Tirzepatide Side Effects: What Studies and Users Report
What FDA labels and clinical studies report for Tirzepatide, how strong that evidence is, and what is still unknown.
Side effects reported in studies
Adverse reactions from the FDA label come first, then side effects reported in individual studies. Frequencies are quoted as the source gives them; animal results are labelled.
| Side effect | How common | Study type | Source |
|---|---|---|---|
| Most common adverse reactions (5% or more) | 5% or more of patients | FDA label | FDA label (Mounjaro) |
| Nausea (placebo, 5 mg, 10 mg, 15 mg) | placebo 4%; 5 mg 12%; 10 mg 15%; 15 mg 18% | FDA label | FDA label (Mounjaro) |
| Diarrhea (placebo, 5 mg, 10 mg, 15 mg) | placebo 9%; 5 mg 12%; 10 mg 13%; 15 mg 17% | FDA label | FDA label (Mounjaro) |
| Vomiting (placebo, 5 mg, 10 mg, 15 mg) | placebo 2%; 5 mg 5%; 10 mg 5%; 15 mg 9% | FDA label | FDA label (Mounjaro) |
| Most common adverse reactions (5% or more) | 5% or more of patients | FDA label | FDA label (Zepbound) |
| Nausea (placebo, 5 mg, 10 mg, 15 mg) | placebo 8%; 5 mg 25%; 10 mg 29%; 15 mg 28% | FDA label | FDA label (Zepbound) |
| Vomiting (placebo, 5 mg, 10 mg, 15 mg) | placebo 2%; 5 mg 8%; 10 mg 11%; 15 mg 13% | FDA label | FDA label (Zepbound) |
| Discontinuation due to adverse reactions | 4.8%, 6.3%, 6.7% (5, 10, 15 mg) vs 3.4% placebo | FDA label | FDA label (Zepbound) |
| Gastrointestinal events | most common | Human controlled trialn = 751 | The New England journal of medicine 2025, PMID 40353578 |
| Gastrointestinal events | more with tirzepatide | Human RCTn = 13165 | The New England journal of medicine 2025, PMID 41406444 |
| Discontinuation due to adverse events | 6.3% vs 1.4% placebo | Human RCTn = 731 | The New England journal of medicine 2025, PMID 39555826 |
| Gastrointestinal events | most common | Human RCTn = 670 | JAMA 2024, PMID 38078870 |
| Gastrointestinal events | most frequent | Human RCT | The New England journal of medicine 2024, PMID 38912654 |
| Gastrointestinal events | most common | Human RCTn = 190 | The New England journal of medicine 2024, PMID 38856224 |
| Low blood pressure events | infrequent, higher than placebo | Human RCT | Heart 2024, PMID 39084707 |
| Gastrointestinal events | most frequent | Human RCTn = 938 | Lancet 2023, PMID 37385275 |
| Serious adverse events | 68 (7%) participants overall | Human RCTn = 938 | Lancet 2023, PMID 37385275 |
| Gastrointestinal events | most common | Human RCTn = 579 | Nature medicine 2023, PMID 37840095 |
| Gastrointestinal events | most common | Human RCTn = 2539 | The New England journal of medicine 2022, PMID 35658024 |
| Discontinuation due to adverse events | 4.3%, 7.1% and 6.2% (5, 10, 15 mg) vs 2.6% placebo | Human RCTn = 2539 | The New England journal of medicine 2022, PMID 35658024 |
| Diarrhea and nausea | diarrhea 12%-21% vs 10%; nausea 13%-18% vs 3% | Human RCTn = 475 | JAMA 2022, PMID 35133415 |
| Gastrointestinal events | nausea 12-18% vs 6%; diarrhoea 12-14% vs 8%; vomiting 2-6% vs 2% (placebo) | Human RCTn = 478 | Lancet 2021, PMID 34186022 |
| Hypoglycaemia | none reported | Human RCTn = 478 | Lancet 2021, PMID 34186022 |
| Hypoglycemia | 0.6%, 0.2%, 1.7% (tirzepatide 5/10/15 mg) vs 0.4% (semaglutide) | Human controlled trialn = 1879 | The New England journal of medicine 2021, PMID 34170647 |
| Nausea | 17 to 22% (tirzepatide) vs 18% (semaglutide) | Human controlled trialn = 1879 | The New England journal of medicine 2021, PMID 34170647 |
| Hypoglycaemia | 1-2% tirzepatide vs 7% insulin degludec | Human RCTn = 1437 | Lancet 2021, PMID 34370970 |
| Nausea, diarrhoea | nausea 12-24%, diarrhoea 15-17%, decreased appetite 6-12%, vomiting 6-10% | Human RCTn = 1437 | Lancet 2021, PMID 34370970 |
| Hypoglycaemia | 6-9% tirzepatide vs 19% glargine | Human RCTn = 1995 | Lancet 2021, PMID 34672967 |
| Nausea | nausea 12-23%, diarrhoea 13-22%, decreased appetite 9-11%, vomiting 5-9% | Human RCTn = 1995 | Lancet 2021, PMID 34672967 |
| Gastrointestinal events | similar | Human observationaln = 18386 | JAMA internal medicine 2024, PMID 38976257 |
| Gastrointestinal events | most frequent | Meta-analysisn = 4795 | Endocrine 2024, PMID 38850440 |
| Gastrointestinal events | increased odds vs placebo | Meta-analysisn = 5800 | International journal of obesity 2023, PMID 37253796 |
What is not known
- How common each effect is at the doses people use outside of studies.
- Effects that take longer to appear than the length of the published studies.
- How Tirzepatide interacts with other medicines and supplements.
- Whether research-grade products, which are not checked by the FDA, behave like the material used in studies.
When to get medical help
Get urgent care for: trouble breathing, swelling of the face or throat, a widespread rash, severe or lasting stomach pain, fainting, or an injection site that becomes hot, red and spreading.
This is not a complete list. A doctor or pharmacist can help you judge whether a symptom is related.
Common questions
What are the side effects of Tirzepatide?
The FDA label lists most common adverse reactions (5% or more), nausea (placebo, 5 mg, 10 mg, 15 mg), diarrhea (placebo, 5 mg, 10 mg, 15 mg) among others. The table on this page gives how often each happened and links each source.
Is Tirzepatide safe?
Tirzepatide has an FDA-approved label that lists its known risks. That label covers the approved product used as prescribed, not compounded or research-chemical versions.
More on Tirzepatide
DosageDoses used in published studies, with the source for each.CalculatorVial, water and dose to syringe units.ResultsStudy outcomes and when they were measured.PricePrice per mg and per week from dated listings. No vendor links.Legal statusFDA, compounding and WADA status with dates.How to injectSites, syringe types and hygiene, step by step.
Sources
- 1These highlights do not include all the information needed to use MOUNJARO safely and effectively. See full prescribing information for MOUNJARO. MOUNJARO ® (tirzepatide) Injection, for subcutaneous uFDA label (Mounjaro), DailyMed · current labeldailymed.nlm.nih.govAccessed 2 Oct 2026
- 2These highlights do not include all the information needed to use ZEPBOUND safely and effectively. See full prescribing information for ZEPBOUND. ZEPBOUND ® (tirzepatide) Injection, for subcutaneous uFDA label (Zepbound), DailyMed · current labeldailymed.nlm.nih.govAccessed 2 Oct 2026
- 3Tirzepatide as Compared with Semaglutide for the Treatment of Obesity.The New England journal of medicine · 2025PMID 40353578Accessed 2 Oct 2026
- 4Cardiovascular Outcomes with Tirzepatide versus Dulaglutide in Type 2 Diabetes.The New England journal of medicine · 2025PMID 41406444Accessed 2 Oct 2026
- 5Tirzepatide for Heart Failure with Preserved Ejection Fraction and Obesity.The New England journal of medicine · 2025PMID 39555826Accessed 2 Oct 2026
- 6Continued Treatment With Tirzepatide for Maintenance of Weight Reduction in Adults With Obesity: The SURMOUNT-4 Randomized Clinical Trial.JAMA · 2024PMID 38078870Accessed 2 Oct 2026
- 7Tirzepatide for the Treatment of Obstructive Sleep Apnea and Obesity.The New England journal of medicine · 2024PMID 38912654Accessed 2 Oct 2026
- 8Tirzepatide for Metabolic Dysfunction-Associated Steatohepatitis with Liver Fibrosis.The New England journal of medicine · 2024PMID 38856224Accessed 2 Oct 2026
- 9Tirzepatide and blood pressure reduction: stratified analyses of the SURMOUNT-1 randomised controlled trial.Heart (British Cardiac Society) · 2024PMID 39084707Accessed 2 Oct 2026
- 10Tirzepatide once weekly for the treatment of obesity in people with type 2 diabetes (SURMOUNT-2): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial.Lancet (London, England) · 2023PMID 37385275Accessed 2 Oct 2026
- 11Tirzepatide after intensive lifestyle intervention in adults with overweight or obesity: the SURMOUNT-3 phase 3 trial.Nature medicine · 2023PMID 37840095Accessed 2 Oct 2026
- 12Tirzepatide Once Weekly for the Treatment of Obesity.The New England journal of medicine · 2022PMID 35658024Accessed 2 Oct 2026
- 13Effect of Subcutaneous Tirzepatide vs Placebo Added to Titrated Insulin Glargine on Glycemic Control in Patients With Type 2 Diabetes: The SURPASS-5 Randomized Clinical Trial.JAMA · 2022PMID 35133415Accessed 2 Oct 2026
- 14Efficacy and safety of a novel dual GIP and GLP-1 receptor agonist tirzepatide in patients with type 2 diabetes (SURPASS-1): a double-blind, randomised, phase 3 trial.Lancet (London, England) · 2021PMID 34186022Accessed 2 Oct 2026
- 15Tirzepatide versus Semaglutide Once Weekly in Patients with Type 2 Diabetes.The New England journal of medicine · 2021PMID 34170647Accessed 2 Oct 2026
- 16Once-weekly tirzepatide versus once-daily insulin degludec as add-on to metformin with or without SGLT2 inhibitors in patients with type 2 diabetes (SURPASS-3): a randomised, open-label, parallel-group, phase 3 trial.Lancet (London, England) · 2021PMID 34370970Accessed 2 Oct 2026
- 17Tirzepatide versus insulin glargine in type 2 diabetes and increased cardiovascular risk (SURPASS-4): a randomised, open-label, parallel-group, multicentre, phase 3 trial.Lancet (London, England) · 2021PMID 34672967Accessed 2 Oct 2026
- 18Semaglutide vs Tirzepatide for Weight Loss in Adults With Overweight or Obesity.JAMA internal medicine · 2024PMID 38976257Accessed 2 Oct 2026
- 19Efficacy and safety of once-weekly tirzepatide for weight management compared to placebo: An updated systematic review and meta-analysis including the latest SURMOUNT-2 trial.Endocrine · 2024PMID 38850440Accessed 2 Oct 2026
- 20Efficacy and safety of tirzepatide for treatment of overweight or obesity. A systematic review and meta-analysis.International journal of obesity (2005) · 2023PMID 37253796Accessed 2 Oct 2026
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