Objective To analyse adverse drug event (ADE) signals associated with dexmedetomidine using the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database, and to provide a reference for drug safety monitoring and rational clinical use.

Methods Reports of dexmedetomidine-associated ADEs submitted to the FAERS database from 2004 through the first quarter of 2026 were retrieved. Signal detection was performed using the reporting odds ratio, proportional reporting ratio, Bayesian confidence propagation neural network, and multi-item gamma Poisson shrinker methods. Signals were classified by system organ class (SOC) and preferred term (PT) according to the Medical Dictionary for Regulatory Activities (MedDRA, version 26.1), and the time-to-onset characteristics of ADEs were analyzed.

Results A total of 2,456 ADE reports in which dexmedetomidine was designated as the primary suspect drug were identified. Overall, 216 positive PT signals simultaneously meeting the criteria of all four signal-detection algorithms were detected, involving 27 SOCs. At the SOC level, cardiac disorders, vascular disorders, and endocrine disorders met the positive-signal criteria of all four algorithms. Based on the MedDRA SOC classification of PTs, ADE occurrences were mainly distributed across cardiac disorders; injury, poisoning and procedural complications; and general disorders and administration site conditions. The five most frequently reported PTs were bradycardia, off-label use, cardiac arrest, hypotension, and diabetes insipidus. In addition to risks already documented in the prescribing information, including bradycardia, hypotension, sinus arrest, diabetes insipidus, and polyuria, this study also identified suspected signals such as coronary artery spasm and torsade de pointes that were not explicitly listed as identical PTs in the prescribing information and warrant further attention and validation. The median time to onset of ADEs was 2.00 days (IQR: 1.00-5.75 days), and most events occurred within 0-30 days after treatment initiation.

Conclusion Dexmedetomidine-associated ADEs involved a broad range of events and were predominantly reported during the early treatment period. Enhanced early monitoring and risk prevention are warranted in clinical practice, with particular attention to heart rate, blood pressure, arrhythmias, fluid and electrolyte disturbances, and withdrawal reactions. Greater vigilance is especially needed in perioperative settings, during intensive care unit sedation, and when dexmedetomidine is co-administered with anesthetic agents or other drugs with cardiovascular depressant effects.

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