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Relafen (NABUMETONE)
Relafen (Nabumetone) is a nonsteroidal anti-inflammatory drug (NSAID) that targets prostaglandin G/H synthase 1. It was originally developed and is currently owned by Smithkline Beecham. Nabumetone is used to treat osteoarthritis and rheumatoid arthritis, and is available as a generic medication. The drug has a half-life of 24 hours and bioavailability of 35%. It was FDA approved in 1991 and is now off-patent.
At a glance
| Generic name | NABUMETONE |
|---|---|
| Sponsor | Smithkline Beecham |
| Drug class | Nonsteroidal Anti-inflammatory Drug [EPC] |
| Target | Prostaglandin G/H synthase 1 |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
| First approval | 1991 |
Approved indications
- Osteoarthritis
- Rheumatoid Arthritis
Boxed warnings
- 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 treatment and may increase with duration of use [see Warnings and Precautions ]. Nabumetone tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery [see Contraindications and Warnings ]. Gastrointestinal Risk NSAIDs cause an increased risk of serious gastrointestinal 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 are at greater risk for serious gastrointestinal events (see WARNINGS). 1 Throughout this package insert, the term NSAID refers to a non-aspirin non-steroidal anti-inflammatory drug.
Common side effects
- Diarrhea
- Dyspepsia
- Abdominal pain
- Dizziness
- Headache
- Fatigue
- Constipation
- Flatulence
- Nausea
- Pruritus
- Rash
- Tinnitus
Drug interactions
- ACE-Inhibitors
- Aspirin
- Diuretics (furosemide and thiazides)
- Lithium
- Methotrexate
- Warfarin
Key clinical trials
- Effect of the Bioheat Patch on Pain Following the HyFoSy Procedure (NA)
- Acute Appendicitis: Active Observation With and Without Antibiotics (PHASE4)
- Single Dose Two-Way Crossover Fed Bioequivalence Study of Nabumetone 750 mg Tablets in Healthy Volunteers (PHASE1)
- To Compare the Efficacy and Safety of LAYLA in Osteoarthritis Patients of the Knee (PHASE4)
- The Effect on Knee Joint Loads of Analgesic Use Compared With Exercise in Patients With Knee Osteoarthritis - An RCT (NA)
- Single Dose Two-Way Crossover Fasted Bioequivalence Study of Nabumetone 750 mg Tablets in Healthy Volunteers (PHASE1)
- Bioequivalence Study of Nabumetone 750 mg Tablets of Dr. Reddy's Under Fasting Conditions (PHASE1)
- Bioequivalence Study of Nabumetone 750 mg Tablets of Dr. Reddy's Under Fed Conditions (PHASE1)
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:
- Relafen CI brief — competitive landscape report
- Relafen updates RSS · CI watch RSS