Status checked on October 6, 2026 dailymed.nlm.nih.gov
The Wegovy pill (oral semaglutide) is FDA approved for adults: approval, how the label says to take it, OASIS 4 results, pill vs injection and self-pay 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
- Pill (tablet)
- How often
- Daily
- Manufacturer
- Novo Nordisk
- Approved for weight
- Yes
- First approved
- 2025
- Generic available
- No
- Controlled substance
- No
- Official label
- Prescribing information
Key takeaways
- Wegovy tablets were FDA approved on December 22, 2025 for adults, for weight reduction and maintenance and for cardiovascular risk reduction.[2]
- The tablet is taken once daily in the morning on an empty stomach with up to 4 ounces of water, then waiting at least 30 minutes before food, drink or other medicines.[1]
- In OASIS 4, oral semaglutide 25 mg led to a 13.6% average weight loss at 64 weeks, versus 2.2% on placebo.[4]
- NovoCare Pharmacy listed the pill at $149 to $299 a month self-pay depending on strength, checked on 2026-10-06.[7]
In short: The Wegovy pill is FDA approved. Wegovy (semaglutide) tablets were approved on December 22, 2025 for adults, together with a reduced-calorie diet and more physical activity, to reduce excess body weight and keep it off long term (obesity, or overweight with at least one weight-related condition) and to lower the risk of heart attack, stroke and cardiovascular death in adults with heart disease and obesity or overweight. It is one tablet a day, taken in the morning on an empty stomach (status checked on DailyMed and Drugs@FDA on 2026-10-06).
This page covers what is specific to the tablet: its approval, how the label says to take it, what the trial showed, and how it compares with the weekly injection. For everything shared with the injection, such as the boxed warning, see our main Wegovy page.
FDA status
Drugs@FDA lists Wegovy tablets under their own application (NDA 218316), approved on December 22, 2025 as a new dosage form of semaglutide. The approval letter covers two uses in adults: cardiovascular risk reduction in people with established cardiovascular disease and obesity or overweight, and weight reduction and long-term maintenance in adults with obesity or overweight plus a weight-related condition. Unlike the injection, the tablets are not approved for teenagers or for MASH, the fatty liver indication. Labeling updates followed in 2026; the current label on DailyMed was revised in June 2026.
How it is taken, in general
The label is specific about the daily routine, and following it matters for the tablet to work as studied. The tablet is taken once a day, in the morning, on an empty stomach, with a small amount of water (up to 4 ounces). After swallowing it, the label says to wait at least 30 minutes before eating, drinking anything else or taking other oral medicines. Like the injection, the label describes starting at a low strength and stepping up about once a month to a maintenance dose; the tablet strengths are 1.5, 4, 9 and 25 mg. Your prescriber decides the dose and what to do if a dose is missed.
This routine matters for anyone who takes other medicines in the morning. Ask your prescriber or pharmacist how to fit them together.
What the trial showed
The OASIS 4 trial, published in the New England Journal of Medicine in 2025, enrolled 307 adults without diabetes with a BMI of 30 or more, or 27 or more with an obesity-related complication. They took oral semaglutide 25 mg or placebo once daily, with lifestyle support. At 64 weeks, average weight change was -13.6% with the pill and -2.2% with placebo, and more people on the pill reached losses of 5%, 10%, 15% and 20%. Digestive side effects were more common with semaglutide. The cardiovascular indication of the tablet rests on the same molecule’s heart-outcome evidence described on the Wegovy page.
Pill vs injection
| Wegovy tablets | Wegovy injection | |
|---|---|---|
| How often | Once daily | Once weekly |
| Routine | Empty stomach, up to 4 oz water, wait 30 minutes | Any time of day, with or without food |
| Approved ages | Adults | Adults; teens 12+ with obesity |
| Approved uses | Weight; cardiovascular risk reduction | Weight; cardiovascular risk reduction; MASH (accelerated approval) |
| Main weight trial | OASIS 4: -13.6% vs -2.2% at 64 weeks | STEP 1: -14.9% vs -2.4% at 68 weeks |
| Self-pay (NovoCare, 2026-10-06) | $149 to $299 a month by strength | $349 a month ($399 for Wegovy HD) |
The two trials were separate, with different people and lengths, so the numbers are not a head-to-head comparison. Some people prefer a pill to needles; others find a weekly injection easier than a strict daily routine. That is a conversation for you and your clinician. Our injections vs pills comparison looks at the choice across all products.
How it differs from Rybelsus, Ozempic tablets and Foundayo
Rybelsus and Ozempic tablets are also oral semaglutide, but they are approved for type 2 diabetes, not for weight, and come in different strengths; the labels say the oral products are not interchangeable milligram for milligram. Foundayo (orforglipron) is a different molecule from Eli Lilly, approved for weight in April 2026, which the label says can be taken with or without food. Our oral GLP-1 guide lines up all the pills.
Side effects and warnings
The tablets share the Wegovy label with the injection: the same boxed warning about thyroid C-cell tumors seen in rodents, the same contraindications (personal or family history of medullary thyroid carcinoma or MEN 2, serious allergy to semaglutide), and the same warnings about pancreatitis, gallbladder disease, low blood sugar with other diabetes medicines, kidney injury from dehydration and aspiration during anesthesia. In the tablet trial, about 6.9% of people stopped because of side effects, compared with 5.9% on placebo, according to the label. Nausea, vomiting, diarrhea and constipation are the most common. See GLP-1 side effects.
Cost and coverage
Checked on 2026-10-06 on NovoCare Pharmacy: $149 a month for 1.5 mg, $199 for 4 mg and $299 for 9 mg and 25 mg, self-pay, where one month is a bottle of 30 tablets. The list price is $1,349.02 per package, the same as the pen. People with commercial coverage may pay as little as $25 a month with the savings offer (government beneficiaries excluded). Medicare’s GLP-1 Bridge, July 2026 to December 2027, includes Wegovy tablets for weight management with a $50 copay for those who qualify. More detail is on the Wegovy cost page and in the GLP-1 cost comparison, and our medications hub lists every approved option.
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 overweight with at least one weight-related comorbid condition | Yes | December 22, 2025 | Source |
| Reduce the risk of major adverse cardiovascular events | Adults with established cardiovascular disease and either obesity or overweight | No | 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)
One tablet a day in the morning on an empty stomach with up to 4 ounces of water; wait at least 30 minutes before food, drink or other oral medicines. The label describes starting low and increasing about monthly to a maintenance dose. 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 |
|---|---|---|---|
| OASIS 4 NCT05564117 | 307 adults with BMI 30+ (or 27+ with a complication), no diabetes | 64 weeks (71-week trial) | Weight change -13.6% with oral semaglutide 25 mg vs -2.2% with placebo.[4] |
Average results from trials; individual results vary. Results from different trials cannot be compared directly.
Side effects
| Common side effect | How often (label) |
|---|---|
| Nausea, vomiting, diarrhea, constipation, abdominal pain | Most common; see label section 6 for tablet-specific rates |
Serious risks
- Thyroid C-cell tumors (boxed warning, rodents)
- Acute pancreatitis
- Acute gallbladder disease
- Hypoglycemia with insulin or sulfonylureas
- Acute kidney injury
- Severe gastrointestinal reactions
- Diabetic retinopathy complications
- Pulmonary aspiration during anesthesia or deep sedation
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. Contraindicated with a personal or family history of MTC or 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 MEN 2
- Prior serious hypersensitivity to semaglutide or product components
Interactions, pregnancy and breastfeeding
| Drug or class | What the label says |
|---|---|
| Other oral medicines | Take them at least 30 minutes after the tablet, as the label describes; ask the pharmacist about timing. |
| Other semaglutide products or GLP-1 receptor agonists | Not to be used together (label). |
Pregnancy and breastfeeding
Same label as the injection: weight loss offers no benefit in pregnancy and may cause fetal harm; discontinue when pregnancy is recognized. Discuss breastfeeding with the prescriber.
Cost, insurance and savings
| Price | Amount | Basis | Checked on |
|---|---|---|---|
| Self-pay / cash | 149 USD | per month, 1.5 mg (30 tablets), NovoCare Pharmacy | October 6, 2026 |
| Self-pay / cash | 199 USD | per month, 4 mg | October 6, 2026 |
| Self-pay / cash | 299 USD | per month, 9 mg or 25 mg | October 6, 2026 |
| List price | 1,349.02 USD | per package | 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 coverage; as little as $25 a month; government beneficiaries excluded (checked October 6, 2026)
- Medicare GLP-1 Bridge: Eligible Part D enrollees for weight management, $50 copay, July 1, 2026 to December 31, 2027 (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 (semaglutide): uses, side effects, cost and FDA statusSemaglutide: one ingredient, several brands · Injection · Weekly
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 managementPrescriptionInjectionWegovy Side Effects: common, serious and long-termSemaglutide: one ingredient, several brandsSame class
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
FDA approved for weight managementPrescriptionInjectionLiraglutide: the daily GLP-1 (Saxenda, Victoza) and genericsInjection · Daily
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
FDA approved for weight managementPrescriptionInjectionSemaglutide: one ingredient, several brandsInjection · Daily, WeeklyCompare with
Non-drug approaches
FDA approved for weight managementPrescriptionInjectionWegovy (semaglutide): uses, side effects, cost and FDA statusSemaglutide: one ingredient, several brands · Injection · WeeklyFDA approved for weight managementPrescriptionPillFoundayo (orforglipron): status, uses and what is confirmedOrforglipron: the small-molecule GLP-1 pill and its current status · Pill (tablet) · DailyFDA approved for another useOff-label use discussedPrescriptionPillRybelsus (oral semaglutide): a diabetes pill, not a weight-loss approvalSemaglutide: one ingredient, several brands · Pill (tablet) · Daily
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- Would a daily pill or a weekly injection fit my routine and other medicines better?
- How should I time my other morning medicines around the tablet?
- Is there anything in my thyroid or family history that rules semaglutide out?
- Which side effects should prompt a call to you?
- What does my insurance cover, and is the pill or the pen cheaper for me?
Frequently asked questions
Is the Wegovy pill FDA approved?
Yes. Wegovy tablets were approved on December 22, 2025 (NDA 218316) for adults with obesity, or overweight with a weight-related condition, and for cardiovascular risk reduction in adults with heart disease and obesity or overweight.
Is the Wegovy pill as effective as the shot?
Their main trials were separate: about 13.6% average loss at 64 weeks for the 25 mg pill (OASIS 4) and 14.9% at 68 weeks for the 2.4 mg injection (STEP 1). There is no head-to-head trial in the label.
Is the Wegovy pill the same as Rybelsus?
Both contain semaglutide, but Rybelsus is approved for type 2 diabetes and uses different strengths. The products are not interchangeable.
Can teenagers take the Wegovy pill?
No. As of 2026-10-06 the tablets are approved for adults only; the injection is the form approved for teens 12 and older with obesity.
Official sources
References
- WEGOVY (semaglutide) injection and tablets: prescribing information. Novo Nordisk, via DailyMed, 2026. (accessed October 7, 2026) Drug label
- Drugs@FDA: Wegovy tablets, NDA 218316. U.S. Food and Drug Administration. (accessed October 7, 2026) Government page
- NDA 218316 approval letter, Wegovy (semaglutide) tablets. U.S. Food and Drug Administration, 2025. (accessed October 6, 2026) Government page
- Wharton S, Lingvay I, Bogdanski P, et al.. Oral Semaglutide at a Dose of 25 mg in Adults with Overweight or Obesity (OASIS 4). New England Journal of Medicine, 2025. doi:10.1056/NEJMoa2500969 · PMID 40934115 · NCT05564117 (accessed October 6, 2026) Randomized trial
- RYBELSUS and OZEMPIC (semaglutide) tablets: prescribing information. Novo Nordisk, via DailyMed. (accessed October 6, 2026) Drug label
- FOUNDAYO (orforglipron) tablets: prescribing information. Eli Lilly and Company, via DailyMed, 2026. (accessed October 7, 2026) Drug label
- Wegovy at NovoCare Pharmacy: self-pay prices. Novo Nordisk (NovoCare Pharmacy). (accessed October 7, 2026) Other
- Wegovy cost, coverage and savings resources. Novo Nordisk (NovoCare). (accessed October 6, 2026) Other
- Medicare GLP-1 Bridge: information for providers. Centers for Medicare and Medicaid Services. (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.