The FAERS database explained

On March 11, 2026, FDA moved the contents of its drug safety reporting database into a new system and gave it a new name. The database that researchers, reporters and lawyers had known since 2012 as FAERS, the FDA Adverse Event Reporting System, now lives inside the Adverse Event Monitoring System, or AEMS, according to FDA's page on quarterly safety signals². It is the second migration in 14 years. The earlier system, AERS, was folded into FAERS on September 10, 2012.

Little about the data changed in the move. GxRadar's count of FDA's openFDA adverse event records¹⁰ found 1,307,794 reports that FDA first received in 2025, and 1,035,214 in 2026 through the most recent quarterly load. FDA says¹ the system is being built to take in reports across every product it regulates, from vaccines and devices to tobacco and cosmetics.

How the numbers get used matters more than the name. Report counts are easy to pull and easy to misread, and FDA attaches the same warning to every public view of the data: a report about a drug does not mean the drug caused the problem. This explainer covers what goes into the database, how many reports arrive each year, the three public ways to get the data, and the limits FDA itself spells out.

What goes into the database

The database holds adverse event reports, medication error reports and product quality complaints that resulted in adverse events, according to FDA¹. Its record structure follows the international ICH E2B standard¹⁵ for individual case safety reports, and the events are coded in MedDRA, the medical terminology regulators use worldwide.

Reports come from three directions. Health professionals and consumers can report directly to FDA through MedWatch¹⁴, the agency's voluntary reporting program (GxRadar covers it in a separate explainer). They can also report to the company that sells the product. Companies are then required to pass reports on, as the dashboard's FAQ⁷ explains.

Federal regulations set the company rules. Under 21 CFR 314.80¹², an application holder must send FDA a 15-day "Alert report" for each adverse drug experience that is both serious and unexpected, counted from when the company first learns of it. Other reports go in periodic filings, quarterly for three years after approval and annually after that. Generic makers are bound by the same section through 21 CFR 314.98¹³, which applies it to every approved abbreviated new drug application. A report about a generic sits in the same database as a report about the brand.

How many reports arrive each year

FDA's own statistics pages stopped updating in November 2015. Its table of reports received and entered by year⁸ shows how lopsided the sources are. In 2014, FDA entered 1,204,685 reports. Only 34,246 of them, about 2.8 percent, came directly from health professionals or consumers. The rest arrived through manufacturers.

Sources: FDA, reports received and entered by year⁸ and patient outcomes by year⁹, both as of November 2015. A report "listing death" means death was recorded as an outcome. FDA notes that recording an outcome does not mean the suspect product caused it.

For later years, GxRadar counted records in the openFDA drug adverse event endpoint by the date FDA first received each report, a field the openFDA field reference¹¹ defines as the date the first version arrived. The endpoint covers publicly releasable records from 2004 on. These counts will not match the dashboard exactly, because the two handle case versions differently.

Source: GxRadar analysis of openFDA drug adverse event data¹⁰, last updated October 28, 2026. "From consumers" counts reports whose primary source was coded as a consumer or non-health professional.

Volume peaked in 2021 and has eased since. In 2025, consumers were the primary source on about 48 percent of reports, and about 54 percent were flagged serious. Neither figure says anything about how often a reaction happens. FDA is explicit on that point.

Three ways to get the data

FDA's public dashboard⁴ is the easiest entry point. It lets anyone search by product or reaction and see counts by year, age, sex and outcome, and FDA says⁷ the dashboard data are updated daily. Exports are limited to a subset of fields.

Raw data come in quarterly data files⁵. Each quarter's file covers only that quarter's reports, and FDA warns that using them takes skill with relational databases. They contain demographic, drug, reaction, outcome and report-source tables plus a README. The download page⁶ shows the July to September 2026 file posted October 28, 2026, at 59.7 megabytes for the ASCII version.

Programmers usually reach for openFDA¹⁰, which serves the same reports through an API. Its documentation says the data may lag by three months or more. Anyone who wants an individual case report, or a summary report for a product, can ask FDA through a Freedom of Information Act request, as the data files page⁵ explains.

What FDA says the numbers cannot show

FDA lists the limits on the dashboard page⁴ itself, and they are worth reading in full:

• Duplicate and incomplete reports are in the system. The same event can be reported by a consumer and by a company.
• A report does not establish causation. The event may have come from the underlying disease, another drug or something else.
• Information in reports has not been verified.
• Rates of occurrence cannot be calculated from the reports.

FDA's dashboard FAQ⁷ adds that FDA does not receive a report for every event, and that reporting rises and falls with how long a product has been on the market and with publicity. A 2006 systematic review in Drug Safety put a rough number on the gap. Across 37 studies in 12 countries, Hazell and Shakir found¹⁶ a median under-reporting rate of 94 percent for spontaneous reporting systems.

FDA's dashboard page closes the list with a line aimed at patients: they should talk to their doctor before stopping or changing how they take their medicines. Questions about what a report means for a specific prescription are ones for a prescriber or pharmacist.

What FDA does with a signal

Reviewers in FDA's drug and biologics centers screen the database as routine safety monitoring. Since the Food and Drug Administration Amendments Act of 2007, FDA has had to post a quarterly list of potential signals of serious risk that came wholly or partly from the database, according to the signals page². The 21st Century Cures Act of 2016 replaced the original "bi-weekly screening" language with "screenings."

A listing is a starting point. FDA says the appearance of a product on the list does not mean it has concluded the product has the risk. Follow-up can include studies in larger data systems such as the Sentinel System¹⁷, and outcomes range from no action to labeling changes, a REMS, or, rarely, removal from the market. The most visible labeling outcome is often a boxed warning or a revised Medication Guide. Product labels themselves can be checked on DailyMed.

FDA's April to June 2026 report³ carried additional-information entries updated as of September 4, 2026. FDA notes that listed products may include generic versions. Quality problems that lead to recalls are tracked separately, on GxRadar's recall data page.

The next quarterly extract, for October to December 2026, would post in late January 2027 if the posting pattern of recent years holds. It will be among the first full quarters reported entirely under the AEMS name.