An updated safety profile of etodolac in several thousand patients.

Abstract

The safety of etodolac, a new nonsteroidal anti-inflammatory drug (NSAID), was reviewed by examining data from 3,302 patients enrolled in double-blind and open-label clinical trials and from 8,334 patients taking etodolac in post-marketing surveillance studies. The review determined that gastrointestinal disturbances are the most frequently reported side effects, followed by headache, dizziness, rash, and pruritus. The rate of abdominal pain and dyspepsia is similar to that observed with several other NSAIDs but is lower than that seen with aspirin. Gastrointestinal ulceration occurs in less than 0.3% of patients taking etodolac, and drug-related hepatic, renal, and hematologic dysfunctions are rare. The elderly appear to be no more at risk of experiencing adverse effects than the general population. Overall, the review confirmed the excellent safety profile of etodolac reported previously.