ORIGINAL RESEARCH article
Front. Immunol.
Sec. Autoimmune and Autoinflammatory Disorders : Autoimmune Disorders
Analysis of Adverse Drug Reactions Associated with Ravulizumab: A Retrospective Pharmacovigilance Study Utilizing the FAERS Database
Provisionally accepted
- Department of Neurology, Xinqiao Hospital, Chongqing, China
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Background Ravulizumab is a long-acting C5 complement inhibitor that provides sustained suppression of the complement pathway. It is currently approved by the US Food and Drug Administration (FDA) for the treatment of generalized myasthenia gravis, paroxysmal nocturnal hemoglobinuria, and atypical hemolytic uremic syndrome. With its increasing clinical use, concerns regarding Ravulizumab-associated adverse drug reactions have grown. Methods This study utilized a dataset extracted from the Adverse Event Reporting System (FAERS) database, comprising adverse event reports from the fourth quarter of 2018 to the second quarter of 2025. Four distinct disproportionality analysis methods—the Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Multi-item Gamma Poisson Shrinker (MGPS), and Bayesian Confidence Propagation Neural Network (BCPNN)—were applied. Additionally, the time-to-onset profile of adverse events was assessed using the Weibull distribution model. Results A total of 9,090 adverse event reports associated with ravulizumab were included in this analysis. Commonly reported adverse events included fatigue, asthenia, headache, malaise, dyspnea, back pain, This is a provisional file, not the final typeset article feeling abnormal, and diplopia. Furthermore, potential adverse events not listed on the drug label were identified, such as anemia, dysphagia, urinary tract infection, and somnolence. Conclusion This investigation identified several adverse events associated with ravulizumab and revealed potential adverse reaction signals that were not previously recognized. Healthcare providers may consider these safety signals to more comprehensively assess potential risks in patients during clinical practice.
Keywords: FAERS, Mg, Pharmacovigilance, PNH, ravulizumab
Received: 31 Oct 2025; Accepted: 09 Feb 2026.
Copyright: © 2026 Zhou, Wu, Su and Meng. 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: Zhao-you Meng
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