Compounded GLP-1/GIP (Tirzepatide) Safety Information

Do Not Use If You:

Have a personal or family history of medullary thyroid carcinoma (MTC)

Have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)

Are pregnant or planning to become pregnant

Are breastfeeding

Have had a serious allergic reaction to tirzepatide or any of its ingredients

Before Using Compounded GLP-1/GIP

Tell your healthcare provider about your full medical history, including if you have:

Pancreatitis, gallbladder disease, or pancreas problems

Kidney or liver disease

Severe stomach or gastrointestinal problems (including gastroparesis)

A history of diabetic retinopathy

Depression, suicidal thoughts, or other mental health changes

Any other medical conditions or allergies

Also inform your provider if you take:

Diabetes medicines such as insulin or sulfonylureas (may increase risk of low blood sugar)

Birth control pills (effectiveness may decrease for 4 weeks after starting or increasing your dose; an alternative form of contraception may be needed)

Any prescription, over-the-counter, or herbal medicines

Pregnancy, Breastfeeding & Contraception

Do not use if you are pregnant, planning to become pregnant, or breastfeeding.

This medication may harm your unborn baby.

Use effective contraception while on treatment.

Discuss contraception options with your provider, as oral contraceptive effectiveness may be affected.

Serious Warnings: Call Your Doctor Immediately If You Experience:

Thyroid C-cell tumor symptoms (see Black Box Warning above)

Pancreatitis: severe abdominal pain (with or without vomiting) that may radiate to your back

Gallbladder disease: upper abdominal pain, fever, yellowing of skin or eyes, clay-colored stools

Kidney problems or failure: especially if dehydrated from nausea, vomiting, or diarrhea

Serious allergic reaction: swelling of face, lips, tongue, or throat; difficulty breathing or swallowing; rash, itching, fainting, dizziness, or rapid heartbeat

Low blood sugar (hypoglycemia): dizziness, sweating, confusion, blurred vision, shakiness, rapid heartbeat, hunger, or irritability, especially if on insulin or sulfonylureas

Changes in vision

Depression or suicidal thoughts: changes in mood, behavior, or thoughts

If any of these occur, stop treatment and seek immediate medical attention.

Common Side Effects

Some people experience no side effects. The most common include:

Nausea, vomiting, diarrhea, constipation, abdominal pain

Indigestion, acid reflux, belching

Injection site reactions

Fatigue

Decreased appetite

Hair loss

Side effects often lessen over time as your body adjusts. Contact your provider if they persist or worsen.

Drug Interactions

Compounded tirzepatide slows gastric emptying and may affect the absorption of certain oral medications.

Dose adjustments may be required for insulin, sulfonylureas, and medications with a narrow therapeutic index.

Do not use with other tirzepatide-containing products or any GLP-1 receptor agonists.

Important Note on Compounded Medications

Compounded tirzepatide is prepared by a licensed compounding pharmacy and is not evaluated by the FDA for safety or effectiveness. It is not equivalent to FDA-approved tirzepatide products such as Zepbound® or Mounjaro®.

Emergency Information

In case of a medical emergency, call 911 or go to the nearest emergency room.

To report side effects, contact the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.