251 Contact dermatitis adverse events: A review of contact dermatitis-associated reports from the FDA adverse event reporting system (FAERS)

The FDA Adverse Events Reporting System (FAERS) is a computerized database of adverse events submitted by product manufacturers, consumers, and health care professionals. repository part the agency’s post-marketing safety surveillance program with relatively few published dermatologic-related reports. We analyzed FAERS public data base using search terms “dermatitis, contact” sorted as whole from 1969 more specifically for past two years. Daily Med (National Library Medicine) was consulted to verify routes exposure. There are 12,841 total cases contact dermatitis since 1968, which 4355 were non-serious further 2020-2021 reviewing 203 Of these only 43 reports reactions topical medications including anti acne, ophthalmic, antifungal, corticosteroid, transdermal patches. largest number single injectable treprostinil (27) dupilumab (18) oral drug lenalidomide (18). remaining 97 most other drugs some included. Other diagnoses included in reports, one occupationally related. Factors affecting reporting include media attention, litigation, nature event, regulations. may be duplicative not verified, existence report does necessarily establish causation. In case irritant rather than allergic dermatitis. reported here, many administered subcutaneously local dermatitis; have been systemic dermatitis, non-contact cutaneous evident. includes all US marketed products ideal identifying trends emerging concerns.