THE SAFETY OF RANITIDINE IN OVER A DECADE OF USE

Background: Ranitidine hydrochloride (Zantac) is one of the most exten sively studied and widely used drugs of all time; This has provided an excellent opportunity to define its safety profile. Methods: Data fro m 189 controlled clinical trials in which more than 26000 patients rec eived daily doses of ranitidine for 4 weeks or more were reviewed. Mor e than 80% of patients were treated with up to 300 mg ranitidine daily ; the remaining patients received doses of up to 1200 mg daily. Eighty -seven trials were placebo controlled. Analyses of post-marketing surv eillance and a database of all spontaneously reported adverse events w ere also evaluated, Results: Overall in the clinical trial programme a dverse events were reported by 20% of those receiving ranitidine compa red with 27% of those receiving placebo. The pattern of events was sim ilar in all treatment groups with no evidence of dose-related toxicity in regimens encompassing an eightfold range of therapeutic doses. Sim ilarly in a programme of studies designed to evaluate a dose of raniti dine of 75 mg for non-prescription (over-the-counter) use in the treat ment of heartburn, ranitidine was not associated with an adverse event profile distinct from that of placebo. Analysis of spontaneously repo rted adverse event data allowed identification of rare idiosyncratic e vents, Conclusions: Review of data from a large population of controll ed clinical trials with analyses of postmarketing surveillance studies and spontaneously reported adverse events confirmed the excellent saf ety profile of ranitidine.