Report a side effect of a medicine

29 October 2015

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  • Reporting a suspected side effect to the TGA helps us monitor the safety of medicines in Australia. You can report side effects from any medicine or vaccine, including medicines you get on prescription and over-the-counter or complementary medicines that you buy from a pharmacy, supermarket, health food shop or the internet.

    If you believe you are having a side effect it is important to speak to a health professional.

    Why report a side effect?

    The TGA monitors the safety of medicines to contribute to a better understanding of their possible side effects. Unfortunately it's impossible to know all side effects of a medicine before it is approved for use.

    When people tell us about their experiences using a particular medicine it helps us to understand more about the possible side effects of the medicine.

    More information: Reporting adverse events involving medicines, vaccines or medical devices

    Using this form

    • Required fields are yellow and are marked (required) - all other questions are optional.
    • Some questions have help text to give you more information about the question. Look for the question mark in the green circle ?  and hover your mouse over it (or tap it if you are using a mobile device) to see the tip.
    • The form has four sections. All four are listed at the top of each section and the green underline tells you where you are in the form. The headings can also be used to quickly jump between sections.
    • At the end of each section are left Sample left arrow and right Sample up right arrows. You can use these to move to the next section (right arrow) or the previous section (left arrow).

    To get started click the blue button below or to the left and then use the arrows to move through the form.

    • Required fields are yellow and are marked (required) - all other questions are optional.
    • Mouse over the question mark in the green circle ?  to see help text.

    Personal information

    We ask for contact details so that we can send you confirmation that we have received your report. We may also need to contact you for more information about your report.

    Personal information identifying the reporter or a patient is kept confidential. You can read the current adverse event report privacy statement here.

    About you

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    Postal (required)






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    About the person who had the side effect

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    Previous section - Introduction Next section - Suspected medicines
    • Required fields are yellow and are marked (required) - all other questions are optional.
    • Mouse over the question mark in the green circle ?  to see help text.

    About the medicines you think caused the side effect

    Having the medicine packaging with you will help when you're filling out this section.

    Please tell us as much as you can about the medicine but remember - it's better to report the side effect with some information missing than to not report it at all.

    Suspected medicine 1

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    More examples of AUST R numbers
    The AUST R number will be written on the packaging and should look like the examples below:
    Sample AUST R number Sample AUST R number Sample AUST R number

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    Medicine 2

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    Number of doses:
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    Medicine 3

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    Number of doses:
    Type of dose:
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    Previous section - Introduction Next section - About the side effect
    • Required fields are yellow and are marked (required) - all other questions are optional.
    • Mouse over the question mark in the green circle ?  to see help text.

    About the side effect

    (required)?


    This information is important to help the TGA investigate your side effect. Please be as specific as possible. If you know the exact date please give this in the format DD/MM/YYYY. If you don’t know the exact date you could:
    • Give the month and/or year the side effect started
    • Give an approximate timeframe such as ‘About 6 months ago’.







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    Previous section - Suspected medicinesNext section - Additional details
    • Required fields are yellow and are marked (required) - all other questions are optional.
    • Mouse over the question mark in the green circle ?  to see help text.

    Other information and additional comments

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    We're sending your report - please wait.
    Previous section - About the side effect

Thank you for reporting a side effect

Post-it note with the words thank-you written in bold handwriting

Thank you for submitting a suspected side effect report. Your report has been received and forwarded to the TGA Pharmacovigilance and Special Access Branch.

Your report reference number is: .

Please quote it in any correspondence with the TGA about this report.

You can print a summary of the report details you have provided to the TGA.

View Report

Side Effect Report Summary (Reference number: )

Personal Information:


About the person who had the side effect:


Suspected Medicines:


About the side effect:

Other Information:

Report another suspected side effect.

What will happen to my report

The TGA enters every report we receive of a possible side effect to a medicine into a database, which we analyse to identify safety signals.

A safety signal might be a number of similar reports of an unexpected side effect with a particular drug and is a 'flag' for a possible safety issue with a medicine. We investigate safety signals in detail to work out the possible role of the medicine or vaccine in causing the side effect.

Three months after a report has been entered into the database, we make it publicly available in the Database of Adverse Event Notifications. The three month time lag allows us to check and analyse the information in the database.

We don't make any information public that could identify the reporter or the person who experienced the side effect.

Contact

Report another suspected side effect.

Email adr.reports@tga.gov.au
Fax +61 2 6232 8392
Mail

Therapeutic Goods Administration
PO Box 100
Woden ACT 2606
Australia