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Signal Detection of Depression and Suicidality Associated with Finasteride and Dutasteride: Updated Pharmacovigilance Evidence and Recommendations for Comprehensive Psychiatric Assessment

Stefania Chiappini Orcid Logo, John Martin Corkery Orcid Logo, Amira Guirguis Orcid Logo, Alessio Mosca Orcid Logo, Mya Murray Orcid Logo, Davide Arillotta Orcid Logo, Luigi Dattoli Orcid Logo, Giovanni Martinotti Orcid Logo, Stefania Bonaccorso, Fabrizio Schifano Orcid Logo, Nicolò Schifano

Brain Sciences, Volume: 16, Issue: 4, Start page: 394

Swansea University Authors: Amira Guirguis Orcid Logo, Mya Murray Orcid Logo

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DOI (Published version): 10.3390/brainsci16040394

Abstract

Background/Objectives: Finasteride and dutasteride are 5α-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, f...

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Published in: Brain Sciences
ISSN: 2076-3425
Published: MDPI AG 2026
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Used mainly for benign prostatic hyperplasia and androgenic alopecia, finasteride selectively inhibits type-2 5&#x3B1;-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&#x2014;including depression, suicidal ideation, and cognitive decline&#x2014;potentially 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. 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spelling 2026-05-06T15:25:46.9710784 v2 71711 2026-04-02 Signal Detection of Depression and Suicidality Associated with Finasteride and Dutasteride: Updated Pharmacovigilance Evidence and Recommendations for Comprehensive Psychiatric Assessment b49270b9a0d580cf4f31f9a1b6c93f87 0000-0001-8255-0660 Amira Guirguis Amira Guirguis true false bb0ac1b4e7191ba6380658c553cefdeb 0009-0000-6870-0941 Mya Murray Mya Murray true false 2026-04-02 MEDS Background/Objectives: Finasteride and dutasteride are 5α-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 5α-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—including depression, suicidal ideation, and cognitive decline—potentially 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. Journal Article Brain Sciences 16 4 394 MDPI AG 2076-3425 finasteride; dutasteride; FAERS; pharmacovigilance; suicide; depression; anxiety; libido; sexual dysfunctions 4 4 2026 2026-04-04 10.3390/brainsci16040394 COLLEGE NANME Medical School COLLEGE CODE MEDS Swansea University Not Required 2026-05-06T15:25:46.9710784 2026-04-02T18:35:22.5301143 Faculty of Medicine, Health and Life Sciences Swansea University Medical School - Pharmacy Stefania Chiappini 0000-0002-6810-1540 1 John Martin Corkery 0000-0002-3849-817x 2 Amira Guirguis 0000-0001-8255-0660 3 Alessio Mosca 0000-0003-3832-1398 4 Mya Murray 0009-0000-6870-0941 5 Davide Arillotta 0000-0002-8843-0595 6 Luigi Dattoli 0000-0002-8463-163x 7 Giovanni Martinotti 0000-0002-7292-2341 8 Stefania Bonaccorso 9 Fabrizio Schifano 0000-0002-4178-5401 10 Nicolò Schifano 11 71711__36670__63ea1a250db64cb381b6e885c5cbf677.pdf 71711.VOR.pdf 2026-05-06T15:21:48.3843236 Output 1190724 application/pdf Version of Record true © 2026 by the authors. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license. true eng https://creativecommons.org/licenses/by/4.0/
title Signal Detection of Depression and Suicidality Associated with Finasteride and Dutasteride: Updated Pharmacovigilance Evidence and Recommendations for Comprehensive Psychiatric Assessment
spellingShingle Signal Detection of Depression and Suicidality Associated with Finasteride and Dutasteride: Updated Pharmacovigilance Evidence and Recommendations for Comprehensive Psychiatric Assessment
Amira Guirguis
Mya Murray
title_short Signal Detection of Depression and Suicidality Associated with Finasteride and Dutasteride: Updated Pharmacovigilance Evidence and Recommendations for Comprehensive Psychiatric Assessment
title_full Signal Detection of Depression and Suicidality Associated with Finasteride and Dutasteride: Updated Pharmacovigilance Evidence and Recommendations for Comprehensive Psychiatric Assessment
title_fullStr Signal Detection of Depression and Suicidality Associated with Finasteride and Dutasteride: Updated Pharmacovigilance Evidence and Recommendations for Comprehensive Psychiatric Assessment
title_full_unstemmed Signal Detection of Depression and Suicidality Associated with Finasteride and Dutasteride: Updated Pharmacovigilance Evidence and Recommendations for Comprehensive Psychiatric Assessment
title_sort Signal Detection of Depression and Suicidality Associated with Finasteride and Dutasteride: Updated Pharmacovigilance Evidence and Recommendations for Comprehensive Psychiatric Assessment
author_id_str_mv b49270b9a0d580cf4f31f9a1b6c93f87
bb0ac1b4e7191ba6380658c553cefdeb
author_id_fullname_str_mv b49270b9a0d580cf4f31f9a1b6c93f87_***_Amira Guirguis
bb0ac1b4e7191ba6380658c553cefdeb_***_Mya Murray
author Amira Guirguis
Mya Murray
author2 Stefania Chiappini
John Martin Corkery
Amira Guirguis
Alessio Mosca
Mya Murray
Davide Arillotta
Luigi Dattoli
Giovanni Martinotti
Stefania Bonaccorso
Fabrizio Schifano
Nicolò Schifano
format Journal article
container_title Brain Sciences
container_volume 16
container_issue 4
container_start_page 394
publishDate 2026
institution Swansea University
issn 2076-3425
doi_str_mv 10.3390/brainsci16040394
publisher MDPI AG
college_str Faculty of Medicine, Health and Life Sciences
hierarchytype
hierarchy_top_id facultyofmedicinehealthandlifesciences
hierarchy_top_title Faculty of Medicine, Health and Life Sciences
hierarchy_parent_id facultyofmedicinehealthandlifesciences
hierarchy_parent_title Faculty of Medicine, Health and Life Sciences
department_str Swansea University Medical School - Pharmacy{{{_:::_}}}Faculty of Medicine, Health and Life Sciences{{{_:::_}}}Swansea University Medical School - Pharmacy
document_store_str 1
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description Background/Objectives: Finasteride and dutasteride are 5α-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 5α-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—including depression, suicidal ideation, and cognitive decline—potentially 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.
published_date 2026-04-04T06:22:26Z
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