Abstract: Objective To study the features of adverse drug reactions (ADR) induced by omeprazole sodium injection, and provide a basis rational usage of drugs in clinic. Methods 162 cases of ADR reports caused by omeprazole sodium injection were collected from January 1, 2015 to March 31, 2020 from Beijing ADR monitoring system. The field in each case report was standardized, and the ADR symptoms were extracted and standardized by WHO adverse reaction terminology. In addition, genders, ages, and ADR involved organs/systems, adverse reaction time, drug dispensing, administration route, dosage of administration, drug combination, severity and outcome of adverse reactions in ADR were retrospectively analyzed. Results 82 patients over 60 years old were reported to have ADR, accounting for 50.62% of all cases reported. Adverse reactions/events related to omeprazole sodium injection were mainly rashes, elevated transaminases, pruritus, chills, etc. to the percentage of skin damage (32.18%) and systemic damage (14.37%) were relatively high. Most of these adverse reactions occurred in the initial stage of drug administration. Hepatobiliary system damage accounted for 13.79%. Such adverse reactions usually occurred after a few days of drug administration. There were many cases of unreasonable drug usage and off-label drug usage. Conclusion Clinical management of omeprazole sodium injection should be strengthened, and the process of drug administration should be closely observed to reduce the occurrence of ADR. Production enterprises should promptly revise and improve the safety information of drug instructions to ensure the safety of drug usage for patients.

Key words: omeprazole sodium for injection, adverse drug reaction, safety analysis, case report