A pharmacovigilance study on the safety of faricimab in real-world scenario using FDA adverse event reporting system database

Faricimab is predominantlyprescribed for conditions such as age-related macular degeneration (AMD),diabetic macular edema (DME), and macular edema related to retinal veinocclusion (RVO-ME). Currently, a notable absence of large-scale, real-worldstudies focusing on the adverse reactions of faricimab exists. Thisstudy assesses the side effects of faricimab by analyzing reports of adverseevents (AEs) from the FDA's AEReporting System (FAERS) database. Through disproportionality analysis, thisstudy substantiates the drug's safety oversight. Our study revealed 2,746 instances ofadverse events linked to faricimab, spanning 21 system organ classes (SOCs).The study retained 121 significant disproportionality preferred terms (PTs)that met criteria across all four analytical methods. Faricimab-associated AEsnot documented in the drug instructions included visual impairment, blindness,retinal hemorrhage, anterior chamber inflammation, keratic precipitates, dryeye, chorioretinitis, diabetic retinopathy, and others. The majority of our results align withearlier clinical studies and the details outlined in the product's manual. Additionally, we identifiedseveral unforeseen and potential AEsignals related to faricimab use. These insights are instrumental for ongoingclinical surveillance and risk assessment associated with the drug.