic class, with prices and generics
- Celecoxib side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other