Abstract:Abstract: OBJECTIVE To provide reference for clinical application of edaravone via excavating relevant clinical reports of adverse events in FAERS database of American and analyze the safety and effectiveness of edaravone in clinical treatment. METHODS Clinical reports of adverse events related to Edaravone from April 2017 to December 2022 were collected from the FAERS database,and the data were analyzed using the Reporting Odds Ratio (ROR) method and the proportional Reporting Gratio (PRR) report commonly used internationally. RESULTS 4 367 reports were collected, covering 13 categories of system/organ classification items, including systemic diseases and various reactions at the administration site (43.46%), various neurological diseases (13.28%), and respiratory, thoracic, and mediastinal diseases (6.69%) . Among them, report numbers of drug ineffectiveness,disease progression,and worsening of the condition were 239,227,and 125,respectively. The signal intensity of amyotrophic lateral sclerosis was high (PRR=1 269.58), and all of these adverse events were appeared in the instruction manual. CONCLUSION The relevant reports indicate that edaravone may have low efficacy in clinical treatment. Therefore,in the clinical application of edaravone,in addition to closely monitor the adverse events that may occur in the patient’s manual,it is also necessary to adopt combination medication strategies based on the actual situation of the patient to ensure the effectiveness of clinical intervention.