Drug-induced dementia: a pharmacovigilance analysis of the FAERS database

Dementia is a global public health challenge. Certain medications, such as anticholinergics and benzodiazepines, have been linked to an increased dementia risk. However, most studies focused on a limited range of drugs, lacking a comprehensive overview. This article addressed this gap by analyzing drugs associated with dementia using data from the FDA Adverse Event Reporting System (FAERS).

The FAERS database was queried using Open Vigil 2.1 to extract reports of drug-induced dementia events from January 2004 to September 2023. Signal detection was performed using Reporting Odds Ratio (ROR) and Proportional Reporting Ratio methods.

We analyzed 21,509 reports. There were 163 drugs positively associated with dementia, including neurological drugs (51 drugs, 31.3%), cardiovascular drugs (25 drugs, 15.3%), alimentary tract/metabolism drugs (24 drugs, 14.7%) and genito urinary system/sex hormones drugs (15 drugs, 9.2%). Besides neurological drugs, the drugs with the highest number of reports were apixaban, valsartan and atorvastatin.

We found that tamsulosin, alfuzosin, and megestrol may be associated with an increased risk of dementia, and further research is required to clarify these relationships. In clinical practice, it is important to monitor the cognitive status of patients when using drugs that may increase the risk of dementia.