Reporting side effects in a medicine for animal use – information for vets and animal owners

If you think an animal in your care has experienced an adverse event, it is important to report it. Adverse events include side effects and other issues that may happen after using a veterinary medicine.

Reporting helps us to make medicines safer. When you report, we learn more about a medicine. It helps us to better understand known side effects and identify new side effects.

See an overview of reporting in the video below and read the information below for more details on reporting.

How do I report?

You can report in one of the following ways.

  • Use our online reporting form.
  • Report the issue to the company that markets the medicine (the marketing authorisation holder) using the contact details in the package leaflet.

It is only necessary to report to one of the above, not both.

If you're an animal owner, you can ask your vet to report on your behalf. They have access to the animal’s medical records and may be best placed to do so.

What should I report?

You should report any suspected reaction, whether mild or serious. Even if you’re not sure if it was the medicine that caused the reaction, you can still report it. You can also report other issues that happened after using a medicine.

  • Reactions in animals, whether the medicine was used as directed or not
  • Medicine not working as expected (e.g. an animal still showing signs of inflammation after receiving anti-inflammatory medication)
  • Reactions in people after exposure to the medicine or coming into contact with it. These reactions can happen immediately or even days or weeks later.
  • Residues of the medicine found in food products above legal safety limits
  • Harmful effects on the environment

Why is it important to report?

When you report, you help us to learn more about a medicine. It helps us to better understand known side effects and identify new side effects. Each report can add to a bigger picture, helping us to spot trends and identify a potential safety issue sooner.

Medicines are tested for safety and effectiveness before they are allowed to be sold. However, some less common side effects, or ones that affect certain breeds, may only become clear after a medicine has been used more widely. This is why it is important to report.

What can the HPRA do if there is a safety issue?

We make decisions about the safety of medicines based on a range of evidence and information, including reports of side effects. We may carry out one of these actions:

  • Place the medicine under additional monitoring
  • Update the package leaflet for animal owners and the summary of product characteristics for vets to include new information about side effects and contraindications
  • Publish safety or advisory notices to support safe prescribing and use of the medicines
  • In rare cases, we may decide to recall a medicine or remove it from the market.

Who can report?

Anyone can report, including:

  • Veterinary professionals, such as vets, veterinary nurses and pharmacists
  • Wholesalers and licensed retailers
  • Animal owners, including farmers and pet owners

What information do I need to report?

When completing the online form, you will be asked for:

  • Your name and contact details*
  • Animal species, age, breed, weight
  • Medicine name and authorisation number on the packaging (e.g. VPA 12345/678/000 or EU/1/23/456/789)
  • Details of the side effect or adverse event
  • Photographs, lab reports or post-mortem findings – these are not essential to provide but are helpful if available.

What happens after I report?

You will receive a confirmation email to let you know we have received your report.

Our team will review the details of your report, and we may contact you if we need more information. We will only contact you if necessary.

We send some information from reports to the European Union Pharmacovigilance Database, but we never share personal details such as your name or address. This database managed by the European Medicines Agency on behalf of medicines regulators across the EU.

Anyone can check the European database of suspected adverse drug reaction reports to see if side effects or other adverse events have been reported for a specific medicine or active substance. The database does not contain any personal information.

Where can I find more information about how medicines are monitored for safety?

Visit our webpage containing information about monitoring medicines for animal use.