Side effects are a type of adverse event
An adverse event is an unintended and usually harmful occurrence associated with a medicine which may or may not be causally related.
Side effects are also unintended but are more predictable symptoms that can develop while taking a medicine. They are often harmful or unpleasant but can sometimes have positive effects. For example, some diabetes medicines can cause weight loss as a side effect
What to do if you experience an adverse event
If you suspect you have had an adverse event, talk to your pharmacist or GP about it. You or your health professional can then report it to us. Detailed information on how and what to report is available at Report a problem or side effect.
Products included in the DAEN - medicines
The database includes adverse event reports for medicines, vaccines and biological therapies used in Australia. The majority of reports are for products listed in the Australian Register of Therapeutic Goods (ARTG) such as medicines:
- prescribed or dispensed by a health professional
- purchased from a supermarket, pharmacy or another outlet without a prescription.
The database does contain some reports involving products advertised as a medicine or vaccine that are not in the ARTG.
The database does not include information about medicines accessed via the:
- Special Access Scheme
- Authorised Prescriber Scheme
- Clinical trial notification and Clinical trial approval schemes
The DAEN - medicines is not a substitute for medical advice
We encourage you to visit your health professional if you think you are experiencing an adverse event related to a medicine or have any questions about the medicines you are taking.
Just because a medicine is listed in the database, it does not mean it’s dangerous
You should not stop or change your medication based on information in the database. Always seek the advice of a health professional first.
If we approve a medicine or vaccine, it means that the benefits are considered to outweigh its risks if used as authorised in the Australian population. It is up to your health professional, in consultation with you, to decide if a medicine is appropriate after considering the benefits and the risks.
To find out about the limitations of information in the database, see About the DAEN - medicines.
Where information in the database comes from
The data comes from adverse event reports sent to us by the general public, health professionals and pharmaceutical companies.
Reports in the database start from 1 January 1971 up to 14 days before the date of access.
What the TGA does with information in the database
We use information from adverse event reports to detect unusual or unexpected patterns in the data which may indicate a safety signal related to medicine use signal detection.
Find out more about:
If you submit an adverse event you cannot be identified in the database
All personal information in our adverse event reports is de-identified before being published in the database.
This is in line with the Privacy Act and National Privacy Principles.
How to use the Database
Instructions can be found at Tips for searching the DAEN - medicines.
You can search the database using a product's trade name or active ingredient.
Where medical terms used in the database come from
We use the Medical Dictionary for Regulatory Activities (MedDRA) to code adverse events reported to us.
MedDRA is an internationally used set of standardised terms relating to medical conditions, medicines and medical devices. It is used by other medicines regulators around the world and allows us to share our adverse event data with them and contribute to global medicine safety monitoring.
The same search done on different days will give different results
The DAEN - medicines is a 'living' database. It is constantly updated and maintained to ensure it reflects the latest adverse event information. The information 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.
Not all adverse event reports sent to the TGA are included in the DAEN - medicines
While most reports are published in the database, some are not. This could be because:
- There is no reasonable temporal association between the medicine and the adverse event. For example, the adverse event occurred before the medicine was taken.
- The report does not contain enough information for an adequate assessment, or the information was contradictory or found to be false.
How to export your search results
- Hover over the data you wish to export.
- Click on the three dot icon for options to export data.
- Click on 'export data' and select 'Data with current layout' to export in Microsoft Excel (.xlsx) format or 'Summarised data' to export in a Comma Separated Values (CSV) format.
- Limits to how many rows of data can be exported in a single file apply:
- 150,000 rows for .xlsx.
- 30,000 rows for .csv
How to find information on the known side effects of a medicine
Information on the safe and effective use of all prescription and pharmacist-only medicines and their known side effects is available at:
- Consumer Medicine Information (CMI) (for consumers)
- Product Information (PI) (for health professionals)
You can also ask your pharmacist for a CMI leaflet.
Why TGA monitors adverse events and where you can find more information
When a medicine or vaccine is first registered in Australia, information about its safety and effectiveness is usually only available from clinical trials. These trials do not detect all possible adverse effects because they:
- Often do not continue for long enough to detect side effects that take a long time to develop.
- May not include enough patients to detect rare side effects.
- May not include all the different types of people who might eventually use the medicine and who might be more susceptible to some side effects, such as older people, children, pregnant women, or people with certain medical conditions.
For more information on how we monitor and manage adverse events see:
Where you can find more information on adverse events following COVID-19 vaccination
In addition to including adverse event reports in the DAEN – medicines, the also TGA publishes a COVID-19 vaccine safety report which gives an overview of the vaccines and up-to-date information about their safety.
The National Centre for Immunisation Research & Surveillance (NCIRS) also publishes vaccine safety information from the AusVaxSafety survey.