Safety profile of ticagrelor: an analysis based on literature and database review

Ticagrelor, a reversible P2Y12 receptor antagonist, is widely used in acute coronary syndromes (ACS) for its superior efficacy over clopidogrel. However, emerging evidence highlights unique adverse effects, including dyspnea, bradyarrhythmias, QT prolongation, and ventricular pauses. Studies on the real-world safety of ticagrelor are limited. This study aimed to explore the adverse drug reactions (ADRs) linked to ticagrelor and assess their clinical features and management strategies. We retrieved data on ADRs related to the P2Y12 receptor antagonist inhibitors ticagrelor from the World Health Organization (WHO) adverse event reporting system database (VigiAccess) for the period from December,2010 to August 2025. Additionally, we conducted a retrospective analysis of case reports and case series on ticagrelor-related ADRs published from 2010 to 2025. A total of 30,437 ADR reports were analyzed from the WHO-VigiAccess database. The most commonly reported ADRs were dyspnea (6,532 cases, 21.5%), chest pain (1,666 cases, 5.5%), and myocardial infarction (1,337 cases, 4.4%). Bradyarrhythmias, including bradycardia (242 cases), sinus arrest (77 cases), and atrioventricular block (77 cases), were frequently reported. From the literature review, 30 cases of ticagrelor-induced bradyarrhythmias were identified, with a median age of 62.4 years (range: 39–82) and a male predominance (73.3%). The median time to onset was 363 h (range: few mins to 10 months). Management strategies included discontinuation of ticagrelor and switching to clopidogrel or prasugrel, with resolution of symptoms in 93.3% of cases. This review synthesizes data from case and case series reports, and pharmacovigilance databases to analyze ticagrelor’s safety profile, focusing on its adenosine-mediated mechanisms and clinical implications. We propose risk stratification strategies and management algorithms to mitigate these risks, emphasizing the need for vigilant monitoring in high-risk populations. Early identification and active symptomatic treatment to reduce the risk of death are key management strategies.