How to report a problem with an animal drug

If an animal is unwell now, contact a veterinarian first. Reporting can wait; care cannot. Reporting matters afterwards, because FDA's monitoring depends on it and FDA considers adverse events under-reported.

FDA-approved animal drugs

Call the drug company. FDA recommends this route. The phone number is on the label or package insert. Companies are required to send every report to FDA, and their veterinarians can often advise your own veterinarian on the case.
Or report directly to FDA using Form FDA 1932a, "Veterinary Adverse Drug Reaction, Lack of Effectiveness or Product Defect Report". FDA's page How to Report Animal Drug and Device Side Effects and Product Problems has the form and instructions.

The same routes cover a product that did not work as expected and a defect in the product or its packaging.

What to have ready

The product name, strength and lot number from the package.
What was given, how much, when, and by which route.
Everything else the animal receives: other drugs, supplements, flea and tick products, diet.
The animal's species, breed, age, weight and existing conditions.
What was observed, when it began, what was done and how it turned out. Your veterinarian's records and test results are the most useful part of a report.

Products that go elsewhere

Vaccines and other biologics are regulated by the U.S. Department of Agriculture. Report to the manufacturer or to the USDA Center for Veterinary Biologics.
Many spot-on flea and tick products and collars are registered as pesticides by the Environmental Protection Agency, not approved by FDA. The label shows an EPA registration number instead of a NADA or ANADA number. Report to the manufacturer, which must inform EPA, or through the National Pesticide Information Center.
Pet food and treats: FDA's Safety Reporting Portal.
Human drugs given to animals and compounded drugs: Form FDA 1932a still applies.

What happens next

The report is coded and added to FDA's database, and reaches the public openFDA files three to six months later without anything that identifies you, your veterinarian or your animal. It will then be one of the reports counted on this site.