Mounjaro in Australia: what it is and where it stands.
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Mounjaro is the brand name of tirzepatide, a once-weekly injection made by Eli Lilly. In Australia it is approved for three uses: type 2 diabetes, weight management and obstructive sleep apnoea. This page explains what it is, who it is approved for, whether it is on the PBS, what the trials found, its side effects and its safety precautions, in plain English. It is information, not advice.
Mounjaro (tirzepatide) is a prescription-only weekly injection approved in Australia for type 2 diabetes, chronic weight management in adults, and moderate to severe obstructive sleep apnoea in adults with obesity. It is not on the PBS for any use, so patients pay the full private price. In the main weight trial, average weight change was −16% to −22.5% over 72 weeks, depending on dose. Stomach side effects are the most common.
- Mounjaro is tirzepatide, sold in Australia as a KwikPen holding four weekly doses.
- Approved uses: type 2 diabetes, weight management in adults, and obstructive sleep apnoea in adults with obesity.
- For weight: adults with a BMI of 30 or more, or 27 to under 30 with a weight-related condition.
- Not PBS-listed for any use as of 9 November 2026. Eli Lilly declined a type 2 diabetes listing in April 2026.
- Nausea, diarrhoea, vomiting and constipation are the most common side effects. Compounded or imported “tirzepatide” is not lawful.
- December 2022: registered for type 2 diabetes. TGA record.
- September 2024: chronic weight management added for adults. TGA record.
- Current Product Information (2 Oct 2026): also lists moderate to severe obstructive sleep apnoea in adults with obesity. Mounjaro PI.
- PBS: not listed for any use. Lilly declined the recommended type 2 diabetes listing in April 2026 and the process has ceased. PBS medicine status.
- Copies: compounding GLP-1 medicines has been unlawful since 1 October 2024. On 6 October 2026 the TGA fined two Victorians for importing Mounjaro pens. TGA media release.
What is Mounjaro?
Mounjaro is a prescription medicine containing tirzepatide, injected under the skin once a week. It copies two gut hormones, GIP and GLP-1, which tell the body it has eaten: it slows how fast the stomach empties, acts on appetite centres in the brain and helps the body release insulin when blood sugar rises.
Because it acts on two hormones, it is called a dual GIP/GLP-1 receptor agonist. The sponsor in Australia is Eli Lilly Australia. How Mounjaro works, in more detail.
In Australia it comes as a KwikPen: a pre-filled pen that holds four weekly doses at one strength. Six strengths are registered: 2.5, 5, 7.5, 10, 12.5 and 15 mg. Treatment starts at 2.5 mg for four weeks and may step up by 2.5 mg every four weeks. Mounjaro doses and the KwikPen.
What is Mounjaro approved for in Australia?
Mounjaro has three TGA-approved uses in Australia: type 2 diabetes, chronic weight management in adults who are overweight or have obesity, and moderate to severe obstructive sleep apnoea in adults with obesity. It is prescription-only for all three.
| Use | Who it is approved for | Since |
|---|---|---|
| Type 2 diabetes | Adults; and children and teenagers aged 10 or over weighing at least 50 kg | December 2022 (adults) |
| Weight management | Adults with a BMI of 30 or more, or 27 to under 30 with a weight-related condition, alongside diet and activity | September 2024 |
| Obstructive sleep apnoea | Adults with obesity and moderate to severe sleep apnoea | Listed in the current PI (2 Oct 2026) |
Sources: Mounjaro Australian PI, revised 2 Oct 2026; Mounjaro KwikPen CMI, Sep 2026; TGA registration records. Registration criteria are not a recommendation for any individual.
Who can be prescribed Mounjaro for weight loss?
For weight management, Mounjaro is approved for adults with a BMI of 30 or more, or a BMI of 27 to under 30 with at least one weight-related condition. Examples in the Product Information include high blood pressure, high cholesterol, sleep apnoea, heart disease, prediabetes and type 2 diabetes.
It is not approved for weight management in anyone under 18. The PI says safety and effectiveness have not been established in children and teenagers for uses other than type 2 diabetes.
Meeting the criteria does not mean Mounjaro suits you. A prescriber considers your history, other medicines and goals, and must assess you before prescribing.
Is Mounjaro on the PBS?
No. As of 9 November 2026, Mounjaro is not PBS-listed for any use, so people prescribed it pay the full private price, which varies by dose and by pharmacy. A PBS medicine search for tirzepatide returned no results on 9 November 2026.
The PBAC recommended a type 2 diabetes listing in March 2026, after earlier submissions were not recommended or deferred. In April 2026 Eli Lilly declined, saying the proposed price was lower than any other reimbursed price in the world. The PBS records that the listing process has ceased. No weight-management listing has been sought.
Full history: Is Mounjaro on the PBS?.
How well does Mounjaro work for weight loss?
In SURMOUNT-1, a 72-week trial in adults with obesity or overweight and a related condition but no diabetes, average weight change was −16.0% on 5 mg, −21.4% on 10 mg and −22.5% on 15 mg, compared with −2.4% on placebo. Everyone also had lifestyle counselling.
| Weight lost | 5 mg | 10 mg | 15 mg | Placebo |
|---|---|---|---|---|
| At least 5% | 89.4% | 96.2% | 96.3% | 27.9% |
| At least 10% | 73.4% | 85.9% | 90.1% | 13.5% |
| At least 15% | 50.2% | 73.6% | 78.2% | 6.0% |
| At least 20% | 31.6% | 55.5% | 62.9% | 1.3% |
Share of people reaching each threshold at 72 weeks (efficacy estimand, as if everyone stayed on treatment). Source: Mounjaro Australian PI, Table 12; Jastreboff et al., NEJM 2022. Group averages, not predictions.
In SURMOUNT-5, an open-label head-to-head trial, tirzepatide gave −20.2% compared with −13.7% for semaglutide 2.4 mg (the Wegovy dose). Mounjaro results by dose and week · Mounjaro vs Ozempic.
What are the side effects of Mounjaro?
The Australian CMI says the most common side effects are nausea, diarrhoea, vomiting and constipation, and that they are usually not severe. They are more likely while the dose is going up. In SURMOUNT-1 on 5 mg, 24.6% of people had nausea, 18.7% diarrhoea, 16.8% constipation and 8.3% vomiting.
Other less serious effects listed include stomach pain, heartburn, bloating, burping, tiredness, dizziness, injection-site reactions, changes to taste and hair loss (5.1% on 5 mg in SURMOUNT-1). In that trial, 4.3% to 7.1% of people stopped because of side effects, compared with 2.6% on placebo.
The CMI says to call your doctor straight away or go to the Emergency Department if you have:
- severe stomach pain that may spread to your back and does not go away (possible pancreatitis)
- signs of an allergic reaction
- sudden severe upper-stomach pain, fever, yellow skin or eyes, or pale stools (possible gallbladder problems)
- changes to, or loss of, vision
Full list and timing: Mounjaro side effects.
Is Mounjaro safe?
Mounjaro was assessed by the TGA for quality, safety and effectiveness for its approved uses. Like every medicine it has risks, and some people should take extra care. Your prescriber checks these before starting and at reviews.
- Tell your doctor about any history of pancreatitis, gallbladder problems or malnutrition.
- Tell your anaesthetist before surgery or deep sedation: since June 2025 these medicines carry a warning about inhaling stomach contents.
- With insulin or a sulfonylurea, blood sugar can go too low; doses of those may need changing.
- The CMI asks you to tell your doctor if you drink alcohol, as it can mask or worsen low blood sugar. Mounjaro and alcohol
- Drink plenty of fluids if you have vomiting or diarrhoea, to avoid dehydration.
- Watch for new or worsening low mood; class warnings advise monitoring, although a causal link is not established.
Report suspected side effects to your doctor or pharmacist, or directly to the TGA.
Is Mounjaro the same as Zepbound or Ozempic?
Zepbound is the United States brand of tirzepatide for weight management, so it is the same medicine as Mounjaro. In Australia, tirzepatide is supplied under the brand name Mounjaro for all its uses; Zepbound is the US name. Zepbound in Australia.
Ozempic is a different medicine: semaglutide, which acts on GLP-1 only. In Australia Ozempic is approved for type 2 diabetes, while Wegovy is the semaglutide brand approved for weight management. Mounjaro vs Ozempic compared.
Are compounded or imported Mounjaro copies legal?
No. Since 1 October 2024 pharmacists in Australia may not compound GLP-1 medicines, including tirzepatide. Vials or powders sold as “tirzepatide”, “research use only” peptides and Zepbound packs are not registered medicines here.
Importing is tightly limited too. In October 2026 the TGA issued infringement notices to two Victorians for importing Mounjaro pens that were not on the ARTG. How to spot an illegal Mounjaro seller.
What should you eat on Mounjaro?
Most people eat less on Mounjaro, so each meal needs to work harder for protein, fibre and fluids. A 2025 joint advisory from US nutrition and obesity bodies suggests about 1.2 to 1.6 g of protein per kilogram of body weight a day during active weight loss.
Practical starting points: protein first, small portions eaten slowly, water through the day. The Mounjaro diet plan, protein on a GLP-1 and foods for nausea go further. An Accredited Practising Dietitian can tailor it.
What is Mounjaro?
Mounjaro is the brand name for tirzepatide, a once-weekly prescription injection made by Eli Lilly. It acts on two gut hormones, GIP and GLP-1, which slow stomach emptying, reduce appetite and help control blood sugar.
What is Mounjaro used for in Australia?
It is TGA-approved for type 2 diabetes, chronic weight management in adults who are overweight or have obesity, and moderate to severe obstructive sleep apnoea in adults with obesity.
Is Mounjaro approved for weight loss in Australia?
Yes. Since September 2024 it has been approved for chronic weight management in adults with a BMI of 30 or more, or 27 to under 30 with a weight-related condition, alongside diet and physical activity.
Is Mounjaro on the PBS?
No. As of 9 November 2026 Mounjaro is not PBS-listed for any use. The PBAC recommended a type 2 diabetes listing in March 2026, but Eli Lilly declined in April 2026 and the process has ceased.
Is Mounjaro safe?
It was assessed by the TGA for safety, quality and effectiveness for its approved uses. Common side effects are nausea, diarrhoea, vomiting and constipation; rare serious ones include pancreatitis, gallbladder problems and allergic reactions. A prescriber checks whether it suits you.
Is Zepbound the same as Mounjaro?
Yes, both contain tirzepatide. Zepbound is the US brand for weight management. In Australia tirzepatide is supplied as Mounjaro.
Can you get Mounjaro without a prescription?
No. Mounjaro is prescription-only. Websites selling it without a prescription, and compounded or research-use tirzepatide, are not lawful sources.
Related explainers: Weight loss injections in Australia · Mounjaro results · Is Mounjaro on the PBS? · Tirzepatide in Australia · Mounjaro vs Wegovy
Primary sources checked for this page.
- Mounjaro Australian Product Information, revised 2 Oct 2026.
- Mounjaro KwikPen Consumer Medicine Information, Sep 2026.
- TGA: Mounjaro registration (type 2 diabetes).
- TGA: Mounjaro registration (weight management).
- PBS medicine status: tirzepatide.
- RACGP newsGP: Lilly rejects PBS recommendation, 28 Apr 2026.
- TGA: GLP-1 RA pharmacy compounding changes.
- TGA: infringement notices for importing Mounjaro pens, 6 Oct 2026.
- TGA safety update: GLP-1 medicines and anaesthesia.
- TGA safety update: suicidal thoughts warnings aligned.
- Jastreboff et al., SURMOUNT-1, NEJM 2022.
- Aronne et al., SURMOUNT-5, NEJM 2025.
- Mozaffarian et al., joint nutrition advisory, Am J Clin Nutr 2025.
Editorial method: Australian regulatory sources (TGA, PBS, Medical Board, Ahpra, healthdirect) were checked first, then the Australian Product Information and Consumer Medicine Information, then peer-reviewed trial publications. Status statements are dated and may change. A named clinical review is pending; until then this is editorial research, not clinical opinion. See the Preptide editorial policy.
Important: General information only, not medical advice. Brand names are registered trademarks of their respective owners; Preptide is independent and is not affiliated with, endorsed by or sponsored by any medicine manufacturer. Preptide is food, not medication, and does not prescribe, sell, recommend or promote prescription medicines. Talk to your doctor or pharmacist about any medicine. In an emergency call 000. Read our editorial policy and Health Acknowledgement.






