**Please note: Due to the current COVID-19 situation, we may have limited access to paper Adverse Drug Events (ADEs) submitted to the agency. Please consider submitting ADEs electronically.**
**Nota: Debido a la situación actual de COVID-19, es posible que tengamos acceso limitado a los eventos adversos de medicamentos (ADE, signas en inglés) enviados a la agencia en papel. Considere enviar los ADE electrónicamente.**
The FDA encourages veterinarians and animal owners to report adverse events associated with drugs or devices used in animals. We use the information from these reports to monitor the safety of products once they have reached the market.
What types of problems can I report?
Adverse events can include:
- Side effects in animals, such as vomiting, diarrhea, colic, seizures, and other symptoms.
- Side effects in people exposed to drugs and devices used in animals, such as needle stick injuries, rashes, or headache or nausea secondary to product contact.
- Product defects, such as broken product seals, leaking bottles, and other problems.
- Medication errors, such as giving the wrong drug or dose, giving a drug too frequently, and other scenarios.
- Lack of effectiveness, such as a product not working, a product that stops working, or a product that isn’t working as well as it did.
Which drugs and devices used in animals can I report to FDA?
FDA-approved animal drugs have a six-digit New Animal Drug Application (NADA) number, or for generic animal drugs, an Abbreviated New Animal Drug Application (ANADA) number. Many drug manufacturers list the six-digit NADA or ANADA number and the statement, “Approved by FDA,” on the drug’s label, although they aren’t required to do so. On the packaging for FDA-approved products you may see the following information: “NADA XXX-XXX Approved by the FDA.”
Indexed animal drugs are drugs listed in FDA’s Index of Legally Marketed Unapproved New Animal Drugs for Minor Species, referred to simply as ‘the Index’. Animal drugs listed in the Index are unapproved but can be legally marketed for a specific use in certain minor species. All indexed drugs have a six-digit Minor Species Index File (MIF) number that begins with the number nine (for example, MIF 9XX-XXX). The six-digit MIF number is required on the drug’s label.
Medical devices include thermometers, glucose meters, and bandage materials.
The information below explains how to report an event. Veterinary biologic products, including animal vaccines, and many flea and tick products are not regulated by FDA.
Animal Drugs and Devices - see instructions below
Animal Vaccines - contact the USDA APHIS Center for Veterinary Biologics at (800) 752-6255.
Flea and Tick Products
Some flea and tick products are regulated by FDA, and some are regulated by the Environmental Protection Agency (EPA). The label of the product can help you determine if the product is an FDA-approved or an EPA-registered flea and tick product or other pesticide:
- To report a problem with a flea or tick product that is FDA-approved, see instructions below.
- To identify an EPA-registered product, look for an EPA registration number on the back panel of the package, usually near the manufacturer’s address: “EPA Reg. No.” For EPA-registered products or other pesticides – contact the National Pesticide Information Center at 800-858-7378.
How Do I Report Adverse Events for Animal Drugs and Devices?
You can report adverse drug events to FDA in one of the following ways:
- For an FDA-approved product or an Indexed product, we recommend calling the drug company to report the adverse drug events. The company responsible for the approved or Indexed drug product(s) is required to submit reports of adverse drug events to FDA. The drug company’s phone number can usually be found on the product’s labeling. When you call, tell them that you wish to report an adverse drug event and ask to speak to a technical services representative. The technical services representative will likely ask you a series of questions about the event and is required to send the information to the FDA’s Center for Veterinary Medicine (CVM). If you are an animal owner, the representative may also contact the veterinarian who treated your pet to obtain more information about the adverse drug event. The report will be assigned a unique case number by the company, which you can request.
If you prefer to report directly to the FDA for an approved product, you can submit FORM FDA 1932a, as described below in #2.
- For unapproved drugs and devices, submit FORM FDA 1932a, "Veterinary Adverse Experience, Lack of Effectiveness or Product Defect Report". You can use this form to report adverse events for any animal drug (FDA-approved or unapproved) or animal device. Unapproved animal drugs include compounded drug products.
- Download/open the fillable 1932a electronic form
Note: If the PDF form does not open automatically in your browser or you get a “Please Wait…” error message, try downloading it as follows:
1. Right-click the 1932a electronic form link above.
2. Click your browser’s Save option. On most browsers, this is the Save Link As option, but on other browsers this may be Save Target As or Download Linked File and save the file to your computer.
Open the file, complete the fillable form, and email the completed form to CVM1932a@fda.hhs.gov.
You may also need to upgrade your version of Adobe Reader - http://get.adobe.com/reader/.
PDF Forms must be opened using a Windows or Mac (Apple) desktop or laptop computer. Currently, NO smartphones or tablets are supported.
- Download/open the fillable 1932a electronic form
For unapproved animal products, you also should report the problem to the manufacturer or distributor shown on the label and to the store where you purchased the product.
What information should I include in my report?
Reports should preferably include:
- health of the animal before the event, including pre-existing medical problems,
- the names and doses of drugs, vitamins, and supplements the animal has been given,
- veterinary examination findings, including specialist exams (neurologist, internist, etc.),
- test results (bloodwork, urinalysis, fecal exam, x-ray findings, blood pressure, etc.),
- current type and/or brand of food/feed and treats.
Follow-up information can be submitted if your animal’s health changes as a result of the event after your initial report.
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.
For questions about ADE reporting or to request a hard copy of the form, please contact CVM at AskCVM@fda.hhs.gov, 1-888-FDA-VETS (1-888-332-8387), or by mail:
Center for Veterinary Medicine
Food and Drug Administration
7500 Standish Place
Rockville, MD 20855
- Adverse Event Reports for Animal Drugs and Devices
- How can I tell if a drug is legally marketed for animals?
- Unapproved Animal Drugs Versus Legally Marketed Drugs
- Veterinary Medication Errors