A disproportionality analysis of nifedipine in the overall population and in pregnant women using the FDA Adverse Event Reporting System (FAERS) database.

ABSTRACT: Nifedipine, a dihydropyridine calcium channel blocker, is widely used in the management of hypertension and as a tocolytic agent to delay preterm labor, including in pregnant women. However, its safety profile, particularly in pregnant populations, remains insufficiently characterized. This study aimed to evaluate adverse event (AE) signals associated with nifedipine use, with a specific focus on pregnancy-related outcomes. Nifedipine-related AEs reported in U.S. Food and Drug Administration Adverse Event Reporting System database (Q1 2004-Q4 2024) were analyzed. Disproportionality analysis was conducted using 4 established signal detection methods: reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian Confidence Propagation Neural Network, and Multi-item Gamma Poisson S

SUBMITTER: Ju G 

PROVIDER: S-EPMC12582688 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature