FDA Launches Adverse Event Reporting Dashboard for Approved COVID-19 Therapeutics

Subjects ” General neurology

The Food and Drug Administration (FDA) has introduced the public dashboard of the FDA Adverse Event Reporting System (FAERS) for COVID-19 Emergency Use Authorization (EUA) products.

The COVID-19 FAERS public dashboard provides weekly updates of adverse event reports submitted to FAERS for drugs and therapeutic biological products used under the EEA for COVID-19. Adverse event reports can be submitted by the pharmaceutical industry, healthcare providers, and consumers. Reports can be filtered by report type, reporter, region, severity, age group, and gender.

In a statement, the agency stated that the FAERS data alone cannot be used to determine the safety profile of a drug or biological. The database contains duplicate or incomplete reports with information that may not have been medically confirmed. Therefore, the presence of a report is not a cause and cannot be used to estimate occurrence rates.

The tool intended to expand access to FAERS data to the general public can be found here. Patients are advised to contact their doctor before stopping or changing medication.


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

This article originally appeared on MPR


COVID19 General Neurology

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