A Patient Guide for Reporting Side Effects from Health Products

2011
ISBN: 978-1-100-18846-1 (PDF Version)
Cat: H14-35/2011E (PDF Version)
HC Pub: 110124 (PDF Version)

Have you experienced a side effect?

What is a side effect?

Side effects, also known as adverse reactions, are troublesome symptoms or feelings that occur when taking a health product.*

Side effects can range from minor irritations, such as a skin rash, to serious and life-threatening reactions, such as a heart attack or liver damage. They can occur within minutes after taking a medicine, or can take years to develop.

Why should I report a side effect?

All health products have benefits and risks. Although health products are carefully tested before they are licensed for sale in Canada, some side effects may become evident only after a product is in use by the general population.

When you report a side effect to the Canada Vigilance Program, the information from your report, along with other information, is used to check for new safety concerns about a product. As a consumer, your report contributes to improving the safe use of health products for everyone.

Information related to the identity of a patient and/or reporter of the adverse reaction will be protected as personal information under the Privacy Act, and under the Access to Information Act in the case of an access to information request

When should I report a side effect?

Side effects should be reported as soon as possible, especially if they interfere with everyday activities or if they are not mentioned in the information supplied with the health product.

Do you know what to do?

How can I report a side effect?

There are three easy ways to report a side effect to the Canada Vigilance Program.

• Online at www.health.gc.ca/medeffect MedEffect Canada
• By completing a Consumer Side Effect Reporting Form which you can send by postage paid mail or fax toll-free to 1-866-678-6789
  
  The form and Canada Vigilance Postage Paid Label are available at www.health.gc.ca/medeffect or by calling 1-866-234-2345
• By calling toll-free at 1-866-234-2345

When reporting a side effect, your pharmacist, doctor or other health professional can provide information that will help you complete your report.

Want to know more on what to report?

MedEffect™ Canada is a Government of Canada Initiative where you can report side effects and also obtain new risk information on health products (such as advisories and product recalls).

MedEffect™ Canada also provides additional information to help you better understand and learn about reporting side effects from health products.

Visit the MedEffect™ Canada Web site at www.health.gc.ca/medeffect.

* Health products include both prescription and non-prescription medications, biologics (including fractionated blood products, as well as vaccines), natural health products and radiopharmaceuticals.