Skip to main content

Database of Adverse Event Notifications for medicines (DAEN)

The TGA uses adverse event reports to identify when a safety issue may be present. An adverse event report does not mean that the medicine is the cause of the adverse event.

If you are experiencing an adverse event, or think you may be experiencing one, please seek advice from a health professional as soon as possible.
The TGA strongly advises people taking prescription medicines not to change their medication regime without prior consultation with a health professional.

About the Database of Adverse Event Notifications (DAEN) - medicines

  • The DAEN - medicines contains information from reports of adverse events that the TGA has received in relation to medicines including vaccines used in Australia.
  • The DAEN - medicines does not contain all known safety information about a particular medicine. Please do not make an assessment about the safety of a medicine based on the information in the DAEN - medicines.

Access DAEN

The TGA medicine safety monitoring program

More information about the DAEN - medicines and the TGA medicines safety monitoring program is available at:

  • About the DAEN - medicines
  • Medicines safety

You are encouraged to report an adverse event suspected of being related to a medicine used in Australia. Reports of adverse events in relation to medicines and vaccines can be reported using the 'blue card' reporting formby phone and online.

Other useful sources of information on Australian medicines

More information about a medicine is available from the Product Information (PI) and Consumer Medicine Information (CMI) leaflet or the labelling of the medicine. Australian Public Assessment Report for Prescription Medicines (AusPARs) for some prescription medicines, are also available from the TGA website.

Your health professional can also provide help and assistance on how to use medicines.

Information on medicines used in Australia is available from NPS MedicineWise.

About the release of this information

While reasonable care is taken to ensure that the information is an accurate record of the adverse events reported to the TGA, the TGA does not guarantee or warrant the accuracy, reliability, completeness or currency of the information or its usefulness in achieving any purpose.

To the fullest extent permitted by law, including but not limited to section 61A of the Therapeutic Goods Act 1989, the TGA will not be liable for any loss, damage, cost or expense incurred in or arising by reason of any person relying on this information.

Copyright restrictions apply to the DAEN - medicines.

Help us improve the Therapeutic Goods Administration site