A FAERS pharmacovigilance analysis of dementia-related adverse event reports.
6 affiliations
- 1Department of Gastroenterology, Mianyang Central Hospital, School of Medicine, University of Electronic Science and Technology of China, Mianyang, Sichuan, China.
- 2Department of Radiology, West China Hospital Sichuan University Jintang Hospital, Jintang First People's Hospital, Chengdu, China.
- 3Department of Pharmacy, The Affiliated Hospital, Southwest Medical University, Luzhou, China.
- 4Department of Clinical Pharmacy, School of Pharmacy, Southwest Medical University, Luzhou, China.
- 5College of Pharmaceutical Sciences, Guizhou University of Traditional Chinese Medicine, Guiyang, China.
- 6Department of Pharmacy, Mianyang Central Hospital, School of Medicine, University of Electronic Science and Technology of China, Mianyang, Sichuan, China.
Abstract
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.
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BibTeX
@article{tao2026faers,
title = {{A FAERS pharmacovigilance analysis of dementia-related adverse event reports.}},
author = {Tiantian Tao and Bingyao Liu and Chao Tao and Weiyi Chen and Ruixiao Li and Shiying Mao and Ke Wang and Meiling Zhou and Xianbin Liu},
journal = {Medicine},
year = {2026},
month = oct,
doi = {10.1097/md.0000000000051134},
url = {https://europepmc.org/article/MED/42888596},
note = {CC BY},
}
RIS
TY - JOUR
TI - A FAERS pharmacovigilance analysis of dementia-related adverse event reports.
AU - Tiantian Tao
AU - Bingyao Liu
AU - Chao Tao
AU - Weiyi Chen
AU - Ruixiao Li
AU - Shiying Mao
AU - Ke Wang
AU - Meiling Zhou
AU - Xianbin Liu
PY - 2026
DA - 2026/10/01
JO - Medicine
DO - 10.1097/md.0000000000051134
UR - https://europepmc.org/article/MED/42888596
AB - 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.
SN - 0304-5412
SN - 1536-5964
ER -