| アブストラクト | 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. |
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| ジャーナル名 | Frontiers in psychiatry |
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| Pubmed追加日 | 2026/6/29 |
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| 投稿者 | Wu, Lifang; Chen, Yan; Huang, Yaping; Jiang, Shaojun; Ke, Chengjie |
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| 組織名 | Department of Pharmacy, Second Affiliated Hospital of Xiamen Medical College,;Xiamen, China.;Department of Pharmacy, Pingtan Comprehensive Experimental Area Hospital, Pingtan;Comprehensive Experimental Area, Fuzhou, China.;Department of Pharmacy, Fujian Provincial Hospital, Fuzhou University Affiliated;Provincial Hospital, Fuzhou, China.;Department of Pharmacy, The First Affiliated Hospital, Fujian Medical University,;Fuzhou, China.;Department of Pharmacy, National Regional Medical Center, Binhai Campus of the;First Affiliated Hospital, Fujian Medical University, Fuzhou, China. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/42368799/ |
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