ArticleNaunyn-Schmiedeberg's archives of pharmacology2026
The safety of rituximab in pediatric nephrotic syndrome patients: a pharmacovigilance study of the FAERS database.
Article in Naunyn-Schmiedeberg's archives of pharmacology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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7 authors.
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Abstract
This study aims to systematically evaluate the safety of rituximab (RTX) in pediatric nephrotic syndrome (NS) using real-world data from the US Food and Drug Administration Adverse Event Reporting System (FAERS). We analyzed FAERS data from Q1 2013 to Q4 2024, focusing on individual case safety reports (ICSRs) involving NS patients under 18 years old where RTX was the primary suspected drug. Adverse events (AEs) were coded using preferred terms (PTs) and mapped to system organ classes (SOCs). Four pharmacovigilance data analysis methods-reporting odds ratio (ROR), proportional reporting ratio (PRR), multinomial gamma Poisson shrinkage (MGPS), and Bayesian confidence propagation neural network (BCPNN)-were employed to assess drug-related AE risks. Among 275 RTX-related ICSRs, the most frequently reported AEs were hypogammaglobulinemia and granulocytopenia. The strongest signals were observed for CD19
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