Prescription medicine
Nabumetone Brand names: Relafen
Nabumetone (Relafen) is a prescription medicine with an FDA approval on record since 1991. FDA's NDC Directory lists it from 28 generic labelers, and pharmacies paid $0.128 per nabumetone 500 mg tablet in the October 7, 2026 NADAC survey; its other strengths are brand-only, $31.67 per Relafen ds 1,000 mg tablet.
- Generic listed
- Boxed warning
Check it at the source: the nabumetone FDA label on DailyMed (effective January 13, 2025, ScieGen Pharmaceuticals Inc); the NDA 19583 record on Drugs@FDA; every nabumetone label on DailyMed.
Highlights of the record
FDA label of January 13, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
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 1 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.
Used for
From the label: indications and usageCarefully consider the potential benefits and risks of nabumetone tablets, USP and other treatment options before deciding to use nabumetone tablets.
Forms and strengths
- 500 mg
- 750 mg
- 1000 mg
Tablet; film-coated tablet.
On the market
- Earliest approval on file
- December 24, 1991 Relafen, Smithkline Beecham; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 14 first May 26, 2000; 8 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 28 of which 28 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.128 per tablet Nabumetone 500 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2013 0 Class I among all firms' recalls; latest June 10, 2020; 2 more by firms not listed as its makers
- FAERS reports
- 6,395 through July 30, 2026
What is nabumetone used for?
From the label: indications and usageCarefully consider the potential benefits and risks of nabumetone tablets, USP and other treatment options before deciding to use nabumetone tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Nabumetone tablets, USP are indicated for relief of signs and symptoms of osteoarthritis and rheumatoid arthritis.
Conditions named in the indications of nabumetone's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Nonsteroidal Anti-inflammatory Drug.
Source: FDA drug label (Nabumetone), ScieGen Pharmaceuticals Inc, effective January 13, 2025 (SPL set 80c6888d-03b4-44f3-b94d-bcf5154ceae5), via openFDA; the full label on DailyMed
What does the patient leaflet for nabumetone say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about medicines called Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)?NSAIDs can cause serious side effects, including: • Increased risk of a heart attack or stroke that can lead to dea th. This risk may happen early in treatment and may increase: with increasing doses of NSAIDs with longer use of NSAIDs Do not take NSAIDs right before or after a heart surgery called a “coronary artery bypass graft (CABG)." Avoid taking NSAIDs after a recent heart attack, unless your healthcare provider tells you to. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack. • Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach and intestines: anytime during use without warning symptoms that may cause death The risk of getting an ulcer or bleeding increases with: past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs taking medicines called “corticosteroids”, “anticoagulants”, “SSRIs”, or “SNRIs” increasing doses of NSAIDs longer use of NSAIDs smoking drinking alcohol older age poor health advanced liver disease bleeding problems NSAIDs should only be used: exactly as prescribed at the lowest dose possible for your treatment for the shortest time needed
Source: FDA drug label (Nabumetone), ScieGen Pharmaceuticals Inc, effective January 13, 2025 (SPL set 80c6888d-03b4-44f3-b94d-bcf5154ceae5), via openFDA; the full label on DailyMed
Is there a generic for nabumetone (Relafen)?
The FDA approved the first generic nabumetone on May 26, 2000. 14 generic applications are approved; 8 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists nabumetone from 28 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1991 earliest approval on file
- 2000 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for nabumetone (Relafen)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.128 per Nabumetone 500 mg tablet, up 5% from $0.122 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Nabumetone 500 mg tablet (generic)
- Relafen ds 1,000 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Nabumetone 500 mg tablet | Generic | $0.128 per tablet | $3.84 | +5% |
| Nabumetone 750 mg tablet | Generic | $0.183 per tablet | $5.50 | +26% |
| Relafen ds 1,000 mg tablet | Brand | $31.67 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $950.00 | n/a |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has nabumetone been recalled?
The FDA's Enforcement Report lists 3 recalls naming nabumetone since 2013: 0 Class I (the most serious), 1 Class II, 2 Class III; 0 still ongoing. 2 of them are by firms that FDA's NDC Directory does not list as a maker of nabumetone and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| June 10, 2020 | Class III | American Health Packaging | Labeling Not Elsewhere Classified: The statement Pharmacist: Dispense with the accompanying Medication Guide was not included on the carton label. |
| November 19, 2015 | Class III | Teva Pharmaceuticals USA not a listed maker | Labeling: Not Elsewhere Classified: Lack of leaflets and approved labels on bottles. |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup: NABUMETONE, Tablet, 500 mg may have potentially been mislabeled as the following drug: guaiFENesin ER, Tablet, 600 mg, NDC 63824000834 … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the nabumetone label say about other medicines?
The nabumetone label names 5 other medicines in its interaction, contraindication or warning sections. The labels of 14 other medicines name nabumetone. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Aspirin | contraindications | Nabumetone tablets should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. |
| Furosemide | drug interactions | Clinical studies, as well as post marketing observations, have shown that nabumetone can reduce the natriuretic effect of furosemide and thiazides in some patients. |
| Lithium | drug interactions | NSAIDs have produced an elevation of plasma lithium levels and a reduction in renal lithium clearance. |
| Methotrexate | drug interactions | Methotrexate: NSAIDs have been reported to competitively inhibit methotrexate accumulation in rabbit kidney slices. |
| Warfarin | drug interactions | The effects of warfarin and NSAIDs on GI bleeding are synergistic, such that users of both drugs together have a risk of serious GI bleeding higher than users of either drug alone. |
Other labels that name nabumetone
Source: FDA drug label (Nabumetone), ScieGen Pharmaceuticals Inc, effective January 13, 2025 (SPL set 80c6888d-03b4-44f3-b94d-bcf5154ceae5), via openFDA; the full label on DailyMed
What do FAERS reports show for nabumetone?
The FDA Adverse Event Reporting System holds 6,395 reports that list nabumetone among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 363 are coded as a death and 1,515 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as nabumetone?
21 other medicines are given the same way (oral) and in the same FDA class as nabumetone or labeled mainly for the same use (osteoarthritis), the same class first. Osteoarthritis lists all 27 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Ibuprofen | Osteoarthritis, Rheumatoid arthritis | 273 labelers | $0.0573 per tablet 800 mg tablet | No current entry |
| Naproxen | Osteoarthritis, Rheumatoid arthritis | 146 labelers | $0.0565 per tablet 500 mg tablet | No current entry |
| Celecoxib | Osteoarthritis, Rheumatoid arthritis | 65 labelers | $0.0762 per capsule 200 mg capsule | No current entry |
| Diclofenac | Osteoarthritis, Rheumatoid arthritis | 67 labelers | $0.0619 per tablet 75 mg tablet | A presentation being discontinued |
| Meloxicam | Osteoarthritis, Rheumatoid arthritis | 43 labelers | $0.0166 per tablet 7.5 mg tablet | No current entry |
| Etodolac | Osteoarthritis, Rheumatoid arthritis | 30 labelers | $0.262 per tablet 400 mg tablet | No current entry |
| Indomethacin | Osteoarthritis, Rheumatoid arthritis | 25 labelers | $0.210 per capsule 75 mg capsule | No current entry |
| Diclofenac and misoprostol | Osteoarthritis, Rheumatoid arthritis | 10 labelers | $0.665 per tablet 50-0.2 mg tablet | No current entry |
Every medicine labeled for the same conditions as nabumetone
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does nabumetone compare with medicines for the same use?
5 side-by-side pages set nabumetone beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to nabumetone
- 21 medicines for the same use
- Other NSAIDs
- the pharmacologic class, with prices and generics
- Nabumetone side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other