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Database of Adverse Event Notifications (DAEN)
Provides information about adverse events and incidents related to therapeutic goods used in Australia.
The Therapeutic Goods Administration (TGA) receives adverse event reports associated with medicines and medical devices. These reports come from a wide range of sources, including members of the public, general practitioners, nurses, other health professionals and the therapeutic goods industry.
There are 2 search facilities below:
- DAEN - medicines provides information about adverse events related to medicines and vaccines used in Australia.
- DAEN - medical devices provides information about adverse events related to medical devices used in Australia.
DAEN - medicines
The Database of Adverse Event Notifications - medicines contains information from reports of adverse events that the TGA has received in relation to medicines, including vaccines, used in Australia.
Try the beta version of DAEN - medicines
More information about DAEN - medicines
- Consumer questions and answers: DAEN - medicines
Consumer questions and answers about the DAEN - medicines. - About the DAEN - medicines
Limitations of the data and search results. - Instructions for searching DAEN - medicines
How to use the DAEN - medicines. - About the search results: DAEN - medicines
Information about the two types of search results from the DAEN - medicines. - TGA safety monitoring of medicines
The TGA, like other regulatory agencies around the world, monitors the safety of medicines, including vaccines, to contribute to a better understanding of their possible adverse effects when they are used outside the controlled conditions of clinical trials. - Overview of how TGA manages medicine adverse event reports
The information in the internal TGA database is analysed by the TGA for patterns of adverse events that may indicate a safety issue. - Medical Dictionary for Regulatory Activities - MedDRA
The Medical Dictionary for Regulatory Activities (MedDRA) is an internationally used set of terms relating to medical conditions, medicines and medical devices. - Adverse event monitoring internationally
Worldwide, a number of regulatory agencies make information about reported adverse events publicly available.
DAEN - medical devices
The Database of Adverse Event Notifications - medical devices contains information from reports of adverse events that the TGA has received in relation to medical devices used in Australia.
More information about DAEN - medical devices
- Consumer questions and answers: DAEN - medical devices
Consumer questions and answers about the DAEN - medical devices. - About the DAEN - medical devices
Limitations of the data and search results. - Instructions for searching the DAEN - medical devices
How to use the DAEN - medical devices. - About the search results: DAEN - medical devices
Information about the two types of search results from the DAEN - medical devices. - TGA safety monitoring of medical devices
How the TGA monitors medical devices and detects potential safety concerns. - Overview of how TGA manages medical device adverse event reports
A look at TGA's medical device event report process. - Global Medical Device Nomenclature - GMDN
Global Medical Device Nomenclature classification information. - Adverse event monitoring internationally
Worldwide, a number of regulatory agencies make information about reported adverse events publicly available.