Characteristics of adverse events and clinical risks of intravenous immunoglobulin: a pharmacovigilance study based on FDA Adverse Event Reporting System (FAERS).

ABSTRACT:

Background

Intravenous immunoglobulin (IVIg) is widely used to treat primary immunodeficiency, chronic inflammatory demyelinating polyneuropathy, immune thrombocytopenia, and other disorders. Although effective in maintaining IgG trough levels and reducing infections, its safety profile requires further characterization.

Methods

A large-scale pharmacovigilance study was conducted using the U.S. FDA Adverse Event Reporting System (FAERS) from Q1 2004 to Q4 2024. Four disproportionality methods-reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and multi-item gamma Poisson shrinker (MGPS)-were applied to detect adverse event signals. Weibull modeling was used to assess temporal risk patterns.

Results

A

SUBMITTER: Lu Z 

PROVIDER: S-EPMC12819674 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature