The FDA’s Drug Adverse Event Database Is Now Updated in Real Time: Here’s How to Use It

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<p>On Friday, August 22, the Food and Drug Administration (FDA) announced <a href="https://www.fda.gov/news-events/press-announcements/fda-begins-real-time-reporting-adverse-event-data" target="_blank" rel="noreferrer noopener">in a press release</a> that it would begin updating its Adverse Events Reporting System (FAERS) in real time, replacing the agency’s previous quarterly update schedule. The agency said the change “demonstrates [the FDA’s] commitment to radical transparency and real-time protection of public health.”</p>
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<p>Patients, doctors, and even family members can submit reports directly to the FAERS database if they suspect a symptom is related to a medication. Reports can include both side effects and cases where a medication that once worked <a href="https://medshadow.org/generic-adhd-medication-issues-new-study/?fbclid=IwY2xjawKm121leHRuA2FlbQIxMQBicmlkETFHVFFCRmh6bkZ1YWVmaXRHAR6Go9pjePSuzECknaq72XlUeY6eOgM4aXElppg1se2oDyqX1Y8lGrEOx5Y7hA_aem_xIwQlbpuu-sPzuDbnYZ2WA" target="_blank" rel="noreferrer noopener">no longer seems effective</a>.</p>
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<div class="wp-block-myplugin-custom-alignment-block alignright"><h2>To Search The Database</h2><p>Click the blue search bar at the top of the <a href="https://fis.fda.gov/sense/app/95239e26-e0be-42d9-a960-9a5f7f1c25ee/sheet/7a47a261-d58b-4203-a8aa-6d3021737452/state/analysis" target="_blank" rel="noreferrer noopener"><strong>dashboard</strong></a> and type in the name of the drug you’re interested in. After clicking search, the results will show the number of reactions submitted per year, but not the specific side effects. To view those, use the drop-down menu on the right-hand side above the bar graph and select “cases by reaction.”</p></div>
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<p>To report your experience to FAERS, <a href="https://www.accessdata.fda.gov/scripts/medwatch/index.cfm" target="_blank" rel="noreferrer noopener">click here</a>.</p>
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<p>FDA scientists routinely monitor the database for patterns of serious side effects or signs of inefficacy that warrant further investigation. Those investigations can lead the agency to add new warnings to medication labels, downgrade a <a href="https://medshadow.org/generic-vyvanse-not-working/" target="_blank" rel="noreferrer noopener">generic drug’s bioequivalence status</a> (meaning it is no longer considered interchangeable with the brand-name drug), or even remove the medication from the market.</p>
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<p>While this public, searchable database is useful for keeping track of certain medications, it does not provide a complete or verified picture of a drug’s side effects or safety profile, and individual reports <a href="https://www.fda.gov/drugs/fdas-adverse-event-reporting-system-faers/fda-adverse-event-reporting-system-faers-public-dashboard" target="_blank" rel="noreferrer noopener">are not independently confirmed</a>. <a href="https://www.linkedin.com/in/madris/" target="_blank" rel="noreferrer noopener">Madris Kinard</a>, who previously worked in post-market safety at the FDA, told <a href="https://www.statnews.com/2025/08/22/fda-faers-drugs-adverse-events/?utm_campaign=pharmalittle&utm_medium=email&_hsenc=p2ANqtz-_8IVoo5HiUjUdjf2WTlOPG9wFZo-n6yV-XIWyP4uyn6NFOfmG9YqQ0GfpGu2zCCnaYKIQvI1hceDSQ5k9Xr15JRxd9Zw&_hsmi=377400854&utm_content=377400854&utm_source=hs_email" target="_blank" rel="noreferrer noopener">STAT</a> that the move was a step in the right direction, but without fuller context on each report, the data may have limited value unless someone is closely monitoring a specific medication.</p>
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