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Ozempic® Important Safety Information | WW USA

Important Ozempic® Safety Information

Most Important Safety Information

  • Risk of thyroid C-Cell tumors. In studies with mice and rats, semaglutide (the active ingredient in Ozempic) caused thyroid C-cell tumors, including medullary thyroid cancer. It is not known if Ozempic will cause thyroid C-cell tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people. Tell your provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer.
  • Do not use Ozempic if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
  • Do not use Ozempic if you have had a serious allergic reaction to semaglutide or any of the ingredients in Ozempic.

What is the FDA-approved use of Ozempic?

Ozempic is a glucagon-like peptide-1 (GLP-1) receptor agonist that is used:

  • with diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.
  • to reduce the risk of major adverse cardiovascular events in patients with type 2 diabetes mellitus and established cardiovascular disease.

Limitations of Use:

  • Ozempic has not been studied in patients with a history of pancreatitis.
  • Ozempic is not for treatment of type 1 diabetes mellitus.

What should I tell my provider before using Ozempic?

Drugs you are taking. It’s important to tell your provider all of the medications you are currently taking, including prescription, over-the-counter medications, vitamins, and herbal and dietary supplements.

Your entire medical history. In particular, tell your provider if you have a past history of:

  • Type 1 or type 2 diabetes
  • Medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
  • Pancreatitis
  • Gallbladder Issues
  • Severe problems with your stomach, including gastroparesis or problems digesting food
  • Kidney disease
  • Diabetic retinopathy
  • History of Eating Disorders
  • Depression
  • Suicidal thoughts or behavior, or other mental health issues
  • History of a suicide attempt

Whether you are pregnant, planning to become pregnant, or breastfeeding.

If you are pregnant: Ozempic should not be used during pregnancy. Based on animal studies, there may be potential risks to an unborn baby from exposure to Ozempic during pregnancy. There is no benefit to weight loss during pregnancy and it may cause harm to the unborn baby.

If you are a female or male of reproductive potential: Discontinue Ozempic at least 2 months before a planned pregnancy since the drug can stay in the bloodstream for a long time.

If you are breastfeeding: Ozempic was found in the milk of lactating rats. Tell your WeightWatcher Clinic provider if you are breastfeeding before you start Ozempic.

Pregnancy registry: There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to semaglutide (the active ingredient in Ozempic) during pregnancy. Pregnant women exposed to these products and healthcare providers are encouraged to contact Novo Nordisk at 1-800-727-6500.

Withholding or providing inaccurate information about your health and medical history in order to obtain treatment may result in harm, including, in some cases, death.

What drug interactions do I need to be aware of?

Some medications to watch out for include:

  • Insulin
  • Sulfonylureas (these can cause blood sugar levels to drop dangerously low when combined with Ozempic)
  • Hormonal birth control pills (Ozempic may decrease its efficacy, especially after the first dose)
  • Other GLP-1 or GLP-1/GIP receptor agonist medications such as liraglutide, dulaglutide, or tirzepatide
  • You should limit your alcohol intake while taking this drug because alcohol can lower blood sugar. Combining alcohol with Ozempic may cause blood sugars to fall too fast, leading to fainting and dizziness.
  • If you’re using other products for weight loss, including dietary supplements

What are the most serious side effects that I or a caregiver should monitor for when taking Ozempic?

If you are experiencing a medical emergency, call 911 or seek immediate medical attention.

These serious side effects can occur with Ozempic. You or a caregiver should carefully monitor for these side effects, especially in the beginning of treatment and with dose changes.

  • Thyroid C-Cell Tumors: In mice and rats, semaglutide (the active ingredient in Ozempic) caused an increase in thyroid C-cell tumors, including medullary thyroid carcinoma (MTC). It is unknown whether Ozempic causes thyroid C-cell tumors in humans. There were cases of MTC reported in patients who took liraglutide (the active ingredient in Victoza and Saxenda) after the drug was put on the market. Ozempic is contraindicated in patients with a family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Tell your provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer.
  • Inflammation of Pancreas (Acute Pancreatitis): Monitor for signs of acute pancreatitis, including severe abdominal pain that does not go away, sometimes radiating to the back, with or without vomiting.
  • Acute Gallbladder Disease: Ozempic may cause gallbladder problems, including gallstones. Some gallbladder problems require surgery. Tell your provider right away if you have pain in your upper stomach, yellowing of skin or eyes (jaundice), fever, or clay-colored stools.
  • Low Blood Sugar (hypoglycemia): Ozempic lowers blood glucose. It can cause too low blood sugar in patients with type 2 diabetes who also take another glucose control medication. Monitor your blood sugar and watch out for signs of too low blood sugar such as dizziness, blurred vision, mood changes, sweating, or fast heartbeat.
  • Acute Kidney Injury: In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration) which may cause kidney problems to get worse. It is important for you to drink plenty of water to help reduce your chance of dehydration.
  • Serious Allergic Reactions: Stop using Ozempic right away if you experience symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, severe rash or itching, very rapid heartbeat, problems breathing or swallowing, or fainting or feeling dizzy.
  • Diabetic Retinopathy Complications in Patients with Type 2 Diabetes: If you have type 2 diabetes, tell your provider right away if you experience changes in vision.
  • Increase in Heart Rate: Tell your provider right away if you have a racing heartbeat while at rest.
  • Suicidal Behavior and Ideation: You should pay attention to any mental health changes, especially sudden changes in your mood, behaviors, thoughts, or feelings. Call your healthcare provider right away if you have any mental changes that are new, worse, or worry you.
  • Never Share a Pen: Pen-sharing poses a risk of infection.

These common side effects can occur with Ozempic.

  • Nausea
  • Diarrhea
  • Vomiting
  • Constipation
  • Abdominal pain

You are encouraged to report negative side effects of prescription products:

Contact Novo Nordisk Inc. at 1-833-934-6891

Contact FDA MedWatch at 1-800-FDA-1088 or visit fda.gov/medwatch

This information is not comprehensive. Please see the full Prescribing Information for complete safety information.

Disclaimer: Ozempic® is a registered trademark of Novo Nordisk.