Status checked on October 6, 2026 dailymed.nlm.nih.gov
Ozempic (semaglutide) is FDA approved for type 2 diabetes, not weight management: approved uses, how it differs from Wegovy, side effects, counterfeit warnings and prices.
Fact-checked against FDA labels and official sources; not yet reviewed by a licensed clinician. This page is education, not medical advice. Talk to your doctor before starting, stopping or changing any treatment.
Key facts
- Active ingredient
- Semaglutide: one ingredient, several brands
- Class
- GLP-1 receptor agonist
- Route
- Injection
- How often
- Weekly
- Manufacturer
- Novo Nordisk
- Approved for weight
- No
- First approved
- 2017
- Generic available
- No
- Controlled substance
- No
- Official label
- Prescribing information
Key takeaways
- Ozempic is FDA approved for adults with type 2 diabetes, including heart and kidney risk reduction; it is not approved for weight management.[1]
- Wegovy contains the same active ingredient, semaglutide, and is the brand approved for chronic weight management.[3]
- In SUSTAIN-6, major cardiovascular events occurred in 6.6% of people on semaglutide vs 8.9% on placebo.[4]
- The FDA has found counterfeit Ozempic 1 mg pens in the U.S. supply chain several times, most recently announced in December 2025.[6]
Approved uses
Ozempic (semaglutide): approved uses and how it differs from Wegovy is FDA approved for Improve glycemic control, as an adjunct to diet and exercise; Reduce the risk of major adverse cardiovascular events; Reduce the risk of sustained eGFR decline, end-stage kidney disease and cardiovascular death. It is not approved for weight management.
Wegovy (semaglutide): uses, side effects, cost and FDA status, Wegovy HD (semaglutide 7.2 mg): what the higher dose is, results and status, Wegovy Pill (oral semaglutide): status, how it is taken, how it compares contains the same active ingredient and is approved for chronic weight management.
In short: Ozempic is semaglutide approved by the FDA for adults with type 2 diabetes: to improve blood sugar control, to lower the risk of heart attack, stroke and cardiovascular death in those with heart disease, and to lower the risk of kidney decline, kidney failure and cardiovascular death in those with chronic kidney disease. It is not FDA approved for weight management. Wegovy contains the same active ingredient and is the semaglutide brand approved for weight (checked on the FDA label on 2026-10-06).
Ozempic is one of the most searched medicine names in the U.S., often by people who heard it helps with weight. This page sets out what it is approved for, how it differs from Wegovy, and what the label says about side effects, warnings and cost. It is general information, not medical advice.
What Ozempic is
Ozempic at a glance
- Type 2 diabetesthe only condition Ozempic is approved for; weight management is not an approved useOzempic label, section 1
- 26%lower relative risk of heart attack, stroke or cardiovascular death in SUSTAIN-6 (6.6% vs 8.9%)Ozempic label, Table 9
- 24%lower relative risk of the kidney composite outcome in FLOW (18.7% vs 23.2%)Ozempic label, section 14.3
- Weeklyone injection on the same day each week, any time, with or without mealsOzempic label, section 2.1
Checked on October 6, 2026
Ozempic is made by Novo Nordisk. Its active ingredient, semaglutide, is a GLP-1 receptor agonist: it helps the pancreas release insulin when blood sugar is high, lowers glucagon and slows stomach emptying, which also reduces appetite. Our semaglutide page explains the mechanism in more depth. The original form is a once-weekly injection pen. The current label also covers Ozempic tablets, an oral form for type 2 diabetes.
FDA status and approved uses
Drugs@FDA lists the original Ozempic approval on December 5, 2017 for blood sugar control in adults with type 2 diabetes, alongside diet and exercise. A cardiovascular indication followed on January 16, 2020: reducing the risk of major adverse cardiovascular events in adults with type 2 diabetes and established heart disease. On January 28, 2025 the FDA added a kidney indication: reducing the risk of sustained decline in kidney function, end-stage kidney disease and cardiovascular death in adults with type 2 diabetes and chronic kidney disease.
Ozempic tablets (oral semaglutide) appear on DailyMed in a combined label with Rybelsus, approved for blood sugar control and cardiovascular risk reduction in adults with type 2 diabetes. That label notes that Rybelsus and Ozempic tablets are not substitutable milligram for milligram.
Ozempic and weight loss: approved or off-label?
People with type 2 diabetes often lose some weight on Ozempic, and the trials recorded that, but weight management is not one of its approved uses. Prescribing it only for weight would be off-label: legal for a clinician in many circumstances, but outside what the FDA reviewed for this product, and insurance plans usually do not cover it for that purpose. For weight, the FDA approved the same molecule as Wegovy, with its own doses and trial program. Our guide to Ozempic for weight loss covers the off-label question in detail, and Ozempic vs Wegovy lines the two up side by side.
Here is how the two semaglutide injections differ on paper, according to their current labels:
- Approved uses: Ozempic, type 2 diabetes with heart and kidney protection; Wegovy, chronic weight management, heart protection in people with obesity or overweight, and MASH.
- Highest dose: Ozempic tops out at 2 mg a week; Wegovy goes to 2.4 mg, with a 7.2 mg option for adults.
- Who: Ozempic is for adults; the Wegovy injection is also approved for teens 12 and older with obesity.
- Insurance: plans often cover Ozempic for diabetes and treat weight-only use differently; Medicare’s GLP-1 Bridge covers Wegovy for weight but not diabetes drugs.
Our pages on Ozempic for weight loss and Ozempic vs Wegovy go deeper into that question.
Who it is labeled for
Adults with type 2 diabetes, with the cardiovascular and kidney indications applying to adults with type 2 diabetes who also have established cardiovascular disease or chronic kidney disease. It is not approved for weight management in people with or without diabetes.
How it is taken, in general
The injection is used once a week on the same day, any time of day, with or without meals. The label describes a low starting dose for four weeks, meant to reduce stomach side effects, followed by step-ups at least four weeks apart if more effect is needed, up to a maximum set in the label. The prescriber chooses the dose and adjusts other diabetes medicines when needed.
How the label describes starting Ozempic, in general
- First 4 weeksA low starting dose to reduce stomach side effects; it is a starting dose, not the long-term one.
- ThenThe dose is raised in steps at least 4 weeks apart, based on blood sugar, up to the label maximum.
- Kidney diseaseFor people with type 2 diabetes and chronic kidney disease, the label names one maintenance dose.
- Missed a dose?It can be taken within 5 days; after that, skip it and keep the usual day.
Injections go under the skin of the stomach area, thigh or upper arm, using a different spot each week. People who also take insulin inject the two separately and never mix them. The weekly day can be moved if at least two days separate doses. Pens must never be shared, even with a new needle.
What the studies showed
In SUSTAIN-6 (2016), 3,297 adults with type 2 diabetes at high cardiovascular risk took weekly semaglutide or placebo. The main outcome, cardiovascular death, nonfatal heart attack or nonfatal stroke, occurred in 6.6% of the semaglutide group and 8.9% of the placebo group. The same trial found more diabetic eye complications with semaglutide, which is why the label carries a retinopathy warning. In FLOW (2024), adults with type 2 diabetes and chronic kidney disease had a 24% lower risk of the main kidney and cardiovascular outcome with semaglutide than with placebo (hazard ratio 0.76).
| Item | Ozempic | Placebo |
|---|---|---|
| SUSTAIN-6, heart attack, stroke or CV death | 6.6% | 8.9% |
| FLOW, kidney composite outcome | 18.7% | 23.2% |
| FLOW, 50% or more sustained eGFR decline | 9.3% | 12.1% |
| FLOW, cardiovascular death | 7% | 9.6% |
| FLOW, death from any cause | 12.8% | 15.8% |
Percent of people with at least one event during follow-up (SUSTAIN-6 at least 2 years; FLOW median 3.4 years). Lower is better.
Source: Ozempic prescribing information, Tables 9 and 10 (DailyMed, revised June 2026) (checked on October 6, 2026)
Blood sugar is the main goal of Ozempic. In the 30-week monotherapy trial in the label, HbA1c (a three-month average of blood sugar) fell by 1.4 and 1.6 points on the two doses tested, versus 0.1 on placebo, and 73% and 70% reached an HbA1c under 7%, versus 28%. Weight fell an average of 3.8 kg and 4.7 kg (about 8 and 10 pounds), versus 1.2 kg on placebo. These diabetes-trial weight changes are much smaller than in the Wegovy weight trials, which used a higher dose in people without diabetes.
| Item | Ozempic 0.5 mg | Ozempic 1 mg | Placebo |
|---|---|---|---|
| Reached HbA1c under 7% | 73% | 70% | 28% |
Source: Ozempic prescribing information, Table 3 (DailyMed) (checked on October 6, 2026)
Side effects
| Item | Ozempic 0.5 mg | Ozempic 1 mg | Placebo |
|---|---|---|---|
| Nausea | 15.8% | 20.3% | 6.1% |
| Vomiting | 5% | 9.2% | 2.3% |
| Diarrhea | 8.5% | 8.8% | 1.9% |
| Abdominal pain | 7.3% | 5.7% | 4.6% |
| Constipation | 5% | 3.1% | 1.5% |
Reactions in at least 5% of people on Ozempic. Rates are lower than in the Wegovy weight trials, which used higher doses.
Source: Ozempic prescribing information, Table 1 (DailyMed) (checked on October 6, 2026)
In the label’s placebo-controlled diabetes trials, nausea affected 15.8% of people on 0.5 mg and 20.3% on 1 mg (6.1% on placebo), vomiting 5.0% and 9.2% (2.3%), diarrhea 8.5% and 8.8% (1.9%), abdominal pain 7.3% and 5.7% (4.6%) and constipation 5.0% and 3.1% (1.5%). Warnings include acute pancreatitis, diabetic retinopathy complications, low blood sugar with insulin or sulfonylureas, kidney injury from dehydration, severe digestive reactions, allergic reactions, gallbladder disease and aspiration during anesthesia. The label also warns never to share a pen. See Ozempic side effects and the class overview in GLP-1 side effects.
Overall, 32.7% and 36.4% of people on the two doses had a digestive side effect, compared with 15.3% on placebo, mostly during dose increases, and 3.1% and 3.8% stopped Ozempic because of them. Indigestion, burping, gas and reflux were each reported by under 5%.
Diabetic eye disease: what the numbers mean
In the two-year SUSTAIN-6 trial, diabetic retinopathy complications occurred in 3.0% of people on Ozempic versus 1.8% on placebo. The extra risk was concentrated in people who already had retinopathy (8.2% versus 5.2%), compared with 0.7% versus 0.4% in those without it. The label asks for monitoring of people with a history of retinopathy, so an eye exam belongs in the plan.
Boxed warning and who should not use it
Ozempic has a boxed warning: semaglutide caused thyroid C-cell tumors in rodents, and it is unknown whether it causes them, including medullary thyroid carcinoma (MTC), in humans. It must not be used by people with a personal or family history of MTC or with MEN 2, or by anyone with a serious allergy to semaglutide.
Pregnancy, breastfeeding and other situations
The Ozempic label advises stopping at least 2 months before a planned pregnancy, because semaglutide takes weeks to leave the body, and says there are no data on semaglutide in human milk. Blood sugar control matters a great deal in pregnancy, so anyone with type 2 diabetes who is planning a pregnancy should work out a medicine plan with their diabetes team rather than stopping on their own.
The label also asks people to tell their care team before surgery or any procedure with anesthesia or deep sedation, because slower stomach emptying raises the risk of inhaling stomach contents. Severe vomiting or diarrhea can dehydrate the body and strain the kidneys, so drinking enough fluid and calling the prescriber when you cannot keep liquids down are part of safe use.
Ozempic tablets and Rybelsus
Oral semaglutide for type 2 diabetes is sold as Rybelsus and as Ozempic tablets, both in one combined label for blood sugar control and cardiovascular risk reduction in adults with type 2 diabetes at high risk (label revised January 2026). The label warns that the two tablet brands are not substitutable milligram for milligram, and that the tablets follow strict morning, empty-stomach instructions. The weight-management tablet is a different product, the Wegovy pill.
Stopping Ozempic
When a GLP-1 medicine stops, appetite usually returns and blood sugar can rise again. For people with diabetes that means the treatment plan needs a replacement, not just a stop date. Weight regain after stopping was well documented in the Wegovy trials; our guide to life after a GLP-1 explains what the research shows and what helps.
Counterfeit Ozempic warnings
The FDA has repeatedly found counterfeit Ozempic 1 mg pens in the U.S. drug supply: in December 2023, in April 2025 and again in December 2025, with specific lot numbers listed on its alert page. Some counterfeit needles could not be confirmed sterile. The FDA advises buying only with a prescription from a state-licensed pharmacy and checking the product against the alert. Compounded semaglutide is a separate issue, covered in compounded GLP-1s.
Cost and savings
Checked on 2026-10-06 on NovoCare Pharmacy: self-pay for Ozempic pens is $349 a month for the 0.25 mg, 0.5 mg and 1 mg strengths and $499 a month for 2 mg, with an introductory $199 a month for the first two fills of the lowest strengths for new patients (through December 31, 2026). With commercial insurance, the savings card can lower the cost to as little as $25 a month, up to $100 in savings a month; government beneficiaries are excluded. Novo Nordisk has announced a lower list price for Ozempic from January 1, 2027. Medicare’s GLP-1 Bridge does not apply to diabetes treatment, which goes through regular Part D plans.
Related options
Within type 2 diabetes, tirzepatide is sold as Mounjaro. For weight management, the approved options are listed on our medications hub. Whatever the medicine, food, movement and sleep remain the base; see how to lose weight.
Before you start: questions worth asking
InstaTuck is an information site and does not sell or prescribe medicine. Ozempic needs a prescription after a licensed clinician reviews your diabetes care, kidney function, eye health and other medicines. Bring these to the visit: your latest HbA1c and kidney results, the date of your last eye exam, any personal or family history of thyroid cancer or MEN 2, past pancreatitis or gallbladder problems, and a full list of medicines. If weight is your main goal and you do not have diabetes, ask about the medicines approved for weight on our medications hub and read type 2 diabetes and weight for how the two conditions connect. Our obesity medicine guide explains which specialists treat both.
FDA status and approved uses
| Indication | Labeled population | For weight | Approved | Source |
|---|---|---|---|---|
| Improve glycemic control, as an adjunct to diet and exercise | Adults with type 2 diabetes mellitus | No | December 5, 2017 | Source |
| Reduce the risk of major adverse cardiovascular events | Adults with type 2 diabetes and established cardiovascular disease | No | January 16, 2020 | Source |
| Reduce the risk of sustained eGFR decline, end-stage kidney disease and cardiovascular death | Adults with type 2 diabetes and chronic kidney disease | No | January 28, 2025 | Source |
From the FDA label. Who a medicine is labeled for is not the same as whether it fits you; only a clinician can decide that.
How it is taken (in general)
Once weekly under the skin, same day each week, any time of day, with or without meals. The label describes a starting dose for 4 weeks to improve tolerability, then increases at least 4 weeks apart if needed, up to the label maximum. Follow your prescriber.
This is what the label describes in general, never a personal dose or schedule. Follow your prescriber.
What studies showed
| Trial | Population | Duration | Outcome as reported |
|---|---|---|---|
| SUSTAIN-6 NCT01720446 | 3,297 adults with type 2 diabetes at high cardiovascular risk | Cardiovascular death, nonfatal heart attack or nonfatal stroke: 6.6% vs 8.9% with placebo (hazard ratio 0.74); more retinopathy complications with semaglutide.[4] | |
| FLOW NCT03819153 | Adults with type 2 diabetes and chronic kidney disease | Median follow-up 3.4 years | Primary kidney and cardiovascular composite 24% lower with semaglutide (hazard ratio 0.76).[5] |
Average results from trials; individual results vary. Results from different trials cannot be compared directly.
Side effects
| Common side effect | How often (label) |
|---|---|
| Nausea | 15.8% (0.5 mg), 20.3% (1 mg) vs 6.1% placebo |
| Vomiting | 5.0%, 9.2% vs 2.3% placebo |
| Diarrhea | 8.5%, 8.8% vs 1.9% placebo |
| Abdominal pain | 7.3%, 5.7% vs 4.6% placebo |
| Constipation | 5.0%, 3.1% vs 1.5% placebo |
Serious risks
- Thyroid C-cell tumors (boxed warning, seen in rodents)
- Acute pancreatitis
- Diabetic retinopathy complications
- Hypoglycemia with insulin or insulin secretagogues
- Acute kidney injury
- Severe gastrointestinal adverse reactions
- Hypersensitivity reactions
- Acute gallbladder disease
- Pulmonary aspiration during general anesthesia or deep sedation
- Never share an Ozempic pen between patients
More detail: Ozempic Side Effects: what the label lists and when to get help
Warnings and who should not use it
Boxed warning
Risk of thyroid C-cell tumors: in rodents, semaglutide causes thyroid C-cell tumors. It is unknown whether Ozempic causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans. Ozempic is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
Who should not use it (per the label)
- Personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
- Known serious hypersensitivity to semaglutide or any of the product components
Interactions, pregnancy and breastfeeding
| Drug or class | What the label says |
|---|---|
| Insulin or insulin secretagogues (sulfonylureas) | Higher risk of low blood sugar; the prescriber may lower those doses. |
| Oral medications | Delayed stomach emptying may change absorption of oral medicines. |
Pregnancy and breastfeeding
The label advises stopping Ozempic in women at least 2 months before a planned pregnancy because of the long washout period for semaglutide, and states there are no data on semaglutide in human milk. Discuss pregnancy plans and breastfeeding with the prescriber.
Cost, insurance and savings
| Price | Amount | Basis | Checked on |
|---|---|---|---|
| Self-pay / cash | 349 USD | per month, pens 0.25 mg, 0.5 mg or 1 mg, NovoCare Pharmacy | October 6, 2026 |
| Self-pay / cash | 499 USD | per month, 2 mg pen, NovoCare Pharmacy | October 6, 2026 |
| Self-pay / cash | 199 USD | per month, first 2 fills of 0.25 mg and 0.5 mg for new patients, through 2026-12-31 | October 6, 2026 |
| With savings program | 25 USD | per month with commercial coverage (max savings $100 a month; government beneficiaries excluded) | October 6, 2026 |
Prices change often and depend on pharmacy, plan and location. Insurance can change what you pay. Every price shows the date we checked it.
Savings programs
- Ozempic Savings Offer: Commercial insurance; government beneficiaries excluded (checked October 6, 2026)
Stopping and keeping results
Trials show that weight often returns after these medicines are stopped. Plan any change with your prescriber. Stopping a GLP-1: what trials show and how people keep results
Compounded and counterfeit versions
Compounded semaglutide and tirzepatide are not FDA approved: the FDA does not review them for safety, quality or effectiveness. Counterfeit pens and "research peptides" sold online have caused harm. Buy only from a licensed pharmacy with a prescription.
Same active ingredient
FDA approved for another usePrescriptionInjectionOzempic Side Effects: what the label lists and when to get helpSemaglutide: one ingredient, several brands
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FDA approved for weight managementPrescriptionInjectionWegovy (semaglutide): uses, side effects, cost and FDA statusSemaglutide: one ingredient, several brands · Injection · Weekly
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Non-drug approaches
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- Is Ozempic the right fit for my type 2 diabetes, or are there options that suit my heart or kidney health better?
- If my goal includes weight, would a medicine approved for weight management be more appropriate?
- How should my other diabetes medicines change if I start Ozempic?
- Do I need an eye exam before starting, given the retinopathy warning?
- What does my plan cover, and is the injection or the tablet a better fit for me?
Frequently asked questions
Is Ozempic approved for weight loss?
No. As of 2026-10-06, Ozempic is FDA approved for adults with type 2 diabetes. Wegovy, which contains the same active ingredient, is the semaglutide brand approved for chronic weight management.
What is the difference between Ozempic and Wegovy?
Both contain semaglutide. They differ in approved uses (type 2 diabetes vs weight management and cardiovascular risk in people with obesity or overweight), doses, devices and insurance coverage.
Is there an Ozempic pill?
Yes. The current DailyMed label lists Ozempic tablets (oral semaglutide) for adults with type 2 diabetes, in a combined label with Rybelsus.
How do I avoid counterfeit Ozempic?
The FDA advises getting it only with a prescription from a state-licensed pharmacy and checking the lot number against its counterfeit alert. Avoid sellers that do not require a prescription.
How much weight do people lose on Ozempic?
Ozempic is a diabetes medicine, so its trials focused on blood sugar. In the 30-week monotherapy trial in the label, average weight change was -3.8 kg and -4.7 kg on the two doses versus -1.2 kg on placebo. Higher doses studied for weight are sold as Wegovy.
Does Ozempic protect the kidneys?
Since January 2025 Ozempic is approved to lower the risk of sustained kidney function decline, kidney failure and cardiovascular death in adults with type 2 diabetes and chronic kidney disease. In the FLOW trial the combined kidney outcome occurred in 18.7% versus 23.2% on placebo.
What if I miss an Ozempic dose?
The label says to take it as soon as possible within 5 days. If more than 5 days have passed, skip it and take the next dose on the usual day. Check with your prescriber if unsure.
Can Ozempic affect my eyes?
In SUSTAIN-6, diabetic retinopathy complications were more common with Ozempic (3.0% vs 1.8%), mostly in people who already had retinopathy. The label advises monitoring people with a history of diabetic eye disease.
How do I know an Ozempic pen is real?
Get it with a prescription from a state-licensed pharmacy and compare the lot number with the FDA counterfeit alert page. The FDA has found counterfeit 1 mg pens several times since December 2023.
Official sources
References
- OZEMPIC (semaglutide) injection: prescribing information. Novo Nordisk, via DailyMed, 2026. (accessed October 7, 2026) Drug label
- RYBELSUS and OZEMPIC (semaglutide) tablets: prescribing information. Novo Nordisk, via DailyMed. (accessed October 6, 2026) Drug label
- Drugs@FDA: Ozempic, NDA 209637, approval history. U.S. Food and Drug Administration. (accessed October 6, 2026) Government page
- Marso SP, Bain SC, Consoli A, et al.. Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes (SUSTAIN-6). New England Journal of Medicine, 2016. doi:10.1056/NEJMoa1607141 · PMID 27633186 · NCT01720446 (accessed October 7, 2026) Randomized trial
- Perkovic V, Tuttle KR, Rossing P, et al.. Effects of Semaglutide on Chronic Kidney Disease in Patients with Type 2 Diabetes (FLOW). New England Journal of Medicine, 2024. doi:10.1056/NEJMoa2403347 · PMID 38785209 · NCT03819153 (accessed October 7, 2026) Randomized trial
- FDA warns consumers not to use counterfeit Ozempic found in U.S. drug supply chain. U.S. Food and Drug Administration, 2025. (accessed October 7, 2026) Government page
- Ozempic online pharmacy: self-pay prices and savings. Novo Nordisk (NovoCare Pharmacy). (accessed October 7, 2026) Other
- Novo Nordisk announces significant reduction in US list price for Wegovy, Ozempic and Rybelsus. Novo Nordisk (press release), 2026. (accessed October 7, 2026) News (reported facts only)
- Medicare GLP-1 Bridge: information for providers. Centers for Medicare and Medicaid Services. (accessed October 7, 2026) Government page
- WEGOVY (semaglutide) injection and tablets: prescribing information. Novo Nordisk, via DailyMed, 2026. (accessed October 7, 2026) Drug label
Facts checked on October 6, 2026
Educational information, not medical advice. Talk with a qualified healthcare professional about your own situation. In an emergency call 911.