Mounjaro prescribing information, also called the package insert or PI, is the official label for Eli Lilly's brand-name tirzepatide injection, and the current version is dated August 2026. In plain terms: Mounjaro is labeled for blood-sugar control in type 2 diabetes, in adults and children 10 and older, and since August 2026 for lowering the risk of heart attack, stroke or heart-related death in adults with type 2 diabetes who are at high risk. It starts at 2.5 mg once a week and tops out at 15 mg for adults. People with certain thyroid-cancer histories must not use it.
Below is that label, section by section, in everyday words. Its doses are facts about a document; a prescriber sets the actual dose.
What changed in the Mounjaro prescribing information in 2026
As of September 22, 2026, the day this article was written, the Mounjaro label on DailyMed reads Revised: 8/2026. The changes came from two supplements the FDA signed off on in one letter dated August 27, 2026. Three matter to a reader:
- A heart use was added. More on it below.
- 2.5 mg is no longer only a starter dose. Earlier versions, including January 2026's, said 2.5 mg "is for treatment initiation and is not intended for glycemic control." The letter says the new wording indicates it "can be used for ongoing glycemic control," meaning everyday blood-sugar management.
- The eye warning was reworded. The existing caution about diabetic retinopathy, damage to the back of the eye from long-standing diabetes, lost a line saying Mounjaro hadn't been studied in more advanced eye disease.
What Mounjaro is labeled to treat, including the cardiovascular indication
An indication is a use written into the label after the evidence was reviewed. Mounjaro has two:
- Alongside diet and exercise, improving blood-sugar control in adults and children 10 and older with type 2 diabetes.
- Reducing the risk of cardiovascular death, non-fatal heart attack or non-fatal stroke "in adults with type 2 diabetes mellitus who are at high risk for these events."
The first rests on the SURPASS trials. In SURPASS-1, HbA1c, a blood test reflecting average sugar over about three months, fell 1.87 to 2.07 points on tirzepatide over 40 weeks and rose 0.04 on placebo (Rosenstock et al., The Lancet 2021).
The second rests on SURPASS-CVOT, which gave 13,299 adults with type 2 diabetes and known heart disease either tirzepatide or dulaglutide, an older weekly injection that already had heart evidence. In the label's table, a heart attack, stroke or cardiovascular death happened in 12.1% on tirzepatide and 13.0% on dulaglutide over a median of about four years (hazard ratio 0.92). The paper, counting a slightly different group, reports 12.2% against 13.1% (Nicholls et al., New England Journal of Medicine 2025). That met the bar for "not worse"; the label says superiority was not established. Tirzepatide heart benefits tells the longer story.
Weight management isn't on this label. The same molecule carries that use under the Zepbound name; Mounjaro vs Zepbound explains the split, and Zepbound's prescribing information walks that label.
What the label says about dose
Label facts, not directions. The starting dose is 2.5 mg under the skin once a week. If more blood-sugar control is needed, the label raises it in 2.5 mg steps after at least four weeks on the current dose. The ceiling is 15 mg weekly for adults and 10 mg for children.
The boxed warning and contraindications
A boxed warning is a label's most prominent caution. Mounjaro's concerns thyroid C-cell tumors: tirzepatide caused them in rats, and the label says their relevance to humans "has not been determined." Tirzepatide and thyroid cancer covers the evidence.
A contraindication is a reason the drug must not be used. There are two: a personal or family history of medullary thyroid carcinoma (MTC), a rare thyroid cancer, or multiple endocrine neoplasia syndrome type 2 (MEN 2), an inherited tumor condition; and a known serious allergy to tirzepatide or any ingredient.
Mounjaro warnings and precautions, in plain language
The label numbers ten warnings. Past the thyroid one:
- Pancreatitis, an inflamed pancreas, with persistent severe belly pain as the pattern.
- Low blood sugar alongside insulin or a sulfonylurea, a pill that pushes the pancreas to release insulin.
- Serious allergic reactions and kidney injury from dehydration after vomiting or diarrhea.
- Severe stomach and bowel reactions, 0.4% to 1.3% across doses against 0.9% on placebo; not recommended in severe gastroparesis, a stomach that empties very slowly.
- Diabetic retinopathy that can briefly worsen when blood sugar improves fast.
- Gallbladder disease, such as gallstones: 0.6% on Mounjaro, 0% on placebo.
- Pulmonary aspiration, stomach contents entering the lungs under anesthesia or deep sedation, which is why the label wants planned procedures raised with the care team.
- Sharing a KwikPen, which the label forbids even with a new needle.
Adverse reactions: the label's own table
Adverse reactions are side effects recorded in trials. This is the label's pool of two placebo-controlled trials in adults, SURPASS-1 and SURPASS-5, showing reactions in at least 5% of people on Mounjaro.
| Reaction | Placebo | 5 mg | 10 mg | 15 mg |
|---|---|---|---|---|
| Nausea | 4% | 12% | 15% | 18% |
| Diarrhea | 9% | 12% | 13% | 17% |
| Decreased appetite | 1% | 5% | 10% | 11% |
| Vomiting | 2% | 5% | 5% | 9% |
| Constipation | 1% | 6% | 6% | 7% |
| Indigestion | 3% | 8% | 8% | 5% |
| Abdominal pain | 4% | 6% | 5% | 5% |
Most stomach upset came while doses were climbing and eased over time. Stopping because of stomach side effects ran from 3.0% at 5 mg to 6.6% at 15 mg, against 0.4% on placebo. Tirzepatide side effects covers the less common ones.
Drug interactions
With insulin or a sulfonylurea, the label suggests considering lower doses of those. Because Mounjaro slows stomach emptying, it can also change how pills are absorbed, so drugs with a narrow safe range, such as the blood thinner warfarin, get monitored.
The one most people meet is the pill. The label advises switching to a non-oral method, or adding a barrier method, for four weeks after starting and four weeks after each dose increase. Tirzepatide and birth control explains why the window repeats.
Pregnancy, breastfeeding and other groups
Human pregnancy data are too limited to measure risk, and animal studies suggest possible harm to a fetus. In 11 breastfeeding women given one 5 mg dose, tirzepatide was undetectable in 164 of 171 milk samples; effects on a nursing infant are unknown. Children in the trial had more vomiting, belly pain and low blood sugar than adults. Kidney or liver problems don't change the labeled dose.
Where semaglutide shows up in the label
The label includes one head-to-head. In SURPASS-2, 1,879 adults on metformin took tirzepatide or semaglutide 1 mg for 40 weeks, open-label, meaning people knew whether they were on tirzepatide or semaglutide. HbA1c fell 2.0 to 2.3 points on tirzepatide against 1.9 on semaglutide, and weight fell 7.6 to 11.2 kg against 5.7 kg (Frías et al., New England Journal of Medicine 2021). Those are one trial's averages, not a forecast; semaglutide has its own labels, and a prescriber weighs the two against one person's history.
How Mounjaro is supplied
Six strengths, 2.5 mg through 15 mg, come as single-dose pens and vials, four-dose vials and four-dose KwikPens. They're kept refrigerated, never frozen; single-dose pens and vials tolerate up to 21 days at room temperature.
What the Mounjaro label does not say about compounded tirzepatide
The Mounjaro label belongs to the branded product. It doesn't set the ingredients, strength, storage or directions of a compounded preparation, and its heart indication is Mounjaro's alone. Through Promise, tirzepatide is dispensed as a compounded medication, which is different from an FDA-approved product: the formulation offered here is not FDA-approved. The FDA says it does not verify the safety, effectiveness or quality of compounded drugs before they are marketed.
A licensed provider may still prescribe a compounded formulation; that decision is between you and your doctor. At Promise, a licensed provider reviews every request and either prescribes or declines, and not everyone qualifies. The pharmacy's label and the prescriber's directions govern what actually arrives.