26 FDA Aderse Event Reporting System (FAERS)
26.3 Description
- Database that contains information on adverse event and medication error reports submitted to FDA.
- Designed to support the FDA’s post-marketing safety surveillance program for drug and therapeutic biologic products.
- Adverse events and medication errors are coded to terms in the Medical Dictionary for Regulatory Activities (MedDRA) terminology.
26.6 Collection Methodology
- Healthcare professionals, consumers, and manufacturers submit reports to FAERS.
- FDA receives voluntary reports directly from healthcare professionals (such as physicians, pharmacists, nurses and others) and consumers (such as patients, family members, lawyers and others).
- If a manufacturer receives a report from a healthcare professional or consumer, it is required to send the report to FDA as specified by regulations.
26.7 Available at
https://fis.fda.gov/extensions/FPD-QDE-FAERS/FPD-QDE-FAERS.html
26.12 Special Notes
- There is no certainty that the reported event (adverse event or medication error) was due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event.
- FDA does not receive reports for every adverse event or medication error that occurs with a product.
- There are also duplicate reports where the same report was submitted by a consumer and by the sponsor.
- FAERS data cannot be used to calculate the incidence of an adverse event or medication error in the U.S. population.