OBJECTIVE: To explore and analyze the adverse event signals of ticagrelor after the listing

and provide reference for the safe clinical use of the drug. METHODS: From the US Food and Drug Administration Adverse Event Reporting System（FAERS） database

42 quarters of adverse event reports due to ticagrelor were extracted from the first quarter of 2011 to the second quarter of 2021. The data mining and signal detection were performed by reporting odds ratio（ROR） and proportional reporting ratio（PRR）. RESULTS: A total of 34 611 adverse event records with ticagrelor as the primary suspected drugs were extracted

and a total of 317 adverse event signals were detected

including 13 930 adverse event reports in 20 system and organ classifications

among which cardiac diseases（3 269 cases

23.47%）

respiratory system

thoracic and mediastinal diseases（3 014 cases

21.64%） and systemic diseases and various reactions at the administration site（1 407 cases

10.10%） took the lead. The frequency of adverse event signals was generally consistent with the drug instructions. Signals that were not mentioned in the drug instructions and required clinical concern included: increased blood pressure

memory impairment

abnormal sensation

hearing loss and ventricular rhythm. CONCLUSIONS: When using ticagrelor

in addition to the common respiratory and bleeding adverse drug reactions

other rare severe adverse drug reactions such as intracranial hemorrhage

bradycardia and tidal breathing should also receive clinical attention.