OBJECTIVE： To explore the general rules and characteristics of ADR/ADE induced by Monosialotetrahexosylganglioside sodium injection （GM1） as well as related risk factors， and to provide reference for safe， effective and economical drug use in clinic. METHODS： By hospital LAN， non-interventional centralized monitoring was conducted among patients receiving GM1 in our hospital from Jan.-Jun. 2016. The patients’ information， drug use， ADR/ADE and clinical outcomes were analyzed statistically. RESULTS： A total of 621 patients were involved， including 393 male patients and 228 female patients with male-to-female ratio of 1.72 ∶ 1. The patients who were more than 61 years old were the majority （60.39％）. GM1 was mainly used in neurology department （71.18％）， emergency department （6.28％）， neurosurgery department （6.12％）， general practice department （4.67％） and TCM rehabilitation department （4.03％）. Among them， there were 28 ADR/ADE cases， with incidence of 4.51％. Among 42 patients with off-indication， 3 cases had ADR/ADE， with incidence of 7.14％.  Meanwhile， the constituent ratio of ADR/ADE in male （67.86％） was higher than that in female （32.14％）. Twenty-two cases received more than three or more drugs （78.57％）. Furthermore， ADR/ADE mainly manifested as systemic damage （35.71％）， lesion of skin and its appendants （28.57％）. Among 579 patients met drug use with indication， there were 165 cured cases， 405 recovered cases and 9 uncured cases. In addition， the average expenditure of using GM1 was 5 108.08 yuan， accounting for 9.07％ of total hospitalization cost and 23.33％ of total drug cost. CONCLUSIONS： It is necessary to strengthen rational drug use and monitoring of GM1， understand the regularity and characteristics of GM1-induced ADR/ADE， so as to reduce the incidence of ADR/ADE and ensure safe， effective and economical drug use.