Last updated: June 2026
This document provides safety information for medications that may be offered through this program: compounded semaglutide and compounded tirzepatide. This document is a summary and does not include all possible information, warnings, contraindications, drug interactions, or side effects. It is not medical advice and does not replace advice from a licensed health care provider.
The assessment available on this website does not create a doctor-patient relationship. Clinical services are provided by networks of U.S.-licensed clinicians who determine eligibility for GLP-1 or GIP/GLP-1 treatment based on medical history, assessment responses, contraindications, medication availability, and clinical judgment. Providers retain full discretion to prescribe, decline, change, or discontinue medication.
FDA-approved indications are listed for medication-safety and prescribing-information context. This program may not evaluate, diagnose, treat, or monitor all conditions listed in FDA-approved labeling, including established cardiovascular disease, metabolic dysfunction-associated steatohepatitis (MASH), or obstructive sleep apnea (OSA), unless those services are expressly included in the program. Eligibility for medication through this program is determined by a licensed clinician based on the assessment, medical history, contraindications, medication availability, and program scope.
Results vary and depend on individual factors, adherence to the prescribed plan, provider guidance, and lifestyle changes such as nutrition and physical activity. Product appearance, packaging, labeling, dose concentration, device type, and instructions may differ from website images and may vary by product, pharmacy, manufacturer, or dispensing facility.
Compounded medications may be prepared by state-licensed pharmacies, federal facilities, physician compounders, or FDA-registered outsourcing facilities, as applicable. Compounded medications are not FDA-approved. FDA does not verify the safety, effectiveness, or quality of compounded drugs before they are marketed. Compounded medications should be used only when a patient's individualized medical need cannot be met by an FDA-approved medication, or when otherwise permitted under applicable federal and state law.
As of this document's last updated date, FDA states that semaglutide and tirzepatide do not currently appear on FDA's drug shortage list or FDA's 503B bulks list. FDA has also proposed excluding semaglutide, tirzepatide, and liraglutide from the 503B bulks list after finding no clinical need for outsourcing facilities to compound these drugs from bulk substances. Federal and state requirements may change. Prescribing and dispensing decisions must comply with applicable law at the time of care.
The American Diabetes Association recommends against using non-FDA-approved compounded GLP-1 receptor agonist and dual GIP/GLP-1 receptor agonist products because of uncertainty about their content, safety, quality, and effectiveness. Other clinical and regulatory authorities have raised concerns about compounded incretin products, including concerns about dosing errors, product quality, illegal online sales, and lack of FDA review.
Use only medication that was prescribed specifically for you and dispensed by a licensed pharmacy or appropriate compounding facility. Do not buy GLP-1 or GIP/GLP-1 medications from online sellers, social media, marketplaces, peptide sellers, or suppliers that label products as "research use only" or "not for human use."
Before using a compounded GLP-1/GIP medication, check the label and packaging carefully. Confirm the medication name, active ingredient, concentration, prescribed dose, injection volume, beyond-use date, storage instructions, and pharmacy contact information. Do not use the medication if the label appears suspicious, has spelling errors, lists an incorrect or unfamiliar pharmacy, lacks clear dosing instructions, or does not match your provider's instructions.
Injectable GLP-1/GIP medications generally require refrigeration unless the dispensing pharmacy's written instructions state otherwise. Do not use an injectable GLP-1/GIP medication that arrives warm, without adequate cold packaging, frozen when it should not be frozen, or otherwise outside the storage conditions listed by the pharmacy. Contact the dispensing pharmacy and your provider before use.
Do not use compounded semaglutide made with semaglutide sodium or semaglutide acetate. These are different active ingredients than the semaglutide used in FDA-approved products, and FDA has stated it is not aware of a lawful basis for their use in compounding.
Do not use retatrutide, cagrilintide, or other non-FDA-approved incretin or peptide products outside of an FDA-authorized clinical trial. FDA states that retatrutide and cagrilintide cannot be used in compounding under federal law and have not been found safe and effective for any condition.
Report suspected product-quality issues, dosing errors, or adverse reactions to your provider, the dispensing pharmacy, and FDA MedWatch.
The following safety issues may apply to semaglutide and tirzepatide, and related compounded formulations. Product-specific sections below provide additional details.
Tell your provider about all medications and supplements you take, including prescription medications, over-the-counter medications, vitamins, herbal products, dietary supplements, and other weight-loss products. GLP-1 and GIP/GLP-1 medications delay gastric emptying and may affect the absorption of medications taken by mouth. Your provider can advise whether timing changes, monitoring, or dose adjustments are needed.
Tell your provider if you have or have had:
Your provider may consider your mental health history when determining whether treatment is appropriate and what follow-up is needed. Seek immediate help if you have thoughts of harming yourself or others.
Serious side effects can occur, especially when treatment begins or the dose changes. Contact your provider right away if you develop symptoms that concern you. If you are experiencing a medical emergency, call 911 or seek immediate medical attention.
Potential serious side effects include:
Do not use more than one GLP-1 or GIP/GLP-1 medication at the same time unless your provider specifically instructs you to do so. Taking more than one of these medications at the same time can increase the risk of serious side effects.
Your medical provider may recommend compounded semaglutide based on an individualized medical review. Compounded semaglutide is not FDA-approved and does not have FDA-approved indications. FDA does not review compounded drugs for safety, effectiveness, or quality before they are marketed. Federal law permits drug compounding only under specific conditions, including when an FDA-approved medication cannot meet an individual patient's medical need, or when otherwise allowed under applicable law. Your clinician may prescribe a compounded product only after an individualized medical review and only when prescribing and dispensing comply with applicable federal and state law.
The safety information below is derived in part from FDA-approved prescribing information for Wegovy® (semaglutide), the FDA-approved product containing semaglutide. Compounded semaglutide has not been independently studied for safety or efficacy and may differ from FDA-approved products in composition, concentration, sterility, packaging, quality, dosing instructions, and device or vial presentation.
Based on an individualized medical review, a licensed clinician may consider compounded semaglutide for adults with obesity or excess weight who have weight-related medical problems when an FDA-approved medication cannot meet the patient's medical need, or when otherwise permitted under applicable law. It should be used with a reduced-calorie diet and increased physical activity. Your provider will determine eligibility based on your medical evaluation, including body mass index, medical history, contraindications, and the presence of weight-related conditions.
Compounded semaglutide should not be used with Wegovy®, Ozempic®, Rybelsus®, any other semaglutide-containing product, or any other GLP-1 or GIP/GLP-1 receptor agonist unless your provider specifically instructs you to do so. It is not known if compounded semaglutide is safe and effective when used with other prescription, over-the-counter, or herbal weight-loss products. It is not known if compounded semaglutide can be used safely in people who have had pancreatitis. It is not known if compounded semaglutide is safe and effective for use in children under 18 years of age.
In mice and rats, semaglutide caused thyroid tumors, including thyroid cancer. It is not known whether compounded semaglutide will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people. Tell your provider if you develop a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer.
Do not use compounded semaglutide if you or any member of your family has ever had MTC or if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Do not use compounded semaglutide if you have had a serious allergic reaction to semaglutide or to any ingredient in the compounded product.
Compounded semaglutide is administered by subcutaneous injection as directed by your provider and dispensing pharmacy. It is injected under the skin of the stomach area, thigh, or upper arm once weekly, on the same day each week. Rotate your injection site with each weekly injection. Do not use the same injection site each time.
Follow the exact dosing instructions provided by your prescriber and dispensing pharmacy. Before injecting, confirm the prescribed dose in milligrams, the medication concentration, the injection volume, the syringe units if applicable, and the titration schedule. Do not calculate or convert your dose on your own. If your prescription label, portal instructions, syringe markings, or pharmacy instructions are unclear or do not match, do not inject the medication until your provider or pharmacy confirms the correct dose.
Your provider may guide you through a treatment regimen that includes dose increases. Do not change your dosing regimen or stop using compounded semaglutide without discussing it with your provider first. If you use too much compounded semaglutide, call your provider, seek medical advice promptly, or contact Poison Help at 1-800-222-1222.
Tell your provider about all medications you take, including prescription medications, over-the-counter medications, vitamins, herbal products, dietary supplements, and other weight-loss products.
Important medications and products to discuss include:
Tell your provider if you are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed.
If you are pregnant: Compounded semaglutide should not be used for weight loss during pregnancy. Weight loss offers no benefit during pregnancy and may harm the unborn baby. Based on animal studies, there may be potential risks to an unborn baby from semaglutide exposure during pregnancy. Discontinue compounded semaglutide when pregnancy is recognized unless your provider determines otherwise for a non-weight-loss indication.
If you are of reproductive potential: For patients using semaglutide for weight reduction or cardiovascular risk reduction, discontinue semaglutide at least 2 months before a planned pregnancy because semaglutide can stay in the body for a long time.
If you are breastfeeding or plan to breastfeed: Tell your provider before using compounded semaglutide. It is not known whether subcutaneously administered semaglutide passes into human breast milk, affects a breastfed infant, or affects milk production. Because compounded semaglutide is not FDA-approved and may differ from FDA-approved products in composition, concentration, and quality, discuss the potential benefits and risks with your provider before use while breastfeeding.
Withholding or providing inaccurate information about your health, medication use, pregnancy status, breastfeeding status, or medical history in order to obtain treatment may result in harm, including, in some cases, death.
If you currently use, or recently used, any compounded or brand-name GLP-1 or GIP/GLP-1 medication, do not start another GLP-1 or GIP/GLP-1 medication unless your provider specifically instructs you to do so. Taking more than one GLP-1 or GIP/GLP-1 medication at the same time can increase the risk of serious side effects. Tell your provider about all current or recent weight-loss or diabetes medications, including the medication name, dose, concentration if compounded, last dose date, pharmacy, and prescriber. You may be asked to provide documentation before treatment is prescribed.
Serious side effects that may occur with semaglutide include thyroid C-cell tumors, acute pancreatitis, acute gallbladder disease, hypoglycemia, acute kidney injury due to dehydration or volume depletion, severe gastrointestinal reactions, serious allergic reactions, diabetic retinopathy complications in patients with type 2 diabetes, increased heart rate, pulmonary aspiration during anesthesia or deep sedation, and infection risk from sharing vials, syringes, or needles. These risks are described in more detail in the common safety section above.
Call your provider right away if you have symptoms that are new, severe, worsening, or concerning. If you are experiencing a medical emergency, call 911 or seek immediate medical attention.
Common side effects can include nausea, diarrhea, vomiting, constipation, abdominal pain, unusual skin sensations, headache, fatigue, indigestion, dizziness, abdominal bloating, belching, low blood sugar in patients with type 2 diabetes, flatulence, gastroenteritis, gastroesophageal reflux disease, hair loss, and injection-site swelling, redness, or itching.
Nausea often lessens as treatment continues. Vomiting or diarrhea that does not stop may result in dehydration. Contact your provider promptly if you notice symptoms of dehydration, such as unusual dry mouth, thirst, dizziness, or lightheadedness.
This is not a complete list of possible side effects. You may report side effects or product-quality concerns to FDA MedWatch at 1-800-FDA-1088 or www.fda.gov/medwatch.
Your medical provider may recommend compounded tirzepatide based on an individualized medical review. Compounded tirzepatide is not FDA-approved and does not have FDA-approved indications. FDA does not review compounded drugs for safety, effectiveness, or quality before they are marketed. Federal law permits drug compounding only under specific conditions, including when an FDA-approved medication cannot meet an individual patient's medical need, or when otherwise allowed under applicable law. Your clinician may prescribe a compounded product only after an individualized medical review and only when prescribing and dispensing comply with applicable federal and state law.
The safety information below is derived in part from FDA-approved prescribing information for Zepbound® (tirzepatide), the FDA-approved product containing tirzepatide. Compounded tirzepatide has not been independently studied for safety or efficacy and may differ from FDA-approved products in composition, concentration, sterility, packaging, quality, dosing instructions, and device or vial presentation.
Based on an individualized medical review, a licensed clinician may consider compounded tirzepatide for adults with obesity or excess weight who have weight-related medical problems when an FDA-approved medication cannot meet the patient's medical need, or when otherwise permitted under applicable law. It should be used with a reduced-calorie diet and increased physical activity. Your provider will determine eligibility based on your medical evaluation, including body mass index, medical history, contraindications, and the presence of weight-related conditions.
Compounded tirzepatide should not be used with Zepbound®, Mounjaro®, any other tirzepatide-containing product, or any other GLP-1 or GIP/GLP-1 receptor agonist unless your provider specifically instructs you to do so. It is not known if compounded tirzepatide is safe and effective when used with other prescription, over-the-counter, or herbal weight-loss products. It is not known if compounded tirzepatide can be used safely in people who have had pancreatitis. It is not known if compounded tirzepatide is safe and effective for use in children under 18 years of age.
In rats, tirzepatide caused thyroid tumors, including thyroid cancer. It is not known whether compounded tirzepatide will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people. Tell your provider if you develop a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer.
Do not use compounded tirzepatide if you or any member of your family has ever had MTC or if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Do not use compounded tirzepatide if you have had a serious allergic reaction to tirzepatide or to any ingredient in the compounded product.
Compounded tirzepatide is administered by subcutaneous injection as directed by your provider and dispensing pharmacy. It is injected under the skin of the stomach area, thigh, or upper arm once weekly, on the same day each week. Rotate your injection site with each weekly injection. Do not use the same injection site each time.
Follow the exact dosing instructions provided by your prescriber and dispensing pharmacy. Before injecting, confirm the prescribed dose in milligrams, the medication concentration, the injection volume, the syringe units if applicable, and the titration schedule. Do not calculate or convert your dose on your own. If your prescription label, portal instructions, syringe markings, or pharmacy instructions are unclear or do not match, do not inject the medication until your provider or pharmacy confirms the correct dose.
Your provider may guide you through a treatment regimen that includes dose increases. Do not change your dosing regimen or stop using compounded tirzepatide without discussing it with your provider first. If you use too much compounded tirzepatide, call your provider, seek medical advice promptly, or contact Poison Help at 1-800-222-1222.
Tell your provider about all medications you take, including prescription medications, over-the-counter medications, vitamins, herbal products, dietary supplements, and other weight-loss products.
Important medications and products to discuss include:
Tell your provider if you are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed.
If you are pregnant: Compounded tirzepatide should not be used for weight loss during pregnancy. Weight loss offers no benefit during pregnancy and may harm the unborn baby. Based on animal studies, there may be potential risks to an unborn baby from tirzepatide exposure during pregnancy. Discontinue compounded tirzepatide when pregnancy is recognized unless your provider determines otherwise for a non-weight-loss indication.
If you are of reproductive potential: Tirzepatide may reduce the effectiveness of oral hormonal contraceptives. Switch to a non-oral contraceptive method or add a barrier method for 4 weeks after starting tirzepatide and for 4 weeks after each dose increase.
If you are breastfeeding or plan to breastfeed: Tell your provider before using compounded tirzepatide. A single-dose clinical lactation study of Zepbound® found tirzepatide in breast milk to be undetectable or low compared with the maternal dose, but there are no available data on the effects of tirzepatide on the breastfed infant or on milk production. Because compounded tirzepatide is not FDA-approved and may differ from FDA-approved products in composition, concentration, and quality, discuss the potential benefits and risks with your provider before use while breastfeeding.
Withholding or providing inaccurate information about your health, medication use, pregnancy status, breastfeeding status, or medical history in order to obtain treatment may result in harm, including, in some cases, death.
If you currently use, or recently used, any compounded or brand-name GLP-1 or GIP/GLP-1 medication, do not start another GLP-1 or GIP/GLP-1 medication unless your provider specifically instructs you to do so. Taking more than one GLP-1 or GIP/GLP-1 medication at the same time can increase the risk of serious side effects. Tell your provider about all current or recent weight-loss or diabetes medications, including the medication name, dose, concentration if compounded, last dose date, pharmacy, and prescriber. You may be asked to provide documentation before treatment is prescribed.
Serious side effects that may occur with tirzepatide include thyroid C-cell tumors, severe gastrointestinal reactions, acute kidney injury due to dehydration or volume depletion, acute gallbladder disease, acute pancreatitis, serious allergic reactions, hypoglycemia, diabetic retinopathy complications in patients with type 2 diabetes, pulmonary aspiration during anesthesia or deep sedation, and infection risk from sharing vials, syringes, or needles. These risks are described in more detail in the common safety section above.
Call your provider right away if you have symptoms that are new, severe, worsening, or concerning. If you are experiencing a medical emergency, call 911 or seek immediate medical attention.
Common side effects can include nausea, diarrhea, vomiting, constipation, abdominal pain, indigestion, injection-site reactions, fatigue, allergic or hypersensitivity reactions, belching, hair loss, and gastroesophageal reflux disease.
Nausea often lessens as treatment continues. Vomiting or diarrhea that does not stop may result in dehydration. Contact your provider promptly if you notice symptoms of dehydration, such as unusual dry mouth, thirst, dizziness, or lightheadedness.
This is not a complete list of possible side effects. You may report side effects or product-quality concerns to FDA MedWatch at 1-800-FDA-1088 or www.fda.gov/medwatch.
This revised draft was prepared using the uploaded June 2026 medication-safety text and the following current public sources. Final language should be reviewed by prescribing clinicians and legal/regulatory counsel before publication.
Last updated: June 2026