Abstract: Objective Analyzed serious adverse drug reaction/event（ADR/ADE） of traditional Chinese medicine（TCM） occurred in our hospital and discuss the related factors of ADR/ADE. Methods 178 ADR reports of TCM collected by our hospital from JUN.2006 to AUG.2008 were analyzed using retrospective study method. Results Amo-ng the 178 ADR/ADE reports, 105 kinds of drugs were involved in different dosage forms and specifications, 96（53.93%） ADR reports were happened in one hour. skin and its adjunct is likely to be the most affected organ. the top three of occurrence frequency in ADR/ADE were injections; and the reports of new ADR/ADE caused by Chi-nese patent medicine is 99（55.62%）. 11 severe adverse reactions were occurred, and oral drugs accounted for a higher proportion.Conclusion ADR monitoring should be strengthened to improve the rational use of drug.

Key words: traditional Chinese medision（TCM）, adverse drug reaction/event（ADR/ADE）, rational use of drug