Psychiatric events induced by roflumilast: a real-world pharmacovigilance study of the FDA Adverse Event Reporting System database (opens in new tab)

BackgroundRoflumilast has approved treatment in patients with chronic obstructive pulmonary disease. The post-marketing data concerning roflumilast remain limited, and the outcomes of relevant studies are yet to yield conclusive evidence supporting the long-term psychiatric safety of roflumilast.MethodsThis investigation comprehensively assessed psychiatric adverse events (AEs) attributed to roflumilast by employing data mining techniques, utilizing the FDA Adverse Event Reporting System (FAE...