Important Safety Information for Compounded Tirzepatide

What is Compounded Tirzepatide?

Compounded Tirzepatide is a prescription medication used alongside a reduced-calorie diet and regular physical activity to support weight management in adults with obesity (BMI ≥30) or overweight (BMI ≥27) with at least one weight-related health condition such as high blood pressure, type 2 diabetes, or high cholesterol. Tirzepatide is a dual GLP-1/GIP receptor agonist that works by regulating appetite, slowing digestion, and improving how your body responds to insulin.

Boxed Warning: Thyroid C-Cell Tumor Risk

In animal studies, tirzepatide and similar medications have caused thyroid tumors, including thyroid cancer. While it is not known whether tirzepatide causes thyroid tumors in humans, this medication should not be used if you or any blood relative has ever been diagnosed with medullary thyroid carcinoma (MTC) or if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

Contact your healthcare provider immediately if you notice any of the following symptoms, which may indicate a thyroid tumor:

• A lump or swelling in your neck
• Difficulty swallowing
• Hoarseness or voice changes that don't go away
• Persistent shortness of breath

Who Should Not Use Compounded Tirzepatide?

Do not use this medication if you:

• Have a personal or family history of medullary thyroid carcinoma (MTC)
• Have been diagnosed with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
• Have had a serious allergic reaction to tirzepatide or any ingredient in this medication
• Have a history of severe gastrointestinal disease, including gastroparesis (delayed stomach emptying)
• Are currently pregnant or planning to become pregnant
• Are breastfeeding or planning to breastfeed

Warnings and Precautions

1. Inflammation of the Pancreas (Pancreatitis)Tirzepatide may cause pancreatitis, which can be severe and potentially life-threatening. Stop taking tirzepatide and contact your healthcare provider immediately if you experience intense, persistent abdominal pain that may spread to your back, with or without vomiting. Do not restart tirzepatide if pancreatitis is confirmed.

2. Low Blood Sugar (Hypoglycemia)When tirzepatide is combined with insulin or medications that stimulate insulin release (such as sulfonylureas), the risk of dangerously low blood sugar increases. Your healthcare provider may need to reduce the dose of your other diabetes medications. Know the symptoms of low blood sugar: shakiness, sweating, confusion, rapid heartbeat, dizziness, and hunger.

3. Kidney ProblemsTirzepatide has been associated with kidney injury, including worsening of existing kidney disease. Dehydration from nausea, vomiting, or diarrhea can increase this risk. Drink adequate fluids and inform your provider if you experience severe or prolonged gastrointestinal symptoms.

4. Gallbladder ProblemsGLP-1 medications may increase the risk of gallbladder disease, including gallstones and gallbladder inflammation. Contact your provider if you experience sudden pain in the upper right abdomen, pain between your shoulder blades, or nausea and vomiting associated with this pain.

5. Severe Allergic ReactionsSerious allergic reactions including anaphylaxis, angioedema (swelling of the face, lips, tongue, or throat), and severe skin reactions have been reported. Discontinue tirzepatide immediately and seek emergency medical care if you experience difficulty breathing, severe rash, rapid heartbeat, or significant swelling.

6. Digestive System EffectsNausea, vomiting, diarrhea, constipation, and abdominal discomfort are common with tirzepatide, especially when starting treatment or increasing doses. These effects typically diminish over time. Eating smaller meals, avoiding fatty foods, and staying hydrated may help reduce these symptoms.

7. Surgical Procedures and AnesthesiaTirzepatide slows stomach emptying, which may increase the risk of aspiration (inhaling stomach contents) during procedures requiring sedation or general anesthesia. Inform your surgical team and anesthesiologist that you are taking this medication well before any planned procedure.

Common Side Effects

The most frequently reported side effects include:

• Nausea
• Diarrhea
• Vomiting
• Constipation
• Stomach pain or discomfort
• Decreased appetite
• Indigestion
• Fatigue
• Injection site reactions (redness, itching, or swelling)

These side effects are often most noticeable during the initial weeks of treatment and when doses are increased. Many patients find that side effects improve as their body adjusts to the medication.

Pregnancy and Breastfeeding

Pregnancy: Do not use tirzepatide during pregnancy. Weight loss during pregnancy offers no benefit and may harm your baby. Animal studies have shown potential risks to fetal development. Discontinue tirzepatide at least 4 weeks before a planned pregnancy due to the medication's extended duration in your system.

Breastfeeding: It is not known whether tirzepatide passes into breast milk. Because of potential risks to nursing infants, discuss with your healthcare provider whether to discontinue breastfeeding or the medication.

Drug Interactions

Inform your healthcare provider about all medications you take, including:

• Insulin and insulin-stimulating medications (sulfonylureas) – may require dose reduction
• Oral contraceptives – absorption may be affected; consider alternative contraception methods
• Blood thinners (warfarin) – monitoring may be needed
• Oral medications taken on a specific schedule – tirzepatide may delay absorption
• Other GLP-1 receptor agonists – do not use together

Because tirzepatide slows stomach emptying, it may affect how quickly other oral medications are absorbed. Your provider may need to adjust timing or dosing of other medications.

Important Patient Information

• Administer tirzepatide as a subcutaneous injection once weekly, on the same day each week
• Inject in your abdomen, thigh, or upper arm, rotating injection sites with each dose
• Never share injection pens or needles with another person, even if the needle is changed
• Store unused medication in the refrigerator; once in use, store at room temperature and use within 28 days
• Follow the dosing schedule prescribed by your provider; do not adjust doses without medical guidance
• Attend all scheduled follow-up appointments for monitoring
• Report any concerning symptoms to your healthcare provider promptly

When to Seek Emergency Medical Care

Seek immediate medical attention if you experience:

• Severe abdominal pain that does not improve
• Signs of allergic reaction (difficulty breathing, swelling of face/throat, severe rash)
• Symptoms of severe dehydration (dizziness, rapid heartbeat, decreased urination)
• Vision changes or sudden vision loss
• Signs of thyroid tumor (neck lump, persistent hoarseness, difficulty swallowing)
• Thoughts of self-harm or suicide

Reporting Side Effects

You are encouraged to report negative side effects of prescription medications to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

This information does not replace a conversation with your healthcare provider. Discuss all questions and concerns about tirzepatide therapy with your prescribing provider.