Analysis of adverse drug reactions associated with ravulizumab: a retrospective pharmacovigilance study utilizing the FAERS database - PubMed
7 hours ago
- #pharmacovigilance
- #ravulizumab
- #FAERS
- Ravulizumab is a long-acting C5 complement inhibitor used for treating generalized myasthenia gravis, paroxysmal nocturnal hemoglobinuria, and atypical hemolytic uremic syndrome.
- The study analyzed adverse event reports from the FAERS database (Q4 2018 to Q2 2025) using disproportionality methods (ROR, PRR, MGPS, BCPNN) and Weibull distribution for time-to-onset analysis.
- Common adverse events included fatigue, asthenia, headache, malaise, dyspnea, back pain, feeling abnormal, and diplopia.
- New potential adverse events not on the drug label were identified, such as anemia, dysphagia, urinary tract infection, and somnolence.
- The findings highlight the need for healthcare providers to consider these safety signals for better risk assessment in clinical practice.