Analysis of Onset Timing and Risk Factors for Mesalazine-related Adverse Events Using the JADER Database

BACKGROUND/AIM: Mesalazine is a cornerstone therapy in the treatment of inflammatory bowel disease (IBD). Although formulated for local action, it can cause serious adverse events (AEs), such as interstitial lung disease and myocarditis, as well as mesalazine-specific drug intolerance. However, the timing of onset and associated risk factors remain insufficiently understood. This study aimed to analyze the onset timing and risk factors for mesalazine-related AEs using the Japanese Adverse Drug Event Report (JADER) database to provide pharmacists with essential information for effective monitoring of AEs. PATIENTS AND METHODS: Reporting odds ratios (RORs) for mesalazine-associated AEs in the JADER database were calculated to detect safety signals. Time-to-onset analyses were performed to classify patterns of mesalazine-induced AEs. Risk factors for mesalazine-induced drug intolerance were further evaluated using multivariate logistic regression analysis. RESULTS: -values