The clinical safety of omeprazole.

An assessment of the safety of omeprazole treatment based on data from more than 13,000 patients and subjects is given. Treatment times were up to 6 years and daily doses of up to 360 mg were administered. The incidence of serious adverse events reported in comparative short-term studies with H2-receptor antagonists and placebo were similar. No specific pattern of symptoms could be ascribed to omeprazole. In addition, serious adverse events reported in long-term studies with omeprazole did not indicate any specific drug-related effects. The spectrum of subjective side-effects (non-serious) reported in a large number of comparative studies with H2-receptor antagonists did not differ between the drugs. The laboratory data obtained during omeprazole therapy revealed no clinically significant effects in any parameter studied. Omeprazole did not influence blood pressure, heart rate or ECG.