FDA Approval & Clinical Studies

Please be aware that compounded drugs are not FDA-approved and do not undergo clinical studies to evaluate their safety and efficacy, as is required for FDA-approved, commercially available products. However, compounded products may still be legally prescribed. Your healthcare provider may issue you a prescription for compounded tirzepatide based on your medical consultation.

Indication for Use

Tirzepatide is a glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist used for chronic weight management. It should be used in combination with:

• A reduced-calorie diet

• Increased physical activity

Tirzepatide is indicated for individuals with an initial body mass index (BMI) of:

• ≥ 30 kg/m² (obesity) or

• ≥ 27 kg/m² (overweight) with at least one weight-related comorbidity, such as:

  • Hypertension

  • Type 2 diabetes mellitus

  • Dyslipidemia

  • Obstructive sleep apnea

  • Cardiovascular disease

Consult your healthcare provider to determine if tirzepatide is right for you.

Serious Side Effects

Tirzepatide may cause serious side effects, including:

1. Possible Thyroid Tumors (Including Cancer)

• Tell your healthcare provider if you notice:

  • A lump or swelling in your neck

  • Hoarseness

  • Trouble swallowing

  • Shortness of breath

• In animal studies, tirzepatide caused dose-dependent and treatment-duration-dependent thyroid C-cell tumors.

• It is unknown whether tirzepatide causes medullary thyroid carcinoma (MTC) in humans.

2. Paralysis of the Stomach (Gastroparesis)

• Symptoms include:

  • Feeling full quickly after starting a meal

  • Prolonged fullness after eating

  • Nausea

  • Vomiting

• Tirzepatide is not recommended for patients with severe gastrointestinal disease, including severe gastroparesis.

3. Inflammation of the Pancreas (Pancreatitis)

• Seek immediate medical attention if you experience:

  • Severe stomach pain (that does not go away)

  • Pain with or without vomiting

4. Gallbladder Problems

• Symptoms may include:

  • Pain in the upper stomach (abdomen)

  • Fever

  • Yellowing of the skin or eyes (jaundice)

  • Clay-colored stools

• Gallbladder issues may require surgery.

5. Increased Risk of Low Blood Sugar (Hypoglycemia) in Type 2 Diabetes

• Signs of low blood sugar include:

  • Dizziness or light-headedness

  • Blurred vision

  • Anxiety or irritability

  • Mood changes

  • Sweating

  • Slurred speech

  • Hunger

  • Confusion or drowsiness

  • Shakiness

  • Weakness

  • Headache

  • Rapid heartbeat

• If you take insulin or sulfonylureas, consult your healthcare provider, as tirzepatide may increase hypoglycemia risk.

6. Kidney Problems (Kidney Failure)

• Diarrhea, nausea, and vomiting may lead to dehydration, worsening kidney problems.

• Staying hydrated is crucial.

7. Serious Allergic Reactions

• Stop using tirzepatide immediately and seek medical attention if you experience:

  • Swelling of the face, lips, tongue, or throat

  • Difficulty breathing or swallowing

  • Severe rash or itching

  • Fainting or dizziness

  • Rapid heartbeat

8. Vision Changes (For Patients with Type 2 Diabetes)

• Notify your healthcare provider if you notice any vision changes.

9. Depression or Suicidal Thoughts

• Be mindful of mood, behavior, or thought changes.

• If you experience worsening mental health symptoms, contact your healthcare provider immediately.

Who Should NOT Use Tirzepatide

Do not use tirzepatide if you:

• Have or have had a type of thyroid cancer called medullary thyroid carcinoma (MTC).

• Have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

• Have had a serious allergic reaction to tirzepatide in the past.

Before starting tirzepatide, inform your healthcare provider if you:

• Have pancreatic or kidney problems.

• Have severe stomach issues (e.g., gastroparesis).

• Have diabetic retinopathy.

• Have a history of depression, suicidal thoughts, or mental health issues.

• Are pregnant or planning pregnancy.

  • Tirzepatide should not be used during pregnancy.

  • Discuss when to stop tirzepatide before pregnancy.

• Are breastfeeding or planning to breastfeed.

  • It is unknown if tirzepatide passes into breast milk.

Drug Interactions

Tirzepatide may affect the way certain medications work.
Tell your healthcare provider about:

• All prescription and over-the-counter medications

• Vitamins and herbal supplements

• Diabetes medications (including insulin or sulfonylureas)

Common Side Effects

The most common side effects of tirzepatide include:

• Nausea

• Diarrhea

• Vomiting

• Constipation

• Stomach (abdominal) pain

• Indigestion

• Injection site reactions

• Fatigue

• Allergic reactions

• Belching

• Hair loss

• Heartburn

These are not all the possible side effects. Talk to your healthcare provider if any side effect bothers you or does not go away.

Tirzepatide Administration

• Tirzepatide is self-administered as a subcutaneous injection in the:

  • Stomach

  • Thigh

  • Upper arm

• It is taken once weekly, on the same day each week.

• Your healthcare provider will guide you on:

  • How to administer your dose properly

  • A suitable treatment regimen

• Do not change your dose or stop taking tirzepatide without consulting your provider.

Reporting Side Effects

If you experience negative side effects, you are encouraged to report them:

📞 FDA MedWatch: 1-800-FDA-1088
🌐 Visit: www.fda.gov/medwatch

Mechanism of Action

Tirzepatide is a dual GIP and GLP-1 receptor agonist that:

• Selectively binds and activates GIP and GLP-1 receptors.

• Enhances insulin release after eating.

• Helps regulate blood sugar levels.

Tirzepatide belongs to a class of drugs known as incretin mimetics.

Final Reminder

This is not comprehensive medical advice.
For more details, risks, or concerns, please discuss with your healthcare provider.

If you are experiencing a medical emergency, call 911 or seek immediate medical attention.