In March 2026, the FDA folded seven separate safety-reporting databases into a single system and gave it a new name: the Adverse Event Monitoring System, or AEMS. If you have ever looked up the reported side effects of a medication, the data almost certainly came from one of those older systems. The best known of them was FAERS, the FDA Adverse Event Reporting System, which had been the backbone of post-market drug-safety monitoring since 2012. As of March 11, 2026, FAERS is now part of AEMS.
Most people taking medications never heard a word about it. But because PillSignal is built on exactly this data, we think it is worth explaining plainly: what AEMS is, what actually changed, and, just as importantly, what did not.
What AEMS replaced
Before AEMS, the FDA ran a patchwork of separate databases, each covering a different kind of product. FAERS handled prescription and over-the-counter drugs and biologics. VAERS, run jointly with the CDC, handled vaccines. CAERS covered foods, dietary supplements, and cosmetics. There were others for medical devices, tobacco products, and veterinary medicine. Each had its own interface, its own quirks, and its own update schedule.
AEMS consolidates all of that into one platform spanning every product category the FDA regulates. The stated goals are to standardize how reports are collected, reduce duplicated effort, and make it easier to spot safety patterns across product types. The FDA has also said the new system is expected to save roughly $120 million over five years compared with running the old systems separately.
Importantly, the old data did not vanish. The FDA migrated the historical records from the legacy systems, including all of FAERS, into AEMS when it launched. The decades of reports that PillSignal draws on are still there. They simply live under a new name now.
What actually changed
Three things are genuinely new.
The data is now near real time. This is the biggest practical shift. FAERS published on a roughly quarterly cycle, so the public data always lagged a few months behind. AEMS refreshes daily, which means newly filed reports show up far faster than they used to.
It is one front door instead of seven. Anyone can now search drugs, vaccines, devices, supplements, and more from a single public dashboard, rather than learning a different tool for each. The dashboard lets you query by product name or by specific adverse event term and download the underlying case listings.
It leans on artificial intelligence. The FDA has described AEMS as using AI-based tools for tasks like redacting personal information, digitizing older reports, and helping flag potential safety signals. The agency's stated aim is faster processing, while keeping safeguards in place so that individually identifiable patient information is not disclosed.
What did not change
The FDA says this directly in its own guidance on the new system: the data does not confirm a causal relationship between a product and a reported event, the true rate of any event cannot be determined from the reports alone, and the reports may be incomplete, unverified, or inaccurate. These are the same limitations that have always applied to this data, restated for the new system.
The reporting rules did not change either. The same people can report the same things in the same ways, including through MedWatch for drugs and VAERS for vaccines. Only the system that receives and displays the reports is different.
If anything, the move to real-time public data makes careful reading more important, not less. Some safety experts have noted that faster, more accessible reporting can lead to more misinterpretation, with people treating a fresh, unverified report as if it were a confirmed finding. The data got faster. The need to read it carefully got bigger.
What this means if you are looking up a medication
The AEMS public dashboard is a genuinely useful tool, and for clinicians, researchers, and the deeply curious, it is worth knowing about. But it is built for querying, not for browsing. It is an interactive analytics tool designed for people who already know what they are looking for and how to interrogate a dataset. If you just got a new prescription and want to understand what others have reported about it, a query dashboard is a steep place to start.
That is the gap PillSignal fills. We take this same FDA data — the data that now lives in AEMS and was called FAERS before that — and lay it out as plain, readable pages, one per medication, with the context and caveats built in. The dashboard is the raw, real-time source for experts. PillSignal is the plain-language front door for everyone else. Both rest on the same reports, and both come with the same fundamental rule: a report is a flag for investigation, never proof of harm.
As always, the data is a way to walk into a conversation with your doctor or pharmacist better informed. It is not a substitute for that conversation. Whether you read the reports on the FDA's new dashboard or on PillSignal, treat the numbers as a starting point for questions, not as answers. Our guide on what FDA drug reports actually show puts the full picture in context.
New to this data? How to Read FDA Adverse Event Reports →
Want to file a report of your own? How to Report a Drug Side Effect to the FDA →
Ready to look up a medication? Search PillSignal →