FDA Adverse Event Reporting System (FAERS)
You can now use FAERS Online to find information about adverse events (side effects) and medication errors reported to FDA for drugs and therapeutic biologics. Using the new search, you can enter the name of a medication and a year to create an Event Tally Report or a Detailed Report online. This is the same information you would have received by submitting a Freedom of Information Act (FOIA) request to FDA.
- Data from 1968 through August 27, 2012 are available through FAERS Online.
- In September 2012, FDA moved its adverse event data to a new database. Once we have completed the programming changes needed to extract data from the new internal database, we plan to update the data available through FAERS Online.
- FAERS data have limitations. There is no certainty that the reported event (adverse event or medication error) was actually due to the product. The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to compare products or estimate the incidence of these events. You should talk to your health care provider about any concerns you have with a medication, including side effects. You should not stop taking your medicine unless your health care provider tells you to.
- Health care professionals and consumers can report serious adverse events or product quality problems with the use of a drug product to FDA's MedWatch Adverse Event Reporting program.
To learn more about how FDA uses adverse event information in its activities, such as looking for new safety concerns that might related be related to a marketed drug product, please see the FDA Adverse Event Reporting System (FAERS) page.
FDA Adverse Event Reporting System (FAERS) Help
- FDA Adverse Event Reporting System (FAERS)
Background information and details about FAERS.
- Quarterly Data Files from the FDA Adverse Event Reporting System (FAERS)
Raw data extracted from the AERS and FAERS databases.
- Reporting an Adverse Event or Medication Error to FDA
MedWatch: The FDA Safety Information and Adverse Event Reporting Program