About the Database of Adverse Event Notifications (DAEN): medicines

You can access the DAEN directly here: Database of Adverse Event Notifications (DAEN) - medicines

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.

Find out more about:

• what we do with adverse event reports
• how we monitor, identify and manage medicine safety issues.

Anyone can report an adverse event to us including members of the public, health professionals and pharmaceutical companies. To report a suspected adverse event, go to:

• Report an adverse event or problem (consumers)
• Report an adverse event or problem (health professionals)
• Report and adverse event or problem (industry).

Causality

• 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.

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 Medicines Information (CMI)
• Product Information.

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 already taken by the TGA 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 DAEN is a 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.