Ozempic Safety Information

Ozempic (Semaglutide)

Warning: Risk of Thyroid C-Cell Tumors

In animal studies, semaglutide - the active ingredient in Ozempic - caused thyroid C-cell tumors, including thyroid cancer. It is not known whether Ozempic causes thyroid tumors, including medullary thyroid carcinoma (MTC), in humans.

Tell your healthcare provider right away if you notice a lump or swelling in your neck, hoarseness, difficulty swallowing, or shortness of breath. These may be symptoms of thyroid cancer.

Do not use Ozempic if you or any member of your family has ever had medullary thyroid carcinoma (MTC) or if you have an endocrine condition known as Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

FDA-Approved Uses

Ozempic (semaglutide) is a glucagon-like peptide-1 (GLP-1) receptor agonist approved by the U.S. Food and Drug Administration (FDA) to:

• Improve blood sugar control in adults with type 2 diabetes mellitus, alongside diet and exercise.

• Reduce the risk of major adverse cardiovascular events (such as heart attack, stroke, or cardiovascular death) in adults 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 indicated for treatment of type 1 diabetes mellitus.

• Your provider may, under medical discretion, prescribe semaglutide for chronic weight management in adults with obesity or overweight.

Who Should Not Use Ozempic

Do not use Ozempic if:

• You or a family member has ever had medullary thyroid carcinoma (MTC).

• You have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

• You are allergic to semaglutide or any of its ingredients.

How to Use Ozempic

Ozempic is administered as a subcutaneous injection (under the skin) once per week, on the same day each week, in the stomach, thigh, or upper arm. Rotate injection sites with each dose. It may be taken with or without food.

Do not adjust your dose or stop treatment without speaking to your healthcare provider. Your provider may guide you through gradual dose increases to minimize side effects.

Before Using Ozempic - Tell Your Healthcare Provider

Tell your healthcare provider about all medications you take, including:

• Prescription and over-the-counter drugs

• Vitamins and herbal supplements

• Dietary supplements or weight-loss products

Possible drug interactions include:

• Diabetes medications: Combining Ozempic with insulin or sulfonylureas (such as glipizide or glimepiride) may increase the risk of hypoglycemia (low blood sugar).

• Other GLP-1 receptor agonists: Do not combine Ozempic with Wegovy, Saxenda, Victoza, Byetta, or Bydureon.

• Oral medications: Ozempic delays gastric emptying, which can affect absorption of medications taken by mouth. Your provider can help you schedule dosing appropriately.

Provide a complete medical history, especially if you have or have ever had:

• Type 1 or type 2 diabetes

• Thyroid disorders or cancer

• Pancreatitis

• Kidney disease or liver disease

• Diabetic retinopathy

• Depression or suicidal thoughts

Pregnancy and breastfeeding:

• Ozempic should not be used during pregnancy. Weight loss during pregnancy provides no benefit and may harm the unborn baby.

• Stop Ozempic at least 2 months before a planned pregnancy, as the drug remains in the body for an extended time.

• It is not known whether Ozempic passes into human breast milk. Discuss risks and benefits with your provider before breastfeeding.

Pregnancy registry: Women exposed to semaglutide during pregnancy and their healthcare providers are encouraged to enroll in the Semaglutide Pregnancy Registry by contacting 1-800-727-6500.

Providing inaccurate or incomplete health information may lead to serious harm.

Serious Side Effects - Seek Medical Help Immediately

Call 911 or seek emergency care if you experience any of the following:

• Thyroid tumors: Lump in the neck, hoarseness, trouble swallowing, or shortness of breath.

• Pancreatitis: Severe, persistent abdominal pain (may radiate to the back), with or without vomiting.

• Diabetic retinopathy: Sudden or worsening vision changes.

• Severe allergic reaction: Swelling of the face, lips, tongue, or throat; rash; itching; trouble breathing; or dizziness/fainting.

• Gallbladder problems: Upper abdominal pain, jaundice (yellow skin or eyes), fever, or pale stools.

• Acute kidney injury: Nausea, vomiting, or dehydration that worsens existing kidney issues.

• Hypoglycemia (low blood sugar): Dizziness, sweating, mood changes, blurred vision, or rapid heartbeat - especially if using insulin or other diabetes medication.

• Increased heart rate: Report persistent racing heartbeat at rest.

• Suicidal thoughts or mood changes: Contact your provider immediately if you notice new or worsening mental-health symptoms.

Never share your injection pen with another person. Pen-sharing can spread infections.

Most Common Side Effects

The most frequently reported side effects of Ozempic include:

• Nausea

• Vomiting

• Diarrhea

• Stomach pain

• Constipation

These effects are typically mild to moderate and often decrease as your body adjusts to treatment.

Reporting Adverse Events

To report side effects or adverse reactions:

• Contact US Quick Health Support or your licensed healthcare provider, or

• Report directly to the U.S. Food and Drug Administration (FDA) via www.fda.gov/medwatch or call 1-800-FDA-1088.

Additional Information

This summary does not include all potential safety information. Refer to the full FDA-approved Prescribing Information or speak to your healthcare provider for complete details.