OBJECTIVES: We conducted a literature review on the adverse drug reaction(ADR) of 33 variety of traditional Chinese medicine injections(TCMIs) on the national essential medicine list (2004 edition). METHODS: We electronically searched three major Chinese Databases(CBM, CNKI, VIP) since their inception to end-April, 2009. We also retrieved the websites of Ministry of Health and State Food and Drug Administration as well as Newsletter of Adverse Drug Reactions (issue 1 to 22). We descriptively analyzed the TCMIs ADR literatures. RESULTS: Among 5405 citations searched, only 1010 studies met the eligible criteria. The total and cumulative amounts of included articles about TCMIs ADRs significantly increase over time. The included 1010 articles were scattered among 297 periodicals, including 55 journals on pharmaceutical medicine (containing 399 articles, accounted for 39.50%) and 64 journals on traditional Chinese medicine(containing only 197 articles, amounted for 19.50%). The articles included were categorized into eight types of design as follows: 348 case reports and 254 case series which accounted for 34.46% and 25.15% of the total articles, 119 overviews (11.78%), 116 randomized control trials (11.49%), 78 cross-sectional studies (7.72%), 61 ADR literature analyses (6.04%), and 28 non-randomized controlled clinical studies (2.77%). The reports of ADRs to Shuanghuanglian, Qingkailing and Yuxingcao injections were the most in all reports for TCMIs (more than 200 articles for each injections, accounting for 41.95% of the total). The four kinds of TCMIs (Shuanghuanglian, Ciwujia, Yuxingcao, Yinzhihuang injections) among the top 5 reported ADR literatures were removed for the market. CONCLUSIONS: Articles published on TCMIs ADRs increased year by year, but the research is of low quality and is scattered in a large number of sources. Four TCMIs (Shuanghuanglian, Ciwujia, Yuxingcao, and Yinzhihuang) among the top 5 ADR literatures reported were terminated for sale and use. It is necessary to enforce safety re-evaluation of TCMIs and to promote the clinical rational use.