Table of Contents

ADE Home
ADE Reports
FAQ's About ADE's
Cumulative Reports
How to Report an ADE
ADE Report Description
Glossary of Terms
Form 1932a
Brochure
Additional Information

Veterinarians and animal owners are encouraged to report Veterinary Adverse Drug Experiences (ADEs) and suspected product failures to the government Agency that regulates the product in question. Pre-testing by the manufacturer and review of the data by the government does not guarantee absolute safety and effectiveness of approved veterinary drugs due to the inherent limitations imposed by testing the product on a limited population of animals. Anyone with information to report is also encouraged to contact the manufacturer of the suspect product.

Tips on reporting ADEs

To help FDA’s Center for Veterinary Medicine (CVM) accurately analyze the report, it is important that the reports include sound clinical information about an animal.  This means that the report should preferably include a good medical history, all other drugs the animal has been given at the same time, any recent surgical procedures, and as much in the way of clinical findings as is possible.  Clinical findings would include veterinary exam, clinical chemistries, complete blood counts, urinalysis, fecal exams, radiographic results, and data such as blood pressure, any other pressure measurements in or around the heart, and neurologic assessments.

Questions regarding ADE Reporting should be addressed to:

Center for Veterinary Medicine
Division of Surveillance, HFV-210
7519 Standish Place
Rockville, MD 20855
1-888-FDA-VETS

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