Federal Adverse Event Reporting System (FAERS) postmarketing reports of injection site reactions with biologics approved to treat moderate-to-severe psoriasis

Introduction and Objectives: Injection-site reactions (ISRs) are localized skin reactions after an injection, typically characterized by erythema, edema and/or pain. Biologics used to treat moderate-to-severe plaque psoriasis (Ps) may cause ISRs. ISR frequency is often included in product labels. The United States (US) Food and Drug Administration collects spontaneous postmarketing reports of adverse events (AE) from drugs/biologics; these are included in the Federal Adverse Event Reporting System (FAERS) where they are coded by Medical Dictionary for Regulatory Activities preferred terms.
Source: Journal of the American Academy of Dermatology - Category: Dermatology Source Type: research