Safety assessment of dexmedetomidine: Real-world adverse event analysis from the Food and Drug Administration Adverse Events Reporting System public dashboard.

Abstract

Dexmedetomidine (DEX), as a widely used medication for sedation, its usage has increased significantly. The concerns about its side effects remain, making a thorough safety evaluation necessary. Data on adverse drug events related to DEX from the first quarter of 2004 to the fourth quarter of 2023 were collected from the US Food and Drug Administration. Signal quantification techniques were used for the analysis, including reporting odds ratios (RORs), proportional reporting ratios, Bayesian confidence propagation neural network and empirical Bayes geometric mean. An analysis of 20,629,811 adverse event (AE) reports identified 1977 cases of DEX-related AEs, covering 24 system organ classes and 344 preferred terms (PTs). The most common PTs were bradycardia (n = 263), cardiac arrest (n = 150), and hypotension (n = 141). Based on the ROR algorithm, the top three were: transcranial electrical motor evoked potential monitoring abnorma, acute motor axonal neuropathy, and trigemino-cardiac reflex. In addition, this study identified the adverse effects such as diabetes insipidus, coronary arteriospasm, and intestinal pseudo-obstruction, which were not previously mentioned in the instructions. It is essential to monitor, identify, and address these adverse reactions effectively.