Drug Side Effect Reporting

Health Canada has launched a new Consumer Side Effect Reporting Form making it easier for consumers to report side effects to drugs and other health products to the Canada Vigilance Program.

Reporting side effects, also known as adverse reactions, is important to health product safety. Each report may contribute to improving the safe use of health products – including prescription and non-prescription drugs, and natural health products.

Information received from adverse reaction reports is combined with other sources of safety information in an effort to help identify unrecognized, rare or serious adverse reactions. The data collection may in turn lead to changes in product safety information or other regulatory actions.

In addition to the new form, which can be sent by postage-paid mail or by toll-free fax, consumers can also report online or by calling toll-free at 1-866-234-2345. The Consumer Side Effect Reporting Form and other information on reporting side effects is available at the MedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect.

Health Canada is encouraging all serious side effects be reported to a health professional and then to Health Canada.

The purpose of the Health Canada’s MedEffect™ Canada initiative is to provide centralized access to new safety information about marketed health products and to easily submit adverse reaction reports.

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