OBJECTIVE:To probe into relevant factors and regularities of adverse drug reactions (ADR)/ adverse drug events (ADE) induced by general characteristics, so as to provide references for promoting clinical rational drug application. METHODS:301 cases of ADR/ADE reports in National Center for ADR Monitoring from Jan. 1st 2006 to Apr. 30th 2014 were collected and retrospectively analyzed in terms of patients` ages, genders, diseases, routes of administration, drug combinations, occurrence time, species of antibiotics, organs and (or) systems involved and their clinical features, severe ADR/ADE involved drugs, etc. RESULTS:Of 301 reports on ADR/ADE induced by antibiotics, the number of female was slightly more than male; mostly aged over 60 years(122 cases, accounted for 40.53%); mostly respiratory disease (139 cases, accounted for 46.18%); intravenous drip was the main route of administration inducing ADR/ADE; most ADR/ADE were induced by drug combination. Cephalosporins was the No.1 antibiotics inducing ADR/ADE, secondly were fluoroquinolones and penicillin; the top 3 drugs were respectively cefoperazone tazobactam, levofloxacin and ciprofloxacin. The main organs and (or) systems involved by ADR was skin and its accessories, secondly were systemic damage and digestive system damage. Of 301 reports of ADR/ADE, 24 cases (accounted for 7.97%) were severe ADR/ADE, mostly were induced by cephalosporins. CONCLUSIONS:The occurrence of ADR/ADE is related to many factors, doctor-medicine-patients cooperation should be reinforced to develop the function of clinical pharmacist, so as to promote rational drug application. [ABSTRACT FROM AUTHOR]