Rybelsus Long-Term Side Effects: What Years of Data Show
Rybelsus has been sold in the US since 2019. The long-term label warnings are thyroid C-cell tumors (seen in rodents), pancreatitis, gallbladder disease and kidney injury from fluid loss.
- Sold in the US since
- 2019
- 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 remains 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.
Prices by month in US dollars include the list price and self-pay offers, with each amount taken from the maker’s price page.
Sources: FDA label (DailyMed), healthsystemtracker.org, Novo Nordisk pricing, Novo Nordisk.
Serious warnings in plain language
- Boxed warning about Thyroid C-cell tumors. This drug caused thyroid C-cell tumors in rodents, but whether it causes the same tumors in people remains unknown. Do not take it if your personal or family history includes medullary thyroid cancer (MTC), or if you have MEN 2.
- Pancreatitis. Pancreatitis, or inflammation of the pancreas. Seek care and stop taking it if severe stomach pain continues, as it sometimes spreads into the back.
- Worsening diabetic eye disease. In people with type 2 diabetes, diabetes-related eye disease may worsen, particularly when blood sugar drops quickly. Eye checks are important when you already have it.
- Low blood sugar. This medicine makes low blood sugar more likely when combined with insulin or a sulfonylurea. Those drug doses may need lowering.
- Kidney damage due to fluid loss. Fluid loss from vomiting or diarrhea may damage your kidneys. Report heavy fluid loss and also drink fluids.
- Severe side effects in the stomach and gut. Stomach and gut side effects occur often, and some can be severe. Severe gastroparesis means this medicine is not recommended for you.
- Serious allergic reactions. Reports include serious allergic reactions with swelling of the face, lips or throat. If this occurs, stop taking it and get help right away.
- Gallbladder disease. You may develop gallstones or inflammation of the gallbladder. If you notice yellow skin or eyes, fever, or pain in the upper right belly, report it.
- Food reaching your lungs during anesthesia or sedation. Food can remain in your stomach longer, which matters during anesthesia or deep sedation. Inform the care team before any procedure.
Information from the DailyMed FDA label.
Information from the DailyMed FDA label.
Rybelsus long term side effects: label rates vs placebo
The FDA label lists 6 common Rybelsus side effects from placebo-controlled trials. The final column shows how much more often each side effect appeared 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 |
Information from the DailyMed FDA label.