Abstract: OBJECTIVE To analyze the specification safety information of Chinese patent drugs combined with the adverse drug reactions monitoring data and provide basis for rational use of Chinese patent drugs in clinic. METHODS Making statistics and analysis of safety information by collecting 410 varieties of Chinese patent drugs leaflets in the field. Then selecting the key varieties and comparing the differences between the leaflets and monitoring data by searching Zhejiang sub-database of China adverse drug reaction database. RESULTS A total of 410 leaflets for Chinese patent drugs were collected. The "adverse reactions" item of 302 leaflets were "unclear"(73.66%). The "contraindications" item of 262 leaflets were "unclear"(63.90%). Only three leaflets had relevant regulations under the "use in specific populations" item. The adverse reaction monitoring data of key varieties showed that the adverse reactions of Chinese patent drugs were not uncommon, and involved multiple systems and organs. CONCLUSION The safety monitoring results of Chinese patent drugs have not been fully implemented in the revision and improvement of safety information. Manufactures should take full responsibility for drug safety, and update the safety informations actively.