Indications and Usage 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 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.

Adverse Reactions Section 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 (greater than 1%) and many of the less common events (less than 1%) represent results of US clinical studies.

Of the 1,677 patients who received nabumetone during US clinical trials, 1,524 were treated for at least 1 month, 1,327 for at least 3 months, 929 for at least a year, and 750 for at least 2 years.

More than 300 patients have been treated for 5 years or longer.

The most frequently reported adverse reactions were related to the gastrointestinal tract and included diarrhea, dyspepsia, and abdominal pain.

Incidence ≥1%— Probably Causally Related Gastrointestinal: Diarrhea (14%), dyspepsia (13%), abdominal pain (12%), constipation*, flatulence*, nausea*, positive stool guaiac*, dry mouth, gastritis, stomatitis, vomiting.

Central Nervous System: Dizziness*, headache*, fatigue, increased sweating, insomnia, nervousness, somnolence.

Dermatologic: Pruritus*, rash*.

Special Senses: Tinnitus*.

Miscellaneous: Edema* ———————————————————————————————————— *Incidence of reported reaction between 3% and 9%.

Reactions occurring in 1% to 3% of the patients are unmarked.

Incidence < 1% — Probably Causally Related† Gastrointestinal: Anorexia, jaundice, duodenal ulcer, dysphagia, gastric ulcer, gastroenteritis, gastrointestinal bleeding, increased appetite, liver function abnormalities, melena, hepatic failure.

Central Nervous System: Asthenia, agitation, anxiety, confusion, depression, malaise, paresthesia, tremor, vertigo.

Dermatologic: Bullous eruptions, photosensitivity, urticaria, pseudoporphyria cutanea tarda, toxic epidermal necrolysis, erythema multiforme, Stevens-Johnson syndrome.

Cardiovascular:Vasculitis.

Metabolic: Weight gain.

Respiratory:Dyspnea, eosinophilic pneumonia, hypersensitivity pneumonitis, idiopathic interstitial pneumonitis.

Genitourinary:Albuminuria, azotemia, hyperuricemia, interstitial nephritis, nephrotic syndrome, vaginal bleeding, renal failure.

Special Senses: Abnormal vision.

Hematologic/Lymphatic: Thrombocytopenia.

Hypersensitivity: Anaphylactoid reaction, anaphylaxis, angioneurotic edema ———————————————————————————–––––––––––– † Adverse reactions reported only in worldwide postmarketing experience or in the literature, not seen in clinical trials, are considered rarer and are italicized.

Incidence < 1% — Causal Relationship Unknown Gastrointestinal: Bilirubinuria, duodenitis, eructation, gallstones, gingivitis, glossitis, pancreatitis, rectal bleeding.

Central Nervous System: Nightmares.

Dermatologic: Acne, alopecia.

Cardiovascular: Angina, arrhythmia, hypertension, myocardial infarction, palpitations, syncope, thrombophlebitis.

Respiratory: Asthma, cough.

Genitourinary: Dysuria, hematuria, impotence, renal stones.

Special Senses: Taste disorder.

Body as a Whole: Fever, chills.

Hematologic/Lymphatic: Anemia, leukopenia, granulocytopenia.

Metabolic/Nutritional: Hyperglycemia, hypokalemia, weight loss.