Glp-1 (semaglutide/tirzepatide) Safety Information
Last updated: March 2026
Compounded Medication Notice
This medication is compounded and has not been approved by the FDA. Compounded drugs are not required to undergo the same clinical studies as FDA-approved medications. Your prescribing provider has determined that this compounded medication is appropriate for your individual treatment plan.
What Is This Medication?
GLP-1 receptor agonists, including semaglutide and tirzepatide, are injectable medications used for weight management in adults. These medications work by mimicking natural hormones that regulate appetite and blood sugar. They slow gastric emptying, reduce hunger signals, and help you feel full longer after eating. GLP-1 therapy is indicated for adults with a body mass index (BMI) of 30 or greater, or a BMI of 27 or greater with at least one weight-related health condition such as high blood pressure, type 2 diabetes, or high cholesterol.
Who Should Consider This Treatment?
You may be a candidate for GLP-1 therapy if you are an adult who has struggled to lose weight through diet and exercise alone and meet the BMI criteria listed above. This treatment is most effective when combined with a reduced-calorie eating plan and increased physical activity. Your healthcare provider will evaluate your complete medical history, current medications, and health goals during your consultation to determine if GLP-1 therapy is appropriate for you.
Who Should Not Use This Medication?
Do not use GLP-1 receptor agonists if you have any of the following:
- A personal or family history of medullary thyroid carcinoma (MTC)
- Multiple Endocrine Neoplasia syndrome type 2 (MEN2)
- A known hypersensitivity or allergy to semaglutide, tirzepatide, or any of their ingredients
- Are currently pregnant or planning to become pregnant
- Are currently breastfeeding
- A history of pancreatitis or active pancreatic disease
Warnings and Precautions
- Thyroid C-Cell Tumors (Boxed Warning): In animal studies, GLP-1 receptor agonists caused thyroid C-cell tumors. It is unknown whether these medications cause thyroid C-cell tumors, including medullary thyroid carcinoma, in humans. Monitor for symptoms such as a lump in the neck, hoarseness, difficulty swallowing, or shortness of breath.
- Discontinue use and contact your healthcare provider immediately if you experience severe abdominal pain that does not go away, as this may indicate pancreatitis.
- Use with caution if you have a history of kidney disease. Dehydration from nausea, vomiting, or diarrhea may worsen kidney function.
- Patients with diabetic retinopathy should be monitored closely, as rapid improvements in blood sugar control may temporarily worsen diabetic eye disease.
- Women of childbearing potential should use effective contraception during treatment and for at least two months after discontinuing.
Common Side Effects
The most commonly reported side effects include:
- Nausea (especially during dose escalation)
- Vomiting
- Diarrhea
- Constipation
- Abdominal pain or discomfort
- Headache
- Fatigue
- Injection site reactions (redness, swelling, itching)
Many of these side effects are mild to moderate and tend to improve as your body adjusts to the medication. Your provider may recommend a gradual dose increase to minimize gastrointestinal symptoms.
Serious Side Effects
Seek immediate medical attention if you experience any of the following:
- Pancreatitis: severe, persistent abdominal pain that may radiate to your back, with or without vomiting
- Gallbladder problems: upper abdominal pain, fever, jaundice (yellowing of skin or eyes), or clay-colored stools
- Kidney injury: decreased urination, swelling in your legs or ankles, or confusion
- Thyroid tumors: a lump or swelling in the neck, difficulty swallowing, hoarseness, or shortness of breath
- Severe allergic reactions: rash, itching, swelling of the face, lips, tongue, or throat, difficulty breathing, or rapid heartbeat
- Diabetic retinopathy complications: changes in vision
Drug Interactions
Tell your healthcare provider about all medications you are taking, including prescription drugs, over-the-counter medicines, vitamins, and supplements. GLP-1 receptor agonists may interact with:
- Insulin and sulfonylureas: Using these medications together may increase your risk of low blood sugar (hypoglycemia). Dose adjustments may be necessary.
- Oral medications: Because GLP-1 agonists slow gastric emptying, they may affect how quickly your body absorbs other oral medications. Take time-sensitive oral medications (such as oral contraceptives or antibiotics) as directed by your provider.
Before Starting Treatment
Before beginning GLP-1 therapy, inform your healthcare provider if you:
- Have or have had pancreatitis
- Have kidney or liver problems
- Have a history of diabetic retinopathy
- Have a history of depression or suicidal thoughts
- Have a history of gallbladder disease
- Are pregnant, planning to become pregnant, or breastfeeding
- Have scheduled any upcoming surgeries
How to Use This Medication
GLP-1 medications are administered as a subcutaneous injection, typically once per week. Inject into the abdomen, thigh, or upper arm, rotating injection sites each week to reduce irritation. Your provider will prescribe a starting dose that gradually increases over several weeks to help minimize side effects. Always follow your prescribed dosing schedule. If you miss a dose, take it as soon as you remember if your next dose is more than two days away. If your next dose is less than two days away, skip the missed dose and resume your regular schedule. Do not take two doses at the same time. Store the medication as directed, typically refrigerated before first use.
Emergency Information
If you experience a medical emergency, call 911 or go to your nearest emergency room immediately. Do not delay seeking emergency care.
To report side effects or adverse reactions, contact the FDA MedWatch program at www.fda.gov/medwatch or call 1-800-FDA-1088.
This safety information is provided for educational purposes and does not replace the advice of your healthcare provider. Always consult with your prescribing provider before starting, stopping, or changing any medication. Individual results may vary. INA facilitates access to licensed healthcare providers who independently determine appropriate treatments.