Analysis of Adverse Drug Reactions of Clofazimine Reported in the FDA Adverse Event Reporting System from 2004 to 2025 Q1

Our pharmacovigilance assessment of FAERS data from 2004 to 2025 not only identified multiple serious and consistent safety signals associated with clofazimine such as prolonged QT intervals but also revealed a life-threatening AE respiratory failure. Although the analysis of these AEs cannot directly reflect causal relationships due to the nature of the FAERS data from spontaneous reporting, our findings highlight the critical importance of continuous pharmacovigilance, targeted clinical monitoring, and consideration of sex-based risk differences to ensure the safe use of clofazimine in clinical practice.