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CELECOXIB
CELECOXIB is a Nonsteroidal Anti-inflammatory Drug [EPC] drug. It is currently FDA-approved (first approved 1998).
Celecoxib is a small molecule inhibitor that targets Prostaglandin G/H synthase 2, specifically acting as a cyclooxygenase-2 inhibitor. It has been studied for various pain conditions, including chronic and acute low back pain, as well as chronic and acute pain, through various interventions such as medication.
At a glance
| Generic name | CELECOXIB |
|---|---|
| Drug class | Nonsteroidal Anti-inflammatory Drug [EPC] |
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 1998 |
Approved indications
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
- Peripheral edema
- Accidental injury
- Dizziness
- Pharyngitis
- Rhinitis
- Sinusitis
- Upper respiratory tract infection
- Rash
Serious adverse events
- Cardiovascular thrombotic events
- GI bleeding
- GI ulceration
- GI perforation
- Hepatotoxicity
- Hypertension
- Heart failure
- Renal toxicity
- Hyperkalemia
- Anaphylactic reactions
Key clinical trials
- Examining Analgesic Synergy and Efficacy in Trauma Care (PHASE4)
- Celecoxib Plus R-CHOP vs R-CHOP in Newly Diagnosed Advanced CD5+ DLBCL (PHASE2)
- A Phase Ib Study to Evaluate the Efficacy and Safety of HRS-2129 in Patients With Knee Osteoarthritis (PHASE1)
- Nonopioid Analgesia After Anterior Cruciate Ligament Reconstruction (PHASE2, PHASE3)
- Safety of Fluvastatin-Celebrex Association in Low-grade and High Grade Optico-chiasmatic Gliomas (PHASE1)
- I-SPY COVID-19 TRIAL: An Adaptive Platform Trial for Critically Ill Patients (PHASE2)
- Metformin Safety and Efficacy in Osteoarthritis. (PHASE3)
- TAS-102 With or Without Celecoxib in ctDNA-defined Minimal Residual Disease in Colorectal Cancer After Completion of Adjuvant Chemotherapy (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- CELECOXIB CI brief — competitive landscape report
- CELECOXIB updates RSS · CI watch RSS
Frequently asked questions about CELECOXIB
What is CELECOXIB?
CELECOXIB is a Nonsteroidal Anti-inflammatory Drug [EPC] drug.
What drug class is CELECOXIB in?
CELECOXIB belongs to the Nonsteroidal Anti-inflammatory Drug [EPC] class. See all Nonsteroidal Anti-inflammatory Drug [EPC] drugs at /class/nonsteroidal-anti-inflammatory-drug-epc.
When was CELECOXIB approved?
CELECOXIB was first approved on 1998.
What development phase is CELECOXIB in?
CELECOXIB is FDA-approved (marketed).
What are the side effects of CELECOXIB?
Common side effects of CELECOXIB include Abdominal pain, Diarrhea, Dyspepsia, Flatulence, Peripheral edema, Accidental injury. Serious adverse events: Cardiovascular thrombotic events, GI bleeding, GI ulceration, GI perforation.
Related
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing