Troxipide - Safety and Tolerability

Safety and Tolerability

A post-marketing study, conducted by the innovator, in over 12,000 patients showed that only 0.75% of them developed adverse events attributable to the drug. The adverse reactions were mild to moderate, which resolved when the drug was discontinued. Commonly observed adverse events included constipation (0.19%) and increase in levels of liver enzymes, AST (0.17%) and ALT (0.25%). In a post-marketing study conducted in 1500 Indian patients, only 9 adverse events were reported in 9 patients (0.63%) that were of mild to moderate intensity. Adverse events observed included constipation, acidity, nausea, fatigue and headache, and were of mild to moderate intensity. In all clinical studies, troxipide was well tolerated. In a comparative study with ranitidine, troxipide was assessed as a more tolerable medication than ranitidine. A favorable tolerability profile for troxipide was reported by 95.45% of the investigators as compared to 65.45% for ranitidine while favorable tolerability profile was reported by 93.67% of the patients for troxipide and 64.55% for ranitidine.