Key result
Immune checkpoint inhibitors linked to ~3.4-fold higher reporting of pericardial adverse events in FAERS.
Why the study?
Immune checkpoint inhibitors can cause immune-related adverse events in almost any organ, and while myocarditis has received the most attention, data on pericardial disease with ICI use are limited.
Does exposure to immune checkpoint inhibitors increase the reporting frequency of pericardial adverse events compared with other drugs and other antineoplastic agents in the FDA Adverse Event Reporting System?
Observational (n=18,514,045)
Does exposure to immune checkpoint inhibitors increase the reporting frequency of pericardial adverse events compared with other drugs and other antineoplastic agents in the FDA Adverse Event Reporting System?
In FAERS, pericardial adverse events—particularly cardiac tamponade and pericardial effusion—are disproportionately reported with immune checkpoint inhibitors compared to all other drugs, although the excess reporting is modest when compared against other antineoplastic agents and has declined over time.
Answers are grounded in this paper and cite their sources.
May warrant closer pericardial monitoring with ICIs; leaves open true incidence versus reporting bias.
Background Immune checkpoint inhibitors (ICIs) can cause immune-related adverse events in almost any organ. While myocarditis has received the most attention, data on pericardial disease with ICI use are limited. We examined pericardial adverse event reporting with nine ICIs using the FDA Adverse Event Reporting System (FAERS). Methods We combined legacy AERS and current FAERS quarterly files from January 2011 to June 2026 into 18,629,240 unique cases, deduplicated by case number, and removed cases the FDA had listed as deleted. ICI exposure was identified from generic names, brand names, development code names and the active-ingredient field. Pericardial events were defined by seven MedDRA preferred terms. We estimated reporting odds ratios (ROR), proportional reporting ratios (PRR), Bayesian information components (IC) and empirical Bayes geometric means (EBGM). We also examined myocarditis co-reporting, time trends, a comparison with other antineoplastic agents, a MedDRA query-based outcome, and 14 alternative definitions. Results The analysis included 18,514,045 cases: 277,434 involved an ICI, 34,792 carried a pericardial term, and 1,680 had both. Pericardial events were reported disproportionately with ICIs (ROR 3.35 (95% CI 3.19 to 3.52); PRR 3.34; IC025 1.62). Eight of nine agents had a ROR above 1 (3.32 to 5.63). Among the most frequently reported terms, estimates were highest for cardiac tamponade (5.59 (95% CI 4.98 to 6.28)), followed by pericardial effusion (3.83 (95% CI 3.60 to 4.07)) and pericarditis (2.09 (95% CI 1.89 to 2.31)). After removing cases that also reported myocarditis, the ROR was 3.13 (95% CI 2.98 to 3.30). Most sensitivity analyses gave similar estimates (ROR 3.13 to 3.47); defining exposure by generic drug names alone, which identified only 44% of exposed cases, gave 3.99. Compared with cases naming other L01 antineoplastic agents, the ROR was 1.13 (95% CI 1.08 to 1.19): 1.28 (95% CI 1.20 to 1.36) for ICI-only cases and 0.96 (95% CI 0.89 to 1.04) when another antineoplastic was also named. The ICI-specific reporting odds ratio fell each quarter (odds ratio 0.977 per quarter, 95% CI 0.973 to 0.980). Conclusions In FAERS, pericardial events were reported more often with ICIs than with other drugs across most agents and terms; however, incidence and causation cannot be determined. The excess over other antineoplastic agents was small, and reporting disproportionality declined over time. These findings support clinical awareness of pericardial disease in patients receiving ICIs and warrant study in data that can measure incidence.
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Balakrishna et al. (2026) conducted an observational in Pericardial adverse events in patients receiving immune checkpoint inhibitors (n=18,514,045). Immune checkpoint inhibitors (ipilimumab, tremelimumab, nivolumab, pembrolizumab, cemiplimab, dostarlimab, atezolizumab, durvalumab, avelumab) vs. Reference cases in FAERS naming none of the nine study immune checkpoint inhibitors (and secondary comparison against other L01 antineoplastic agents) was evaluated on Pericardial adverse events defined by seven MedDRA preferred terms (pericarditis, pericardial effusion, cardiac tamponade, pericarditis constrictive, autoimmune pericarditis, pericardial disease, immune-mediated pericarditis) (ROR 3.35, 95% CI 3.19 to 3.52). Immune checkpoint inhibitors were associated with disproportionately higher reporting of pericardial events compared to all other drugs in FAERS (0.61% vs 0.18%; ROR 3.35, 95% CI 3.19 to 3.52).
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