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Common listed Rybelsus® side effects include nausea, vomiting, diarrhea, constipation and abdominal pain.
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Common listed Rybelsus® side effects include nausea, vomiting, diarrhea, constipation and abdominal pain. Studies also show a concerning link between Rybelsus, a semaglutide drug like Ozempic®, and serious side effects that are not or weren’t initially warned of, like deep vein thrombosis, gastroparesis and ileus (intestinal obstruction).
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. Rybelsus 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. The semaglutide activates the GLP-1 receptors, reducing feelings of hunger. Rybelsus can also slow gastric emptying, making patients feel full for longer. However, Wegovy is the only semaglutide approved by the U.S. Food and Drug Administration (FDA) to aid weight loss.
Novo Nordisk makes Rybelsus in addition to Ozempic and Wegovy, two other semaglutide drugs. 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. Wegovy injections are approved to help adults and children 12 and older lose weight. Wegovy is the only semaglutide Novo Nordisk makes that’s approved to treat obesity.
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 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. There have been more than 3,300 FDA adverse event reports filed for Rybelsus. Thousands more reports concern Ozempic and Wegovy. Some of the alleged injuries include debilitating conditions like deep vein thrombosis, gastroparesis and bowel obstruction.
If you notice any side effects from taking Rybelsus, reach out to your doctor for medical advice or attention immediately. 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.
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:
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 lung. If you are experiencing any of these symptoms you need to seek medical attention immediately.
The FDA is also investigating reports of a link between DVT and semaglutide, an active ingredient in Rybelsus. This semaglutide side effect hasn’t attracted much attention. But facts from the FDA Adverse Events Reporting System (FAERS) should concern everyone using the drug. Reports include 57 suspected pulmonary embolism cases and 19 deep vein thrombosis cases. These reports are from people who have reported adverse drug effects.
Patients with Type 2 diabetes and who are obese are at an increased risk of developing a DVT. The risk increases because being overweight can increase pressure in the veins. This reality makes these suspected cases of adverse reactions to semaglutide even more alarming.
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:
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 271 cases of impaired gastric emptying.
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.
Semaglutide, the active ingredient in Rybelsus, has been linked to intestinal obstructions. FDA data for the first half of 2024 shows:
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:
10 incidents of patients experiencing ileus after taking Rybelsus were reported to FAERS.
Rybelsus symptoms of an intestinal obstruction include:
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.
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:
The researchers concluded that “this study’s findings suggest an association between semaglutide and NAION.”
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.
If you or a loved one experienced a serious unlisted Rybelsus side effect, you may be eligible to sue Novo Nordisk, the manufacturer of Rybelsus, Wegovy and Ozempic.
Complete this webform or call 1.800.768.4026 to contact attorneys Sara Couch or Jonathan Orent for more information or to discuss a potential claim.
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.
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 Rybelsus experienced side effects than those who were given the placebo. Common adverse reactions included:
Side Effect | % on Placebo | % on 7 mg dose | % on 14 mg dose |
Nausea | 6% | 11% | 20% |
Abdominal pain | 4% | 10% | 11% |
Diarrhea | 4% | 9% | 10% |
Decreased appetite | 1% | 6% | 5% |
Vomiting | 3% | 6% | 8% |
Constipation | 2% | 6% | 5% |
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 July 15, 2024, FAERS has recorded:
Other common reported reactions to the database include an increase in blood glucose (184), weight loss (167), headache (145), constipation (130) and dizziness (127).
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. In addition, FAERS may include duplicate reports or may significantly undercount the number of women whose copper IUDs have broken during removal.
Severe side effects can have long-term health implications. Among the most concerning long-term side effects of Rybelsus are:
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.
Common Rybelsus side effects may include:
Serious side effects have been reported. Among them are long-term conditions like blood clots and deep vein thrombosis (DVT), gastroparesis and intestinal obstructions.
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.
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.
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.
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.
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:
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.
What is Rybelsus?
Unlisted side effects of Rybelsus
Listed Rybelsus side effects
Frequently asked questions about Rybelsus side effects
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Sara Couch is a trial lawyer who contributes to litigation across several of the firm’s practice areas, including defective medical devices, toxic exposure, consumer protection, and technology & privacy actions.
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Jonathan Orent is a seasoned trial lawyer who advocates for people hurt by medical devices, pharmaceutical drugs, social media addiction and other consumer products.
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