Signal Mining of Tacrolimus-related Cardiovascular Adverse Events based on the US FAERS database

Objective: To explore signals related to tacrolimus-induced cardiovascular adverse events using the U.S. Food and Drug Administration's Adverse Event Reporting System (FAERS), providing references for the drug's safe use in clinical practice. Methods: Tacrolimus-induced adverse drug events (ADEs) were extracted from the FAERS database between 1 January 2004 and 30 September 2024. The ADEs were categorised using the System Organ Classification (SOC) and Preferred Term (PT) in the Medical Dictionary for Regulatory Activities (MedDRA), and analysed using the ratio of reported values (RRV) method to identify ADE signals. Results: There was a correlation between tacrolimus and hypertension, cardiac arrest, cardiac failure, ventricular hypertrophy, cardiomyopathy， andcardiac hypertrophy. Conclusion: It is suggested that tacrolimus has cardiovascular-related disease risk. When clinically applied, tacrolimus should be combined with the patients' underlying diseases and co-administration of drugs, closely monitor its adverse reactions, and adjust the dosage in time to ensure the safety of long-term use of drugs for patients.