Ebrotidine is the first of a new generation of H2 receptor antagonists with gastroprotective activity It stimulates epithelial cell proliferative activity and produces beneficial physicochemical changes in the gastric mucus that contribute to its gastro-protective action against ethanol-, aspirin- or stress-induced gastric mucosal damage The antisecretory properties of ebrotidine are similar to those of ranitidine and approximately 10-fold greater than those of cimetidine This drug exhibits anti-Helicobacter pylori activity that is synergistic with a number of antibacterial agents; it inhibits the urease enzyme and the proteolytic and mucolytic activities of H. pylori, and counteracts the inhibitory effects of H. pylori lipopolysaccharide Ebrotidine is as effective as ranitidine for the treatment of patients with gastric or duodenal ulcers or erosive reflux oesophagitis Ebrotidine therapy results in significantly better ulcer healing rates than ranitidine treatment in patients who smoke. Ebrotidine was marketed in Spain in early 1997 and withdrawn in July 1998. Shortly after the drug was approved, several cases of acute liver injury were reported to the Regional Pharmacosurveillante Centers, the manufacturer and to a Registry of Hepatotoxicity in use in Southern Spain since 1994. On the basis of these cases the manufacturer withdrew ebrotidine from the market on 27 July 1998. This drug was also marketed in two other countries: Paraguay and Maurice Island.