Important Regulatory Note:
Compounded GLP-1 gummies are not approved by the U.S. Food and Drug Administration (FDA). These formulations are custom-prepared by licensed U.S. compounding pharmacies based on a healthcare provider’s prescription. They are intended for patients who may be unable or unwilling to use injectable medications or other oral forms. These products have not undergone FDA review for safety, effectiveness, or quality control.

Intended Use:
Compounded GLP-1 gummies may be prescribed for chronic weight management in adults with:

• A body mass index (BMI) ≥30 kg/m² (obesity), or
• A BMI ≥27 kg/m² (overweight) with at least one weight-related comorbid condition (e.g., type 2 diabetes, hypertension, or high cholesterol).
  They are intended for use in combination with a calorie-reduced diet and increased physical activity.
  
  

Contraindications:
Do not use compounded GLP-1 gummies if:

• You or any family member has ever had medullary thyroid carcinoma (MTC)
• You have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
• You have known allergies to GLP-1 receptor agonists or any ingredients in the gummy formulation
  
  

Warnings & Serious Risks:

• Thyroid tumors: Risk identified in animal studies; unknown if it applies to humans.
• Pancreatitis: Stop treatment and seek urgent care if you experience persistent abdominal pain that may radiate to the back.
• Gallbladder disease: Includes risk of gallstones or inflammation.
• Kidney impairment: Diarrhea, vomiting, or inadequate hydration may contribute to dehydration and worsen kidney function.
• Hypoglycemia: Can occur, especially when used with insulin or sulfonylureas.
• Diabetic retinopathy: May worsen in those with a history of this condition.
• Behavioral or mood changes: Monitor for signs of depression, anxiety, or suicidal thoughts.
• Gastrointestinal sensitivity: Use caution in patients with a history of gastroparesis or chronic GI conditions.
  
  

Common Side Effects:

• Nausea
• Bloating
• Diarrhea
• Constipation
• Flatulence
• Headache
• Decreased appetite
• Indigestion
• Fatigue
• Mild abdominal discomfort
• Sweet aftertaste or temporary change in taste

Most side effects are mild and may improve with continued use and dose adjustment.

Drug Interactions:
As with other GLP-1 therapies, compounded GLP-1 gummies may:

• Delay gastric emptying and affect the absorption of oral medications
• Require caution when taken with:
  • Oral contraceptives (backup contraception may be needed)
  • Medications with narrow therapeutic ranges
  • Insulin or sulfonylureas

Always disclose all medications and supplements to your healthcare provider.

Pregnancy & Breastfeeding:

• Not recommended for use during pregnancy. Discontinue at least 2 months prior to planned conception.
• Unknown if GLP-1 active ingredients are excreted in breast milk. Avoid use while breastfeeding unless specifically advised by your provider.
  
  

Administration:
Chew the gummy thoroughly as directed by your provider. Do not exceed the prescribed dose. Some formulations may require dosing on an empty stomach—follow the pharmacy label or medical guidance provided.

Storage:
Store at room temperature in a sealed container. Protect from moisture, heat, and direct sunlight. Keep out of reach of children. Follow your pharmacy’s expiration and storage guidelines closely.

Emergency Situations:
Seek emergency care for severe or unusual side effects, allergic reactions, or behavioral changes. Call 911 for life-threatening symptoms.

Disclaimer:
This content is for educational purposes only and does not replace medical advice from a licensed provider. Compounded GLP-1 gummies are prescribed off-label and are not FDA-approved. Report suspected adverse events to your provider or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.