About compounded Semaglutide and/or Tirzepatide

You may receive a compounded version of semaglutide or tirzepatide if your provider determines it is medically appropriate for you. Please note that compounded GLP-1 medications are not FDA-approved or evaluated for safety or effectiveness.

Common Side Effects

Nausea

Diarrhea

Vomiting

Indications

Compounded semaglutide and/or tirzepatide are GLP-1 receptor agonists used as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with a Body Mass Index (BMI) of:

≥ 27 kg/m² (overweight or obese)

Limitations of Use

Co-administration with other GLP-1 receptor agonists or additional semaglutide/tirzepatide products is not recommended.

Safety and efficacy in combination with other weight loss medications have not been established.

These medications have not been studied in patients with a history of pancreatitis.

Important Safety Information

Risk of Thyroid C-Cell Tumors

In rodent studies, GLP-1 medications like semaglutide and tirzepatide have caused thyroid C-cell tumors at clinically relevant exposures. It is not known whether this occurs in humans.

Do not take these medications if you have:

A personal or family history of medullary thyroid carcinoma (MTC)

Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)

Patients should be counseled on the potential risks and symptoms of thyroid tumors.

Do NOT Take Compounded Semaglutide or Tirzepatide If You:

Have a personal or family history of MTC or MEN 2

Have been diagnosed with Type 1 or Type 2 Diabetes

Have a current or past history of pancreatitis

Have gastroparesis or other significant gastrointestinal motility disorders

Have a known allergy to semaglutide, tirzepatide, or any inactive ingredients in the compounded formula

Have a history of suicide attempts or active suicidal ideation

Warnings and Precautions

Acute Pancreatitis: Has occurred in clinical trials. Discontinue immediately if suspected.

Gallbladder Disease: Monitor for symptoms; perform gallbladder studies if cholelithiasis is suspected.

Gastroparesis: Can worsen; use caution.

Hypoglycemia: Especially when used with insulin or insulin secretagogues. Monitor closely.

Kidney Injury: Monitor renal function, particularly in patients with severe gastrointestinal side effects.

Hypersensitivity: Discontinue immediately if anaphylaxis or angioedema occurs.

Pregnancy: Discontinue at least 2 months before a planned pregnancy due to the long half-life.

Reproductive Health: Both males and females should stop treatment 2 months prior to conception.

Eye Health: Diabetic retinopathy and rare reports of NAION (Non-Arteritic Anterior Ischemic Optic Neuropathy) have been noted. Monitor patients with a history of eye disease.

Heart Rate: GLP-1 medications may increase heart rate; monitor regularly.

Mental Health: Monitor for depression or suicidal thoughts. Discontinue if concerning symptoms develop.

Possible Side Effects

Most common side effects (≥5% incidence) in adults and children aged 12+ may include:

Nausea

Diarrhea

Vomiting

Constipation

Abdominal pain

Headache

Fatigue

Indigestion (dyspepsia)

Dizziness

Bloating

Belching

Hypoglycemia (in patients with type 2 diabetes)

Flatulence

Gastroenteritis

Acid reflux

Nasal/throat irritation (nasopharyngitis)

Drug Interactions

These medications delay gastric emptying, which may impact the absorption of oral medications. Use with caution and inform your provider of all medications you are taking.

Use in Special Populations

Pregnancy: May cause fetal harm. Discontinue immediately if pregnancy is detected.

Planning Pregnancy: Discontinue at least 2 months prior to conception.

Reporting Adverse Reactions

To report a suspected adverse reaction, contact the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch