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 contains information from reports of adverse events (also known as side effects or adverse reactions) we have received in relation to medicines, vaccines and biological therapies used in Australia. The database includes information about products:
- prescribed or dispensed by a health professional, with a prescription
- purchased from a supermarket, pharmacy or another outlet without a prescription.
The DAEN – medicines does not contain information about adverse events related to medical devices, which is instead accessed through the DAEN – medical devices.
Search DAEN - medicines
DAEN - medicines does not contain all known information concerning a medicine. An assessment of the safety of a medicine cannot be made based on this information.
You can search the database for medicines by their trade names or active ingredient.
DAEN – medicines: quick guide
- About the DAEN - medicines
Learn more about the Database and its limitations. - DAEN – medicines: Information for consumers
Find answers to commonly asked questions.
- Tips for searching the DAEN - medicines
Learn how to search adverse event data, interact with your search results and export the data.
Safety monitoring and adverse events
- TGA safety monitoring of medicines and vaccines
Discover what pharmacovigilance is and how we monitor the safety of medicines, including vaccines once they are launched into the Australian market. - TGA safety monitoring of biological therapies
Find out more about biovigilance responsibilities for sponsors of biological products such as cell and tissue therapies. - Overview of how TGA manages medicine adverse event reports
Learn more about what we do with adverse events after they are reported to TGA and how we use them to identify emerging safety issues relating to medicines. - Adverse event monitoring internationally
Search for other medicine regulators and find out where to access their adverse event databases.
Classification and naming conventions
- Medical Dictionary for Regulatory Activities - MedDRA
Find out what MedDRA is and how we use it to code adverse event reports.
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.
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.
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.