OBJECTIVE： To investigate the regularity and characteristics of adverse drug reactions （ADR） induced by Xianling gubao capsule， and to provide reference for rational drug use in the clinic. METHODS： ADR induced by Xianling gubao capsule were retrieved from CJFD， CBM， Wanfang database， VIP during Jan. 2007-Oct. 2016. The related information of 185 ADR cases were statistically analyzed. RESULTS： Among 185 patients， primary disease was mainly osteoporosis （63 cases， 34.05％）. The incidence of ADR induced by drug combination （70.81％） was higher than single drug （29.19％）. ADR mostly occurred within 90 d after medication （67.03％）. Main clinical manifestation was digestive system damage （82.68％）. Most patients （61.62％） did not need treatment， symptomatic treatment or drug withdrawal to relieve ADR symptoms. CONCLUSIONS： The monitoring for ADR induced by Xianling gubao capsule should be strengthened in clinic，especially for ADR of liver fuction，soas to promote rational drug use.