The Food and Drug Administration (FDA) has launched the FDA Adverse Event Reporting System (FAERS) Public Dashboard for COVID-19 Emergency Use Authorization (EUA) products.

The COVID-19 FAERS Public Dashboard will provide weekly updates of adverse event reports submitted to FAERS for drugs and therapeutic biological products used under EUA for COVID-19. Adverse event reports can be submitted by the pharmaceutical industry, health care providers, and consumers. Reports can be filtered by report type, reporter, region, seriousness, age group, and sex.

In a statement, the Agency noted that the FAERS data alone cannot be used to establish the safety profile of a drug or biologic. The database includes duplicate or incomplete reports with information that may not have been medically confirmed; therefore the existence of a report does not establish causation and cannot be used to estimate occurrence rates.

The tool, which is intended to expand access of FAERS data to the general public, can be found here. Patients are advised to consult with their health care providers prior to discontinuing or changing any medications.


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Reference

FDA Adverse Event Reporting System (FAERS) Public Dashboard. [press release]. Silver Springs, MD: US Food and Drug Administration; March 15, 2021.