Abstract: Objective To find out the essential features of adverse drug reactions/events(ADR/ADE) induced by traditional Chinese medicine preparations, deepen our recognition of Chinese medicine's ADR/ADE and boost the rational use of Chinese medicine preparations. Methods Retrospective analysis was used. All reported ADR/ADE cases from all organizations from 2008 to 2009 in Shenzhen were downloaded from Guangdong Center for ADR Monitoring in the form of Excel electronic forms. ADR/ADE reports of traditional Chinese medicine preparations were screened and analyzed. Results 1 768 ADR/ADE cases of traditional Chinese medicine preparations were screened out and involved 468 traditional Chinese medicine products from 368 manufacturers. The injection was the primary dosage form that caused ADR/ADE. Total 61 injection products led to 854(48.30%) ADR/ADE reports and the intravenous route of administration were used in the absolutely most of cases. All kinds of oral dosage forms led to 45.59% of ADR/ADE cases. The lesions of ADR/ADE involved primarily in skin and its accessories, followed by the gastrointestinal system, systemic lesions, the nerve system, etc. The new ADR/ADE cases reached 1 144 (64.71%). Most of ADR/ADE cases had good prognosis. Conclusion The occurrence of ADR/ADE induced by traditional Chinese medicine preparations is universal and monitoring of ADR/ADE induced by traditional Chinese medicine preparations, especially injection, should be enhanced. The use of traditional Chinese medicine injections should be decreased or avoided as possible, especially in children population. The drug administration authorities should pay more attention to the instruction of traditional Chinese medicines.

Key words: Chinese Medicine preparations, adverse drug reactions/events(ADR/ADE), analysis