Serious cardiovascular/GI risk; kidney limits can be lower than ordinary dosing.
Use the lowest effective dose for the shortest needed duration. CABG use is contraindicated. Avoid about thirty weeks of pregnancy onward; twenty-to-thirty-week use requires special fetal renal precautions.
Warnings and precautionsIndications
The selected prescription indication is OA/RA symptom relief.
Labeled uses
Nabumetone tablets relieve signs and symptoms of osteoarthritis and rheumatoid arthritis. Weigh alternatives and individual cardiovascular, gastrointestinal and renal risks. No pediatric or off-label acute-pain regimen is supplied.
Dosage and administration
Adult dosing and renal ceilings are distinct.
Ordinary OA/RA dose
Start 1,000 mg orally as one dose, with or without food. Some patients obtain additional relief at 1,500–2,000 mg/day, in a single or twice-daily regimen; over 2,000 mg/day has not been studied. Patients under 50 kg may be less likely to need over 1,000 mg. Individualize to response and use the lowest effective dose.
Selected renal instructions
| Renal CLcr | Starting / carefully monitored ceiling |
|---|---|
| At least 50 mL/min | Adjustment generally unnecessary; monitor risk |
| 30–49 mL/min | Start no more than 750 mg once daily; after careful renal monitoring, maximum 1,500 mg/day |
| Below 30 mL/min | Start no more than 500 mg once daily; after careful renal monitoring, maximum 1,000 mg/day |
Dose boundaries
The warnings do not recommend treatment in advanced renal disease; if unavoidable, monitor closely. The numeric PK-section renal limits are not permission to disregard this warning. No validated pediatric, hepatic percentage, dialysis replacement or universal missed-dose algorithm is provided.
Safety
CV events, bleeding, kidney injury and systemic hypersensitivity require vigilance.
Warnings and precautions
MI/stroke risk may begin early and rise with duration/dose. Avoid recent-MI or severe-heart-failure use unless benefits outweigh risk; monitor BP, edema and ischemic symptoms. Ulceration, GI bleeding or perforation can occur without warning, especially with prior ulcer/bleeding, older age, anticoagulants or steroids. Renal injury is more likely with impaired perfusion, kidney/liver disease, failure or diuretics. Severe allergy, SJS/TEN and DRESS can occur; stop and evaluate rash, fever or systemic signs. Liver injury, anemia and photosensitivity are reported. Avoid fetal ductus closure risk at about thirty weeks onward; earlier twenty-week renal risk also applies.
Contraindications
Known nabumetone/ingredient hypersensitivity, prior asthma/urticaria/allergic-type reaction to aspirin or another NSAID, and the CABG-surgery setting are contraindicated.
Boxed warning
The selected label warns of potentially fatal MI/stroke and serious GI bleeding, ulceration or perforation, including events without symptoms. CV risk can occur early/increase with duration; older adults have greater GI risk. CABG use is contraindicated.
Adverse reactions
Common reported effects include diarrhea, dyspepsia and abdominal pain, with nausea, constipation, dizziness, headache, rash/pruritus, tinnitus and edema also reported. Serious reactions include bleeding, renal/hepatic injury, anaphylaxis and severe skin reactions; do not infer clinical safety from older surrogate endoscopy comparisons.
Drug interactions
Bleeding and renal/hemodynamic interactions can compound risk.
Bleeding combinations
Aspirin and other NSAIDs add adverse effects and concurrent aspirin is generally not recommended. Warfarin/NSAID GI bleeding effects are synergistic; corticosteroids also increase GI risk. Review all OTC pain products and anticoagulants rather than unintentionally duplicate NSAIDs.
Renal and other interactions
Nabumetone may reduce ACE-inhibitor antihypertensive and diuretic natriuretic effects; monitor pressure, kidney status and diuretic response. Lithium levels may rise and methotrexate toxicity may increase; use appropriate monitoring. Aluminum antacid did not materially alter active-metabolite bioavailability in the cited study, which does not establish compatibility with every drug.
Use in specific populations
Pregnancy and kidney disease substantially change selection.
Pregnancy and lactation
Limit necessary use between about twenty and thirty weeks to the lowest dose/shortest duration; consider amniotic-fluid ultrasound if treatment exceeds forty-eight hours and stop if oligohydramnios develops. Avoid about thirty weeks onward because of ductus closure risk. Earlier pregnancy data are inconclusive. Human milk excretion is unknown; animal active-metabolite milk transfer and possible infant harm warrant deciding between discontinuing nursing or medicine according to maternal need.
Children and older adults
Pediatric safety/effectiveness are unestablished. Older adults may have higher active-metabolite exposure and are more vulnerable to serious GI, renal and cardiovascular complications; age findings in trials do not negate cautious selection.
Renal and hepatic considerations
Follow the renal table together with advanced-disease avoidance. Active 6MNA is highly protein bound and not dialyzable. Severe hepatic data are limited; both prodrug activation and further metabolism depend on liver function, so no numeric hepatic regimen is invented. Stop/evaluate suspected liver injury.
Clinical pharmacology
Hepatic conversion produces the prostaglandin-inhibiting active metabolite.
Mechanism
Nabumetone is converted to 6-methoxy-2-naphthylacetic acid (6MNA), which inhibits prostaglandin synthesis and accounts for anti-inflammatory activity.
Disposition
Parent drug is not detected in plasma after rapid biotransformation. 6MNA is more than 99% protein bound; its half-life is approximately twenty-four hours and longer with renal impairment/older age. Metabolites are largely eliminated in urine. Food accelerates appearance/increases peak but does not change overall conversion exposure; renal protein binding makes dialysis ineffective for active-metabolite removal.
Monitoring and counseling
Monitor treatment benefit against continuing organ and bleeding risk.
Monitoring and counseling
Monitor BP, edema, kidney function and bleeding symptoms; long-term use warrants periodic CBC/chemistry as clinically directed. Review liver symptoms and drug combinations. Seek immediate care for chest/stroke symptoms, GI bleeding, breathing/facial swelling or serious rash/systemic fever. Review pregnancy plans and avoid unnecessary OTC NSAIDs. Persistent abnormal liver tests or clinical organ/systemic manifestations require stopping/evaluation.
Overdose
Seek medical/Poison Control assessment. There is no specific antidote; severe effects include bleeding, kidney injury and respiratory/CNS compromise. Legacy label emesis/cathartic instructions and apparently tolerated large doses are not home-treatment advice or safe thresholds. Dialysis is unlikely to help because of high protein binding.
Product identification
Representative repackaging supplies a specific 500 mg tablet.
Representative product
- Product
- Bryant Ranch nabumetone 500 mg
- Route
- Oral film-coated tablet
- Appearance
- White, oval, biconvex; 3670 / plain
- Example package
- Bottle 30 · NDC 71335-1234-2
Dosage forms and strengths
The selected supply record lists 500 mg tablets in several bottle sizes. Other strengths/manufacturers have different identification records; no liquid, injection, pediatric or compounded preparation is reviewed.
Storage and handling
Store at 20–25°C in a tight, light-resistant container with the required child-resistant closure. Follow actual expiry; no independently verified crushing/tube or compounded beyond-use protocol is supplied.
References
Original sources for the clinical and product information.
- DailyMed / Bryant Ranch PrepackNabumetone tablets · Full prescribing information
Current SPL version 5, effective 2025-09-18.