Label: NABUMETONE tablet, film coated

  • NDC Code(s): 76282-257-01, 76282-257-05, 76282-258-01, 76282-258-05
  • Packager: Exelan Pharmaceuticals Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated March 19, 2025

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  • SPL UNCLASSIFIED SECTION
    NABUMETONE TABLETS USP - Rx only
  • BOXED WARNING (What is this?)

    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

    • NSAIDs1 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).
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  • SPL UNCLASSIFIED SECTION
    1Throughout this package insert, the term NSAID refers to a non-aspirin non-steroidal anti-inflammatory drug.
  • DESCRIPTION
    Nabumetone, USP is a naphthylalkanone designated chemically as 4-(6-methoxy-2- naphthalenyl)-2-butanone. Nabumetone is a white to off-white crystalline substance. It is nonacidic and ...
  • CLINICAL PHARMACOLOGY
    Nabumetone is a non-steroidal anti-inflammatory drug (NSAID) that exhibits anti-inflammatory, analgesic, and antipyretic properties in pharmacologic studies. As with other non-steroidal ...
  • CLINICAL TRIALS
    Osteoarthritis: The use of nabumetone in relieving the signs and symptoms of osteoarthritis (OA) was assessed in double-blind, controlled trials in which 1,047 patients ...
  • INDICATIONS AND USAGE
    Carefully 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 ...
  • CONTRAINDICATIONS
    Nabumetone tablets are contraindicated in patients with known hypersensitivity to nabumetone or its excipients. Nabumetone tablets should not be given to patients who have experienced asthma ...
  • WARNINGS
    CARDIOVASCULAR EFFECTS - Cardiovascular Thrombotic Events - Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious ...
  • PRECAUTIONS
    General: Nabumetone tablets cannot be expected to substitute for corticosteroids or to treat corticosteroid insufficiency. Abrupt discontinuation of corticosteroids may lead to disease ...
  • ADVERSE REACTIONS
    Adverse reaction information was derived from blinded-controlled and open-labeled clinical trials and from worldwide marketing experience. In the description below, rates of the more common events ...
  • OVERDOSAGE
    Symptoms following acute NSAIDs overdoses are usually limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which are generally reversible with supportive care. Gastrointestinal ...
  • DOSAGE AND ADMINISTRATION
    Carefully consider the potential benefits and risks of nabumetone tablets and other treatment options before deciding to use nabumetone. Use the lowest effective dose for the shortest duration ...
  • HOW SUPPLIED
    Nabumetone Tablets USP: 500 mg–White film-coated, oval-shaped biconvex tablets debossed with IG on one side and 257 on the other are supplied in bottles of 100 (NDC 76282-257-01) and 500 (NDC ...
  • Medication Guide forNon-Steroidal Anti-inflammatory Drugs (NSAIDs)
    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 ...
  • PRINCIPAL DISPLAY PANEL
    NDC 76282-257-01 - NABUMETONE - Tablets, USP - 500 mg - ATTENTION PHARMACIST: Each patient - is required to receive a Medication Guide. EXELAN - Rx Only                  100 Tablets - NDC ...
  • INGREDIENTS AND APPEARANCE
    Product Information