Report a side effect
Privacy notice: The personal information you provide to Health Canada is governed in accordance with the Privacy Act. We only collect the information Health Canada needs to administer the Canada Vigilance adverse reaction reporting program authorized under the Department of Health Act, section 4 and the Food and Drug Regulations, Section C.01.020.
Purpose of collection: Health Canada requires this information to assess adverse reaction reports, monitor the safety of health products and enforce relevant legislation where applicable. Personal information may be used to analyze general trends, report to senior management and evaluate related programs and services. Trend and safety data in a de-identified format may be communicated by a variety of risk communication tools and/or responses to inquiries. A subset of de-identified Canada Vigilance adverse reaction reporting program data is made publicly available from the Canada Vigilance adverse reaction online database.
Other uses or disclosures: Personal information may be shared within Health Canada and with the Public Health Agency of Canada, the Canadian Medication Incident Reporting and Prevention System Program (managed in partnership with the Canadian Institute for Health Information, the Institute for Safe Medication Practices Canada, and the Canadian Patient Safety Institute), and international regulatory and health product monitoring authorities, for monitoring adverse reactions. In limited and specific situations, your personal information may be disclosed without your consent in accordance with subsection 8(2) of the Privacy Act.
For more information: This personal information collection is described in Info Source, available online at https://www.canada.ca/en/health-canada/corporate/about-health-canada/activities-responsibilities/access-information-privacy/info-source-federal-government-employee-information.html#a26. Refer to the personal information bank HC PPU 417.
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What is a Side Effect?
Side effects 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 of liver damage. A side effect can also be when a product has no effect or has not performed the intended treatment. They can occur within minutes after taking a medicine, or can take years to develop.
Side effects are troublesome symptoms or feelings that you may not expect that show up when you are taking a medicine. Side effects are sometimes also called adverse reactions, especially by doctors and other health professionals.
What types of Side Effects should be reported?All suspected side effects should be reported, especially those that are:
- Unexpected, regardless of their severity, i.e., not consistent with product information or labelling; or
- Serious, whether expected or not, i.e., that requires being admitted to the hospital, lengthened hospital stay, causes a birth defect, disability, is life-threatening or results in death;
- Reactions to recently marketed health products (on the market for less than five years), regardless of their nature or severity.
ContactFor additional information about the Canada Vigilance Program or on reporting side effects:
- Call toll free 1-866-234-2345
- Email firstname.lastname@example.org
A. Report and reporter information
Health Canada reference number: If the report is identified as a follow-up, indicate the reference number provided by Health Canada after submitting an initial report.
Reporter file number: Indicate the reporter’s identification number for the case. For follow-up reports, the file number should be the same as the number assigned to the initial report.
Organization: Enter the name of the reporter’s organization/facility, if applicable.
Criteria that best describes you: Select the option that best describes you.
B. About the person who had the side effect
Height: Enter the person’s height.
Weight: Enter the person’s weight.
Known medical conditions and lifestyle factors: If available, provide information on the person’s history and other known conditions.
Known allergies: Provide the allergies the person is known to have experienced, whether to food, drugs, environmental components, etc.
C. Information on the side effect
Reason for seriousness: Select one or more criteria that best describes the side effect. Enter the date of death if known. Partial dates are acceptable.
Did the person recover? Indicate the outcome of the side effect.
Reaction start date: Provide the date the side effect started. Partial dates are acceptable.
Reaction end date: Provide the date the side effect ended, if applicable. Partial dates are acceptable. Do not provide this date for reports involving death.
D. Suspected heath product
Strength: Strength is defined as the amount of an active ingredient that the product contains. Provide the amount of active ingredient per single dosage form of the drug. For example, if the person took two tablets of a medication, please provide the strength of only one tablet. If applicable, indicate other strength unit in Other field.
Dosage form: Indicate the dosage form of the product (e.g. tablet, powder, liquid).
Manufacturer name: Indicate the manufacturer name of the suspected health product.
Lot number: If known, indicate the lot number(s) of the suspected health product.
Expiry date: If known, indicate the expiry date.
Therapy information at the time of the side effect:
Product start date: Indicate the date when product use started. If the exact date is not known, partial dates are acceptable.
Product end date: Indicate the date when product use ended, if applicable. Partial dates are acceptable. Please only enter data in this field if it is known that the product use was stopped.
Dose: Indicate the amount of product taken (i.e. dosing regimen). Dose is normally expressed as a quantity.
Frequency: Indicate how often the dose was taken.
How was the product taken? Provide the means by which the drug entered the body. The top five most common ways are at the top of the dropdown list. If applicable, indicate other route of administration in Other field.
What was the product prescribed/taken for? Enter the reason for use.
Did you also report to the manufacturer? Indicate if the side effect details were provided to the manufacturer. If so, please provide the date on which the case was reported to the manufacturer and the reference number, if known.
Action taken: Indicate what action was taken with the product.
Side effect stopped if dose was reduced or removed: Indicate if the side effect stopped after the suspect product was discontinued or the dose was reduced.
Side effect returned with reintroduction: Indicate if the side effect reappeared after the suspect product was restarted.
E. Other health product(s)
List all known health products, other than the suspect product(s), that were taken at the same time the side effect occurred. Information related to therapy details of these products is not required but encouraged. Do not include health products used to treat the side effect.
F. Additional information
This section can be used to provide a narrative summary of the side effect, additional information on the underlying diagnosis that is pertinent to the side effect, or information that did not fit in the structured fields that could help to determine why the side effect occurred.