Report side effects from cannabis products
On this page
- Defining side effects
- Reporting side effects Consumers, patients and health care practitioners
- Mandatory reporting of serious side effects: Licence holders
Defining side effects
The Cannabis Regulations define an adverse reaction, also known as a side effect, as a noxious (harmful, unpleasant) or unintended response to a cannabis product.
Side effects may be serious or non-serious.
The Cannabis Regulations classify an adverse reaction (side effect) as serious if it:
- requires in-patient hospitalization
- prolongs existing hospitalization
- causes congenital malformation
- results in persistent or significant disability or incapacity
- is life-threatening or results in death
Other serious situations might include medically important events that may not be immediately life-threatening or result in death or hospitalization, but may:
- endanger the patient
- require intervention to prevent one of the other serious outcomes
You may report a side effect to a cannabis product based on a suspicion. This does not necessarily mean that the product caused the reaction. If in doubt, report the side effect.
Reporting side effects: Consumers, patients and health care practitioners
Consumers, patients and health care practitioners are encouraged to report side effects from cannabis products to the licence holder of the product.
Information related to the identity of the patient (or consumer) and the identity of the person who is reporting the information (reporter) is protected under the Privacy Act.
Consumers or patients who are using cannabis products for medical or non-medical purposes and who have experienced a side effect are encouraged to consult with their health care practitioner for:
- management of side effects
- help completing a Side Effect report
This is especially important for patients using cannabis products for medical purposes that may:
- be using a number of different drugs or health products
- have a number of serious health conditions
Report a side effect:
Other ways of reporting:
- Telephone 1-866-234-2345 (toll free)
How to complete a Side Effect Reporting form
- Use a separate form for each patient or consumer who experienced a side effect.
- All sections of the form should be filled in as completely as possible.
- Give as much information about the suspect cannabis product(s) as possible (brand name, licence holder, details from the suspect cannabis product label(s), lot number(s)).
- Include all suspect product(s) in a single report if possible. Additional pages can be included to the Side Effect Reporting form (Printable). If an additional report is required (Online Form), follow step 5.
- Follow-up information for a side effect that has already been reported can be submitted using a new form:
- Indicate that it consists of follow-up information, including, if known, the original report reference number provided by Health Canada and/or date of the original report.
You can find more information at MedEffect Canada.
Mandatory reporting of serious side effects: Licence holders
Under the Cannabis Regulations, a holder of a licence to sell or distribute a cannabis product must report all serious adverse reaction(s) to Health Canada within 15 days of becoming aware of them.
Medical and scientific judgement by a qualified health care practitioner should be used to determine if an adverse reaction is serious.
An adverse reaction should not be downgraded from serious to non-serious if the licence holder disagrees with the seriousness of the adverse reaction reported. If it is unclear whether the adverse reaction is serious or not we recommend submitting the report to Health Canada.
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