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<p>Tyrosine kinase inhibitors (TKIs) have revolutionized the treatment of cancer and immune disorders. However, their cardiotoxicity, particularly the risk of atrial fibrillation (AF), raises growing concerns. We aimed to comprehensively examine the associations between TKIs and AF using real-world pharmacovigilance data. We conducted a case–control study by analyzing adverse event (AE) reports from the FDA Adverse Event Reporting System between 2004 and 2023 for 56 FDA-approved TKIs. AF cases were identified using the preferred term “atrial fibrillation”. Patient characteristics were compared between fatal and non-fatal cases. Disproportionality analysis, quantified using the reporting odds ratio (ROR), was employed to assess the associations between TKIs and AF. Among 561,551 TKI-related AE reports, 3794 (0.7%) involved AF. The majority of AF events (89.7%) were classified as serious, with 11.3% associated with fatal outcomes. Significant differences in gender, age, drug categories, and systems involved in the indication were observed between fatal and non-fatal outcome groups (all <i>P</i> &lt; 0.05). Disproportionality analysis identified 12 TKIs significantly associated with AF. Notably, Bruton’s tyrosine kinase inhibitors showed the strongest signals, with ibrutinib (ROR: 9.83; 95% CI: 9.34–10.34) leading, followed by zanubrutinib (ROR: 6.29; 95% CI: 3.70–10.69) and acalabrutinib (ROR: 5.58; 95% CI: 4.38–7.11). Additionally, nine other TKIs, including nilotinib, ponatinib, and nintedanib, among others, were associated with increased reporting frequencies. These findings suggest that certain TKIs are associated with an elevated risk of AF, underscoring the importance of vigilant cardiovascular monitoring during TKI therapy.</p>

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Atrial fibrillation associated with tyrosine kinase inhibitors: A case–control study of real-world pharmacovigilance data

  • 期刊论文

  • 发表日期：

    2026年2月10日

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  • Jun Wang,
  • Jing Shi,
  • Chenyu Guo

摘要

Tyrosine kinase inhibitors (TKIs) have revolutionized the treatment of cancer and immune disorders. However, their cardiotoxicity, particularly the risk of atrial fibrillation (AF), raises growing concerns. We aimed to comprehensively examine the associations between TKIs and AF using real-world pharmacovigilance data. We conducted a case–control study by analyzing adverse event (AE) reports from the FDA Adverse Event Reporting System between 2004 and 2023 for 56 FDA-approved TKIs. AF cases were identified using the preferred term “atrial fibrillation”. Patient characteristics were compared between fatal and non-fatal cases. Disproportionality analysis, quantified using the reporting odds ratio (ROR), was employed to assess the associations between TKIs and AF. Among 561,551 TKI-related AE reports, 3794 (0.7%) involved AF. The majority of AF events (89.7%) were classified as serious, with 11.3% associated with fatal outcomes. Significant differences in gender, age, drug categories, and systems involved in the indication were observed between fatal and non-fatal outcome groups (all P < 0.05). Disproportionality analysis identified 12 TKIs significantly associated with AF. Notably, Bruton’s tyrosine kinase inhibitors showed the strongest signals, with ibrutinib (ROR: 9.83; 95% CI: 9.34–10.34) leading, followed by zanubrutinib (ROR: 6.29; 95% CI: 3.70–10.69) and acalabrutinib (ROR: 5.58; 95% CI: 4.38–7.11). Additionally, nine other TKIs, including nilotinib, ponatinib, and nintedanib, among others, were associated with increased reporting frequencies. These findings suggest that certain TKIs are associated with an elevated risk of AF, underscoring the importance of vigilant cardiovascular monitoring during TKI therapy.