How to report a reaction to FDA

Get help for your pet first

If your pet has an emergency, call your veterinarian or an emergency clinic. Reporting can wait while you seek care. For other concerns, contact your veterinarian and describe what you noticed. Talk to your veterinarian before starting, stopping or changing a medicine, including when you suspect a reported reaction.

You do not need to decide what caused a change before describing it. Keep your observations separate from your questions about the medicine. Saying what you saw and when you saw it gives your veterinarian a concrete starting point for the conversation.

Gather the label and treatment history

Keep the product package and label nearby. Gather the medicine instructions, treatment records and notes about when the medicine was given. Include the timing of the signs you noticed in relation to treatment. If you do not remember something, say so instead of filling the gap with a guess.

Write down other medicines or products given to your pet and any existing conditions you discussed with your veterinarian. Include changes to the routine that you think might help explain the sequence of events. The aim is to make your account understandable, without deciding which detail explains the problem.

Describe the signs in everyday language

Use concrete observations: what looked different, what your pet did, and how the situation developed. Describe what you personally observed and distinguish it from information someone else gave you. If you have photos or notes, keep them with the product information for reference.

Ask your veterinarian to help you describe any part you do not understand. You can explain that you are preparing a report and want the treatment history to be clear. Reporting a concern and working with your veterinarian are compatible parts of responding to a change in your pet.

Use the reporting route for the product

Follow FDA’s animal drug and device reporting instructions. Those instructions cover FDA Form 1932a. You can also contact the drug company using the phone number on the label. Keep a copy of the information you provide for your own records.

For EPA-registered flea and tick products such as many collars, spot-ons and shampoos, consult the National Pesticide Information Center about the relevant reporting route.

Understand what a report means

Reports do not prove cause. FDA report counts depend on use and reporting, so they cannot estimate risk or compare products. Brand names are masked in FDA’s public report data. A report describes a concern; it does not establish that a medicine caused it. Read more about these limits in the site’s data source explanation.