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 U.S. clinical studies. Of the 1,677 patients who received nabumetone during U.S. 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*2, flatulence*2, nausea*2, positive stool guaiac*2, dry mouth, gastritis, stomatitis, vomiting. Central Nervous System Dizziness*2, headache*2, fatigue, increased sweating, insomnia, nervousness, somnolence. Dermatologic Pruritus*2, rash*2. Special Senses Tinnitus*2. Miscellaneous Edema*2. 2* Incidence of reported reaction between 3% and 9%. Reactions occurring in 1% to 3% of the patients are unmarked. Incidence < 1% - Probably Causally Related†3 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. 3 † 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.