Evidence review
Does semaglutide cause cancer?
Quick answer
Nobody knows whether it causes thyroid tumors in people, and the label says exactly that. The boxed warning comes from rodents, where semaglutide caused thyroid C-cell tumors; the label adds that it is “unknown whether WEGOVY® causes thyroid C-cell tumors… in humans.” In the human trials, cancer has not shown up as a difference: in SELECT, malignant neoplasms were reported by 4.8% on semaglutide against 4.7% on placebo over a mean of 39.8 months. The thyroid cancer studies disagree with each other, and most of them are about the drug class rather than semaglutide.
What the warning actually says1
Both semaglutide labels open with the same boxed warning, and it is worth reading for what it does not claim. It reports an animal finding, then states the human question is open:
In rodents, semaglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures. It is unknown whether WEGOVY® 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.
The second half of the warning is a rule rather than a finding: semaglutide is contraindicated in anyone with a personal or family history of MTC, or with Multiple Endocrine Neoplasia syndrome type 2. The Ozempic label carries the same two paragraphs with its own brand name.11 The full text, verbatim, is on the boxed warning page.
What happened in the rodents1
Section 13.1 is where the numbers are. Two lifetime studies, one in mice and one in rats:
- Mice, two years. Doses up to 7-fold the maximum recommended human dose in males and 2-fold in females, measured by drug exposure rather than milligrams. The label reports “a statistically significant increase in thyroid C-cell adenomas and a numerical increase in C-cell carcinomas… in males and females at all dose levels.”
- Rats, two years. Doses up to 0.7-fold human exposure — below the human dose. A significant increase in C-cell adenomas at every dose level in both sexes, and in carcinomas in males at the higher doses.
- Then the sentence that matters. “Human relevance of thyroid C-cell tumors in rats is unknown and could not be determined by clinical studies or nonclinical studies.”
The label also records that semaglutide “was not mutagenic or clastogenic in a standard battery of genotoxicity tests” — it does not damage DNA in the usual assays. Whatever happened in those rodent thyroids, it was not that.
What the label says about people1
Section 5.1 adds three human-facing points, and none of them is a rate:
- A different drug’s reports. “Cases of MTC in patients treated with liraglutide, another GLP-1 receptor agonist, have been reported in the postmarketing period; the data in these reports are insufficient to establish or exclude a causal relationship between MTC and GLP-1 receptor agonist use in humans.” That is liraglutide, not semaglutide, and the label draws no conclusion from it.
- Screening does not help. Routine monitoring of serum calcitonin or thyroid ultrasound “is of uncertain value for early detection of MTC,” and “may increase the risk of unnecessary procedures” because the test is not specific enough and thyroid disease is common anyway.
- What to report. The label asks prescribers to inform patients of the symptoms of thyroid tumors: a mass in the neck, difficulty swallowing, shortness of breath, persistent hoarseness.
Neither label’s postmarketing section — the list of things reported after approval — contains a thyroid or cancer entry. What it does contain is pancreatitis, ileus, obstruction, severe constipation, hypersensitivity, aspiration and acute kidney injury.
What the semaglutide trials recorded2
SELECT is the longest randomized record of semaglutide 2.4 mg: 17,604 adults, mean follow-up 39.8 months. Malignant neoplasms were a prespecified adverse event of special interest, which means they were collected deliberately rather than incidentally.
| In SELECT | Semaglutide (8,803) | Placebo (8,801) |
|---|---|---|
| Malignant neoplasms | 422 (4.8%) | 418 (4.7%) |
| Serious events: neoplasms benign, malignant and unspecified | 405 (4.6%) | 402 (4.6%) |
| Stopped the drug because of a neoplasm | 80 (0.9%) | 105 (1.2%) |
The authors’ own summary sentence is narrower than a headline but clear: “serious adverse events related to gastrointestinal disease, acute kidney failure, pancreatitis, cancers, or psychiatric disorders were not more frequent with semaglutide than with placebo.” One caveat travels with every SELECT figure: the trial collected only serious adverse events, events that led to stopping, and events of special interest — not everything that happened. The rest of what it recorded is on long-term safety.
STEP 1, the pivotal obesity trial, is shorter — 1,961 adults, 68 weeks — and reports the same shape of result: malignant neoplasms in 14 of 1,306 on semaglutide (1.1%) and 7 of 655 on placebo (1.1%), with the authors writing that “there was no difference between groups in the incidence of benign and malignant neoplasms.”3 Sixty-eight weeks is far too short for a tumor to begin and be found, which is why neither trial answers the label’s question. The trial itself is on the STEP 1 page.
Thyroid cancer in the trials4
Thyroid cancer is rare enough that no single trial can measure it, so the manufacturer pooled its own: 93 trials of liraglutide or semaglutide, 101,732 participants, 207,000 patient-years. Across all of them, thyroid cancer was reported in 0.08% of people on a GLP-1 drug and 0.06% on placebo — a hazard ratio of 1.70, with a confidence interval of 0.99 to 3.03 that just touches no-difference. Medullary thyroid cancer, the type the boxed warning names, was reported in three people on the drugs and four on placebo.
Its table of the six long cardiovascular and kidney outcome trials is the closest thing to a semaglutide-specific count, so here are the semaglutide ones, participants with at least one malignant thyroid neoplasm:
| Trial | Semaglutide | Placebo |
|---|---|---|
| SUSTAIN 6 (injection, type 2 diabetes) | 1 of 1,648 | 1 of 1,649 |
| PIONEER 6 (tablet, type 2 diabetes) | 2 of 1,591 | 0 of 1,592 |
| SELECT (injection, weight management) | 5 of 8,803 | 5 of 8,801 |
| SOUL (tablet, type 2 diabetes) | 6 of 4,825 | 2 of 4,825 |
| FLOW (injection, kidney disease) | 1 of 1,767 | 1 of 1,766 |
Single digits either way, in trials of thousands. Two things follow. Counts this small cannot distinguish a real effect from chance — and they also cannot rule one out. The analysis was funded by Novo Nordisk, which makes both drugs, and the trials in it were too.
The observational studies6
This is where the public argument lives, and the first column is the one to read. Most of these studies are about the GLP-1 class, and in the biggest of them semaglutide is a minority of the drug exposure.
| Study | Drugs it covered | What it found |
|---|---|---|
| Scandinavian cohort, 2024 PMID 38683947 | GLP-1 class. Liraglutide 57.3% of use, semaglutide 32.9%, dulaglutide 4.9%, exenatide 4.1%, lixisenatide 0.9% | No increased risk against DPP-4 inhibitors: hazard ratio 0.93 (95% CI 0.66 to 1.31), 76 cancers in 145,410 people against 184 in 291,667. Medullary thyroid cancer 1.19 (0.37 to 3.86). |
| International multisite cohort, 2025 PMID 39772758 | GLP-1 class, six national databases; the drugs are not broken out | No increased risk against DPP-4 inhibitors: pooled hazard ratio 0.81 (0.59 to 1.12), median follow-up 1.8 to 3.0 years. The authors say the follow-up was too short to rule out a long-term excess. |
| French nested case-control, 2023 PMID 36356111 | GLP-1 class in France, 2006 to 2018 | Increased risk after 1 to 3 years of use: all thyroid cancer 1.58 (1.27 to 1.95), medullary thyroid cancer 1.78 (1.04 to 3.05). |
| Meta-analysis of GLP-1 trials, 2024 PMID 38018310 | GLP-1 class, 64 randomized trials lasting at least 52 weeks | Odds ratio 1.52 (1.01 to 2.29) for thyroid cancer, with a fragility index of 1 — one event would overturn it — and a five-year number needed to harm of 1,349. Papillary and medullary subtypes were not significant on their own. |
| Semaglutide-only meta-analysis, 2023 PMID 37531876 | Semaglutide only, 37 randomized trials and 19 real-world studies | Against placebo: thyroid cancer odds ratio 2.04 (0.33 to 12.61), pancreatic cancer 0.25 (0.03 to 2.24), all neoplasms 0.95 (0.62 to 1.45). The authors conclude no increased risk of any cancer type. |
| Manufacturer's pooled analysis, 2026 PMID 41287564 | Liraglutide and semaglutide, pooled: 93 trials, post-marketing reports, one US claims database | Thyroid cancer in 0.08% on a GLP-1 drug against 0.06% on placebo; hazard ratio 1.70 (0.99 to 3.03). Three medullary cases on the drugs against four on placebo. Claims database: 0.87 (0.58 to 1.29). |
How to read that table
- The one study that is only about semaglutide found nothing. Its confidence interval runs from 0.33 to 12.61, which is another way of saying the trials it pooled contained almost no thyroid cancers.5
- The study that found a class increase was mostly not semaglutide. The French analysis covers prescriptions from 2006 to 20187, and the semaglutide-only review describes the drugs behind that signal as exenatide, liraglutide and dulaglutide.5
- The two neutral cohorts are short. Mean follow-up on semaglutide in the Scandinavian study was 1.1 years; the multisite study’s median was under three8. Both sets of authors say so, and the second adds that the evidence was “insufficient to rule out excess risk with long-term use.”
- A meta-analysis of trials found a fragile class signal. Odds ratio 1.52, and a fragility index of 1: a single reclassified event would erase it.9
- Other cancers point the other way, and prove nothing either. A 2026 analysis of 161,798 matched adults with obesity and no diabetes reported fewer obesity-associated cancers among users of GLP-1 drugs as a class, semaglutide and tirzepatide included, hazard ratio 0.59 — and its authors write that “prospective trials are needed to confirm causality.” People prescribed these drugs are not like people who are not, and nothing in that design fixes it.10
What none of it settles
On the label — Wegovy / Ozempic
An animal finding, a contraindication, no human rate, and up to about four years of randomized follow-up in which cancers were no more frequent than on placebo. The label’s own position is that the human question is undetermined.
In a compounded vial
Nothing measured on a compounded product: no trial has been run on one, and the boxed warning attaches to the molecule whoever prepared it. FDA has also warned that some compounded semaglutide may be a salt form, which is a different active ingredient — see is compounded semaglutide safe?
Cancer takes years to appear and years to find. Semaglutide has been marketed since 2017, the longest randomized follow-up is under four years, and the drug’s heaviest use began in the 2020s. A study that could settle the thyroid question does not exist yet, and will not for some time. What exists is a warning that says so.
This page reports the approved labels and the published studies, quoted and attributed, and takes no position of its own on whether anyone should start, continue or stop the drug — that is a prescriber’s judgment, and this is not medical advice. Every study was located on PubMed and its PMID resolved before it was cited, and each row above names the drugs the study actually included. See the medical disclaimer.
Continue
Questions
- Does semaglutide cause cancer?
- It is not known to. In rodents, semaglutide caused thyroid C-cell tumors, which is why the label carries a boxed warning; the label states that it is unknown whether it causes those tumors in humans, because the human relevance of the rodent finding has not been determined. In SELECT, the longest randomized trial, malignant neoplasms were reported by 4.8% on semaglutide and 4.7% on placebo over a mean of 39.8 months.
- Does Ozempic cause thyroid cancer?
- No human study has shown that it does, and the Ozempic label says the question is undetermined. Thyroid cancer counts in the long semaglutide trials are single digits on both sides: 1 against 1 in SUSTAIN 6, 5 against 5 in SELECT, 6 against 2 in SOUL, 1 against 1 in FLOW.
- Why does the label warn about thyroid cancer at all?
- Because of two-year studies in mice and rats, in which semaglutide produced a statistically significant increase in thyroid C-cell adenomas at every dose level, including doses below human exposure in rats. The label says the human relevance of that finding could not be determined.
- Who must not take semaglutide because of the cancer warning?
- The label contraindicates it in anyone with a personal or family history of medullary thyroid carcinoma, and in anyone with Multiple Endocrine Neoplasia syndrome type 2. That is the label's rule, not this page's advice.
- Do the studies agree about thyroid cancer?
- No. A French analysis of GLP-1 drugs used between 2006 and 2018 found an increased risk after one to three years of use; a Scandinavian cohort and a six-database international cohort found none; a meta-analysis of 64 trials found a fragile class-level increase. Most of this work is about the GLP-1 class rather than semaglutide, and in the largest neutral cohort semaglutide was under a third of the exposure.
- Should I have my thyroid checked while taking semaglutide?
- The label addresses that directly and discourages routine screening: monitoring serum calcitonin or using thyroid ultrasound is “of uncertain value for early detection of MTC” and may increase the risk of unnecessary procedures. What to do in an individual case is a question for a prescriber.
Sources
- FDA prescribing information for WEGOVY (semaglutide), boxed warning and sections 4, 5.1, 6.1, 6.2, 13.1 and 17, revision 6/2026 DailyMed
- Lincoff AM et al., 'Semaglutide and Cardiovascular Outcomes in Obesity without Diabetes' (SELECT), New England Journal of Medicine 2023;389(24):2221-2232 (PMID 37952131), full text and Table 4
- Wilding JPH et al., 'Once-Weekly Semaglutide in Adults with Overweight or Obesity' (STEP 1), New England Journal of Medicine 2021;384(11):989-1002 (PMID 33567185), full text and Table 3
- Vilsbøll T et al., 'Assessment of thyroid cancer risk associated with glucagon-like peptide 1 receptor agonist use', Diabetes, Obesity and Metabolism 2026;28(2):1499-1507 (PMID 41287564), full text; funded by Novo Nordisk
- Nagendra L et al., 'Semaglutide and cancer: A systematic review and meta-analysis', Diabetes & Metabolic Syndrome 2023;17(9):102834 (PMID 37531876), abstract
- Pasternak B et al., 'Glucagon-like peptide 1 receptor agonist use and risk of thyroid cancer: Scandinavian cohort study', BMJ 2024;385:e078225 (PMID 38683947), full text
- Bezin J et al., 'GLP-1 Receptor Agonists and the Risk of Thyroid Cancer', Diabetes Care 2023;46(2):384-390 (PMID 36356111), abstract
- Baxter SM et al., 'Glucagon-Like Peptide 1 Receptor Agonists and Risk of Thyroid Cancer: An International Multisite Cohort Study', Thyroid 2025;35(1):69-78 (PMID 39772758), abstract
- Silverii GA et al., 'Glucagon-like peptide-1 receptor agonists and risk of thyroid cancer: A systematic review and meta-analysis of randomized controlled trials', Diabetes, Obesity and Metabolism 2024;26(3):891-900 (PMID 38018310), abstract
- Hsu AH et al., 'GLP-1 receptor agonist use and cancer risk in obese nondiabetic adults', Annals of Oncology 2026;37(8):1178-1185 (PMID 42252247), abstract
- FDA prescribing information for OZEMPIC (semaglutide) injection, boxed warning and sections 5.1 and 13.1, revision 5/2026 DailyMed