| アブストラクト | BACKGROUND: Alopecia is a significant adverse effect that profoundly impacts quality of life. Although numerous medications are implicated, the real-world risk profiles across drug classes and patient demographics remain poorly quantified. OBJECTIVE: To identify and characterize drugs associated with alopecia using real-world data from the FDA Adverse Event Reporting System (FAERS). METHODS: FAERS reports from Q1 2004 to Q4 2024 were analyzed using four disproportionality methods (ROR, PRR, BCPNN, MGPS) to detect signals of drug-alopecia associations. Subgroup analyses were conducted by age, gender, and drug category. Time-to-onset (TTO) was analyzed using the Weibull distribution model. RESULTS: A total of 181,838 reports with drug-associated alopecia were identified. The mean age was 53.84 +/- 16.28 years, and 76.82% of reports were from females. Oncology medications showed strongest association (37.5%), especially docetaxel (ROR = 70.38). Endocrine (18.8%) and immune system medications (10.9%) were also prominent. The TTO analysis revealed a bimodal distribution, with 40.2% of cases occurring within 30 days and 13.1% manifesting at 240-360 days. Males experienced a significantly shorter onset latency compared to females (108 days vs. 236 days, P < 0.001). Oncology drugs also showed shorter latency than non-oncology agents (198 vs. 308 days, P < 0.001). Notably, comparison with United States prescribing information revealed that 23.4% of high-signal drugs lacked documentation of alopecia in their official labels. CONCLUSION: This large-scale pharmacovigilance study identified 64 drugs with significant alopecia signals, highlighting distinct demographic patterns and latency periods. The findings underscore the need for heightened clinical vigilance, gender-specific monitoring, and updates to labels to better reflect real-world risks. |
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| ジャーナル名 | Frontiers in pharmacology |
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| Pubmed追加日 | 2025/12/15 |
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| 投稿者 | Li, Huixiang; Wei, Haijian; Shentu, Qiaoqiao; Cui, Jianxin; Chen, Jiaojiao |
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| 組織名 | Department of Pharmacy, Yantai Yuhuangding Hospital Affiliated to Qingdao;University, Yantai, Shandong, China.;Department of Organ Transplantation, Yantai Yuhuangding Hospital Affiliated to;Qingdao University, Yantai, Shandong, China.;Department of pharmacy, Dongyang Red Cross Hospital, Dongyang, Zhejiang, China. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/41394129/ |
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