The Safety Profile of Ticagrelor among Older Adults (Age ≥75 years): A Pharmacovigilance Analysis.

INTRODUCTION

Ticagrelor is a widely used potent P2Y12 inhibitor in patients aged ≥75 years with acute coronary syndromes. Despite its widespread use, data on ticagrelor's safety in older adults remain limited.

METHODS

We performed a retrospective pharmacovigilance analysis using the FDA Adverse Event Reporting System from 2010 to 2024. Disproportionality analysis compared ticagrelor with clopidogrel, assessing predefined adverse events in adults (<75 years) and older adults (≥75 years). For each group, reporting odds ratios (RORs) with 95% confidence intervals (CIs) were calculated, and differences between age groups were evaluated using interaction analysis.

RESULTS

A total of 6,476 ticagrelor-related adverse event reports were included: 4,795 (74%) adults and 1,681 (26%) older adults. In older adults, ticagrelor was not associated with increased reporting of dyspnea, intracranial hemorrhage, complete atrioventricular block, or gout. Acute kidney injury (AKI) was the only event reported more frequently in older adults (ROR 2.3 [95% CI: 1.5-3.6] vs. 0.6 [95% CI: 0.4-0.9]; p < 0.001). Ticagrelor was associated with lower reporting of gastrointestinal bleeding, hematuria, hemoptysis, and anemia in both age subgroups. Bradycardia and syncope were reported more frequently among adults (p = 0.002 and p < 0.001, respectively).

CONCLUSION

Ticagrelor appears generally safe in older adults (≥75 years), with no excess reporting of major adverse events compared to younger adults, aside from a higher reporting of AKI.