Welcome to the Australian Adverse Drug Reaction Reporting System.
In this system, you can report a case of a suspected adverse reaction in association with a medicine (including complementary, OTC or prescription) or a vaccine.
For general privacy information, go to http://www.tga.gov.au/about/website-privacy.htm.
Information in this report is collected to assist in the post market monitoring of the safety of therapeutic goods under the Therapeutic Goods Act 1989 (the Act). All reports are assessed and entered into the Therapeutic Goods Administration’s (TGA’s) Australian Adverse Drug Reactions System (the ADRS). Further information about how the TGA uses adverse event information that is reported to it is available at http://www.tga.gov.au/safety/problem-medicine.htm.
The TGA collects personal information in this report to:
- Assess the safety of medicines and vaccines under the Act.
- Contact the reporter of the adverse event if further information is required.
- Contact representatives of entities that supply therapeutic goods, to discuss reported adverse events.
- Check that the same information has not been received multiple times for the same adverse event.
At times, this information is collected from someone other than the individual to whom the personal information relates. This can occur when an adverse event is reported to a person or an entity other than the TGA (such as a health professional or a hospital), and that person or entity passes the information on to the TGA.
Personal information collected in this report may be disclosed by consent or where the disclosure is required by, or authorised under, a law (for example, under section 61 of the Act). Where a report relates to vaccine events, personal information about the reporter or the patient may be disclosed to State and Territory health agencies under subsection 61(3) of the Act.
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