Abstract: Objective To set the alarm conditions of the active surveillance and assessment system of adverse drug events(ADE-ASAS), so as to obtain the automatic surveillance results of omeprazole related abnormal liver function and hepatic impairment. Methods The ADE-ASAS was set with the criteria for abnormal liver function and hepatic impairment. The abnormal liver function and hepatic impairment of omeprazole were analyzed retrospectively, and the correlative factors were analyzed by nested case control study. Results Of the 5 352 patients included, under the two setting conditions, there were 1 256 cases and 385 cases of alarm cases. There were 175 (3.27%) cases of abnormal liver function, including ALT cases (126,2.35%), AST cases (92, 1.72%), ALP cases (25, 0.47%) and TB cases (45, 0.84%), and 64(1.20%) cases of hepatic impairment. Combined use of antimicrobials was a risk factor for abnormal liver function and hepatic impairment caused by omeprazole. Conclusion Hepatic impairment is more serious than abnormal liver function and should be paid more clinical attention, and setting the system with the standard of hepatic impairment can significantly reduce the cost of human screening. The tendency of abnormal liver function to hepatic impairment should be warned when combined with antibacterial agents.

Key words: omeprazole, abnormal liver function, hepatic impairment, automatic surveillance