# Tirzepatide side effects per the Zepbound® label

Canonical page: https://bodienvi.com/blog/tirzepatide-side-effects

Published September 22, 2026. Updated September 22, 2026. By Bodi Envi Clinical Content Team.

The side effects the Zepbound® label reports for tirzepatide by dose, when they occur, why, what a provider may do and when to seek care.

## What this guide reports

Tirzepatide is the active ingredient in two FDA-approved products, Zepbound® for weight management and obstructive sleep apnea in adults with obesity, and Mounjaro® for type 2 diabetes. Their prescribing information is the FDA-approved record of what the medication did to people in its trials, and this guide reports that record: the common side effects with their frequencies by dose, when the label says they occur, the serious warnings, what the label says a provider may do, and the symptoms that need prompt attention. The Zepbound® label is the main source because its trials were in the population a weight management program serves.

This is general information and not medical advice. The figures describe Zepbound® at its approved doses. Personalized Compounded tirzepatide, which Bodi Envi's programs may include, is not FDA-approved, was not studied in these trials and is not equivalent to the approved products. Brand names are trademarks of their respective owners. Your licensed provider is the person to ask about your own situation and to tell when something is wrong.

Personalized compounded medications differ from commercially available brand-name products in formulation, concentration, excipients, preparation methods, and other characteristics. Accordingly, clinical data from studies involving brand-name products should not be assumed to apply to personalized compounded formulations.

At this time, the studies referenced above have not evaluated the specific personalized compounded formulations being provided. Therefore, no claims of equivalence in safety, efficacy, quality, or clinical outcomes should be inferred from these studies.

## The common side effects, by dose

The Zepbound® label reports adverse reactions from a pool of two placebo-controlled trials in which 2,519 adults with obesity or overweight took tirzepatide for up to 72 weeks; the mean age was 47, 37 percent were male, and a quarter had type 2 diabetes. The label lists the reactions that occurred in at least 2 percent of treated patients and more often than with placebo.

| Reaction reported in the Zepbound® label | 5 mg | 10 mg | 15 mg | Placebo |
| --- | --- | --- | --- | --- |
| Nausea | 25% | 29% | 28% | 8% |
| Diarrhea | 19% | 21% | 23% | 8% |
| Vomiting | 8% | 11% | 13% | 2% |
| Constipation | 17% | 14% | 11% | 5% |
| Abdominal pain | 9% | 9% | 10% | 5% |
| Dyspepsia | 9% | 9% | 10% | 4% |
| Injection site reactions | 6% | 8% | 8% | 2% |
| Fatigue | 5% | 6% | 7% | 3% |
| Hypersensitivity reactions | 5% | 5% | 5% | 3% |
| Eructation | 4% | 5% | 5% | 1% |
| Hair loss | 5% | 4% | 5% | 1% |
| Gastroesophageal reflux disease | 4% | 4% | 5% | 2% |
| Flatulence | 3% | 3% | 4% | 2% |
| Abdominal distension | 3% | 3% | 4% | 2% |
| Dizziness | 4% | 5% | 4% | 2% |
| Hypotension | 1% | 1% | 2% | 0% |

Two patterns are visible in the table. Nausea, vomiting and diarrhea rise modestly with dose, while constipation falls. And the difference from placebo is largest for the gastrointestinal effects and smallest for the rest. The label's summary is that gastrointestinal adverse reactions of any kind occurred in 56 percent of treated patients at each dose against 30 percent on placebo.

Personalized compounded medications differ from commercially available brand-name products in formulation, concentration, excipients, preparation methods, and other characteristics. Accordingly, clinical data from studies involving brand-name products should not be assumed to apply to personalized compounded formulations.

At this time, the studies referenced above have not evaluated the specific personalized compounded formulations being provided. Therefore, no claims of equivalence in safety, efficacy, quality, or clinical outcomes should be inferred from these studies.

## When they tend to occur

The label is specific about timing. It states that the majority of nausea, vomiting and diarrhea events occurred during dose escalation and decreased over time. It states that 4.8, 6.3 and 6.7 percent of patients on the three doses permanently discontinued because of adverse reactions against 3.4 percent on placebo, that most of those who discontinued did so during the first few months because of gastrointestinal reactions, and that discontinuation specifically for gastrointestinal reactions was 1.9, 3.3 and 4.3 percent against 0.5 percent.

SURMOUNT-1, the reference trial published in the New England Journal of Medicine in 2022, describes the same pattern in its abstract on PubMed: the most common adverse events were gastrointestinal, most were mild to moderate in severity, and they occurred primarily during dose escalation. That trial's escalation period was 20 weeks of its 72.

Personalized compounded medications differ from commercially available brand-name products in formulation, concentration, excipients, preparation methods, and other characteristics. Accordingly, clinical data from studies involving brand-name products should not be assumed to apply to personalized compounded formulations.

At this time, the studies referenced above have not evaluated the specific personalized compounded formulations being provided. Therefore, no claims of equivalence in safety, efficacy, quality, or clinical outcomes should be inferred from these studies.

## Why the label says they happen

The label explains the gastrointestinal effects through the mechanism. Tirzepatide activates the GIP and GLP-1 receptors, and the label states in its drug interaction section that it delays gastric emptying, which is the reason it can affect the absorption of oral medications and, the label notes, the reason it may reduce the effectiveness of oral contraceptives for a period after starting and after each dose increase. Delayed emptying is also the physiological source of nausea, fullness, bloating, reflux and belching. The label says the delay is largest after the first dose and diminishes over time, which matches its observation that the effects concentrate in escalation.

The label states that the escalation schedule, a starting dose of 2.5 mg for four weeks and then steps of 2.5 mg at intervals of at least four weeks, exists to reduce the risk of gastrointestinal adverse reactions, and that 2.5 mg is for initiation and is not approved as a maintenance dose.

Injection site reactions are the one common effect the label ties to something other than the gut. It reports them in 6 to 8 percent of treated patients and notes that they, and hypersensitivity reactions, were more frequent in patients who developed anti-tirzepatide antibodies.

Personalized compounded medications differ from commercially available brand-name products in formulation, concentration, excipients, preparation methods, and other characteristics. Accordingly, clinical data from studies involving brand-name products should not be assumed to apply to personalized compounded formulations.

At this time, the studies referenced above have not evaluated the specific personalized compounded formulations being provided. Therefore, no claims of equivalence in safety, efficacy, quality, or clinical outcomes should be inferred from these studies.

## The serious warnings

The Zepbound® and Mounjaro® labels carry the same boxed warning and the same warnings and precautions, and each is given here as the label states it.

Thyroid C-cell tumours. Tirzepatide caused dose and duration dependent thyroid C-cell tumours in rats at clinically relevant exposures, and it is unknown whether it causes them, including medullary thyroid carcinoma, in humans. The medication is contraindicated in people with a personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2.

Severe gastrointestinal reactions. Reported in 1.7, 2.5 and 3.1 percent of treated patients across the three doses against 1 percent on placebo. The medication is not recommended in patients with severe gastroparesis, and the label's postmarketing section lists ileus, intestinal obstruction and severe constipation including fecal impaction.

Acute kidney injury. Postmarketing reports, some requiring dialysis, mostly in patients who became dehydrated from nausea, vomiting or diarrhea, with monitoring advised especially during initiation and escalation.

Acute gallbladder disease and acute pancreatitis. The label warns of both, reports adjudicated acute pancreatitis in 0.2 percent of treated and 0.2 percent of placebo patients in its weight reduction trials, and directs that the medication be discontinued if pancreatitis is suspected.

Hypersensitivity. Serious reactions including anaphylaxis and angioedema have been reported, and a known serious hypersensitivity is a contraindication.

Hypoglycemia. The label reports low blood sugar in 4.2 percent of treated patients with type 2 diabetes against 1.3 percent on placebo, rising to 10.3 percent in those also taking a sulfonylurea, and advises considering a reduced dose of insulin or a sulfonylurea when starting.

Diabetic retinopathy complications, in patients with type 2 diabetes and a history of retinopathy, and pulmonary aspiration during general anesthesia or deep sedation, complete the list, along with a direction never to share a multi-dose pen between patients.

Personalized compounded medications differ from commercially available brand-name products in formulation, concentration, excipients, preparation methods, and other characteristics. Accordingly, clinical data from studies involving brand-name products should not be assumed to apply to personalized compounded formulations.

At this time, the studies referenced above have not evaluated the specific personalized compounded formulations being provided. Therefore, no claims of equivalence in safety, efficacy, quality, or clinical outcomes should be inferred from these studies.

## What the label says a provider may do

The label gives a provider three explicit levers. Escalation proceeds only after at least four weeks on the current dose, so a provider can hold a dose longer. If a maintenance dose is not tolerated, the label says to consider a lower maintenance dose. And the medication is stopped if pancreatitis is suspected, and for a serious hypersensitivity reaction. The label also says to consider treatment response and tolerability when selecting the maintenance dose, which makes tolerability a stated part of the decision rather than something to endure.

With a compounded prescription those decisions are your provider's. Personalized Compounded tirzepatide is typically measured from a vial with a syringe, and the FDA's statement on unapproved GLP-1 drugs, dated September 1, 2026, reports adverse events in patients given doses beyond what the approved label describes and asks providers to be vigilant about dosing and titration. Do not adjust your own dose to manage a side effect; message your care team.

Personalized compounded medications differ from commercially available brand-name products in formulation, concentration, excipients, preparation methods, and other characteristics. Accordingly, clinical data from studies involving brand-name products should not be assumed to apply to personalized compounded formulations.

At this time, the studies referenced above have not evaluated the specific personalized compounded formulations being provided. Therefore, no claims of equivalence in safety, efficacy, quality, or clinical outcomes should be inferred from these studies.

## Practical steps the label supports

The label's medication guide supports a short list. Drink fluids, because diarrhea, nausea and vomiting may cause dehydration that can lead to kidney problems, and tell your provider right away about nausea, vomiting or diarrhea that does not go away. Rotate injection sites between the abdomen, thigh and upper arm, as the label's administration instructions describe, and use a new needle for each injection. Tell every clinician who treats you that you take the medication, especially before any procedure under anesthesia. If you use oral hormonal contraceptives, the label advises switching to a non-oral method or adding a barrier method for four weeks after starting and after each dose increase. And if you take a medication that depends on steady absorption, tell your provider.

Personalized compounded medications differ from commercially available brand-name products in formulation, concentration, excipients, preparation methods, and other characteristics. Accordingly, clinical data from studies involving brand-name products should not be assumed to apply to personalized compounded formulations.

At this time, the studies referenced above have not evaluated the specific personalized compounded formulations being provided. Therefore, no claims of equivalence in safety, efficacy, quality, or clinical outcomes should be inferred from these studies.

## When to contact your provider or seek care

The label's counselling section names the symptoms that need prompt attention. Severe abdominal pain that does not go away, with or without nausea or vomiting, possibly felt through to the back: stop the medication and contact your provider, since this may signal pancreatitis. Symptoms of a serious allergic reaction, such as swelling of the face, lips, tongue or throat, trouble breathing or swallowing, severe rash or itching, fainting or a very rapid heartbeat: stop the medication and get medical help right away. A lump or swelling in the neck, hoarseness, trouble swallowing or shortness of breath. Nausea, vomiting or diarrhea that does not go away. Pain in the upper abdomen, fever, yellowing of the skin or eyes, or clay-colored stools. Changes in vision, for patients with type 2 diabetes. And the signs of low blood sugar for anyone also on insulin or a sulfonylurea. Seek emergency care first for anything severe.

Personalized compounded medications differ from commercially available brand-name products in formulation, concentration, excipients, preparation methods, and other characteristics. Accordingly, clinical data from studies involving brand-name products should not be assumed to apply to personalized compounded formulations.

At this time, the studies referenced above have not evaluated the specific personalized compounded formulations being provided. Therefore, no claims of equivalence in safety, efficacy, quality, or clinical outcomes should be inferred from these studies.

## What the care team messaging is for

Bodi Envi's programs include messaging with your care team through the patient portal, and side effects are exactly what it is for: a step that is not tolerable, a symptom that persists, missed doses because of symptoms, uncertainty about whether something matters, or a change in your medications or health. A licensed provider, through Wasef Health, PC for applicable programs, makes the clinical decisions. The FDA also asks patients and providers to report adverse events with any medication, including compounded ones, to its MedWatch program.

Bodi Envi is a telehealth platform and not a medical practice, pharmacy or medication manufacturer. Personalized Compounded tirzepatide is not FDA-approved and is not equivalent to Zepbound® or Mounjaro®; the figures here describe the branded product in its trials. This is general information and not medical advice, and your licensed provider is the person to ask.

## Frequently asked questions

### What are the most common side effects of tirzepatide?

Per the Zepbound® label, gastrointestinal ones. Across its 5 mg, 10 mg and 15 mg doses it reports nausea in 25 to 29 percent of patients against 8 percent on placebo, diarrhea in 19 to 23 percent, constipation in 11 to 17 percent, vomiting in 8 to 13 percent, and abdominal pain and dyspepsia in 9 to 10 percent each. Personalized compounded medications differ from commercially available brand-name products in formulation, concentration, excipients, preparation methods, and other characteristics. Accordingly, clinical data from studies involving brand-name products should not be assumed to apply to personalized compounded formulations. At this time, the studies referenced above have not evaluated the specific personalized compounded formulations being provided. Therefore, no claims of equivalence in safety, efficacy, quality, or clinical outcomes should be inferred from these studies.

### When do they happen?

The Zepbound® label states that the majority of nausea, vomiting and diarrhea events occurred during dose escalation and decreased over time, and that most patients who discontinued because of adverse reactions did so in the first few months. Personalized compounded medications differ from commercially available brand-name products in formulation, concentration, excipients, preparation methods, and other characteristics. Accordingly, clinical data from studies involving brand-name products should not be assumed to apply to personalized compounded formulations. At this time, the studies referenced above have not evaluated the specific personalized compounded formulations being provided. Therefore, no claims of equivalence in safety, efficacy, quality, or clinical outcomes should be inferred from these studies.

### Do side effects get worse at higher doses?

The label's figures rise with dose for some effects and not for others. Nausea was 25, 29 and 28 percent across 5, 10 and 15 mg, vomiting 8, 11 and 13 percent, and constipation 17, 14 and 11 percent. Discontinuation because of adverse reactions was 4.8, 6.3 and 6.7 percent against 3.4 percent on placebo. Personalized compounded medications differ from commercially available brand-name products in formulation, concentration, excipients, preparation methods, and other characteristics. Accordingly, clinical data from studies involving brand-name products should not be assumed to apply to personalized compounded formulations. At this time, the studies referenced above have not evaluated the specific personalized compounded formulations being provided. Therefore, no claims of equivalence in safety, efficacy, quality, or clinical outcomes should be inferred from these studies.

### Are injection site reactions common?

The Zepbound® label reports injection site reactions in 6 to 8 percent of treated patients against 2 percent on placebo, and notes they were more frequent in patients who developed antibodies to tirzepatide. Personalized Compounded tirzepatide is typically injected from a vial with a syringe, and the pharmacy's instructions on technique apply. Personalized compounded medications differ from commercially available brand-name products in formulation, concentration, excipients, preparation methods, and other characteristics. Accordingly, clinical data from studies involving brand-name products should not be assumed to apply to personalized compounded formulations. At this time, the studies referenced above have not evaluated the specific personalized compounded formulations being provided. Therefore, no claims of equivalence in safety, efficacy, quality, or clinical outcomes should be inferred from these studies.

### What can a provider do?

The Zepbound® label says to consider a lower maintenance dose if one is not tolerated, allows escalation to proceed only after at least four weeks on a dose, and directs that the medication be discontinued if pancreatitis is suspected. With a compounded prescription, your provider makes those decisions. Personalized compounded medications differ from commercially available brand-name products in formulation, concentration, excipients, preparation methods, and other characteristics. Accordingly, clinical data from studies involving brand-name products should not be assumed to apply to personalized compounded formulations. At this time, the studies referenced above have not evaluated the specific personalized compounded formulations being provided. Therefore, no claims of equivalence in safety, efficacy, quality, or clinical outcomes should be inferred from these studies.

### Which symptoms need urgent care?

The label's counselling section names severe abdominal pain that may radiate to the back, symptoms of a serious allergic reaction, a lump or swelling in the neck, persistent nausea, vomiting or diarrhea, and symptoms of gallbladder disease. Seek emergency care for anything severe. Personalized compounded medications differ from commercially available brand-name products in formulation, concentration, excipients, preparation methods, and other characteristics. Accordingly, clinical data from studies involving brand-name products should not be assumed to apply to personalized compounded formulations. At this time, the studies referenced above have not evaluated the specific personalized compounded formulations being provided. Therefore, no claims of equivalence in safety, efficacy, quality, or clinical outcomes should be inferred from these studies.

## Sources

- Zepbound® (tirzepatide) injection prescribing information, DailyMed, revised August 2026: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=487cd7e7-434c-4925-99fa-aa80b1cc776b (checked September 2026)
- Mounjaro® (tirzepatide) injection prescribing information, DailyMed, revised August 2026: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d2d7da5d-ad07-4228-955f-cf7e355c8cc0 (checked September 2026)
- Jastreboff et al., Tirzepatide Once Weekly for the Treatment of Obesity (SURMOUNT-1), New England Journal of Medicine, 2022, PubMed: https://pubmed.ncbi.nlm.nih.gov/35658024/ (checked September 2026)
- FDA, FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss, dated September 1, 2026: https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss (checked September 2026)