Important Safety Information for Oral Semaglutide

What is Oral Semaglutide?

Oral Semaglutide is a prescription sublingual (under-the-tongue) formulation of semaglutide, a GLP-1 receptor agonist medication for weight management. Used alongside diet and exercise, it helps reduce appetite and caloric intake for sustainable weight loss in adults with obesity or overweight with weight-related health conditions. This needle-free option provides an alternative for patients who prefer not to inject.

Boxed Warning: Thyroid C-Cell Tumor Risk

Semaglutide causes thyroid C-cell tumors in rodents at clinically relevant exposures. It is unknown whether semaglutide causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans. Semaglutide should not be used in patients with a personal or family history of MTC or in patients with MEN 2.

Alert your healthcare provider immediately if you develop:

• A lump or swelling in your neck
• Persistent hoarseness
• Difficulty swallowing
• Breathing difficulties

Who Should Not Use Oral Semaglutide?

This medication is contraindicated if you:

• Have a personal or family history of medullary thyroid carcinoma (MTC)
• Have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
• Have previously had a severe allergic reaction to semaglutide
• Have active pancreatitis or a history of recurrent pancreatitis
• Are pregnant or planning to become pregnant
• Are breastfeeding

Warnings and Precautions

1. PancreatitisAcute and chronic pancreatitis have been reported with GLP-1 medications. Immediately discontinue oral semaglutide if you experience severe, persistent abdominal pain—particularly if it radiates to your back—with or without vomiting. Do not restart if pancreatitis is confirmed.

2. Diabetic RetinopathyPatients with type 2 diabetes and existing diabetic eye disease may experience temporary worsening of retinopathy when blood sugar improves rapidly. Report any vision changes to your healthcare provider promptly.

3. HypoglycemiaUsing oral semaglutide with insulin or sulfonylureas increases low blood sugar risk. Be aware of hypoglycemia symptoms and always carry fast-acting glucose. Your provider may reduce doses of other diabetes medications.

4. Acute Kidney InjuryDehydration from GI side effects can lead to kidney problems. Those with existing kidney disease face higher risk. Report severe nausea, vomiting, or diarrhea to your provider and maintain adequate fluid intake.

5. Gallbladder DiseaseGLP-1 medications may increase gallstone and cholecystitis risk. Seek medical attention for severe upper abdominal pain, fever, or jaundice.

6. Hypersensitivity ReactionsSerious allergic reactions including anaphylaxis and angioedema have occurred. Discontinue immediately and seek emergency care if you experience severe rash, facial swelling, breathing difficulty, or signs of shock.

7. Heart Rate ElevationSome patients experience increased resting heart rate. Discuss with your provider if you have heart disease or notice persistent rapid heartbeat.

8. Mental Health EffectsWhile uncommon, mood changes, depression, and suicidal thoughts have been reported with weight loss medications. Contact your healthcare provider immediately if you experience changes in mood or thoughts of harming yourself.

9. Surgical and Anesthesia ConsiderationsSemaglutide slows gastric emptying, potentially affecting anesthesia safety. Inform your surgical team about this medication before any procedure requiring sedation.

Common Side Effects

Frequently reported side effects:

• Nausea (most common)
• Vomiting
• Diarrhea
• Constipation
• Abdominal pain or discomfort
• Heartburn
• Belching
• Bloating
• Gas
• Headache
• Dizziness
• Fatigue
• Reduced appetite

Side effects typically occur during dose initiation or escalation and generally improve with continued use.

Pregnancy and Breastfeeding

Pregnancy: Do not use oral semaglutide during pregnancy. Weight loss offers no benefit and may harm the developing baby. Animal reproduction studies indicate risk. Discontinue at least 2 months before a planned pregnancy due to the medication's long half-life.

Breastfeeding: It is not known if semaglutide passes into breast milk. Potential risks to nursing infants have not been studied. Work with your healthcare provider to determine whether to stop nursing or stop the medication.

Drug Interactions

Discuss all medications with your healthcare provider, including:

• Insulin and sulfonylureas – may require dose reduction to prevent hypoglycemia
• Oral contraceptives – backup contraception recommended
• Levothyroxine – may need monitoring as semaglutide may affect absorption
• Warfarin – increased monitoring may be needed
• Any medications with narrow therapeutic windows

Do not combine with other semaglutide products, other GLP-1 agonists, or tirzepatide.

How to Take Oral Semaglutide

• Administer the prescribed dose under your tongue using the provided syringe
• Hold the liquid under your tongue for at least 90 seconds to allow absorption
• Do not eat, drink, or take other medications for at least 30 minutes after your dose
• Take at a consistent time daily (many patients prefer morning)
• Follow your prescribed dosing schedule—do not adjust doses without provider guidance
• Begin with the starter dose and increase only as directed by your healthcare provider

Storage Instructions

• Keep at room temperature between 59°F and 86°F (15°C to 30°C)
• Protect from light and heat
• Do not freeze
• Keep the container tightly sealed
• Store out of reach of children and pets

When to Seek Emergency Medical Care

Get emergency help for:

• Severe, unrelenting stomach pain
• Signs of severe allergic reaction (facial/throat swelling, difficulty breathing)
• Symptoms of severe dehydration (extreme thirst, minimal urination, rapid heartbeat, confusion)
• Signs of low blood sugar unresponsive to treatment
• Sudden vision changes
• Thoughts of suicide or self-harm
• Chest pain or difficulty breathing

Reporting Side Effects

Report adverse effects to the FDA online at www.fda.gov/medwatch or by phone at 1-800-FDA-1088.

This information is intended for educational purposes and does not replace professional medical advice. Always follow your healthcare provider's instructions regarding your medication.