ArticleEuropean journal of clinical pharmacology2025
Signal detection between 5-alpha reductase inhibitors and the risk of suicidality and depression: an international pharmacovigilance analysis.
Article in European journal of clinical pharmacology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
2 citing papers in PubMed.
- Finasteride, pharmacogenomics, and suicide risk: a public health concern.The pharmacogenomics journal · 2026Review
- Signal Detection of Depression and Suicidality Associated with Finasteride and Dutasteride: Updated Pharmacovigilance Evidence and Recommendations for Comprehensive Psychiatric Assessment.Brain sciences · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
Abstract
objectiveThis study aims to investigate the signal detection between the use of finasteride and dutasteride and the occurrence of suicidality, including suicidal ideation, attempts, and completed suicide, as well as the development of depression.
methodsThis study utilized data from a global pharmacovigilance database encompassing over 35 million adverse event reports from more than 140 countries. Suicidality and depression were defined by MedDRA terms version 26.0. To analyze the data, two well-established pharmacovigilance indicators were applied: the information component (IC) and the reporting odds ratio (ROR).
resultsA total of 395 and 1299 reports of suicidality and depression, respectively, were identified in signal detection with finasteride and dutasteride. Reporting trends showed that cases first emerged in 1992, with a notable increase after 2010. The main analysis identified signal detections between finasteride use and both suicidality (ROR, 7.28 [95% CI, 6.57-8.06]; IC, 2.82 [IC
conclusionsAlthough our study does not imply causality, this findings suggest a statistically significant disproportionality in reports of suicidality and depression associated with finasteride use and increased signal risks of suicidality and depression highlighting the need for further large-scale epidemiological studies to confirm these findings and investigate the underlying mechanisms.
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Registered trials
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