Mining of Adverse Event Signals Associated with Fluticasone Furoate/Umeclidinium/Vilanterol Triple Therapy: A Post-Marketing Analysis Based on FAERS

Chronic obstructive pulmonary disease (COPD) is a major global health burden. The fluticasone furoate (FF)/umeclidinium (UMEC)/vilanterol (VI) triple therapy provides new treatment, but its long-term real-world safety lacks evidence. A post-marketing analysis used the FAERS database to identify adverse event (AE) signals for FF/UMEC/VI. Disproportionality methods including reporting odds ratio (ROR), proportional reporting ratio (PRR), information component (IC), and empirical Bayesian geometric mean (EBGM), were applied to detect AE signals, focusing on reports from third quarter (Q3) 2019 to Q3 2024. Among 16,238 reports listing FF/UMEC/VI as primary suspect, significant AE signals occurred in ‘injury, poisoning and procedural complications’ (n = 9067, ROR 2.46, PRR 2.08, IC 1.06, EBGM 2.08), and ‘respiratory, thoracic and mediastinal disorders’ (n = 6567, ROR 4.87, PRR 4.15, IC 2.05, EBGM 4.13). A total of 196 significantly disproportionate preferred terms (PTs) were identified, including previously undocumented AEs such as chronic eosinophilic rhinosinusitis, dysphonia, and vocal cord dysfunction. This post-marketing safety study revealed significant signals for dysphonia and vocal cord dysfunction associated with FF/UMEC/VI, suggesting that clinicians should remain vigilant for these events.