Compounded Tirzepatide Safety Information

Compounded tirzepatide is a glucagon-like peptide-1 (GLP-1) receptor agonist that may be prescribed for chronic weight management when deemed medically appropriate by a licensed healthcare provider. This medication is prepared by licensed 503A compounding pharmacies and is not FDA-approved.

⚠️ Important Notice

Oral Only does not offer or distribute Zepbound®, Mounjaro®, or any branded tirzepatide medications. These are registered trademarks of Eli Lilly and Company. Oral Only is not affiliated with Eli Lilly or any brand manufacturer. The compounded tirzepatide available through Oral Only is independently prepared and prescribed only when clinically appropriate by a licensed medical provider.

What is Compounded Tirzepatide?

Compounded tirzepatide may be considered for adults with:

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

It is intended to be used with a reduced-calorie diet and increased physical activity. All prescribing decisions are made only after a proper medical evaluation by a licensed provider.

❌ Is It FDA-Approved?

No. Compounded tirzepatide is not approved by the FDA and does not undergo FDA review for:

  • Safety
  • Efficacy
  • Manufacturing consistency

It is compounded under federal law in accordance with applicable regulations and may be prescribed only when FDA-approved versions are unavailable or unsuitable for the patient.

🚫 Limitations of Use

  • Do not use with other tirzepatide-containing medications or GLP-1 receptor agonists.
  • Do not combine with weight loss supplements or medications without provider supervision.
  • Not recommended for:
  • Individuals under 18
  • Pregnant or breastfeeding individuals
  • Patients with a history of pancreatitis

⚠️ Safety Warnings

Thyroid C-Cell Tumors

In animal studies, tirzepatide was associated with thyroid tumors. The risk to humans remains unknown.

Do NOT use compounded tirzepatide if you or a family member has a history of:

  • Medullary thyroid carcinoma (MTC)
  • Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)

Other Serious Risks:

  • Acute pancreatitis
  • Gallbladder disease
  • Hypoglycemia, especially when used with insulin or sulfonylureas
  • Acute kidney injury, particularly due to dehydration
  • Serious allergic reactions
  • Diabetic retinopathy complications
  • Suicidal ideation or behavior

💊 Common Side Effects

  • Nausea
  • Vomiting
  • Diarrhea
  • Constipation
  • Indigestion
  • Acid reflux or bloating
  • Tiredness
  • Injection site reactions

💉 Use Instructions

  • Administer once weekly via subcutaneous injection in the thigh, upper arm, or abdomen
  • Use on the same day each week
  • Rotate injection sites with each dose

💬 Drug Interactions

Tell your provider about all medications and supplements, including:

  • Insulin or sulfonylureas (e.g., Glucotrol®, Amaryl®)
  • Oral medications, including birth control pills
  • Over-the-counter drugs and herbal supplements

Compounded tirzepatide slows gastric emptying, which can affect how your body absorbs oral medications.

📞 Additional Information

For questions about your medication, treatment plan, or pharmacy services, contact Oral Only at +1 (833)-605-3463
.

Compounded tirzepatide is available by prescription only. Your provider will determine if it is clinically appropriate for you.

Disclaimer

Zepbound® and Mounjaro® are registered trademarks of Eli Lilly and Company. Oral Only is not affiliated with Eli Lilly or its products. The compounded tirzepatide provided through Oral Only is not manufactured by Eli Lilly or any associated company.

Oral Only is a telehealth support platform that offers administrative and operational services to licensed healthcare providers who independently evaluate and treat patients. Oral Only does not provide medical or pharmacy services, does not employ medical professionals, and does not influence clinical decision-making. Payment for telehealth services does not guarantee a prescription or specific treatment. All prescribing decisions are made solely by the evaluating healthcare provider.

This information is for educational purposes only and should not replace professional medical advice. If you have concerns about your health or medications, please consult your healthcare provider directly.

OralOnly LLC

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

#1074
5500 Sunrise Highway Unit 50
Massapequa, NY 11758
United States