Semaglutide
GLP-1 receptor agonist. Sold as Wegovy, Ozempic injection, Rybelsus and Ozempic tablets.
Semaglutide is sold in the United States under three brand names, and they are not interchangeable. Only Wegovy is approved for weight management. Ozempic and Rybelsus are approved for type 2 diabetes, and weight loss is not listed as an approved use in their labels.
Brands and what each one is approved for
One active ingredient can hold several separate FDA approvals. They are different documents with different approved uses, and mixing them up is the most common mistake made about these medications.
| Brand | Status for this use | Supply | Label version |
|---|---|---|---|
| WegovyA-S Medication Solutions | Approved for weight loss | Prescription | 23 April 2024 |
| Ozempic injectionA-S Medication Solutions | Approved for another condition | Prescription | 22 November 2023 |
| Rybelsus and Ozempic tabletsNovo Nordisk Pharmaceutical Industries, LP | Approved for another condition | Prescription | 30 January 2026 |
WARNING: RISK OF THYROID C-CELL TUMORS
This warning appears in the labels for Wegovy, Ozempic injection, Rybelsus and Ozempic tablets. Quoted below from the Wegovy label.
- In rodents, semaglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures. It is unknown whether WEGOVY causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of semaglutide-induced rodent thyroid C-cell tumors has not been determined.
- WEGOVY is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk for MTC with the use of WEGOVY and inform them of symptoms of thyroid tumors (e.g. a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with WEGOVY. See full prescribing information for complete boxed warning.
- In rodents, semaglutide causes thyroid C-cell tumors at clinically relevant exposures. It is unknown whether WEGOVY causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as the human relevance of semaglutide-induced rodent thyroid C-cell tumors has not been determined.
A boxed warning is the most serious warning the FDA requires. This text is reproduced from the label.
How it works
Written by us
Semaglutide copies the action of GLP-1, a hormone the gut releases after eating. The FDA labels state that it increases insulin release when blood glucose is high, lowers glucagon release, and slows the rate at which the stomach empties. The Wegovy label attributes the reduction in body weight to lower calorie intake, and reports a reduction in appetite along with it.
From the mechanism of action section of the Wegovy label
Semaglutide is a GLP-1 analogue with 94% sequence homology to human GLP-1. Semaglutide acts as a GLP-1 receptor agonist that selectively binds to and activates the GLP-1 receptor, the target for native GLP-1.
What the FDA approved it for
The approved uses, as worded in the label.
From the FDA label
Wegovy
- to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with established cardiovascular disease and either obesity or overweight.
- to reduce excess body weight and maintain weight reduction long term in: Adults and pediatric patients aged 12 years and older with obesity; Adults with overweight in the presence of at least one weight-related comorbid condition.
- Coadministration with other semaglutide-containing products or with any other GLP-1 receptor agonist is not recommended.
Ozempic injection
- an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
- to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease.
- Has not been studied in patients with a history of pancreatitis. Consider another antidiabetic therapy.
- Not for treatment of type 1 diabetes mellitus.
Rybelsus and Ozempic tablets
- as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
- to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus who are at high risk for these events.
Forms and strengths
The presentations and strengths listed in the label.
From the FDA label
Wegovy
2.4 mg/0.75 mL Injection: pre-filled, single-dose pen that delivers doses of 0.25 mg, 0.5 mg, 1 mg, 1.7 mg or 2.4 mg.
Ozempic injection
- Single-patient-use pen that delivers 0.25 mg or 0.5 mg per injection Injection: 4 mg/3 mL (1.34 mg/mL) available in:
- Single-patient-use pen that delivers 1 mg per injection Injection: 8 mg/3 mL (2.68 mg/mL) available in:
- Single-patient-use pen that delivers 2 mg per injection
Rybelsus and Ozempic tablets
- RYBELSUS tablets: 3 mg, 7 mg and 14 mg
- OZEMPIC tablets: 1.5 mg, 4 mg and 9 mg
How the label says it is taken
What the label states about administration. It is not a dosing instruction for any individual.
From the FDA label
Wegovy
- Administer WEGOVY once weekly as an adjunct to diet and increased physical activity, on the same day each week, at any time of day, with or without meals.
- Inject subcutaneously in the abdomen, thigh or upper arm.
- In patients with type 2 diabetes, monitor blood glucose prior to starting and during WEGOVY treatment.
- Initiate at 0.25 mg once weekly for 4 weeks. Then follow the dosage escalation schedule, titrating every 4 weeks to achieve the maintenance dosage.
- The maintenance dosage of WEGOVY in adults is either 2.4 mg (recommended) or 1.7 mg once weekly.
- The maintenance dosage of WEGOVY in pediatric patients aged 12 years and older is 2.4 mg once weekly. Important Monitoring and Administration Instructions
Ozempic injection
- Administer once weekly at any time of day, with or without meals.
- Start at 0.25 mg once weekly. After 4 weeks, increase the dosage to 0.5 mg once weekly.
- If additional glycemic control is needed, increase the dosage to 1 mg once weekly after at least 4 weeks on the 0.5 mg dose.
- If additional glycemic control is needed, increase the dosage to 2 mg once weekly after at least 4 weeks on the 1 mg dosage.
- If a dose is missed administer within 5 days of missed dose.
- Inject subcutaneously in the abdomen, thigh, or upper arm. Important Administration Instructions
Rybelsus and Ozempic tablets
- Take RYBELSUS or OZEMPIC tablets orally once daily on an empty stomach in the morning with water (up to 4 ounces of water); do not take with other liquids besides water.
- Swallow tablets whole. Do not split, crush, chew or dissolve in any solution.
- After taking RYBELSUS or OZEMPIC tablets, wait at least 30 minutes before eating food, drinking beverages or taking other oral medications.
- See the Full Prescribing Information for instructions on switching between RYBELSUS and OZEMPIC tablets and from OZEMPIC injections to RYBELSUS or OZEMPIC tablets. Recommended Starting, Escalation and Maintenance Dosage of RYBELSUS and OZEMPIC Tablets RYBELSUS
- On Day 61 or thereafter, if: No additional glycemic control is needed, maintain the dosage at 7 mg orally once daily.; Additional glycemic control is needed, increase the dosage to 14 mg orally once daily. OZEMPIC Tablets
Most common adverse reactions
The adverse reactions the label reports as most common.
From the FDA label
Wegovy
- Most common adverse reactions (incidence ≥ 5%) in adults or pediatric patients aged 12 years and older are: nausea, diarrhea, vomiting, constipation, abdominal pain, headache, fatigue, dyspepsia, dizziness, abdominal distension, eructation, hypoglycemia in patients with type 2 diabetes, flatulence, gastroenteritis, gastroesophageal reflux disease, and nasopharyngitis.
- most common adverse reactions leading to discontinuation were nausea (1.8% versus 0.2%), vomiting (1.
Ozempic injection
most common adverse reactions, reported in ≥5% of patients treated with OZEMPIC are: nausea, vomiting, diarrhea, abdominal pain and constipation.
Rybelsus and Ozempic tablets
Most common adverse reactions (incidence ≥5%) are nausea, abdominal pain, diarrhea, decreased appetite, vomiting and constipation. To report SUSPECTED ADVERSE REACTIONS, contact Novo Nordisk Inc.
Warnings and precautions
The warnings and precautions section of the label.
From the FDA label
Wegovy
- Acute Pancreatitis: Has occurred in clinical trials. Discontinue promptly if pancreatitis is suspected. Do not restart if pancreatitis is confirmed.
- Acute Gallbladder Disease: Has occurred in clinical trials. If cholelithiasis is suspected, gallbladder studies and clinical follow-up are indicated.
- Hypoglycemia: Concomitant use with insulin or an insulin secretagogue may increase the risk of hypoglycemia, including severe hypoglycemia. Reducing the dose of insulin or insulin secretagogue may be necessary. Inform all patients of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia.
- Acute Kidney Injury: Has occurred. Monitor renal function when initiating or escalating doses of WEGOVY in patients reporting severe adverse gastrointestinal reactions or in those with renal impairment reporting severe adverse gastrointestinal reactions.
- Hypersensitivity Reactions: Anaphylactic reactions and angioedema have been reported postmarketing. Discontinue WEGOVY if suspected and promptly seek medical advice.
- Diabetic Retinopathy Complications in Patients with Type 2 Diabetes: Has been reported in trials with semaglutide. Patients with a history of diabetic retinopathy should be monitored.
- Heart Rate Increase: Monitor heart rate at regular intervals.
- Suicidal Behavior and Ideation: Monitor for depression or suicidal thoughts. Discontinue WEGOVY if symptoms develop. Risk of Thyroid C-Cell Tumors In mice and rats, semaglutide caused a dose-dependent and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) after lifetime exposure at clinically relevant plasma exposures.
Ozempic injection
- Pancreatitis: Has been reported in clinical trials. Discontinue promptly if pancreatitis is suspected. Do not restart if pancreatitis is confirmed.
- Diabetic Retinopathy Complications: Has been reported in a clinical trial. Patients with a history of diabetic retinopathy should be monitored.
- Never share an OZEMPIC pen between patients, even if the needle is changed.
- Hypoglycemia: Concomitant use with an insulin secretagogue or insulin may increase the risk of hypoglycemia, including severe hypoglycemia. Reducing dose of insulin secretagogue or insulin may be necessary.
- Acute Kidney Injury: Monitor renal function in patients with renal impairment reporting severe adverse gastrointestinal reactions.
- Hypersensitivity Reactions: Serious hypersensitivity reactions (e.g., anaphylaxis and angioedema) have been reported. Discontinue OZEMPIC if suspected and promptly seek medical advice.
- Acute Gallbladder Disease: If cholelithiasis or cholecystitis are suspected, gallbladder studies are indicated. Risk of Thyroid C-Cell Tumors In mice and rats, semaglutide caused a dose-dependent and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) after lifetime exposure at clinically relevant plasma exposures.
Rybelsus and Ozempic tablets
- Acute Pancreatitis: Has been observed in patients treated with GLP-1 receptor agonists, including RYBELSUS or OZEMPIC tablets. Discontinue if pancreatitis is suspected.
- Diabetic Retinopathy Complications: Has been reported in a cardiovascular outcomes trial with semaglutide injection. Patients with a history of diabetic retinopathy should be monitored.
- Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin: May increase the risk of hypoglycemia, including severe hypoglycemia. Reducing the dosage of insulin secretagogue or insulin may be necessary.
- Acute Kidney Injury Due to Volume Depletion: Monitor renal function in patients reporting adverse reactions that could lead to volume depletion.
- Severe Gastrointestinal Adverse Reactions: Use of RYBELSUS or OZEMPIC tablets has been associated with gastrointestinal adverse reactions, sometimes severe. RYBELSUS and OZEMPIC tablets are not recommended in patients with severe gastroparesis.
- Hypersensitivity Reactions: Serious hypersensitivity reactions (e.g., anaphylaxis and angioedema) have been reported. Discontinue RYBELSUS or OZEMPIC tablets if hypersensitivity reactions occur and monitor until signs and symptoms resolve.
- Acute Gallbladder Disease: If cholelithiasis or cholecystitis are suspected, gallbladder studies are indicated.
- Pulmonary Aspiration During General Anesthesia or Deep Sedation: Has been reported in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures. Instruct patients to inform healthcare providers of any planned surgeries or procedures.
Contraindications
Situations in which the label states the medication must not be used.
From the FDA label
Wegovy
- Personal or family history of MTC or in patients with MEN 2.
- Known hypersensitivity to semaglutide or any of the excipients in WEGOVY.
Ozempic injection
- Personal or family history of MTC or in patients with MEN 2.
- Serious hypersensitivity reaction to semaglutide or any of the excipients in OZEMPIC.
Rybelsus and Ozempic tablets
- Personal or family history of MTC or in patients with MEN 2 syndrome type 2
- Prior serious hypersensitivity reaction to semaglutide or any of the excipients in OZEMPIC
Drug interactions
Interactions the label singles out.
From the FDA label
Wegovy
- WEGOVY delays gastric emptying.
- May impact absorption of concomitantly administered oral medications.
- Use with caution.
Ozempic injection
- Oral Medications: OZEMPIC delays gastric emptying.
- May impact absorption of concomitantly administered oral medications.
- Use with caution.
Rybelsus and Ozempic tablets
- Other Oral Drugs: RYBELSUS and OZEMPIC tablets delay gastric emptying.
- Consider increased clinical or laboratory monitoring when co-administered with other oral medications that have a narrow therapeutic index or that require clinical monitoring.
Pregnancy and breastfeeding
The opening of the pregnancy section of the label. The full section is longer and is in the source document.
From the FDA label
Wegovy
Pregnancy Exposure Registry There will be a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to semaglutide during pregnancy. Pregnant women exposed to WEGOVY and healthcare providers are encouraged to contact Novo Nordisk at 1-877-390-2760 or www.wegovypregnancyregistry.com. Risk Summary Based on animal reproduction studies, there may be potential risks to the fetus from exposure to semaglutide during pregnancy.
Ozempic injection
There are limited data with semaglutide use in pregnant women to inform a drug-associated risk for adverse developmental outcomes. There are clinical considerations regarding the risks of poorly controlled diabetes in pregnancy (see Clinical Considerations). Based on animal reproduction studies, there may be potential risks to the fetus from exposure to semaglutide during pregnancy.
Rybelsus and Ozempic tablets
Available data with semaglutide use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. There are clinical considerations regarding the risks of poorly controlled diabetes in pregnancy (see Clinical Considerations). Based on animal reproduction studies, there may be potential risks to the fetus from exposure to semaglutide during pregnancy.
Generic or brand
Written by us
There is no FDA-approved generic semaglutide. Preparations sold as compounded semaglutide are made by compounding pharmacies, are not reviewed or approved by the FDA, and are not covered by any of the labels linked on this page.
The FDA label database lists no approved generic application for this ingredient.
What affects the cost
Written by us
All three products are sold at brand prices, because no generic has been approved. What a person pays varies with insurance coverage, and coverage rules commonly differ between the diabetes products and the weight management product even though the active ingredient is the same. This site does not track prices and does not link to sellers.
Common questions
- Are Ozempic and Wegovy the same medicine?
- They contain the same active ingredient, semaglutide, but they are separate FDA approvals with separate labels, different maximum doses and different approved uses. The Wegovy label covers weight management and, in people with cardiovascular disease and obesity or overweight, reduction of cardiovascular risk. The Ozempic label covers type 2 diabetes.
- Is semaglutide approved by the FDA for weight loss?
- As Wegovy, yes. Its label lists reduction of excess body weight and long-term maintenance of that reduction, in adults and in patients aged 12 and older with obesity, and in adults with overweight plus at least one weight-related condition. As Ozempic and Rybelsus, no. Those labels list type 2 diabetes.
- What does the boxed warning on semaglutide say?
- All semaglutide labels carry a boxed warning about the risk of thyroid C-cell tumours. It states that semaglutide caused thyroid C-cell tumours in rodents, that whether it does so in humans is not known, and that the medication is contraindicated in people with a personal or family history of medullary thyroid carcinoma or with Multiple Endocrine Neoplasia syndrome type 2. The full text is quoted on this page.
- Is compounded semaglutide the same thing?
- No. Compounded preparations are not FDA-approved products. They have not been through the review that produced the labels quoted here, and none of the information on this page describes them.
Sources
Every fact above comes from one of these documents. The date is the effective date of the label version this page was built from.
FDA prescribing information for Wegovy
A-S Medication Solutions. Label version 6, effective 23 April 2024.
FDA prescribing information for Ozempic injection
A-S Medication Solutions. Label version 3, effective 22 November 2023.
FDA prescribing information for Rybelsus and Ozempic tablets
Novo Nordisk Pharmaceutical Industries, LP. Label version 13, effective 30 January 2026.
Page last updated: 29 July 2026
Compiled by the HealthyStudy editorial team from FDA source documents. No medical reviewer is credited on this page, because none reviewed it.