OBJECTIVE:To probe into the correlation between new/severe adverse drug reaction（ADR） of traditional Chinese medicine injections and drug instructions in Wuzhou

Guangxi Zhuang Autonomous Region（hereinafter referred to as " Wuzhou"）.METHODS:Retrospective analysis method was adopted

statistics of " new general"

" new severe" and " severe" ADR of traditional Chinese medicine injections and related drug instructions in Wuzhou from Jan.2011 to Jun.2020 were made.Patient’s gender

age

ADR involved organs and/or systems and clinical manifestations were summarized and analyzed.Correlation analysis was performed between the description of " adverse drug reaction" items（adverse drug reaction classification or severe adverse drug reaction） in the drug instructions of traditional Chinese medicine injections and the reported occurrence of ADR of traditional Chinese medicine injections in this region.RESULTS:A total of 602 cases of ADR of traditional Chinese medicine injections and 50 drug instructions（with 39 manufacturers） were collected.There were 429 cases（71.26%） of new general ADR

114 cases（18.94%） of severe ADR

and 59 cases（9.80%） of new severe ADR.New/severe ADR of traditional Chinese medicine injections in this region mainly concentrated in Xueshuantong injection（111 cases）;the main clinical manifestations were fever with systemic damage（19.64%）.There was a correlation between the new general and new severe ADR caused by traditional Chinese medicine injection and the item description of " adverse reactions" in the drug instructions（whether there is adverse reaction classification and whether there is warning serious adverse reaction）.There were differences in the content of ADR in the same generic name drug package produced by different manufacturers.CONCLUSIONS:The contents of instructions for traditional Chinese medicine injections are imperfect

the classification and description of " adverse drug reactions" items are not standardized

and the contents of medications for special populations are generally lacking

which still needs to be improved continuously.