Frontiers in Medicine
Real-world safety profile of alectinib: a 10-year pharmacovigilance study based on the FDA adverse event reporting system
Objective Alectinib is the standard first-line therapy for treatment-naïve ALK-positive non-small cell lung cancer (NSCLC). Given its increasing clinical utilization, a comprehensive pharmacovigilance evaluation of its adverse events (AEs) is warranted. Methods We assessed alectinib-associated AEs using the FDA Adverse Event Reporting System (FAERS) database from Q4 2015 to Q3 2025. AEs were categorized per MedDRA, and four disproportionality analysis algorithms were used to detect potential safety signals. Results …