Rybelsus

Medically Reviewed by Dr. Harshi Dhingra, M.D.

Last Reviewed: Jan 09, 2025

Warnings


Rybelsus Risks, Warnings, and Complications


Rybelsus can cause or worsen health problems, especially in certain high-risk patients. Some of the risks of Rybelsus therapy include:

  • RISK OF THYROID TUMORS: Animal studies have indicated that Rybelsus (semaglutide) can cause an increase in the risk of thyroid cancer called thyroid C-cell tumors, including medullary thyroid carcinoma. This risk increases at higher doses and with a longer treatment duration. It is unclear if there is an increased risk of thyroid cancer related to semaglutide use in humans. However, there are reports of medullary thyroid cancer in people treated with liraglutide, which is also a GLP-1 receptor agonist. The data is insufficient, however, to establish a direct causal relationship between thyroid cancer and the use of GLP-1 receptor agonists in humans.

    People with a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 (MEN 2) should not take Rybelsus (semaglutide). 

    You should seek immediate medical attention if you develop signs and symptoms of thyroid tumors, such as a mass in the neck, hoarseness, trouble swallowing, or shortness of breath. 

  • PANCREATITIS: Controlled clinical trials have shown that people taking Rybelsus can develop pancreatitis (inflammation of the pancreas). Tell your doctor immediately or seek emergency medical attention if you develop signs and symptoms of pancreatitis, such as ongoing severe pain in the abdomen (middle or upper stomach), which may radiate to the back, with or without vomiting. You will need to stop taking Rybelsus (semaglutide oral tablets) if you develop pancreatitis.

  • VISION PROBLEMS RELATED TO DIABETIC RETINOPATHY: Taking Rybelsus has been linked to an increased incidence of diabetic retinopathy related complications in controlled trials. This risk is higher among patients with a preexisting history of diabetic eye problems. Scientists believe that the rapid improvement in blood sugar control can cause a temporary worsening of diabetic eye complications. We do not know the long-term effects of Rybelsus-induced blood sugar control on diabetic eye complications. Tell your doctor if you have a history of diabetic retinopathy. Your provider will monitor you carefully for the progression of the condition.

  • SEVERE HYPOGLYCEMIA (LOW BLOOD SUGAR): People taking Rybelsus (semaglutide) and other diabetes medications such as insulin or insulin secretagogues (sulfonylureas) are at an increased risk of severe hypoglycemia or dangerously low blood sugar. Your doctor may adjust the dose of your other diabetes medications after starting you on Rybelsus. Talk to your doctor about how to recognize hypoglycemia (low blood sugar) and what to do if it occurs.

  • ACUTE KIDNEY INJURY: There are postmarketing reports of kidney damage and worsening kidney failure, including the need for hemodialysis, related to the use of semaglutide and other GLP-1 receptor agonists. Acute kidney injury has been reported in patients with no prior history of kidney problems. Risk factors for kidney damage include dehydration, nausea, vomiting, and diarrhea. Your health care provider will monitor you for kidney problems when you first start Rybelsus (semaglutide), after an increase in the dose, or if you develop severe gastrointestinal side effects.

  • SERIOUS ALLERGIC REACTIONS: There are reports of severe allergic reactions, including anaphylaxis (throat closing) and angioedema (swelling) in patients treated with Rybelsus (semaglutide). Stop using Rybelsus and seek emergency medical care if you develop signs and symptoms of serious allergic reactions, such as skin rash, hives, itching, swelling, or difficulty breathing. People who have previously had a serious allergic reaction to Rybelsus should not take this medicine again. Rybelsus should be used with caution in people with an allergic reaction to other GLP-1 receptor agonists.

  • GALLBLADDER PROBLEMS: There are postmarketing reports of cholelithiasis (gallstones) and cholecystitis (gallbladder inflammation) related to GLP-1 receptor agonist use. Tell your doctor without delay if you develop signs and symptoms of gallbladder problems such as pain in the middle or right upper stomach, fever, or yellowing of the skin or whites of the eyes.


Precautions Before Starting Rybelsus

Tell your healthcare provider if you have ever had an allergic reaction to semaglutide (Rybelsus, Ozempic, Wegovy), any of the active or inactive ingredients in Rybelsus tablets, other GLP-1 receptor agonists, or any other medications. Your pharmacy can give you a list of ingredients. Examples of other GLP-1 receptor agonists include liraglutide (Saxenda, Victoza, in Xultophy), dulaglutide (Trulicity), lixisenatide (Adlyxin, in Soliqua), and exenatide (Bydureon, Byetta).

Give your doctor a complete list of your medications, including prescription drugs, over-the-counter medicines, vitamins, dietary supplements, and herbal products. This can help avoid serious interactions between Rybelsus and your other medications.

Give your doctor a complete medical history. Rybelsus may not be safe for people with certain medical conditions such as kidney disease, pancreatitis, gallbladder disease, or diabetic retinopathy.  

Tell your doctor if you are pregnant, could be pregnant, plan to get pregnant, or breastfeeding. Rybelsus may harm the unborn baby if used by pregnant women. Your healthcare provider will recommend stopping Rybelsus at least 2 months before a planned pregnancy. Also, tell your doctor if you are nursing an infant with breast milk.

Precautions During Use of Rybelsus

Keep all your medical and laboratory appointments while on Rybelsus. Your doctor may want to adjust the dose of your other diabetes medications based on your response to Rybelsus (semaglutide). They may also order certain blood tests to monitor you for adverse effects.

Tell your doctor if you have nausea, vomiting, diarrhea, or are unable to drink fluids by mouth, which can lead to dehydration. Also, tell your doctor if you have major changes in your diet, exercise routine, body weight, or have a fever, infection, injuries, surgery, or unusual emotional stress - these conditions can affect your blood sugar levels and how much Rybelsus (semaglutide) you need to take.

Talk to your doctor about how to recognize the signs and symptoms of hypoglycemia (low blood sugar) and what to do if it happens. The risk is higher if you are also taking other diabetes medications.

Call your doctor if you become pregnant while using Rybelsus.

Rybelsus Drug Interactions

Taking Rybelsus with certain other drugs can affect how the medications work. Interactions between medications can also increase the potential risk of serious side effects. For example, other medicines can affect how the body absorbs Rybelsus. Your physician may choose alternative medications rather than prescribe Rybelsus, change the dose of your other medicines, and/or monitor you closely for side effects if there are known interactions between Rybelsus and your other medications. Rybelsus can interact with the following medications: 

  • Insulin
  • Sulfonylureas (oral diabetes medicines), such as glipizide (Glucotrol), glimepiride (Amaryl, in Duetact), chlorpropamide (Diabinese, Glucamide), tolbutamide, glyburide (DiaBeta, Glynase), and tolazamide
  • Levothyroxine

This list does not describe all possible Rybelsus interactions. Give your healthcare professionals a complete list of your medications, including prescription drugs, over-the-counter medicines, vitamins, dietary supplements, and herbal products. Also, tell your healthcare provider if you smoke, drink alcohol, or use illegal drugs because some of these substances can cause serious health complications when used with prescription drugs.