Before You Start a GLP-1: What the FDA Labels Say

Before you start a GLP-1, know what its label warns about. Every warning on this page comes from the FDA-approved labels for Wegovy, Zepbound and Foundayo, or from the FDA’s own guidance on compounded drugs. Read it before your first visit, then go over anything that applies to you with your prescriber.

This page isn’t medical advice. It has no provider buttons. It sums up what the drug labels tell prescribers and patients, so you know which questions to ask.

Taken from FDA labels
FDA Labels Checked:
Contraindications

Who Shouldn’t Take a GLP-1

Before you start a GLP-1, your prescriber will ask about each of these. The labels list only a few hard stops.
  • You or someone in your family has had medullary thyroid carcinoma (MTC), a rare thyroid cancer.
  • You have multiple endocrine neoplasia syndrome type 2 (MEN 2).
  • You’ve had a serious allergic reaction to the drug or to any ingredient in it.
  • You’re pregnant. The labels say to stop once a pregnancy is confirmed, because weight loss has no benefit during pregnancy and the drug may harm the baby.

Don’t take two GLP-1 drugs at once. The Foundayo label says so directly. The same goes for tirzepatide, which also acts on the GLP-1 receptor.

The Boxed Warning

The Thyroid Warning on Every GLP-1 Label

Wegovy, the Wegovy pill, Zepbound, Foundayo, Ozempic and Mounjaro all carry the same boxed warning, the FDA’s strongest kind.

The heading reads “Risk of thyroid C-cell tumors.” In studies in rats and mice, these drugs caused thyroid C-cell tumors. Nobody knows yet whether they do the same in people. That’s why a personal or family history of MTC or MEN 2 rules them out.

The labels ask you to tell your prescriber about a lump or swelling in your neck, trouble swallowing, a hoarse voice that doesn’t go away, or shortness of breath.

Your Health History

Tell Your Prescriber About These First

Go over this list before you start a GLP-1. None of these rules the drug out on its own, but each one changes how you start or what you watch for.
  • Pancreatitis, now or in the past. The labels warn about acute pancreatitis.
  • Gallbladder problems or gallstones. Fast weight loss raises the risk, and the labels list acute gallbladder disease.
  • Kidney disease. Vomiting and diarrhea can dehydrate you and, in some people, injure the kidneys.
  • Diabetes treated with insulin or a sulfonylurea such as glipizide. Adding a GLP-1 can push blood sugar too low, so those doses may need to come down.
  • Diabetic eye disease (retinopathy). The labels flag faster-than-expected worsening in people with type 2 diabetes.
  • Surgery, a colonoscopy or anything else that needs anesthesia or deep sedation. More on that below.
  • Pregnancy plans, breastfeeding or birth control pills. Also below.
  • Every medicine and supplement you take. GLP-1s slow digestion, which can change how pills by mouth are absorbed.
Plan Ahead

Pregnancy, Birth Control and Surgery on a GLP-1

Three situations where the labels give specific timing.
  • Planning a pregnancy? The Wegovy label says to stop at least 2 months before you try to conceive, because semaglutide stays in the body for weeks. Ozempic’s label says the same. For Zepbound and Foundayo, the labels say to stop once you know you’re pregnant.
  • Taking birth control pills with Zepbound or Mounjaro? Tirzepatide can make the pill less reliable. The Zepbound label says to switch to a non-oral method, or add a barrier method such as condoms, for 4 weeks after you start and for 4 weeks after each dose increase.
  • Taking birth control pills with Foundayo? Its label gives the same advice for 30 days after you start and 30 days after each dose increase.
  • Having surgery or sedation? The labels warn that food can stay in your stomach and be inhaled into the lungs under general anesthesia or deep sedation. Tell the surgeon and the anesthesia team you take a GLP-1, and ask whether to pause it or change how you fast beforehand.
Side by Side

GLP-1 Warnings Compared by Medication

Section 5 of each label, “Warnings and Precautions,” lists the serious risks. Here’s how the three weight-loss labels compare.
WarningWegovy and Wegovy pillZepboundFoundayo
Thyroid C-cell tumors (boxed)YesYesYes
Acute pancreatitisYesYesYes
Acute gallbladder diseaseYesYesYes
Severe stomach and bowel reactionsYesYesYes
Kidney injury from dehydrationYesYesYes
Low blood sugarYesYesYes
Serious allergic reactionsYesYesYes
Diabetic eye disease getting worseYesYesYes
Inhaling food under anesthesiaYesYesYes
Faster heart rateYesNot listedNot listed
Label revisedJune 2026August 2026July 2026

Sources: the Wegovy label, the Zepbound label and the Foundayo label on DailyMed. Ozempic and Mounjaro are approved for type 2 diabetes and carry the same boxed warning. Each medication page has its own details.

Compounded GLP-1s

If You’re Considering a Compounded GLP-1

Compounded semaglutide and tirzepatide aren’t FDA-approved. The FDA doesn’t review them for safety, effectiveness or quality.

As of May 31, 2026, the FDA had received 990 adverse event reports linked to compounded semaglutide and more than 730 linked to compounded tirzepatide. Some patients ended up in the hospital after dosing mistakes, such as drawing the wrong amount from a vial or following a dose schedule that rose faster than the approved one. The FDA also says it doesn’t know whether the salt forms some compounders use, semaglutide sodium and semaglutide acetate, work like the approved drug.

If you go the compounded route, these checks follow from the FDA’s warnings:

  • Get the prescription from a licensed clinician who reviews your health history.
  • Make sure a state-licensed pharmacy fills it. Ask for its name.
  • Check that the dose is written in milligrams and in syringe units, and ask how to measure it if you’re not sure.
  • Don’t use a vial that arrives warm or not properly cold.
  • Throw out a multi-dose vial 28 days after you first open it.
  • Report side effects to the FDA through MedWatch.

Source: FDA’s concerns with unapproved GLP-1 drugs used for weight loss, updated October 1, 2026.

Warning Signs

When to Get Medical Help Right Away

Mild nausea in the first weeks is common. These signs are different.
  • Severe stomach pain that won’t go away, with or without vomiting. It can spread to your back. This can be pancreatitis.
  • Pain in the upper right side of your belly, fever, yellow skin or eyes, or clay-colored stools. These can point to a gallbladder problem.
  • Swelling of the face, lips, tongue or throat, trouble breathing or swallowing, a bad rash or a racing heartbeat. These are signs of a serious allergic reaction.
  • Vomiting or diarrhea that keeps you from drinking enough, or much less urine than usual.
  • Shakiness, sweating, confusion or a fast heartbeat if you also take insulin or a sulfonylurea. Your blood sugar may be too low.
  • Vision changes if you have type 2 diabetes.

For everyday side effects, like nausea, constipation and fatigue, and how long they last, see our GLP-1 side effects guide.

How We Wrote This

Where This Information Comes From

We summarize the labels. We don’t add our own medical claims.

Labels

Each warning comes from the current FDA-approved label on DailyMed, the National Library of Medicine’s database of drug labels.

Dates

We checked every label and the FDA’s compounding page on October 5, 2026. The table shows each label’s revision date.

Not Advice

This page can’t tell you whether a GLP-1 is right for you. A licensed clinician who knows your history can.

Updates

We recheck the labels every month and after any FDA safety announcement. If you spot an error, write to us through the contact page.
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Common Questions

Before You Start a GLP-1: FAQ

Short answers based on the FDA labels.

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