Mounjaro

Mounjaro (tirzepatide) is used for type 2 diabetes to help lower blood sugar levels and improve A1C (glycemic control) in adults and children 10 years and older, in addition to diet and exercise.

Mounjaro is also approved to lower the risk of major adverse cardiovascular events (cardiovascular death, non-fatal heart attack, or non-fatal stroke) in adults with type 2 diabetes who are at high risk for these events. The FDA added this second use on August 28, 2026, based on the SURPASS-CVOT trial.

It is a once-weekly injection that can be self-administered at home.

Body weight was measured as a secondary outcome in the Mounjaro trials. Across those trials, people taking Mounjaro lost more weight on average than people taking placebo or a comparator medicine. Mounjaro itself is not approved as a weight loss treatment. Zepbound, which contains the same active ingredient, is the tirzepatide product approved for weight management.

Mounjaro works by activating two gut hormone receptors, GIP and GLP-1, to manage blood sugar. This triggers insulin release when blood sugar rises, reduces glucagon secretion, slows digestion to prevent post-meal sugar spikes, and helps you feel fuller for longer. All of these effects work together to lower blood sugar levels, improve A1C, and reduce how much you eat. Mounjaro belongs to the class of medications called dual GIP/GLP-1 receptor agonists (glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptor agonists).

Mounjaro (tirzepatide) gained FDA approval on May 13, 2022. There is no Mounjaro generic. The 2 different brands of tirzepatide (Mounjaro and Zepbound) are made by Eli Lilly and Company but are FDA-approved for different conditions.

• Mounjaro: Approved for type 2 diabetes management in adults and children 10 years and older, and to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes at high risk for these events.
• Zepbound: Approved as a weight loss treatment for adults with obesity or who are overweight with related health conditions, and for moderate to severe obstructive sleep apnea (OSA).

See Zepbound vs Mounjaro: Comparison Guide for Weight Loss and Diabetes Treatment.

You should read the Instructions for Use carefully and ask your pharmacist or doctor to explain any part you do not understand. It is important to use this medicine exactly as directed. Do not take more or less of it or more often than your doctor prescribes.

Mounjaro is injected under the skin (subcutaneously) using a single-dose pen, a single-dose vial, a multi-dose vial, or the single-patient-use Mounjaro KwikPen.

• Mounjaro is usually given 1 time a week.
• It can be given with or without meals at any time of the day.
• It may be injected under the skin of the thigh or abdomen, or another person can inject it in the back of your upper arm.
• You should rotate the injection site for each dose.
• Check the medicine before you use it. It should look clear and colorless to slightly yellow. Do not use it if you see particles in it or if the color looks wrong.
• If you are using Mounjaro vials, always use a new syringe and needle for each injection, and use a syringe that can measure your dose, such as a 1 mL syringe that measures 0.5 mL or 0.6 mL.

See Where is the best place to inject Mounjaro? for more information.

A caregiver may give you Mounjaro injections, or you may self-inject if a healthcare provider determines that it is appropriate. The Mounjaro KwikPen is not recommended for self-injection by people with visual impairment. Children should not inject themselves with the Mounjaro KwikPen; an adult caregiver should give a child their injections.

Your healthcare provider will usually start you on a low dose, which will be gradually increased, but not more often than once every 4 weeks.

You may change the day of the week you use this medicine as long as there are at least 3 days (72 hours) between doses.

You may give insulin in the same area of the body as this medicine, but they should not be given right next to each other. Do not mix insulin and Mounjaro in the same injection.

Mounjaro controls type 2 diabetes but does not cure it. It may take four weeks or longer before you see the full benefit of this medicine. Continue to take this medicine even if you feel well. Do not stop taking this medicine without talking to your doctor.

For more detailed instructions with diagrams on how to use this medicine, see Instructions for Mounjaro Single-Dose Pen or Instructions for Mounjaro Multidose KwikPen.

Mounjaro carries a Boxed Warning for the risk of possible thyroid tumors.

Possible thyroid tumors (including cancer)

Tirzepatide caused thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in rats. It is not known whether Mounjaro causes thyroid C-cell tumors in people, because the relevance of the rat findings to humans has not been determined. Watch for possible symptoms, such as a lump or swelling in the neck, hoarseness, trouble swallowing, or shortness of breath. If you have any of these symptoms, tell your healthcare provider.

• Do not use Mounjaro if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC).
• Do not use Mounjaro if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
• Do not use Mounjaro if you are allergic to tirzepatide or any of the ingredients in Mounjaro.

Routinely checking blood calcitonin levels or having thyroid ultrasounds is of uncertain value for the early detection of MTC in people taking Mounjaro, and may lead to unnecessary procedures.

Do not use Mounjaro if you:

• Have had a serious allergic reaction to tirzepatide or to any of the inactive ingredients in Mounjaro prefilled pens, KwikPens, or vials (see below for a list of ingredients)
• Or any of your family members have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC)
• Have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)

Before receiving or using Mounjaro, tell your healthcare provider about all your medical conditions, including if you:

• Have or have had problems with your pancreas
• Have severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems with digesting food. Mounjaro is not recommended if you have severe gastroparesis
• Have a history of diabetic retinopathy
• Have kidney problems. No dose change is needed, but your healthcare provider may check your kidney function when you start Mounjaro or increase your dose, especially if you have severe stomach or bowel side effects
• Have liver problems. No dose change is needed
• Are scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation)
• Are pregnant or plan to become pregnant
• Are breastfeeding or plan to breastfeed

It is not known if Mounjaro is safe and effective for use in children under 10 years of age.

Pregnancy

There is not enough information from use in pregnant women to know whether Mounjaro increases the risk of birth defects or miscarriage. In animal studies, tirzepatide caused harm to the developing baby. Mounjaro should be used during pregnancy only if the potential benefit justifies the potential risk to the baby. Poorly controlled diabetes in pregnancy also carries risks for both mother and baby. Tell your healthcare provider if you become pregnant while using this medicine.

There is a pregnancy exposure registry for women who take this medicine during pregnancy to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part, or contact Eli Lilly and Company at 1-800-545-5979.

Birth control pills taken by mouth may not work as well while using Mounjaro. If you take birth control pills by mouth, your healthcare provider may recommend you switch to a non-oral method, or add a barrier method of contraception, for 4 weeks after you start Mounjaro and for 4 weeks after each dose increase. Hormonal contraceptives that are not taken by mouth, such as the implant, injection, patch, ring, or hormonal IUD, should not be affected. Talk to your healthcare provider about birth control methods that may be right for you while using this medicine.

Breastfeeding

In a lactation study, tirzepatide was either undetectable in breast milk or present at very low levels compared with the mother's dose. There is no information on the effects of tirzepatide on a breastfed baby or on milk production. Talk to your healthcare provider about the best way to feed your baby if you are using Mounjaro.

Mounjaro may cause serious side effects, including:

Inflammation of the pancreas (pancreatitis)

Stop using Mounjaro and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without nausea or vomiting. Sometimes you may feel the pain from your abdomen to your back. Acute pancreatitis, including forms that cause bleeding or tissue death and that can be fatal, has been reported.

Low blood sugar (hypoglycemia)

Your risk for getting low blood sugar may be higher if you use Mounjaro with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. Your healthcare provider may lower the dose of your sulfonylurea or insulin when you start Mounjaro. Signs or symptoms of low blood sugar levels may include dizziness or light-headedness, sweating, confusion or drowsiness, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, or mood changes, hunger, weakness, and feeling jittery.

Serious allergic reactions

Stop using Mounjaro and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue, or throat (angioedema), problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, and a very rapid heartbeat. Anaphylaxis and angioedema have been reported with Mounjaro and other GLP-1 receptor agonists.

Dehydration leading to kidney problems

Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems. There have been reports of acute kidney injury, in some cases requiring dialysis, mostly in people who became dehydrated from stomach and bowel side effects. You need to drink fluids to help reduce your chance of dehydration. Tell your healthcare provider right away if you have nausea, vomiting, or diarrhea that does not go away.

Severe stomach problems

Stomach and bowel problems, sometimes severe, have been reported in people who use Mounjaro. These have included blockage of the intestines (ileus and intestinal obstruction) and severe constipation, including impacted stool. Mounjaro is not recommended if you have severe gastroparesis (a condition where the stomach empties too slowly). Tell your healthcare provider if you have stomach problems that are severe or will not go away.

Eye problems in people with a history of diabetic retinopathy

Diabetic retinopathy has temporarily worsened in people whose blood sugar improved quickly. If you have a history of diabetic retinopathy, your healthcare provider should monitor you for it getting worse. Tell your healthcare provider if you have changes in vision during treatment with Mounjaro.

Gallbladder problems

Gallbladder problems have happened in some people who use Mounjaro. In placebo-controlled trials in adults, acute gallbladder disease was reported by 0.6% of people taking Mounjaro and 0% of people taking placebo. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include pain in your upper stomach (abdomen), fever, yellowing of skin or eyes (jaundice), and clay-colored stools.

Food or liquid getting into the lungs during surgery or procedures

Mounjaro slows stomach emptying and may increase the chance of food getting into your lungs during surgery or other procedures that use anesthesia or deep sedation. Tell all your healthcare providers that you are taking Mounjaro before you are scheduled to have surgery or other procedures. There is not enough information to say whether changing your fasting instructions or pausing Mounjaro before a procedure would reduce this risk.

Never share a Mounjaro KwikPen between patients

Never share a Mounjaro KwikPen with another person, even if the pen needle is changed. Sharing a pen can pass on blood-borne infections such as hepatitis B, hepatitis C, or HIV.

Mounjaro was previously in short supply because of high demand. The FDA confirmed the shortage was resolved in 2024. Some pharmacies may still have temporary local supply gaps.

Common side effects

The most common side effects of Mounjaro, reported in at least 5% of adults in clinical trials, are nausea, diarrhea, decreased appetite, vomiting, constipation, indigestion (dyspepsia), and stomach (abdominal) pain. Most reports of nausea, vomiting, and diarrhea happened while the dose was being increased and became less common over time.

Children 10 years and older may have a higher chance of vomiting, stomach pain, and low blood sugar (hypoglycemia) than adults.

Other side effects reported in trials include injection site reactions (3.2% of people taking Mounjaro compared with 0.4% taking placebo), hypersensitivity reactions such as hives and eczema (3.2% compared with 1.7% taking placebo), and a small average increase in heart rate of 2 to 4 beats per minute. In the cardiovascular outcomes trial, fatigue was reported by 10% of people taking Mounjaro. Hair loss (alopecia) has been reported since Mounjaro came on the market.

These are not all the possible side effects of Mounjaro. Talk to your healthcare provider about any side effect that bothers you or does not go away.

Tell your healthcare provider if you have any side effects. You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch.

SURPASS-CVOT (NCT04255433) was the trial that supported the cardiovascular use of Mounjaro. It randomized 13,299 adults who had type 2 diabetes and established cardiovascular disease to Mounjaro (up to 15 mg once weekly) or dulaglutide 1.5 mg once weekly, a GLP-1 medicine already approved to reduce cardiovascular risk. Over a median follow-up of about 4 years:

• Cardiovascular death, non-fatal heart attack, or non-fatal stroke occurred in 12.1% of people taking Mounjaro and 13.0% of people taking dulaglutide (hazard ratio 0.92, 95.3% CI 0.83 to 1.01).
• Mounjaro met the trial's goal of being non-inferior to dulaglutide. It was not shown to be superior to dulaglutide.
• Death from any cause occurred in 8.5% of people taking Mounjaro and 10.1% of people taking dulaglutide (hazard ratio 0.84, 95% CI 0.75 to 0.94). This was not a primary endpoint and was not adjusted for multiple comparisons.

Because the comparator was an active medicine rather than placebo, these results show how Mounjaro performs against another GLP-1 medicine, not how much it reduces risk compared with no treatment.

Tirzepatide (Mounjaro) and semaglutide (Ozempic, Wegovy) are both effective treatments for type 2 diabetes and, in some formulations, weight management. Tirzepatide activates two gut hormone receptors, GIP and GLP-1, while semaglutide activates GLP-1 alone. In several trials, tirzepatide has produced larger average reductions in HbA1c and body weight than the semaglutide doses it was compared against, but how the two compare depends heavily on the specific doses studied and on the individual. Response varies from person to person; some comparisons used semaglutide doses that are no longer the highest available, and no completed head-to-head trial has compared the two medicines at their current highest approved doses.

Blood sugar control

• In the SURPASS-2 head-to-head trial (NCT03987919), tirzepatide 15 mg reduced HbA1c by 2.3% at week 40, compared with 1.9% for semaglutide 1 mg.
• In this trial, semaglutide was given at 1 mg, the maintenance dose studied at the time.
• The FDA has since approved a higher 2 mg maintenance dose of Ozempic, which was not part of this comparison.
• Presentations at the ADA 85th Scientific Sessions in June 2025 looked at A1C reduction and weight loss across the five SURPASS trials.
• Real-world data are broadly consistent, with tirzepatide users lowering HbA1c by about 1.3% on average versus 0.9% with semaglutide.
• Individual results depend on starting A1C, dose reached, and how well the medicine is tolerated.

Other trials

The SURMOUNT-5 head-to-head trial (NCT05822830) compared tirzepatide with semaglutide in adults with obesity who did not have type 2 diabetes. The reported average weight loss at 72 weeks was 20.2% with tirzepatide and 13.7% with semaglutide. Since then, a higher 7.2 mg dose of Wegovy has been approved, with roughly 19% to 21% weight loss in its own trial, and it has not been compared head-to-head with tirzepatide.

In people with both type 2 diabetes and obesity, an indirect comparison drawing on the separate SURMOUNT-2 (NCT04657003) and STEP 2 (NCT03552757) trials, rather than a single head-to-head study, reported weight reduction of up to 15.7% with tirzepatide and 10.6% with semaglutide 2.4 mg. Indirect comparisons carry more uncertainty than a direct trial. As with blood sugar, the amount of weight a person loses depends on the dose they reach and their individual response.

A post-hoc analysis of SURMOUNT-5 estimated a larger reduction in predicted 10-year cardiovascular risk with tirzepatide (23.7%) than semaglutide (13.6%), but these are modeled projections, not measured outcomes. Separately, a pair of target-trial-emulation analyses using real-world data (NCT06779929) compared tirzepatide with dulaglutide and with semaglutide in high-risk adults with type 2 diabetes and reported broadly comparable cardiovascular event rates. Target-trial emulations use observational records rather than randomization, so they carry more uncertainty than a randomized trial. This is a separate study from the randomized SURPASS-CVOT trial (NCT04255433) described above.

Without insurance, Mounjaro's retail price is typically $1,000 to $1,300 per month, though pharmacy discount networks can reduce this, with some pharmacies pricing it as low as around $995. With eligible commercial insurance and the Lilly Mounjaro Savings Card, costs may be as low as $25 per prescription. Note that tirzepatide tends to have better insurance coverage when prescribed for type 2 diabetes than when used for weight loss.

For current pricing at your pharmacy, see Mounjaro Prices, Coupons, Copay Cards & Patient Assistance. You may also be eligible for additional savings. See Can you afford Mounjaro without insurance?.

Dose of Mounjaro for type 2 diabetes (adults and children 10+)

Notes:

• Starting at 2.5 mg and increasing the dose slowly is intended to reduce the risk of stomach and bowel side effects.
• The day of weekly administration can be changed, if necessary, as long as the time between the 2 doses is at least 3 days (72 hours).
• The same dosing schedule applies whether Mounjaro is prescribed for blood sugar control or to reduce cardiovascular risk.

Dose of Mounjaro to Reduce Cardiovascular Risk (Adults With Type 2 Diabetes at High Risk)

• The same dosing and escalation schedule applies. The label does not give a separate regimen for this use: start at 2.5 mg subcutaneously once a week and increase in 2.5 mg increments after at least 4 weeks on the current dose, up to a maximum of 15 mg once a week.
• In the SURPASS-CVOT trial, participants were titrated to 15 mg once weekly or their maximum tolerated dose.

What strengths are Mounjaro pens?

Mounjaro is available as a single-dose pen or single-dose vial in the following strengths:

• 2.5 mg/0.5 mL
• 5 mg/0.5 mL
• 7.5 mg/0.5 mL
• 10 mg/0.5 mL
• 12.5 mg/0.5 mL
• 15 mg/0.5 mL

Single-dose pens come in cartons of 4. Single-dose vials, multi-dose vials, and KwikPens come 1 per carton.

Mounjaro KwikPen and multi-dose vial

Mounjaro is also available as the single-patient-use Mounjaro KwikPen and as a multi-dose vial, both for subcutaneous use. Each contains 4 doses, with one dose injected once a week.

The Mounjaro KwikPen and multi-dose vial come in the following strengths:

• 10 mg/2.4 mL (4.17 mg/mL), providing four 2.5 mg/0.6 mL doses
• 20 mg/2.4 mL (8.33 mg/mL), providing four 5 mg/0.6 mL doses
• 30 mg/2.4 mL (12.5 mg/mL), providing four 7.5 mg/0.6 mL doses
• 40 mg/2.4 mL (16.7 mg/mL), providing four 10 mg/0.6 mL doses
• 50 mg/2.4 mL (20.8 mg/mL), providing four 12.5 mg/0.6 mL doses
• 60 mg/2.4 mL (25 mg/mL), providing four 15 mg/0.6 mL doses

What should I do if I miss a dose?

Take the missed dose as soon as you remember it, within 4 days (96 hours) after the missed dose. If more than 4 days have passed, skip the missed dose and take your next dose on your regularly scheduled day. In either case, carry on with your usual once-weekly schedule. Do not inject two doses within 3 days of each other.

What should I do in case of an overdose?

In case of overdose, call the Poison Help line at 1-800-222-1222. Information is also available online at Poison Help. If the victim has collapsed, had a seizure, has trouble breathing, or cannot be awakened, immediately call emergency services at 911. Because tirzepatide stays in the body for about 5 days, a period of observation and treatment may be needed.

Tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• Birth control pills may not work as well while receiving Mounjaro. Your doctor may suggest you use another form of birth control for 4 weeks after starting this medicine and for 4 weeks after each dose change. Hormonal contraceptives that are not taken by mouth should not be affected.
• Before using Mounjaro, talk to your healthcare provider about low blood sugar and how to manage it. Tell your healthcare provider if you are taking other medicines to treat diabetes, including insulin and sulfonylureas, because the combination may increase the risk of low blood sugar. Your provider may reduce the dose of these medicines when you start Mounjaro.
• Do not take other GLP-1 medicines (such as Ozempic or Zepbound) with Mounjaro because they work through similar pathways and can significantly increase the risk of side effects such as nausea, vomiting, diarrhea, and low blood sugar levels without offering any added benefit.
• Mounjaro delays gastric emptying and may change the absorption of other medicines taken by mouth. Your provider may monitor you more closely if you take an oral medicine that needs to stay within a narrow range to work safely, such as warfarin, or one that only works above a certain blood level.

This list is not complete. Many other drugs may interact with this medicine, including prescription and over-the-counter medicines, vitamins, and herbal products. To check for interactions with this medicine, click the link below.

Store Mounjaro in its original carton, away from heat and light, and never freeze it. Do not use Mounjaro if it has been frozen.

Single-dose pens and single-dose vials

• Store in the refrigerator between 36°F and 46°F (2°C and 8°C).
• If needed, each single-dose pen or single-dose vial can be stored at room temperature up to 86°F (30°C) for up to a total of 21 days.
• Throw away the single-dose pen or single-dose vial after a total of 21 days at room temperature.

Multi-dose vials and KwikPens, before first use

• Store in the refrigerator between 36°F and 46°F (2°C and 8°C). Kept in the refrigerator, an unopened multi-dose vial or KwikPen can be used until the expiration date on the label.
• If stored at room temperature up to 86°F (30°C), throw away the unopened multi-dose vial or KwikPen after 30 days.

Multi-dose vials and KwikPens, after first use

• Store in the original carton, either in the refrigerator between 36°F and 46°F (2°C and 8°C) or at room temperature up to 86°F (30°C).
• Throw away the multi-dose vial or KwikPen after a total of 30 days at room temperature, 30 days after first use, or after taking 4 weekly doses, whichever comes first, even if it still has medicine in it.

Keep out of reach of children.

Active ingredient: tirzepatide

Inactive ingredients: sodium chloride, sodium phosphate dibasic heptahydrate, and water for injection. Benzyl alcohol, glycerin, and phenol are also inactive ingredients in the multi-dose vial and single-patient-use KwikPen. Hydrochloric acid solution and/or sodium hydroxide solution may have been added to adjust the pH.

Mounjaro is made by Eli Lilly and Company, commonly known as Lilly. They are an American pharmaceutical company based in Indianapolis that was founded in 1876. Mounjaro is marketed by Lilly USA, LLC, Indianapolis, IN 46285, USA.