FDA Logo links to FDA home page HHS Logo links to Department of Health and Human Services website U.S. Food and Drug Administration Center for Veterinary Medicine link to the Minor Uses and Minor Species page link to the Antimicrobial Resistance page link to the Biotechnology page link to the Aquaculture page link to the Food Safety page link to the BSE page link to the Guidance Documents page link to the Green Book page link to the Freedom of Information page
Center for Veterinary Medicine
Spacer Spacer


Powered by Google

" "

Table of Contents

Spacer Spacer
Glossary of Adverse Drug Experience (ADE) Terms

Number of Animals Evaluated

Total number of animals reported to the FDA for evaluation.

NOTE: After analyzing the reports, CVM veterinarians may determine that some of the potential adverse experiences in the animal were not possibly, probably, or definitely drug related.  Therefore, these ADEs are not included in the Cumulative Adverse Drug Experiences (ADE) Summaries Report.


Description of reported adverse experience or clinical manifestation associated with drug use.  This is a link to the abbreviations used for these signs.


The ADE report did not indicate the route of administration.


The ADE report states that the route of administration is unknown.

Extra-Label or Off-label

The use of an approved drug in a manner that is not in accordance with the approved label directions.  For example, a product is used for indications or species for which it is not approved.

Web Page Updated by hd - November 29, 2007, 10:08 AM ET

horizonal rule