Glossary
Each term has one meaning on this site. Where FDA or openFDA publishes words for the term, the entry shows them as a quotation and names the page.
The site read the FDA pages on . How the site counts reports shows how the site uses each term.
- Adverse event
A health problem that a person reports after the use of a medical product. A report of an adverse event does not show that the product caused it.
An adverse event is any undesirable experience associated with the use of a medical product in a patient.
Source: FDA, What is a Serious Adverse Event?. Content current as of . The site read the page on .
- Report
One adverse event report that FDA received. The site counts reports. One report can name more than one product and can record more than one reaction term.
- FAERS and AEMS
FAERS is the FDA system that holds the adverse event reports about drugs and therapeutic biologics. FDA is now implementing AEMS, which consolidates its reporting systems. The openFDA files still use the name FAERS.
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. 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 .
- MAUDE
MAUDE is the FDA database of reports about medical devices. The site uses the openFDA copy of it.
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 .
- MDR (medical device report)
One report about a medical device. Manufacturers, importers, user facilities and voluntary reporters send them to FDA. The site counts MDRs as device reports.
Mandatory reporters (that is, manufacturers, device user facilities, and importers) are required to submit to the FDA certain types of reports for adverse events and product problems about medical devices.
Source: FDA Center for Devices and Radiological Health, Medical Device Reporting (MDR): How to Report Medical Device Problems. Content current as of . The site read the page on .
- MedWatch
The FDA program that takes voluntary reports about medical products from health professionals, patients and consumers.
MedWatch is the Food and Drug Administration's (FDA) program for reporting serious reactions, product quality problems, therapeutic inequivalence/failure, and product use errors with human medical products, including drugs, biologic products, medical devices, dietary supplements, infant formula, and cosmetics.
Source: FDA, Reporting Serious Problems to FDA. Content current as of . The site read the page on .
- Suspect drug
A drug that the reporter named as a possible cause of the event. FDA does not validate this role. The site counts the reports in which a drug is suspect or interacting.
Suspect (the drug was considered by the reporter to be the cause)
Source: openFDA, Drug adverse event fields (YAML reference). The site read the page on .
Any number of the drugs may be marked as suspect if thought to be responsible for one or more of the reactions, but that information is not validated.
Source: openFDA, Drug Adverse Event Overview. The site read the page on .
- Concomitant drug
A drug that the report names as taken at the same time as the suspect drug. The site does not count it in the figures of a drug page.
Concomitant (the drug was reported as being taken along with the suspect drug)
Source: openFDA, Drug adverse event fields (YAML reference). The site read the page on .
- Interacting drug
A drug that the reporter named as having interacted with the suspect drug. The site counts it with the suspect drugs.
Interacting (the drug was considered by the reporter to have interacted with the suspect drug)
Source: openFDA, Drug adverse event fields (YAML reference). The site read the page on .
- Reaction term
A coded term that a report records for what happened to the patient, for example "Nausea". The site shows the term as openFDA publishes it. A term in a report does not show that a product caused it.
Adverse events and medication errors are coded using terms in the Medical Dictionary for Regulatory Activities (MedDRA) terminology.
Source: FDA, FDA Adverse Event Monitoring System (AEMS). Content current as of . The site read the page on .
- MedDRA preferred term
MedDRA is the Medical Dictionary for Regulatory Activities. FDA uses it to code the words of a reporter. A preferred term is one standard name in that dictionary. The plain meaning that the site gives under a term is the site's own words, not a definition of MedDRA.
- Outcome
What the report says happened to the patient because of the event, in the terms of FDA. The reporter gives it and FDA does not verify it. A report can have more than one outcome.
- Serious
An adverse event is serious when the patient outcome is one of the outcome terms below. In the openFDA files the field "serious" has the value 1 for such a report. The report sender sets it.
The event is serious and should be reported to FDA when the patient outcome is:
Source: FDA, What is a Serious Adverse Event?. Content current as of . The site read the page on .
The adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition
Source: openFDA, Drug adverse event fields (YAML reference). The site read the page on .
- Death
The patient died, and the report says that the death was an outcome of the event. It is not proof that a product caused it.
The term of FDA:
Death
Report if you suspect that the death was an outcome of the adverse event, and include the date if known.
Source: FDA, What is a Serious Adverse Event?. Content current as of . The site read the page on .
- Life-threatening
The patient was at substantial risk of dying at the time of the event.
The term of FDA:
Life-threatening
Report if suspected that the patient was at substantial risk of dying at the time of the adverse event, or use or continued use of the device or other medical product might have resulted in the death of the patient.
Source: FDA, What is a Serious Adverse Event?. Content current as of . The site read the page on .
- Hospitalization (initial or prolonged)
The event led to admission to a hospital, or to a longer stay.
The term of FDA:
Hospitalization (initial or prolonged)
Report if admission to the hospital or prolongation of hospitalization was a result of the adverse event.
Source: FDA, What is a Serious Adverse Event?. Content current as of . The site read the page on .
- Disability or Permanent Damage
The event led to a lasting change in the body or in what the person can do.
The term of FDA:
Disability or Permanent Damage
Report if the adverse event resulted in a substantial disruption of a person's ability to conduct normal life functions, i.e., the adverse event resulted in a significant, persistent or permanent change, impairment, damage or disruption in the patient's body function/structure, physical activities and/or quality of life.
Source: FDA, What is a Serious Adverse Event?. Content current as of . The site read the page on .
- Congenital Anomaly/Birth Defect
The report says that exposure before conception or in pregnancy may have led to an adverse outcome in the child.
The term of FDA:
Congenital Anomaly/Birth Defect
Report if you suspect that exposure to a medical product prior to conception or during pregnancy may have resulted in an adverse outcome in the child.
Source: FDA, What is a Serious Adverse Event?. Content current as of . The site read the page on .
- Other Serious (Important Medical Events)
A serious event that does not fit the other outcome terms.
The term of FDA:
Other Serious (Important Medical Events)
Report when the event does not fit the other outcomes, but the event may jeopardize the patient and may require medical or surgical intervention (treatment) to prevent one of the other outcomes.
Source: FDA, What is a Serious Adverse Event?. Content current as of . The site read the page on .
- Event type
The class that a device report gives to the event: Death, Injury, Malfunction or Other. The sender chooses it and FDA does not verify it. "Not given" means that the report has no answer.
Outcomes associated with the adverse event. Other serious/important medical event.
Source: openFDA, Device adverse event fields (YAML reference). The site read the page on .
- Malfunction
A report says that the device did not work as it should. It can be with or without harm to a person.
Product malfunction.
Source: openFDA, Device adverse event fields (YAML reference). The site read the page on .
- Reporter
The person or the company that sent a report. A drug report gives the type of reporter, for example a physician, a pharmacist or a consumer. The site never shows a name.
- Duplicate report
A second report of an event that FDA has already received. The public files do not link such reports, so the counts of the site include them.
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 .
- Brand name and generic name
A brand name is the name under which a company sells a product. A generic name is the name of the active ingredient. A reporter can write either name, so each name has its own page.
- Active ingredient
The substance in a drug that has the effect of the drug. A page of a drug shows the other names of the same ingredient. The page labels their sum as a sum of separately reported names.
- Drug class
The Established Pharmacologic Class (EPC) on the label of a drug, from the National Drug Code Directory and the reports. A drug is in the class that its reports name most often.
- Device type and product code
Each type of medical device has a product code of three letters. A report has the product code of its device. A page of a device type has the reports of every brand of that type.
- Manufacturer
The company that a device report gives as the manufacturer of the device. The name is as written on the report, so a subsidiary or a spelling can be a separate name. A name that reads as a person is not published.
- Closed quarter
A quarter of a year for which the FDA files have most of the reports. The site compares the count of the latest closed quarter with the quarter before it and with the same quarter one year before.
- Held page
A page that the site published earlier and keeps, although the new FDA data no longer meet the condition for a new page. It is marked noindex and says why, with the date of the data.
Last checked against FDA pages: .