Rybelsus prescribing information covers a daily semaglutide tablet for adults with type 2 diabetes. It describes blood-sugar control, heart-risk reduction, dosing, side effects and the thyroid tumor warning. It also covers Ozempic tablets, whose strengths differ. Neither tablet's label is a general weight-loss label.
Which Rybelsus prescribing information is current?
As of October 1, 2026, the day this article was written, DailyMed's latest posting is August 19, 2026. The combined Rybelsus/Ozempic tablet label still prints “Revised: 1/2026.” A posting date and a revision date aren't the same thing.
The FDA letter signed January 30, 2026 renamed Rybelsus formulation R2 as Ozempic tablets. In this label, Rybelsus means 3, 7 and 14 mg tablets; Ozempic tablets means 1.5, 4 and 9 mg. Ozempic injection has separate prescribing information. The 2019 Rybelsus approval history explains how the tablet arrived.
Section 1: what the tablets are labeled to treat
An indication is a use listed in the prescribing information. These tablets have two:
- Improving blood-sugar control alongside diet and exercise in adults with type 2 diabetes.
- Reducing cardiovascular death, nonfatal heart attack or nonfatal stroke in adults with type 2 diabetes at high risk for those events.
The heart wording rests on SOUL, a trial of 9,650 adults reported in the New England Journal of Medicine in 2025 (McGuire and colleagues). Our SOUL results guide explains the numbers. This label does not list type 1 diabetes, weight management or the injection's kidney-risk indication. Wegovy prescribing information covers that separate semaglutide brand.
As of October 1, 2026, the day this article was written, a September 17 study in Diabetes Therapy adds evidence from insurance records. In adults with type 2 diabetes and established artery disease, oral semaglutide was associated with 17% lower relative risk of the three-part heart outcome. The comparison was other non-insulin diabetes treatments. That means a proportional difference between groups, not 17 fewer events per 100 people. The study cannot prove cause and effect or expand the label's uses.
Sections 2–3: administration and strengths
The label describes once-daily morning dosing “on an empty stomach” with water, “up to 4 ounces,” followed by “at least 30 minutes” before food, other drinks or oral medicines. Those are label facts; the prescriber sets the actual dose and directions.
It specifies whole tablets, without splitting, crushing, chewing or dissolving. Its missed-dose rule skips that day's tablet and resumes the following day. How oral semaglutide works explains why absorption depends on the tablet's formulation and timing.
| Label stage | Rybelsus daily dose | Ozempic tablet daily dose |
|---|---|---|
| Days 1–30 | 3 mg | 1.5 mg |
| Days 31–60 | 7 mg | 4 mg |
| Day 61 onward, if more blood-sugar control is needed | 14 mg | 9 mg |
The starting doses aren't effective for blood-sugar control. Maintenance can remain at 7 mg or 4 mg. The products are not substitutable milligram for milligram. The prescriber sets any switch.
Boxed warning and section 4: contraindications
A boxed warning is the label's most prominent safety warning. Here it concerns thyroid C-cell tumors, tumors in one type of thyroid cell, found in mice and rats. Whether semaglutide causes them in humans is unknown.
A contraindication is a reason the branded medicine must not be used. The label names a personal or family history of medullary thyroid carcinoma, a rare thyroid cancer. It also names MEN 2 in the patient, an inherited tumor syndrome, and a previous serious allergy to semaglutide or a tablet ingredient.
That is specific wording. It doesn't turn every thyroid condition into the same diagnosis. The label also says routine thyroid ultrasound or calcitonin testing, a blood test for a hormone made by thyroid C-cells, has uncertain value for early detection.
Section 5: warnings in everyday words
Beyond the thyroid warning, the label flags:
- Pancreatitis: inflammation of the pancreas, with persistent or severe belly pain, sometimes reaching the back; fatal cases have been reported.
- Diabetic retinopathy: diabetes-related eye damage that can worsen during rapid blood-sugar improvement.
- Hypoglycemia: low blood sugar, with higher risk alongside insulin or sulfonylureas, diabetes pills that increase insulin release.
- Kidney injury from dehydration: vomiting or diarrhea can cause enough fluid loss to affect kidney function, in some reported cases severely enough to need dialysis.
- Severe stomach and bowel reactions: the tablets aren't recommended with severe gastroparesis, a stomach that empties very slowly.
- Serious allergic reactions: including dangerous swelling or breathing problems.
- Gallbladder disease: gallstones or gallbladder inflammation.
- Pulmonary aspiration: stomach contents entering the lungs during anesthesia or deep sedation.
Persistent severe pain, breathing difficulty or severe ongoing vomiting warrants prompt medical assessment. Planned procedures belong in the medical team's discussion because the tablets slow stomach emptying.
Section 6: the adverse-reaction table
Adverse reactions are side effects recorded during studies. These figures come from the label's two placebo-controlled Rybelsus trials. Placebo means a look-alike pill without the active medicine.
| Reaction | Placebo | Rybelsus 7 mg | Rybelsus 14 mg |
|---|---|---|---|
| Nausea | 6% | 11% | 20% |
| Belly pain | 4% | 10% | 11% |
| Diarrhea | 4% | 9% | 10% |
| Decreased appetite | 1% | 6% | 9% |
| Vomiting | 3% | 6% | 8% |
| Constipation | 2% | 6% | 5% |
At 14 mg, about 1 in 5 reported nausea. Stomach or bowel reactions led 4% at 7 mg and 8% at 14 mg to stop, versus 1% on placebo. Most nausea, vomiting and diarrhea arose while doses increased. Reports received after marketing cannot reliably establish frequency or prove the medicine caused a reaction.
Sections 7–8: interactions and specific populations
The label considers closer monitoring when slowed stomach emptying could affect another oral medicine. Levothyroxine, thyroid hormone replacement, had 33% higher total exposure in a drug-interaction study. Exposure means the amount reaching the bloodstream over time; it isn't an instruction to lower a dose by 33%.
Insulin and sulfonylurea doses may need review because of low-blood-sugar risk. Medication changes remain the prescriber's decision.
Human pregnancy data are insufficient, and animal studies raise fetal-risk concerns. The label reserves pregnancy use for situations where potential benefit justifies potential fetal risk. It specifies stopping at least two months before a planned pregnancy, under a clinician's plan.
Breastfeeding isn't recommended during tablet treatment because SNAC, the ingredient that helps absorption, or its breakdown products enter milk. Children's safety and effectiveness aren't established. No overall difference was observed between older and younger adults, and kidney or liver impairment doesn't change the label's recommended dose.
Section 16: how supplied and stored
The branded tablets are listed in bottles of 30. Rybelsus tablets are oval; Ozempic tablets are round. Section 16 specifies storage at 68°F–77°F, with permitted excursions to 59°F–86°F. The original bottle protects against moisture, and the label specifies a dry storage place.
These details belong to those branded products. Tirzepatide is a different molecule a provider may consider; its own product information governs its dosing and storage. The broader pills-versus-injections comparison explains how treatment routines differ.
What this label means for compounded semaglutide
The label doesn't establish a compounded preparation's absorption, ingredients, strength, storage or directions. Its trial findings belong to the products studied.
Through Promise, semaglutide is dispensed as a compounded medication, which is different from an FDA-approved product: the formulation offered here is not FDA-approved. FDA explains that it doesn't verify compounded drugs' safety, effectiveness or quality before marketing. A licensed provider may still prescribe — that decision is between you and your doctor.
At Promise, a licensed provider reviews every request, and not everyone qualifies. The prescription and pharmacy label identify the preparation actually dispensed.
