OBJECTIVE： To study the general pattern， characteristics and related risk of adverse drug reaction （ADR） induced by Monosialotetrahexosylganglioside sodium injection， and to provide reference for safe use of drugs in the clinic. METHODS： Using “monosialotetrahexosylganglioside” and “ADR” as keywords， literautres were retrieved from CJFD， Wanfang and VIP database according to inclusion and exclusion criteria in Oct. 2014， and cases reports were extracted and analyzed statistically. RESULTS： A total of 19 literatures were included， involving 56 patients， with the ratio of male to female was 6.17 ∶ 1， and the most of patients aged 0-9 years， ≥60 years， accounting for 44.64％（25 cases）， 30.36％ （17 cases）. Multiple organs or systems were involved in ADR； the most common reactions are fever （29 cases） and shiver （28 cases）， etc.， and severe ADR can cause green-barry syndrome， anaphylactic shock， etc. CONCLUSIONS： Thus， it is important to pay attention to ADR caused by Monosialotetrahexosylganglioside sodium injection， to prevent the occurrence of serious ADR， to perfect drug instructions， and to ensure clinical safe administration.