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Compounded semaglutide and compounded tirzepatide injection · Last updated September 12, 2026

Important Safety Information

Summarized from the FDA-approved prescribing information for Wegovy® and Zepbound®. This page has not yet been clinically reviewed.

Boxed warning — risk of thyroid C-cell tumors

In rodents, semaglutide and tirzepatide cause dose-dependent and treatment-duration-dependent thyroid C-cell tumors. It is unknown whether these medications cause thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans.

Do not use these medications if you or any of your family have ever had MTC, or if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Tell your provider if you develop a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath.

Do not use if you

These are the contraindications on the approved labels — the conditions under which these medications must not be used at all:

  • Have a personal or family history of medullary thyroid carcinoma (MTC), or have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
  • Have had a serious allergic reaction to semaglutide itself — this rules out compounded semaglutide, but not tirzepatide
  • Have had a serious allergic reaction to tirzepatide itself — this rules out compounded tirzepatide, but not semaglutide

Tell your clinician before you start if you

With one exception, none of these rules out treatment on its own — each changes the decision, and your clinician needs to know about it before writing a prescription. The exception is pregnancy, and it is first:

  • Are pregnant. Both labels direct stopping these medications when pregnancy is recognized, because of potential harm to an unborn baby. Do not start them while pregnant, and if you become pregnant during treatment, stop and tell your clinician.
  • Are planning to become pregnant. The semaglutide label directs stopping at least 2 months before a planned pregnancy, because of how long the drug stays in the body; the tirzepatide label sets no preconception interval, so ask your clinician how far ahead to stop.
  • Have had a serious allergic reaction to an inactive ingredient in a medication you were given before. Each label contraindicates its own product for its own inactive ingredients, and a compounded preparation is not made to that formula — it may contain some of them, or none. Tell your clinician exactly what you reacted to, so the preparation you are offered can be checked against it.
  • Are breastfeeding. Neither label rules it out, and they do not say the same thing. There are no data on semaglutide in human milk, and its label directs weighing the benefit of breastfeeding against your need for the medication and any risk to the infant; a lactation study of tirzepatide found it undetectable or at low concentrations in milk. That is a decision to make with your clinician, not one either label makes for you.
  • Have had pancreatitis. The labels say these medications have not been studied in people with a history of pancreatitis, and your clinician will weigh that against the benefit.
  • Have type 1 diabetes, or have had diabetic ketoacidosis. These medications are not a substitute for insulin and are not indicated for type 1 diabetes.
  • Have diabetic retinopathy, severe gastrointestinal disease including gastroparesis, or kidney disease.
  • Are under 18. Compounded semaglutide and compounded tirzepatide are not FDA-approved at any age, and a compounded preparation is not necessarily made from an approved product. For reference, the approved products set their own limits: Wegovy is approved for weight management from age 12, Zepbound in adults. Whether treatment is appropriate for anyone under 18 is a decision for your clinician, not something either label settles here.

Warnings

GLP-1 medications may cause serious side effects, including:

Inflammation of the pancreas (pancreatitis)
Severe abdominal pain that will not go away, with or without vomiting. Stop use and get medical help right away.
Gallbladder problems, including gallstones
Pain in the upper stomach, fever, yellowing of the skin or eyes, or clay-colored stools.
Kidney problems
Including worsening kidney failure, often from dehydration caused by nausea, vomiting, or diarrhea.
Low blood sugar (hypoglycemia)
Especially when used with insulin or a sulfonylurea. Signs include dizziness, sweating, shakiness, confusion, and a fast heartbeat.
Serious allergic reactions
Swelling of the face, lips, tongue, or throat; trouble breathing; severe rash. Get emergency help immediately.
Changes in vision
Reported in patients with type 2 diabetes. Tell your provider about any change in vision during treatment.
Increased heart rate
Tell your provider if you feel your heart racing or pounding while at rest.

Earlier labeling for these medications carried a warning about suicidal thoughts and behavior. The FDA completed its review and asked manufacturers to remove it in January 2026: the evidence did not show these medications cause it. Changes in mood are still worth telling your provider about, and if you have thoughts of suicide or self-harm, call or text 988 at any time.

These medications delay gastric emptying, which may affect absorption of oral medications. Tell your provider about all medicines you take, including insulin, sulfonylureas, and birth control pills. Tirzepatide may reduce the effectiveness of oral contraceptives — use a backup method for 4 weeks after starting and after each dose increase.

Tell your care team about any scheduled surgery or procedure with anesthesia and follow their instructions about stopping treatment beforehand.

Common side effects

The most common side effects include nausea, vomiting, diarrhea, constipation, stomach pain, indigestion, injection-site reactions, fatigue, and headache. These are most likely when starting treatment or increasing a dose, and usually lessen over time.

Contact your care team if side effects persist or worsen — dose adjustments often help.

Read more about managing side effects

About compounded medications

Compounding is the preparation of a medication for an individual patient by a pharmacy, rather than its manufacture by the drug's maker. Which pharmacies would prepare a Leland Health prescription is not published yet, so this page makes no claim about where a medication you receive would come from. Compounded medications are not FDA-approved and have not been evaluated by the FDA for safety, efficacy, or quality.

Your provider will discuss whether a compounded medication or an FDA-approved alternative such as Wegovy® or Zepbound® is appropriate for you. This page is a summary and does not replace the counseling provided by your clinician and pharmacist or the medication guide included with your prescription.

Risks specific to a compounded injection

These are not on the approved labels, because there is no FDA-approved compounded version of these medications. They come from the FDA's own statement on unapproved GLP-1 drugs, linked in the sources below:

  • Dosing errors have put people in hospital. FDA has received multiple reports of adverse events, some requiring hospitalization, that may be related to dosing errors with compounded injectable semaglutide — patients measuring and self-administering the wrong dose, and in some cases clinicians miscalculating it. If you are given a vial and a syringe, ask whoever prescribed or compounded it to show you exactly how to measure your dose before you take it.
  • A vial may hold more than one dose, and you may be the one measuring them. FDA says it is aware that compounded GLP-1 medications are sometimes dispensed this way, and that a vial holding several doses of sterile medication carries a raised risk of contamination once it has been in use for over four weeks. The approved pens hold several doses too; what differs is who draws each one.
  • FDA has had complaints about how compounded orders arrive. It says it has received reports of compounded GLP-1 medications arriving warm, or with too little ice to hold the temperature they need. How a preparation must be kept, and how long it may be used once it has been opened, are properties of the exact product dispensed — this site does not yet publish which preparations it would offer, so it cannot tell you what yours would be, and the instructions that come with the medication you are given are the ones that apply to it.
  • A salt form is not the same active ingredient. FDA is aware that some compounded semaglutide is made from salt forms — semaglutide sodium, semaglutide acetate — which are different active ingredients from the one in the approved drugs, and says salt forms should not be used to compound semaglutide. Ask the pharmacy which form it dispenses.

Emergencies and reporting a reaction

If you believe you are experiencing a medical emergency, call 911 or go to the nearest emergency room. If you are having thoughts of suicide or self-harm, call or text 988 — the Suicide & Crisis Lifeline is free and available 24/7.

To report a suspected adverse reaction to a medication you are already taking, tell the clinician who prescribed it — they can advise you on whether to keep taking it and what to do next. Do not email clinical details to Leland Health; email is not a monitored clinical channel. You can also report it directly to the FDA MedWatch program at 1-800-FDA-1088 or online.

Sources