FDA retires FAERS and launches AEMS, a single look-up tool for adverse event reports

The FDA retired its main drug side effect database on March 11, 2026, folding it and two other reporting systems into one public tool. The replacement, the FDA Adverse Event Monitoring System, or AEMS, absorbs what used to be FAERS, VAERS and AERS ^[1].

FAERS held reports for drugs, biologics, cosmetics and color additives. VAERS covered vaccines and is run jointly with the Centers for Disease Control and Prevention. AERS was actually two databases, one for animal drugs and one for animal foods ^[1].

More databases follow in May 2026, when MAUDE (medical devices), HFCS (human foods and dietary supplements) and CTPAE (tobacco products) are replaced by the new platform. By the end of that month, the FDA says AEMS will carry real-time reports for every product category it regulates ^[1].

The agency described the old setup as seven separate databases handling about 6 million reports a year at a cost of about $37 million annually. It projects savings of about $120 million over five years under the consolidated system ^[1].

One change affects anyone who checks these records: submissions appear as they arrive rather than on a quarterly release schedule. The FDA expects that to sharply cut the number of public records requests it receives for reports it has not yet published ^[1].

"These clunky systems also wasted millions of taxpayer dollars and created blind spots in our postmarket surveillance," FDA Commissioner Marty Makary said in the announcement ^[1]. Chief AI Officer Jeremy Walsh said the consolidation amounted to the biggest technical transformation in the agency's history ^[1].

AEMS is built to hold more than side effect reports. The FDA describes it as a central place for consumer complaints, reports of regulatory misconduct and whistleblower submissions across its centers, using automated redaction and digitization, standard reporting protocols and cross-product analytics ^[2]. The agency says it will not publish individually identifiable patient or consumer information ^[1].

Why it matters for patients

Reports sent in by patients, clinicians and manufacturers are one of the inputs the FDA uses to look for safety signals, meaning patterns or clusters of events that might indicate a risk not seen in clinical trials. The agency also states plainly that these reports have limits and that a filed report does not by itself show a product caused the problem ^[1].

Drug reports are one of the categories AEMS covers ^[1][2]. That includes reports involving semaglutide, sold as Ozempic, Wegovy and Rybelsus, and tirzepatide, sold as Mounjaro and Zepbound. There is no separate section for weight-loss or diabetes drugs; they sit in the same pool as every other medicine.

Because entries post as they come in, a person searching for recently reported problems will see them sooner than under the quarterly schedule that applied to FAERS ^[1]. What has not been reported is how far back the migrated historical records will reach, when that migration is finished, or whether the agency will keep issuing separate periodic summaries of potential safety signals alongside the raw reports ^[1].

Practical effects for a patient who wants to look up reports tied to a specific drug are mostly about where to search and how fresh the results are. The FDA says the dashboard is meant to be easier to use than the systems it replaced, which the agency said had a poor interface ^[1].

What happens next

• March 11, 2026: AEMS opens with reports for drugs, biologics, vaccines, cosmetics and animal food ^[1].
• May 2026: MAUDE, HFCS and CTPAE move to AEMS ^[1].
• By the end of May 2026: real-time reports for all FDA-regulated products are expected to be in the system ^[1].
• No date announced: migration of historical data, shutdown of any remaining legacy systems, and release of enhanced data tools and analytics ^[1].