| アブストラクト | Fentanyl is associated with significant respiratory, cardiovascular, and neurological adverse events (AEs). This study aimed to describe the safety of fentanyl administered through different routes of administration, with a focus on brain lesions. Safety data related to fentanyl were extracted from the EudraVigilance database up to March 7, 2024. Descriptive and disproportionality analyses were performed. A total of 6,441 cases were classifiable for the administration route. The transdermal route (80.9%) was the most reported route. Most cases were from adults and females. Overall, 92.8% of AEs were serious. The intravenous route had a higher disproportionate reporting of "nervous system disorders" than transdermal (ROR 1.31; [95% CI, 1.12-1.41]) and oral transmucosal (1.30; [1.12-1.49]). Among central nervous system disorders, 50 brain lesions were identified, with no statistically significant difference observed. Nasal administration had a higher reporting frequency of "central nervous system vascular disorders" compared to transdermal (2.45; [1.14-5.24]), intravenous (2.53; [1.09-5.87]), and oral transmucosal routes (4.89; [1.54-15.51]). On the other hand, the intravenous had a higher disproportionate reporting of "seizures" compared to nasal (3.19; [1.17-8.69]), oral transmucosal (2.09; [1.31-3.32]), and transdermal routes (2.41; [1.96-2.96]). The study provides a comprehensive safety profile of fentanyl across different administration routes, highlighting a higher disproportionate reporting of central neurologic and cardiovascular AEs with nasal and intravenous routes. |
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| ジャーナル名 | Naunyn-Schmiedeberg's archives of pharmacology |
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| Pubmed追加日 | 2026/2/27 |
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| 投稿者 | Di Napoli, Raffaella; Mascolo, Annamaria; Balzano, Nunzia; Zinzi, Alessia; Nicoletti, Maria Maddalena; Capuano, Annalisa; Gargano, Francesca |
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| 組織名 | Department of Experimental Medicine, - Section of Pharmacology "L. Donatelli",;University of Campania "Luigi Vanvitelli", Costantinopoli 16, 80138, Naples,;Italy.;Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, 80138,;Naples, Italy.;Department of Life Science, Health, and Health Professions, Link Campus;University, Rome, Italy.;Italy. nunzia.balzano@unicampania.it.;Naples, Italy. nunzia.balzano@unicampania.it.;Department of Precision Medicine, University of Campania "Luigi Vanvitelli",;80138, Naples, Italy.;Unit of Anesthesia and Intensive Care, Fondazione Policlinico Universitario;Campus Bio-Medico, 00128, Rome, Italy. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/41748944/ |
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