Pharmacovigilance Analysis of Lifitegrast-Associated Adverse Events Using the FDA Adverse Event Reporting System (FAERS) Database

Lifitegrast is the first lymphocyte function–associated antigen-1 antagonist approved by the United States Food and Drug Administration (FDA) for the treatment of the signs and symptoms of dry eye disease. Its safety has not been fully elucidated in a real-world analysis. Thus, we conducted a pharmacovigilance analysis using data on lifitegrast-associated adverse events (AEs) from the FDA’s adverse event reporting system (FAERS). A comprehensive search of the FAERS database was conducted to extract all available data on lifitegrast from the time of its initial market release (July 2016) until March 2024. Signals of lifitegrast-associated AEs were quantified by calculating reporting odds ratio, proportional reporting ratio, information component, and empirical Bayesian geometric mean. In total 12 929,815 AE reports were collected from the FAERS database. Lifitegrast was deemed the primary suspect in 12 390 of these reports. Comprehensive analysis using four algorithms resulted in the identification and retention of 179 preferred terms exhibiting significant disproportionality. In addition to known AEs, unexpected and novel AEs, such as hypoacusis, instillation site infection, temporomandibular joint syndrome, and reduced blood folate levels, were identified. Most lifitegrast-related AEs identified in this study were consistent with those described on the drug label, but some other signals potentially associated with lifitegrast were identified. Prospective studies are needed to verify and clarify these AEs’ relationship to lifitegrast. 12,390 reports of lifitegrast-related AEs and detected 60 preferred were identified.There were 24 new AEs found in this study, such as hypoacusis, instillation site infection, temporomandibular joint syndrome, and reduced blood folate levels.Our research would provide valuable evidence for healthcare professionals to mitigate the risk of lifitegrast-related AEs, offering practical insights that can help clinical decision-making and patient management during lifitegrast application. 12,390 reports of lifitegrast-related AEs and detected 60 preferred were identified. There were 24 new AEs found in this study, such as hypoacusis, instillation site infection, temporomandibular joint syndrome, and reduced blood folate levels. Our research would provide valuable evidence for healthcare professionals to mitigate the risk of lifitegrast-related AEs, offering practical insights that can help clinical decision-making and patient management during lifitegrast application.