Wegovy® Oral Safety Information

Wegovy® oral contains semaglutide, the same active ingredient used in certain injectable GLP-1 medications. While the method of administration differs (oral tablet vs. injection), the safety profile and boxed warning are based on semaglutide itself.

Boxed Warning: Risk of Thyroid C-Cell Tumors

In studies in rodents, semaglutide caused thyroid C-cell tumors, including medullary thyroid carcinoma (MTC). It is unknown whether semaglutide causes thyroid C-cell tumors, including MTC, in humans.

Do not use Wegovy® oral if:

• You or any family member has ever had medullary thyroid carcinoma (MTC)
• You have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)

Tell your provider right away if you experience:

• A lump or swelling in the neck
• Hoarseness
• Trouble swallowing
• Shortness of breath

These may be symptoms of thyroid cancer.

What Is Wegovy® Oral Used For?

Wegovy® oral is prescribed, along with a reduced-calorie diet and increased physical activity, to:

Help reduce excess body weight and maintain weight loss long-term in adults with:

• BMI ≥ 30 kg/m² (obesity), or
• BMI ≥ 27 kg/m² (overweight) with at least one weight-related condition (such as hypertension, type 2 diabetes, or dyslipidemia)

It may also be prescribed to reduce the risk of major cardiovascular events (such as heart attack, stroke, or cardiovascular death) in adults with established cardiovascular disease and overweight or obesity.

Important Differences: Oral vs. Injectable Wegovy®

• Wegovy® Oral: Taken once daily by mouth.
• Wegovy® Injectable: Administered once weekly via subcutaneous injection.

Both formulations contain semaglutide and share similar safety warnings and contraindications. Dosing schedules, titration plans, and administration instructions differ. Follow your provider’s guidance carefully.

Do Not Use Wegovy® Oral With

• Other semaglutide-containing products
• Any other GLP-1 receptor agonist medications

Who Should Not Use Wegovy® Oral?

Do not use if:

• You or a family member has had MTC
• You have MEN 2
• You have had a serious allergic reaction to semaglutide

Before Taking Wegovy® Oral, Tell Your Provider If You:

• Have type 1 or type 2 diabetes
• Have a history of pancreatitis
• Have kidney problems
• Have diabetic retinopathy
• Have depression or a history of suicidal thoughts
• Are pregnant, planning pregnancy, or breastfeeding

Pregnancy & Reproductive Planning

Wegovy® should not be used during pregnancy.

Stop Wegovy® at least 2 months before a planned pregnancy.

There is no benefit to weight loss during pregnancy and it may harm an unborn baby.

A pregnancy registry is available for women exposed to semaglutide during pregnancy.

Drug Interactions

Wegovy® oral may delay gastric emptying and affect how other oral medications are absorbed.

Tell your provider if you take:

• Insulin or sulfonylureas
• Other GLP-1 medications
• Prescription, OTC medications, vitamins, or supplements
• Other weight-loss products

Serious Side Effects

Seek medical attention immediately if you experience symptoms of:

• Thyroid tumors, neck lump, hoarseness, swallowing difficulty
• Pancreatitis, severe abdominal pain that may radiate to the back
• Gallbladder disease, upper stomach pain, jaundice, fever
• Low blood sugar, especially if taking insulin or sulfonylureas
• Kidney problems, especially with dehydration from vomiting or diarrhea
• Serious allergic reactions, swelling of face or throat, difficulty breathing
• Vision changes, particularly in patients with type 2 diabetes
• Increased heart rate
• Mood changes or suicidal thoughts

Most Common Side Effects

• Nausea
• Diarrhea
• Vomiting
• Constipation
• Abdominal pain
• Headache
• Fatigue
• Dizziness
• Indigestion
• Gas or bloating

Side effects are most common during dose escalation.

Additional Safety Notes

• Do not adjust your dose without speaking to your provider.
• Do not combine with other GLP-1 medications.
• Provide complete and accurate medical history to avoid serious harm.

Reporting Side Effects

Contact:

Novo Nordisk: 1-833-934-6891
FDA MedWatch: 1-800-FDA-1088 or www.fda.gov/medwatch

This summary does not replace full Prescribing Information. Review complete prescribing information before initiating treatment.

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