Spectrum and Signals of Medication-Associated Cognitive Disorder: A Comprehensive Disproportionality Analysis with Cross-Database Validation

April 2026 in “ Frontiers in Pharmacology ”

Hao Wen, Yajie Dong, Ruiting Wang

Studysummary This study revealed significant signals of drug-related cognitive disorders in several medications that lack relevant FDA label warnings, suggesting a need for increased clinical awareness and potential label updates.

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This study conducted a comprehensive disproportionality analysis using data from the FDA Adverse Event Reporting System and validated findings with international databases to identify significant signals of drug-related cognitive disorders across 41,775 reports. It found that 50 medications, including finasteride, showed notable signals for cognitive disorders, with 74% lacking relevant warnings on FDA labels. The analysis revealed that certain drugs were disproportionately reported in vulnerable groups, such as children and seniors. The study emphasizes the need for further research and potential updates to drug labels, while noting that the findings indicate statistical associations rather than causal links between the drugs and cognitive disorders.

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research Anxiety and Depression-Like Behaviour Following Short-Term Finasteride Administration Is Associated With Impaired Synaptic Plasticity and Cognitive Behaviour in Male Rats

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This study observed that short-term administration of finasteride in male Wistar rats induced anxiety-like and depression-like behaviors, impaired spatial learning and memory, and reduced synaptic plasticity in the hippocampus, with a trend of increased corticosterone levels noted.

research Association of 5α-Reductase Inhibitors With Dementia, Depression, and Suicide

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This study found that men using 5-alpha-reductase inhibitors showed an increased risk for dementia shortly after starting treatment, which diminished over time, and a consistent association with depression, but no link to suicide.

research Assessment of a Bidirectional Association Between Major Depressive Disorder and Alopecia Areata

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This study found a bidirectional relationship between major depressive disorder and alopecia areata, with each condition significantly increasing the risk of subsequently developing the other.

Treatment of Male Rats with Finasteride, an Inhibitor of 5alpha-Reductase Enzyme, Induces Long-Lasting Effects on Depressive-Like Behavior, Hippocampal Neurogenesis, Neuroinflammation, and Gut Microbiota Composition

research Treatment of Male Rats with Finasteride, an Inhibitor of 5alpha-Reductase Enzyme, Induces Long-Lasting Effects on Depressive-Like Behavior, Hippocampal Neurogenesis, Neuroinflammation, and Gut Microbiota Composition

37 citations , September 2018 in “Psychoneuroendocrinology”

This study found that finasteride treatment in male rats led to enduring effects on depressive-like behavior, hippocampal neurogenesis and neuroinflammation, and gut microbiota composition after withdrawal.

research Neuroactive Steroid Levels and Psychiatric and Andrological Features in Post-Finasteride Patients

58 citations , April 2017 in “The Journal of Steroid Biochemistry and Molecular Biology”

This study found that patients with post-finasteride syndrome exhibited major depressive disorder, severe erectile dysfunction, and neuropathy, alongside altered neuroactive steroid levels in cerebrospinal fluid.

research Studies on Neurosteroids XXV: Influence of a 5α-Reductase Inhibitor, Finasteride, on Rat Brain Neurosteroid Levels and Metabolism

61 citations , January 2008 in “Biological & Pharmaceutical Bulletin”

In this study, finasteride dose-dependently inhibited stress-induced increases in allopregnanolone in rats, while enhancing 20alpha-reduction of progesterone without affecting 3alpha-dihydroprogesterone or 11-deoxycorticosterone levels.