Safety Information for Ozempic®

1. What can Ozempic® be prescribed for?

Ozempic® is a GLP-1 receptor agonist that can be prescribed for the following:

• Improving blood sugar control (FDA-approved use): Ozempic® is approved for use by adults with type 2 diabetes to manage their blood sugar levels.
• Reducing heart risk (FDA-approved use): For those with type 2 diabetes and heart disease, Ozempic® lowers the risk of major cardiovascular events like heart attacks and strokes.
• Weight loss (off-label): Ozempic® can be prescribed to help with weight loss by regulating appetite and promoting gradual weight reduction.

 
Limitations of use:

• Ozempic® has not been studied in people with a history of pancreatitis. If you have or have had this condition, your healthcare provider may recommend other treatments.
• Ozempic® is not intended for treating type 1 diabetes.

For more details, please see the official prescribing information for Ozempic®.

2. Who should not use Ozempic®?

Your doctor will not prescribe Ozempic® if:

• You or a family member has had medullary thyroid carcinoma (MTC) or if you have a condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
• You are allergic to semaglutide or any other ingredient in Ozempic®. If you’re concerned about allergic reactions, check the section on possible side effects for more details.

 
Before starting Ozempic®, make sure to inform your healthcare provider if you:

• Have had any issues with your pancreas or kidneys in the past.
• Have a history of eye problems including diabetic retinopathy, as this could affect your treatment.
• Are pregnant, planning to become pregnant, or are breastfeeding. The effects of Ozempic® on an unborn baby or in breast milk aren’t fully known. You will need to stop using Ozempic® at least two months before trying to conceive.

3. How do I take Ozempic®?

Ozempic® is a once-a-week shot taken under the skin, usually on your belly, thigh, or upper arm. To avoid irritation, remember to rotate your injection sites. The pre-filled pen is easy to use and should be stored in the refrigerator until you’re ready to use it. Ozempic® can be taken with or without food.

4. What should I tell my doctor before starting the medication?

Before you start Ozempic®, it’s important to share some key information.

Medical history

Discuss any health conditions you have or that are in you family history, such as:

• Type 1 diabetes: Ozempic® is not intended for treating type 1 diabetes.
• Thyroid cancer: Ozempic® carries a boxed warning for the potential risk of thyroid tumors, including cancer. If you or a family member have a history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2), do not use Ozempic®. While rodent studies showed a link between Ozempic® and thyroid tumors, it’s unclear if this applies to humans.
• Allergies: Inform your clinician if you’re allergic to semaglutide or any of the ingredients in Ozempic®.
• Pancreas problems: If you’ve had pancreatitis (inflammation of the pancreas), Ozempic® is not recommended.
• Gallbladder issues: Ozempic® can worsen gallbladder disease; let your clinician know if you’ve had problems in the past.
• Kidney or liver problems: Ozempic® may need to be used cautiously if you’ve had kidney or liver issues.
• Eye problems: Ozempic® can sometimes worsen diabetic retinopathy.

Always provide accurate and complete information about your health. Not sharing important details can lead to serious risks and complications. This helps your clinician ensure Ozempic® is safe for you.

Medications and supplements

List all the medications and supplements you’re currently taking, including:

• Prescription drugs
• Over-the-counter medications
• Vitamins
• Herbal or dietary supplements

Ozempic® can interact with certain medications, particularly those used to treat diabetes. Be sure to mention if you’re taking:

• Insulin (Lantus, Humalog, Novolog):
  May increase the risk of low blood sugar (hypoglycemia) in people with type 2 diabetes.
• Sulfonylureas (Glipizide, Glyburide, Glimepiride):
  May increase the risk of low blood sugar (hypoglycemia) in people with type 2 diabetes.
• Other GLP-1 medications (Trulicity, Wegovy, Saxenda, Zepbound, Mounjaro, Victoza, Rybelsus):
  There have not been enough clinical studies to determine the safety and efficacy of combining GLP-1s.
• Medications for cutaneous T-cell lymphoma (CTCL) (Bexarotene):
  May increase the probability of pancreatitis or inflammation of the pancreas.
• Medications that can affect blood glucose levels (Gatifloxacin):
  May cause severe levels of hypoglycemia (low blood sugar) that can result in death.

When considering Ozempic®, be aware it may interact with other medications. Since it slows stomach emptying, it can affect how your body absorbs oral medications. Your clinician will guide you on how to schedule your medications. Always check with your clinician before combining any medication with Ozempic®.

Pregnancy and breastfeeding

If you’re pregnant, planning to become pregnant, or breastfeeding, please inform your healthcare provider.

• You cannot use Ozempic® during pregnancy due to potential risks to the baby. Women who are planning to become pregnant should stop using Ozempic® at least two months before trying to conceive.
• If you’re breastfeeding, tell your clinician. There’s no information on how Ozempic® affects breast milk or the baby and you shouldn’t use it while breastfeeding.

If you find out you’re pregnant while taking Ozempic®, reach out to your doctor immediately. There’s also a pregnancy registry to help track outcomes. You and your healthcare provider can call Novo Nordisk at 1-800-727-6500 to report the exposure and get registered.

For more information, check the Ozempic® prescribing information.

5. Ozempic® side effects

Your health is important to us. We want to ensure you’re informed about Ozempic®’s potential side effects, both common and serious.  Below is an overview of potential side effects, starting with common ones and followed by more serious concerns.

Most common side effects

Ozempic® may cause some common side effects, which are often temporary and more likely to occur when you’re new to the medication or increasing your dose. These can include:

• Nausea
• Vomiting
• Diarrhea
• Abdominal pain
• Constipation
• Fatigue

While there are no foods you must completely avoid, certain foods can impact the effectiveness of Ozempic® or worsen side effects. Some foods may also worsen common side effects of Ozempic®, so be cautious when consuming them. Limiting sugary drinks, fried foods, and gas-forming vegetables can help. Learn more about managing your diet with Ozempic®.

If you’re looking for a structured approach, Noom’s color-coded food system can guide you toward better food choices.

Serious side effects and warnings

Ozempic® can cause serious side effects (including a boxed warning for certain serious side effects). If you experience any of the following, get immediate medical care:

• Thyroid tumors: Watch for a lump or swelling in your neck, hoarseness, difficulty swallowing, or shortness of breath. Increased risk of thyroid tumors has been observed in animal studies.
• Pancreatitis: Look out for severe, persistent stomach pain that may radiate to your back, with or without vomiting.
• Vision changes: Inform your clinician if you notice any changes in your vision while using Ozempic®. For any sudden vision changes, get immediate medical attention.
• Low blood sugar (hypoglycemia): If you have diabetes and use Ozempic® with other medications that lower blood sugar, like sulfonylureas or insulin, you might experience low blood sugar. Symptoms include dizziness, blurred vision, anxiety, irritability, sweating, confusion, shakiness, weakness, headache, and fast heartbeat.
• Kidney problems: Ozempic® may worsen kidney issues, especially if you have diarrhea, nausea, or vomiting, leading to dehydration. Symptoms of kidney problems can include swelling in your legs or ankles, fatigue, shortness of breath, or changes in urination. Drink plenty of fluids to help prevent dehydration.
• Allergic reactions: Stop using Ozempic® and seek immediate medical help if you experience severe allergic reactions such as swelling of the face, lips, tongue, or throat, trouble breathing or swallowing, severe rash or itching, fainting, dizziness, or rapid heartbeat.
• Gallbladder issues: If you experience upper stomach pain, fever, yellowing of the skin or eyes, or clay-colored stools, get medical attention.

For more detailed information about side effects, visit the Ozempic® side effects website and/or contact your healthcare provider.

6. Who should I contact if I have questions or concerns?

• Consult your doctor or clinician for guidance if you’re experiencing mild side effects.
• Call 911 immediately if you think you are having a medical emergency
• If you have product questions or need to report side effects, contact Novo Nordisk Inc. at https://www.novonordisk-us.com/contact-us.html. 
• You can also report negative side effects to the FDA at www.fda.gov/medwatch or call 1-800-FDA-1088.

Ozempic® prescribing information