ORIGINAL RESEARCH article
Front. Pharmacol.
Sec. Pharmacoepidemiology
This article is part of the Research TopicBiologic Drugs for immune-mediated inflammatory diseases (IMIDs) and Vaccines for infections: Validation, Drug-Utilization, Effectiveness, Regulation, Costs, and Safety in the real worldView all 8 articles
Comparative Safety Profiles of Risankizumab versus Guselkumab: A Pharmacovigilance Study Based on the FAERS Database
Provisionally accepted
- 1Department of Gastroenterology, Ningbo Hospital of Traditional Chinese Medicine, Ningbo, China
- 2Department of Traditional Chinese Medicine, Ningbo Hospital of Traditional Chinese Medicine, Ningbo, China
- 3Department of Pharmacy, Ningbo Hospital of Traditional Chinese Medicine, Ningbo, China
- 4Department of Gastroenterology, First Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, China
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Background: Risankizumab and guselkumab are two leading interleukin-23 (IL-23) inhibitors for treating immune-mediated inflammatory diseases. While effective, a direct comparison of their real-world safety profiles is lacking. Understanding the distinct differences in their adverse event (AE) profiles is crucial for clinicians to make appropriate treatment decisions. Research Design and Methods: We conducted a disproportionality analysis on post-marketing data obtained from the FDA Adverse Event Reporting System (FAERS) database from Q3 2017 to Q2 2025 to detect and compare the AE signals of guselkumab and risankizumab. Results: A total of 22,470 and 48,141 AE reports for guselkumab and risankizumab, respectively, were analyzed. The analysis revealed markedly different safety profiles. Risankizumab showed significant signals for skin cancer (particularly in patients ≥65 years), intestinal obstruction, and other newly identified serious events such as myocardial infarction and cerebrovascular accident. In contrast, guselkumab's primary signals were dominated by medication management issues like "product dose omission issue" and "accidental exposure to product," which correlated with reports of decreased therapeutic effect. Unique, unlabeled signals for guselkumab included a different spectrum of AEs, such as Hodgkin's disease, pemphigoid, and autoimmune thyroiditis. Furthermore, the median time-to-onset was significantly shorter for guselkumab (62 days) compared to risankizumab (168 days). Conclusions: Guselkumab and risankizumab exhibit divergent real-world safety profiles, challenging the notion of a uniform class effect. Clinicians should be vigilant for malignancies and serious systemic events with risankizumab, particularly in the elderly, while prioritizing patient education for guselkumab to prevent administration errors. These findings support individualized treatment strategies to minimize drug-specific risks.
Keywords: Disproportionality analysis, drug safety, FAERS, guselkumab, interleukin-23 inhibitors, Pharmacovigilance, risankizumab
Received: 10 Dec 2025; Accepted: 04 Feb 2026.
Copyright: © 2026 Wang, Xu, Lin, Zhang, Ding, Jiang, Fan and Sun. 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: Changbo Sun
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