Abstract: OBJECTIVE To investigate the situation of off-label drug uses of drug adverse reaction reports, and to promote clinical rational drug use. METHODS A retrospective analysis was conducted on 700 cases of adverse drug reactions reported in our hospital in 2014, according to the drug instructions. RESULTS A total of 1 605 drug prescriptions was recorded in 700 cases of ADR reports, 267 ADR reports involved off-label drug uses(38.1%), 416 drug prescriptions involved off-label drug uses(25.9%). The top three types of off-label uses were off-label administration frequency, overdose, and off-indication use; and the top three drugs were Ginkgo Dipyidamolum, Alprostadil injection, and mezlocillin sodium for injection. CONCLUSION Off-label drug uses are common in ADR reports in our hospital. It is important to tighten monitoring on the off-label drug uses and to promote clinical rational drug uses so as to reduce the incidence of ADR.