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ZAMRA Adverse Event Reporting System: Latest Quarterly Data Files

The Adverse Events (AE) Quarterly Data files listed on this page contain raw data extracted from the AE database for the indicated time ranges and are not cumulative.

The quarterly data files, which are available in Excel format, include:

  • demographic and administrative information and the report ID number (if available);
  • drug information from the case reports;
  • reaction information from the reports;
  • patient outcome information from the reports;
  • a “README” file containing a description of the files.

Disclaimer

While the Adverse Events (AE) Quarterly Data files contain raw data extracted from the AE database, there remain limitations to the data. For example, while the AE Quarterly Data files contain reports on a particular medicines or allied substance, this does not mean that the medicines or allied substance caused the adverse event. Importantly, the AE Quarterly Data files by themselves are not an indicator of the safety profile of the medicines or allied substance. Some additional limitations to note include:

  1. Duplicate and incomplete reports are in the system: There are many instances of duplicative reports, and some reports do not contain all the necessary information.
  2. Existence of a report does not establish causation: For any given report, there is no certainty that a suspected drug caused the event.  While consumers and healthcare professionals are encouraged to report adverse events, the event may have been related to the underlying disease being treated or caused by some other medicines or allied substance being taken concurrently or occurred for other reasons. The information in these reports reflects only the reporter’s observations and opinions.
  3. Information in reports has not been verified: Submission of a report does not mean that the information included in it has been medically confirmed nor it is an admission from the reporter that the drug caused or contributed to the event.
  4. Rates of occurrence cannot be established with reports: The information in these reports cannot be used to estimate the incidence (occurrence rates) of the events reported.
  5. Patients should talk to their doctor before stopping or changing how they take their medications.

Improving data access and transparency are core concepts that drove the development of the public database, Adverse Events Quarterly Data files.  ZAMRA anticipates that this increased transparency will help to spur the submission of more detailed and complete reports from consumers, healthcare providers and other members of the public. Complete and detailed reports are immensely helpful to the Authority when identifying safety signals and choosing particular products for further scrutiny.