Risk factors for drug-related urticaria: an analysis of the FDA Adverse Event Reporting System (FAERS)

Despite established associations between certain medications and urticaria, the risk profiles of most pharmaceutical agents remain poorly characterized. This investigation aimed to identify risk factors for medication-induced urticaria through comprehensive analysis of the FDA Adverse Event Reporting System (FAERS) database. We employed reporting odds ratios (ROR) to evaluate drug-urticaria associations using FAERS data spanning from Q1 2004 to Q3 2024. Analytical approaches included univariate screening, LASSO regression, and multivariate logistic regression to identify potential risk factors. Multiple comparison adjustments were implemented using the Bonferroni method. The study identified 1807 pharmaceutical agents potentially associated with urticaria development. Univariate analysis categorized these agents into several therapeutic classes: antimicrobials (19/85), biologics (16/85), analgesics (8/85), dermatologicals (3/85), anti-rheumatic agents (4/85), hormonal preparations (3/85), antihypertensives (2/85), neuropsychiatric medications (2/85), uric acid-lowering drugs (2/85), multiple sclerosis therapies (2/85), and miscellaneous agents (17/85). Multivariate analysis identified three significant risk determinants: middle-aged individuals (36–53 years), female gender, and exposure to any of 82 specific medications. These evidence-based findings provide valuable insights for early clinical recognition of drug-induced urticaria and establish a foundation for subsequent mechanistic investigations into medication-related hypersensitivity reactions.