Semaglutide Exposure During Pregnancy: Results from the FAERS Database.

Background/

Objectives

The increased incidence of obesity and type 2 diabetes, along with the growing use of glucagon-like peptide-1 receptor agonists (GLP-1 RAs), particularly semaglutide, among women of childbearing age makes it especially important to assess their safety profile during pregnancy.

Methods

A post-marketing study was conducted using reports from the U.S. FDA Adverse Event Reporting System (FAERS) database (2017-2025). Descriptive analyses focused on pregnancy outcomes and fetal/neonatal disorders. Disproportionality analyses assessed adverse event (AE) reporting by System Organ Class (SOC) and pregnancy-related AEs associated with semaglutide versus other medications. A Standardized MedDRA Query (SMQ)-based disproportionality analysis was also performed.

Results

A total of 249 cases involving semaglutide use during pregnancy were identified, comprising 922 AEs. "Injury, poisoning and procedural complications" was the most frequently reported SOC, while abortion- and pregnancy loss-related events accounted for 27.3% of reported AEs. Compared with other medications, semaglutide showed higher reporting odds for "Pregnancy, puerperium and perinatal conditions" (ROR 1.59; 95% CI 1.37-1.86), "Injury, poisoning and procedural complications" (ROR 1.93; 95% CI 1.70-2.20), and gastrointestinal disorders (ROR 1.72; 95% CI 1.38-2.15), with no significant association for "Congenital, familial and genetic disorders" or "Reproductive system and breast disorders". SMQ-based analysis showed increased reporting odds for "Termination of pregnancy and risk of abortion" (ROR 3.71; 95% CI 3.07-4.48).

Conclusions

Disproportionate reporting was identified for pregnancy- and perinatal-related events, procedural/exposure-related complications, and pregnancy termination, with no evidence of a disproportionate congenital-anomaly signal. These findings should be interpreted cautiously and do not necessarily indicate a causal association.