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

Figures

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  Figure 1. Flow chart of Japanese Adverse Drug Event Report (JADER) analysis for mesalazine-induced adverse events (AEs). Reports published between April 2004 and January 2025 were extracted from the JADER database. Three datasets (DEMO, DRUG, and REAC) were merged, and only records involving mesalazine and adverse events of special interest (AESI) were retained. This dataset was used to calculate the reporting odds ratios (RORs), time to cause an adverse event, and the effects of background and concomitant drugs.

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  Figure 2. Time to mesalamine-induced adverse events of special interest (AESI). Frequency polygon (histogram displayed as a polygon) for the time-to-onset of AESI for mesalazine. The horizontal axis represents the number of days from mesalazine administration to the onset of AESI.

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  Figure 3. Histogram and Weibull shape parameter of mesalazine-induced adverse events of special interest (AESI). The histogram and Weibull shape parameters of mesalazine-induced AESI were generated according to a previous report (9). The right panel shows box plots in which the horizontal line within each box denotes the median. The lower and upper boundaries of the box correspond to the first (25th percentile) and third (75th percentile) quartiles, respectively. The diamonds indicate the mean and 95% confidence intervals. Whiskers extend to the most extreme data points within 1.5 times the interquartile range. The brackets outside the box represent the shortest half, corresponding to the densest 50% of the observations. A) Drug hypersensitivity, B) Hypersensitivity, C) Pleurisy, D) Drug intolerance, E) Myocarditis, F) Pericarditis, G) Hepatic function abnormal, H) Pancreatitis, I) Pancreatitis acute, J) Eosinophilic pneumonia, K) Eosinophilic pneumonia, L) Interstitial lung disease, M) Agranulocytosis, N) Jaundice, O) Neutropenia, P) Drug reaction with eosinophilia and systemic symptoms, Q) Tubulointerstitial nephritis, R) Pancytopenia, S) Leukopenia, T) Aplastic anemia.