How to report a problem with an animal drug
Last checked against the FDA pages:
This guide repeats what FDA says on its page How to Report Animal Drug and Device Side Effects and Product Problems. The site does not take reports. FDA does.
A report to FDA is one of the reports that this site counts. The site read the FDA pages on .
Who FDA asks to report
The FDA encourages veterinarians and animal owners to report adverse events associated with drugs or devices used in animals.
FDA Center for Veterinary Medicine. Source: How to Report Animal Drug and Device Side Effects and Product Problems
FDA lists these problems that a person can report:
- side effects in animals;
- side effects in people who were exposed to a drug or a device that is used in animals;
- product defects, for example a broken seal or a leaking bottle;
- medication errors;
- lack of effectiveness.
The two ways that FDA lists
For an FDA-approved product or an indexed product, FDA recommends a call to the drug company. The phone number of the company is usually on the label of the product.
The company responsible for the approved or Indexed drug product(s) is required to submit reports of adverse drug events to FDA.
FDA Center for Veterinary Medicine. Source: How to Report Animal Drug and Device Side Effects and Product Problems
For unapproved drugs and devices, submit FORM FDA 1932a, "Veterinary Adverse Experience, Lack of Effectiveness or Product Defect Report".
FDA Center for Veterinary Medicine. Source: How to Report Animal Drug and Device Side Effects and Product Problems
FDA says that the form is for any animal drug, approved or not. The FDA page gives the steps to save and fill the form, and the address to send it to.
Products that other agencies handle
Veterinary biologic products, including animal vaccines, and many flea and tick products are not regulated by FDA.
FDA Center for Veterinary Medicine. Source: How to Report Animal Drug and Device Side Effects and Product Problems
- Vaccines: the page of the USDA Animal and Plant Health Inspection Service.
- Flea and tick products that EPA registers: the page of the National Pesticide Information Center.
- Pet food: the FDA page How to Report a Pet Food Complaint.
The FDA page says that the label of a flea or tick product can show if FDA or EPA regulates it.
What FDA asks you to include
FDA says that a report should preferably include these items:
- the health of the animal before the event, with existing medical problems;
- the names and doses of the drugs, vitamins and supplements that the animal got;
- the findings of a veterinary examination;
- test results;
- the type or brand of food and treats.
IMPORTANT: The identities of all persons and animals are held in strict confidence by FDA and are protected to the fullest extent of the law.
FDA Center for Veterinary Medicine. Source: How to Report Animal Drug and Device Side Effects and Product Problems
What happens to a report
FDA puts the reports in a public data set after a delay. This site counts the reports in that data set.
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 pages in this guide
- How to Report Animal Drug and Device Side Effects and Product ProblemsThe FDA page on how to report a side effect or a product problem.
- Form FDA 1932a (PDF)The form that FDA names for a report to FDA.
- Contact CVMThe contact page of the FDA Center for Veterinary Medicine.
- How to Report a Pet Food ComplaintThe FDA page for a complaint about pet food.
- Adverse Event ReportingThe USDA page for vaccines and other veterinary biologics.
- Where to Start with Pesticide IncidentsThe page that the FDA page links for pesticide products, such as flea and tick products that EPA registers.
The site checked these addresses on . The links open in a new tab. For an animal that is ill, speak to a veterinarian.