Indoprofen

Systematic reviews

A survey of adverse reactions in 6764 patients, mostly treated for 1 month or less, showed that life-threatening events were rare [ ]. These data were compiled by combining the results of: a phase IV multicenter study in 4042 patients with osteoarthritis who took oral indoprofen 400–800 mg/day for about 4 weeks; a survey based on a heterogeneous series of 2722 subjects from phase I, II, and III investigations, and taking 200–1200 mg/day orally and/or parenterally for from 1 to more than 180 days; and a laboratory study in 472 patients, most of whom had participated in the first study and the rest in the second. Adverse events of any type occurred in 22% of patients in the first study and in 13% in the second, but treatment had to be withdrawn for drug-related reasons in under 5% in both. Potentially life-threatening events were rare, and included 16 cases of clinically overt gastrointestinal bleeding and two anaphylactic reactions. There were changes in laboratory measurements from normal to abnormal values in about 10% of cases. The adverse reactions profile of indoprofen was similar to that of most NSAIDs. The top of the dose response curve was reached at 400–600 mg/day. Adverse reactions were less frequent with parenteral than oral administration.