{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T20:49:26Z","timestamp":1792097366587,"version":"4.4.0"},"reference-count":27,"publisher":"MDPI AG","issue":"4","license":[{"start":{"date-parts":[[2026,4,4]],"date-time":"2026-04-04T00:00:00Z","timestamp":1775260800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Brain Sciences"],"abstract":"<jats:p>Background\/Objectives: Finasteride and dutasteride are 5\u03b1-reductase inhibitors that block the conversion of testosterone to dihydrotestosterone, reducing androgenic stimulation of tissues such as the prostate and hair follicles. Used mainly for benign prostatic hyperplasia and androgenic alopecia, finasteride selectively inhibits type-2 5\u03b1-reductase isoenzyme, while dutasteride inhibits both type-1 and type-2. Although sexual adverse effects like erectile dysfunction are well-documented, emerging evidence suggests possible neuropsychiatric reactions\u2014including depression, suicidal ideation, and cognitive decline\u2014potentially linked to reduced neurosteroid synthesis, such as that of allopregnanolone. Causality cannot be inferred from spontaneous reporting data. This study aimed to assess pharmacovigilance signals for psychopathological disorders associated with finasteride and dutasteride in the FAERS database. Methods: Cleaned FAERS data referring to years up to 2025 after deduplication were analyzed, excluding non-serious cases and those without the drug as the sole suspect (MedDra 29.0). Reporting Odds Ratios (RORs) with 95% CIs were calculated to compare psychiatric reactions between finasteride and dutasteride. Python 3.11 was used to screen and summarize relevant cases, accounting for differences in total case numbers. Results: This pharmacovigilance study analyzed FAERS data to assess the neuropsychiatric and sexual adverse reactions associated with finasteride and dutasteride. Depression, anxiety, suicidality, and libido-related issues were reported more frequently for finasteride, especially in younger men using low-dose therapy for alopecia. Potential mechanisms include reduced neurosteroid synthesis, androgen\/sex-hormone axis disruption, altered hippocampal neurogenesis, and dopaminergic changes. Conclusions: A baseline psychiatric assessment and the regular monitoring of mood, sexual function, and suicidal ideation are recommended. Limitations include under-reporting, reporting bias, and a lack of incidence data. The findings underscore the need for ongoing surveillance and controlled studies to clarify the clinical significance of these signals.<\/jats:p>","DOI":"10.3390\/brainsci16040394","type":"journal-article","created":{"date-parts":[[2026,4,6]],"date-time":"2026-04-06T03:11:28Z","timestamp":1775445088000},"page":"394","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Signal Detection of Depression and Suicidality Associated with Finasteride and Dutasteride: Updated Pharmacovigilance Evidence and Recommendations for Comprehensive Psychiatric Assessment"],"prefix":"10.3390","volume":"16","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6810-1540","authenticated-orcid":false,"given":"Stefania","family":"Chiappini","sequence":"first","affiliation":[{"name":"School of Medicine, UniCamillus University, via di S. Alessandro 8, 00131 Rome, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3849-817X","authenticated-orcid":false,"given":"John Martin","family":"Corkery","sequence":"additional","affiliation":[{"name":"Psychopharmacology, Drug Misuse and Novel Psychoactive Substances Research Unit, Hertfordshire Medical School, University of Hertfordshire, Hatfield AL10 9AB, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8255-0660","authenticated-orcid":false,"given":"Amira","family":"Guirguis","sequence":"additional","affiliation":[{"name":"Pharmacy, Medical School, Swansea University, Swansea SA2 8PP, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3832-1398","authenticated-orcid":false,"given":"Alessio","family":"Mosca","sequence":"additional","affiliation":[{"name":"Department of Neuroscience, Imaging and Clinical Sciences, \u201cG. D\u2019Annunzio\u201d University, 66100 Chieti, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0000-6870-0941","authenticated-orcid":false,"given":"Mya","family":"Murray","sequence":"additional","affiliation":[{"name":"Pharmacy, Medical School, Swansea University, Swansea SA2 8PP, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8843-0595","authenticated-orcid":false,"given":"Davide","family":"Arillotta","sequence":"additional","affiliation":[{"name":"Psychopharmacology, Drug Misuse and Novel Psychoactive Substances Research Unit, Hertfordshire Medical School, University of Hertfordshire, Hatfield AL10 9AB, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8463-163X","authenticated-orcid":false,"given":"Luigi","family":"Dattoli","sequence":"additional","affiliation":[{"name":"Department of Neuroscience, Imaging and Clinical Sciences, \u201cG. D\u2019Annunzio\u201d University, 66100 Chieti, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7292-2341","authenticated-orcid":false,"given":"Giovanni","family":"Martinotti","sequence":"additional","affiliation":[{"name":"Department of Neuroscience, Imaging and Clinical Sciences, \u201cG. D\u2019Annunzio\u201d University, 66100 Chieti, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stefania","family":"Bonaccorso","sequence":"additional","affiliation":[{"name":"North Islington Core Team, RCPsych, London N7 8US, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4178-5401","authenticated-orcid":false,"given":"Fabrizio","family":"Schifano","sequence":"additional","affiliation":[{"name":"Psychopharmacology, Drug Misuse and Novel Psychoactive Substances Research Unit, Hertfordshire Medical School, University of Hertfordshire, Hatfield AL10 9AB, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicol\u00f2","family":"Schifano","sequence":"additional","affiliation":[{"name":"ASST Sette Laghi\u2013Circolo e Fondazione Macchi Hospital, via Luigi Borri 57, 21100 Varese, Italy"},{"name":"School of Medicine, Universit\u00e0 degli Studi dell\u2019Insubria, via Ravasi 2, 21100 Varese, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2026,4,4]]},"reference":[{"key":"ref_1","first-page":"1251","article-title":"Efficacy and safety of finasteride therapy for benign prostatic hyperplasia: Results of a 2-year randomized controlled trial (the PROSPECT study). 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