FAERS
Medical abbreviation · Medical Research
| Stands for | FDA Adverse Event Reporting System |
|---|---|
| Categories | Medical |
FAERS stands for FDA Adverse Event Reporting System, a medical research abbreviation.
FDA database of adverse event and medication error reports submitted by manufacturers, health professionals and consumers for drugs and therapeutic biologics. Analysts search it for safety signals that may lead to label changes or other regulatory action.
Example: FAERS signal: a cluster of pancreatitis reports prompted an FDA safety review.
Usage notes
Consumers and clinicians report through MedWatch, and manufacturers must submit reports they receive. Like other spontaneous reporting systems, FAERS cannot prove that a drug caused an event or show how often it occurs, because reporting is incomplete and unverified. Vaccine reports go to a separate system, VAERS.
Related abbreviations
More medical research abbreviations
- DALY – Disability-adjusted life year
- DSMB – Data and safety monitoring board
- EBM – Evidence-based medicine
- EDC – Electronic data capture
- EMA – European Medicines Agency
- EUA – Emergency use authorization
- FIH – First-in-human
- FWA – Federalwide Assurance
- GCP – Good Clinical Practice
- GLP – Good Laboratory Practice
- GRADE – Grading of Recommendations Assessment, Development and Evaluation
- HR – Hazard ratio
See all 94 medical research abbreviations →
This entry is for general education and is not medical advice. Abbreviation use varies between institutions; always confirm in context.