B12
FDA adverse event reports for this product.
Top reactions reported
MedDRA Preferred Terms, ranked by frequency in the reports. Shown as percent of all reports for this product. A single report can list multiple reactions, so percentages can sum above 100%.
Outcomes
How the reports resolved, shown as percent of all reports. Outcomes can overlap (one report can have multiple outcomes), so percentages do not sum to 100%.
What to do next
Tools for reporting or tracking adverse events — both for cosmetics and the wider universe of prescription and OTC drugs.
Submit a MoCRA-compliant adverse event report to the FDA for a cosmetic product. Free, no login required.
Open the form →Generate a completed FDA 3500A form for a prescription or over-the-counter drug. The drug AE dataset is far larger (~25M reports) than cosmetics, with richer fields and tools.
Open the form →Weekly alerts when new research papers or preprints surface adverse events for a drug you care about. Covers up to three drugs per account.
Get started →Share this page
About this data
This page summarizes adverse event reports from the FDA's adverse event reporting system for cosmetic products. Reactions are coded in MedDRA. Reports come from consumers, health professionals, and industry. The presence of a report does not establish that the product caused the event - it only reflects what was reported to FDA.
Limitations: The public dataset does not include free-text case narratives, only structured fields.
Data as of June 17, 2026. Source: FDA.