Abstract: Objective To analyse the characteristics of adverse drug reaction/event(ADR/ADE) induced by Mailuo Shutong pills, so as to provide reference for clinical safe medication. Methods Five hundred and sixty cases of ADR/ADE reports involving Mailuo Shutong pills in Shandong Province Adverse Drug Reaction Monitoring System between 2004 and 2023 were analyzed in terms of the types of reports, categories of reporting institutions, annual changes, gender, age, systems-organs ADR/ADE involved, clinical manifestations, reasons for medication, combined medications and clinical outcomes. Results There were a total of 560 cases of ADR/ADE caused by Mailuo Shutong pills, 540 (96.43%) of which were normal ones, and 20 (3.57%) were severe ones. The main systems-organs involved in ADR/ADE were the gastrointestinal system, skin and its accessories, systemic reactions, and the central and peripheral nervous system. The clinical manifestations of ADR/ADE were mostly nausea, vomiting, diarrhea, itching and rash. In 471 of these cases (84.11%), ADR/ADE had no significant effect on the preexisting diseases, but 19 s (3.39%) refused to improve, and 70 (12.50%) lost contact. Conclusion The post-marketing safety of Mailuo Shutong pills is good, but there are occasionally serious adverse reactions. Clinicians need to be alert to potential risks to drug quality or medications.

Key words: Mailuo Shutong pills, adverse drug reactions/events (ADR/ADE), gastrointestinal, cutaneous, central nervous system, peripheral nervous system, safety