About the Database of Adverse Event Notifications

The DAEN is our online database. It contains information from suspected adverse events reported to us. 

We use information from these adverse event reports to detect unusual or unexpected patterns in the data which may indicate a safety signal related to a product. 

This passive signal detection surveillance system relies on people reporting an adverse event which they suspect is linked to a medicine or device.

The number of reports received is influenced by: 

• the market share of the medical device
• the length of time the medical device has been on the market
• publicity about a possible link between an adverse event and a medical device
• regulatory actions
• the user reporting events to sponsors and/or the TGA.
• Adverse event reports from consumers and health professionals to the TGA are voluntary; therefore, not all adverse events may be reported by these groups. This is the same around the world.
• It is mandatory under the Therapeutic Goods Act 1989 for sponsors and manufacturers to report serious or potentially serious adverse events associated with their medical device to the TGA. As a result, the search results in the DAEN - medical devices may reflect a higher ratio of serious to non-serious adverse event reports.

Interpreting the data

• Adverse event reports that we receive reflect the observations of the people submitting them.
• Adverse events are suspected of being related to a medicine, but this relationship is usually not certain - the symptom may be related to an underlying illness or to other factors.
• There might be no relationship between the adverse event and the medicine. The symptoms may instead have occurred coincidentally.
• Sometimes the adverse event may have been caused by the other ingredients in the medicine such as an excipient ingredient. See Ingredient basics for definition.
• The reports received by the TGA contain suspected associations that reflect the observations of an individual reporter.
• Adverse events are suspected of being associated with the use of a medical device, but this relationship is usually not certain - the adverse event may be related to an underlying illness, a person's anatomical structure or to other factors.
• There might be no relationship between the adverse event and the medical device - it may be a coincidence that the adverse event occurred when the medical device was used.

Limitations of the data

We encourage people to report even if there is only a very small chance that a medicine was the cause. These reports are entered into the database without being confirmed or assessed to determine if they are caused by a medicine. Many of the reports are made voluntarily and may be incomplete or inaccurate.

The database does not contain all known information concerning a medicine. Therefore, an assessment of a product's safety cannot be made based on this information.

Additional information about known side effects is available in the:

• Consumer Medicine Information (CMI)
• Product Information (PI)

The number of reports received for a particular product cannot be used to compare its safety to other products. 

This is because many factors can influence reporting of adverse events for an individual product including:

• how long it has been available and how much it is used in Australia
• publicity about a possible side effect
• steps we've already taken following a safety concern

Search results cannot be used to determine how common an adverse event is in people taking that product. This is because the database does not include information on the total number of:

• patients taking the product
• adverse events occurring.

Under the Therapeutic Goods Act 1989, pharmaceutical companies must report all serious adverse events suspected of being related to their products. This means search results in the DAEN may reflect a higher ratio of serious to non-serious adverse event reports.

The Database of Adverse Event Notifications - medical devices does not contain all known information concerning a medical device, and an assessment of the safety of a medical device cannot be made based on this information. The TGA uses the adverse event reports to identify when a safety issue may be present.

Living database

Reports in the database start from 1 January 1971 up to 14 days prior to the date of access. We are constantly updating the database to ensure it reflects the latest adverse event information that we receive. The information in the database may change if we:

• Receive follow-up information on an existing adverse event report.
• Identify more than one report relating to the same adverse event in a patient and combine them into a single report.
• Update adverse event reports as part of data quality assurance activities.

This means searches for the same date range performed on different days may give slightly different results.

The entry date of the report does not necessarily reflect the date when the adverse event happened. Reports are often received soon after an adverse event happened.

However, there are occasions when we receive reports many years later. This sometimes occurs in response to a particular adverse event being publicised.