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Is Mounjaro safe for people with heart disease?

GLP Guidebook teamUpdated 5 Oct 202617 sourcesWritten from published sources
The short answer

In heart patients, Mounjaro (tirzepatide) caused no more heart attacks in its main trial. In people with type 2 diabetes and heart disease, 4.7% had one over 4 years. On dulaglutide, an older heart-protective injection, it was 5.4% (US label). It raises heart rate slightly and causes nausea in up to 18%. We found no Indian heart approval for it.

Before you go further
  • Mounjaro and other GLP‑1 medicines are prescription-only in India, not sold over the counter.13
  • A government statement on 1 Apr 2026 said only endocrinologists, internal-medicine specialists and cardiologists can prescribe them.13 CDSCO expert-committee minutes attach a similar condition to some approvals (endocrinologist or internal-medicine specialist), but we found no rule covering every brand.11
  • Trial results are group averages. Whether Mounjaro suits one person's heart is their cardiologist's decision; Guide 4 covers who these medicines are and aren't for.
  • The risks are in Guide 5: Side effects and risks.

Can Mounjaro cause a heart attack?

In SURPASS-CVOT, its main heart trial, heart attacks were not more common on Mounjaro than on dulaglutide, an older injection shown to lower heart events.1

It enrolled 13,299 adults with type 2 diabetes and heart disease. They took Mounjaro up to 15 mg or dulaglutide 1.5 mg.1,2 Over about 4 years, the US label counts heart attacks in 4.7% on Mounjaro and 5.4% on dulaglutide.1 A heart attack, stroke or heart death hit 12.1% and 13.0%.1 That passed the test for "not worse", but not for "better".1,2 Eli Lilly paid for it.2

In August 2026 the US label added a heart-risk use. It covers adults with type 2 diabetes at high risk of these events.1 In June 2026, Europe's regulator accepted that Mounjaro lowers heart-event risk in these patients. Its diabetes use already covers them, so the data went into the label instead.3

Is Mounjaro approved for heart failure?

Neither the US nor Europe has approved Mounjaro for heart failure, although it cut heart-failure events in one trial of people with obesity.4,5,6

SUMMIT tested Mounjaro up to 15 mg against a dummy injection in 731 adults. All had obesity and a stiff heart (heart failure with preserved ejection fraction).4 Over about 2 years, heart death or worsening heart failure hit 9.9% on Mounjaro and 15.3% on the dummy.4 Heart deaths were too few to tell either way: 8 people on Mounjaro (2.2%) against 5 on the dummy (1.4%).4 Side effects, mostly stomach ones, made 6.3% stop Mounjaro, against 1.4%.4

Lilly withdrew its US application in 2025 when the FDA asked for another trial.5 In January 2026 Europe's regulator also declined a separate use, unsure the benefit went beyond weight loss.6

What do the labels say about heart rate, rhythm and blood pressure?

Mounjaro raises heart rate a little, and the US label calls the meaning of that "uncertain".1

We found no heart-failure or rhythm warning in the US or European label.1,7 In the US label's diabetes trials, heart rate rose 2 to 4 beats a minute, against 1 on a dummy.1 A jump of 15 beats or more hit 10% on 15 mg and 4% on the dummy.1 In SURPASS-CVOT, whose patients all had heart disease, the largest average rise was 6 beats a minute (EU label).7 The EU label found rhythm problems similar: 2% to 4% on Mounjaro, 3% on a dummy.7

In Zepbound's US weight trials (the same medicine), low blood pressure hit 1.6% against 0.1%. It was more common with blood-pressure pills or dehydration.8

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Does India approve any GLP‑1 medicine for the heart?

Novo Nordisk says Wegovy has an Indian heart approval, and CDSCO's expert committee backed heart uses for two other semaglutide forms.10,16,17 We found none for Mounjaro (tirzepatide) as of 5 Oct 2026.11,12

At Wegovy's June 2025 India launch, Novo Nordisk called it India's only drug approved to lower heart-event risk.10 That rests on SELECT, in 17,604 adults with heart disease but no diabetes. Over about 3 years, heart attack, stroke or heart death hit 6.5% on Wegovy 2.4 mg and 8.0% on a dummy.9 Side effects made 17% stop Wegovy, against 8%.9

That is no longer the full picture. CDSCO's expert committee then recommended heart-risk uses for two Novo semaglutide forms. These were the injection in Ozempic's doses (July 2025) and the tablets (November 2025).16,17 The CDSCO minutes we found for Mounjaro cover its first approval (2023) and weight (2024), not the heart.11,12

Get help now: call 112 for chest pain that feels tight or squeezing, or spreads to your arm, neck or jaw, or for severe trouble breathing.14 A heart attack can also feel like nausea or indigestion, which Mounjaro causes too, so don't assume it's the medicine.14 Get help at once for signs of a serious allergic reaction: swelling of the face or throat, fainting, or a very fast heartbeat.15
RisksThe risks, in brief
  • Stomach effects. Nausea hit 12% to 18% on Mounjaro vs 4% on a dummy injection in the US label's diabetes trials.1 The EU label calls nausea very common (more than 1 in 10).7
  • Faster heart rate and low blood pressure. Heart rate rises 2 to 4 beats a minute on average; low blood pressure is more likely with blood-pressure pills or dehydration.1,8
  • Pancreatitis, gallbladder and kidney problems. Severe stomach pain that won't go away can be pancreatitis; vomiting or diarrhoea can dehydrate you enough to harm the kidneys.1
  • Thyroid warning. The US label's boxed warning covers thyroid C-cell tumours seen in rats; not for anyone with a personal or family history of medullary thyroid cancer or MEN 2.1
  • Hypos with insulin or a sulfonylurea, a type of diabetes tablet.1
  • Not for pregnancy. The EU label advises against it in pregnancy and says to stop at least 1 month before a planned pregnancy.7
Full detail in Guide 5: Side effects and risks →
Mounjaro side effects: what the trials and the label say →

Read the full picture

Related questions

What is tirzepatide? Is Mounjaro available in India? Is Ozempic safe? How long do Mounjaro side effects last? Which symptoms on a GLP‑1 need urgent care?
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Sources

  1. Eli Lilly. Mounjaro (tirzepatide) US prescribing information, revised 08/2026. US label, not the Indian one: we found no public Indian label. Boxed warning; sections 1, 4, 5.1-5.3, 5.5, 5.8, 6.1 (Table 1, Heart Rate Increase), 14.6 (Table 10). pi.lilly.com
  2. Nicholls SJ et al. Cardiovascular outcomes with tirzepatide versus dulaglutide in type 2 diabetes (SURPASS-CVOT). N Engl J Med 2025;393:2409-2420. Funded by Eli Lilly. doi:10.1056/NEJMoa2505928 · PMID 41406444
  3. European Medicines Agency. Outcome of assessment on use of Mounjaro to reduce the risk of serious events affecting the heart and blood circulation, EMA/140483/2026, 26 Jun 2026. ema.europa.eu
  4. Packer M et al. Tirzepatide for heart failure with preserved ejection fraction and obesity (SUMMIT). N Engl J Med 2025;392:427-437. Funded by Eli Lilly. doi:10.1056/NEJMoa2410027 · PMID 39555826
  5. Armstrong A. Lilly unfazed as CVS picks Novo's side in obesity market battle. BioSpace, 1 May 2025. biospace.com
  6. European Medicines Agency. Outcome of assessment on use of Mounjaro in treatment of heart failure with preserved ejection fraction in adults with obesity, EMA/18704/2026, 30 Jan 2026. ema.europa.eu
  7. European Medicines Agency. Mounjaro: summary of product characteristics (EU label), sections 4.3, 4.4, 4.6 (Pregnancy), 4.8 (Table 1, Heart rate) and 5.1 (SUMMIT, Table 14). ema.europa.eu
  8. Eli Lilly. Zepbound (tirzepatide, the same medicine as Mounjaro) US prescribing information, revised 08/2026. Section 6.1, Hypotension. pi.lilly.com
  9. Lincoff AM et al. Semaglutide and cardiovascular outcomes in obesity without diabetes (SELECT). N Engl J Med 2023;389:2221-2232. Funded by Novo Nordisk. doi:10.1056/NEJMoa2307563 · PMID 37952131
  10. Dutta SS. Fat-busting blockbuster drug Wegovy launched in India, in pre-filled pens that can be self-administered. ThePrint, 24 Jun 2025. theprint.in
  11. CDSCO. Recommendations of the SEC (Endocrinology & Metabolism), 100th meeting, 20-21 Apr 2023, item 1 (tirzepatide). cdsco.gov.in · archived copy
  12. CDSCO. Recommendations of the SEC (Endocrinology & Metabolism), 19 Jun 2024, item 3 (tirzepatide, chronic weight management). cdsco.gov.in · archived copy
  13. PIB Research. GLP-1 drugs: use, risks, and regulation (backgrounder), 1 Apr 2026. static.pib.gov.in
  14. NHS. Heart attack (page last reviewed 31 Mar 2026). UK page; in India the emergency number is 112. nhs.uk
  15. Eli Lilly. Mounjaro Medication Guide (US), revised August 2026. pi.lilly.com
  16. CDSCO. Recommendations of the SEC (Endocrinology & Metabolism), 17 Jul 2025, item 3 (semaglutide injection 0.25/0.5/1 mg, Novo Nordisk India, additional cardiovascular indication). cdsco.gov.in · archived copy (rolling file)
  17. CDSCO. Recommendations of the SEC (Endocrinology & Metabolism), 6 Nov 2025, item 1 (semaglutide tablets 3/7/14 mg, Novo Nordisk India, additional cardiovascular indication). cdsco.gov.in · archived copy

Last checked 5 Oct 2026 · Next review due 5 Oct 2027 · Report an error

How this answer was made. Written by the GLP Guidebook team from the sources above. It's general information, not medical advice. Talk to a qualified doctor before starting, stopping or changing any medicine. How we write