Brand-name medicine
What is Rybelsus?
Rybelsus is Novo Nordisk's once-daily tablet of semaglutide, a GLP-1 receptor agonist.1 It is a prescription medicine for adults with type 2 diabetes.12 The label covers blood sugar control with diet and exercise and, since October 2025, lowering the risk of cardiovascular death, non-fatal heart attack or non-fatal stroke in adults at high risk.15
This page summarizes published sources for information only. It is not medical advice and does not tell anyone to use a product. Questions about your own health belong with a licensed clinician. For questions about an order or a product, contact us.
Key facts
| Class | GLP-1 receptor agonist; the active ingredient is semaglutide1 |
|---|---|
| Also known as | Semaglutide tablets, oral semaglutide; FDA letters call the original tablet formulation R114 |
| Maker | Novo Nordisk1 |
| Strengths | 3 mg, 7 mg and 14 mg tablets, each in bottles of 301 |
| Forms we sell | Not sold here |
| Regulatory status | FDA approved September 20, 2019 (NDA 213051); prescription only23 |
| WADA status | Not prohibited; semaglutide is watched under WADA's 2026 Monitoring Program, and the status of GLP-1 drugs is unchanged for 202789 |
What sources report
Rybelsus is semaglutide in tablet form, taken once a day by mouth, and semaglutide is a GLP-1 receptor agonist.1 FDA describes these drugs as mimicking GLP-1, a hormone made in the intestine: they stimulate insulin release, lower blood sugar after meals and slow food moving through the digestive tract.7 The Rybelsus label adds that semaglutide raises insulin and lowers glucagon only when blood sugar is high, and slightly slows stomach emptying after a meal.1
Semaglutide was first approved in the US as Ozempic, a weekly injection, on December 5, 2017.1011 FDA approved Rybelsus on September 20, 2019, for use with diet and exercise to improve blood sugar control in adults with type 2 diabetes.23 For the molecule itself and the other brands made from it, read the semaglutide profile.
What is in the tablet
- Strengths: 3 mg, 7 mg and 14 mg. Each tablet is white to light yellow and oval, stamped with its strength on one side and "novo" on the other.1
- Packaging: a bottle of 30 tablets for each strength (NDC 0169-4303-30, 0169-4307-30 and 0169-4314-30).1
- Inactive ingredients: magnesium stearate, microcrystalline cellulose, povidone and salcaprozate sodium (SNAC). SNAC is an absorption enhancer that helps semaglutide get absorbed, mainly in the stomach.1
- Active ingredient: semaglutide, molecular formula C187H291N45O59, molecular weight 4113.58 g/mol. Its peptide backbone is made by yeast fermentation.1
The main findings
In a 26-week trial of 703 adults whose type 2 diabetes was not controlled by diet and exercise alone, HbA1c fell 1.2 points on 7 mg and 1.4 points on 14 mg, against 0.3 on placebo.1 In a cardiovascular outcomes trial of 9,650 adults with type 2 diabetes and heart or blood vessel disease, chronic kidney disease or both, followed for a median of about 49.6 months, a first major cardiovascular event occurred in 12.0% on 14 mg and 13.8% on placebo (hazard ratio 0.86).15
Every finding, with its evidence level, is in Rybelsus benefits and uses. Glucose results trial by trial are in Rybelsus and blood sugar, and the weight data from the same trials are in Rybelsus and weight loss.
What the label does not cover
The approved uses are narrow. Rybelsus is not approved for weight loss, prediabetes is not a labeled use, and safety and effectiveness have not been established in patients under 18.1 The label also does not recommend it for people with severe gastroparesis, meaning very slow stomach emptying.1
Side effects
In the label's pool of two placebo-controlled trials, stomach or gut side effects of any kind affected 32% of people on 7 mg and 41% on 14 mg, against 21% on placebo.1 The six reported by at least 5% of patients were nausea (the most frequent, 11% on 7 mg and 20% on 14 mg against 6% on placebo), stomach pain, diarrhea, decreased appetite, vomiting and constipation.1 The label carries a boxed warning about thyroid C-cell tumors seen in mice and rats, and Rybelsus must not be used by anyone with a personal or family history of medullary thyroid carcinoma or with MEN 2.1 Full list: Rybelsus side effects.
Dosage information
The label starts Rybelsus at 3 mg once daily for 30 days, a starting dose it says is not effective for blood sugar control.1 On day 31 it rises to 7 mg, and from day 61 it can rise to 14 mg, the maximum, if more blood sugar control is needed.1 The prescriber sets and adjusts the dose; nothing on this page is advice for any person. Full schedule and switching rules: Rybelsus dosage.
How it is used
The label sets strict rules for each tablet, because food, drink and the amount of water all change how much semaglutide is absorbed.1
- One tablet, once a day, in the morning on an empty stomach.1
- Swallowed whole with plain water, no more than 4 ounces, and no other liquid.1 The tablet is not split, crushed, chewed or dissolved.1
- At least 30 minutes pass before any food, drink or other oral medicine.1
In studies in healthy people, more semaglutide was absorbed when the tablet was taken with 50 mL of water than with 240 mL, and absorption rose with a longer wait before eating.1 Only about 0.4% to 1% of a Rybelsus dose is estimated to reach the bloodstream, absorbed mostly in the stomach, and blood levels peak about 1 hour after a dose.1
Storage
Rybelsus is kept at room temperature, 68°F to 77°F (20°C to 25°C), with short excursions from 59°F to 86°F (15°C to 30°C) allowed; it needs no refrigeration.1 The label says to keep the tablets in the original closed bottle until each one is taken, to protect them from moisture, and not to store them in any other container.1 The bottle belongs in a dry place, out of the reach of children.1
Regulatory status
- September 20, 2019: FDA approved Rybelsus tablets under NDA 213051, for blood sugar control in adults with type 2 diabetes. Drugs@FDA records the approval as type 3, a new dosage form.23
- December 9, 2024: FDA approved a second tablet formulation, called R2 in its letter (the original is R1), with its own dosing and rules for switching between the two.4
- October 17, 2025: FDA added a second use, lowering the risk of major cardiovascular events in adults with type 2 diabetes at high risk, and removed the label's limitation of use about type 1 diabetes.5
- January 30, 2026: FDA approved renaming formulation R2 from Rybelsus to Ozempic tablets (1.5 mg, 4 mg and 9 mg). One label now covers both brands.61
- October 2026: Drugs@FDA lists all three Rybelsus strengths with prescription status.2
In sport, semaglutide is not banned.8 Its markers are monitored in and out of competition under WADA's 2026 Monitoring Program, and WADA has said the status of GLP-1 receptor agonists stays unchanged for 2027.98
Ozempic and Wegovy, the other semaglutide brands, have their own pages: see the Ozempic profile and the Wegovy profile. How the brand and its ingredient differ is set out in Rybelsus vs Semaglutide.
More on Rybelsus
Rybelsus side effects
Side effects of Rybelsus as reported in labels, trials and published studies, with links to the full profile. Reviewed by a qualified reviewer.
Rybelsus dosage
Published dosing information for Rybelsus from labels and studies, with its source, and why it is not advice for you.
Rybelsus benefits and uses
What published sources report about Rybelsus and its uses, with the evidence level of each finding. No promises.
Frequently asked questions
Is Rybelsus a prescription drug?
Yes. Rybelsus is available in the US only with a prescription, and as of October 2026 Drugs@FDA lists all three strengths (3 mg, 7 mg and 14 mg) with the marketing status Prescription.2 Its labeled uses are for adults with type 2 diabetes.1 Whether it suits a patient, and at which dose, is the prescriber's decision.
What are the key differences between Ozempic and Rybelsus?
Both contain semaglutide and come from Novo Nordisk, but they are different products. Rybelsus is a tablet taken once a day by mouth.1 The Ozempic injection is a once-weekly shot from a prefilled pen, at doses from 0.25 mg up to a maximum of 2 mg.11 Its label also covers kidney risk reduction in adults with type 2 diabetes and chronic kidney disease, a use the Rybelsus label does not include.111 Since January 2026, the Ozempic name also covers a daily tablet that shares the Rybelsus label.61 See Ozempic vs Rybelsus.
Is Rybelsus being phased out?
Not according to FDA's records. As of October 2026, Drugs@FDA still lists Rybelsus 3 mg, 7 mg and 14 mg as prescription products.2 What did change involves a newer tablet: FDA approved a second Rybelsus formulation, called R2, in December 2024, then approved renaming it Ozempic tablets in January 2026.46 The original oval Rybelsus tablets kept their name, and one label now covers both brands.1
How long does it take for Rybelsus to leave your system?
Semaglutide has a half-life of about 1 week, and the label says it stays in the blood for about 5 weeks after the last tablet.1 Daily dosing also takes 4 to 5 weeks to reach steady blood levels.1 That slow clearance is the reason the label says to stop Rybelsus at least 2 months before a planned pregnancy.1
Is Rybelsus as strong as Ozempic?
It depends on which Ozempic product. The tablets are not substitutable mg for mg: the shared label matches Rybelsus 7 mg with Ozempic tablets 4 mg and 14 mg with 9 mg, and in healthy volunteers those pairs gave similar semaglutide levels.1 The weekly Ozempic injection was never tested head to head in the Rybelsus trials, whose active comparators were empagliflozin, sitagliptin and liraglutide.1 The label does let people on Ozempic 0.5 mg weekly switch to Rybelsus 7 mg or 14 mg daily, one week after the last injection.1 Details: Rybelsus dosage.
Written by D2C Peptides Editorial Team.
Pending qualified review.
Updated .
Sources
- RYBELSUS and OZEMPIC (semaglutide) tablets, Prescribing Information and Medication Guide (NDA 213051/S-030, revised 1/2026). U.S. Food and Drug Administration (Novo Nordisk labeling), 2026.
- Drugs@FDA: NDA 213051, Rybelsus and Ozempic (semaglutide) tablets, application overview. U.S. Food and Drug Administration, 2026.
- Approval letter, NDA 213051 Rybelsus (semaglutide) tablets. U.S. Food and Drug Administration, 2019.
- Supplement approval letter, NDA 213051/S-020 and S-021 (Rybelsus formulation R2). U.S. Food and Drug Administration, 2024.
- Supplement approval letter, NDA 213051/S-024, S-028, S-029 (cardiovascular risk reduction indication). U.S. Food and Drug Administration, 2025.
- Supplement approval letter, NDA 213051/S-030 (name change of Rybelsus formulation R2 to Ozempic tablets). U.S. Food and Drug Administration, 2026.
- Update on FDA's ongoing evaluation of reports of suicidal thoughts or actions in patients taking a certain type of medicines approved for type 2 diabetes and obesity (Drug Safety Communication, 01-11-2024). U.S. Food and Drug Administration, 2024.
- WADA publishes 2027 Prohibited List. World Anti-Doping Agency, 2026.
- WADA publishes Prohibited List 2026. NADA Germany (National Anti Doping Agency), 25 September 2025, 2025.
- Drugs@FDA: OZEMPIC, NDA 209637. U.S. Food and Drug Administration.
- OZEMPIC (semaglutide) injection prescribing information, Indications and Usage; DailyMed listing. DailyMed, U.S. National Library of Medicine (Novo Nordisk label, revised 5/2026), 2026.