Glossary
Last reviewed
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 source.
- Adverse event
A health problem, a product problem or a lack of effect that a person reports in connection with an animal drug. A report does not show that the drug caused the event.
Problems include undesired side effects (adverse events) associated with a drug, and product defects. Adverse events also include a lack of effectiveness (the drug doesn’t do what it’s supposed to do) and unfavorable reactions in people who handle the drug.
FDA Center for Veterinary Medicine. Source: Frequently Asked Questions about Animal Drugs
- Report
One adverse event report that FDA received. The site counts reports. One report can name more than one drug and can list more than one clinical sign.
It’s also important to recognize the information in the database is as reported to the FDA’s CVM, and the agency has not necessarily determined if the product(s) in question was/were the actual cause of the events reported.
FDA Center for Veterinary Medicine. Source: Adverse Event Reports for Animal Drugs and Devices
- Clinical sign
A coded term that a report lists for what the reporter saw in the animal, for example "Vomiting". The site says sign for clinical sign. A report that lists a sign does not show that a drug caused it.
- VeDDRA term
A term from the VeDDRA list, which FDA and drug companies use to code the clinical signs of a report. A report from before FDA used VeDDRA can have an older term. The site marks such a term.
The VeDDRA Vocabulary is the VICH-harmonized list for submission of adverse event terms. VeDDRA medical terminology describes adverse clinical manifestations.
FDA Center for Veterinary Medicine. Source: Data Mining at the Center for Veterinary Medicine
- Active ingredient
A substance in a drug that has the effect of the drug. A report names the active ingredients of each drug in it. The site counts reports by active ingredient.
- Drug
On this site, a drug is one set of active ingredients, as the reports name it. One set can be sold under many brand names. A drug page covers one set.
- Brand name
The name under which a company sells a drug. The Green Book lists brand names. The openFDA reports do not give them, so the site gives no count to a brand name.
- Masked (MSK)
The openFDA records give the value MSK for the brand name and for the manufacturer name of each drug. FDA says that MSK means masked.
MSK is a null flavor that means "masked." MSK is used when there is information available for the value, but it has not been provided to the sender due to security, privacy, or other reasons.
openFDA. Source: Animal and Veterinary Adverse Events, Searchable Fields
- Green Book
The FDA list of approved animal drug products. The site uses it for active ingredient names, brand names, species, dose forms and routes. The site does not link an entry of the Green Book to a report.
Most FDA-approved animal drugs are included in a publicly available list of approved animal drug products. This list is called the Green Book for short, and FDA updates it in its entirety every month.
FDA Center for Veterinary Medicine. Source: Approved Animal Drug Products (Green Book)
- Sponsor
The company that holds the approval of an animal drug in the Green Book. The site shows the name as FDA gives it, and gives it no count.
- Extra-label use, off-label use
Use of a drug in a species, or for a condition, that its approval does not cover. FDA uses both terms. The site uses extra-label use.
If the drug wasn’t approved for the species it was used in or the condition it was used to treat. This is called an “extra-label” or “off label” use.
FDA Center for Veterinary Medicine. Source: Adverse Event Reports for Animal Drugs and Devices
- Outcome
What the person who sent the report says about the animal at the time of the report, for example "Recovered/Normal" or "Died". The site shows the outcome words of FDA. An outcome is not proof that a drug caused it.
- Lack of efficacy
A report that says a drug did not do what it should. VeDDRA has terms for it, for example "Lack of efficacy". The report kind "Lack of expected effectiveness" is about the same fact. It is not a harm to the animal.
Lack of effectiveness, such as a product not working, a product that stops working, or a product that isn’t working as well as it did.
FDA Center for Veterinary Medicine. Source: How to Report Animal Drug and Device Side Effects and Product Problems
- Serious flag
A mark in a report that says the event was serious. The person who sends the report sets it. The site shows the share of reports that have the flag.
- Month of receipt
The month in which FDA received a report. It is not the month of the event.
- Closed quarter
A quarter of a year for which the openFDA files have most of the reports. The site compares the count of a closed quarter with the quarter before it and with the same quarter one year before.
The site read the quotations on . How the site counts reports shows how each term is used.