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Database of Adverse Event Notifications - medicines

Important information on the Database of Adverse Event Notifications - medicines

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.

The TGA medicine safety monitoring program

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

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 form, by 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.

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Important information! 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.

The Database of Adverse Event Notifications (DAEN) - medicines allows you to search adverse event reports for medicines including vaccines received by the TGA. These reports came from a wide range of sources, including from members of the public, GPs, other health professionals and from the therapeutic goods industry.

People who experienced an adverse event cannot be identified, and maintaining their privacy has been of paramount importance to the TGA.

More about the database

The DAEN - medicines is being made available to the members of the public as part of TGA initiatives to be more transparent about its activities. It is also hoped that access to this information will support the quality use of medicines and encourage reporting of adverse events.

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 report of an adverse event in relation to a medicine should not be taken to mean that the medicine is the cause of the adverse event.

The DAEN - medicines does not contain all known safety information concerning a medicine, and an assessment of the safety of a medicine cannot be made based only on this information. More information is available at:

Search the DAEN - medicines

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No adverse events found for the medicines and date range selected.

All adverse event reports are coded into MedDRA terminology by the TGA.

Choose a MedDRA system organ class, then MedDRA reaction terms to restrict your search.

MedDRA system organ classes for selected medicines