Report side effects to the TGA in Australia

Had side effects from an antidepressant, finasteride or isotretinoin, and live in Australia? You can report them to the TGA, Australia’s medicines regulator, yourself. You don’t need to be sure the medicine caused them, and the TGA says it sometimes gets reports many years after the event.

That includes problems that continued after stopping, which patients call PSSD after an antidepressant, PFS after finasteride and PAS after isotretinoin.

The TGA’s own count shows how few reach it. By April 2024 it had 89 reports of sexual problems on SSRI and SNRI antidepressants, and 4 described problems that went on after stopping. The TGA says such cases are “likely to be underreported”.

The TGA needs only a few details. Finding the words is often the hard part, so each step below has an example.

Can I report a side effect to the TGA myself?

Yes. “Anyone can make a report,” the TGA says. “You can submit a report for yourself or on behalf of another person.”

You don’t need proof either. The TGA encourages reports “even if you’re not 100% sure the medicine caused them”. In its words: “You don’t need to be certain.”

The report can’t be anonymous. The TGA asks for your name and contact details so it can come back with questions. The person affected is described by sex and age.

You can also ask your GP, nurse practitioner, midwife or community pharmacist to help you report, as the TGA’s page for consumers suggests.

The phone line that used to take reports, the Consumer Medicines Line, was due to close on 30 July 2026, when its funding ended. Older pages may still give its number. Report online instead, or through your GP or pharmacist.

How do I fill in the TGA’s online form?

Go to the Adverse Event Management System, the TGA’s reporting site. Choose Report (without registering) if you don’t want an account. A privacy statement comes first, then the form.

The TGA asks for the details below. The more you give, “the better picture we can build”.

1

About you

Your name and contact details, even if the report is about someone else.

2

The person affected

Their sex and age.

3

The medicine

“Escitalopram 10 mg a day for anxiety, June 2021 to March 2023.”

4

What happened

One symptom at a time: “genital numbness”, “emotions feel flat”. Then: “Symptoms continued after stopping.”

5

Since then

Any treatment for it, and whether you've recovered.

Name every symptom, not only sexual ones. Criteria for these conditions proposed in 2022 also describe emotional numbing, problems with cognition and changes in other senses.

The TGA codes reports with MedDRA, the international dictionary of medical terms. So if your symptoms continued after stopping, use the term in the box below.

Each report gets its own ID number. Keep it: the TGA says to quote it if you want to add more later.

What did Australia’s 2024 warning say?

It said sexual problems on SSRI and SNRI antidepressants can last after stopping. In May 2024, the TGA said the prescribing information for all of them now carries the warning.

The wording added for six of them reads: “There have been reports of long-lasting sexual dysfunction where the symptoms have continued despite discontinuation of SSRIs/SNRI.” The TGA adds that these effects “can persist for weeks to years”.

The nine medicines named are citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, desvenlafaxine, duloxetine and venlafaxine.

For isotretinoin, a TGA update in April 2025 told prescribers that stopping “may not alleviate symptoms” of sexual problems. Our page on what regulators say about PSSD compares Australia with other countries.

What can I do if I think I have it?

These medicines help many people. If you have side effects, that’s a decision for you and your prescriber. Don’t stop an antidepressant suddenly. For finasteride and isotretinoin, follow what the leaflet says.

Report it: it helps everyone

A doctor’s note helps you. A report to the medicines regulator helps everyone else: it is how patterns get noticed.

• No proof needed. The TGA asks for a suspicion, and it takes reports long after the event.
• Where: the TGA, through its online form or with help from your GP or pharmacist.
• Use the right words. After an antidepressant, write Post-SSRI sexual dysfunction (MedDRA 10086208). After finasteride, write Post 5-alpha-reductase inhibitor syndrome (MedDRA 10082430). PAS has no term yet, so say that the symptoms continued after stopping.

Our reporting guide walks you through it

What else do people ask?

Is it too late if I stopped years ago? The TGA’s pages set no deadline that we could find. Its database notes say “there are occasions when we receive reports many years later”. More in our article on reporting a side effect years later, written for the UK and US.

Can I see what other Australians have reported? Yes, in the Database of Adverse Event Notifications, or DAEN. It holds reports from 1971 onwards. The TGA warns that search results “cannot be used to determine how common an adverse event is”.

Can I report for my partner or child? Yes. The TGA says you can report “on behalf of another person”. Your details go in as the reporter, and theirs as the person affected.

Your report can be short: the medicine, the dates, and one plain line saying the symptoms continued after stopping. Our page on post-drug syndromes explains why that line matters.

Sources

1. Therapeutic Goods Administration (TGA), Overview of adverse event reporting for medicines, last updated 9 February 2026. “Anyone can make a report. You can submit a report for yourself or on behalf of another person”. “We encourage you to report adverse events or side effects even if you’re not 100% sure the medicine caused them. You don’t need to be certain, just suspicious”. What to include: patient sex and age; reporter name and contact details; product name, what it was used for and how it was taken; what happened, any treatment and whether the person recovered. “We cannot accept anonymous reports”. The page also lists the kinds of problems the TGA “especially” wants to know about; we don’t repeat that list, as it is not a question on how to answer the form. Read 6 November 2026.
2. TGA, Reporting adverse events for consumers, last updated 4 November 2026. Medicines are reported online through the Adverse Event Management System; “You can also contact a health professional - your GP, nurse practitioner, midwife or community pharmacist - to help you report an adverse event”. The page gives no phone number for medicine reports. Read 6 November 2026.
3. TGA, Adverse Event Management System, home page. “You can submit an adverse event as either a registered or unregistered user”, with a “Report (without registering)” link, which opens a privacy statement with an “I agree” button. The privacy statement says “A subset of this de-identified information is published on the public Database of Adverse Event Notifications”. We did not agree to the statement or open the form itself. Read 6 November 2026.
4. TGA, How we manage your medicines adverse event reports, last updated 1 October 2025. “Each report is given a unique ID number. You should use this number if you need to add more information about the event to your existing report”. Reports help the TGA identify “safety signals”; actions include adding warnings to the Product Information and Consumer Medicine Information. Read 6 November 2026.
5. Australian Government Department of Health, Disability and Ageing, Consumer Medicines Line closure, last updated 11 June 2026. “The Consumer Medicines Line – also known as the adverse medicine events line – will close when the current funding agreement ends on 30 July 2026”. “You can report side effects or problems with medicines directly to the TGA”. Read 6 November 2026.
6. TGA, Updated warnings about persistent sexual dysfunction for antidepressants, Medicines Safety Update, 23 May 2024, written for health professionals. The Product Information for all SSRIs and SNRIs “have been aligned”; desvenlafaxine, sertraline and venlafaxine already carried the warning, and six were updated with the wording we quote. Effects “can persist for weeks to years”. “89 reports describing sexual dysfunction with an SSRI or SNRI in our Adverse Event Management System database (to April 2024). Of these, 4 described persistent sexual dysfunction after treatment was stopped”, lasting “12 months to 3.5 years”. The TGA writes that persistent sexual dysfunction “is thought to be rare”, citing one review, and adds that the symptoms “are likely to be underreported and their prevalence is not currently known”. Read 6 November 2026.
7. TGA, New safety warnings for isotretinoin (Roaccutane), Medicines Safety Update, 7 April 2025. New Product Information text, section 4.4, Sexual Disorders: “discontinuation of Roaccutane may not alleviate symptoms and therefore further specialist evaluation may be necessary”. Section 4.8: “A causal association with these adverse effects has not been established”. Read 6 November 2026.
8. TGA, About the Database of Adverse Event Notifications (DAEN): medicines, last updated 16 February 2023. “Reports in the database start from 1 January 1971 up to 14 days prior to the date of access”. “However, there are occasions when we receive reports many years later”. “Search results cannot be used to determine how common an adverse event is in people taking that product”. Read 6 November 2026.
9. TGA, Database of Adverse Event Notifications (DAEN), last updated 17 July 2026. MedDRA “is an international medical terminology used to code, classify and group medicine adverse event reports” in the DAEN. Read 6 November 2026.
10. Healy D, Bahrick A, Bak M and colleagues. Diagnostic criteria for enduring sexual dysfunction after treatment with antidepressants, finasteride and isotretinoin. Int J Risk Saf Med 2022;33(1):65-76. Proposed criteria developed through expert agreement. Section 3 lists “emotional numbing”, “cognitive impairment” and “other sensory problems involving skin, smell, taste or vision”. “The incidence of these conditions is unknown”. Read 6 November 2026.
11. MedDRA terms as listed in our reporting data: Post-SSRI sexual dysfunction (10086208) and Post 5-alpha-reductase inhibitor syndrome (10082430). There is no term yet for lasting effects after isotretinoin.

Sources checked on 6 November 2026. AI-assisted writing and review, not clinical review.