Database of Adverse Event Notifications
Important information on the Database of Adverse Event Notifications
- 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)
- The DAEN contains information from reports of adverse events that the TGA has received in relation to medicines including vaccines used in Australia.
- The DAEN 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.
The TGA medicine safety monitoring program
More information about the DAEN 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. Australian Public Assessment Report for Prescription Medicines (AusPARs) for some prescription medicines, are also available from this website.
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.
Find out more...
- Questions about medicines? Visit the NPS MedicineWise website.
- Talk to a health professional - 1800 022 222
- Look up a medical term
- Concerns about poisoning - Poisons Information Centre on 13 11 26
- About DAEN - contact the TGA on 1800 020 653
You appear to be viewing this page in Internet Explorer 6 or below. You may experience technical difficulties or delays using this database.
- 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.
In 2011, the Therapeutic Goods Administration (TGA) received over 14,000 adverse event reports for medicines including vaccines. 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.
The Database of Adverse Event Notifications (DAEN) contains around 251,000 reports of adverse event notifications. People who experienced an adverse event cannot be identified, and maintaining their privacy has been of paramount importance to the TGA.
The DAEN 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 stimulate reporting of adverse events.
More about the databaseThe DAEN 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 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 Database of Adverse Event Notifications
You must have JavaScript enabled in your web browser to use this search facility.
You must select medicines and a date range.