FDA Approval & Clinical Studies

Please be aware that compounded drugs are not FDA-approved and do not undergo clinical studies to evaluate their safety and efficacy, as is required for FDA-approved, commercially available products. However, compounded products may still be legally prescribed. Your healthcare provider may issue you a prescription for compounded semaglutide based on your medical consultation.

Indication for Use

Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist used for chronic weight management in combination with:

• A reduced-calorie diet

• Increased physical activity

Semaglutide is indicated for individuals with an initial body mass index (BMI) of:

• ≥ 30 kg/m² (obesity) or

• ≥ 27 kg/m² (overweight) with at least one weight-related comorbidity, such as:

  • Hypertension

  • Type 2 diabetes mellitus

  • Dyslipidemia

Speak with your healthcare provider to determine if semaglutide is right for you.

Serious Side Effects

Semaglutide may cause serious side effects, including:

1. Possible Thyroid Tumors (Including Cancer)

• Notify your healthcare provider if you experience:

  • A lump or swelling in your neck

  • Hoarseness

  • Trouble swallowing

  • Shortness of breath

• In animal studies, semaglutide caused thyroid tumors, including thyroid cancer.

• It is unknown whether semaglutide causes medullary thyroid carcinoma (MTC) in humans.

2. Paralysis of the Stomach (Gastroparesis)

• Symptoms include:

  • Feeling full quickly after starting a meal

  • Prolonged fullness after eating

  • Nausea

  • Vomiting

• Semaglutide is not recommended for patients with severe gastrointestinal disease, including severe gastroparesis.

3. Inflammation of the Pancreas (Pancreatitis)

• Seek immediate medical attention if you experience:

  • Severe stomach pain (that does not go away)

  • Pain with or without vomiting

4. Gallbladder Problems

• Symptoms may include:

  • Pain in the upper stomach (abdomen)

  • Fever

  • Yellowing of the skin or eyes (jaundice)

  • Clay-colored stools

• Gallbladder issues may require surgery.

5. Increased Risk of Low Blood Sugar (Hypoglycemia) in Type 2 Diabetes

• Signs of low blood sugar include:

  • Dizziness or light-headedness

  • Blurred vision

  • Anxiety or irritability

  • Mood changes

  • Sweating

  • Slurred speech

  • Hunger

  • Confusion or drowsiness

  • Shakiness

  • Weakness

  • Headache

  • Rapid heartbeat

• If you take insulin or sulfonylureas, consult your healthcare provider, as semaglutide may increase hypoglycemia risk.

6. Kidney Problems (Kidney Failure)

• Diarrhea, nausea, and vomiting may lead to dehydration, worsening kidney problems.

• Staying hydrated is crucial.

7. Serious Allergic Reactions

• Stop using semaglutide immediately and seek medical attention if you experience:

  • Swelling of the face, lips, tongue, or throat

  • Difficulty breathing or swallowing

  • Severe rash or itching

  • Fainting or dizziness

  • Rapid heartbeat

8. Vision Changes (For Patients with Type 2 Diabetes)

• Notify your healthcare provider if you notice any vision changes.

9. Increased Heart Rate

• Semaglutide may increase your resting heart rate.

• Consult your healthcare provider if you feel:

  • Your heart racing or pounding unexpectedly.

10. Depression or Suicidal Thoughts

• Be mindful of mood, behavior, or thought changes.

• If you experience worsening mental health symptoms, contact your healthcare provider immediately.

Who Should NOT Use Semaglutide

Do not use semaglutide if you:

• Have or have had a type of thyroid cancer called medullary thyroid carcinoma (MTC).

• Have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

• Have had a serious allergic reaction to semaglutide in the past.

Before starting semaglutide, inform your healthcare provider if you:

• Have pancreatic or kidney problems.

• Have type 2 diabetes and a history of diabetic retinopathy.

• Have a history of depression, suicidal thoughts, or mental health issues.

• Are pregnant or planning pregnancy.

  • Semaglutide should not be used during pregnancy.

  • Stop using semaglutide at least 2 months before pregnancy.

• Are breastfeeding or planning to breastfeed.

  • It is unknown if semaglutide passes into breast milk.

Drug Interactions

Semaglutide may affect the way certain medications work.
Tell your healthcare provider about:

• All prescription and over-the-counter medications

• Vitamins and herbal supplements

• Diabetes medications (including insulin or sulfonylureas)

Common Side Effects

The most common side effects of semaglutide include:

• Nausea

• Diarrhea

• Vomiting

• Constipation

• Stomach (abdominal) pain

• Headache

• Fatigue

• Upset stomach

• Dizziness

• Bloating

• Belching

• Gas

• Gastroenteritis (stomach flu)

• Heartburn

• Runny nose or sore throat

These are not all the possible side effects. Talk to your healthcare provider if any side effect bothers you or does not go away.

Semaglutide Administration

• Semaglutide can be taken with or without food.

• It is self-administered as a subcutaneous injection in the:

  • Stomach

  • Thigh

  • Upper arm

• It is taken once weekly, on the same day each week.

• Your healthcare provider will guide you on:

  • How to administer your dose properly

  • A suitable treatment regimen

• Do not change your dose or stop taking semaglutide without consulting your provider.

Reporting Side Effects

If you experience negative side effects, you are encouraged to report them:

📞 FDA MedWatch: 1-800-FDA-1088
🌐 Visit: www.fda.gov/medwatch

Mechanism of Action

Semaglutide is a synthetic GLP-1 receptor agonist that belongs to a class of drugs called incretin mimetics.
It works by:

• Binding to the GLP-1 receptor

• Stimulating insulin secretion

• Inhibiting glucagon release

• Regulating appetite and caloric intake
  GLP-1 receptors are found in several areas of the body, including the brain regions responsible for appetite regulation.

Final Reminder

This is not comprehensive medical advice.
For more details, risks, or concerns, please discuss with your healthcare provider.

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