Short answer: In the label's placebo-controlled trials, nausea was the most common side effect of Rybelsus: 11% on 7 mg and 20% on 14 mg, against 6% on placebo. Stomach pain, diarrhea, decreased appetite, vomiting and constipation followed. Most nausea, vomiting and diarrhea happened while the dose was being raised. The label carries a boxed warning about thyroid C-cell tumors seen in rodents.
What Rybelsus is approved for: The label says Rybelsus is approved, along with diet and exercise, to improve blood sugar control in adults with type 2 diabetes, and to lower the risk of major heart events (heart death, non-fatal heart attack or non-fatal stroke) in adults with type 2 diabetes who are at high risk for these events. The same label also covers Ozempic tablets.
Source
RYBELSUS (semaglutide) tablets and OZEMPIC (semaglutide) tablets, for oral use, prescribing information and Medication Guide. Novo Nordisk. DailyMed, version published August 19, 2026. DailyMed setid 27f15fac-7d98-4114-a2ec-92494a91da98
WARNING: RISK OF THYROID C-CELL TUMORS
In rodents, semaglutide caused thyroid C-cell tumors, and it is not known whether Rybelsus or Ozempic tablets cause these tumors, including medullary thyroid carcinoma (MTC), in people. They must not be used by people with a personal or family history of MTC or with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). The label lists a lump in the neck, trouble swallowing, shortness of breath and lasting hoarseness as possible thyroid tumor symptoms.
These are the label's own numbers from the Adverse Reactions section. Where the label compares with placebo (a dummy treatment), both columns are shown, so you can see how much more often a reaction happened on Rybelsus.
| Adverse reaction | Placebo (N=362) % | Semaglutide Tablets 7 mg (N=356) % | Semaglutide Tablets 14 mg (N=356) % |
|---|---|---|---|
| Nausea | 6 | 11 | 20 |
| Abdominal Pain | 4 | 10 | 11 |
| Diarrhea | 4 | 9 | 10 |
| Decreased appetite | 1 | 6 | 9 |
| Vomiting | 3 | 6 | 8 |
| Constipation | 2 | 6 | 5 |
Pooled from 2 placebo-controlled trials in adults with type 2 diabetes: 1,071 patients took semaglutide tablets (3 mg, 7 mg or 14 mg once daily) for a mean of 41.8 weeks. The label calls Rybelsus "semaglutide tablets" here. Low blood sugar is not included in this table.
| Trial and definition | Placebo | Semaglutide Tablets 7 mg | Semaglutide Tablets 14 mg |
|---|---|---|---|
| Monotherapy: Severe* | 0% | 1% | 0% |
| Monotherapy: Plasma glucose <54 mg/dL | 1% | 0% | 0% |
| Moderate renal impairment add-on: Severe* | 0% | - | 0% |
| Moderate renal impairment add-on: Plasma glucose <54 mg/dL | 3% | - | 6% |
| Add-on to insulin with or without metformin: Severe* | 1% | 0% | 1% |
| Add-on to insulin with or without metformin: Plasma glucose <54 mg/dL | 32% | 26% | 30% |
Three trials: tablets alone for 26 weeks (N=178 placebo, 175 on 7 mg, 175 on 14 mg); add-on in people with moderate kidney impairment for 26 weeks (N=161 placebo, 163 on 14 mg; no 7 mg group); add-on to insulin for 52 weeks (N=184, 181, 181). "Severe" means an episode that needed another person's help.
Stomach and gut side effects overall: 41% on 14 mg, 32% on 7 mg and 21% on placebo, including severe reactions in 2.0%, 0.6% and 0.3%.
Stopping treatment because of stomach and gut side effects: 8% on 14 mg and 4% on 7 mg, against 1% on placebo.
In a 4-year heart outcomes trial (Trial 7), the study drug was stopped because of a side effect in 15.5% on semaglutide tablets and 11.6% on placebo.
Amylase rose by a mean of 10% on 7 mg and 13% on 14 mg; lipase rose by 30% and 34%. Heart rate rose by a mean of 1 to 3 beats per minute.
Eye complications from diabetes were reported in 4.2% on semaglutide tablets and 3.8% on comparators in the larger trial pool.
The Warnings and Precautions part of the label lists these. Each line gives the label's heading and what it means in plain words.
Risk of thyroid C-cell tumors. Semaglutide caused thyroid C-cell tumors in mice and rats; whether this happens in people is unknown. People with a personal or family history of MTC or with MEN 2 must not use Rybelsus.
Acute pancreatitis. Inflammation of the pancreas, including fatal cases, has been seen with GLP-1 drugs including semaglutide tablets. The label says to stop Rybelsus if pancreatitis is suspected.
Diabetic retinopathy complications. Eye complications from diabetes were reported in 4.2% on semaglutide tablets and 3.8% on comparators. The label says people with a history of diabetic retinopathy should be monitored.
Low blood sugar with insulin or sulfonylureas. Using Rybelsus with insulin or a sulfonylurea may raise the risk of low blood sugar, including severe episodes. The label says a lower dose of those medicines may reduce this risk.
Kidney injury from fluid loss. Acute kidney injury, sometimes needing dialysis, has been reported, mostly in people who became dehydrated from nausea, vomiting or diarrhea. The label says to monitor kidney function in these people, especially when starting or raising the dose.
Severe stomach and gut side effects. Severe stomach and gut side effects were reported in 0.6% on 7 mg and 2% on 14 mg, against 0.3% on placebo. Rybelsus is not recommended in people with severe gastroparesis.
Allergic reactions. Serious allergic reactions such as anaphylaxis and angioedema have been reported. The label says to stop Rybelsus if they occur.
Gallbladder disease. Gallstones were reported in 1% on 7 mg in placebo-controlled trials. In a 4-year trial on 14 mg, gallstones were reported in 1.1% (0.9% on placebo) and gallbladder inflammation in 1.1% (0.7% on placebo).
Food or liquid in the lungs during anesthesia. Rybelsus slows stomach emptying. Rare reports describe food entering the lungs during procedures with general anesthesia or deep sedation. The label says to tell your providers you take it before any planned procedure.
From the Medication Guide that comes with Rybelsus:
Dose Track has a side-effect log. Each entry records the symptom, a severity (none, mild, moderate, severe or life-threatening), the date and an optional note, and can be tied to a specific dose or logged on its own. The history screen shows what you logged over time, which makes it easier to tell your prescriber when a reaction started and whether it is easing. The app records what you enter; it does not judge whether a symptom is serious. For anything on the label's call-your-doctor list, call your doctor.
This page is what the FDA label says, in plain words. It is not medical advice. Follow your prescriber, and ask them or your pharmacist about anything here.