Demographics, Overlap, and Latency of Severe Cutaneous Adverse Reactions in an FDA Database.

ABSTRACT:

Importance

Severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS-TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP), and generalized bullous fixed drug eruption (GBFDE), are rare but life-threatening drug hypersensitivity syndromes. Due to their low incidence and diagnostic complexity, large-scale characterization of SCAR is challenging.

Objective

To characterize the demographics, causative agents, trends, latency, and phenotypic overlap of SCAR using a large-scale, sanitized pharmacovigilance dataset from FAERS (FDA Adverse Event Reporting System).

Design

Cross-sectional study of spontaneous adverse event reports. Cases were drawn from the U.S.

SUBMITTER: Mukherjee EM 

PROVIDER: S-EPMC11908287 | biostudies-literature | 2025 Aug

REPOSITORIES: biostudies-literature