Mao_2025_Int.J.Risk.Saf.Med__9246479251385395

Background: People with dementia (PwDs) are particularly vulnerable to adverse events (AEs). Recognising and understanding AEs is essential to improve patient safety.Objective: This study analysed FAERS data from the past decade to identify AE symptom characteristics in PwDs.MethodsThe FAERS data (2014-2024) was reviewed, extracting reports with dementia as an indication. The reports' features were described and analysed, including k-means clustering to identify patterns.Results: From 2014 to 2024, 20,913 reports related to PwDs were extracted. Consumers and health care professionals were the most common reporters. Regarding patient outcomes, 38.7% of records reported hospitalisation and 10.6% reported death. The most frequently reported AEs were death, aggression, and bradycardia. Cholinesterase inhibitors (ChEIs), antipsychotics, and anticonvulsants were frequently associated with nervous system and psychiatric disorders. K-means clustering identified four groups, with older PwDs on ChEIs experiencing cardiovascular issues, while younger PwDs on antipsychotics faced higher mortality, drug ineffectiveness, and fall risks.Conclusions: Many symptoms observed in PwDs are often attributed to ageing or disease progression, potentially obscuring their link to drug-related causes. Enhancing AE reporting across healthcare roles, promoting public awareness, conducting regular medication reviews, and providing training in early detection are vital for the safe management of dementia.