Abstract
OBJECTIVE: To evaluate the adverse event profile and potential safety signals associated with glyburide use during pregnancy using data from the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS). METHODS: Data from FAERS (Q1 2015-Q1 2025) were analyzed. Pregnant cases and glyburide exposures were identified using standardized MedDRA terminology. Signal detection was conducted using the reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-Item Gamma Poisson Shrinker (MGPS) algorithms. RESULTS: A total of 284 712 pregnant women were included, among whom 164 used glyburide. Seventeen positive safety signals were detected. Hypoglycaemia neonatal, congenital anomaly in offspring, and maternal hypoglycaemia were consistent with drug labeling and previous reports. Additional newly identified signals included caesarean section, placenta praevia, amniotic fluid volume decreased, blood creatinine increased, hypoxia, metabolic acidosis, umbilical cord abnormality, and others. At the system organ class (SOC) level, positive signals were observed for metabolism and nutrition disorders, endocrine disorders, and pregnancy, puerperium and perinatal conditions. CONCLUSION: This real-world FAERS-based analysis suggests that glyburide use during pregnancy may be associated with various adverse metabolic and pregnancy-related outcomes. Caution is warranted when prescribing glyburide for patients with HIP, with particular attention to monitoring placental function and neonatal glucose levels. Further prospective studies are needed to validate these findings.