Nabumetone
Nabufex · ATC code M01AX01
Also known as: Nabumeton, Nabumetone 500 mg
- Key facts
- Active substance
- Nabumetone
- ATC code
- M01AX01
- Authorisation
- authorised nationally; no central EU authorisation
- Information as of
- 2026-10-29
Boxed warning
Cardiovascular Risk
- 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 is 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 ].
* Throughout this package insert, the term NSAID refers to a non-aspirin non-steroidal anti-inflammatory drug.
Key facts
Nabumetone is a nonsteroidal anti-inflammatory drug (NSAID). Per the US prescribing information, it is used to relieve the signs and symptoms of osteoarthritis and rheumatoid arthritis.
What it is used for
- Relief of signs and symptoms of osteoarthritis
- Relief of signs and symptoms of rheumatoid arthritis
Dosing
- Start with 1,000 mg as a single dose, with or without food
- Some patients obtain more relief from 1,500 mg to 2,000 mg per day, given once or twice daily; doses above 2,000 mg per day have not been studied
- Patients under 50 kg are less likely to need more than 1,000 mg
- Moderate renal impairment (creatinine clearance 30 to 49 mL/min): dose adjustment may be warranted; use the lowest effective dose for the shortest duration
Contraindications
- Known hypersensitivity to nabumetone or excipients
- Asthma, urticaria or allergic-type reactions after aspirin or other NSAIDs
- In the setting of coronary artery bypass graft (CABG) surgery
Important warnings
- Boxed warning: increased risk of serious, possibly fatal cardiovascular thrombotic events (myocardial infarction, stroke), which may occur early in treatment
- Boxed warning: gastrointestinal bleeding, ulceration and perforation, possibly without warning symptoms; elderly patients at greater risk
- Anaphylactoid reactions may occur without prior exposure
- Further NSAID warnings (renal, hepatic, hypertension, heart failure, skin): see the full text
Side effects
- Most frequent are gastrointestinal: diarrhea 14%, dyspepsia 13%, abdominal pain 12%
- Common (3% to 9%): constipation, flatulence, nausea, dizziness, headache, pruritus, rash, tinnitus, edema
Interactions
- ACE inhibitors: diminished antihypertensive effect; furosemide and thiazides: reduced natriuretic effect
- Aspirin: concomitant use generally not recommended
- Warfarin: higher risk of serious GI bleeding
- Lithium: increased lithium levels; methotrexate: possible enhanced toxicity
Pregnancy and breastfeeding
- Limit dose and duration between about 20 and 30 weeks; avoid from about 30 weeks (premature ductus arteriosus closure, oligohydramnios)
- Not known whether excreted in human milk; discontinue nursing or the drug
Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
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For patients
Patient information (US)
This product has no separate US patient information.
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
Germany
- RelifexViatris Healthcare Gmbh · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29
Turkey
- NabufexNOBEL İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
USA
- Relafen DSCarwin Pharmaceutical Associates, LLC · 1 register entry
Source: U.S. FDA – Drug labels (openFDA/DailyMed), as of 2026-10-29
Brand names in 16 more European countries
- Belgium
- Gambaran, Nabumeton Tillomed, Nabumétone Tillomed
- Estonia
- Relifex
- France
- Nabucom
- Greece
- Akratol, Nabuton
- Hungary
- Relifex
- Iceland
- Relifex
- Ireland
- Nabumetone Tillomed, Relifex
- Italy
- Nabuser
- Latvia
- Relifex
- Lithuania
- Relifex
- Luxembourg
- Gambaran
- Netherlands
- Mebutan
- Norway
- Relifex
- Poland
- Nabuton Vp
- Spain
- Relif
- Sweden
- Relifex
EMA – Article 57 product data (EU/EEA), 2026-10-29
Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.
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Sources
- U.S. Food and Drug Administration. Nabumetone 500 mg (LGM PHARMA SOLUTIONS, LLC) – Prescribing Information, 2025-08-06. DailyMed (NLM), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=ef7c3da8-797f-4ea9-8999-53509785a0f7
- EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
- U.S. FDA – Drug labels (openFDA/DailyMed), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/
Editorial: Medelix editorial team · last updated 2026-10-29 · How these pages are made · Report an error
Source: U.S. Food and Drug Administration (FDA), prescribing information, via DailyMed (NLM); public domain. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.