Citizens Committee on Human Rights

The Mental Health Watchdog

Australian National Office

Government Drug Data

computer key safety firstThere are Australian documents that contain medical information on all drugs including psychiatric drugs. These are available on-line and in Australia’s main drug manual MIMS (Monthly Index of Medical Specialties).

Pharmaceutical companies write and Australia’s drug regulatory agency, the Therapeutic Goods Administration (TGA) approves these documents on drugs.1 They cover such vital information as warnings, potential side effects, contraindications and other important information that is needed by anyone to be able to give fully informed consent. They also enable the consumer and their family to be able to be alert for potentially very dangerous side effects.

These documents are:

  • Product Information (PI): used by doctors, pharmacists and other health professionals. This is the most comprehensive document and includes any “boxed warnings” (the strongest warning placed on a drug, written in a text box). Anyone can ask their doctor at time of prescribing for this or the pharmacist when filling the prescription
  • Consumer Medicine Information (CMI): an abbreviated form of the Product Information written for consumers. Any information related to a boxed warning is placed in the CMI but not in the same words and not in a box so the reader does not know the strongest warning in Australia has been placed on the drug. Anyone can ask their doctor at time of prescribing for this or the pharmacist when filling the prescription.

Both the CMI and the PI for all drugs can be located on the TGA’s website: https://www.ebs.tga.gov.au/

No one should stop taking any psychiatric drug without the advice and assistance of a competent medical doctor. Always call 000 in an emergency.

Australian Psychiatric Drug Warnings

Pill on antidepressant factsheetAs the TGA is responsible for monitoring the safety of drugs in Australia they issue warnings about drugs which the public are not always aware of. There have been over 60 psychotropic drug warnings, (including safety advisories, investigations the TGA have performed and information they and the Government have issued) issued since 1995.

It is vital for the public to be aware of these warnings so as to be able to give fully informed consent. CCHR has collated them in layman’s terms with full references. They can be viewed here.

Side effects reported to the TGA for psychiatric drugs in Australia

Doctor holding clipboardThe TGA has a database of all the side effects reported by doctors, chemists and the public for all drugs available on their website. It is very simple to generate side effect reports for psychiatric drugs using this database.

These reports generated include the number of deaths linked to the drug. Each time this is done for a drug, two reports are generated so both should be looked at. It is also a good idea to save the reports as they can then be fully searched for specific side effects.

Use this direct link for the TGA database: https://www.tga.gov.au/database-adverse-event-notifications-daen

Or see under “Adverse Events” on the TGA homepage https://www.tga.gov.au/

More information on other specific drug side effects from the TGA can be found on CCHR’s side effect page.


  1. Information about prescription medicines drugs in Australia” https://www.ebs.tga.gov.au