Abstract: Objective To analyze the adverse drug reactions (ADR) reports induced by edaravone injection,so as to provide reference for rational drug use. Methods Reports from Beijing Adverse Drug Reaction Monitoring Center about adverse drug reaction induced by edaravone from January 2012 to December 2016 were analyzed. Patients' age, gender, disease, primary diseases, medication regimen, occurrence time, systems involved and clinical manifestations, severity and prognosis were collected. Results A total of 93 cases of adverse drug reaction reports induced by edaravone were collected, in which 9 cases (9.68%) were serious adverse drug reactions. There were 49 cases of elderly patients, accounting for 52.69%. Clinical manifestations involved skin and appendages disorders, liver and biliary system disorders ,nervous system disorders. 67 cases(72.04%) happened from the day starting edaravone to the fifth day. 23 cases(24.73%) have off-label use in indication. 1 case(1.07%) have contraindication. 29 cases(31.18%) have overuse or underuse of edaravone. 3 cases(3.23%) have a longer treatment time than that indicated in the label. Conclusion Medication regimen should be made in accordance to indication and dosage in drug labels. Patients should be under close attention so that adverse drug reactions could be detected as soon as possible. Once adverse drug reaction occurred, strategies such as stopping the medication and treatment should be quickly undertaken.

Key words: edaravone, adverse drug reaction(ADR), medication error, pharmacovigilance