OBJECTIVE： To analyze the characteristics and regularity of new/severe pediatric ADR in Shandong province， and to promote the safe use of drugs in children. METHODS： A retrospective analysis of new/severe pediatric ADR in the Shandong Provincial ADR database 2016-2017 was conducted in respects of children’s gender and age， primary disease， ADR history， family ADR history， dosage form， route of administration， drug type， systems/organs involved in ADR， clinical manifestations， off-label drug use， drug combination， occurrence time， effects of ADR on primary disease， outcome， etc. RESULTS： A total of 44 742 pediatric ADR cases were collected from Shandong province ADR database from 2016 to 2017， including 27 060 male， 17 664 female and 18 gender unknown. 530 cases were diagnosed as new/severe pediatric ADR， including 334 male and 196 female with ratio of male to female 1.70 ∶ 1. New/severe ADR reports of children aged 1-3 took up the highest proportion （158 cases， 29.81％）. Primary diseases were mainly respiratory disease （190 cases， 25.85％）； there were 10 children with ADR history （1.89％）， 2 with family ADR history （0.38％）. Dosage forms were mainly injection （358 cases， 67.55％）. Route of administration were mainly intravenous drip （431 cases， 81.32％）. The drugs that caused ADR included 20 categories and 162 species， mainly including drug for regulating hydroelectric acid-base balance （148 cases caused by 8 kinds of drugs， 27.92％）， antibiotics （89 cases caused by 33 kinds of drugs， 16.79％）， traditional Chinese medicine and its extract （80 cases caused by 24 kinds of drugs， 15.09％）. The systems/organs involved in ADR were mainly systemic injury （201 cases， 37.92％， main clinical manifestations included chills and fever， etc.）， followed by skin and its appendants （99 cases， 18.68％， mainly clinical manifestations included rash and itching， etc.）， respiratory system （76 cases， 14.43％， main clinical manifestations included dyspnea and cough， etc.）. Off-label drug use were found in 41 cases （7.74％）， including the safety of drug use was not clear in drug instructions （20 cases， 3.77％）； no drug testing was carried out and no reliable references were available （13 cases， 2.45％）， that medicine was prohibited was stated in drug instructions （2 cases， 0.38％）. 106 cases （20.00％） had drug combination， including combined use of two drugs， three drugs and four drugs （62， 36， 8 cases）. ADR occurred mainly within 0-5 min （140 cases， 26.42％）. Among 530 children， ADR had no obvious effect on the outcome of the disease in 457 cases （86.23％）； ADR caused longer course of disease in 57 cases （10.75％）. 278 cases （52.45％） were cured and 243 cases （45.85％） were recovered. CONCLUSIONS： It is necessary to strengthen the monitoring of drug use in children， formulate national standards and relevant laws and regulations for children’s rational drug use， improve the awareness of medical staff to children’s ADR， strengthen the education and publicity of the knowledge about safe drug use in children， and to promote rational drug use.