Adverse veterinary drug reactions

Health Canada's Pharmacovigilance Program at the Veterinary Drugs Directorate receives and assesses suspected adverse veterinary drug reactions (also known as adverse events). This page provides links to our reporting form and additional information about the reporting process. 

On this page

• What is an adverse veterinary drug reaction?
• Who can report adverse drug reactions?
• What types of adverse reactions should be reported?
• When to report adverse drug reactions?
• Why report adverse drug reactions?
• Veterinary pharmacovigilance program
• For more information

What is an adverse veterinary drug reaction?

An adverse veterinary drug reaction is any unwanted or harmful event that occurs after administration of a veterinary drug (according to the label and/or off-label). Included are adverse events in animals and/or humans involved in administering a veterinary drug to an animal, and those that result from a suspected lack of effect.

Who can report adverse drug reactions?

Anyone can report suspected adverse reactions to veterinary drugs. Reporting is mandatory for manufacturers as per Canada's Food and Drug Regulations, however, veterinary health care professionals and animal owners are strongly encouraged to submit reports.

What types of adverse reactions should be reported?

All suspected adverse reactions should be reported, especially those that are:

• unexpected (not consistent with product information or labelling), regardless of their severity
• serious, whether expected or not

When to report adverse drug reactions?

An adverse event should be reported as soon as possible after the reaction has occurred, even if you are not certain that a particular veterinary drug is the cause.

Why report adverse drug reactions?

All veterinary drugs have benefits and risks. Although veterinary drugs are carefully tested before they are marketed in Canada, some adverse reactions may become evident only after a product is in use by the general population.

When you report a suspected adverse event, you contribute to the ongoing collection of information that occurs once health products are on the market.

Your report may contribute to:

• the identification of previously unrecognized rare, or serious adverse reactions
• changes in product safety information, or other regulatory actions such as the withdrawal of a product from the Canadian market
• international data regarding benefits, risks or effectiveness of drugs and health products
• health product safety that benefits all Canadians and animals in Canada

Veterinary pharmacovigilance program

We monitor the safety and efficacy of approved drugs for the prevention, diagnosis and treatment of disease in animals through the pharmacovigilance program. The purpose of this surveillance is to monitor:

• the safety and efficacy of veterinary drugs used in animals
• the safety of humans handling these products
• the safety of consuming food derived from treated animals

Adverse drug reaction reports are reviewed and assessed to find out if they are related to the administered drug(s). This process is conducted in accordance with the international guidelines for pharmacovigilance activities.

For more information

Canada

• Adverse Reaction Information
• Drug Product Database
• Canadian Food Inspection Agency (CFIA): Veterinary Biologics
• Guidelines for Reporting Suspected Adverse Reactions to Veterinary Biologics
• Veterinary Health Products (VHPs)
• Report a side effect involving a Veterinary Health Product
• Report an incident involving a pesticide
• Report an incident involving a consumer product or cosmetic
• Canadian Veterinary Medical Association (CVMA)
• Marketed Health Products Directorate (MHPD)

International

• VICH (International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products)
• US Food and Drug Administration (FDA), Centre for Veterinary Medicine (CVM) Adverse Drug Experience Reports
• Australian Pesticides and Veterinary Medicines Authority, Adverse Experience Reporting Program for Veterinary Medicines
• European Agency for the Evaluation of Medicinal Products (EMEA), pharmacovigilance of veterinary medicines
• Gov.uk (United Kingdom), Report a suspected problem with an animal medicine or microchip