Assessing drug-associated adverse events of spontaneous abortion or fetal death: A disproportionality analysis based on FDA adverse event reporting system

Background: Spontaneous abortion and fetal death represent significant reproductive health challenges, affecting approximately 10-20% of recognized pregnancies. Certain medications are an acquired risk factor for spontaneous abortion or fetal death. Objectives: This pharmacovigilance investigation sought to systematically assess the disproportionality signal of medication-associated spontaneous abortion or fetal death by leveraging the most extensive publicly accessible database of adverse event reports. Methods: Reports from the FDA Adverse Event Reporting System (FAERS) were used to conduct disproportionality analysis, ranging from the first quarter of 2004 to the second quarter of 2025. Medications were categorized based on the Anatomical Therapeutic Chemical (ATC) classification system. Results: The analysis identified 43,199 reports of drug-related spontaneous abortion or fetal death, involving 1,001 different drugs. 119 drugs were identified as significantly associated with disproportionality by the disproportionality analysis. The largest therapeutic category was anti-infective for systemic use (J), comprising 41 drugs (34.5%). Following this were the genitourinary system and sex hormones (G), which had 22 drugs (18.5%), the nervous system (N) with 15 drugs (12.6%), the alimentary tract and metabolism (A) with 9 drugs (7.6%) and antineoplastic and immunomodulating agents (L) with 8 drugs (6.7%). Conclusions: A total of 119 medications were identified as potentially associated with spontaneous abortion or fetal death. This study emphasizes the elevated disproportionality signal associated with anti-infectives for systemic use, as well as the genitourinary system and sex hormones. Identification of specific medications linked to these adverse outcomes can guide targeted medication counseling for women planning pregnancy.