FDA retires FAERS and launches the Adverse Event Monitoring System

The U.S. Food and Drug Administration launched a new adverse event look-up platform on March 11, 2026, called the FDA Adverse Event Monitoring System (AEMS) ^[1]. It replaces FAERS, the FDA Adverse Event Reporting System, which for years has been the public's main way to search side effect reports filed for prescription drugs, including GLP-1 medicines such as semaglutide (Ozempic, Wegovy, Rybelsus) and tirzepatide (Mounjaro, Zepbound) ^[1][2].

AEMS pulls reports from several separate systems into one dashboard. As of launch, it covers adverse event reports for drugs, biologics, vaccines, cosmetics and animal food ^[1]. Three legacy systems are being retired now: FAERS, which held reports for drugs, biologics, cosmetic products and color additives; VAERS, the vaccine system co-managed by the FDA and the Centers for Disease Control and Prevention; and AERS, two databases covering animal drugs and animal foods ^[1]. The FDA says VAERS data will be displayed inside AEMS ^[1].

Three more systems move over later: MAUDE for medical devices, HFCS for human foods and dietary supplements, and CTPAE for tobacco products and electronic nicotine delivery systems ^[1]. The agency says that by the end of May 2026, AEMS will contain real-time adverse event reports for all FDA-regulated products, while still withholding individually identifiable patient or consumer information ^[1].

The numbers behind the switch

The FDA says it has been processing roughly 6 million adverse event reports a year across a patchwork of seven databases that cost about $37 million annually to operate ^[1]. The agency expects AEMS to save approximately $120 million over the next five years ^[1]. FDA Commissioner Marty Makary said the older systems were "outdated and fragmented and made important data difficult to access" and "created blind spots in our postmarket surveillance" ^[1]. Chief AI Officer Jeremy Walsh called the consolidation "the biggest technical transformation in agency history" ^[1].

One change matters for anyone who tracks side effect data over time: the FDA says AEMS will publish reports in real time rather than quarterly, and expects that shift to cut down on Freedom of Information Act requests for reports that had not yet been released ^[1]. The agency also says it will migrate historical adverse event data into AEMS, decommission certain legacy systems, and roll out enhanced application programming interfaces (APIs) and data analytics tools in the months ahead ^[1].

AEMS is also meant to do more than host reports. The FDA describes it as a centralized platform for consumer complaints, regulatory misconduct reports and whistleblower submissions across all FDA centers, with AI-based redaction and digitization tools and cross-product surveillance built in ^[2].

Why it matters for patients

Adverse event reports are voluntary filings from patients, caregivers, clinicians and manufacturers. They are not proof that a drug caused a problem. The FDA itself notes these reports have limitations, but says they can help identify potential safety signals — patterns or clusters of events that might point to a previously unknown risk ^[1].

For GLP-1 users, the practical effect is mostly about where to look. People who have been searching FAERS for reports tied to semaglutide, tirzepatide or other GLP-1 drugs will now use AEMS instead ^[1][2]. If a news story, lawyer's ad or social media post cites "FAERS data" going forward, that data is being folded into the new system ^[1].

Real-time posting also means raw report counts may appear to move faster than they did under quarterly releases ^[1]. A rising count in a public database is not the same as a confirmed risk, and the FDA has not said in these announcements how it will handle interpretation of the newly real-time data.

What happens next

The FDA says remaining product centers will begin processing adverse event reports in AEMS in the coming months, with the full build-out — including devices, dietary supplements and tobacco products — targeted for the end of May 2026 ^[1].

Several details are not addressed in the FDA's announcement or its AEMS page. These include whether the quarterly list of potential signals of serious risk will continue in its current form, how quickly older FAERS records will be fully searchable inside AEMS, and what the new download files will look like for researchers. Those points are not yet known from the material the FDA has published.