FAERS, the FDA Adverse Event Reporting System, is the largest public collection of drug side-effect reports in the U.S. Here is how to search FAERS data on FDA's dashboard and through openFDA, what the reports can and cannot prove, and how ClinicaLister puts a drug's serious-report summary beside its trials and approvals.
FAERS collects reports of adverse events and medication errors involving drugs and therapeutic biologics. Reports come from manufacturers, which must forward the reports they receive, and from health professionals and consumers, who report voluntarily through FDA's MedWatch program. FDA uses the database for post-marketing safety surveillance and signal detection.
In March 2026 FDA moved FAERS data into its new Adverse Event Monitoring System (AEMS), and the old FAERS Public Dashboard address now redirects to the AEMS dashboard. The FAERS-derived dataset is still published on openFDA as the drug adverse event endpoint, with more than 20 million reports from 2004 onward.
Each report describes a patient (age, sex, weight where given), the suspect and concomitant drugs, the reactions coded in MedDRA terms, the outcome, and whether the case was serious — death, hospitalization, disability, a life-threatening event or another serious outcome.
There are two official routes: FDA's public dashboard for point-and-click searches, and the openFDA API for counts and bulk pulls.
Open the AEMS public dashboard on fda.gov (the former FAERS Public Dashboard) and search by product name. It summarizes reports by year, seriousness, outcome and reaction, and lets you drill into case listings.
Query https://api.fda.gov/drug/event.json with search=patient.drug.openfda.generic_name:"tirzepatide" and count=patient.reaction.reactionmeddrapt.exact to get the most frequently reported reactions. Count queries are the fastest way to see a drug's report profile.
Add serious:1 to the search to keep only serious cases, or use the seriousness fields (seriousnessdeath, seriousnesshospitalization and others) to split them by outcome.
openFDA returns at most 1,000 records per call, and the skip parameter stops at 25,000. Without an API key you get 1,000 requests a day per IP address; a free key raises that to 120,000. For full extracts, use the downloadable files instead of paging.
Reporters name drugs in many ways. Search on openfda.generic_name and openfda.brand_name, and check medicinalproduct for free-text names, or you will miss reports.
For each FDA drug product, ClinicaLister keeps a summary of its serious FAERS reports: the total, the number involving death, hospitalization, disability or a life-threatening event, and the five most-reported reactions. It is a summary, not a copy of the individual reports.
The summary sits in the same drug view as the molecule's trials, approvals, label, patents and shortages, so a safety question about a competitor product does not mean opening five sites.
Alongside the post-marketing summary you can see the serious adverse events sponsors report in ClinicalTrials.gov results, which come from controlled studies rather than spontaneous reports.
Your AI assistant can pull a drug's FAERS summary next to its trial and regulatory record through the ClinicaLister MCP server — for example "compare serious-report outcomes for the GLP-1 drugs in phase 3 obesity trials".
Serious
reports summarized per FDA drug product
Top 5
reported reactions per product
≤ 90 days
maximum age of each summary
ClinicaLister stores a summary of serious reports per FDA drug product, queried from openFDA by brand and generic name and refreshed at least every 90 days. It does not store individual case reports; a product with no reports may also be a product whose name did not match. For case-level work, use FDA's dashboard or openFDA directly.
FAERS is FDA's database of adverse event and medication error reports for drugs and therapeutic biologics, filed by manufacturers, health professionals and consumers. Since March 2026 FDA has run it inside the Adverse Event Monitoring System (AEMS); the data is still published on openFDA.
It is the reference source for post-marketing reports, but individual reports are not verified, duplicates exist, and a report does not show that the drug caused the event. Use it to spot possible signals, not to measure risk.
MedWatch is FDA's program and form for submitting safety reports. FAERS is where the drug and biologic reports end up and are analysed.
The openFDA drug event endpoint offers search and count queries plus downloadable files. Without an API key you are limited to 1,000 requests a day per IP address; a free key allows 120,000.
No. ClinicaLister keeps a summary of serious reports for each FDA drug product — totals, outcomes and the top reactions — so you can read safety in context with trials and approvals. For individual cases, use FDA's tools.
See a drug's safety summary beside its trials and approvals
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