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Tirzepatide side effects: what the Zepbound and Mounjaro labels report

One molecule, two labels. The side effects of tirzepatide by dose on Zepbound and Mounjaro, the warnings they share, and what's different about compounded versions.

Marisol Keane

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The short answer

Tirzepatide's most common side effects are digestive: nausea, diarrhea, vomiting and constipation. On Zepbound, nausea affected 25–29% against 8% on placebo; on Mounjaro, 12–18% against 4%. Both labels say these mostly happen while the dose is being raised and then decrease. Rarer serious risks include pancreatitis, gallbladder disease and kidney injury from dehydration.

Key takeaways

  • On Zepbound, 56% of people had a digestive side effect at every dose, against 30% on placebo; 4.8–6.7% stopped because of side effects, against 3.4%.
  • On Mounjaro, digestive side effects reached 37.1%, 39.6% and 43.6% at 5, 10 and 15 mg, against 20.4% on placebo.
  • Injection-site reactions (including bruising), fatigue, allergic-type reactions, burping, hair loss and reflux each reached 5% or more on Zepbound.
  • Both labels carry the same boxed warning about thyroid tumors in rodents and rule out people with a history of medullary thyroid cancer or MEN 2.
  • Both labels advise people on birth-control pills to switch or add a barrier method for 4 weeks after starting and after each dose increase.

Tirzepatide is one drug sold under two names, and the side-effect numbers you see depend on which label they came from. Zepbound's trials enrolled people with obesity or overweight, mostly without diabetes. Mounjaro's enrolled people with type 2 diabetes. The figures below come from both current US labels, dated August 2026 [1] [2]. For the molecule itself, see our tirzepatide guide.

Tirzepatide is sold as Zepbound and Mounjaro, and their trials enrolled different people

  • Zepbound treats weight long term in adults with obesity, or overweight plus a weight-related condition, and treats moderate to severe obstructive sleep apnea in adults with obesity [1]. See our Zepbound guide.
  • Mounjaro improves blood sugar in adults and children 10 and older with type 2 diabetes, and since August 2026 lowers the risk of heart attack, stroke and heart-related death in adults with type 2 diabetes at high risk [2]. See our Mounjaro guide.

Both labels start at 2.5 mg once a week and allow up to 15 mg. Your prescriber decides the dose steps in between. The populations differ in ways that move the numbers, so read each label's rates against its own placebo group.

Digestive effects lead both lists, and they're more frequent in the weight trials

Tirzepatide side effects by label, across the 5, 10 and 15 mg doses (% of people)
Side effectZepbound placeboZepbound 5–15 mgMounjaro placeboMounjaro 5–15 mg
Nausea825–29412–18
Diarrhea819–23912–17
Vomiting28–1325–9
Constipation511–1716–7
Abdominal pain59–1045–6
Indigestion (dyspepsia)49–1035–8
Decreased appetitenot in tablenot in table15–11
Injection-site reactions (incl. bruising on Zepbound)26–80.43.2 (pooled)
Fatigue35–7not in tablenot in table
Allergic-type (hypersensitivity) reactions351.73.2 (pooled)
Burping (eructation)14–50.42.5–3.3
Hair loss14–5not in tablepostmarketing
Heartburn and reflux (GERD)24–50.41.7–2.5
Gas (flatulence)23–401.3–2.9
Bloating (abdominal distension)23–40.40.4–2.9
Dizziness24–5not in tablenot in table
Low blood pressure01–2not in tablenot in table

Zepbound Table 1 (Studies 1 and 2, up to 72 weeks) and Mounjaro Table 1 and §6.1 (SURPASS-1 and -5), DailyMed version 40 for each, August 2026. Ranges run across the 5, 10 and 15 mg arms. "Not in table" means that label's table doesn't report it. Different populations; not a head-to-head comparison.

Any digestive side effect, highest dose vs placebo
Zepbound placebo
30%[1]
Zepbound 15 mg
56%[1]
Mounjaro placebo
20.4%[2]
Mounjaro 15 mg
43.6%[2]

Stopping for side effects follows the same split. On Zepbound, 4.8%, 6.3% and 6.7% stopped at 5, 10 and 15 mg, against 3.4% on placebo; for digestive reasons alone, 1.9% to 4.3% against 0.5% [1]. On Mounjaro, 3.0% to 6.6% stopped for digestive reasons, against 0.4% [2]. For Zepbound's bowel effects in detail, see does Zepbound cause constipation?

Both labels say most nausea, vomiting and diarrhea came while the dose was rising

The majority of nausea, vomiting, and/or diarrhea events occurred during dose escalation and decreased over time.[1]

Mounjaro's label uses almost the same words [2]. Zepbound's adds when people tended to quit: "The majority of patients who discontinued ZEPBOUND due to adverse reactions did so during the first few months of treatment due to gastrointestinal adverse reactions" [1]. Neither label gives a number of days. The week-by-week picture for Zepbound is in Zepbound side effects.

Hair loss, low blood pressure, dry mouth and taste changes are on the Zepbound label at lower rates

  • Hair loss: 7.1% of women and 0.5% of men on Zepbound, against 1.3% and 0% on placebo. The label links it to weight reduction, and no one on Zepbound stopped because of it.
  • Low blood pressure: 1.6% against 0.1%, more often in people on blood pressure medicine (2.2%) and sometimes with dehydration.
  • Faster heart rate: an average rise of 1 to 3 beats per minute on Zepbound, and 2 to 4 on Mounjaro.
  • Dry mouth or throat: 1% against 0.1%.
  • Taste changes (dysgeusia): 0.4% against 0%.
  • Low blood sugar: 4.2% against 1.3% in Zepbound's diabetes trial, and 10.3% in people also taking a sulfonylurea.

All from the Zepbound label [1], except Mounjaro's heart-rate figure [2]. One thing people ask about isn't on either label: feeling cold. Neither label mentions cold or chills. For peeing more and dry mouth on Mounjaro, see does Mounjaro make you pee more?

The Warnings sections of both labels match closely

Serious risks on both tirzepatide labels
RiskRate (label, which trials)Signs the label listsZepbound § / Mounjaro §
Thyroid C-cell tumorsSeen in rats; unknown in peopleLump in the neck, trouble swallowing, shortness of breath, hoarsenessBoxed, 5.1 / Boxed, 5.1
Acute pancreatitis0.23 vs 0.11 patients per 100 years (diabetes trials); 0.14 vs 0.15 (Zepbound weight trials)Persistent or severe belly pain, sometimes into the back5.5 / 5.2
Gallbladder inflammation (cholecystitis)0.7% vs 0.2% (Zepbound); gallbladder disease 0.6% vs 0% (Mounjaro)Upper belly pain, fever, yellow skin or eyes, clay-colored stools5.4 / 5.8
Kidney injury from dehydration0.5% vs 0.2% (Zepbound)Follows vomiting, diarrhea or nausea that won't stop5.3 / 5.5
Severe digestive reactions1.7–3.1% vs 1% (Zepbound)Stomach problems that are severe or won't go away5.2 / 5.6
Allergic reactionsImmediate reactions 2.1% vs 0.4%; severe 0.1% vs 0% (Zepbound)Swelling of face or throat, trouble breathing, severe rash5.6 / 5.4
Low blood sugar with insulin or a sulfonylurea10.3% with a sulfonylurea (Zepbound diabetes trial)Shakiness, sweating, confusion, fast heartbeat5.7 / 5.3
Eye complications in diabetesTemporary worsening with rapid blood sugar improvementChanges in vision5.8 / 5.7
Food in the lungs under anesthesiaRare postmarketing reportsTell the surgical team you take it5.9 / 5.9

Zepbound and Mounjaro prescribing information, DailyMed version 40, August 2026. Both labels also say tirzepatide is not recommended for people with severe gastroparesis.

After approval, both labels add reports of hemorrhagic or necrotizing pancreatitis (sometimes fatal), ileus, intestinal obstruction, severe constipation including fecal impaction, anaphylaxis, angioedema, and acute kidney failure, sometimes needing dialysis [1] [2]. These come from voluntary reports, so their frequency is unknown. Whether Mounjaro suits someone with diabetes is covered in is Mounjaro safe?

In Mounjaro's heart-outcomes trial, side effects were similar to earlier trials, with some higher rates

SURPASS-CVOT compared Mounjaro (up to 15 mg) with dulaglutide, another GLP-1 drug, in 13,299 adults with type 2 diabetes and heart disease, over a median of about four years. Heart attack, stroke or heart-related death occurred in 12.1% on Mounjaro against 13.0% on dulaglutide (hazard ratio 0.92). That showed Mounjaro was not worse; it didn't prove it was better [2].

Side effects in that trial were similar to the earlier ones, with a few exceptions the label names: decreased appetite (17%), constipation (13%), vomiting (12%), abdominal pain (10%), fatigue (10%) and skin-sensation changes (0.7%) [2].

Tirzepatide can make birth-control pills less reliable for a few weeks at a time

Advise patients using oral hormonal contraceptives to switch to a non-oral contraceptive method, or add a barrier method of contraception for 4 weeks after initiation with ZEPBOUND and for 4 weeks after each dose escalation.[1]

Mounjaro's label says the same. The reason is slower stomach emptying, which the Zepbound label says is largest after the first dose and fades over time. Birth control that isn't taken by mouth isn't affected [1] [2].

On pregnancy, the labels differ because the uses differ. Zepbound's says weight loss "offers no benefit to a pregnant patient and may cause fetal harm" and to stop Zepbound when a pregnancy is recognized. Mounjaro's says human data are insufficient, animal studies showed reduced fetal growth, and poorly controlled diabetes in pregnancy carries its own risks [1] [2]. Plan this with your prescriber.

Compounded tirzepatide carries the label's drug risks, plus quality risks the brands don't

Compounded tirzepatide is not FDA-approved, and FDA does not review its safety, effectiveness or quality before it is sold [3]. The molecule's side effects above still apply. On top of them sit questions about what is in the vial.

Brand vs compounded tirzepatide: what's known about safety
QuestionZepbound or MounjaroCompounded tirzepatide
Reviewed by FDA before sale?Yes, approved with labelsNo; not FDA-approved
Adverse-event reportsCollected through the labels' reporting linesMore than 730 reports to FDA as of May 31, 2026, likely underreported
Product quality evidenceManufactured under FDA approvalA 2026 lab study by Eli Lilly scientists found a new impurity in tirzepatide plus vitamin B12 products; clinical effects unknown

FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss; Jordan 2026 (all authors employed by Eli Lilly, which makes Zepbound and Mounjaro).

FDA notes it is "likely that adverse events from compounded versions of these drugs are underreported" [3]. The impurity study tested tirzepatide combined with B12 analogs bought on the US market; its authors, all Lilly employees, say the impurity's clinical effects are unknown [4]. For more, see is compounded tirzepatide safe?, our compounded tirzepatide guide and the starting dose of compounded tirzepatide. For how semaglutide compares, see Wegovy side effects.

See how the 88 compounded tirzepatide providers we score compare on monthly cost and care.

Providers that offer Tirzepatide

  • SnagRxPartner

    You want compounded semaglutide or tirzepatide at one flat price for every dose, with the pharmacies named, and you're happy to pay month to month or commit to a longer plan up front.

    SnagRx review →
  • EdenPartner

    You want a compounded GLP-1 at one flat price that won't rise with your dose, with labs and round-the-clock messaging included and no membership.

    Eden review →
  • EmbodyPartner

    You're sure you want a compounded GLP-1, you like a price that holds at every dose, and you want the pharmacies and the doctor network named before you start.

    Embody review →
  • altRx

    You want compounded semaglutide or tirzepatide at one flat monthly price that doesn't rise with your dose, and you're settled enough on treatment that a no-refund policy won't bite.

    altRx review →
  • Pepti

    You want to see every dose's price before you commit, like a named pharmacy, and are comfortable with an online-only physician review and 28-day billing.

    Pepti review →

See all 88 providers on the compounded tirzepatide lineup →

Frequently asked

What is the most common side effect of tirzepatide?
Nausea. It affected 25–29% of people on Zepbound (8% on placebo) and 12–18% on Mounjaro (4% on placebo). Diarrhea comes a close second on both labels.
Does tirzepatide cause hair loss?
It can. Hair loss was reported by 4–5% of people on Zepbound against 1% on placebo, and by 7.1% of women. The label links it to weight reduction. Mounjaro lists it among reports after approval.
Is being cold a side effect of tirzepatide?
Neither the Zepbound nor the Mounjaro label lists feeling cold or chills. If you feel cold all the time, mention it to your prescriber so they can look for another cause.
Are Mounjaro and Zepbound side effects the same?
The drug and the warnings are the same. The rates differ because the trials enrolled different people: Zepbound's weight trials reported more stomach side effects (56% vs 30% on placebo) than Mounjaro's diabetes trials (37–44% vs 20%).
Is compounded tirzepatide riskier?
It carries the same drug risks plus quality risks, because it is not FDA-approved and FDA doesn't check its safety, effectiveness or quality before it's sold. FDA had more than 730 adverse-event reports for compounded tirzepatide by May 31, 2026.

Sources

  1. [1] ZEPBOUND (tirzepatide) injection, prescribing information (DailyMed, version 40, August 2026) (2026). DailyMed label
  2. [2] MOUNJARO (tirzepatide) injection, prescribing information (DailyMed, version 40, August 2026) (2026). DailyMed label
  3. [3] FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss (content current as of October 1, 2026) (2026). FDA
  4. [4] Jordan B. A novel, widespread impurity in mass-compounded tirzepatide/B12 products: potential patient safety implications (2026). PMID 42010938

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