To analyze the adverse events related to ticagrelor usage and evaluate its overall safety profile using the VigiAccess database and existing literature from January 2010 to August 2025.
Key Findings:
Ticagrelor is associated with adverse events such as slow arrhythmia and ventricular cardiac arrest, which necessitate careful clinical monitoring.
The WHO-VigiAccess database recorded a total of 30 adverse drug reactions related to ticagrelor as of August 2025, highlighting the need for ongoing surveillance.
Ticagrelor's unique mechanism of action leads to both therapeutic benefits and potential risks, particularly related to adenosine metabolism, which should be considered in clinical decision-making.
Interpretation:
The findings highlight the need for careful monitoring of ticagrelor's safety profile in clinical practice, particularly regarding serious adverse events such as slow arrhythmia and cardiac arrest.
Limitations:
The VigiAccess database is a spontaneous reporting system, which may lead to under-reporting and bias; future studies should consider complementary data sources.
Reported counts do not allow for estimation of incidence or comparative risk; researchers should aim to establish denominator data in future analyses.
Causal relationships cannot be definitively established from the reported ADRs; further studies are needed to explore these associations.
Conclusion:
Further research is essential to better understand the safety profile of ticagrelor and to guide its clinical application, emphasizing the importance of ongoing monitoring and data collection.
