GLP-1 Safety Information

The information on this page is provided for general educational purposes only and is not intended to promote any specific product. It is a summary. It does not contain everything that is known about these medications, it is not medical advice, and it is not a substitute for a conversation with your own clinician.

On this page: FDA-approved medications · About compounded medications · Compounded semaglutide · Compounded tirzepatide · Reporting a side effect

FDA-approved medications

We prescribe Zepbound® (tirzepatide), an FDA-approved medication, dispensed through our pharmacy partner. It is not a compounded preparation.

Because it is an approved product, it carries FDA-approved labeling — a Medication Guide, full Prescribing Information, and a boxed warning — written and kept current by its manufacturer. That labeling, not this page, is the authoritative source for it. Read it before you start, and read it again if anything changes: zepbound.lilly.com.

The class warning below about thyroid C-cell tumors applies to Zepbound® as well, and the questions to raise with your clinician are the same ones. What differs is that the approved product's safety and effectiveness have been evaluated by the FDA, and the compounded preparations described further down have not.

About compounded medications

A compounded medication is prepared for an individual patient by a licensed compounding pharmacy, on the order of a licensed prescriber. Compounding is permitted under federal and state law in defined circumstances. It is not the same thing as an FDA-approved drug.

Compounded medications are not FDA-approved. The FDA has not evaluated them for safety, effectiveness, or quality. They do not carry FDA-approved indications, and they have not been through the clinical trial programs that FDA-approved medications go through. Published trial results for FDA-approved GLP-1 medications were produced with those approved products and do not describe compounded preparations.

Whether a compounded medication is appropriate for you is a clinical decision made by your licensed medical professional after evaluating your history, and it is made individually. Selecting a program on this website is a preference, not a prescription. Your clinician may prescribe something different, or nothing at all.

Compounded GLP-1 medications are not available in every state, and availability can change.

Where your medication comes from. If prescribed, your medication is dispensed by a U.S. state-licensed pharmacy, regulated by the pharmacy board of the state it operates in. Biomarker Health does not manufacture or compound any medication. We work with more than one licensed pharmacy, so the vial, bottle, or carton you receive may look different from the images shown on this website. Product images on this site are illustrations.

Compounded semaglutide (GLP-1)

Compounded semaglutide is an injectable prescription medicine containing semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist. It is prescribed alongside a reduced-calorie diet and increased physical activity. It is not FDA-approved, and the FDA has not evaluated it for safety, effectiveness, or quality.

Who should not use it

• Anyone with a personal or family history of medullary thyroid carcinoma (MTC), or with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
• Anyone who has had an allergic reaction to semaglutide or to any ingredient in the preparation.
• Anyone who is pregnant, trying to become pregnant, or breastfeeding. There is no benefit to weight loss during pregnancy, and there may be risk to a developing baby.

Before you start

Tell your clinician about every medication you take, including prescriptions, over-the-counter medicines, vitamins, herbal products, and supplements. Tell your clinician if you have a history of type 1 or type 2 diabetes, thyroid disease or thyroid cancer, pancreatitis, gallbladder disease, kidney disease, diabetic retinopathy, depression, or suicidal thoughts or behavior.

Medications in this class slow stomach emptying, which can change how other oral medications are absorbed. This matters particularly if you take insulin or a sulfonylurea, which can cause low blood sugar when combined with a GLP-1.

Withholding or giving inaccurate information about your health in order to obtain a prescription can cause serious harm.

How it is taken

Compounded semaglutide is given as a subcutaneous injection — into the stomach, thigh, or upper arm — once a week, on the same day each week, with or without food. Your clinician sets your starting dose and any changes to it. Do not change your dose or stop taking it without speaking to your clinician first.

Side effects

The most common side effects are gastrointestinal and are usually worst in the first weeks: nausea, vomiting, diarrhea, constipation, abdominal pain, indigestion, reflux, bloating, headache, fatigue, and dizziness. Redness, swelling, or itching at the injection site can occur.

Vomiting or diarrhea that does not stop can lead to dehydration and kidney problems. Contact your clinician promptly if either persists.

Serious but less common problems reported with medications in this class include inflammation of the pancreas (pancreatitis), gallbladder problems including gallstones, low blood sugar, kidney injury, allergic reactions, changes in vision in people with diabetic retinopathy, and depression or suicidal thoughts. Get medical help right away for severe or persistent abdominal pain, especially with vomiting, or for swelling of the face, lips, tongue, or throat, or trouble breathing.

Compounded tirzepatide (GLP-1/GIP)

Compounded tirzepatide is an injectable prescription medicine containing tirzepatide, which acts on both the GIP and GLP-1 receptors. It is prescribed alongside a reduced-calorie diet and increased physical activity. It is not FDA-approved, and the FDA has not evaluated it for safety, effectiveness, or quality.

Who should not use it

• Anyone with a personal or family history of medullary thyroid carcinoma (MTC), or with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
• Anyone who has had an allergic reaction to tirzepatide or to any ingredient in the preparation.
• Anyone who is pregnant, trying to become pregnant, or breastfeeding.

Before you start

The same conversation applies as for semaglutide: every medication you take, and any history of diabetes, thyroid disease, pancreatitis, gallbladder disease, kidney disease, diabetic retinopathy, depression, or suicidal thoughts or behavior.

Tirzepatide can reduce how well oral contraceptives work. If you use an oral contraceptive, talk to your clinician about a backup method or a non-oral option.

How it is taken

Compounded tirzepatide is given as a subcutaneous injection once a week, on the same day each week, with or without food. Your clinician sets your dose and any changes to it.

Side effects

The side-effect profile is broadly similar to semaglutide: nausea, vomiting, diarrhea, constipation, abdominal pain, indigestion, injection-site reactions, fatigue, and dizziness are the most common, and are usually worst early. The same serious problems — pancreatitis, gallbladder disease, low blood sugar, kidney injury, allergic reactions, retinopathy changes, and mood changes including suicidal thoughts — have been reported with this class.

Reporting a side effect

Tell your care team first — message us through your portal, and call your clinician or seek emergency care if a symptom is severe. You can also report side effects directly to the FDA at fda.gov/medwatch or by calling 1-800-FDA-1088.

Wegovy®, Ozempic®, and Rybelsus® are registered trademarks of Novo Nordisk A/S. Zepbound® and Mounjaro® are registered trademarks of Eli Lilly and Company. Those products are FDA-approved and are not compounded. Biomarker Health is not affiliated with, endorsed by, or sponsored by either company, and compounded medications are not those products.