Abstract: Objective To mine and evaluate the risk signals of antidepressants use in fetus and neonate adverse events based on the database of the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS), and provide reference for clinical rational drug use. Methods Filter primary suspect and second suspect antidepressants AE reports from 1th January 2004 to 31th December 2022 in FAERS database. Mine the signals of fetus or neonate adverse events with antidepressants via reporting odds ratio (ROR) and proportional reporting ratio (PRR). Results There are 14 492 cases of fetal and neonatal anomalies in the study, including 5 546 fetal abnormal cases and 8 946 neonatal abnormal cases. From drug aspect, there 68.97% foetal adverse signals and 56.35% neonatal adverse signals are selective serotonin reuptake inhibitors (SSRIs). From adverse event aspect, there 51.72% foetal adverse signals is related to amniotic fluid and 20.99% neonatal adverse signals is respiratory system disorders. Signals of Citalopram and Venlafaxine are highlighted after the second screening, which have adverse signals not specified in the label. Conclusion The overall signal characteristics of antidepressants are basically consistent with the existing safety data. However, some adverse events such as fetal amniotic fluid disorders and neonatal heart disorders are not listed in label through group analysis, which should be paid attention to in clinical use.

Key words: antidepressant, selective serotonin reuptake inhibitor, fetus and neonate, FAERS, reporting odds ratio, proportional reporting ratio, drug safety, drug event, signal