Journal of Clinical Medicine Research

Objective: To mine the adverse drug event signals of tislelizumab based on the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database, and provide reference for clinical safe medication. Methods: Adverse event data of tislelizumab in the FAERS database from its launch (December 26, 2019) to December 31, 2024 were collected, and data mining was conducted using the Reporting Odds Ratio (ROR) and the Medicines and Healthcare products Regulatory Agency (MHRA) method in the disproportionality method. Results: 2745 ADE reports with tislelizumab as the primary suspect were screened, with annual increases. Among reports with age/gender data, 18-64 was the main age group and males outnumbered females. Medical professionals (98.51%) were main reporters. Of 108 positive signals, common ADEs included myelosuppression (unlisted in instructions), decreased white/neutrophil counts, rash, pruritus. High-intensity signals (e.g., elevated cytokines) existed, some unlisted. SOC showed ADEs mainly involved blood/lymphatic, immune, skin/subcutaneous systems. Conclusion: It is recommended that in the clinical use of tislelizumab, focus on the patient's hematological indicators (such as white blood cell and neutrophil counts) and immune-related adverse reactions (such as pancreatitis, myasthenia gravis, etc.), and take timely intervention measures to ensure the safety of patients' medication.