This is one label's record. It reads the MOUNJARO prescribing information (Eli Lilly and Company, NDA 215866, SPL version 40, effective 27 August 2026) as published by the manufacturer on DailyMed and read on 24 September 2026. Brand-name searches of the FDA's label database return repackagers' older copies of this label first; this page uses Lilly's own current one.
Mounjaro is tirzepatide approved for type 2 diabetes, not for weight management. Every number below comes from people with diabetes, most of them already on other diabetes medicines. That is why this label shows things the weight-loss label does not — and why its headline rates are lower. The weight-management label is on our Zepbound side effects page; the class-wide picture is on our GLP-1 side effects page.
Nothing here tells anyone what to do about a symptom. Where the label addresses prescribers or patients, that is reported as what the label says.
The counted reactions, with placebo subtracted
The label's Table 1 pools two placebo-controlled trials: SURPASS-1 (Mounjaro on its own) and SURPASS-5 (added to basal insulin, with or without metformin). 718 people received Mounjaro, for a mean of 36.6 weeks. Their mean age was 58, they had had diabetes for an average of 9.1 years, and 13% already had diabetic eye disease at baseline. The last column is our arithmetic: the 15 mg rate minus placebo.
| Reaction | Placebo | 5 mg | 10 mg | 15 mg | Excess at 15 mg |
|---|---|---|---|---|---|
| Nausea | 4% | 12% | 15% | 18% | +14 |
| Diarrhoea | 9% | 12% | 13% | 17% | +8 |
| Decreased appetite | 1% | 5% | 10% | 11% | +10 |
| Vomiting | 2% | 5% | 5% | 9% | +7 |
| Constipation | 1% | 6% | 6% | 7% | +6 |
| Indigestion (dyspepsia) | 3% | 8% | 8% | 5% | +2 |
| Abdominal pain | 4% | 6% | 5% | 5% | +1 |
Below the 5% line the label lists burping (up to 3.3% against 0.4%), flatulence (up to 2.9% against 0%), reflux (up to 2.5% against 0.4%) and abdominal distension (up to 2.9% against 0.4%).
Decreased appetite is on this table and not on Zepbound's. In a weight-management trial, eating less is the intended effect. In a diabetes trial it is recorded as an adverse reaction — at 11% on the top dose against 1% on placebo. The same molecule is doing the same thing; the label's population decides what it is called.
On this label, the stomach rate does rise with dose
The share of Mounjaro patients reporting any gastrointestinal reaction was 37.1%, 39.6% and 43.6% on the three doses, against 20.4% on placebo. The share who stopped because of one was 3.0%, 5.4% and 6.6%, against 0.4%.
This is a different shape from the weight label, where the share with any stomach complaint sat at 56% at every dose and only the share who quit climbed. Here both climb. We do not offer a reason, and the label does not either; it gives the two numbers and says most nausea, vomiting and diarrhoea "occurred during dose escalation and decreased over time".
Severe gastrointestinal reactions do not follow the dose at all: 1.3% on 5 mg, 0.4% on 10 mg and 1.2% on 15 mg, against 0.9% on placebo. Small numbers in each arm make that line noisy; it is reported because the label prints it.
Low blood sugar depends on what Mounjaro is added to
This is the axis a diabetes label has and a weight label barely touches. The label's Table 2 splits the two placebo-controlled trials:
| Background treatment (40 weeks) | Placebo | 5 mg | 10 mg | 15 mg |
|---|---|---|---|---|
| None (SURPASS-1): glucose below 54 mg/dL | 1% | 0% | 0% | 0% |
| None: severe episodes | 0% | 0% | 0% | 0% |
| Basal insulin ± metformin (SURPASS-5): glucose below 54 mg/dL | 13% | 16% | 19% | 14% |
| Basal insulin: severe episodes | 0% | 0% | 2% | 1% |
A "severe" episode is one where another person had to give carbohydrate, glucagon or other help. Outside the placebo trials, in a trial of up to 104 weeks where Mounjaro was given alongside a sulfonylurea, readings below 54 mg/dL occurred in 13.8%, 9.9% and 12.8% of patients, and severe episodes in 0.5%, 0% and 0.6%.
Read together: on its own, Mounjaro produced no low readings in its 40-week monotherapy trial. The risk arrives with insulin or a sulfonylurea — which is why the label's section 7 tells prescribers to consider reducing the dose of those medicines when Mounjaro is started. That is a prescribing decision, not one a reader can make from a table. The Zepbound label reports 4.2% against 1.3% in its diabetes trial; our Mounjaro and Ozempic comparison covers how the two diabetes drugs were studied against each other.
Heart rate: the Japan subgroup
Mounjaro raised mean heart rate by 2 to 4 beats per minute against 1 on placebo. The label then prints a finer figure. Episodes of sinus tachycardia — a fast regular rhythm with a rise of at least 15 beats per minute — were reported in:
| Placebo | 5 mg | 10 mg | 15 mg | |
|---|---|---|---|---|
| All patients | 4.3% | 4.6% | 5.9% | 10% |
| Patients enrolled in Japan | 7% (3/43) | 7.1% (3/42) | 9.3% (4/43) | 23% (10/43) |
The Japan figures rest on about 43 people per arm, so a handful of patients moves them a long way. The label reports them and states that "the clinical relevance of heart rate increases is uncertain". It gives no explanation for the difference and neither do we.
The heart trial: a different population, a different list
The current label carries a second indication: reducing major cardiovascular events in adults with type 2 diabetes at high risk of them. It rests on SURPASS-CVOT, which randomised 13,299 adults with diabetes and established heart disease to Mounjaro (up to 15 mg) or dulaglutide (Trulicity, 1.5 mg) and followed them for a median of 210 weeks. Their mean age was 64 and they had had diabetes for 15 years.
The label's safety note for that trial is short: side effects were similar to the diabetes trials, except decreased appetite (17%), constipation (13%), vomiting (12%), abdominal pain (10%), fatigue (10%) and dysesthesia (0.7%). Those are Mounjaro-arm rates with no comparator column printed — the comparator was another active drug, not placebo.
The efficacy result, from the label's Table 10:
| Outcome | Dulaglutide (n = 6,647) | Mounjaro (n = 6,647) | Hazard ratio (95% CI) |
|---|---|---|---|
| Heart attack, stroke or cardiovascular death | 13.0% | 12.1% | 0.92 (0.83–1.01) |
| Cardiovascular death | 6.2% | 5.5% | 0.89 (0.77–1.02) |
| Death from any cause | 10.1% | 8.5% | 0.84 (0.75–0.94) |
Mounjaro was non-inferior to dulaglutide; the label states plainly that superiority was not established. The all-cause death line has an interval that excludes 1, but the label marks it "not controlled for family-wise type I error rate" — it is a secondary result the trial was not powered to claim. Our Trulicity and Ozempic comparison covers the comparator.
Children aged 10 and over
Mounjaro is approved for type 2 diabetes from age 10, on a 30-week placebo-controlled trial with a 22-week extension in 99 young people (mean age 15, 61% female). The label says side effects matched adults' except for more vomiting, abdominal pain and low blood sugar:
| During the 30-week placebo period | Placebo | 5 mg | 10 mg |
|---|---|---|---|
| Vomiting | 3% | 16% | 12% |
| Abdominal pain | 9% | 22% | 15% |
| Glucose below 54 mg/dL, on basal insulin | 10% (n = 10) | 30% (n = 10) | 27% (n = 11) |
| Glucose below 54 mg/dL, on metformin only | 4% | 9% | 9% |
The insulin rows describe about ten children each; 30% is three children. No severe low-blood-sugar episode was reported in the trial. Zepbound — the weight-management brand — is not approved for anyone under 18.
Antibodies, allergy and the injection site
In the placebo-controlled pool, hypersensitivity reactions were reported in 3.2% on Mounjaro against 1.7% on placebo, and injection-site reactions in 3.2% against 0.4%. Across seven trials, both were more common in people who developed antibodies to tirzepatide:
| Seven-trial pool, adults | With anti-tirzepatide antibodies | Without |
|---|---|---|
| Injection-site reactions | 4.6% (119/2,570) | 0.7% (18/2,455) |
| Hypersensitivity reactions | 4.1% (106/2,570) | 3.0% (73/2,455) |
The antibody gap is smaller here than in the Zepbound label (11.3% against 1% for injection-site reactions). Nobody is routinely tested for these antibodies, and the label suggests no action based on them.
Laboratory changes and rarer counts
- Pancreatic enzymes. Mean amylase rose 33–38% and lipase 31–42% from baseline on Mounjaro; placebo amylase rose 4% and lipase did not change. The label calls the significance unknown without other signs of pancreatitis.
- Acute pancreatitis. 14 adjudicated events in 13 Mounjaro patients across the programme — 0.23 patients per 100 years of exposure against 0.11 on comparators. Our pancreatitis page holds the class record.
- Gallbladder disease. 0.6% against 0% on placebo; gallbladder page.
- Dysesthesia (abnormal skin sensation). 0.4% at every dose, none on placebo; 0.7% in the heart trial.
- Dysgeusia (altered taste). 0.1% against 0%.
The warnings, and where each is covered
- Thyroid C-cell tumours (boxed warning, from rat studies) — thyroid cancer page.
- Acute pancreatitis, including fatal forms reported after approval.
- Low blood sugar with insulin or a sulfonylurea — above.
- Serious hypersensitivity, including anaphylaxis and angioedema.
- Acute kidney injury from dehydration, in some cases requiring dialysis (postmarketing).
- Severe gastrointestinal reactions; not recommended in severe gastroparesis.
- Diabetic retinopathy complications in people with a history of retinopathy, with rapid improvement in glucose control.
- Acute gallbladder disease.
- Pulmonary aspiration during anaesthesia or deep sedation — see our surgery page.
- Never share a KwikPen, even with a new needle.
The label's section 7 also carries the oral contraceptive advice that appears in Zepbound's: switch to a non-oral method or add a barrier method for 4 weeks after starting and after each dose increase. It is set out, with the reason, on our Zepbound side effects page.
What this page cannot tell you
- What any one person will experience. These are group rates from trials with regular visits.
- How Mounjaro compares with another drug. The label says rates from one drug's trials "cannot be directly compared" with another's — including its own sibling brand.
- How often rare harms occur in practice. The postmarketing list (anaphylaxis, bowel obstruction, faecal impaction, fatal pancreatitis, kidney failure, hair loss) comes from voluntary reports "from a population of uncertain size" and carries no rate.
Anyone experiencing a side effect, or weighing the risk of one, should take it to the person who prescribed the medicine. How rates change as the dose climbs, across the class, is on our dose and side effects page; our tirzepatide review covers the trial record beyond safety.
Sources
- MOUNJARO (tirzepatide) injection, prescribing information, Eli Lilly and Company, NDA 215866, SPL version 40, effective 2026-08-27 — DailyMed setid d2d7da5d-ad07-4228-955f-cf7e355c8cc0, read 2026-09-24: boxed warning, sections 1, 4, 5, 6.1, 6.2, 7, 8.4, 8.5 and 14.6.
- SURPASS-1 NCT03954834 and SURPASS-5 NCT04039503, as pooled in the label's Tables 1 and 2; SURPASS-CVOT NCT04255433, label Table 10.