A Real-World Pharmacovigilance Study of FDA Adverse Event Reporting System (FAERS) for Fedratinib

BackgroundUsing the FDA Adverse Event Reporting System (FAERS) database, this pharmacovigilance investigation systematically assessed the adverse events (AEs) associated with Fedratinib use in real-world clinical practice. MethodsUsing the FAERS database, we performed a disproportionality analysis incorporating four distinct signal detection methodologies: ROR, PRR, BCPNN, and MGPS. Subgroup analyses were conducted to evaluate the effects of age and gender on Fedratinib-associated AEs. Furthermore, a time-to-onset analysis was performed to characterize the temporal patterns of AEs. ResultsThe FAERS database comprised 10,011,422 individual case safety reports, of which 1,284 were classified as Fedratinib-related AEs, encompassing 38 significant preferred terms (PTs). The most frequently reported adverse reactions included diarrhoea, nausea, vomiting, constipation, abdominal discomfort, fatigue, anaemia, platelet count decreased, and Wernickes encephalopathy. New AEs emerged from the study, such as blood potassium increased, hyperkalaemia, gout, hypocalcaemia, renal failure, renal disorder, and gallbladder disorder. Higher rates were observed in males over 65 years of age. Most cases occurred within the first month of Fedratinib treatment, with the incidence of related AEs decreasing over time. ConclusionThis current study marks the debut investigation regarding Fedratinibs safety in actual clinical practice, which providing substantive evidence to inform future pharmacovigilance investigations of this drug.