Risk assessment of the top 50 drugs associated with drug-induced orthostatic hypotension: a disproportionality analysis of the FAERS and JADER databases

To use the FDA Adverse Event Reporting System (FAERS) database to identify drugs associated with orthostatic hypotension. Adverse event reports of orthostatic hypotension from Q1 2004 to Q3 2024 were obtained from the FAERS and JADER databases. We employed algorithms such as the reporting odds ratio (ROR), the proportional reporting ratio (PRR), the Bayesian confidence propagation neural network (BCPNN), and the multi-item gamma Poisson shrinker (MGPS) for signal detection. JADER database was used to validate the findings from FAERS analysis. We identified 15,737 adverse events associated with orthostatic hypotension, involving 15,480 patients for analysis. The patient demographic included 6,745 males (43.5%) and 7,248 females (46.8%), with the largest group comprising adults over 65 years (7,654 cases, 49.4%). The three drugs with the highest ROR risk signals were terazosin [ROR (95% CI): 153.96 (124.57-190.28)], rasagiline [ROR (95% CI): 37.46 (29.99–46.78)], and doxazosin [ROR (95% CI): 37.06 (31.32–43.86)]. Apomorphine, abalopatine and levodopa were associated with the shortest onset time of orthostatic hypotension. Most of the signal detection results from the FAERS database were verified in the JADER database. Drugs associated with orthostatic hypertension still focused on cardiovascular and nervous system drugs. This study employed the FAERS database to identify 33 drugs that may be potentially linked to orthostatic hypotension. Medical workers should remain vigilant regarding the risk of these drugs causing orthostatic hypotension.