| アブストラクト | This study aims to assess the adverse event profile of apremilast using FDA Adverse Event Reporting System (FAERS) data to identify potential safety risks and support clinical use. FAERS data from Q1 2014 to Q1 2024 were analysed. Adverse drug events (ADEs) related to apremilast were extracted and evaluated using four signal detection methods: Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Empirical Bayesian Geometric Mean (EBGM). A total of 122 287 apremilast-related AE reports, encompassing 238 215 adverse reactions across 24 System Organ Classes (SOCs) and 60 apremilast-induced AE signals, were identified. Gastrointestinal disorders, skin and subcutaneous tissue disorders, and musculoskeletal and connective tissue disorders were the most frequently reported SOCs. Common Preferred Terms (PTs) included diarrhoea, nausea, and headache. Notably, some adverse effects not listed in the drug package insert were found, such as multiple allergic reactions and tumour signals. This study identified significant disproportionality signals for ADEs reported with apremilast, particularly concerning gastrointestinal reactions, psychiatric disorders, and infections. While these findings do not establish causality, they offer valuable real-world insights that underscore the importance of continued clinical monitoring and warrant further pharmacoepidemiologic investigation. |
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| ジャーナル名 | Experimental dermatology |
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| Pubmed追加日 | 2026/6/29 |
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| 投稿者 | Gan, Ke; Liu, Jie; Shen, Jianjiang; Lu, Lu; Xu, Ruiyang; Xu, Zenan; Chen, Jianmei; Lu, Yan |
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| 組織名 | Department of Rheumatology, Affiliated Hospital of Nanjing University of Chinese;Medicine (Jiangsu Province Hospital of Traditional Chinese Medicine), Nanjing,;China.;Traditional Chinese Medicine Hospital of Ili Kazakh Autonomous Prefecture,;Xinjiang, China.;Mufushan Community Health Service Center of Gulou District, Nanjing, China.;Department of Clinical Laboratory, Affiliated Hospital of Nanjing University of;Chinese Medicine (Jiangsu Province Hospital of Traditional Chinese Medicine), |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/42366928/ |
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