Definition · Plain-language
FAERS
FAERS, the FDA Adverse Event Reporting System, is the database the US Food and Drug Administration uses to collect adverse-event and medication-error reports for drugs and therapeutic biologics after they reach the market.
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What FAERS is and what it replaced
FAERS is the computerised information system the FDA maintains to support its post-marketing safety surveillance programme for approved drugs and therapeutic biological products. It succeeded the earlier Adverse Event Reporting System (AERS), modernising the data structure and adopting standardised international terminology and report formats. The database aggregates individual case safety reports describing suspected adverse events and medication errors, giving the agency a national picture of safety experience once a product is in widespread clinical use, beyond the controlled conditions of pre-approval trials.
Where the reports come from
Reports reach FAERS through two routes. Voluntary reports are submitted by consumers and healthcare professionals, typically through the FDA’s MedWatch programme. Mandatory reports are submitted by manufacturers, who are required under regulation to forward adverse-event information they receive. Because submission is partly voluntary, the data are not a complete census of events: under-reporting is common and the volume of reports for a product does not directly measure how often an event occurs. The system captures signals, not incidence rates.
How the FDA uses the data
FDA safety reviewers and epidemiologists analyse FAERS data to look for new safety signals, changes in the character or severity of known reactions, and potential medication-error patterns. Findings can prompt further investigation, such as epidemiological studies, and may lead to regulatory action including labelling changes, communications to prescribers, or risk-management measures. FAERS is one input among several; a signal identified in the database is a hypothesis to be evaluated, since the reports are uncontrolled and a causal relationship is not assumed.
Key facts
At a glance
- Definition: US database of post-marketing adverse-event and medication-error reports.
- Stands for: FDA Adverse Event Reporting System.
- Maintained by: US Food and Drug Administration.
- Predecessor: Adverse Event Reporting System (AERS).
- Sources: Voluntary (consumers/HCPs via MedWatch) and mandatory (manufacturers).
- Caveat: A report records a suspected link only; it does not establish causation.
Common misconceptions
What people often get wrong
Often heard: A report in FAERS means the drug was proven to cause the event.
Actually: A FAERS report records a suspected association only. The reports are uncontrolled and unverified, so a single report does not establish that the product caused the event; causation must be assessed separately.
Often heard: The number of FAERS reports tells you how often a side effect happens.
Actually: FAERS counts cannot measure incidence. Reporting is partly voluntary and under-reporting is common, so report volume reflects reporting behaviour and exposure, not a true event rate.
Often heard: Only doctors can submit reports to FAERS.
Actually: Consumers and patients can submit voluntary reports too, usually through MedWatch. Manufacturers are additionally required to submit reports they receive.
Going deeper
