FDA label · type 2 diabetes trials

Mounjaro side effects by dose

The most common Mounjaro side effects are nausea (12–18%), diarrhea (12–17%), decreased appetite (5–11%), vomiting (5–9%) and constipation (6–7%) on 5–15 mg weekly, against 1–9% on placebo. Most stomach effects came while the dose was being raised, and 3.0–6.6% of people stopped Mounjaro because of them.

Tirzepatide Calculator editorial teamUpdated 4 sources

Boxed warningIn rats, tirzepatide caused thyroid C-cell tumors; whether Mounjaro causes them in people, including medullary thyroid carcinoma (MTC), is unknown. Mounjaro must not be used with a personal or family history of MTC or with MEN 2.[1]

Mounjaro side effects by dose

Mounjaro's label lists seven side effects that affected at least 5% of people in its placebo-controlled diabetes trials, all digestive or appetite-related, and most rose with dose.[1]

Mounjaro adverse reactions, % of patients (placebo N=235; 5 mg N=237; 10 mg N=240; 15 mg N=241)
Side effectPlacebo5 mg10 mg15 mg
Nausea4%12%15%18%
Diarrhea9%12%13%17%
Decreased appetite1%5%10%11%
Vomiting2%5%5%9%
Constipation1%6%6%7%
Dyspepsia3%8%8%5%
Abdominal pain4%6%5%5%
Eructation (burping)0.4%3%2.5%3.3%
Gastroesophageal reflux (GERD)0.4%1.7%2.5%1.7%
Flatulence0%1.3%2.5%2.9%
Abdominal distension0.4%0.4%2.9%0.8%

The first seven rows are the label's main table (reactions in at least 5% of people); the last four are the less common stomach effects the label reports in its text.[1] Across seven longer trials, the types and rates of common side effects were similar.[1]

Any stomach side effect on Mounjaro, % of patients
Placebo20.4%
Mounjaro 5 mg37.1%
Mounjaro 10 mg39.6%
Mounjaro 15 mg43.6%

Stopped Mounjaro because of stomach side effects: 3% (5 mg), 5.4% (10 mg), 6.6% (15 mg) vs 0.4% on placebo.

Each common Mounjaro side effect

Every common Mounjaro side effect is digestive except decreased appetite, and the label adds detail on several of them.[1]

Mounjaro nausea and vomiting

Nausea affected 12%, 15%, 18% of people on 5, 10 and 15 mg (placebo 4%), and vomiting 5%, 5%, 9% (placebo 2%).[1] The label says most nausea, vomiting and diarrhea “occurred during dose escalation and decreased over time.”[1]

Mounjaro diarrhea

Diarrhea affected 12–17% of people on Mounjaro against 9% on placebo, highest at 15 mg (17%).[1] With vomiting, it can lead to fluid loss; the label warns that dehydration can cause acute kidney injury and asks people to report diarrhea or vomiting that does not stop.[1]

Mounjaro constipation

Constipation affected 6–7% of people versus 1% on placebo in the diabetes trials, and 13% in the 4-year heart outcomes trial.[1] Reports after approval include severe constipation with fecal impaction, ileus and intestinal obstruction.[1]

Mounjaro heartburn, indigestion and burping

Heartburn-type symptoms were less common than nausea: indigestion (dyspepsia) affected 5–8% versus 3%, reflux (GERD) 1.7–2.5% versus 0.4%, and burping 2.5–3.3% versus 0.4%.[1] The label does not use the word “heartburn”; these are the terms it reports.

Mounjaro hair loss

Hair loss is not in Mounjaro's trial tables; it appears in the label's list of reports after approval (“alopecia”), where the rate cannot be estimated.[1] In the Zepbound weight-loss trials of the same drug, hair loss affected 4–5% versus 1% on placebo, mostly women (7.1% vs 0.5% of men).[2]

Mounjaro pancreatitis

Confirmed acute pancreatitis was uncommon but more frequent than on comparators: 14 events in 13 people on Mounjaro (0.23 per 100 patient-years) versus 3 events (0.11 per 100 patient-years).[1] Mounjaro also raised the pancreatic enzymes amylase (33–38%) and lipase (31–42%) on average; the label says the meaning of those rises without symptoms is unknown.[1]

How long do Mounjaro side effects last?

Most Mounjaro stomach side effects start in the weeks after a dose increase and then fade: the label says nausea, vomiting and diarrhea mostly “occurred during dose escalation and decreased over time.”[1]

When dose increases can happen on the Mounjaro label schedule
WeeksDoseWhat the label says
1–42.5 mgStarting dose; since August 2026 also allowed for ongoing glucose control
5–85 mgFirst possible increase
9 and later7.5 mg, 10 mg, 12.5 mg, 15 mgFurther 2.5 mg steps, each after at least 4 weeks on the current dose
21 at the earliest15 mgMaximum dose

Each step is a new period when side effects can return, so the shortest path to 15 mg holds about 20 weeks of possible escalation effects.[1] The full schedule is on the Mounjaro dosage chart, and a week-by-week view for the same drug is on how long do Zepbound side effects last.

Mounjaro long-term side effects

In the longest Mounjaro trial, SURPASS-CVOT, 6,647 adults with type 2 diabetes and heart disease took Mounjaro for a median follow-up of 210.1 weeks (about 4 years), and side effects were similar to the shorter trials.[1]

Mounjaro over about 4 years (SURPASS-CVOT, label section 6.1 and 14.6)
FindingResult
Side effects more common than in the short trialsDecreased appetite 17%, constipation 13%, vomiting 12%, abdominal pain 10%, fatigue 10%, dysesthesia 0.7%
Major heart events vs dulaglutideHazard ratio 0.92 (95.3% CI 0.83–1.01): non-inferior; superiority not shown
ComparatorDulaglutide 1.5 mg weekly (13,299 people randomized in total)

The label's long-term risks are the boxed thyroid warning from rat studies, pancreatitis, acute gallbladder disease (0.6% vs 0% on placebo), kidney injury from dehydration, and worsening diabetic eye disease in people with a history of diabetic retinopathy.[1] In November 2026 the FDA also required all GLP-1 drug labels, Mounjaro included, to warn about NAION, a rare cause of sudden vision loss in one eye.[4] On the basis of this trial, the FDA approved Mounjaro in August 2026 to reduce cardiovascular risk in adults with type 2 diabetes and heart disease.[3]

Low blood sugar on Mounjaro

Mounjaro alone rarely caused low blood sugar in the trials, but rates rose when it was added to insulin or a sulfonylurea.[1]

Blood sugar below 54 mg/dL, % of patients (Mounjaro label)
TrialPlacebo5 mg10 mg15 mg
Mounjaro alone (40 weeks)1%0%0%0%
Added to basal insulin (40 weeks)13%16%19%14%
With a sulfonylurea (up to 104 weeks)—13.8%9.9%12.8%

Severe low blood sugar, needing another person's help, occurred in 0–2% with basal insulin and 0–0.6% with a sulfonylurea.[1] The label says to consider lowering the insulin or sulfonylurea dose when Mounjaro is started.[1]

Other measured effects

Several smaller effects are reported in the label text rather than the main table.[1]

  • Injection-site reactions: 3.2% vs 0.4% on placebo; see injection sites.
  • Allergic (hypersensitivity) reactions: 3.2% vs 1.7%, sometimes severe, such as hives and eczema.
  • Heart rate: up 2 to 4 beats per minute on average (placebo 1); episodes of fast heart rate in 4.6%, 5.9% and 10% on 5, 10 and 15 mg vs 4.3%.
  • Skin sensations and taste: dysesthesia 0.4% on each dose vs 0%; altered taste 0.1% vs 0%.

Mounjaro side effects in children 10 and older

In 97 children and teenagers with type 2 diabetes treated for a mean of 39.9 weeks, side effects matched those in adults except for more vomiting, abdominal pain and low blood sugar.[1] Over the 30-week placebo-controlled period, vomiting affected 16% (5 mg) and 12% (10 mg) versus 3% on placebo, and abdominal pain 22% and 15% versus 9%; no severe low blood sugar was reported.[1]

When to call a doctor about Mounjaro side effects

The Mounjaro label names the warning signs that need prompt medical attention; severe stomach side effects affected 0.4–1.3% of people on Mounjaro versus 0.9% on placebo.[1]

Serious problems in the Mounjaro label (warnings and precautions)
ProblemSigns the label describesWhat the label says
Acute pancreatitisPersistent or severe abdominal pain, sometimes spreading to the back, with or without nausea or vomitingStop Mounjaro if suspected
Serious allergic reactionAnaphylaxis or angioedema (swelling)Stop Mounjaro and treat promptly
Kidney injury from dehydrationNausea, vomiting or diarrhea leading to fluid lossKidney function monitored, especially while the dose is raised
Acute gallbladder diseaseGallstones or gallbladder inflammationGallbladder tests and follow-up if suspected
Diabetic eye diseaseTemporary worsening of diabetic retinopathy with rapid glucose improvementMonitoring for people with a history of retinopathy
Low blood sugarWith insulin or a sulfonylureaLower doses of those medicines may be needed
Surgery or sedationRisk of breathing in stomach contentsTell the care team about Mounjaro before a procedure
Sudden vision loss in one eye (NAION)[4]Painless decreased or blurred vision in one eyeFDA class warning added November 2026; contact a health care professional right away

Who should not take Mounjaro

The label says Mounjaro must not be used by people with a personal or family history of medullary thyroid carcinoma, by people with MEN 2, or by anyone with a known serious allergy to tirzepatide or the product's ingredients.[1] It is also “not recommended in patients with severe gastroparesis,” and anaphylaxis and angioedema have been reported.[1]

Mounjaro vs Zepbound side effects

Mounjaro and Zepbound are the same drug, tirzepatide, but nausea was about twice as common in the Zepbound weight trials (25–29%) as in the Mounjaro diabetes trials (12–18%).[2][1] Every Mounjaro and Zepbound rate on this page is also in a downloadable file, tirzepatide-side-effects.csv. The two labels side by side, with a nausea chart, are on tirzepatide side effects; Zepbound's own table is on Zepbound side effects.

Frequently asked questions

What are the most common side effects of Mounjaro?

Nausea, diarrhea, decreased appetite, vomiting, constipation, indigestion and abdominal pain. Nausea affected 12–18% of people on 5–15 mg versus 4% on placebo.[1]

How long do Mounjaro side effects last?

The label says most nausea, vomiting and diarrhea occurred during dose escalation and decreased over time. Escalation to 15 mg takes at least 20 weeks, in 4-week steps.[1]

Does Mounjaro cause hair loss?

Hair loss (alopecia) is listed among reports after approval, not in Mounjaro's trial tables. In Zepbound's weight trials of the same drug it affected 4–5% versus 1% on placebo.[1][2]

Can Mounjaro cause pancreatitis?

Yes, rarely: confirmed pancreatitis occurred at 0.23 per 100 patient-years on Mounjaro versus 0.11 on comparators. Severe stomach pain that does not go away needs prompt medical attention.[1]

Does Mounjaro cause heartburn?

The label reports indigestion in 5–8% versus 3% on placebo and reflux in 1.7–2.5% versus 0.4%; it does not use the word heartburn.[1]

Who should not take Mounjaro?

People with a personal or family history of medullary thyroid carcinoma or MEN 2, and people with a known serious allergy to tirzepatide or its ingredients. It is not recommended in severe gastroparesis.[1]

What are Mounjaro withdrawal symptoms?

The Mounjaro label describes no withdrawal syndrome. Tirzepatide has a half-life of about 5 days, so it clears from the body over several weeks after the last dose.[1]

What are the long-term side effects of Mounjaro?

In a trial with a median of 210 weeks, side effects were similar to shorter trials, with decreased appetite in 17% and constipation in 13%. Long-term label warnings include pancreatitis, gallbladder disease and a thyroid tumor warning from rat studies.[1]

Sources

  1. Mounjaro (tirzepatide) injection: prescribing information and Instructions for Use · Eli Lilly and Company, via NLM DailyMed, label effective August 27, 2026
  2. Zepbound (tirzepatide) injection: prescribing information, Medication Guide and Instructions for Use · Eli Lilly and Company, via NLM DailyMed, label effective August 28, 2026
  3. FDA approves Lilly's Mounjaro to reduce cardiovascular risk in adults with type 2 diabetes · Eli Lilly and Company press release, August 28, 2026
  4. FDA requires safety labeling changes for GLP-1 receptor agonists due to potential increased risk of rare but serious eye condition (NAION) · U.S. Food and Drug Administration, Drug Safety Communication, November 9, 2026