FDA Adverse Events Reporting System (FAERS) Dataset
The FAERS public dashboard is a new, user-friendly and interactive web-based tool that was created to give the public the ability to query the FDA FAERS database and improve transparency. The data presented in the FAERS public dashboard has several key limitations. The existence of adverse event reports for a drug or biologic in FAERS does not mean that the drug or biologic caused the adverse event. Importantly, the FAERS data is not an indicator of the safety profile of the drug or biologic.
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Drugevent API
FILENo link available
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Complete Metadata
| @type | Dataset |
|---|---|
| accessRights | public |
| contactPoint |
[ { "fn": "FDA Governance Team", "@type": "Kind", "hasEmail": "mailto:uig@fda.hhs.gov" } ] |
| description | The FAERS public dashboard is a new, user-friendly and interactive web-based tool that was created to give the public the ability to query the FDA FAERS database and improve transparency. The data presented in the FAERS public dashboard has several key limitations. The existence of adverse event reports for a drug or biologic in FAERS does not mean that the drug or biologic caused the adverse event. Importantly, the FAERS data is not an indicator of the safety profile of the drug or biologic. |
| distribution |
[ { "@type": "Distribution", "title": "Drugevent API", "accessService": [ { "@type": "DataService", "title": "Drugevent API", "publisher": { "name": "FDA", "@type": "Organization" }, "endpointURL": [ "https://api.fda.gov/drug/event" ], "contactPoint": [ { "fn": "open FDA", "@type": "Kind", "hasEmail": "mailto:open@fda.hhs.gov" } ], "endpointDescription": [ "https://api.fda.gov/drug/event.json" ] } ], "useRestriction": [ { "@type": "UseRestriction", "restrictionStatus": "unrestricted" } ] } ] |
| identifier | 0001-FDA-CDER-PB-I-202608 |
| inventoried | 2026-09-27 |
| isPartOf | drugevent-api |
| keyword |
[ "Adverse Events/ Prescription Drugs/ Generic Drugs" ] |
| publisher |
{ "name": "Center for Drug Evaluation and Research (CDER)", "@type": "Organization", "subOrganizationOf": [ { "name": "Food and Drug Administration (FDA)", "@type": "Organization", "subOrganizationOf": [ { "name": "U.S. Department of Health and Human Services", "@type": "Organization" } ] } ] } |
| status | Candidate |
| theme |
[ { "@type": "Concept", "prefLabel": "Drugs" } ] |
| title | FDA Adverse Events Reporting System (FAERS) Dataset |
