When searching the database please select:

• medicines
• date range

There is also an advanced search option where you can restrict your search to particular MedDRA reaction terms.

Medicines

Once you have typed the first three letters of a medicine name, a list of trade names will appear with the active ingredients shown in brackets. Where the reporter has only provided the TGA with the active ingredient name, the database will display the trade name as 'Not specified'.

Select the medicines you want to search for by ticking or unticking the boxes. For example, to conduct a search by active ingredient, tick the box for each trade name containing the active ingredient.

More information on medicine name searches

Searches on active ingredient names and trade names will produce different results in many cases, because many active ingredients are marketed by different companies under different trade names.

• Active ingredient searches will usually give the most informative results for most medicines, especially if they are marketed under multiple trade names.
• Trade name searches are particularly useful for the names of biological medicines and vaccines, which often have very long active ingredient names.
• The choice of medicine names is limited to names in the Database of Adverse Event Notifications - medicines.
• The Database does contain reports involving medicines or products advertised as a medicine that are not on the ARTG (at the time of report entry), where possible this will be indicated in the trade name of the product i.e. Product XX - not on the ARTG.
• When searching it should be remembered that some people are often taking multiple medications. The search results will only show cases for which the medicine was suspected of being the cause of the adverse event.

Date range

To select a start date and end date for your search you need to choose a year, month and day. Ensure the 'to' date is after the 'from' date.

The Database of Adverse Event Notifications - medicines includes reports from 1 January 1971 up to three months prior to the date of access. During this time the TGA checks these reports to ensure they are complete and accurate, and undertakes analyses of the data to check for patterns of adverse events that may indicate a safety issue (signal detection).

The entry date does not necessarily reflect the date of the adverse event. Although reports are often received soon after an adverse event occurred, there are occasions, often in response to the publicising of a particular adverse event, that the TGA receives reports of adverse events many years after they occurred.

Search results

There are two types of results shown in two tabs:

• Medicine summary
  This summary groups reported adverse events together. It enables a quick assessment of the most commonly reported adverse events for a particular medicine.
• List of reports
  This lists all relevant reports in chronological order. It contains more information than the medicine summary, but does not group the reports according to adverse event.

Further information about search results is available at DAEN - medicines: about the search results.

Advanced search

Advanced search fields are optional and allow you to specify particular MedDRA reaction terms of interest. This will result in a narrower search. You must select a medicine and a date range before you can open the advanced search options.

Only MedDRA terms reported for your selected medicine/s and date range will be shown.

MedDRA System Organ Classes

The 26 system organ classes are:

1. Blood and lymphatic system disorders
2. Cardiac disorders
3. Congenital, familial and genetic disorders
4. Ear and labyrinth disorders
5. Endocrine disorders
6. Eye disorders
7. Gastrointestinal disorders
8. General disorders and administration site conditions
9. Hepatobiliary disorders
10. Immune system disorders
11. Infections and infestations
12. Injury, poisoning and procedural complications
13. Investigations
14. Metabolism and nutrition disorders
15. Musculoskeletal and connective tissue disorders
16. Neoplasms benign, malignant and unspecified (incl cysts and polyps)
17. Nervous system disorders
18. Pregnancy, puerperium and perinatal conditions
19. Psychiatric disorders
20. Renal and urinary disorders
21. Reproductive system and breast disorders
22. Respiratory, thoracic and mediastinal disorders
23. Skin and subcutaneous tissue disorders
24. Social circumstances
25. Surgical and medical procedures
26. Vascular disorders.

MedDRA reaction terms

Once you have selected MedDRA system organ classes, you can select any number of MedDRA reaction terms.