Psychiatric events induced by roflumilast: a real-world pharmacovigilance study of the FDA Adverse Event Reporting System database

Background Roflumilast 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. Methods This investigation comprehensively assessed psychiatric adverse events (AEs) attributed to roflumilast by employing data mining techniques, utilizing the FDA Adverse Event Reporting System (FAERS). The dataset encompasses the period from the first quarter of 2014 to the first quarter of 2025. A disproportionality analysis was conducted to quantify the correlation between roflumilast and psychiatric AEs. The metrics employed for the evaluation of disproportionality comprise the reporting odds ratio (ROR), the proportional reporting ratio, the information component, and the empirical Bayesian geometric mean. Results A total of 414 reports were identified as related to psychiatric AEs of roflumilast, with the identification of 31 preferred terms. Five of psychiatric AEs exhibited significant positive signals, including insomnia (ROR 3.55), suicidal ideation (ROR 4.32), sleep disorder due to a general medical condition (ROR 13.47), nervousness (ROR 3.30), and eating disorder (ROR 5.16). A relatively increases risk of life-threatening and hospitalization in psychiatric AEs. Conclusion Our findings would provide valued evidence for healthcare professionals to recognize psychiatric AEs associated with roflumilast and guide their clinical practice.