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Nabumetone

Generic nabumetone tablets

An oral NSAID prodrug for osteoarthritis and rheumatoid arthritis with renal-specific limits and the class cardiovascular/GI boxed warning.

Therapeutic class
NSAID · prodrug of 6MNA
Selected product
Bryant Ranch repackaged nabumetone 500 mg
Reference focus
U.S. oral OA/RA labeling; no pediatric or off-label pain regimen
Essential safety

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 precautions
01

Indications

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.

02

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 CLcrStarting / carefully monitored ceiling
At least 50 mL/minAdjustment generally unnecessary; monitor risk
30–49 mL/minStart no more than 750 mg once daily; after careful renal monitoring, maximum 1,500 mg/day
Below 30 mL/minStart 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.

03

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.

04

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.

05

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.

06

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.

07

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.

08

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.

09

References

Original sources for the clinical and product information.

  1. DailyMed / Bryant Ranch PrepackNabumetone tablets · Full prescribing information

    Current SPL version 5, effective 2025-09-18.

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