| アブストラクト | Background/Objectives: Fluoroquinolones (FQNs) are widely prescribed broad-spectrum antibiotics but are associated with central and peripheral nervous system adverse reactions (ARs). Regulatory agencies have issued multiple safety warnings regarding their neuropsychiatric effects; however, large-scale, comparative evaluations across individual FQNs remain limited. This study aimed to comprehensively characterise and compare neuropsychiatric profiles associated with Ciprofloxacin, Levofloxacin, and Moxifloxacin using pharmacovigilance data. Methods: A retrospective pharmacovigilance study was conducted using reports from the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) between 2010 and 2025. Neuropsychiatric ARs were identified using MedDRA terms, including neurological and psychiatric manifestations. Reporting trends, demographic characteristics, and event frequencies were descriptively analysed. Signal detection was performed using the Information Component (IC), Proportional Reporting Ratio (PRR), and Reporting Odds Ratio (ROR). Results: A total of 95,968 individual case safety reports involving neuropsychiatric ARs were included. Levofloxacin accounted for the highest number of reported events, followed by Ciprofloxacin and Moxifloxacin. Disproportionality analyses identified peripheral neuropathy as the strongest neurological signal for Levofloxacin and Moxifloxacin, while Ciprofloxacin showed stronger central nervous system associations. Psychiatric ARs were drug-specific, with anxiety predominating for Ciprofloxacin and Moxifloxacin, and insomnia for Levofloxacin. All major signals were statistically robust (IC025 > 0), confirming distinct compound-specific neuropsychiatric risk profiles. Conclusions: The large-scale 16-year analysis demonstrates distinct, drug-specific neuropsychiatric risk profiles. The available evidence supports a non-interchangeable safety profile among FQNs and emphasises the importance of drug-specific risk-benefit assessment in clinical practice. |
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| ジャーナル名 | Pharmaceuticals (Basel, Switzerland) |
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| Pubmed追加日 | 2026/6/26 |
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| 投稿者 | Rusu, Aura; Stroia, Ioana-Maria; Chereches, Marius Calin |
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| 組織名 | Pharmaceutical and Therapeutic Chemistry Department, Faculty of Pharmacy, George;Emil Palade University of Medicine, Pharmacy, Science, and Technology of Targu;Mures, 540142 Targu Mures, Romania.;Marketing, Management and Sustainability Department, Faculty of Pharmacy, George;Emil Palade University of Medicine, Pharmacy, Science and Technology of Targu |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/42356439/ |
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