faers

is a Data Source.

The FDA Adverse Event Reporting System (FAERS) is a database that contains adverse event reports, medication error reports, and product quality complaints resulting in adverse events submitted to the FDA. FAERS supports the FDA's post-marketing safety surveillance program for drug and therapeutic biologic products. The database adheres to ICH E2B international safety reporting guidance, and adverse events are coded using MedDRA (Medical Dictionary for Regulatory Activities) terminology. FAERS provides quarterly data files in ASCII and XML formats dating back to 2012, with archives available for earlier data.

Domains

pharmacology, drug discovery, clinical, public health

License

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Homepage

faers

Repository

Unknown

Infores ID

infores:faers

FAIRsharing ID

Unknown

Products

From this Resource
ID Name URL Category Format Description
faers.public_dashboard FAERS Public Dashboard analysis GraphicalInterface http Interactive dashboard for exploring F...
faers.quarterly_data_ascii FAERS Quarterly Data Files (ASCII) FPD-QDE-FAERS.html Product txt Quarterly data extracts in ASCII form...
faers.quarterly_data_xml FAERS Quarterly Data Files (XML) FPD-QDE-FAERS.html Product xml Quarterly data extracts in XML format...
faers.faq FAERS FAQ FPD-FAQ.html DocumentationProduct http Frequently asked questions about FAER...
faers.electronic_submissions FAERS Electronic Submissions Portal fda-adverse-event-reporting-system-faers-electronic-submissions GraphicalInterface http Portal for submitting adverse event r...
From other Resources
ID Name URL Category Format Description
aeolus.standardized_data AEOLUS Standardized FAERS Data dryad.8q0s4 Product Standardized and deduplicated version...

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Created: November 04, 2025 | Last modified: November 04, 2025