Ozempic, Wegovy, Mounjaro, Zepbound: What Each Is FDA-Approved For

By the Healthy Weight Loss 4 U Clinical Content Team · Published October 19, 2026 · Updated October 19, 2026 · 9 min read

Key takeaways

• Semaglutide is sold as Ozempic (initial U.S. approval 2017), Wegovy (approved June 4, 2021) and oral tablets; tirzepatide is sold as Mounjaro (initial approval 2022) and Zepbound (approved November 8, 2023) ^{[2][7][8][16]}.
• Ozempic's label lists three uses: glycemic control in adults with type 2 diabetes, reducing major cardiovascular events in type 2 diabetes with established heart disease, and reducing kidney outcomes in type 2 diabetes with chronic kidney disease ^[2].
• Wegovy's label covers weight reduction (patients aged 12 and older with obesity), cardiovascular risk reduction, and MASH with F2 to F3 fibrosis under accelerated approval; the Wegovy tablets are not indicated for MASH ^[1][14].
• Zepbound is labeled for weight management and for moderate to severe obstructive sleep apnea in adults with obesity; the FDA's December 20, 2024 approval rested on two trials with 469 adults ^[5][9].
• As of May 31, 2026, the FDA had 990 adverse event reports for compounded semaglutide and more than 730 for compounded tirzepatide, and states that compounded drugs are not FDA-approved ^[11].

Are Ozempic, Wegovy, Mounjaro and Zepbound the same drug?

Ozempic and Wegovy contain the same active ingredient, semaglutide, and Mounjaro and Zepbound contain the same active ingredient, tirzepatide. Each is a separately approved product with its own label, indications and dosage forms ^[1][2][4][5]. Novo Nordisk describes the oral product the same way: when it announced Ozempic tablets on February 4, 2026, it stated that the active ingredient remains the same semaglutide molecule as in Rybelsus ^[6].

Semaglutide products come from Novo Nordisk ^[2][6]. Ozempic is an injection with initial U.S. approval in 2017 ^[2]. Wegovy is an injection approved June 4, 2021 for chronic weight management, and its current label also includes tablets ^[7][1]. A single oral semaglutide label now covers both Rybelsus and Ozempic tablets ^[3].

Tirzepatide is sold as Mounjaro, which has an initial U.S. approval of 2022, and as Zepbound, which was approved November 8, 2023 for chronic weight management ^[16][8].

Because the molecules are the same, the labels say not to stack them. Wegovy's label states that using it with other semaglutide-containing products or any other GLP-1 receptor agonist is not recommended, and Zepbound's says the same for other tirzepatide-containing products and GLP-1 receptor agonists ^[14][5].

What is each brand FDA-approved for?

Each brand is approved only for the uses printed in its label. The table below summarizes the current DailyMed labels as of October 19, 2026, and the label text controls if there is any difference ^{[1][2][3][4][5]}.

Every weight-management and sleep apnea indication is used with a reduced-calorie diet and increased physical activity ^[1][8][9]. Age limits also differ by label: Ozempic, the oral semaglutide tablets and Zepbound are labeled for adults, Wegovy's weight indication extends to patients aged 12 and older with obesity, and Mounjaro's diabetes indication extends to patients aged 10 and older ^{[1][2][3][4][5]}. A product not listing a use does not mean that use is impossible to prescribe, but it does mean the FDA has not approved that use for that product, a point covered below ^[15].

What do the semaglutide labels cover in more detail?

Ozempic's label, revised May 2026, has three indications. It is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes, to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal heart attack or non-fatal stroke) in adults with type 2 diabetes and established cardiovascular disease, and to reduce sustained eGFR decline, end-stage kidney disease and cardiovascular death in adults with type 2 diabetes and chronic kidney disease ^[2]. Weight management is not among them ^[2].

The oral semaglutide label, revised January 2026, is titled for both Rybelsus and Ozempic tablets and lists two indications: glycemic control in adults with type 2 diabetes and reducing major cardiovascular events in adults with type 2 diabetes at high risk ^[3]. Novo Nordisk's February 2026 announcement says the Ozempic tablets are the proprietary name for oral semaglutide in the 1.5 mg, 4 mg and 9 mg strengths and that patients should continue taking their Rybelsus as prescribed ^[6].

Wegovy's label, revised June 2026, covers more ground. For the injection, it lists reducing cardiovascular risk, reducing excess body weight and maintaining the reduction, and treating noncirrhotic MASH (formerly NASH) with moderate to advanced fibrosis under accelerated approval based on improvement of MASH and fibrosis ^[1][14]. The weight indication includes patients aged 12 and older with obesity ^[1]. The cardiovascular indication was announced by the FDA on March 8, 2024, based on a trial of more than 17,600 participants in which major cardiovascular events occurred in 6.5% of the Wegovy group versus 8% with placebo ^[10]. The accelerated approval means continued approval for MASH may depend on a confirmatory trial ^[14]. The 7.2 mg dose (Wegovy HD) appears in the label as a separate single-dose pen ^[1].

The Wegovy tablets share the weight and cardiovascular indications for adults but are not indicated for MASH ^[1][14].

What do the tirzepatide labels cover in more detail?

Mounjaro's current label, revised August 2026, lists glycemic control in adults and pediatric patients 10 years and older with type 2 diabetes, and reducing the risk of major cardiovascular events in adults with type 2 diabetes who are at high risk ^[4]. The January 2026 FDA label we reviewed listed only the glycemic indication, so the cardiovascular use appears to be a newer addition ^[16]. Mounjaro is not labeled for weight management ^[4][16].

Zepbound, per the label revised August 2026, is indicated to reduce excess body weight and maintain the reduction in adults with obesity, or adults with overweight and at least one weight-related condition, and to treat moderate to severe obstructive sleep apnea in adults with obesity ^[5]. The FDA approved the sleep apnea use on December 20, 2024, based on two randomized, double-blind, placebo-controlled studies of 469 adults without type 2 diabetes over 52 weeks ^[9]. The FDA stated the improvement in apnea-hypopnea index was likely related to weight reduction ^[9].

The original Zepbound approval on November 8, 2023 covered adults with obesity (BMI of 30 or higher) or overweight (BMI of 27 or higher) with at least one weight-related condition ^[8]. Zepbound is supplied as single-dose pens or vials and as a multi-dose KwikPen, and the label warns never to share a KwikPen between patients ^[5].

What is the boxed warning, and who should not use these medicines?

All of these labels carry a boxed warning for the risk of thyroid C-cell tumors. In rodents, semaglutide causes thyroid C-cell tumors, and in rats tirzepatide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors; the labels say it is unknown or has not been determined whether the medicines cause such tumors, including medullary thyroid carcinoma (MTC), in humans ^[2][3][4][5].

The medicines are contraindicated in patients with a personal or family history of MTC or with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2), and in patients with a serious hypersensitivity reaction to the active ingredient or any excipient ^{[1][2][3][4][5]}. Prescribers are to counsel patients about symptoms of thyroid tumors, such as a neck mass, trouble swallowing, shortness of breath or persistent hoarseness, and routine calcitonin monitoring or thyroid ultrasound is described as of uncertain value for early detection ^[3][4].

The weight-management labels also list warnings for acute pancreatitis, acute gallbladder disease, hypoglycemia, acute kidney injury due to volume depletion, severe gastrointestinal reactions, hypersensitivity reactions, diabetic retinopathy complications in people with type 2 diabetes, and pulmonary aspiration during general anesthesia or deep sedation. Wegovy's label also lists heart rate increase ^[14][5].

How do off-label use and compounded versions differ from the approved brands?

Off-label use means a clinician prescribes an FDA-approved product for a use, form or dose its label does not list. The FDA says healthcare providers generally may prescribe an approved drug for an unapproved use when they judge it medically appropriate, but that the FDA has not determined the drug is safe and effective for that unapproved use ^[15]. For example, Ozempic's and Mounjaro's labels do not list weight management, so prescribing either for weight alone would be off-label, while Wegovy and Zepbound carry that indication ^[2][4][1][5].

Compounded drugs are different: they are not approved products at all. The FDA states that compounded drugs are not FDA-approved and that the agency does not review them for safety, effectiveness or quality before they are marketed ^[11]. The FDA says compounding might be appropriate if a patient's medical need cannot be met by an FDA-approved drug ^[11].

The legal setting has changed. The FDA announced the tirzepatide injection shortage resolved on December 19, 2024 and the semaglutide injection shortage resolved on February 21, 2025, and the compounding grace periods that followed ended in 2025 ^[12]. On April 30, 2026, the FDA proposed removing semaglutide, tirzepatide and liraglutide from the 503B bulks list, finding no clinical need for outsourcing facilities to compound them from bulk substances; comments were due June 29, 2026 ^[13].

The FDA also lists specific concerns. As of May 31, 2026 it had received 990 adverse event reports for compounded semaglutide and more than 730 for compounded tirzepatide, and said events are likely underreported. Some reports involved dosing errors, including doses beyond the approved label. The FDA also states that salt forms such as semaglutide sodium and semaglutide acetate are different active ingredients and that it knows of no lawful basis for using them in compounding ^[11].

Why should you check the date on a label?

Labels change, and several of these changed in the past year. Rybelsus became Ozempic tablets in February 2026 ^[6][3]. Mounjaro's label gained a cardiovascular indication between its January and August 2026 versions ^[16][4]. Wegovy's label now covers tablets and a 7.2 mg pen, and the Zepbound label was revised in August 2026 ^[1][5].

A useful habit is to read the revision line at the top of the DailyMed or FDA label. A brand page, video or social post can lag behind the label, and the label text is the controlling statement of what the FDA has approved ^{[1][2][3][4][5]}.

What this means in practice

• Brand names signal labeled use: Ozempic and Mounjaro are labeled for type 2 diabetes, and Wegovy and Zepbound are labeled for weight management ^[1][2][4][5].
• Ozempic, Wegovy and the oral semaglutide products share one active ingredient, and the labels advise against using them together or with another GLP-1 receptor agonist ^[14][5].
• Indications beyond weight loss are specific: MASH with F2 to F3 fibrosis for Wegovy injection, and moderate to severe obstructive sleep apnea in adults with obesity for Zepbound ^[1][5].
• The boxed warning and the MTC and MEN 2 contraindications apply across the brands, and the underlying data come from rodent studies with unknown human relevance ^[2][4].
• Off-label use is a clinician's judgment about an approved product, while compounded products are not FDA-approved and are not reviewed by the FDA for safety, effectiveness or quality ^[15][11].
• Check the revision date on the label, since indications and brand names have changed during 2026 ^[6][4].

When to talk to a clinician

Talk to a licensed clinician before starting, switching or stopping any of these medicines, and raise any personal or family history of thyroid cancer, MEN 2, pancreatitis, gallbladder disease, kidney problems or diabetic eye disease, since these appear in the labels as contraindications or warnings ^{[1][2][5][14]}. Tell your clinician about every medicine and supplement you take, including any compounded or online GLP-1 product, so that you are not using two products with the same active ingredient.

At Healthy Weight Loss 4 U, every program begins with a clinician evaluation. That evaluation is the place to ask which labeled use applies to you, whether a brand-name or other option is appropriate, and what the label says about your history; we do not make promises about outcomes.

Frequently asked questions

Sources

1. WEGOVY (semaglutide) injection and tablets, prescribing information (revised 6/2026). DailyMed, U.S. National Library of Medicine, 2026. dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=ee06186f-2aa3-4990-a760-757579d8f77b&type=display
2. OZEMPIC (semaglutide) injection, prescribing information (revised 5/2026). DailyMed, U.S. National Library of Medicine, 2026. dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79&type=display
3. RYBELSUS and OZEMPIC (semaglutide) tablets, prescribing information (revised 1/2026). DailyMed, U.S. National Library of Medicine, 2026. dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=27f15fac-7d98-4114-a2ec-92494a91da98&type=display
4. MOUNJARO (tirzepatide) injection, prescribing information (revised 8/2026). DailyMed, U.S. National Library of Medicine, 2026. dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=d2d7da5d-ad07-4228-955f-cf7e355c8cc0&type=display
5. ZEPBOUND (tirzepatide) prescribing information (revised 8/2026). DailyMed, U.S. National Library of Medicine, 2026. dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=487cd7e7-434c-4925-99fa-aa80b1cc776b&type=display
6. FDA Approves Ozempic Tablets. Novo Nordisk U.S. (press release), 2026. www.novonordisk-us.com/media/press-releases/fda-approves-ozempic-pill-tablets.html
7. NDA 215256 approval letter, Wegovy (semaglutide) injection, June 4, 2021. U.S. Food and Drug Administration, 2021. www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/215256Orig1s000ltr.pdf
8. FDA Approves New Medication for Chronic Weight Management (Zepbound). U.S. Food and Drug Administration, 2023. www.fda.gov/news-events/press-announcements/fda-approves-new-medication-chronic-weight-management
9. FDA Approves First Medication for Obstructive Sleep Apnea. U.S. Food and Drug Administration, 2024. www.fda.gov/news-events/press-announcements/fda-approves-first-medication-obstructive-sleep-apnea
10. FDA Approves First Treatment to Reduce Risk of Serious Heart Problems Specifically in Adults with Obesity or Overweight. U.S. Food and Drug Administration, 2024. www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-reduce-risk-serious-heart-problems-specifically-adults-obesity-or
11. FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss. U.S. Food and Drug Administration, 2026. www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss
12. FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize. U.S. Food and Drug Administration, 2026. www.fda.gov/drugs/drug-alerts-and-statements/fda-clarifies-policies-compounders-national-glp-1-supply-begins-stabilize
13. FDA Proposes to Exclude Semaglutide, Tirzepatide, and Liraglutide on 503B Bulks List. U.S. Food and Drug Administration, 2026. www.fda.gov/news-events/press-announcements/fda-proposes-exclude-semaglutide-tirzepatide-and-liraglutide-503b-bulks-list
14. WEGOVY (semaglutide) injection and tablets, FDA label (revised 02/2026). U.S. Food and Drug Administration, 2026. www.accessdata.fda.gov/drugsatfda_docs/label/2026/215256s033lbl.pdf
15. Understanding Unapproved Use of Approved Drugs "Off Label". U.S. Food and Drug Administration, 2024. www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/understanding-unapproved-use-approved-drugs-label
16. MOUNJARO (tirzepatide) injection, FDA label (revised 01/2026). U.S. Food and Drug Administration, 2026. www.accessdata.fda.gov/drugsatfda_docs/label/2026/215866s041lbl.pdf

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