Health Canada's Caveats And Limitations: Please note that there may be reports that have been received but not yet processed and entered into the database. New or additional information may be available at a later date.

The Canadian Adverse Drug Reaction Monitoring Programme (CADRMP) maintains a database of suspected adverse reactions to marketed therapeutic products reported to the program directly by health care professionals, consumers or through the pharmaceutical manufacturer. The CADRMP database only contains reports of reactions that have occurred in Canada with Canadian marketed products. Any information related to the reporter and patient identifiers is kept confidential as per 19(1) of the Access to Information Act.

The caveat below applies to all information provided by the Marketed Health Products Safety Effectiveness and Information Division. This caveat appears at the bottom of each page of the search request [in the Canadian Adverse Drug Reaction Information System] to assist with interpretation of the data.

CAVEAT: The vast majority of reports on which this summary is based are submitted by health practitioners and to a lesser extent laypersons. Each report represents the suspicion, opinion or observation of the individual reporter. Cause and effect relationships have not been established in the vast majority of reports submitted. The information contained in these reports to the Health Products & Food Branch is raw information and has not been scientifically or otherwise verified as to cause and effect relationship by Health Products & Food Branch scientists. Only a small proportion of suspected adverse reactions are reported to the program, consequently this information must not be used to estimate the incidence of adverse reactions. Reports submitted by Market Authorization Holders are included in this summary.

A serious adverse drug reaction is defined as: A noxious and unintended response to a drug, which occurs at any dose and requires in-patient hospitalization or prolongation of existing hospitalization, causes congenital malformation, results in persistent or significant disability or incapacity, is life-threatening or results in death. Important medical events that may not be immediately life-threatening or result in death or hospitalization, but may jeopardize the patient or may require intervention to prevent one of the outcomes listed above, may also be considered serious.