OBJECTIVE： To understand the basic information and characteristics of severe ADR/ADE （SADR/SADE） in children. METHODS： The SADR/SADE collected from Shanxi Children’s Hospital during 2010-2013 were analyzed statistically in respects of the population， drug category， clinical manifestation，hospitalization expenses，outcomes， etc.， and then were compared with which reported on 2008-2009. RESULTS： Of 123 SADR/SADE cases during 2012-2013， male （51.22％） was more than female （48.78％）； main type of SADR/SADE-inducing drugs was anti-infective drugs （30.40％）， followed by antipyretic analgesic and anti-inflammatory drugs（19.20％）；main clinical manifestations were lesion of skin and its appendants （35.88％）， followed by neurological symptoms damage（34.35％）. The types of SADR/SADE in two periods were drug misuse， irrational drug use and severe SADR， without statistical significance （P＞0.05）. There was no statistically significant difference in the proportion of main involved drugs （P＞0.05）. CONCLUSIONS： SADR/SADE monitoring and prevention in children should be strengthened continuously， and effective measures also should be adopted so as to guarantee the safety of drug use.