Ozempic®: FDA Warning Label Information

Ozempic® is a glucagon-like peptide 1 (GLP-1) receptor agonist drug made by Novo Nordisk. Its active ingredient is semaglutide. Ozempic is FDA-approved for patients with type 2 diabetes to manage blood sugar and reduce the risk of heart attack and stroke.

Current FDA Ozempic labels include the following side effects under the warnings and precautions section:

• Acute gallbladder disease
• Acute kidney injury
• Hypersensitivity reactions (severe immune responses/allergic reactions)
• Hypoglycemia (extremely low blood sugar)
• Loss of vision caused by diabetic retinopathy
• Pancreatitis
• Risk of thyroid c-cell tumors

Recent updates to Ozempic warning label

FDA Ozempic warnings were most recently updated in September 2023 to include ileus in the drug’s list of adverse reactions. Ileus is included under the section on postmarketing experience. The label states that postmarketing warnings stem from patients’ voluntarily reported reactions to a medication.

Ileus is a severe medical condition caused by a temporary lack of movement in the intestines. It prevents food and waste from moving through the body. Symptoms of ileus can cut off the blood supply to the intestines, causing tissue death. Ileus can also cause pain, infections and intestinal tearing. In some cases, the buildup of unpassed food can create a blockage.

Other adverse reactions listed on Ozempic’s label include:

• Abdominal pain
• Constipation
• Diarrhea
• Dizziness
• Fatigue
• Increased heart rate
• Injection-site reactions
• Nausea
• Vomiting

Conditions not on Ozempic’s FDA warning label

Ozempic lawsuit plaintiffs and plaintiffs injured by other GLP-1 RA medications commonly suffer from severe gastrointestinal and digestive issues. Although Ozempic’s label mentions delayed gastric emptying under drug interactions, it doesn’t mention gastroparesis (stomach paralysis) as a risk or warn against it. However, delayed stomach emptying may lead to this permanent and life-threatening condition.

In addition to experiencing gastrointestinal problems and gastroparesis, plaintiffs in diabetes lawsuits and weight loss drug lawsuits have experienced the following off-label side effects from Ozempic and other GLP-1 RA medications:

• Deep vein thrombosis (DVT): Deep vein thrombosis (DVT) is the formation of a blood clot in one of the body’s deep veins, usually in the legs. When blood clots break loose, they can travel through the bloodstream and stick in the lungs, causing a potentially fatal condition called a pulmonary embolism (PE). Studies find that taking semaglutide can increase the risk of developing DVT by 266%. Semaglutide is the active ingredient in Ozempic, Wegovy and Novo Nordisk’s oral diabetes drug, Rybelsus®.
• Esophageal injury: Research links GLP-1 RA medications to a higher risk of acid reflux disease and a severe form of acid reflux called gastroesophageal reflux disease (GERD). GERD can cause more serious esophageal injuries, including inflammation of the esophagus, narrowing of the esophagus and precancerous changes known as Barrett esophagus.
• Intraoperative aspiration: On June 29, 2023, the American Society of Anesthesiologists warned that Ozempic users should stop taking the medication at least one week before elective surgery. Because GLP-1 RAs delay gastric emptying, patients under anesthesia are at an increased risk of regurgitating and aspirating (inhaling) food into the lungs and airways.
• Malnutrition: Ozempic and other diabetes and weight loss medications reduce appetite and slow digestion, which can lead to malnutrition. Users may not get enough calories, protein, calcium, vitamin D and other essential nutrients. Malnutrition can lead to symptoms like bone pain, muscle pain, fatigue and weakness.
• Vision loss: Semaglutide is linked to diabetic retinopathy (which its label warns of) and a condition called nonarteritic anterior ischemic optic neuropathy (NAION). NAION occurs when a lack of blood flow to the optic nerve causes nerve damage. NAION is a leading cause of blindness in adults.

On December 5, 2017, Novo Nordisk received FDA approval for Ozempic to treat type 2 diabetes in adults. On January 16, 2020, the FDA approved the medication to reduce the risk of cardiovascular events (stroke and heart attack) in adults with type 2 diabetes and known heart disease.

Ozempic is not approved for weight loss, but it has become increasingly popular as off-label weight loss and obesity medication. Its sister medication, Wegovy®, is FDA-approved for this use. Wegovy is a once-weekly injectable or once-daily oral tablet made by Novo Nordisk. It has the same active ingredient (semaglutide) and is very similar to Ozempic.

The FDA approved Wegovy to treat obesity and encourage weight loss in adults on June 4, 2021. Drug approval was expanded to include treatment of teens aged 12 and older on December 23, 2022. On March 8, 2024, the FDA approved it to reduce the risk of cardiovascular events in overweight and obese patients with established cardiovascular disease.

If you or someone you love suffered harm caused by a medication used to treat type 2 diabetes or chronic weight management, you may be eligible for legal action. You could recover compensation for medical bills, lost wages, pain, suffering and more.

Our attorneys have represented thousands of victims hurt by prescription and over-the-counter medications. Our law firm can:

• Review your claim and discuss your options
• Investigate the medication that caused your injury
• Review the drug’s FDA label and the manufacturer’s compliance with FDA regulations
• Inform you about issues that could affect your case

Read more on our medical drug litigation experience.

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. Ozempic, Wegovy, Rybelsus remain approved by the U.S. Food and Drug Administration.