Revista Brasileira de Psiquiatria · Nov 6, 2026

Drugs Associated with Dementia-Related Adverse Event Reports: A Real World Pharmacovigilance Study

By Huang M, Ren H, Ren X et al.

OBJECTIVE: Numerous pharmacological agents have been implicated in elevating the risk of dementia onset. The present study employs a systematic methodology to examine drugs associated with dementia-related adverse event reports. METHODS: The present study extracted case of drugs associated with dementia-related adverse event reports from the FDA Adverse Event Reporting System (FAERS) covering the period from the first quarter of 2004 to the first quarter of 2025. The Reporting Odds Ratio (ROR) was employed as the principal metric for disproportionality analysis. Methodological robustness was validated through the application of the Proportional Reporting Ratio (PRR), the Bayesian Confidence Propagation Neural Network (BCPNN), and the Multi-item Gamma Poisson Shrinker (MGPS). Variable selection was facilitated using least absolute shrinkage and selection operator (LASSO) regression. Temporal relationships were examined via Time-to-Onset analysis. Clinical outcomes among patients with dementia-related adverse event reports were evaluated, including rates of mortality and disability. Furthermore, the clinical indications for the implicated pharmaceuticals were systematically investigated. RESULTS: A total of 13 pharmaceutical agents were ultimately identified as exhibiting a potential association with dementia onset: Apixaban, Insulin glargine, Tafamidis, Insulin lispro, Sacubitril valsartan, Quetiapine, Zoledronic acid, Alendronic acid, Enzalutamide, Pregabalin, Rofecoxib, Dapagliflozin, and Valproic acid. The median time to dementia development following drug initiation was 73 days (interquartile range: 529 days), indicating that 75% of reported cases occurred within approximately 1.45 years post-exposure. Furthermore, the top five agents associated with the highest mortality rates in dementia-related adverse event reports associated with drug exposure were identified as Rofecoxib, Zoledronic acid, Tafamidis, Alendronic acid and Enzalutamide, while the top five agents linked to the highest disability rates included Valproic acid, Alendronic acid, Insulin glargine, Rofecoxib and Zoledronic acid. Finally, the primary clinical indications for these 13 drugs were analyzed. Clinicians should exercise heightened vigilance regarding the potential onset of dementia when utilizing these medications in patient care. CONCLUSION: These findings contribute to early signal detection for pharmacologically associated dementia and may guide clinical medication management, yet they remain pharmacovigilance signals that require prospective confirmation.

doi.org/10.47626/1516-4446-2026-4811Open accessPubMed 42993875Populations