Ozempic in Australia: what it is approved for and what that means.
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Ozempic is the brand name of semaglutide for type 2 diabetes, made by Novo Nordisk. It is one of the most searched medicine names in Australia, often because of weight loss. This page explains what Ozempic is approved for, who can get it on the PBS, why weight-loss use is off-label, the doses, side effects and safety warnings, in plain English. It is information, not advice.
Ozempic (semaglutide) is approved in Australia only for adults with type 2 diabetes, including those with chronic kidney disease. It is PBS-listed for type 2 diabetes under authority rules. It is not approved for weight management; prescribing it for weight is off-label, on a private prescription. The weight-management brand of semaglutide is Wegovy. The TGA lists no active Ozempic shortage as of 9 November 2026.
- Ozempic is a weekly semaglutide injection for type 2 diabetes. Weight loss is listed as a side effect, not an approved use.
- PBS subsidy covers type 2 diabetes only, for people who meet set criteria (including earlier diabetes medicines).
- Off-label prescribing is not banned, but it is a private prescription, and Ozempic cannot be advertised for weight loss.
- Doses step up from 0.25 mg to a maximum of 2 mg a week. Nausea and diarrhoea are the most common side effects.
- Counterfeit “Ozempic” pens have been found in Australia, one containing insulin. Only use pens from a registered pharmacy.
- Approved uses: type 2 diabetes in adults; and in type 2 diabetes with chronic kidney disease, to reduce the risk of kidney decline and cardiovascular death. No weight-management indication. Ozempic PI, revised 25 Sep 2026.
- PBS: listed for type 2 diabetes only. First script needs a telephone or online authority; repeats use a streamlined authority. PBS Schedule.
- Supply: removed from the TGA shortage list from 18 July 2025. The old 1.5 mL 0.25/0.5 mg pen was discontinued (31 Dec 2025) and replaced by a 3 mL pen. TGA shortage database.
- PBAC review: a review of GLP-1 use in type 2 diabetes was moved from the November 2026 meeting to a future meeting. PBAC agenda.
What is Ozempic?
Ozempic is a prescription medicine containing semaglutide, injected once a week. Semaglutide copies the gut hormone GLP-1, which helps the body release insulin when blood sugar rises, slows stomach emptying and reduces appetite. In Australia Ozempic is a type 2 diabetes medicine.
The Consumer Medicine Information says Ozempic is used in adults with type 2 diabetes to lower blood sugar and, if they also have chronic kidney disease, to reduce the risk of the kidney disease getting worse. It has not been studied in children and should not be used under 18.
Is Ozempic approved for weight loss in Australia?
No. Ozempic is approved only for type 2 diabetes. The TGA has said it “is only approved by the TGA for lowering blood sugar in adults with type 2 diabetes” and cannot be advertised for any other condition. Weight loss appears in the CMI as a side effect, not as a use.
A doctor may still prescribe a medicine off-label when they judge it clinically appropriate, with informed consent. Off-label prescribing is not banned, and Ahpra reminded practitioners of their obligations in September 2026. Any such prescription is private, not PBS-subsidised.
The semaglutide brand that is approved for weight management is Wegovy, at higher doses. Wegovy in Australia · Ozempic vs Wegovy.
Is Ozempic on the PBS?
Yes, for type 2 diabetes only. The first PBS prescription needs an authority approval by phone or online, and later prescriptions use a streamlined authority. People must meet clinical criteria set in the PBS Schedule; it is not subsidised for weight loss.
For the first PBS prescription, the PBS Schedule requires that:
- Ozempic is used with at least one of metformin, a sulfonylurea or insulin;
- diabetes has not been well controlled on those medicines, defined as HbA1c above 7%;
- the person has not had a meaningful response to an SGLT2 inhibitor, or could not take one; and
- it is not combined on the PBS with an SGLT2 inhibitor, a DPP-4 inhibitor or another GLP-1 medicine.
Both medical practitioners and nurse practitioners can write PBS prescriptions for Ozempic. Patients pay the standard PBS co-payment.
Source: PBS Schedule, semaglutide, retrieved 9 Nov 2026. These are summary criteria; the prescriber applies the full wording.
Is there still an Ozempic shortage in Australia?
No active shortage was listed on 9 November 2026. The TGA removed Ozempic from its shortage list from 18 July 2025. The only current semaglutide entry is the planned discontinuation of the old 1.5 mL 0.25/0.5 mg pen, replaced by a 3 mL pen that is interchangeable on the PBS.
During the earlier shortage, the TGA advised prescribers in September 2023 not to start new patients without a compelling reason. That advice was tied to the shortage and is now historical.
What doses does Ozempic come in?
Ozempic starts at 0.25 mg once a week for four weeks, then 0.5 mg weekly. The doctor may increase it to 1 mg, then 2 mg weekly if blood sugar is not well enough controlled. Four pens are registered in Australia, although not all pack sizes may be available.
| Pen | Doses it gives | AUST R |
|---|---|---|
| 0.25/0.5 mg pen (1.5 mL or 3 mL) | 0.25 mg or 0.5 mg | 308324 or 446290 |
| 1 mg pen | 1 mg | 315107 |
| 2 mg pen | 2 mg | 388180 |
Source: Ozempic CMI, Aug 2026.
How much weight do people lose on Ozempic?
Ozempic was tested in people with type 2 diabetes, not in weight-management trials. In those trials, average weight change was modest: about 4 to 7 kg over 30 to 104 weeks, depending on dose and trial. These results are for people with diabetes and do not predict anyone’s result.
| Trial | Length | Ozempic | Comparison |
|---|---|---|---|
| SUSTAIN 1 | 30 weeks | −3.7 kg (0.5 mg), −4.5 kg (1 mg) | Placebo −1.0 kg |
| SUSTAIN 7 | 40 weeks | −4.6 kg (0.5 mg), −6.5 kg (1 mg) | Dulaglutide −2.3 / −3.0 kg |
| SUSTAIN FORTE | 40 weeks | −6.9 kg (2 mg) | Ozempic 1 mg −6.0 kg |
| FLOW | 104 weeks | −5.6 kg (1 mg) | Placebo −1.4 kg |
Source: Ozempic Australian PI, revised 25 Sep 2026 (intention-to-treat populations). Weight-management trials used Wegovy doses; see Wegovy in Australia.
What are the side effects of Ozempic?
The CMI says the most common side effects are diarrhoea and nausea, which are usually mild and normally decrease with continued use. In pooled trials, nausea affected 17.0% of people on 0.5 mg and 19.9% on 1 mg; 6.1% and 8.7% stopped because of side effects, versus 1.5% on placebo.
Other less serious effects listed include reduced appetite, headache, vomiting, indigestion, constipation, wind, tiredness, dizziness, altered taste, injection-site reactions, gallstones and hair loss.
The CMI says to call your doctor straight away or go to the Emergency Department for possible pancreatitis (severe, lasting stomach pain), a severe allergic reaction, signs of kidney injury, a bowel blockage or sudden changes to eyesight. Ozempic side effects in full · what “Ozempic face” means.
Is Ozempic safe?
Ozempic is TGA-registered, which means it was assessed for quality, safety and effectiveness for type 2 diabetes. It still has side effects and precautions, and the prescriber checks whether it suits you. The biggest avoidable risk is a fake pen bought outside a pharmacy.
The CMI asks you to tell your doctor if you drink alcohol, as alcohol can mask or worsen low blood sugar, especially with insulin or a sulfonylurea. Tell your anaesthetist before surgery or deep sedation.
The TGA has found counterfeit “Ozempic” pens: in September 2024, fake pens contained insulin and one person had a life-threatening reaction; in April 2025, fake pens with batch number MPSD916 were stopped at the border. How to spot an illegal or fake seller.
How is Ozempic different from Wegovy and Mounjaro?
| Ozempic | Wegovy | Mounjaro | |
|---|---|---|---|
| Active ingredient | semaglutide | semaglutide | tirzepatide |
| Approved for weight management? | No | Yes | Yes |
| Maximum weekly dose | 2 mg | 2.4 mg (7.2 mg in some adults) | 15 mg |
| PBS | Type 2 diabetes only | Not listed | Not listed |
Ozempic vs Wegovy · Mounjaro vs Ozempic · Weight loss injections in Australia.
What should you eat on Ozempic?
With diabetes, food choices are best planned with your GP, diabetes educator or an Accredited Practising Dietitian. Smaller, regular meals with protein, fibre and plenty of fluids are a common starting point, especially while nausea settles.
Read what to eat on Ozempic, the semaglutide food guide and foods for nausea.
What is Ozempic used for in Australia?
Ozempic is approved for adults with type 2 diabetes to lower blood sugar, and, in people with type 2 diabetes and chronic kidney disease, to reduce the risk of kidney decline and cardiovascular death.
Is Ozempic approved for weight loss in Australia?
No. The TGA has approved Ozempic only for type 2 diabetes. Prescribing it for weight is off-label and private. The semaglutide brand approved for weight management is Wegovy.
Is Ozempic on the PBS?
Yes, for type 2 diabetes only. The first PBS prescription needs an authority approval and the patient must meet criteria, including earlier diabetes medicines and an HbA1c above 7%. It is not PBS-subsidised for weight loss.
Is there still an Ozempic shortage?
No active shortage was listed on 9 November 2026. The TGA removed Ozempic from its shortage list from 18 July 2025. The old 1.5 mL starter pen was replaced by a 3 mL pen.
Is Ozempic safe?
Ozempic is TGA-registered for type 2 diabetes. Common side effects are nausea and diarrhoea, usually mild and easing over time. Rare serious risks include pancreatitis and bowel blockage. Counterfeit pens have been found, so only use pens from a registered pharmacy.
What is the highest Ozempic dose in Australia?
The maximum Ozempic dose is 2 mg once a week. Treatment starts at 0.25 mg and steps up to 0.5 mg, then 1 mg and 2 mg if blood sugar needs it.
Related explainers: Ozempic vs Wegovy · Ozempic side effects · Ozempic face · Wegovy in Australia · GLP-1 medicines in Australia
Primary sources checked for this page.
- Ozempic Australian Product Information, revised 25 Sep 2026.
- Ozempic Consumer Medicine Information, Aug 2026.
- PBS Schedule: semaglutide (Ozempic) items, retrieved 9 Nov 2026.
- TGA media release on Ozempic advertising, 12 Jul 2024.
- Ahpra: off-label and unapproved prescribing guidance, 16 Sep 2026.
- TGA medicine shortage database: semaglutide.
- Australian Diabetes Educators Association: Ozempic off the shortage list, 28 Jul 2025.
- RACGP newsGP: 2023 shortage advice.
- PBAC November 2026 meeting agenda (v6).
- TGA: counterfeit Ozempic pens and adverse event, 30 Sep 2024.
- TGA: counterfeit Ozempic pens detected, 3 Apr 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.






