Report an adverse event or problem (consumers)

What you can report

You don't need to be certain, just suspicious. Every report counts.

You can report any suspected adverse event or problem with a therapeutic good.

We particularly want to hear about events that led or could have led to:

• serious illness, injury or death
• permanent injury or damage 
• admission to hospital.

You can also report a problem like product quality, packaging or label issues.

Gather supporting information

Record a full description of your event. Include when it started, ended and how long it lasted.

The packaging and other documents contain important information for your report. This includes:

• product name, AUST number and manufacturer details 
• catalogue, lot, batch or serial numbers 
• expiry dates. 

If you want to report a problem like product quality, packaging or label issues, record:

• when and where the product was purchased
• how it was stored
• when you first noticed the problem

Take photos if you can.

Choose report type: medicine and vaccine or medical device

How you report a problem or side effect depends on whether it is for a:

• medicine or vaccine 
• medical device. 

Don’t worry if you’re not sure what your product is.

Just choose what you think is right and make a report.

Report a medicine or vaccine adverse event or problem

You can report a medicine or vaccine adverse event by phone or online.

If you report by phone, a registered pharmacist will answer your call.

You can also report product quality, packaging or label issues online.

Report by phone

To report a medicine or vaccine adverse event by phone call 1300 MEDICINE (1300 633 424).

Call 1300 633 424 Monday to Friday, 9am to 5pm AEST

A registered pharmacist will give advice about your issue with a medicine or vaccine.

They can take a report of your side effect or adverse event.

This service is free to Australians.

Hearing or speech impairments

If you have a hearing or speech impairment, you can use the National Relay Service (NRS).

Non-English speakers

If you speak a language other than English, you can use the Translating and Interpreting Service (TIS National).

Report online

We have detected intermittent issues with the online reporting form in the link below. We are investigating the problem. If you can't log in, register or submit an adverse event report using the form, please email us at: ADR.Reports@health.gov.au.  

You can also call 1300 MEDICINE (1300 633 424), and a pharmacist will submit the report for you (see Report by phone, above).

You can report medicine or vaccine adverse events online.

This is through the Adverse Event Management System.

Give as much information as you can. This will help us follow up your report.

Report a medicine or vaccine adverse event

Report product quality, packaging or label issues

You can report issues related to medicine or vaccine product quality, packaging or labelling online.

These types of issues are called medicine or vaccine defects. Issues you can report include:

• damaged, mouldy or strange smelling liquids, tablets or capsules 
• foreign objects like metal or plastic 
• medicines, syringes or auto-injectors that don’t work
• labels that are confusing, unclear or hard to read. 

Report a medicine or vaccine defect

Report a medical device adverse event

You can report medical device adverse events or problems online.

This is through the Medical Device Incident Report system.

Give as much information as you can. This will help us follow up your report.

Report a medical device incident

Get help to report a medical device adverse event

You can get help to report a medical device problem.

Call 1800 809 361 from 8:30 am to 5 pm AEST, Monday to Friday, or email iris@health.gov.au

After you report

We monitor reports and act if needed.

Your report and others will be used to identify safety and performance concerns.

If we need more information and you provided details, we will contact you.

If a safety concern is identified

We may investigate if we suspect an issue related to the safety, quality or performance of a product. 

Investigations may be triggered by a single report or a collection of reports.

Reports are shared with the product sponsor and manufacturer for their review and action.

We can take actions including:

• recall or cancel the product 
• limit who can buy it 
• require warnings or changes to the label
• require the sponsor to do further research. 

When we identify concerns or issues with products, we publish safety alerts.

Record of adverse events

Your adverse event report will be checked before it is entered into a publicly available database.

Reports are included in the Database of Adverse Event Notifications.

Why your report is important

Every report is valuable and contributes to our safety monitoring.

When a product is first made available, information is gathered from lab tests and clinical trials. 

Tests and trials don’t:

• detect all possible adverse events 
• uncover issues that are rare or take time to develop 
• involve all types of people who might be susceptible to different issues. 

Low-risk products, like those you can buy at the supermarket, may not undergo clinical trials.

Your report will help fill in this information about a product. It can help keep others safe.

Read more about how we monitor the safety of therapeutic goods.