Real world based on FAERS database:To explore the mining and analysis of adverse pregnancy events related to drug exposure

Objective To explore and analyze the Adverse Pregnancy Events associated with drug exposure through FAERS database, summarize the risk drugs, and provide reference for clinical safe medication in pregnant patients. Methods The APE reports related to drug exposure from the FAERS database from the first quarter of 2004 to the first quarter of 2025 were extracted, and the signal drugs were identified by proportion imbalance (ROR), proportional reporting odds ratio (PRR) and Bayesian trusted propagation neural network (BCPNN). To explore the association between drug exposure and adverse pregnancy events, so as to analyze demographic information, occurrence time and pregnancy outcome. Results A total of 257443 APE related drugs were found. The World Health Organisation Drug Dictionary (Mar 2025) was used to manually standardize drug names (drugnames) in adverse event reports to generic drug names. A total of 1266 reports were screened. After excluding combination drugs and repeated data, a total of 112 drugs met the signal detection of this study, including dermatological drugs, digestive and metabolic system drugs, blood and hematopoietic organs drugs, anti-tumor and immunomodulatory drugs, etc. The median time of APE was about 146d by Weierb distribution analysis. By analyzing this data, it was found that the proportion of death, hospitalization, disability and fetal congenital malformation in the outcomes of APE related to drug exposure was as high as 30.78%. Conclusions APE associated with drug exposure involves more drugs and has poor pregnancy outcomes. This study shows that adverse pregnancy events associated with drug exposure may be related to the accumulation of drug therapy over a long period of time. Therefore, careful use of drugs during pregnancy is the key to avoid APE. Prevention of drug-related adverse pregnancy events.