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Tirzepatide Side Effects: What the Zepbound Label and Trials Recorded

Stomach and bowel effects affected more than half of people in the Zepbound weight trials. Rarer serious events, such as gallbladder inflammation, pancreatitis and kidney injury, each ran under 1%.

Article type
Safety
Evidence on Tirzepatide for weight
Large trials1 randomized trial of 1,000 or more people cited here for weight.
Sources
4
Reading
7 min
By Leah GarnerPublished

Tirzepatide's side effects are well documented, because the Zepbound label pools two placebo-controlled trials in which 2,519 adults took it for up to 72 weeks. [1] Placebo groups are what make that record useful. Many people feel queasy or tired on any given week, and only the gap over placebo belongs to the drug.

How the dose climbs, and why the early weeks are the roughest, is covered in tirzepatide dosage. This page sets out what was recorded, from the common to the rare.

The common side effects, by dose

The label lists every reaction that occurred in at least 2% of people on tirzepatide and more often than on placebo [1]. The trials enrolled adults with obesity or overweight, and 25% of them also had type 2 diabetes.

Adverse reactions in the Zepbound weight trials, percent of people, by weekly dose
Side effectPlacebo5 mg10 mg15 mg
Nausea8%25%29%28%
Diarrhea8%19%21%23%
Vomiting2%8%11%13%
Constipation5%17%14%11%
Abdominal pain5%9%9%10%
Indigestion (dyspepsia)4%9%9%10%
Injection-site reactions2%6%8%8%
Fatigue3%5%6%7%
Hypersensitivity reactions3%5%5%5%
Burping1%4%5%5%
Hair loss1%5%4%5%
Acid reflux2%4%4%5%
Dizziness2%4%5%4%
Adverse reactions in the Zepbound weight trials, percent of people, by weekly dose Zepbound prescribing information, Table 1 (Studies 1 and 2 pooled; placebo n=958, 5 mg n=630, 10 mg n=948, 15 mg n=941). Flatulence, bloating and low blood pressure also appear in the table at 1% to 4%.

Two patterns stand out. Constipation was most common on the lowest dose, 17% on 5 mg against 11% on 15 mg. Most other stomach effects rose with dose, though the steps between 10 mg and 15 mg were small.

Stomach and bowel effects

Taken together, stomach and bowel reactions affected 56% of people on each of the three doses, against 30% on placebo [1]. Treatment was stopped for these reactions by 1.9%, 3.3% and 4.3% on 5, 10 and 15 mg, and by 0.5% on placebo.

The label notes that most nausea, vomiting and diarrhea occurred during dose escalation and eased over time. A pooled look at SURMOUNT-1 to 4 adds a practical detail [3]. When people needed medicine for diarrhea or nausea, they most often started it during those escalation weeks.

The label also warns of severe reactions. It does not recommend tirzepatide for people with severe gastroparesis, a condition in which the stomach empties very slowly [1].

Hair loss, injection sites and allergic reactions

Hair loss in the trials was tied to weight reduction and was far more common in women [1]. On tirzepatide it was reported by 7.1% of women and 0.5% of men. No one on tirzepatide stopped treatment because of it.

Some people develop antibodies to tirzepatide, and they had more skin reactions. Injection-site reactions occurred in 11.3% of people with anti-tirzepatide antibodies, against 1% of those without them [1].

Immediate allergic-type reactions, within a day of a dose, occurred in 2.1% on tirzepatide and 0.4% on placebo. Most were rashes or itching. Anaphylaxis and angioedema have been reported since approval, and the label says to stop the drug and seek care if they occur.

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Less common but serious events

The label’s warnings section lists events that are uncommon but matter more when they occur [1]. The pooled weight trials put a number on several of them.

Less common adverse events in the pooled Zepbound weight trials
EventTirzepatidePlacebo
Gallbladder inflammation (cholecystitis)0.7%0.2%
Gallstones (cholelithiasis)1.1%1%
Gallbladder removal0.2%0%
Acute pancreatitis, confirmed by adjudication0.2%0.2%
Acute kidney injury0.5%0.2%
Low blood pressure1.6%0.1%
Less common adverse events in the pooled Zepbound weight trials Zepbound prescribing information, section 6.1 (Studies 1 and 2 pooled).

Pancreatitis looked different across programs. In the weight trials the rate matched placebo, but the sleep apnea trials recorded 0.84 cases per 100 years of exposure on tirzepatide and none on placebo [1]. The label says to stop tirzepatide if pancreatitis is suspected.

The label ties kidney injury to fluid loss from vomiting and diarrhea, and advises monitoring kidney function in people with those symptoms. Low blood pressure was more frequent in people already taking blood pressure medicine, 2.2% against 1.2%.

Low blood sugar is mainly a risk alongside insulin or sulfonylureas. In the trial of people with type 2 diabetes, glucose below 54 mg/dL was reported in 4.2% on tirzepatide and 1.3% on placebo. Heart rate rose by a mean of 1 to 3 beats per minute.

Reports since approval

Postmarketing reports come from voluntary reporting, so they show what can happen, not how often [1]. The label lists pancreatitis, including severe and fatal forms, and bowel obstruction. It also lists severe constipation, anaphylaxis, and kidney failure that sometimes required dialysis.

One risk surfaces around surgery. Aspiration of stomach contents under anesthesia or deep sedation has been reported with drugs in this class, so the label asks patients to tell their care team about planned procedures.

The label’s change log also records a removal. Suicidal behavior and ideation was dropped from the warnings section in February 2026 [1].

How often people stop

In SURMOUNT-1, the largest single trial, 2,539 adults without diabetes took tirzepatide or placebo for 72 weeks. [2] Most adverse events were stomach-related and mild to moderate, and they occurred mainly while the dose was being raised.

Across the label’s two pooled trials, adverse reactions ended treatment for 4.8%, 6.3% and 6.7% of people on 5, 10 and 15 mg, against 3.4% on placebo [1]. Most of those stops came in the first few months.

A 2025 meta-analysis of phase 1 to 3 trials found adverse events more likely on tirzepatide than placebo, with an odds ratio of 1.34 [4]. Serious adverse events did not differ, and stopping for side effects was more likely at higher doses.

What this means

The record is dominated by stomach and bowel effects that are common, dose-linked and mostly early. The serious events are uncommon, but the label names symptoms for each one, and those deserve a call to a prescriber.

Whether semaglutide carries a lighter burden is taken up in tirzepatide vs semaglutide. The wider question of how peptide safety depends on the compound and its source is in are peptides safe. Other options for weight sit on the weight goal page.

Frequently asked questions

What are the most common tirzepatide side effects?
Nausea, diarrhea, vomiting and constipation. In the Zepbound weight trials nausea affected 25% to 29% of people depending on dose, against 8% on placebo, and stomach or bowel effects overall affected 56% on each dose against 30% on placebo.
Does tirzepatide cause hair loss?
Hair loss was reported more often than on placebo, and the label ties it to weight reduction. It affected 7.1% of women and 0.5% of men on tirzepatide in the pooled trials, and no one on tirzepatide stopped treatment because of it.
Do tirzepatide side effects go away?
The label states that most nausea, vomiting and diarrhea occurred while the dose was being raised and decreased over time. Most people who stopped because of side effects did so in the first few months.
What serious side effects should I know about?
The label warns about gallbladder disease, pancreatitis, kidney injury from fluid loss, severe allergic reactions, low blood sugar with insulin or sulfonylureas, and aspiration during anesthesia. Its boxed warning covers thyroid C-cell tumors seen in rats, whose relevance to people is unknown.

Sources

4 cited
  1. 1Eli Lilly and Company (2026). ZEPBOUND (tirzepatide) injection, for subcutaneous use: prescribing information (revised 08/2026) DailyMed, U.S. National Library of Medicine. Source
  2. 2Jastreboff AM, Aronne LJ, Ahmad NN, Wharton S, Connery L, Alves B, et al. (2022). Tirzepatide Once Weekly for the Treatment of Obesity New England Journal of Medicine. PMID 35658024
  3. 3Rubino DM, Pedersen SD, Connery L, Cao D, Chigutsa F, Stefanski A, et al. (2025). Gastrointestinal tolerability and weight reduction associated with tirzepatide in adults with obesity or overweight with and without type 2 diabetes in the SURMOUNT-1 to -4 trials Diabetes, Obesity and Metabolism. PMID 39789843
  4. 4Tian Q, Song Y, Deng Y, Lin S (2025). Efficacy and safety of tirzepatide for weight loss in patients with obesity or type 2 diabetes: a systematic review and meta-analysis Frontiers in Endocrinology. PMID 40747302

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