药物信息为Nabumetone tablets (Major Pharmaceuticals): ADVERSE REACTIONS

Adverse reaction information was derived from blinded-controlled and open-labeled clinical trials and from world-wide 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*, 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