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Reporting Adverse Events with Animal Drugs or Devices

Reporting Adverse Events with Animal Drugs or Devices

Veterinarians and animal owners are encouraged to report adverse experiences and product failures to the government agency that regulates the product. Owners are encouraged to contact their veterinarian if their pet or animal experiences an adverse reaction to a medication or animal device.

Report an Adverse Experience with an FDA-Approved Animal Drug

  1. You should first call the drug company (manufacturer) to report an adverse drug experience for an FDA-approved animal drug.
  2. Submit Form FDA 1932a: "Veterinary Adverse Experience, Lack of Effectiveness or Product Defect Report". The 1932a is a pre-addressed, prepaid postage form which can be completed and dropped in the mail.

For more information on this topic: www.fda.gov/AnimalVeterinary/SafetyHealth/ReportaProblem/ucm055305.htm

Report Issues with Pet Products (food, treats)

To report adverse reactions or other problems with FDA-regulated products, such as food or treats, contact the FDA's Consumer Complaint Coordinator for Oregon at (800) 353-3965.

For more information on this topic, or to reach other state's coordinators: www.fda.gov/Safety/ReportaProblem/ConsumerComplaintCoordinators

Report an Adverse Event from an Animal Vaccine

Report to USDA APHIS

You can submit a report to USDA APHIS via their online reporting system.

For more information or to contact USDA APHIS: www.aphis.usda.gov/animal_health/vet_biologics/vb_adverse_event.shtml

Reporting an Adverse Event from Flea and Tick Control Products

Regardless of which agency regulates the flea or tick control product, you should first contact the product manufacturer to report a problem.

Report to EPA

If a product is regulated by the Environmental Protection Agency (EPA), it will have an EPA Registration Number (sometimes written as “EPA Reg. No.”) on the label. If the problem is with an EPA-regulated product, you may report the incident to the National Pesticide Information Center (NPIC) at (800) 858-7378.

Report to FDA

If a product is regulated by FDA, it will typically have the statement “Approved by FDA” followed by a six-digit New Animal Drug Application (NADA) or Abbreviated New Animal Drug Application (ANADA) number on the label. If the product is regulated by the FDA, contact the FDA district office consumer complaint coordinator for your geographic area. The FDA's Consumer Complaint Coordinator for Oregon can be reached at (800) 353-3965. To reach other state's coordinators: www.fda.gov/Safety/ReportaProblem/ConsumerComplaintCoordinators