To explore and evaluate the post-marketing safety evaluation methods with the example of three heat-clearing and detoxifying injections of traditional Chinese medicine.Methods：We monitored patients taken the above injections based on active surveillance methods. It is a prospective, multi-center, large sample and nested case-controlled design, to investigate the incidence, characteristics and influencing factors of adverse reaction (ADR). Results：Among 10,029 patients monitored, 26 patients had ADR, 5 of them experienced allergic reactions. IgE of the 5 patients who had allergic reactions was elevated. Conclusion： The overall ADR incidence rate is 0.26% (0.1% ～ 1%) and allergic reactions are probably mediated by IgE.