ABSTRACT This article summarizes the post‐marketing pharmacovigilance safety data of intravenous (IV) edaravone during the 1‐ and 3‐year periods following its launch for amyotrophic lateral sclerosis (ALS) in the United States. The most frequently reported adverse events (AEs) and serious AEs (SAEs) included those consistent with ALS disease progression, such as fatigue and muscular weakness, and were not qualitatively different from those reported in previous ALS trials. There were AEs and SAEs associated with IV administration, such as administration site reactions, and five non‐fatal anaphylaxis SAEs were reported. No new safety signals were identified, and IV edaravone continues to demonstrate a favorable safety profile. These insights are especially useful as treatment transitions to edaravone oral suspension, which avoids IV‐related complications. These findings underscore the importance of ongoing clinical safety assessments in informing ALS treatment decisions.
Genge et al. (2026) studied this question.