What FAERS and MAUDE are
This guide says what the two FDA data sources of the site are. It gives the limits in the words of FDA. The site read the FDA pages on .
FAERS and AEMS
FAERS holds the adverse event reports about drugs and therapeutic biologics. FDA says:
The FDA Adverse Event Reporting System (FAERS) database contains adverse event reports, medication error reports and product quality complaints resulting in adverse events that were submitted to FDA.
Source: FDA, FDA Adverse Event Monitoring System (AEMS). Content current as of . The site read the page on .
The openFDA files hold 20,646,523 drug reports, with the text of the reporter removed. FDA is now implementing AEMS. FDA says:
FDA is implementing the Adverse Event Monitoring System (AEMS) to consolidate multiple disparate reporting systems currently used across all FDA-regulated product categories, including medical products, vaccines, devices, tobacco, food, cosmetics, and veterinary medicines.
Source: FDA, FDA Adverse Event Monitoring System (AEMS). Content current as of . The site read the page on .
FDA's public dashboard of drug reports now has the name AEMS Public Dashboard. The openFDA files still use the name FAERS, and so does this site.
MAUDE
MAUDE holds the reports about medical devices. The openFDA files hold 26,326,888 device reports. FDA says:
The MAUDE database houses medical device reports (MDRs) submitted to the FDA by mandatory reporters (manufacturers, importers and device user facilities) and voluntary reporters such as health care professionals, patients and consumers.
Source: openFDA, Manufacturer and User Facility Device Experience. The site read the page on .
What a report contains
A drug report lists the drugs and the role of each drug: suspect, concomitant or interacting. It lists the reaction terms, the outcomes, the age and sex of the patient and the type of reporter.
A device report gives the brand name, the manufacturer, the product code and the event type. It also gives coded problems of the device and of the patient.
FDA says about the drug reports:
No individual drug is connected to any individual reaction. When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on .
The limits of the drug reports
For any given report, there is no certainty that a suspected drug caused the event. 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. The information in these reports cannot be used to estimate the incidence (occurrence rates) of the events reported. There are many instances of duplicative reports and some reports do not contain all the necessary information.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of . The site read the page on .
There is no certainty that the reported event (adverse event or medication error) was actually 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. Further, FDA does not receive reports for every adverse event or medication error that occurs with a product. Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.
Source: openFDA, Drug Adverse Event Overview. The site read the page on .
The limits of the device reports
Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use.
Source: openFDA, Device Adverse Event Overview. The site read the page on .
MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices. Confirming whether a device actually caused a specific event can be difficult based solely on information provided in a given report.
Source: openFDA, Manufacturer and User Facility Device Experience. The site read the page on .
MDR data is not intended to be used either to evaluate rates of adverse events, evaluate a change in event rates over time, or to compare adverse event occurrence rates across devices. The submission of an MDR itself does not necessarily demonstrate that the device caused or contributed to the adverse outcome or event.
Source: FDA Center for Devices and Radiological Health, About Manufacturer and User Facility Device Experience (MAUDE) Database. Content current as of . The site read the page on .
What this site adds
The site counts reports. It shows each count with the period of the count and with the words of FDA.
The site makes no assessment of a product. A pharmacist or a clinician can answer a question about a medicine or a device.
See also Reading a reaction list, What affects a count of reports and the glossary.
Last checked against FDA pages: .