ORIGINAL RESEARCH article
Front. Med.
Sec. Regulatory Science
Characteristics of adverse events and clinical risks of Intravenous immunoglobulin: a pharmacovigilance study based on FDA adverse event reporting system (FAERS)
Provisionally accepted
- 1The Affiliated Hospital of Jiangxi University of Chinese Medicine, Nanchang, China
- 2Research Center for Differentiation and Development of Basic theory of Traditional Chinese Medicine, Nanchang, China
- 3School of Chinese Medicine, Jiangxi University of Chinese Medicine, Nanchang, China
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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 total of 76,138 IVIg-associated reports were identified. Common events included infusion-site reactions (swelling, erythema, pain), infections (upper respiratory tract infection, bronchitis, pneumonia, influenza, urinary tract infection), and systemic reactions (pyrexia, chills, hypersensitivity, headache, asthenia, nausea, vomiting). Several novel potential safety signals emerged, including blood pressure–related events (hypertension and hypotension), weight changes (loss and gain), and falls. Conclusions: Real-world FAERS data confirm the established tolerability of IVIg while highlighting rare but clinically important safety signals, particularly haemolytic anaemia and aseptic meningitis. These findings warrant further clinical investigation to optimize monitoring and promote safer therapeutic use.
Keywords: Intravenous Immunoglobulin, Drug adverse events, FAERS database, Pharmacovigilance, Drug safety signal detection, Disproportionality analysis
Received: 13 Oct 2025; Accepted: 28 Nov 2025.
Copyright: © 2025 Lu, Lu, Gao, Shang and Zeng. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Yingjian Zeng
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