OBJECTIVE:To investigate the characteristics and regularity of ADR induced by gefitinib. METHODS:31 cases of ADR induced by gefitinib in 23 pieces of literatures collected from domestic medical academic periodicals during 2004～2008 were analyzed retrospectively. RESULTS:Of total 31 cases of ADR,29.03% were occurred in 61～70 aged patients; lesion of skin and its appendants were caused by ADR in 8 cases (25.81%); 10 cases represented as digestive system injury (32.26%),6 cases as interstitial pneumonia (19.35%); 30 cases occurred during medication period,about 30% occurred within 10 days of medication; 3 patients were dead from interstitial pneumonia. CONCLUSION:It is necessary to pay attention to ADR induced by gefitinib in the clinic and strengthen clinical observation during medication in order to reduce the incidence of serious ADR.