Gupta Aditya K, Talukder Mesbah, Keene Sharon A, Bamimore Mary A
Mediprobe Research Inc., London, Ontario, Canada.
Division of Dermatology, Department of Medicine, Temerty Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.
Int J Dermatol. 2025 Jul 15. doi: 10.1111/ijd.17957.
The United States Food and Drug Administration (FDA) approved oral finasteride for androgenetic alopecia. In 2022, approximately 2.6 million U.S. men used it for hair loss and prostate conditions. Post-finasteride syndrome (PFS), proposed in 2012, involves persistent sexual and neuropsychiatric adverse events (AEs) after cessation. These AEs are controversial and often lack assessment of contributing risk factors. We analyzed FDA Adverse Event Reporting System (FAERS) data to explore finasteride's administration route and PFS-like AEs.
Using the information component (IC) method for disproportionality analyses, we assessed signals for 13 PFS-related AEs with topical and oral finasteride and dutasteride across two periods: 2006-2011 (pre-PFS reporting) and 2019-2024 (post-PFS reporting). These periods reflect times before and after formal PFS reporting in 2012. Eight analyses per AE were conducted based on agent, route, and era.
Fewer signals for PFS-like AEs were detected with topical finasteride compared to oral finasteride in both eras. No signals were found for topical dutasteride, possibly because its use is very limited. Many reported AEs, such as erectile dysfunction and depression, may be influenced by age, stress, or comorbidities.
Signals for PFS-like AEs were detected with topical finasteride, but were less frequent than with oral finasteride. The high prevalence of these AEs in the general population and the influence of confounding factors, such as psychological stress or nocebo effects, combined with the lack of genotyping, hormonal assessments, or family history data in most reports, suggest caution in attributing causality to finasteride. Topical finasteride may pose a lower risk, but robust evidence is needed to clarify its safety profile.
美国食品药品监督管理局（FDA）批准口服非那雄胺用于治疗雄激素性脱发。2022年，约260万美国男性将其用于治疗脱发和前列腺疾病。2012年提出的非那雄胺后综合征（PFS），是指停药后持续出现的性和神经精神方面的不良事件（AE）。这些不良事件存在争议，且往往缺乏对相关风险因素的评估。我们分析了FDA不良事件报告系统（FAERS）的数据，以探讨非那雄胺的给药途径和类似PFS的不良事件。
我们使用信息成分（IC）方法进行不成比例分析，在两个时间段评估了局部和口服非那雄胺及度他雄胺与13种PFS相关不良事件的信号：2006 - 2011年（PFS报告前）和2019 - 2024年（PFS报告后）。这两个时间段分别反映了2012年正式报告PFS之前和之后的时间。基于药物、给药途径和时间段，对每种不良事件进行了八项分析。
在两个时间段内，与口服非那雄胺相比，局部使用非那雄胺检测到的类似PFS不良事件信号更少。局部使用度他雄胺未发现信号，可能是因为其使用非常有限。许多报告的不良事件，如勃起功能障碍和抑郁症，可能受年龄、压力或合并症影响。
局部使用非那雄胺检测到了类似PFS不良事件的信号，但比口服非那雄胺的频率更低。这些不良事件在普通人群中普遍存在，以及心理压力或反安慰剂效应等混杂因素的影响，再加上大多数报告中缺乏基因分型、激素评估或家族史数据，表明在将因果关系归因于非那雄胺时需谨慎。局部使用非那雄胺可能风险较低，但需要有力证据来阐明其安全性。
