Purpose: The present study aimed to evaluate the risk of nilotinib-induced cardiac adverse events (CAEs), time to onset, incidence rates, and post hoc outcomes using the Japanese Adverse Drug Event Report database. Methods: We analysed data for the period between April 2004 and March 2022. Data on CAEs were extracted and relative risk of adverse events (AEs) was estimated using the reporting odds ratio (ROR). Results: We analysed 2,021,907 reports and identified 3,545 reports of AEs caused by nilotinib. Of these, 511 reports involved CAEs. Signals were detected for 19 CAEs. Of these, electrocardiogram QT prolonged was the most frequently reported (30.9%). Fatal outcomes were observed in eight AEs: cardiac failure, atrial fibrillation, acute myocardial infarction, pericardial effusion, myocardial infarction, cardiac arrest, pericarditis, and cardiac tamponade. Of these, acute myocardial infarction, myocardial infarction, pericarditis, and cardiac tamponade exhibited mortality rates >10%. A histogram of median times to onset showed nilotinib-associated AEs occurring 3–485 days after nilotinib administration. Conclusions: We focused on CAEs caused by nilotinib as post-marketing AEs. Some cases resulted in serious outcomes. Patients should be monitored for signs of onset of these AEs not only at the start of administration, but for a long period of time.

Aim: The present study aimed to evaluate time to onset, incidence rates, and outcomes for pembrolizumab-induced cardiac adverse events (AEs) in patients with cancer using the Japanese Adverse Drug Event Report database. Methods: We analysed data for the period from April 2004 to March 2022. Data on cardiac AEs were extracted and relative risks of AEs were estimated using the reporting odds ratio. Results: We analysed 2,021,907 reports and identified 15,306 reports of AEs caused by pembrolizumab. Of these, 399 cardiac AEs were associated with pembrolizumab. Signals were detected for six cardiac AEs: myocarditis, immune-mediated myocarditis, pericardial effusion, cardiac tamponade, pericarditis, and pericarditis malignant. A histogram of median times to onset showed occurrence from 33 to 138 days, but some cases occurred even more than 1 year after the start of administration. Among these, myocarditis was the most frequently reported (27.1%), with fatal cases also reported. Conclusion: This study focused on cardiac AEs caused by pembrolizumab as post-marketing AEs. Some cases could potentially involve serious outcomes, so patients should be monitored for signs of onset of these AEs not only at the start of administration, but also over an extended period, especially for myocarditis.