Rybelsus Side Effects

Rybelsus is an oral semaglutide that helps improve blood sugar control in patients with type 2 diabetes. Rybelsus is a glucagon-like peptide-1 receptor agonist (GLP-1 RA), a class of medications that helps manage glucose levels. Some GLP-1 RA drugs can also help treat obesity.

Quick Terms

Semaglutide: The active ingredient in Rybelsus, Ozempic and Wegovy.
GLP-1 RA: The drug class semaglutide medications fit into.
GLP-1: A natural hormone.
RA: A synthetic substance that mimics a natural substance.

Semaglutide mimics GLP-1, a natural hormone produced in the gut that helps regulate a person’s appetite and insulin levels. The synthetic hormone increases insulin secretion when a person’s blood glucose levels are elevated. A patient with type 2 diabetes typically doesn’t produce enough insulin, which leads to high blood sugar levels. Increasing insulin secretion can help manage blood sugar levels, reducing a patient’s risk of developing low blood sugar (hypoglycemia).

Rybelsus is sometimes used off-label as a weight loss medication. It does this by reducing feelings of hunger, causing people to take in fewer calories. Rybelsus can also slow gastric emptying (food moving out of the stomach), making patients feel full for longer. However, Rybelsus is not actually approved to be a weight loss drug. Wegovy is the only semaglutide approved by the U.S. Food and Drug Administration (FDA) to aid weight loss.

Novo Nordisk makes Rybelsus and its sister drugs, Ozempic and Wegovy. Rybelsus is taken orally as a daily tablet. Ozempic and Wegovy are weekly injections. Rybelsus tablets and Ozempic injections have FDA approval to help lower blood sugar levels in adults who have type 2 diabetes. Semaglutide medications like Rybelsus can be valuable in treating type 2 diabetes. But patients should be aware of potential serious side effects before starting treatment.

Rybelsus diabetes medicine side effects can vary, and some are mild. But concerning side effects like vision loss, deep vein thrombosis (DVT) and gastroparesis have been reported. Many allege these serious side effects haven’t been adequately listed on the drug’s prescription label.

Unlisted, adverse side effects have led to numerous complaints and diabetes lawsuits against Novo Nordisk. From the drug’s approval in 2019 through 2024, more than 4,000 FDA adverse event reports have been filed involving Rybelsus. Thousands more reports concern generic semaglutide, Ozempic and Wegovy. Some of the alleged injuries include debilitating conditions like bowel obstruction. People have needed hospitalization and surgery to resolve these issues.

If you notice any side effects from taking Rybelsus, reach out to your doctor for medical advice or attention immediately. Even common side effects like nausea or constipation should be recorded and taken seriously. Because of Rybelsus risks, your healthcare provider may recommend that you stop taking it. But don’t stop taking any medication unless your physician says it’s safe to do so.

* The FDA’s Adverse Event Reporting System (FAERS) is intended to help identify safety concerns related to marketed products, but it does not prove any product or drug is linked or caused a particular side effect or injury. Reports by themselves are not an indicator of a medical product’s safety profile. In addition, FAERS may include duplicate reports or may significantly undercount injuries.

NAION/vision loss

A July 3, 2024, study linked semaglutide use to an increased risk of non-arteritic anterior ischemic optic neuropathy (NAION) for diabetic or overweight patients. NAION occurs when blood flow to the optic nerve is disturbed or cut off, which can lead to vision loss.

Dr. Joseph Rizzo called NAION “in effect, a stroke of the optic nerve.” Rizzo is the director of neuro-ophthalmology at Mass Eye and Ear in Boston and the author of the study.

The July study analyzed:

• A fivefold increase in NAION among type 2 diabetic patients taking semaglutide over type 2 diabetic patients who were not taking semaglutide.
• A more than eightfold increase in NAION among obese patients taking semaglutide over obese patients who were not taking semaglutide.

The researchers concluded that “this study’s findings suggest an association between semaglutide and NAION.” Since then, several other studies and analyses have also found a link between taking semaglutide and developing NAION and other eye diseases.

Delayed gastric emptying, stomach paralysis, gastroparesis

Multiple studies have revealed that Rybelsus may have long-term effects on a person’s gastrointestinal (GI) system. Also known as the digestive system, the GI includes the parts of the body needed to break down food and liquids and absorb nutrients.

While the listed side effects of Rybelsus focus on GI symptoms like nausea and diarrhea, semaglutide lawsuits argue that more serious side effects like gastroparesis should be listed, too.

Gastroparesis is a weakening of the stomach muscles. It’s also called delayed gastric emptying or stomach paralysis. Gastroparesis can slow or stop food from moving out of the stomach into the small intestine. People who suffer from gastroparesis can experience symptoms like:

• Abdominal pain
• Belching
• Feelings of fullness immediately after starting a meal
• Feelings of fullness long after eating a meal
• Heartburn
• Nausea
• Poor appetite
• Vomiting

More serious gastroparesis side effects include dehydration from vomiting, malnutrition from nutrients not being properly absorbed and difficulty controlling blood glucose.

Among the reports of semaglutide side effects in the FDA Adverse Events Reporting System are 790 cases of impaired gastric emptying/gastroparesis.

When a Rybelsus user experiences symptoms of gastroparesis, treatment can be difficult. A simple treatment may include changing eating habits or more invasive treatment may be necessary.

Intestinal obstruction

Semaglutide, the active ingredient in Rybelsus, has been linked to intestinal obstructions. FDA data through 2024 shows:

• 28 reports of intestinal obstructions for Rybelsus patients
• 421 reports of intestinal obstructions for semaglutide patients

Intestinal obstruction is an injury named in Rybelsus lawsuits. This refers to a partial or complete blockage of the bowel. Any contents in the intestine cannot pass through the bowel. Bowel obstruction typically has two causes:

1. A mechanical issue, where something is blocking the bowel, such as hernias, tumors, adhesions after surgery or foreign bodies that were swallowed
2. Ileus, a medical condition that causes the bowel to not function correctly and no mechanical issue causes the obstruction

Fifteen incidents of patients experiencing ileus after taking Rybelsus were reported to FAERS.

Rybelsus symptoms of an intestinal obstruction include:

• Abdominal fullness or gas
• Abdominal pain and cramping
• Abdominal swelling or distention
• Breath odor
• Constipation
• Diarrhea
• Inability to pass gas
• Vomiting

The FDA approved semaglutide in 2017 and Rybelsus in 2019. But Novo Nordisk didn’t add “Gastrointestinal: ileus” to the Rybelsus label until 2023. That was four years after the FDA approved Rybelsus and six years after it approved semaglutide.

Blood clots and deep vein thrombosis (DVT)

Deep vein thrombosis (DVT) is a serious condition of a blood clot forming inside a deep vein. They often form in large veins of a person’s lower leg and thigh. But a person can get DVT from a clot that forms in other areas of the body, including the arms or pelvis.

Symptoms of deep vein thrombosis include:

• A change of skin color on the leg
• A feeling of warmth
• Leg pain
• Leg swelling

These clots can be extremely dangerous if they break off and travel to the lungs. If a clot gets stuck in an artery in the lungs, it can cause a pulmonary embolism. This is a life-threatening condition because the clot blocks blood flow to the lungs. If you experience any of these symptoms, seek medical attention immediately.

The FDA is also investigating reports of a link between DVT and semaglutide, an active ingredient in Rybelsus. Several people have reported these conditions to the FDA Adverse Events Reporting System (FAERS). Reports include 100 suspected pulmonary embolism cases and 50 deep vein thrombosis cases. These reports are from people who have reported adverse drug effects as of December 31, 2024.

Other unlisted side effects

Many allege Rybelsus is linked to other dangerous side effects, including gastroenteritis, pulmonary aspiration, malnutrition, bone density loss and muscle loss. Each of these side effects has been reported in FAERS by patients who were prescribed Rybelsus.

• Gastroenteritis is a common stomach ailment. It’s an inflammation that begins in the stomach and moves into the intestines. Symptoms are usually pain, vomiting and diarrhea.
• Pulmonary aspiration can occur when a patient vomits and some of the liquid or solid stomach contents gets into the windpipe or lungs. It’s usually caused by poor digestion and can also happen when a patient is under anesthesia. Pulmonary aspiration can lead to severe consequences, from respiratory distress to pneumonia and even death.
• Malnutrition can occur when the body can’t absorb nutrients. This can happen when a person has long-term symptoms like vomiting and diarrhea. Both symptoms are common side effects people have reported after taking Rybelsus.
• Bone density loss can be a result of malnutrition. It’s also called soft bones. Malnutrition can cause a vitamin D deficiency that leads to loss of bone density.
• Muscle loss, or atrophy, is another condition that can stem from malnutrition. Atrophied muscles are thinner and smaller than normal.

Data tells us that the Rybelsus side effect of weight loss may lead to muscle mass loss, also called sarcopenia. This loss of muscle mass during rapid weight loss can result in decreases in stamina, strength and resting metabolic rate.

It’s common for drugs to have side effects. The side effects often show up through a combination of preclinical testing, clinical trials and post-marketing surveillance. Healthcare providers and patients can also report them.

Drug manufacturers are required to inform the public about known side effects or allergic reactions. They can use drug labels, package inserts, clinical trial publications and post-marketing surveillance reports.

Side effects of semaglutide in Rybelsus can vary widely by user but range from nausea to abdominal pain and constipation. Being aware of potential side effects is crucial to ensuring patient safety. It also ensures patients and their medical providers have the facts they need to make informed decisions.

Let’s take a closer look at what side effects have been listed on Rybelsus labels.

Most common side effects of Rybelsus

The most common reported side effects of Rybelsus include nausea, vomiting, abdominal pain, diarrhea, a decreased appetite and constipation. Patients typically report these experiences to their doctors and drug manufacturers, who in turn report them to the FDA.

Federal regulations state that when a patient has an unexpected and negative experience with a drug, the drug manufacturer should report the experience as soon as possible. They must report to the FDA no later than 15 calendar days from when they heard from the user.

During placebo-controlled clinical trials, patients with type 2 diabetes were placed in one of three groups. Each group received either a placebo or Rybelsus in a different dosage. The doses were a 7 mg dose or a 14 mg dose. A higher number of participants who took a dose of Rybelsus experienced side effects than those who were given the placebo. Common adverse reactions included:

Outside of clinical trials, all Rybelsus patients start by taking a 3 mg tablet daily for 30 days. Then, the Rybelsus dose is increased to 7 mg. If needed, patients can step up to a 14 mg dose after at least 30 days on the 7 mg dose.

Many of these most common Rybelsus adverse effects align with reports made to the FAERS.

As of year end 2024, FAERS recorded:

• 640 cases of nausea
• 409 cases of vomiting
• 301 cases of diarrhea
• 259 cases of decreased appetite

Other common reported reactions to the database include an increase in blood glucose (214),  constipation (180), headache (176) and dizziness (160).

Don’t downplay even seemingly small side effects like nausea or diarrhea. They could be signs of a more serious condition like intestinal obstruction or gastroparesis. It’s important that you talk with a healthcare professional about any side effects you experience with Rybelsus. They will help you get proper care.

Disclaimer: Reports by themselves are not an indicator of Rybelsus’ safety profile.

Serious long-term Rybelsus risks

Severe side effects can have long-term health implications. Among the most concerning long-term side effects of Rybelsus are:

• Diabetic retinopathy complications
• Difficulty controlling blood glucose levels
• Gallbladder problems
• Intestinal obstructions (ileus)
• Kidney problems
• Pancreatitis
• Thyroid tumors (Novo Nordisk also says that people with a history of the thyroid cancer medullary thyroid carcinoma (MTC) should not take Rybelsus)

Knowing the serious, long-term side effects of a medication helps patients and healthcare providers recognize early warning signs. They can get medical intervention early to prevent further complications. Rybelsus is often prescribed to help patients manage type 2 diabetes, but patients must be able to make informed decisions about their health. Using up-to-date information helps balance Rybelsus risks effectively.

What are the side effects of Rybelsus?

Common Rybelsus side effects may include:

• Abdominal pain
• Decreased appetite
• Diarrhea
• Change in blood glucose levels
• Constipation
• Headache and dizziness
• Nausea and vomiting
• Weight loss

Serious side effects have been reported. Among them are long-term conditions like blood clots and deep vein thrombosis (DVT), gastroparesis and intestinal obstructions.

Do Rybelsus side effects go away?

Some side effects of Rybelsus may ease on their own during treatment or after a patient stops taking the medication. However, some side effects can become long-term conditions that require ongoing and sometimes more complicated medical treatment.

How long do Rybelsus side effects last?

Minor side effects are most common when a patient begins taking Rybelsus or after the dose increases. These side effects may be temporary, lasting a few days to weeks. However, serious side effects may last longer and may require medical intervention. If your side effects are severe, it’s important to talk with your doctor. Do not stop taking Rybelsus unless your physician says it is safe.

Does Rybelsus cause joint pain?

Studies have not specifically linked Rybelsus to joint pain. However, on the FAERS Public Dashboard, a few patients have reported joint swelling as a side effect. This may even be a side effect connected to bone density loss or malnutrition.

Does Rybelsus make you tired?

Fatigue is a reported side effect of Rybelsus. Additional symptoms like nausea, vomiting, diarrhea, headaches and blood glucose level changes can also contribute to feeling tired. If you experience fatigue after taking Rybelsus, it’s important to consult with your doctor.

What is Rybelsus used for?

Rybelsus is an oral tablet that helps patients with Type 2 diabetes regulate blood sugar. It mimics the GLP-1 hormone, which increases insulin secretion from the pancreas when blood glucose levels are high. Rybelsus is also sometimes used off-label as a weight loss medication to control hunger and cause a person to feel full.

Our law firm has experience representing people who have severe side effects from over-the-counter and prescription drugs.

If you believe a diabetes medicine hurt you or someone you love, our attorneys may be able to help:

• Investigate if Rybelsus, or another diabetes drug, could be the cause of your medical issues
• Review if the manufacturer failed to warn you about dangerous side effects
• Identify other issues that could impact your potential claim

Our medical drug attorneys are committed to ensuring you receive the justice you deserve.

Learn more about our medical drug experience here.

Do not stop taking a prescribed medication without first consulting with your doctor. Discontinuing a prescribed medication without your doctor's advice can result in injury or death. Rybelsus, Ozempic and Wegovy remain approved by the U.S. Food and Drug Administration.