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Compound hub · Tirzepatide

Tirzepatide side effects: what trials, labels and the TGA report

Nausea affected 25% to 29% of tirzepatide arms against 8% on placebo in two placebo-controlled trials among 2,519 tirzepatide and 958 placebo adults with obesity or overweight, with and without type 2 diabetes; these group rates do not predict an individual experience (US Zepbound label, DailyMed, 2 September 2026). The label also lists serious warnings, described below alongside the trial records and their limits.

Form Labs materials are research reference materials, not the approved medicines; no Form Labs product is approved for human or veterinary use.

Published 2026-10-14Updated 2026-10-14Written by Form Laboratories research team28 min read

Your gut is the busiest sensor you own. It tastes, stretches, sorts and signals all day, and it reports to the brain through gut hormones. Tirzepatide acts on the receptors for two of those hormones. The trial records open with gut reactions, and so does this page.

This page is part of the tirzepatide hub. It sets out what trials, labels and regulators have recorded about tirzepatide's side effects, with the study, the size and the comparison group beside each figure. It also answers the matching questions about semaglutide, the molecule in Ozempic and Wegovy. The US labels it uses are on DailyMed (Zepbound and Mounjaro, both published 2 September 2026; Wegovy, 30 June 2026; Ozempic, 10 June 2026). The Australian records are the TGA's public assessment report for Mounjaro (finalised 20 September 2024) and its Medicines Safety Updates of 3 June 2025 and 1 December 2025. Here, side effects means the adverse reactions and adverse events that labels and trials record, and a record of an event does not show that the medicine caused it. Nothing here is medical advice, and it describes records, not any one person's experience.

Key facts

Key facts for Tirzepatide side effects: what trials, labels and the TGA report
Common nametirzepatide
Most common reaction, US Zepbound labelnausea: 25% to 29% on tirzepatide, 8% on placebo, in the label's pool of two placebo-controlled trials (2,519 adults with obesity or overweight, with and without type 2 diabetes, on tirzepatide and 958 on placebo, up to 72 weeks); a group figure, not a prediction for any one person (DailyMed, published 2 September 2026)
Gut reactions as a group, US Zepbound label56% in each tirzepatide group, 30% on placebo, in the label's pool of two placebo-controlled trials (2,519 adults with obesity or overweight, with and without type 2 diabetes, on tirzepatide and 958 on placebo, up to 72 weeks); a group figure, not a prediction for any one person (US Zepbound label, DailyMed, 2 September 2026)
Stopped treatment because of an adverse event, US Zepbound label4.8% to 6.7% on tirzepatide, 3.4% on placebo, in the label's pool of two placebo-controlled trials (2,519 adults with obesity or overweight, with and without type 2 diabetes, on tirzepatide and 958 on placebo, up to 72 weeks); a group figure, not a prediction for any one person (US Zepbound label, DailyMed, 2 September 2026)
Pancreatitis, US Zepbound label0.2% on tirzepatide, 0.2% on placebo (acute pancreatitis confirmed by adjudication), in the label's pool of two placebo-controlled trials (2,519 adults with obesity or overweight, with and without type 2 diabetes, on tirzepatide and 958 on placebo, up to 72 weeks); equal observed rates in a pool of that size cannot rule out a rare risk (US Zepbound label, DailyMed, 2 September 2026)
Boxed warningthe US Mounjaro label states that tirzepatide caused thyroid C-cell tumours in rats, gives no animal count in the warning, and says the rat finding does not establish a human result (Mounjaro label, DailyMed, published 2 September 2026)
Longest obesity trial result citedSURMOUNT-1 three-year analysis, 1,032 adults with obesity and prediabetes, 176 weeks; the abstract states no new safety signals were identified, a result limited to a maker-funded subgroup analysis and that follow-up (Jastreboff et al., New England Journal of Medicine, 2025)
Head-to-head obesity trialSURMOUNT-5, 751 adults with obesity and no diabetes, tirzepatide against semaglutide, 72 weeks, open-label (Aronne et al., New England Journal of Medicine, 2025)
Australian registerTGA register entries for Mounjaro dated 23 December 2022, 10 September 2024 and 2 June 2025, read 14 October 2026
US Zepbound label (DailyMed), 2 September 2026US Mounjaro label (DailyMed), 2 September 2026NEJM 2022

What is the most common side effect of tirzepatide?

In the US Zepbound label's pool of two placebo-controlled trials (2,519 adults with obesity or overweight, with and without type 2 diabetes, on tirzepatide and 958 on placebo, followed for up to 72 weeks), nausea was the most commonly reported adverse reaction, reported by 25% to 29% of people across the three tirzepatide groups against 8% on placebo, and the pool does not predict any one person's experience (DailyMed, 2 September 2026). In the Zepbound human trial pool (2,519 adults with obesity or overweight, with and without type 2 diabetes, on tirzepatide and 958 on placebo), diarrhoea affected 19% to 23%, vomiting 8% to 13%, constipation 11% to 17% and abdominal pain 9% to 10% of the tirzepatide groups, group figures that do not predict any one person's experience (US Zepbound label, DailyMed, 2 September 2026). In the Zepbound human trial pool (2,519 adults with obesity or overweight, with and without type 2 diabetes, on tirzepatide and 958 on placebo), the label says the majority of nausea, vomiting and diarrhoea events came early in the trials and decreased over time, a group description from up to 72 weeks of follow-up that does not predict any one person's experience (US Zepbound label, DailyMed, 2 September 2026).

In the Zepbound label's pool of two placebo-controlled trials (2,519 adults with obesity or overweight, with and without type 2 diabetes, on tirzepatide and 958 on placebo, up to 72 weeks), 56% of people in each tirzepatide group reported a gut reaction against 30% on placebo, and stopping treatment for a gut reason happened in 1.9%, 3.3% and 4.3% of the three groups against 0.5% on placebo, group figures from trial participants and not predictions for any person (US Zepbound label, DailyMed, 2 September 2026). In the Mounjaro label's pool of placebo-controlled trials in adults with type 2 diabetes (235 on placebo and 237, 240 and 241 in the three tirzepatide groups in its adverse reaction table), nausea ran from 12% to 18% against 4% on placebo, and gut reactions as a group from 37.1% to 43.6% against 20.4%, figures that come from a different population from the obesity trials (US Mounjaro label, DailyMed, 2 September 2026).

In SURMOUNT-1, a 72-week maker-funded trial of 2,539 adults with obesity or overweight and no diabetes, adverse events were mostly gastrointestinal and mild to moderate and occurred mainly early in the trial, and 4.3%, 7.1% and 6.2% of the three tirzepatide groups stopped treatment because of an adverse event against 2.6% on placebo, group figures that do not predict any one person's experience (Jastreboff et al., New England Journal of Medicine, 2022).

US Zepbound label (DailyMed), 2 September 2026TGA register entries for Mounjaro, read 14 October 2026TGA AusPAR for Mounjaro, 20 September 2024

Evidence limits

Is tirzepatide safe?

The trials, labels and regulator documents cited on this page give no yes-or-no safety verdict for tirzepatide. The TGA's assessment report for Mounjaro includes a risk/benefit analysis for the indication it assessed (TGA AusPAR, 20 September 2024). The TGA register has Mounjaro entries dated 23 December 2022, 10 September 2024 and 2 June 2025 (read 14 October 2026), and the US Mounjaro and Zepbound labels give 2022 as the initial US approval of the active ingredient, which is not necessarily either brand's own first approval date (DailyMed, 2 September 2026). The US labels also carry a boxed warning and a list of serious risks. What the records show is how often each reaction occurred in trials, which the sections below set out one by one.

Trial records have three limits. Trials enrol screened volunteers and follow them for a fixed time, from 40 weeks in some trials to 176 weeks in the longest obesity result cited here. A trial of a few thousand people counts only events that happen often enough to appear in that group. And the label's postmarketing list comes from voluntary reports from a population of uncertain size, so the label says it is not always possible to reliably estimate frequency from it (US Zepbound label, DailyMed, 2 September 2026).

That gap fits the TGA's assessment report, which states that anaphylaxis was identified as a safety signal based on post-market data (TGA AusPAR for Mounjaro, 20 September 2024). The maker of tirzepatide funded SURMOUNT-1 and SURMOUNT-5, and manufacturers hold the labels, so the 2026 Annals of Internal Medicine meta-analysis cited below, which reports no funding, adds a second view.

US Zepbound label (DailyMed), 2 September 2026US Mounjaro label (DailyMed), 2 September 2026

What are all the possible side effects of tirzepatide?

No single list holds every possible side effect, but the US Zepbound label sets out the best-documented ones. In the label's pool of two placebo-controlled trials (2,519 adults with obesity or overweight, with and without type 2 diabetes, on tirzepatide and 958 on placebo), Table 1 lists 16 reactions that occurred in at least 2% of tirzepatide-treated patients and more commonly than with placebo: nausea, diarrhoea, vomiting, constipation, abdominal pain, indigestion, reactions where the study drug was given, tiredness, hypersensitivity, belching, hair loss, acid reflux, flatulence, abdominal bloating, dizziness and low blood pressure, and the table does not cover rarer events (DailyMed, 2 September 2026). Rarer events appear in separate warnings and in a list of reports made after approval.

The label's postmarketing list names acute pancreatitis, including haemorrhagic and necrotising forms that were sometimes fatal, ileus, intestinal obstruction, severe constipation with faecal impaction, anaphylaxis, angioedema, pulmonary aspiration, and acute or worsening chronic kidney failure sometimes needing haemodialysis, all from voluntary reports after approval, for which the label says it is not always possible to reliably estimate frequency (US Zepbound label, DailyMed, 2 September 2026).

In the Zepbound label's pool of two placebo-controlled trials (2,519 adults with obesity or overweight, with and without type 2 diabetes, on tirzepatide and 958 on placebo), mean heart rate rose by 1 to 3 beats per minute against no rise on placebo, and mean pancreatic amylase and lipase levels in the blood rose more on tirzepatide than on placebo, group findings that do not predict any one person's result (US Zepbound label, DailyMed, 2 September 2026). In the Zepbound human trial pool (2,519 adults with obesity or overweight, with and without type 2 diabetes, on tirzepatide and 958 on placebo), dry mouth or dry throat (1% against 0.1%), dysaesthesia (altered skin sensation) and dysgeusia (altered taste, 0.4% against none) were reported more often than on placebo, group figures that do not predict any one person's experience (US Zepbound label, DailyMed, 2 September 2026).

In the tirzepatide group of 6,647 adults with type 2 diabetes and established cardiovascular disease in a cardiovascular outcomes trial, the Mounjaro label lists decreased appetite (17%), constipation (13%), vomiting (12%), abdominal pain (10%), fatigue (10%) and dysaesthesia (0.7%) as the reactions that differed from its other tables, and the passage does not give comparison-group percentages, so the figures describe that group only and not any one person (US Mounjaro label, DailyMed, 2 September 2026).

US Mounjaro label (DailyMed), 2 September 2026US Zepbound label (DailyMed), 2 September 2026TGA AusPAR for Mounjaro, 20 September 2024TGA Medicines Safety Update, 3 June 2025

What are the bad side effects of tirzepatide?

The serious side effects named on tirzepatide labels are severe gut reactions, pancreatitis, gallbladder disease, severe allergic reactions, acute kidney injury, eye complications in people with diabetic retinopathy, low blood sugar in people also taking insulin or insulin secretagogues, and aspiration into the lungs during anaesthesia (US Mounjaro label, DailyMed, 2 September 2026; TGA Medicines Safety Update, 3 June 2025). The labels give separate figures for each. In the US Zepbound label's pool of two placebo-controlled trials (2,519 adults with obesity or overweight, with and without type 2 diabetes, on tirzepatide and 958 on placebo), acute pancreatitis confirmed by adjudication occurred in 0.2% on tirzepatide and 0.2% on placebo, observed trial rates that cannot rule out rare or later risk (US Zepbound label, DailyMed, 2 September 2026).

On gallbladder disease, the Zepbound label's pool of two placebo-controlled trials (2,519 adults with obesity or overweight, with and without type 2 diabetes, on tirzepatide and 958 on placebo) reports cholelithiasis (gallstones) in 1.1% on tirzepatide against 1.0% on placebo, cholecystitis in 0.7% against 0.2%, and cholecystectomy in 0.2% against none, group figures that do not predict any one person's risk and cannot rule out rare events (US Zepbound label, DailyMed, 2 September 2026). The TGA's pooled analysis of SURMOUNT-1 and SURMOUNT-2 (2,519 tirzepatide-treated and 958 placebo-treated adults with obesity or overweight, with and without type 2 diabetes) found serious or severe gallbladder-related events in 28 tirzepatide-treated participants (1.11%) against 8 on placebo (0.84%), a group figure limited to trial follow-up that cannot rule out rare events (TGA AusPAR, 20 September 2024).

On low blood sugar, the Zepbound label reports hypoglycaemia in 4.2% on tirzepatide against 1.3% on placebo in SURMOUNT-2, a trial in adults with obesity or overweight and type 2 diabetes, with 623 tirzepatide participants and 315 placebo participants in the analysed safety data (TGA AusPAR, 20 September 2024), and that figure does not carry over to people without diabetes (US Zepbound label, DailyMed, 2 September 2026). In that trial, in adults with obesity or overweight and type 2 diabetes, the risk was higher in people also taking a sulfonylurea (10.3%) than in people on tirzepatide without one (2.1%), subgroup figures whose denominators the cited passage does not give (US Zepbound label, DailyMed, 2 September 2026). On allergy, the TGA report gives hypersensitivity reactions in 6.2% of tirzepatide-treated participants who developed treatment-emergent antibodies and 3.0% of those who did not, in its pooled SURMOUNT-1 and SURMOUNT-2 data (2,519 tirzepatide-treated and 958 placebo-treated adults with obesity or overweight, with and without type 2 diabetes), where the cited passage gives no antibody-subgroup sizes, so these are group figures and not predictions for any person (TGA AusPAR, 20 September 2024).

US Mounjaro label (DailyMed), 2 September 2026TGA Medicines Safety Update, 1 December 2025TGA Medicines Safety Update, 3 June 2025

What are the risks of tirzepatide?

The main risks sit in the labels' warnings. The boxed warning in the US Mounjaro label states that tirzepatide caused thyroid C-cell tumours in rats and that it is unknown whether it does so in humans, and the warning gives no animal count; the rat finding does not establish a human result (US Mounjaro label, DailyMed, 2 September 2026). The same label lists as contraindications a personal or family history of medullary thyroid carcinoma or the genetic condition MEN 2, and a known serious hypersensitivity to tirzepatide (US Mounjaro label, DailyMed, 2 September 2026). The TGA's Medicines Safety Update of 1 December 2025 records that its investigation could not rule out an association between tirzepatide and reduced effectiveness of oral contraception.

On contraception, the TGA's update of 1 December 2025 records that the TGA changed the product information on the point, and the update's wording is on the TGA site and is not reproduced here. The same update also addresses pregnancy, and this page does not summarise that part (TGA Medicines Safety Update, 1 December 2025).

On anaesthesia, a class-wide warning in Australian product information covers pulmonary aspiration (stomach contents entering the lungs) during general anaesthesia or deep sedation (TGA Medicines Safety Update, 3 June 2025). The US Mounjaro label carries a warning on rare postmarketing reports of pulmonary aspiration in people receiving GLP-1 receptor agonists who had elective surgery or procedures under general anaesthesia or deep sedation (DailyMed, 2 September 2026).

TGA AusPAR for Mounjaro, 20 September 2024TGA register entries for Mounjaro, read 14 October 2026

What are the side effects of tirzepatide in Australia?

In the TGA's assessment of Mounjaro, which pooled SURMOUNT-1 and SURMOUNT-2 (2,519 tirzepatide-treated and 958 placebo-treated adults with obesity or overweight, with and without type 2 diabetes), 153 people (6.07%) on tirzepatide stopped study drug because of an adverse event, against 33 (3.44%) on placebo, group figures from trial participants and not predictions for any person (TGA AusPAR, finalised 20 September 2024). In the TGA pool (2,519 tirzepatide-treated and 958 placebo-treated adults with obesity or overweight, with and without type 2 diabetes), the most frequently reported adverse events were gut reactions, mostly mild to moderate, over trial follow-up and not lifetime risk (TGA AusPAR, 20 September 2024). The Delegate's summary in that report, which covers the chronic weight management submission the report assesses, states that apart from a new risk of anaphylaxis no new concerns were identified in that submission (TGA AusPAR, 20 September 2024).

In the TGA pool (2,519 tirzepatide-treated and 958 placebo-treated adults with obesity or overweight, with and without type 2 diabetes), reactions at the site where the study drug was given occurred in 11.3% of tirzepatide-treated participants who developed treatment-emergent antibodies and in 1.0% of tirzepatide-treated participants who did not, group figures whose antibody-subgroup sizes the cited passage does not give (TGA AusPAR, 20 September 2024). In the TGA pool (2,519 tirzepatide-treated and 958 placebo-treated adults with obesity or overweight, with and without type 2 diabetes), treatment-emergent antibodies to tirzepatide were found in 64.5% of tirzepatide-treated participants, a group figure over planned trial follow-up (TGA AusPAR, 20 September 2024). In the TGA pool (2,519 tirzepatide-treated and 958 placebo-treated adults with obesity or overweight, with and without type 2 diabetes), depression and suicide or self-injury events were reported as similar in the tirzepatide and placebo groups, with severe or serious events in 5 participants (0.20%) on tirzepatide and 1 (0.10%) on placebo, all with pre-existing mental health issues, counts too small to estimate a rate for any individual (TGA AusPAR, 20 September 2024).

The TGA register lists Mounjaro entries dated 23 December 2022 (type 2 diabetes), 10 September 2024 (chronic weight management) and 2 June 2025 (obstructive sleep apnoea), read 14 October 2026. Whether tirzepatide is available in Australia sets out the register, the scheduling and the limits on advertising.

US Zepbound label (DailyMed), 2 September 2026TGA AusPAR for Mounjaro, 20 September 2024ClinicalTrials.gov NCT05822830, read 14 October 2026

Do trials record reactions at the place the study drug was given?

Trials recorded reactions at the site where the study drug was given: 6% to 8% of people across the tirzepatide groups against 2% on placebo in the US Zepbound label's pool of two placebo-controlled trials (2,519 adults with obesity or overweight, with and without type 2 diabetes, on tirzepatide and 958 on placebo), a group figure that does not predict any one person's experience (DailyMed, 2 September 2026). The TGA's assessment gives 11.3% in tirzepatide-treated participants who developed treatment-emergent antibodies against 1.0% in those who did not, in its pooled SURMOUNT-1 and SURMOUNT-2 data (2,519 tirzepatide-treated and 958 placebo-treated adults with obesity or overweight, with and without type 2 diabetes), where the cited passage gives no antibody-subgroup sizes (TGA AusPAR, 20 September 2024). In SURMOUNT-5, an open-label 72-week trial of 751 adults with obesity and no diabetes, funded by the maker of tirzepatide, 8.6% on tirzepatide and 0.3% on semaglutide reported them, and participants and staff knew which drug was given (ClinicalTrials.gov results record NCT05822830, results posted 26 November 2025, read 14 October 2026). The three records group people differently, and this page does not reconcile them.

Compare each figure only with its own comparison group. SURMOUNT-5's primary outcome was weight change, not reaction rates (Aronne et al., New England Journal of Medicine, 2025). In the Zepbound label's pool of two placebo-controlled trials (2,519 adults with obesity or overweight, with and without type 2 diabetes, on tirzepatide and 958 on placebo), hypersensitivity was listed at 5% on tirzepatide against 3% on placebo, a group figure that does not predict any one person's experience (US Zepbound label, DailyMed, 2 September 2026).

US Mounjaro label (DailyMed), 2 September 2026Diabetology & Metabolic Syndrome 2025Lancet Diabetes & Endocrinology 2022NEJM 2024

Is tirzepatide harmful to the kidneys?

The labels warn of acute kidney injury, mostly through dehydration. The US Mounjaro label reports postmarketing cases of acute kidney injury, some needing haemodialysis, in people treated with GLP-1 receptor agonists or Mounjaro, and says the majority of reported events occurred in people whose gut reactions led to dehydration (DailyMed, 2 September 2026). A 2025 meta-analysis of 20 randomised trials and 15,905 participants with type 2 diabetes or obesity found no significant difference in adverse renal events (a group that included urinary tract infections, kidney stones, renal impairment and renal cell carcinoma) against control (risk ratio 1.22, 95% confidence interval 0.78 to 1.89), with short follow-up and heterogeneous outcome definitions as limits (Liu et al., Diabetology & Metabolic Syndrome, 2025).

A post hoc analysis of SURPASS-4, an open-label trial of 2,002 adults with type 2 diabetes at high cardiovascular risk, found that estimated kidney function (eGFR) declined by 1.4 mL per minute per 1.73 m² a year on tirzepatide against 3.6 on insulin glargine, and that a kidney composite outcome had a hazard ratio of 0.58 (95% confidence interval 0.43 to 0.80), in a maker-funded analysis that was run after the trial and not planned as its main question (Heerspink et al., Lancet Diabetes & Endocrinology, 2022).

For semaglutide, the FLOW trial in 3,533 adults with type 2 diabetes and chronic kidney disease, funded by the maker of semaglutide, found a lower risk of its primary composite outcome of kidney and cardiovascular events (hazard ratio 0.76, 95% confidence interval 0.66 to 0.88) over a median of 3.4 years, a result limited to that population (Perkovic et al., New England Journal of Medicine, 2024).

US Mounjaro label (DailyMed), 2 September 2026Annals of Internal Medicine 2026TGA AusPAR for Mounjaro, 20 September 2024

Does tirzepatide cause cancer?

The boxed warning in the US Mounjaro label states that tirzepatide caused thyroid C-cell tumours in rats, gives no animal count in the warning, and says human relevance is unknown; the rat finding does not establish a human result (US Mounjaro label, DailyMed, 2 September 2026). Ko et al.'s 2026 review in Annals of Internal Medicine inventories 48 human placebo-controlled trials with 94,245 participants and cancer-event reporting; its abstract discusses type 2 diabetes and overweight or obesity but gives no trial-specific population breakdown, and the included trials had short follow-up and were not designed to measure cancer outcomes. Neither source closes the question.

Ko et al.'s 2026 Annals of Internal Medicine review describes its selected trial evidence, rather than a lifetime cancer-risk study; the abstract gives no population or participant breakdown for its semaglutide and tirzepatide sensitivity subset.

In the TGA's pooled SURMOUNT-1 and SURMOUNT-2 data (2,519 tirzepatide-treated and 958 placebo-treated adults with obesity or overweight, with and without type 2 diabetes), no medullary thyroid carcinoma cases were reported and one pancreatic cancer occurred in the placebo group, observations limited to trial follow-up that cannot rule out rare or later events (TGA AusPAR, 20 September 2024).

NEJM 2025 (SURMOUNT-1 three-year analysis)NEJM 2025 (SURPASS-CVOT)US Mounjaro label (DailyMed), 2 September 2026TGA register entries for Mounjaro, read 14 October 2026

Is long-term use of tirzepatide safe?

Trial follow-up alone cannot establish safety for every population or duration. In the SURMOUNT-1 three-year analysis of 1,032 adults with obesity and prediabetes assessed over 176 weeks, the abstract states that, other than coronavirus disease 2019, the most common adverse events were gastrointestinal, mostly mild to moderate and mostly in the first 20 weeks, and that 'No new safety signals were identified', a result limited to that maker-funded subgroup and that follow-up (Jastreboff et al., New England Journal of Medicine, 2025). SURPASS-CVOT, in 13,299 randomised adults with type 2 diabetes and atherosclerotic cardiovascular disease, reported that the incidence of adverse events appeared to be similar for tirzepatide and dulaglutide, with more gastrointestinal adverse events on tirzepatide, in a maker-funded trial against an active comparator (Nicholls et al., New England Journal of Medicine, 2025).

The maker of tirzepatide funded both trials. The three-year analysis covers a subgroup of SURMOUNT-1 with prediabetes, followed for 176 weeks plus 17 weeks off treatment (Jastreboff et al., New England Journal of Medicine, 2025). The US Mounjaro label gives 2022 as the initial US approval of the active ingredient (DailyMed, 2 September 2026) and the TGA register entry is dated 23 December 2022, so any records of use after approval cover under four years.

Events that are very rare or take many years to appear fall outside what these records can show. The labels' postmarketing lists record such events as they are reported.

US Wegovy label (DailyMed), 30 June 2026US Ozempic label (DailyMed), 10 June 2026NEJM 2021

What is the biggest side effect of semaglutide?

In the US Wegovy label's pool of three placebo-controlled trials (2,116 adults with obesity or overweight on semaglutide and 1,261 on placebo, up to 68 weeks), nausea was the most frequently reported adverse reaction, in 44% against 16% on placebo, with diarrhoea in 30% against 16%, vomiting in 24% against 6%, and constipation in 24% against 11%, group figures that do not predict any one person's experience (DailyMed, 30 June 2026). In the Wegovy human trial pool (2,116 adults with obesity or overweight on semaglutide and 1,261 on placebo), stopping treatment for an adverse event happened in 6.8% against 3.2%, a group figure that does not predict any one person's experience (US Wegovy label, DailyMed, 30 June 2026). In STEP 1, a 68-week trial of 1,961 adults with overweight or obesity and no diabetes, funded by the maker of semaglutide, 4.5% on semaglutide and 0.8% on placebo discontinued treatment because of gastrointestinal events, a result limited to that trial population and not a prediction for any one person (Wilding et al., New England Journal of Medicine, 2021).

By seriousness, not frequency, the Wegovy and Ozempic labels list warnings that overlap with the tirzepatide labels: pancreatitis, gallbladder disease, hypoglycaemia, acute kidney injury through volume depletion, severe gut reactions, hypersensitivity, diabetic retinopathy complications and pulmonary aspiration (US Wegovy label, DailyMed, 30 June 2026; US Ozempic label, DailyMed, 10 June 2026). The Wegovy label also lists heart rate increase.

In the Wegovy label's pool of three placebo-controlled trials (2,116 adults with obesity or overweight on semaglutide and 1,261 on placebo, up to 68 weeks), abdominal pain (20% against 10%), headache (14% against 10%), fatigue (11% against 5%), indigestion (9% against 3%) and dizziness (8% against 4%) are also in the table, as group figures that do not predict any one person's experience, and the table lists only reactions of at least 2% and greater than placebo, so it excludes rarer events (US Wegovy label, DailyMed, 30 June 2026).

US Ozempic label (DailyMed), 10 June 2026NEJM 2024

What organ is Ozempic bad for?

The labels name warnings, not a single worst organ. The US Ozempic label warns about five organs: the pancreas (pancreatitis), the gallbladder (gallstones and cholecystitis), the kidneys (acute kidney injury, mostly with dehydration), the eyes (diabetic retinopathy complications) and the thyroid (a boxed warning about tumours in rodents, with the human risk unknown) (DailyMed, 10 June 2026). In SUSTAIN-6, the label's two-year trial of 3,297 adults with type 2 diabetes and high cardiovascular risk, retinopathy complications occurred in 3.0% on semaglutide against 1.8% on placebo, a result limited to that high-risk trial population, so the figure is a group figure that does not predict any one person's risk (US Ozempic label, DailyMed, 10 June 2026). A warning records that an event was seen more often than on placebo or was reported after approval, and it does not prove that the medicine caused each case.

In SUSTAIN-6, a two-year trial of 3,297 adults with type 2 diabetes and high cardiovascular risk, the retinopathy figures split by history: complications occurred in 8.2% against 5.2% in people with a history of diabetic retinopathy, and in 0.7% against 0.4% in people without that history, subgroup figures from that trial only, with subgroup denominators that the cited passage does not give (US Ozempic label, DailyMed, 10 June 2026). The label also lists ileus, intestinal obstruction, cholecystitis and acute kidney injury among reports made after approval, which are voluntary reports that do not show how often they occur (US Ozempic label, DailyMed, 10 June 2026).

In contrast, the FLOW trial in 3,533 adults with type 2 diabetes and chronic kidney disease, funded by the maker of semaglutide, found a lower risk of its primary composite outcome of kidney and cardiovascular events (hazard ratio 0.76, 95% confidence interval 0.66 to 0.88), and reported serious adverse events in 49.6% on semaglutide against 53.8% on placebo, results limited to that population (Perkovic et al., New England Journal of Medicine, 2024).

NEJM 2024US Ozempic label (DailyMed), 10 June 2026

How long have trials followed people on Ozempic, and is any duration shown to be safe?

The trial and label records reviewed here define no duration after which Ozempic is safe or unsafe. The longest semaglutide trial in these records, FLOW, funded by the maker of semaglutide, followed 3,533 adults with type 2 diabetes and chronic kidney disease for a median of 3.4 years and reported serious adverse events in 49.6% on semaglutide against 53.8% on placebo, a result limited to that population and that follow-up (Perkovic et al., New England Journal of Medicine, 2024). These are trial results, not a safety verdict for any length of treatment.

The label's two-year cardiovascular trial supplies the other long-run figure, the retinopathy complications covered above (US Ozempic label, DailyMed, 10 June 2026). Weight regain after stopping is a separate question, covered with its trial data in what published studies have found on tirzepatide.

ClinicalTrials.gov NCT05822830, read 14 October 2026NEJM 2025 (SURMOUNT-5)NEJM 2021 (SURPASS-2)

Which is safer, Wegovy or Mounjaro?

SURMOUNT-5 was not designed to establish a safety ranking of tirzepatide and semaglutide. In SURMOUNT-5, an open-label 72-week trial of 751 adults with obesity and no diabetes that compared tirzepatide (the molecule in Mounjaro and Zepbound) with semaglutide (the molecule in Wegovy), serious adverse events were reported by 18 of 374 people (4.8%) on tirzepatide and 13 of 376 (3.5%) on semaglutide, and 6 people left the study for an adverse event in each group, in a trial run by the maker of tirzepatide that was not designed to rank the two on safety (ClinicalTrials.gov results record NCT05822830, results posted 26 November 2025, read 14 October 2026).

In that trial record (SURMOUNT-5, 751 adults with obesity and no diabetes, open-label, 374 and 376 analysed on tirzepatide and semaglutide), gut reactions were close: nausea 43.6% against 44.4%, diarrhoea 23.5% against 23.4%, and constipation 27.0% against 28.5%, as other adverse events reported by at least 5% of people, in an open-label trial not designed to rank safety (ClinicalTrials.gov NCT05822830, read 14 October 2026). In the same record of 751 adults with obesity and no diabetes, vomiting was less frequent on tirzepatide (15.0% against 21.3%), reactions where the study drug was given were more frequent (8.6% against 0.3%), and no deaths were reported in either group, in an open-label trial where the record lists only other adverse events reported by at least 5% of people, so rarer events do not appear (ClinicalTrials.gov NCT05822830, read 14 October 2026).

In SURPASS-2 (1,879 adults with type 2 diabetes, 40 weeks, open-label), serious adverse events were 5% to 7% across the three tirzepatide groups against 3% on semaglutide, and nausea 17% to 22% against 18%, group figures from an open-label trial in people with diabetes (Frias et al., New England Journal of Medicine, 2021), a trial funded by the maker of tirzepatide. Weight results from SURMOUNT-5 are on the study findings page.

US Mounjaro label (DailyMed), 2 September 2026TGA AusPAR for Mounjaro, 20 September 2024

Do these side-effect records apply to research-use tirzepatide?

No. Every figure on this page comes from tirzepatide medicines or trial drug product, given to enrolled participants who were screened and monitored by trial staff (US labels; TGA AusPAR; published trials). Research-use tirzepatide is a laboratory compound. Research material is not a medicine, is not a substitute for one, and is not for human or animal use. No side-effect record on this page describes it, and none of these documents says what any material outside a trial or regulator review would do.

What exists for laboratory work is reference material with paperwork. The catalogue lists tirzepatide reference material as freeze-dried laboratory stock. Current certification for that material is unverified, and nothing on this page describes it. The tirzepatide research guide covers the compound itself, and where tirzepatide comes from covers how it is made.

Comparison

SURMOUNT-5 safety results as posted on ClinicalTrials.gov (NCT05822830; sponsor: the maker of tirzepatide; results posted 26 November 2025; read 14 October 2026). Adults with obesity and no diabetes, 72 weeks, open-label. Share of people at risk in each group. Nausea, diarrhoea, vomiting, constipation and reactions at the site where the study drug was given are other adverse events reported by at least 5% of people. Not a verdict on which is safer.

Comparison: Tirzepatide side effects: what trials, labels and the TGA report
MeasureTirzepatide (Mounjaro, Zepbound)Semaglutide (Wegovy, Ozempic)
People in the safety data374 analysed adults on tirzepatide in SURMOUNT-5 (751 adults with obesity and no diabetes, open-label; ClinicalTrials.gov NCT05822830)376 analysed adults on semaglutide in SURMOUNT-5 (751 adults with obesity and no diabetes, open-label; ClinicalTrials.gov NCT05822830)
Serious adverse events18 of 374 analysed adults (4.8%) on tirzepatide had a serious adverse event, in SURMOUNT-5 (751 adults with obesity and no diabetes), an open-label trial not designed to rank safety (ClinicalTrials.gov NCT05822830 results record)13 of 376 analysed adults (3.5%) on semaglutide had a serious adverse event, in SURMOUNT-5 (751 adults with obesity and no diabetes), an open-label trial not designed to rank safety (ClinicalTrials.gov NCT05822830 results record)
Left the study for an adverse event6 of 375 randomised adults assigned to tirzepatide left the study for an adverse event in the participant-flow record of SURMOUNT-5 (751 adults with obesity and no diabetes), an open-label trial not designed to rank safety (ClinicalTrials.gov NCT05822830 results record)6 of 376 analysed adults on semaglutide left the study for an adverse event, in SURMOUNT-5 (751 adults with obesity and no diabetes), an open-label trial not designed to rank safety (ClinicalTrials.gov NCT05822830 results record)
Deaths0 deaths among 374 analysed adults on tirzepatide, in SURMOUNT-5 (751 adults with obesity and no diabetes), an open-label trial not designed to rank safety or rule out rare events (ClinicalTrials.gov NCT05822830 results record)0 deaths among 376 analysed adults on semaglutide, in SURMOUNT-5 (751 adults with obesity and no diabetes), an open-label trial not designed to rank safety or rule out rare events (ClinicalTrials.gov NCT05822830 results record)
Nausea163 of 374 analysed adults (43.6%) on tirzepatide, an other-adverse-event result at the record's 5% reporting threshold, in SURMOUNT-5 (751 adults with obesity and no diabetes), an open-label trial not designed to rank safety (ClinicalTrials.gov NCT05822830)167 of 376 analysed adults (44.4%) on semaglutide, an other-adverse-event result at the record's 5% reporting threshold, in SURMOUNT-5 (751 adults with obesity and no diabetes), an open-label trial not designed to rank safety (ClinicalTrials.gov NCT05822830)
Diarrhoea88 of 374 analysed adults (23.5%) on tirzepatide, an other-adverse-event result at the record's 5% reporting threshold, in SURMOUNT-5 (751 adults with obesity and no diabetes), an open-label trial not designed to rank safety (ClinicalTrials.gov NCT05822830)88 of 376 analysed adults (23.4%) on semaglutide, an other-adverse-event result at the record's 5% reporting threshold, in SURMOUNT-5 (751 adults with obesity and no diabetes), an open-label trial not designed to rank safety (ClinicalTrials.gov NCT05822830)
Vomiting56 of 374 analysed adults (15.0%) on tirzepatide, an other-adverse-event result at the record's 5% reporting threshold, in SURMOUNT-5 (751 adults with obesity and no diabetes), an open-label trial not designed to rank safety (ClinicalTrials.gov NCT05822830)80 of 376 analysed adults (21.3%) on semaglutide, an other-adverse-event result at the record's 5% reporting threshold, in SURMOUNT-5 (751 adults with obesity and no diabetes), an open-label trial not designed to rank safety (ClinicalTrials.gov NCT05822830)
Constipation101 of 374 analysed adults (27.0%) on tirzepatide, an other-adverse-event result at the record's 5% reporting threshold, in SURMOUNT-5 (751 adults with obesity and no diabetes), an open-label trial not designed to rank safety (ClinicalTrials.gov NCT05822830)107 of 376 analysed adults (28.5%) on semaglutide, an other-adverse-event result at the record's 5% reporting threshold, in SURMOUNT-5 (751 adults with obesity and no diabetes), an open-label trial not designed to rank safety (ClinicalTrials.gov NCT05822830)
Reactions where the study drug was given32 of 374 analysed adults (8.6%) on tirzepatide, an other-adverse-event result at the record's 5% reporting threshold, in SURMOUNT-5 (751 adults with obesity and no diabetes), an open-label trial not designed to rank safety (ClinicalTrials.gov NCT05822830)1 of 376 analysed adults (0.3%) on semaglutide, an other-adverse-event result at the record's 5% reporting threshold, in SURMOUNT-5 (751 adults with obesity and no diabetes), an open-label trial not designed to rank safety (ClinicalTrials.gov NCT05822830)

FAQ

What are the side effects of tirzepatide?

In the US Zepbound label's pool of two placebo-controlled trials (2,519 adults with obesity or overweight, with and without type 2 diabetes, on tirzepatide and 958 on placebo), the leading reactions were gut reactions: nausea affected 25% to 29% of people on tirzepatide against 8% on placebo, a group figure that does not predict any one person's experience (DailyMed, 2 September 2026). The US Mounjaro label also lists pancreatitis, gallbladder disease, allergic reactions and a boxed warning that tirzepatide caused thyroid tumours in rats, with no animal count in the warning and a rat result that does not establish a human result (US Mounjaro label, DailyMed, 2 September 2026).

What is the most common side effect of tirzepatide?

In the US Zepbound label's pool of two placebo-controlled trials (2,519 adults with obesity or overweight, with and without type 2 diabetes, on tirzepatide and 958 on placebo), nausea was reported by 25% to 29% of people across the three tirzepatide groups against 8% on placebo, mostly early in the trials, and the figure does not predict any one person's experience (DailyMed, 2 September 2026).

What are the potential side effects of Mounjaro for weight management?

The weight-management data come from SURMOUNT-1 and SURMOUNT-2, pooled in the Zepbound label and in the TGA's Mounjaro assessment. The TGA report states that, in its pool of adults with obesity or overweight, with and without type 2 diabetes, 6.07% of tirzepatide-treated participants (153 of the 2,519 in the pool) stopped study drug because of an adverse event against 3.44% on placebo (33 of 958), a group figure from trial participants and not a prediction for any person (TGA AusPAR, 20 September 2024).

Is tirzepatide safe?

Trials and labels give no yes-or-no verdict. The US labels carry a boxed warning and a list of serious risks. In the three-year SURMOUNT-1 analysis of 1,032 adults with obesity and prediabetes, a maker-funded subgroup analysis, the abstract states that no new safety signals were identified, a result limited to that group and follow-up (Jastreboff et al., NEJM, 2025).

Is tirzepatide harmful to the kidneys?

The labels warn of acute kidney injury, mostly after gut reactions cause dehydration. A 2025 meta-analysis of 20 randomised trials (15,905 adults with type 2 diabetes or obesity) found no significant difference in adverse renal events against control (risk ratio 1.22, 95% confidence interval 0.78 to 1.89), with short follow-up as a limit (Liu et al., 2025).

Does tirzepatide cause cancer?

The US Mounjaro label's boxed warning states that tirzepatide caused thyroid C-cell tumours in rats with no animal count in the warning and unknown human relevance; this rat finding does not establish a human result (US Mounjaro label, DailyMed, 2 September 2026). Ko et al.'s 2026 Annals of Internal Medicine review inventories 48 human placebo-controlled trials with 94,245 participants; its abstract names type 2 diabetes and overweight or obesity as clinical context but gives no trial-specific population breakdown, and the trials were too short and not designed to establish lifetime cancer risk.

Is long-term use of tirzepatide safe?

The longest obesity result cited here assessed 1,032 adults with obesity and prediabetes over 176 weeks in a maker-funded subgroup analysis, and the abstract states that no new safety signals were identified within that subgroup and 176-week follow-up (Jastreboff et al., NEJM, 2025). Trials cannot declare a medicine safe, and events that are very rare or slow to appear are not answered by the records cited here.

What are the side effects of tirzepatide in Australia?

In the TGA's assessment of Mounjaro, in its pooled SURMOUNT-1 and SURMOUNT-2 data (2,519 tirzepatide-treated and 958 placebo-treated adults with obesity or overweight, with and without type 2 diabetes), gut reactions were the most frequently reported events, and reactions at the site where the study drug was given occurred in 11.3% of tirzepatide-treated participants with treatment-emergent antibodies against 1.0% in those without, group figures whose antibody-subgroup sizes the cited passage does not give (TGA AusPAR, 20 September 2024). The report also notes a new risk of anaphylaxis from post-market data (TGA AusPAR, 20 September 2024). The TGA's safety update of 1 December 2025 also records a change to the product information on contraception.

Which is safer, Wegovy or Mounjaro?

SURMOUNT-5 was not designed to establish a safety ranking. In SURMOUNT-5, an open-label 72-week trial of 751 adults with obesity and no diabetes run by the maker of tirzepatide, serious adverse events were 4.8% on tirzepatide and 3.5% on semaglutide, nausea was 43.6% against 44.4%, and vomiting was 15.0% against 21.3%, in a trial that was not designed to rank the two on safety (ClinicalTrials.gov NCT05822830, read 14 October 2026).

What organ is Ozempic bad for?

The US Ozempic label names no single worst organ. It warns about the pancreas, gallbladder, kidneys (mostly with dehydration), eyes in people with diabetic retinopathy, and the thyroid (tumours in rodents; human risk unknown), and a warning does not prove the medicine caused each case (DailyMed, 10 June 2026).

What is the biggest side effect of semaglutide?

Nausea, at 44% on semaglutide (2,116 adults with obesity or overweight) against 16% on placebo (1,261) in the US Wegovy label's pool of three placebo-controlled trials, a group figure that does not predict any one person's experience (DailyMed, 30 June 2026). In the Wegovy human trial pool (2,116 adults with obesity or overweight on semaglutide and 1,261 on placebo), diarrhoea affected 30%, vomiting 24% and constipation 24%, group figures that do not predict any one person's experience (US Wegovy label, DailyMed, 30 June 2026).

How long have trials followed people on Ozempic?

The records reviewed here define no point after which it becomes safe or unsafe. The FLOW trial, funded by the maker of semaglutide, followed 3,533 adults with type 2 diabetes and chronic kidney disease for a median of 3.4 years, a result limited to that population (Perkovic et al., NEJM, 2024).

Citations

10 sources
  1. Jastreboff AM et al. New England Journal of Medicine. 2022;387(3):205-216.
    doi:10.1056/NEJMoa2206038

  2. Jastreboff AM et al. New England Journal of Medicine. 2025;392(10):958-971.
    doi:10.1056/NEJMoa2410819

  3. Aronne LJ et al. New England Journal of Medicine. 2025;393(1):26-36.
    doi:10.1056/NEJMoa2416394

  4. Frias JP et al. New England Journal of Medicine. 2021;385(6):503-515.
    doi:10.1056/NEJMoa2107519

  5. Nicholls SJ et al. New England Journal of Medicine. 2025;393(24):2409-2420.
    doi:10.1056/NEJMoa2505928

  6. Heerspink HJL et al. Lancet Diabetes & Endocrinology. 2022;10(11):774-785.
    doi:10.1016/S2213-8587(22)00243-1

  7. Liu et al. Diabetology & Metabolic Syndrome. 2025;18(1):12.
    doi:10.1186/s13098-025-02064-1

  8. Ko et al. Annals of Internal Medicine. 2026;179(2):216-229.
    doi:10.7326/ANNALS-25-02237

  9. Wilding JPH et al. New England Journal of Medicine. 2021;384(11):989-1002.
    doi:10.1056/NEJMoa2032183

  10. Perkovic V et al. New England Journal of Medicine. 2024;391(2):109-121.
    doi:10.1056/NEJMoa2403347

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