A FAERS pharmacovigilance analysis of dementia-related adverse event reports

Dementia-related adverse event (AE) reports represent an important area of concern in pharmacovigilance, particularly considering the clinical relevance of cognitive impairment and the complexity of medication use among older adults. This study aims to systematically characterize the reporting patterns of dementia-related AEs and detect disproportionality signals. Dementia-related AE reports in the Food and Drug Administration Adverse Event Reporting System database from the first quarter of 2004 to the first quarter of 2024 were analyzed using the reporting odds ratio and proportional reporting ratio methods. The reports were classified and organized at the Standardized Medical Dictionary for Regulatory Activities Queries and Preferred Term levels to explore the potential association strength between drug-associated dementia and the related drugs and drug categories. We identified a total of 33,772 AE reports related to dementia, with 1103 drugs reported as the main suspected drugs. Overall, immunosuppressants, psycholeptics, and antineoplastic agents were the most frequently reported drug categories. Among them, apixaban exhibited the highest number of AE reports, followed by pimavanserin and lenalidomide. Notably, psycholeptics represented the highest proportion of the top 30 drugs by AE report count. Disproportionality analysis showed that 191 and 135 drugs were associated with potential signals of dementia. This study provides a comprehensive overview of dementia-related AE reports from a pharmacovigilance perspective, offering pharmacovigilance signals that may inform further drug safety evaluation.