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Database of Adverse Event Notifications (DAEN)
16 September 2021
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 two 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.
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 publically 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 publically available