Status checked on October 6, 2026 dailymed.nlm.nih.gov
Wegovy (semaglutide): FDA-approved uses, who the label covers, how it is taken in general, trial results, side effects, boxed warning and dated 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
- Yes
- First approved
- 2021
- Generic available
- No
- Controlled substance
- No
- Official label
- Prescribing information
Key takeaways
- Wegovy is FDA approved for chronic weight management in adults and in teens 12 and older with obesity (injection), always alongside diet and activity changes.[1]
- In STEP 1, adults on weekly semaglutide 2.4 mg lost 14.9% of their body weight on average over 68 weeks, compared with 2.4% on placebo.[6]
- In SELECT, semaglutide lowered the rate of heart attack, stroke or cardiovascular death from 8.0% to 6.5% in adults with heart disease and overweight or obesity.[7]
- Nausea, diarrhea, vomiting and constipation are the most common side effects; Wegovy has a boxed warning about thyroid C-cell tumors seen in rodents.[1]
- Self-pay through NovoCare Pharmacy was $349 a month for regular pens and $149 to $299 for pills, checked on 2026-10-06.[11]
In short: Wegovy is Novo Nordisk’s brand of semaglutide for weight. It is FDA approved, together with a reduced-calorie diet and more physical activity, to reduce excess body weight and keep it off long term in adults and teens 12 and older with obesity, and in adults with overweight plus at least one weight-related condition. It is also approved to lower the risk of heart attack, stroke and cardiovascular death in adults with heart disease and obesity or overweight. It comes as a once-weekly injection and, since December 2025, as a once-daily tablet (status checked on the FDA label on 2026-10-06).
This page explains what the official prescribing information says about Wegovy: who it is labeled for, how it is taken in general terms, what the main trials found, the side effects and warnings, and what it costs. It is general information to help you prepare for a conversation with your clinician, not personal medical advice.
What Wegovy is
The active ingredient in Wegovy is semaglutide, a medicine that acts like GLP-1, a hormone the gut releases after eating. Our semaglutide page explains the mechanism in detail; in short, it slows how fast the stomach empties and acts on appetite centers in the brain, so many people feel full sooner and eat less. Semaglutide belongs to the GLP-1 medication class.
The same molecule is sold under other brand names for other uses. Ozempic is semaglutide approved for type 2 diabetes, not for weight management. Wegovy is the semaglutide brand with the weight indication. The two are not interchangeable: the doses, devices and approved uses are different, and the Wegovy label says it should not be used together with other semaglutide products or any other GLP-1 receptor agonist.
FDA status and approved uses
According to Drugs@FDA, the Wegovy injection was first approved for chronic weight management on June 4, 2021. Later approvals added teens 12 and older with obesity (December 23, 2022), cardiovascular risk reduction in adults with established heart disease and obesity or overweight (March 8, 2024), and, under the FDA’s accelerated approval pathway, the treatment of noncirrhotic MASH (a fatty liver disease) with moderate to advanced liver scarring in adults (August 15, 2025). Accelerated approval means continued approval for MASH may depend on confirmatory results.
Wegovy tablets were approved on December 22, 2025 for adults only, for weight reduction and maintenance and for cardiovascular risk reduction. The tablets are not approved for teens or for MASH. Our Wegovy pill page covers the tablet in detail.
Who it is labeled for
The label describes the population in clinical terms: adults with obesity, adults with overweight in the presence of at least one weight-related comorbid condition, and pediatric patients 12 and older with obesity (injection only). It is always used together with a reduced-calorie diet and increased physical activity. Clinicians usually define obesity and overweight with BMI; the NIH describes weight-management medicines as generally considered for adults with a BMI of 30 or more, or 27 or more with a weight-related condition such as high blood pressure or type 2 diabetes. Whether Wegovy fits a particular person is a decision for that person and their clinician. Our BMI calculator can show where you stand, but it is not a diagnosis.
How it is taken, in general
The injection is given under the skin once a week. The label describes starting at a low dose and stepping up every four weeks over about four months, which gives the stomach time to adjust and reduces nausea. The label lists maintenance options and, in its current version, also a higher-strength Wegovy HD pen. The tablet is taken once a day in the morning on an empty stomach with a small amount of water, then waiting at least 30 minutes before eating, drinking or taking other oral medicines. Your prescriber decides the dose, the pace of increases and what to do about a missed dose; never change these on your own.
What the studies showed
In STEP 1, published in the New England Journal of Medicine in 2021, 1,961 adults without diabetes received weekly semaglutide 2.4 mg or placebo for 68 weeks, both with lifestyle support. Average weight change was -14.9% with semaglutide and -2.4% with placebo, and 86.4% of the semaglutide group lost 5% or more of their weight. Averages hide a wide range: some people lose much more, some much less.
In SELECT, 17,604 adults aged 45 or older with established cardiovascular disease and a BMI of 27 or more, but no diabetes, were followed for an average of about 40 months. A major cardiovascular event (cardiovascular death, nonfatal heart attack or nonfatal stroke) occurred in 6.5% of the semaglutide group and 8.0% of the placebo group, a 20% relative reduction. This trial is the basis for the cardiovascular indication.
STEP 4 looked at what happens when the medicine stops: people who switched to placebo after 20 weeks regained weight (+6.9% over the next 48 weeks), while those who continued kept losing (-7.9%). In the STEP 1 extension, participants had regained about two thirds of their earlier loss one year after stopping. Our guide to life after a GLP-1 covers what helps.
Side effects
Digestive side effects are the most common, especially while the dose is increasing. In the label’s pooled adult weight trials of the 2.4 mg injection, nausea was reported by 44% of people on Wegovy versus 16% on placebo, diarrhea by 30% versus 16%, vomiting by 24% versus 6%, constipation by 24% versus 11% and abdominal pain by 20% versus 10%. About 6.8% of people stopped Wegovy because of side effects, compared with 3.2% on placebo. Headache, fatigue, dizziness, bloating, burping, reflux and hair loss are also listed.
The label’s warnings cover acute pancreatitis, gallbladder problems, low blood sugar when combined with insulin or sulfonylureas, kidney injury from dehydration, severe stomach and bowel reactions, allergic reactions, diabetic eye complications in people with type 2 diabetes, a faster heart rate, and the risk of inhaling stomach contents during anesthesia or deep sedation, so tell any surgical team you take it. See GLP-1 side effects for how these are recognized and managed, and the dedicated Wegovy side effects page.
Boxed warning and who should not use it
Wegovy carries a boxed warning, the FDA’s most prominent warning: semaglutide caused thyroid C-cell tumors in rodents, and it is not known whether it causes these tumors, including medullary thyroid carcinoma (MTC), in humans. Wegovy should not be used by anyone with a personal or family history of MTC or with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2), or by anyone who has had a serious allergic reaction to semaglutide. The label tells patients to report a lump or swelling in the neck, trouble swallowing, hoarseness or shortness of breath.
Pregnancy and breastfeeding
The label states that weight loss offers no benefit during pregnancy and may cause fetal harm, and that Wegovy should be stopped when a pregnancy is recognized when it is used for weight or heart protection. Anyone planning a pregnancy, pregnant or breastfeeding should talk with their clinician before starting or continuing it.
Cost, insurance and savings
Prices checked on 2026-10-06 on Novo Nordisk’s NovoCare site: the list price is $1,349.02 per package for the pen, the HD pen and the pill. Through NovoCare Pharmacy, self-pay is $349 a month for the regular pen strengths and $399 a month for Wegovy HD, with an introductory $199 a month for the first two fills of the two lowest strengths for new patients (through December 31, 2026). Pills are $149 to $299 a month depending on strength. People with commercial insurance that covers Wegovy may pay as little as $25 a month with the savings offer; government beneficiaries are excluded. Novo Nordisk has announced a lower list price of $675 a month from January 1, 2027. Medicare’s temporary GLP-1 Bridge program (July 2026 to December 2027) includes Wegovy for weight management with a $50 copay for people who meet its criteria. The full breakdown is on our Wegovy cost page.
Compounded and counterfeit products
Compounded “semaglutide” is not Wegovy and is not FDA approved. The FDA declared the semaglutide shortage resolved on February 21, 2025, and has reported adverse events linked to compounded products, including dosing errors. The FDA has also seized counterfeit semaglutide pens found in the U.S. supply chain. Buy only with a prescription from a state-licensed pharmacy. Read more in compounded GLP-1s.
Alternatives and comparisons
Other FDA-approved options include Zepbound (tirzepatide, a weekly injection) and Foundayo (orforglipron, a daily pill), as well as older pills and the daily injection Saxenda; our medications hub lists them all with their status badges. For a side-by-side view, see Wegovy vs Zepbound. Medication works best on top of the basics in how to lose weight, and protein and strength training help protect muscle: the protein calculator gives a daily range to discuss with your care team.
FDA status and approved uses
| Indication | Labeled population | For weight | Approved | Source |
|---|---|---|---|---|
| Reduce excess body weight and maintain weight reduction long term (with reduced-calorie diet and increased physical activity) | Adults with obesity, or adults with overweight and at least one weight-related comorbid condition | Yes | June 4, 2021 | Source |
| Reduce excess body weight and maintain weight reduction long term (injection) | Pediatric patients aged 12 years and older with obesity | Yes | December 23, 2022 | Source |
| Reduce the risk of major adverse cardiovascular events (CV death, nonfatal heart attack, nonfatal stroke) | Adults with established cardiovascular disease and either obesity or overweight | No | March 8, 2024 | Source |
| Noncirrhotic MASH with moderate to advanced liver fibrosis (F2 to F3), accelerated approval (injection) | Adults | No | August 15, 2025 | Source |
| Weight reduction and maintenance, and cardiovascular risk reduction (Wegovy tablets) | Adults only | Yes | December 22, 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)
Injection: once weekly under the skin of the stomach, thigh or upper arm, any time of day, with or without meals. The label describes a gradual dose increase every 4 weeks to a maintenance dose to reduce stomach side effects. Tablets: once daily in the morning on an empty stomach with up to 4 ounces of water, waiting at least 30 minutes before food, drink or other oral medicines. Follow your prescriber; never change the dose on your own.
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 |
|---|---|---|---|
| STEP 1 NCT03548935 | 1,961 adults with BMI 30+ (or 27+ with a weight-related condition), no diabetes | 68 weeks | Mean body-weight change -14.9% with semaglutide 2.4 mg vs -2.4% with placebo; 86.4% vs 31.5% lost 5% or more.[6] |
| SELECT NCT03574597 | 17,604 adults 45+ with cardiovascular disease and BMI 27+, no diabetes | Mean follow-up 39.8 months | Major adverse cardiovascular events 6.5% vs 8.0% with placebo (hazard ratio 0.80).[7] |
| STEP 4 NCT03548987 | 803 adults who reached the maintenance dose in a 20-week run-in | 48 weeks after randomization | Continued semaglutide -7.9% vs +6.9% after switching to placebo (weeks 20 to 68).[8] |
Average results from trials; individual results vary. Results from different trials cannot be compared directly.
Side effects
| Common side effect | How often (label) |
|---|---|
| Nausea | 44% vs 16% placebo (adults, 2.4 mg, weight trials) |
| Diarrhea | 30% vs 16% placebo |
| Vomiting | 24% vs 6% placebo |
| Constipation | 24% vs 11% placebo |
| Abdominal pain | 20% vs 10% placebo |
| Headache | 14% vs 10% placebo |
| Fatigue | 11% vs 5% placebo |
Serious risks
- Thyroid C-cell tumors (boxed warning, seen in rodents)
- Acute pancreatitis
- Acute gallbladder disease
- Hypoglycemia, especially with insulin or a sulfonylurea
- Acute kidney injury from fluid loss
- Severe gastrointestinal adverse reactions
- Hypersensitivity reactions
- Diabetic retinopathy complications in people with type 2 diabetes
- Heart rate increase
- Pulmonary aspiration during general anesthesia or deep sedation
More detail: Wegovy Side Effects: common, serious and long-term
Warnings and who should not use it
Boxed warning
Risk of thyroid C-cell tumors: 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. 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). Patients should be counseled on the risk and symptoms of thyroid tumors.
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)
- Prior serious hypersensitivity reaction to semaglutide or any of the product components
Interactions, pregnancy and breastfeeding
| Drug or class | What the label says |
|---|---|
| Other semaglutide products or GLP-1 receptor agonists | Using them together is not recommended by the label. |
| Insulin or insulin secretagogues (such as sulfonylureas) | Higher risk of low blood sugar; the prescriber may adjust those medicines. |
| Oral medications | Semaglutide slows stomach emptying and may affect how other oral medicines are absorbed. |
Supplements with reported interactions: Fiber Supplements for Weight Loss: psyllium, glucomannan and more
Pregnancy and breastfeeding
The label states that weight loss offers no benefit to a pregnant patient and may cause fetal harm; Wegovy used for weight reduction or cardiovascular risk reduction should be discontinued when pregnancy is recognized. Animal studies showed harm to the fetus. Discuss pregnancy plans and breastfeeding with the prescriber.
Cost, insurance and savings
| Price | Amount | Basis | Checked on |
|---|---|---|---|
| List price | 1,349.02 USD | per package (pen, HD pen or pill) | October 6, 2026 |
| Self-pay / cash | 349 USD | per month, pens 0.25 mg to 2.4 mg, NovoCare Pharmacy | October 6, 2026 |
| Self-pay / cash | 399 USD | per month, Wegovy HD 7.2 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
- Wegovy Savings Offer: Commercial insurance that covers Wegovy; government beneficiaries excluded (checked October 6, 2026)
- NovoCare Pharmacy self-pay: Valid prescription; cash price by strength (checked October 6, 2026)
- Medicare GLP-1 Bridge: Eligible Part D enrollees prescribed Wegovy for weight, July 1, 2026 to December 31, 2027; $50 copay; prior authorization (checked October 6, 2026)
Full price guide: Wegovy Cost, Coupons and Savings Programs (prices checked monthly)
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 (semaglutide): approved uses and how it differs from WegovySemaglutide: one ingredient, several brands · Injection · Weekly
FDA approved for another usePrescriptionInjectionOzempic Side Effects: what the label lists and when to get helpSemaglutide: one ingredient, several brands
FDA approved for another useOff-label use discussedPrescriptionPillRybelsus (oral semaglutide): a diabetes pill, not a weight-loss approvalSemaglutide: one ingredient, several brands · Pill (tablet) · Daily
FDA approved for weight managementPrescriptionInjectionWegovy HD (semaglutide 7.2 mg): what the higher dose is, results and statusSemaglutide: one ingredient, several brands · Injection · Weekly
FDA approved for weight managementPrescriptionPillWegovy Pill (oral semaglutide): status, how it is taken, how it comparesSemaglutide: one ingredient, several brands · Pill (tablet) · Daily
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FDA approved for weight managementPrescriptionPillOrforglipron: the small-molecule GLP-1 pill and its current statusPill (tablet) · Daily
FDA approved for weight managementPrescriptionInjectionSaxenda (liraglutide 3 mg): uses, side effects and costLiraglutide: the daily GLP-1 (Saxenda, Victoza) and generics · Injection · Daily
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Wegovy vs Foundayo: injection or pill (status-checked)Medications
Wegovy vs Saxenda: weekly vs daily GLP-1 comparedMedications
Wegovy vs Zepbound: ingredients, results, side effects and costMedications
Weight-Loss Injections vs Pills: GLP-1 shots and oral options comparedMethodsNon-drug approaches
FDA approved for weight managementPrescriptionPillFoundayo (orforglipron): status, uses and what is confirmedOrforglipron: the small-molecule GLP-1 pill and its current status · Pill (tablet) · Daily
Mediterranean Diet for Weight Loss: foods, evidence and a 7-day starterEvidence: High · Easy
FDA approved for weight managementPrescriptionInjectionZepbound (tirzepatide): uses, side effects, cost and FDA statusTirzepatide: how the dual GIP/GLP-1 drug works (Zepbound, Mounjaro) · Injection · WeeklyFDA approved for weight managementPrescriptionInjectionSaxenda (liraglutide 3 mg): uses, side effects and costLiraglutide: the daily GLP-1 (Saxenda, Victoza) and generics · Injection · DailyCost and coverage
Research mentioning it
How to Read a Weight-Loss Study Headline in 5 StepsFive questions to ask before believing a weight-loss headline: who was studied, how many, how long,…
What’s Coming in 2027: Weight-Loss Treatments Awaiting FDA DecisionsWeight-loss treatments awaiting FDA decisions in 2027: CagriSema, retatrutide, survodutide, MariTide and more, with filing dates,…
10 Innovations That Changed Weight Loss (2016 to 2026)Ten weight-loss innovations from 2016 to 2026, listed by date: the new food label, Plenity, Imcivree,…Related guides
GLP-1 Medications: how they work and which are approved for weightGLP-1 medications explained: what GLP-1 is, how the drugs work, which brands are FDA approved for…
GLP-1 Side Effects: common, serious and how they are managedGLP-1 side effects from the FDA labels: common digestive effects by brand, serious risks, the thyroid…
Compounded Semaglutide and Tirzepatide: what FDA says and the risksCompounded semaglutide and tirzepatide explained: not FDA approved, the dated shortage history, FDA safety reports, counterfeit…
Stopping a GLP-1: regain, what trials show and keeping resultsWhat happens when you stop a GLP-1: STEP 1 extension, STEP 4, SURMOUNT-4 and BMJ meta-analysis…Tools for this topic
Questions to ask your doctor or pharmacist
- Based on my health history, what are the possible benefits and risks of Wegovy for me?
- Do I have any personal or family history that would rule it out, such as thyroid cancer or MEN 2?
- How should my other medicines, especially diabetes medicines, be adjusted if I start it?
- Would the injection or the tablet fit my routine better, and how does my insurance treat each?
- What is our plan for nutrition, strength training and the long term if I stop?
Frequently asked questions
Is Wegovy the same as Ozempic?
Both contain semaglutide, but they are different products with different approvals. Wegovy is approved for chronic weight management and cardiovascular risk reduction in people with obesity or overweight; Ozempic is approved for type 2 diabetes and related heart and kidney outcomes. The doses and devices differ.
How much weight do people lose on Wegovy?
In the STEP 1 trial, the average was 14.9% of starting weight after 68 weeks, compared with 2.4% on placebo, with lifestyle support in both groups. Individual results vary widely.
Is there a Wegovy pill?
Yes. Wegovy tablets were approved on December 22, 2025 for adults, for weight reduction and maintenance and for cardiovascular risk reduction. They are taken once daily on an empty stomach.
What happens if I stop taking Wegovy?
In trials, most people regained a large part of the weight after stopping: in the STEP 1 extension about two thirds of the loss returned within a year. Any change should be planned with the prescriber.
Does insurance cover Wegovy?
Coverage depends on the plan. Some commercial plans cover it, often with prior authorization. Medicare Part D plans may cover it for the cardiovascular indication, and Medicare runs a temporary GLP-1 Bridge for weight management from July 2026 through 2027. Check with your plan.
Official sources
References
- WEGOVY (semaglutide) injection and tablets: prescribing information. Novo Nordisk, via DailyMed, 2026. (accessed October 7, 2026) Drug label
- Drugs@FDA: Wegovy, NDA 215256, approval history. U.S. Food and Drug Administration. (accessed October 7, 2026) Government page
- Drugs@FDA: Wegovy tablets, NDA 218316. U.S. Food and Drug Administration. (accessed October 7, 2026) Government page
- 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. (accessed October 7, 2026) Government page
- NDA 215256/S-024 accelerated approval letter (MASH). U.S. Food and Drug Administration, 2025. (accessed October 7, 2026) Government page
- Wilding JPH, Batterham RL, Calanna S, et al.. Once-Weekly Semaglutide in Adults with Overweight or Obesity (STEP 1). New England Journal of Medicine, 2021. doi:10.1056/NEJMoa2032183 · PMID 33567185 · NCT03548935 (accessed October 7, 2026) Randomized trial
- Lincoff AM, Brown-Frandsen K, Colhoun HM, et al.. Semaglutide and Cardiovascular Outcomes in Obesity without Diabetes (SELECT). New England Journal of Medicine, 2023. doi:10.1056/NEJMoa2307563 · PMID 37952131 · NCT03574597 (accessed October 7, 2026) Randomized trial
- Rubino D, Abrahamsson N, Davies M, et al.. Effect of Continued Weekly Subcutaneous Semaglutide vs Placebo on Weight Loss Maintenance (STEP 4). JAMA, 2021. doi:10.1001/jama.2021.3224 · PMID 33755728 · NCT03548987 (accessed October 7, 2026) Randomized trial
- Wilding JPH, Batterham RL, Davies M, et al.. Weight regain and cardiometabolic effects after withdrawal of semaglutide: The STEP 1 trial extension. Diabetes, Obesity and Metabolism, 2022. doi:10.1111/dom.14725 · PMID 35441470 (accessed October 7, 2026) Randomized trial
- Wegovy cost, coverage and savings resources. Novo Nordisk (NovoCare). (accessed October 6, 2026) Other
- Wegovy at NovoCare Pharmacy: self-pay prices. 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
- FDA’s concerns with unapproved GLP-1 drugs used for weight loss. U.S. Food and Drug Administration, 2026. (accessed October 7, 2026) Government page
- Prescription Medications to Treat Overweight & Obesity. National Institute of Diabetes and Digestive and Kidney Diseases (NIH). (accessed October 7, 2026) Government page
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.