Facial Skincare Adverse Event Atlas and Safety Signals From openFDA Cosmetic Reports: A Disproportionality Analysis.

ABSTRACT:

Objective

To construct a facial-skincare adverse event atlas and detect category-level safety signals using the US FDA openFDA Cosmetic Adverse Events database.

Methods

We analyzed publicly available openFDA cosmetic adverse event reports (downloaded 2025-12-15; meta.last_updated 2025-12-10). Suspect products were classified into 12 facial-skincare subcategories using keyword rules, excluding hair, makeup, nail, fragrance, oral, deodorant, and bath/body cleansing products. MedDRA preferred terms were grouped into nine clinically interpretable reaction clusters. Reporting odds ratios (RORs) with 95% confidence intervals were computed versus the full database (primary) and within-cohort comparators (sensitivity), with false discovery rate (FDR) control. We performed "case-chec

SUBMITTER: Sun Z 

PROVIDER: S-EPMC12859173 | biostudies-literature | 2026 Feb

REPOSITORIES: biostudies-literature