Signal Mining of Tacrolimus-related Cardiovascular Adverse Events Based on the US FAERS Database

To mine tacrolimus-related adverse event signals affecting the cardiovascular system based on an international authoritative database, aiming to provide a reference for clinical safe drug use.

Adverse event reports with tacrolimus as the primary suspected drug were retrieved and extracted from the U.S. Food and Drug Administration Adverse Event Reporting System(FAERS) database from January 1, 2004, to September 30, 2024, with a focus on cardiovascular system-related adverse events. Adverse events were categorized using the system organ class(SOC) and preferred terms(PTs) from the Medical Dictionary for Regulatory Activities(MedDRA). Signal mining for cardiovascular system-related adverse drug events(ADEs) was performed using the information component(IC), empirical Bayesian geometric mean(EBGM), and reporting odds ratio(ROR) methods.

A total of 58 357 ADE reports with tacrolimus as the primary suspected drug were retrieved, of which 3173 were related to cardiovascular system disorders. The top five most frequently reported cardiovascular adverse events were hypertension, cardiac arrest, heart failure, myocardial infarction, and atrial fibrillation. ADE signal detection identified correlations between tacrolimus and hypertension, cardiac arrest, heart failure, ventricular hypertrophy, cardiomyopathy, and cardiac hypertrophy. Regarding the outcomes of cardiovascular adverse events, "hospitalization or prolongation of existing hospitalization" was the most common(34.74%), followed by "death"(29.44%).

Tacrolimus carries the risk of inducing various cardiovascular diseases. In clinical practice, when using tacrolimus, attention should be paid to the patient's underlying diseases and concomitant medications, adverse reactions should be closely monitored during the initial and long-term treatment phases, and the dosage should be adjusted in a timely manner to ensure patient safety during long-term therapy.