Ranitidine an extensively studied and one of the most commonly used drugs of all time. A review was done to define the safety profile of this drug by Mills and colleagues.

They reviewed data from 189 controlled clinical trials wherein over 26,000 patients had been administered daily doses of ranitidine for 4 weeks or more. Over 80% of patients were given up to 300 mg ranitidine per day, while the rest of the patients received doses up to 1200 mg daily. A total of 87 trials were placebo-controlled. Investigators also assessed post-marketing surveillance analyses and a database of all spontaneously reported adverse events.

In the clinical trial program, adverse events were reported by 20% of the patients receiving ranitidine compared to 27% of those given placebo. The pattern of events was similar in all the groups with no signs of dose-related toxicity in regimens covering an eightfold range of therapeutic doses.

In a program of studies that evaluated a 75 mg dose of ranitidine for non-prescription (over-the-counter) use in the treatment of heartburn, the drug was not tied to an adverse event profile different from that of placebo.

Evaluation of spontaneously reported adverse event data enabled the identification of rare idiosyncratic events.

Review of data from a large population of controlled clinical trials along with postmarketing surveillance studies and spontaneously reported adverse events confirm an excellent safety profile of ranitidine.

Source: Mills JG, Koch KM, Webster C, et al. The safety of ranitidine in over a decade of use. Aliment Pharmacol Ther. 1997 Feb; 11(1):129-37.