OBJECTIVE:To analyze the characteristics and rules of new and serious ADR induced by Chinese patent medicine in Wuhan during 2012-2013,and to improve the monitoring levels of Chinese patent medicine-induced ADR and clinical rational drug use. METHODS:New and serious Chinese patent medicine-induced ADR cases reported by 16 districts of Wuhan during 2012-2013 were classified and analyzed statistically. RESULTS:A total of 245 cases of new and serious TCM ADR were reported in 2012-2013,accounting for 13.61% of all reports;the incidence of ADR in patients above 51 years old was the highest,account-ing for 55.51%;42.04%of new and serious ADR induced by Chinese patent medicine occurred within 30 minutes after using medi-cine;among suspected drugs,intravenous dripping was the main way to cause new and serious ADR induced by Chinese patent medicine (50.39%);blood-regulating formula was the main cause of new and serious ADR induced by Chinese patent medicine (40.80%);new and serious ADR induced by Chinese patent medicine mainly manifested as systemic damage(25.97%),followed by lesion of skin and its appendants(18.81%). CONCLUSIONS:It is needed to strengthen the rational use of Chinese patent medi-cine and the supervision of TCM injection for activating blood circulation to dissipate blood stasis,strengthen the supervision and improvement of instruction content of Chinese patent medicine. TCM Pharmacists should carry out the clinical pharmaceutical care.