OBJECTIVE： To provide reference for rational drug use in respiratory department. METHODS： ADR/ADE reported by respiratory department of a class three grade A hospital during Jan. 2011 to Dec. 2015 from national ADR monitoring system were collected. 2011-2015 ADR/ADE database of respiratory department in a hospital was established and analyzed statistically. RESULTS： 202 records were gotten， among which 89 cases were male （44.06％） and 113 cases were female （55.94％）； the patients’age approximated normal distribution， the incidence of ADR/ADE was the highest in 61-80 age group （55.94％）； the occurrence time of ADR/ADE was mostly lower than 1 h （47.21％）； the main route of administration was intravenous drip （71.29％）； 22 kinds of drugs were involved， and antibiotics took up the lead （43.11％）； 84 patients （41.58％） used 2 and more kinds of drugs before the occarrence of ADR/ADE； organs/systems involved in ADR/ADE were skin and its appendants （32.86％） and digestive system （26.19％）. Most of the ADR/ADE could be cured or recovered after related treatment. CONCLUSIONS： The occurrence of ADR/ADE in respiratory department is related to various factors， of which advanced age， intravenous administration and antibiotics use are important ones. Great importance should be attached to rational clinical drug use as well as ADR/ADE monitoring and reporting. Clinical also should pay attention to the safety of drug use in elderly patients.