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In two well-controlled clinical trials (n= 280 patients), the following reversible adverse experiences characteristic of salicylates were most commonly reported with DISALCID (salsalate) , listed in descending order of frequency: tinnitus, nausea, hearing impairment, rash, and vertigo. These common symptoms of salicylates, i.e., tinnitus or reversible hearing impairment, are often used as a guide to therapy.

Although cause-and-effect relationships have not been established, spontaneous reports over a ten-year period have included the following additional medically significant adverse experiences: abdominal pain, abnormal hepatic function, anaphylactic shock, angioedema, bronchospasm, decreased creatinine dearance, diarrhea, G.I. bleeding, hepatitis, hypotension, nephritis and urticaria.

DRUG ABUSE AND DEPENDENCE

Drug abuse and dependence have not been reported with DISALCID (salsalate) .