Objective Immunosuppressive regimens after renal transplantation usually include a combination of calcineurin inhibitors, corticosteroids, and a proliferation inhibitor, either azathioprine or mycophenolate mofetil (MMF), to prevent rejection and maintain graft function. MMF has a stronger immunosuppressive effect than does azathioprine. This study aimed to examine MMF-associated adverse events in renal transplant patients. Methods Retrospective pharmacovigilance disproportionality analysis was conducted using the Japanese Adverse Drug Event Report database. Results A total of 11,594 adverse drug events were reported in renal transplant patients; 10,272 (88.6%) involved adults and 1322 (11.4%) involved children. In adult patients, the most frequent adverse events induced by MMF were cytomegalovirus infection (272 reports), urinary tract infection (69 reports), and polyomavirus-associated nephropathy (61 reports). Among adverse events, the highest reporting odds ratio (ROR) was found for cytomegalovirus infection (ROR, 1.58; 95% confidence interval, 1.36–1.83). In pediatric patients, the rank order for MMF-associated adverse events was cytomegalovirus infection (27 reports), bronchitis (23 reports), and cytomegalovirus viremia (19 reports), but these adverse events were not detected as a signal. Conclusion Our results show the safety profile of MMF in pediatric renal transplant patients. These findings can be used to update information used for prescriptions for pediatric patients.
Evaluation of tacrolimus abbreviated area-under-the-curve monitoring in renal transplant patients who are potientially at risk for adverse events
