Comprehensive safety analysis of adverse events associated with eptinezumab in migraine treatment.

Migraine significantly impacts quality of life, with eptinezumab emerging as a promising calcitonin gene-related peptide-targeting therapy. Real-world data and clinical trials are crucial for evaluating its safety and effectiveness comprehensively. This study evaluated its safety using a dual approach: pharmacovigilance analysis of the FDA's Adverse Event Reporting System (FAERS) database (2020-2024) and a systematic review with meta-analysis of clinical trials. FAERS data identified 5,306 adverse event (AE) reports, with "drug ineffective" (ROR = 6.71) and "migraine" (ROR = 67.45) as the strongest signals. Serious adverse events (SAEs) included anaphylactic reactions (ROR = 4.19) and rare events like increased intracranial pressure. Most AEs occurred within the first treatment month. A meta-analysis of six trials (n = 3,148) found no increased overall AE risk versus placebo (RR = 1.02, 95% CI 0.95-1.10) but a higher SAE incidence (RR = 2.87, 95% CI 1.27-6.48). Upper respiratory infections were more frequent (RR = 1.49, P = 0.04), while dizziness, nausea, and fatigue showed no significant differences. Eptinezumab shows promise but warrants further research on safety in vulnerable populations and real-world settings.