Adverse Event Reporting for Vetoryl

To report an adverse event associated with Vetoryl, you can either contact the drug company or submit a report to the U.S. Food and Drug Administration (FDA). More information about both of these processes can be found below.

What types of problems can be reported?

According to FDA, adverse events can include:

• Side effects in animals, such as vomiting, diarrhea, seizures, and other symptoms.

• Side effects in people exposed to animal drugs or devices, such as rashes, headaches, 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, or other scenarios.

• Lack of effectiveness, such as a product not working or a product that stops working.

How to submit a report to the drug company

One way to report adverse events associated with Vetoryl is to contact Dechra, the drug’s manufacturer. You can contact their 24-hour Veterinary Technical Support Team at support@dechra.com or 866-933-2472. When you call, tell them that you want to report an adverse drug event. The technical services representative will likely ask questions about the event and is required to send the information to 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. Dechra will assign a unique case number to the report, which you can request.

How to submit a report to FDA

If you prefer to report an adverse event directly to FDA, you can do so through Form FDA 1932a. NOTE: You must download and save (as described below) the blank form to your computer BEFORE filling out the form.

1. Save the blank Form FDA 1932a to your computer. PDF Forms must be opened using a Windows or Mac desktop or laptop computer. NO smartphones or tablets are supported.

2. Open the file and complete the fillable form.

3. Save the completed form to your computer.

4. Email the completed form to CVM1932a@fda.hhs.gov.

Additional Information

When you submit your report by email, FDA will send you an automatic acknowledgement message. Reports are reviewed by FDA staff, and they will contact you if additional information is needed. For questions about ADE reporting or to request a hard copy of the form, please contact AskCVM@fda.hhs.gov or 1-888-FDA-VETS (1-888-332-8387). You can also contact FDA by mail:

Food and Drug Administration

Center for Veterinary Medicine

5001 Campus Drive

College Park MD 20740

References

How to Report Animal Drug and Device Side Effects and Product Problems, by FDA

Inquiry Form (Dechra)