Compounded Semaglutide Safety Information

Important Notice
Compounded drugs are permitted to be prescribed under federal law but are not FDA-approved and do not undergo FDA review for safety, effectiveness, or manufacturing standards. A licensed medical provider may recommend certain doses of compounded semaglutide based on your individual evaluation.

Indications and Use

Compounded semaglutide is an injectable prescription medication that may assist adults with obesity, or those who are overweight with weight-related medical issues, to lose weight and maintain that loss. It is intended to be used in combination with a reduced-calorie diet and increased physical activity.

It is a synthetic glucagon-like peptide-1 (GLP-1) receptor agonist intended for chronic weight management in adults with:

  • A body mass index (BMI) of 30 kg/m² or greater (obesity), or
  • A BMI of 27 kg/m² or greater (overweight) in the presence of at least one weight-related condition such as type 2 diabetes, hypertension, or dyslipidemia.

Important Safety Information

⚠️ Warning: Risk of Thyroid C-Cell Tumors

In animal studies, semaglutide has been linked to thyroid tumors, including medullary thyroid carcinoma (MTC). It is unknown whether compounded semaglutide poses the same risk in humans.
Tell your provider immediately if you notice:

  • A lump or swelling in your neck
  • Hoarseness
  • Difficulty swallowing
  • Shortness of breath

Do not use compounded semaglutide if:

  • You or a family member has a history of MTC
  • You have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)

Is Compounded Semaglutide FDA-approved?

No. Compounded semaglutide is not FDA-approved. It is used under medical supervision when FDA-approved versions are in shortage or unavailable.

It may be considered for chronic weight management in adults with:

  • Obesity (BMI ≥ 30), or
  • Overweight (BMI ≥ 27) with at least one weight-related comorbidity.

Limitations of Use

  • Should not be used with other semaglutide-containing products or GLP-1 receptor agonists.
  • Not studied in patients with a history of pancreatitis.
  • Not recommended during pregnancy or while breastfeeding.
  • Not intended for children under 18.

Who Should Not Use Compounded Semaglutide?

  • Individuals with a personal or family history of MTC
  • Individuals with MEN 2
  • Anyone with a known allergy to semaglutide or its ingredients

Administration Guidelines

  • Administer once weekly as a subcutaneous injection in the abdomen, thigh, or upper arm.
  • Can be taken with or without food.
  • Dosing should be guided by a licensed provider and not altered without medical direction.
  • Do not share injector pens under any circumstance.

Before You Start: Tell Your Provider If You...

  • Have type 1 or type 2 diabetes
  • Have a history of thyroid cancer or pancreatitis
  • Have kidney disease or diabetic retinopathy
  • Take medications (including insulin, sulfonylureas, or herbal supplements)
  • Are pregnant, trying to conceive, or breastfeeding

Drug Interactions to Discuss with Your Provider

  • Diabetes medications (e.g., insulin, Glucotrol XL, Amaryl)
  • Birth control pills (effectiveness may be reduced)
  • Other GLP-1 medications, such as Ozempic®, WeGovy®, Mounjaro®, Saxenda®, Victoza®, Zepbound®, Byetta®, or Bydureon®

Serious Side Effects to Watch For

If any of the following occur, stop treatment and seek immediate medical attention:

  • Thyroid tumors
  • Pancreatitis: severe abdominal pain with or without vomiting
  • Gallbladder issues: stomach pain, jaundice, fever, pale stools
  • Low blood sugar: dizziness, blurred vision, sweating
  • Kidney problems due to dehydration
  • Serious allergic reactions
  • Vision changes, especially if you have diabetes
  • Racing heartbeat while at rest
  • Mood changes or suicidal thoughts

Common Side Effects

  • Nausea
  • Diarrhea or constipation
  • Vomiting
  • Stomach pain or indigestion
  • Tiredness
  • Injection site irritation
  • Belching or reflux
  • Hair loss
  • Mild allergic reactions

Report side effects to the FDA: www.fda.gov/medwatch or 1-800-FDA-1088.

How to Take Compounded Semaglutide

  • Inject once a week on the same day each week
  • Rotate injection sites to avoid skin irritation
  • If you miss a dose, consult your provider

Pregnancy and Breastfeeding

  • Do not use during pregnancy
  • Stop use 2 months before trying to conceive
  • Not recommended while breastfeeding due to unknown risks

Final Notes

Compounded semaglutide is prescription-only. It is not manufactured or affiliated with Novo Nordisk, Eli Lilly, or Amylin Pharmaceuticals. For questions about your treatment or pharmacy, contact Oral Only at +1 (833)-605-3463
.

This summary does not replace the information provided with your prescription or the advice of your healthcare provider.

Disclaimer

Ozempic®, WeGovy®, Saxenda®, and Victoza® are registered trademarks of Novo Nordisk. Zepbound® and Mounjaro® are trademarks of Eli Lilly. Byetta® and Bydureon® are trademarks of Amylin Pharmaceuticals. Oral Only is not affiliated with any of these companies or their products. The compounded medications provided through Oral Only’s telehealth weight management program are not made or endorsed by these companies.

Oral Only is a telehealth management platform providing administrative and operational support to independent, licensed healthcare providers. Oral Only does not provide medical or pharmacy services and does not influence clinical decisions. Payment for services does not guarantee a prescription or treatment. All care decisions are made solely by the treating provider. This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.

OralOnly LLC

+1 (833)-605-3463
support@oralonly.com

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5500 Sunrise Highway Unit 50
Massapequa, NY 11758
United States