What affects a count of reports
Last checked against the FDA pages:
A count of reports counts reports. It does not count events, and it is not a rate. This guide gives what FDA says about the count. The site read the FDA page on .
The site gives no reason why a count is high or low on its own. It repeats the reasons that FDA gives.
The number of animals that get a drug
In addition, it is important to remember that AERs represent a small percentage of total usage numbers of a product.
Commonly used products may have a higher number of reported adverse events due to the higher total number of animals being given the product.
FDA Center for Veterinary Medicine. Source: Adverse Event Reports for Animal Drugs and Devices
The openFDA files do not give the number of animals that got a drug. So the site cannot show a rate for a drug.
How FDA collects reports
Increases in the total number of AERs is likely a result of improved reporting; however, the FDA believes that AERs are still underreported.
FDA Center for Veterinary Medicine. Source: Adverse Event Reports for Animal Drugs and Devices
FDA gives this reason for the rise in the total number of reports. The site gives no other reason for a rise or a fall.
When FDA posts a report
Reports are not posted in real time. Updates to openFDA are made quarterly, but there may be a 3-6 month delay from the time FDA receives reports until they are posted.
FDA Center for Veterinary Medicine. Source: Adverse Event Reports for Animal Drugs and Devices
The newest months of a chart can get more reports in a later update.
What is in the data
The AER data received by CVM and uploaded to openFDA.gov includes reports associated with approved animal drugs, unapproved/compounded drugs and devices used in animals.
FDA Center for Veterinary Medicine. Source: Adverse Event Reports for Animal Drugs and Devices
FDA Center for Veterinary Medicine. Source: Adverse Event Reports for Animal Drugs and Devices
So a count can include reports of a product defect, reports of a lack of effectiveness, and reports for drugs that FDA has not approved.
Other drugs and other sources
The adverse event may have been related to an underlying disease, other drugs used at the same time or other non-drug related sources.
FDA Center for Veterinary Medicine. Source: Adverse Event Reports for Animal Drugs and Devices
A report lists more than one drug when the animal got more than one. The site counts the report for each active ingredient that it names.
What FDA says to do with a count
An API dataset query result cannot be used to estimate the risk associated with the product or compare one drug or device product with another.
This dataset should not be the sole source of information for clinical decision-making or other assumptions about the safety or effectiveness of a product.
FDA Center for Veterinary Medicine. Source: Adverse Event Reports for Animal Drugs and Devices