Abnormal coagulation indicators associated with β-lactamantibacterial drug: a pharmacovigilance study based on the FAERS database.

To explore the characteristics of adverse events related to abnormal coagulation indicators associated with β-lactam antibacterial drug, identify risk signals, and provide references for clinical rational drug use. Data from the first quarter of 2004 to the third quarter of 2024 were extracted from the FDA Adverse Event Reporting System (FAERS). The reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and multi-item gamma Poisson shrinker (MGPS) were used to identify adverse drug reaction signals associated with abnormal coagulation indicators and analyze the time of occurrence of adverse drug events (ADEs). A total of 828 case reports and 902 adverse reactions have been associated with β-lactam antibacterial drug. 95.55% of the ADEs appeared within 30 days, 60.39% of the patients (n = 500) were ≥ 65 years old, and 10.39% (n = 86) died. The strongest risk signal of abnormal coagulation markers was cefoperazone/sulbactam, following by ceftriaxone and cefotaxime. Cefoperazone/sulbactam lead to abnormal coagulation indexes mainly manifested as PT prolongation, elevated INR, and low fibrinogen. The most common abnormal coagulation markers for other drugs were elevated INR. β-Lactam antibacterial drug may be associated with various abnormal coagulation indicators, particularly cephalosporins such as cefoperazone/sulbactam, ceftriaxone, and cefotaxime. In the process of clinical use, it is necessary to pay close attention to the elderly, liver and kidney dysfunction, and high risk population with a history of blood clotting. The findings from this study can provide valuable insights for enhancing the safe use of β-lactam drugs, particularly in populations at high risk for coagulation abnormalities, thereby guiding clinical practice.