Rybelsus Side Effects by Frequency: Common, Serious
In the Rybelsus label, nausea is the most common side effect: 20% on 14 mg vs 6% on placebo. Next come abdominal pain and diarrhea.
- Most common
- Nausea 20%
- Same on placebo
- 6%
- Trial group
- Adults with type 2 diabetes
Rybelsus facts at a glance
Its half-life is about 1 week. Half disappears after 7 d, while about 3% remains after five half-lives (35 d).
In PIONEER 1, people with type 2 diabetes lost 3.7 kg over 26 weeks, compared with 1.4 kg on placebo.
Monthly prices in US dollars include the list price and self-pay offers. Each comes from the maker's price page.
Sources: FDA label (DailyMed), healthsystemtracker.org, Novo Nordisk pricing, Novo Nordisk.
Rybelsus side effects: label rates vs placebo
The FDA label lists 6 common Rybelsus side effects found in placebo-controlled trials. The final column tells you how much more often each one showed up than on placebo.
| Side effect | Placebo | Rybelsus 7 mg | Rybelsus 14 mg | More than placebo, 14 mg |
|---|---|---|---|---|
| Nausea | 6% | 11% | 20% | +14 points |
| Abdominal Pain | 4% | 10% | 11% | +7 points |
| Diarrhea | 4% | 9% | 10% | +6 points |
| Decreased appetite | 1% | 6% | 9% | +8 points |
| Vomiting | 3% | 6% | 8% | +5 points |
| Constipation | 2% | 6% | 5% | +3 points |
Source: FDA label (DailyMed).
The serious warnings explained simply
- Boxed warning about Thyroid C-cell tumors. In rodents, it caused thyroid C-cell tumors. It is not known whether this happens in people. It should not be used by anyone with a personal or family history of medullary thyroid cancer (MTC), or by anyone with MEN 2.
- Pancreatitis. It may cause inflammation of the pancreas. If severe stomach pain continues, stop taking it and get care. The pain may spread to your back.
- Diabetic eye disease getting worse. In people with type 2 diabetes, diabetic eye disease may worsen, particularly when blood sugar falls quickly. If you already have it, eye checks matter.
- Low blood sugar. Taking it with insulin or a sulfonylurea raises the risk of low blood sugar. Those doses may need to be lowered.
- Kidney injury due to fluid loss. Fluid loss from vomiting or diarrhea can result in kidney injury. If fluid loss is heavy, report it and drink fluids.
- Severe stomach and gut reactions. Stomach and gut side effects are common. Some can be severe. It is not recommended if you have severe gastroparesis.
- Serious allergic reactions. Reports describe serious allergic reactions, including swelling of the face, lips, or throat. If they happen, stop the medicine and get help right away.
- Gallbladder disease. You may get gallstones and inflammation of the gallbladder. Upper-right belly pain, fever, or yellow skin or eyes should be reported.
- Food in your lungs during anesthesia or sedation. During deep sedation or anesthesia, food may remain in the stomach longer, which matters for food reaching the lungs during anesthesia or sedation. Before any procedure, tell your care team.
Source: FDA label (DailyMed).
Source: FDA label (DailyMed).
Common side effects listed separately
- Details on nausea: 20% at 14 mg; placebo, 6%
- Details on diarrhea: 10% at 14 mg; placebo, 4%
- Details on constipation: 6% at 7 mg; placebo, 2%
Additional questions about Rybelsus include Liver effects, Fatigue, Hair loss, Sulfur burps, Butt changes, Muscle loss, Headache, Heartburn and indigestion, Face changes.