Analysis of adverse drug reactions associated with ravulizumab: a retrospective pharmacovigilance study utilizing the FAERS database

TL;DR

This study analyzed adverse drug reactions linked to ravulizumab using FDA safety data, identifying both known and new potential side effects.

Contribution

The study introduces new safety signals for ravulizumab using multiple disproportionality analysis methods and a time-to-onset model.

Findings

Common adverse events included fatigue, asthenia, headache, and dyspnea.

New potential adverse reactions like anemia and urinary tract infection were identified.

Disproportionality analysis confirmed significant safety signals not previously listed on the drug label.

Abstract

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.

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.

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, 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.

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.

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