OBJECTIVE： To investigate the characteristics and rules of new and severe ADR induced by TCM for removing blood stasis and clearing heat in our hospital， and to provide reference for safe drug use in clinic. METHODS： New and severe ADR induced by TCM for removing blood stasis and clearing heat reported to national ADR monitoring center were collected from our hospital during Jan. 2006-Dec. 2016. Those ADR cases were analyzed retrospectively in respects of gender， age， allergic history， route of administration， drug type and dosage form， occurrence time， organs/systems involved and clinical manifestations， outcome. RESULTS： Among 298 reports， the incidence of ADR in female （70.13％） was higher male （29.87％）， especially in patients aged 50-59 （21.48％）； there were 77 allergic cases （25.84％）. Route of administration was mainly oral administration （57.37％）， and dosage form was mainly injection （25.50％）. Main ADR-inducing drug was Chinese patent medicine （53.53％）. ADR mostly occurred over 1 d after medication （48.32％）. Systems/organs involved in ADR were mainly lesion of skin and its appendants， systemic damage and gastrointestinal damage. Main clinical manifestations were rash， contact dermatitis， pruritus， infusion reaction， chills， fever， nausea， vomiting， diarrhea， etc. After drug withdrawal or symptomatic treatment， 97.99％ patients were revered and cured. There was no death case. CONCLUSIONS： TCM for removing blood stasis and clearing heat causes most new and severe ADR. Clinical drug use should be monitored closely to reduce the occurrence of ADR.