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
