Adverse events associated with use of immunoglobulin in pediatric patients reported to the US Food and Drug Administration Adverse Event Reporting System, 2001–2023

Pediatric Allergy and Immunology 2026 Open access

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Authors: Shao-kui Wei, Yeowon Kim, Mary N. Rubin, Srinivas S. Ayyala, Kerry J. Welsh
DOI: 10.1111/pai.70319
Cited by: 2
References: 18

Abstract

BACKGROUND: Immunoglobulin products are widely used for the treatment of immunodeficiency and autoimmune disorders. Although clinical trials have demonstrated their efficacy and tolerability, data describing their postmarketing safety profile in pediatric populations remain limited, particularly regarding rare and serious adverse events. This study aimed to characterize adverse event reports associated with immunoglobulin use in children during the postmarketing period. METHODS: Pediatric adverse event reports (

Fields of Study & Subjects

Platelet Disorders and Treatments Immunodeficiency and Autoimmune Disorders Blood groups and transfusion

Publication details

Journal / source
Pediatric Allergy and Immunology
Publisher
Wiley
Volume
37
Issue
3
Pages
e70319–e70319
Publication date
1 March 2026
Language
EN