What is FAERS?
The FDA Adverse Event Reporting System (FAERS) is a database that contains information on adverse event and medication error reports submitted to FDA.
Key features of FAERS:
- The database is designed to support the FDA’s post-marketing safety surveillance program for drug and therapeutic biologic products.
- The informatic structure of the FAERS database adheres to the international safety reporting guidance issued by the International Conference on Harmonization (ICH E2B).
- Adverse events and medication errors are coded to terms in the Medical Dictionary for Regulatory Activities (MedDRA) terminology.
- The FDA produces FDA Adverse Event Reporting System (FAERS) quarterly data.
- The FAERS includes:
- demographic and administrative information and the initial report image ID number (if available);
- drug information from the case reports;
- reaction information from the reports;
- patient outcome information from the reports;
- information on the source of the reports;
- a “README” file containing a description of the files.
How does FDA use the information in FAERS?
- FAERS is a useful tool for FDA for activities such as looking for new safety concerns that might be related to a marketed product.
- It helps in evaluating a manufacturer’s compliance to reporting regulations.
- If a potential safety concern is identified in FAERS, further evaluation is performed, FDA may take regulatory action(s) to improve product safety and protect the public health, such as updating a product’s labeling information, restricting the use of the drug, communicating new safety information to the public, or, in rare cases, removing a product from the market.
From where are the reports collected?
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). Healthcare professionals and consumers may also report to the products’ manufacturers. 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.
Is FAERS data available to the public?
FAERS data is available to the public in the following ways:
- FAERS dashboard: a highly interactive web-based tool that allows for the querying of FAERS data in a user-friendly fashion.
- FAERS data files: provides raw data consisting of individual case safety reports extracted from the FAERS database. A simple search of FAERS data cannot be performed with these files by persons who are not familiar with the creation of relational databases.
- Individual case safety reports from the FAERS database can also be obtained by sending a Freedom of Information (FOI) request to FDA.
What is FAERS Dashboard?
The FAERS Public Dashboard is a highly interactive web based user-friendly tool that will allow FAERS queries to be easily managed in the database for post-marketing drug safety and monitoring purposes.
How is FAERS Public Dashboard helpful?
FAERS public dashboard helps in extracting data from the FAERS database by generating queries and producing user-friendly information and charts. For example, users can view a summary of adverse event reports received from 1968 to the present or for a specific timeframe. In addition, users can search on a product of interest within a specific timeframe.
By making the FAERS database more easily accessible through the dashboard, the agency’s goal is to better inform patients and health care professionals of adverse events reported with drug and biologic products.
What are the imitations of FAERS Dashboard?
While the FAERS dashboard offers stakeholders many more ways of searching for and organizing data on adverse events reported to the FDA for many drug and biologic products, there remain limitations to the data. For example, while FAERS contains reports on adverse events associated with a particular drug or biologic, this does not mean that the drug or biologic caused the adverse event. Importantly, the FAERS data by themselves are not an indicator of the safety profile of the drug or biologic. Patients should still talk to their health care professional if they have any concerns regarding their medications.
What points should I consider while viewing the dashboard content?
When you view the website output of reported reactions (side effects or adverse drug reactions) for a drug product, it is important to consider the following points:
- Data Quality:There are many instances of duplicative reports and some reports do not contain all the necessary information. Duplicate reporting occurs when the same report is submitted by the consumer and the sponsor. The information in FAERS evolves daily and the number of individual cases may increase or decrease. It is therefore possible that the information on this website may change over time.
- Existence of a report does not establish causation:For any given report, there is no certainty that a suspected drug caused the reaction. While consumers and healthcare professionals are encouraged to report adverse events, the reaction may have been related to the underlying disease being treated, or caused by some other drug being taken concurrently, or occurred for other reasons. The information in these reports reflects only the reporter’s observations and opinions.
- Information in reports has not been verified:Submission of a report does not mean that the information included in it has been medically confirmed nor it is an admission from the reporter that the drug caused or contributed the event.
- Rates of occurrence cannot be established with reports:The number of suspected reactions in FAERS should not be used to determine the likelihood of a side effect occurring. The FDA does not receive reports for every adverse event or medication error that occurs with a product. Many factors can influence whether an event will be reported, such as the time a product has been marketed and publicity about an event. Therefore, information in these reports cannot be used to estimate the incidence (occurrence rates) of the reactions reported.
- Patients should talk to their doctorbefore stopping or changing how they take their medications.
- Patient Outcomes received in FAERS: These data describe the outcome of the patient as defined in U.S. reporting regulations (21 CFR 310.305, 314.80, 314.98, 600.80). Serious means that one or more of the following outcomes were documented in the report: death, hospitalization, life-threatening, disability, congenital anomaly, and/or other serious outcome. Documenting one or more of these outcomes in a report does not necessarily mean that the suspect product(s) named in the report was the cause of the outcomes.
Importantly, the FAERS data by themselves are not an indicator of the safety profile of the drug.
Following is the link to Dashboard and Disclaimer.