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Celebrex (celecoxib)

Celecoxib works by inhibiting COX-2 to reduce prostaglandin synthesis, thereby decreasing pain, inflammation, and fever.

Celecoxib (Celebrex) is the only remaining selective COX-2 inhibitor on the US market, originally developed by Searle and now marketed by Pfizer. Approved in 1998, it provides anti-inflammatory efficacy with reduced GI side effects. Available generically since 2014.

At a glance

Mechanism of action

Celecoxib reduces pain, inflammation, and fever by inhibiting the enzyme COX-2, which is responsible for producing prostaglandins. Prostaglandins play a key role in sensitizing nerves and mediating inflammation, so reducing their levels helps alleviate these symptoms.

Approved indications

• Acute postoperative pain
• Ankylosing spondylitis
• Dysmenorrhea
• Juvenile rheumatoid arthritis
• Osteoarthritis
• Rheumatoid arthritis

Boxed warnings

• 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. 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 )

Common side effects

• abdominal pain
• diarrhea
• dyspepsia
• flatulence
• nausea
• back pain
• peripheral edema
• injury-accidental
• dizziness
• headache
• insomnia
• pharyngitis

Key clinical trials

• Nausea in Patients Receiving Hydromorphone vs Oxycodone After Total Hip Replacement Surgery (Phase 4)
• Phase II Study of the Combination of ZD1839 (Iressa) and Celecoxib in Patients With Platinum Refractory Non-Small Cell Lung Cance (Phase 2)
• Randomized, Double Blind, Positive- Controlled, Three-way Cross-over Human Experimental Biomarker Study of V116517 in Healthy Male Subjects (Phase 1)
• The Effect Of Celecoxib On The Perioperative Inflammatory Response In Colon Cancer Patients - A Double-Blind Placebo-Controlled Trial (NA)
• Determining the Minimum Clinically Important Difference (MCID) and Patient Acceptable Symptom State (PASS) for Acute Pain and Quality of Recovery After Orthopedic Surgery (N/A)
• A Pilot, Open-Label, Randomized, Crossover, Pharmacokinetic Study Of Enhanced Bioavailability Celecoxib Formulations D1, D2 And D3 In Healthy Volunteers (Phase 1)
• ANGIOCOMB Antiangiogenic Therapy for Pediatric Patients With Diffuse Brain Stem and Thalamic Tumors (Phase 2)
• A Phase IIb Cancer Prevention Trial of Celecoxib, a Selective COX-2 Inhibitor, in Oral Leukoplakia (Phase 2)

Patents

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Celebrex CI brief — competitive landscape report
• Celebrex updates RSS · CI watch RSS
• Pfizer Inc. (originally Searle/Pharmacia) portfolio CI