Who the labels say should not take a GLP-1
All four of these labels open with the same boxed warning and name the same two contraindications. Below that they diverge: the warnings and precautions section runs to 10 and 11 subsections depending on the product, and not every warning appears on every one. The shared parts are quoted below; the rest is set out label by label.
Reviewed by Ellis Brandt. Sources checked September 2026.
This guide draws on the cited FDA-approved prescribing information and other FDA sources. It is not medical advice; discuss treatment with your clinician. See the medical disclaimer.
The boxed warning
Every one of these four labels carries a boxed warning, the strongest warning the FDA applies, and all four carry the same one, headed WARNING: RISK OF THYROID C-CELL TUMORS.
Mounjaro’s, in full as the label states it: “In both male and female rats, tirzepatide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures. It is unknown whether MOUNJARO causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of tirzepatide-induced rodent thyroid C-cell tumors has not been determined”.
The semaglutide labels say the same thing about their own molecule. Ozempic: “In rodents, semaglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures. It is unknown whether OZEMPIC causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of semaglutide-induced rodent thyroid C-cell tumors has not been determined”.
Two things in that wording are worth reading precisely, because they are usually paraphrased away. The finding is in rodents. And the labels say the human relevance of that finding has not been determined — not that it has been ruled out, and not that it has been established.
Each boxed warning then adds the same practical instruction: counsel patients about the symptoms of thyroid tumors — “a mass in the neck, dysphagia, dyspnea, persistent hoarseness” — and note that “routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC” in patients taking these drugs.
The contraindications
Section 4 is the short list — the circumstances in which the label says the drug should not be used at all. On all four it holds the same two entries.
Drag the table sideways to read the remaining columns.
| Label | Thyroid contraindication | Hypersensitivity contraindication |
|---|---|---|
| Ozempic | A personal or family history of medullary thyroid carcinoma, or Multiple Endocrine Neoplasia syndrome type 2 | A serious hypersensitivity reaction to semaglutide or to any of the excipients in Ozempic |
| Wegovy | A personal or family history of medullary thyroid carcinoma, or Multiple Endocrine Neoplasia syndrome type 2 | A serious hypersensitivity reaction to semaglutide or to any of the excipients in Wegovy |
| Mounjaro | A personal or family history of medullary thyroid carcinoma, or Multiple Endocrine Neoplasia syndrome type 2 | A serious hypersensitivity reaction to tirzepatide or to any of the excipients in Mounjaro |
| Zepbound | A personal or family history of medullary thyroid carcinoma, or Multiple Endocrine Neoplasia syndrome type 2 | A serious hypersensitivity reaction to tirzepatide or to any of the excipients in Zepbound |
Which warnings appear on which label
Section 5 is longer and it is not identical across the four. The table below lists the subsection titles in each label’s warnings and precautions section, read end to end in September 2026. A blank is an absence from that document, not a statement that the risk does not exist.
Drag the table sideways to read the remaining columns.
| Warning | Ozempic | Wegovy | Mounjaro | Zepbound |
|---|---|---|---|---|
| Risk of thyroid C-cell tumors | 5.1 | 5.1 | 5.1 | 5.1 |
| Acute pancreatitis | 5.2 | 5.2 | 5.2 | 5.5 |
| Acute gallbladder disease | 5.9 | 5.3 | 5.8 | 5.4 |
| Hypoglycemia | 5.5 | 5.4 | 5.3 | 5.7 |
| Acute kidney injury due to volume depletion | 5.6 | 5.5 | 5.5 | 5.3 |
| Severe gastrointestinal adverse reactions | 5.7 | 5.6 | 5.6 | 5.2 |
| Hypersensitivity reactions | 5.8 | 5.7 | 5.4 | 5.6 |
| Diabetic retinopathy complications | 5.3 | 5.8 | 5.7 | 5.8 |
| Pulmonary aspiration during general anesthesia or deep sedation | 5.10 | 5.10 | 5.9 | 5.9 |
| Never share a pen between patients | 5.4 | 5.11 | 5.10 | 5.10 |
| Heart rate increase | — | 5.9 | — | — |
The cells hold the subsection number in that label, so a reader can go to the document and check. 11 warnings appear across the four; 10 are shared, and heart rate increase appears on the Wegovy label alone among these four. Read down the columns instead of across the rows, the four sections run to 10 on Ozempic, 11 on Wegovy, 10 on Mounjaro and 10 on Zepbound.
Ozempic
10 of 11 — missing 1 of them
Wegovy
11 of 11 — every warning named across the four
Mounjaro
10 of 11 — missing 1 of them
Zepbound
10 of 11 — missing 1 of them
Counted the same way as the table above — the subsection titles of section 5 in each of the 4 FDA-approved labels, read end to end in September 2026. The track is all 11 warnings named across the 4 documents; the gap is what that document does not carry. An absence here is an absence from that label, not a statement that the risk does not exist.
Pregnancy, and a number that only two of these labels give
Both semaglutide labels give a discontinuation interval before a planned pregnancy. Neither tirzepatide label gives one. That is a real difference between the documents, and the semaglutide interval is not borrowed across to fill the empty cells.
Drag the table sideways to read the remaining columns.
| Label | What the label states |
|---|---|
| Ozempic | Discontinue in women at least 2 months before a planned pregnancy, because of the long washout period for semaglutide. |
| Wegovy | Because of the potential for fetal harm, discontinue at least 2 months before planning to become pregnant, to account for the long half-life of semaglutide. |
| Mounjaro | No interval stated. section 8.3 of this label covers contraception only and states no pre-pregnancy interval. |
| Zepbound | No interval stated. the label advises patients to discontinue when a pregnancy is recognized, and states no interval before a planned one. |
The semaglutide labels’ two months is not carried across to tirzepatide. The two molecules clear at different rates, and each label states the interval as following from its own. Both tirzepatide labels do carry the oral-contraceptive precaution described on the drug interactions page, which is a different question and is often confused with this one.
Sources
Drag the table sideways to read the remaining columns.
| Label | Applicant on the label | SPL version | Label effective date | Where it was read |
|---|---|---|---|---|
| Ozempic (semaglutide) | Novo Nordisk Pharmaceutical Industries, LP | 20 | 2026-06-01 | DailyMed, set id adec4fd2-6858-4c99-91d4-531f5f2a2d79 |
| Wegovy (semaglutide) | Novo Nordisk Pharmaceutical Industries, LP | 19 | 2026-06-18 | DailyMed, set id ee06186f-2aa3-4990-a760-757579d8f77b |
| Mounjaro (tirzepatide) | Eli Lilly and Company | 40 | 2026-08-27 | DailyMed, set id d2d7da5d-ad07-4228-955f-cf7e355c8cc0 |
| Zepbound (tirzepatide) | Eli Lilly and Company | 40 | 2026-08-28 | DailyMed, set id 487cd7e7-434c-4925-99fa-aa80b1cc776b |
Every figure and quotation comes from the label’s own tables and text. Each label is the FDA-approved version that was current when it was read in September 2026, identified in the table by its version number and effective date.
See the providers
If none of these warnings rule the drug out for you, the boards list the providers who prescribe it and what each one publishes.
- Semaglutide providersprovider board
Compare semaglutide plans, pharmacy details and cancellation terms.
- Tirzepatide providersprovider board
Compare tirzepatide plans, pharmacy details and cancellation terms.
More, read from the same labels
- First-year GLP-1 costsresearch guide
A low monthly headline does not tell you what a year of treatment will cost. Compare the same medication and service package, then separate the total you expect to spend from the amount you must pay before treatment begins.
- Cancellation and refundsresearch guide
Canceling future membership charges, stopping an upcoming medication order and requesting a refund are three different requests. Get a written answer for each one that applies to you.
- Insurance denial documentsresearch guide
The next step depends on why coverage was denied. A missing document, a formulary restriction and an excluded benefit are different problems. Start with the written decision before paying someone to submit another request.
- Savings and cash-pay eligibilityresearch guide
A manufacturer savings card and a self-pay offer can have different eligibility rules, even for the same medicine. Match the offer to your coverage and exact product before using its advertised price in your budget.
- Verify your GLP-1 pharmacyresearch guide
The website taking your payment, the clinician prescribing and the pharmacy dispensing may be different businesses. Identify each one. A recognizable brand or a reassuring badge does not tell you who will fill the prescription.
- Changing GLP-1 providersresearch guide
Before ending your current service, establish what the new practice needs, what it will charge and when it can evaluate you. Transferring your records does not guarantee that another clinician will continue the same prescription.
- Weight regain after stoppingresearch guide
Weight regain occurred after treatment withdrawal in studies of semaglutide and tirzepatide. The findings support planning follow-up and affordability before an interruption, but they do not predict exactly what will happen to one person.
- Semaglutide vs tirzepatideresearch guide
What the four FDA-approved labels say each molecule is, what each is approved to treat, and where the two differ.
- How they workresearch guide
The receptor each molecule switches on, what the labels say that does to appetite, blood sugar and the stomach, and why one dose lasts a week.
- Is Ozempic insulin?research guide
What the Ozempic label calls semaglutide, how that differs from insulin, and where insulin appears on these labels as a separate medicine.
- Zepbound vs Ozempicresearch guide
Four brand names, two molecules and two kinds of approval: which of these products are the same drug, and what each one is actually approved to do.
- Dose escalation schedulesresearch guide
The starting dose, the escalation interval and the maximum dose each label sets, and why they are not interchangeable.
- Side effect ratesresearch guide
What each label reports for nausea, vomiting, diarrhea and constipation — and the sentence every label prints above those numbers.
- Hair lossresearch guide
Which labels report hair loss, the rate against placebo where a trial measured it, and why two of them put no number on it.
- Fatigue and tirednessresearch guide
Which labels list fatigue, the rate against placebo where a trial measured it, and what each label counts as fatigue.
- Missed dose rulesresearch guide
The window each label gives for a late dose, and the minimum gap it requires when the injection day changes.
- Drug interactionsresearch guide
Insulin and sulfonylureas, oral medications, and the oral-contraceptive precaution that appears on two of these four labels and not the other two.
- Buying one onlineresearch guide
The agency's own warning signs for a telehealth GLP-1 seller, its 28-day vial rule, and what it says about drugs that arrive warm.
- Zepbound by doseresearch guide
What each Zepbound dose achieved in the trials printed in its label, what the label says about choosing a maintenance dose, and what the higher doses cost in side effects.
- Zepbound at 3 monthsresearch guide
What does the Zepbound label report about three-month weight loss and maintenance dosing?
- Injecting tirzepatideresearch guide
The injection sites, the rotation rule and the steps for the single-dose pen, the KwikPen and the vial and syringe, exactly as the FDA-approved Instructions for Use give them.
- Refrigeration and storageresearch guide
How cold each pen is kept, how many days it can spend at room temperature, and what the labels say about heat and freezing.
The two contraindications
A personal or family history of medullary thyroid carcinoma, or Multiple Endocrine Neoplasia syndrome type 2. And a serious hypersensitivity reaction to the active ingredient or to any excipient in the product.
Identical on all four labels, read September 2026.