Where these figures come from
The most reliable published account of what these medications do to people is the FDA-approved prescribing information for the branded products, which reports what happened in their clinical trials against placebo. This guide reproduces that account for both semaglutide and tirzepatide: the common side effects with their frequencies, the serious warnings, why the labels say the effects happen, what the labels say a provider may do, and the symptoms the labels say need prompt attention.
Three things to hold in mind while reading. The figures describe Wegovy® and Zepbound® at their approved doses; personalized compounded semaglutide and tirzepatide, which Bodi Envi’s programs may include, are not FDA-approved, were not studied in these trials and are not equivalent to the approved products. The two labels report different trials with different designs and cannot be compared directly with each other; both say so. And this is general information and not medical advice. Your licensed provider is the person to ask about your own situation, and the person to tell when something is wrong.
The common side effects, semaglutide
The Wegovy® label reports adverse reactions from three placebo-controlled trials in which 2,116 adults with obesity or overweight took 2.4 mg weekly for up to 68 weeks and 1,261 took placebo. The reactions reported in at least 2 percent of the treated group and more often than with placebo, in the label’s order, are set out below.
| Reaction reported in the Wegovy® label | Wegovy® 2.4 mg | Placebo |
|---|---|---|
| Nausea | 44% | 16% |
| Diarrhea | 30% | 16% |
| Vomiting | 24% | 6% |
| Constipation | 24% | 11% |
| Abdominal pain | 20% | 10% |
| Headache | 14% | 10% |
| Fatigue | 11% | 5% |
| Dyspepsia | 9% | 3% |
| Dizziness | 8% | 4% |
| Abdominal distension | 7% | 5% |
| Eructation | 7% | under 1% |
| Hypoglycemia in patients with type 2 diabetes | 6% | 2% |
| Flatulence | 6% | 4% |
| Gastroenteritis | 6% | 4% |
| Gastroesophageal reflux disease | 5% | 3% |
| Gastritis | 4% | 1% |
| Viral gastroenteritis | 4% | 3% |
| Hair loss | 3% | 1% |
| Dysesthesia | 2% | 1% |
The label adds that 6.8 percent of treated patients and 3.2 percent on placebo permanently discontinued because of adverse reactions, and that the most common reasons were nausea, vomiting and diarrhea. Severe gastrointestinal adverse reactions were reported in 4.1 percent of treated patients against 0.9 percent on placebo. The label’s heart rate section reports mean increases in resting heart rate of one to four beats per minute compared with placebo. Brand name studies cannot be applied to personalized compounded versions of the medications; no studies have been completed on personalized compounded medications and they cannot be compared. Personalized compounded medication side effects may differ, so please refer to your prescribing provider for side effect information. This is educational only.
The common side effects, tirzepatide
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. Its table lists reactions in at least 2 percent of treated patients and more often than placebo, by dose.
| 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% |
The label reports 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, and that most did so in the first few months of treatment because of gastrointestinal reactions. Gastrointestinal adverse reactions of any kind occurred in 56 percent of treated patients at each dose against 30 percent on placebo, and severe ones in 1.7, 2.5 and 3.1 percent against 1 percent. The label states that the majority of nausea, vomiting and diarrhea events occurred during dose escalation and decreased over time. Brand name studies cannot be applied to personalized compounded versions of the medications; no studies have been completed on personalized compounded medications and they cannot be compared. Personalized compounded medication side effects may differ, so please refer to your prescribing provider for side effect information. This is educational only.
Why the labels say these effects happen
Both labels explain the gastrointestinal effects through the medication’s mechanism. GLP-1 slows the rate at which the stomach empties, and both labels state in their drug interaction sections that the medication delays gastric emptying. That slowing is part of how the medication produces fullness and it is also the direct cause of nausea, bloating, reflux and belching, and of the labels’ warnings about the absorption of oral medications.
Both labels also state that the escalation schedule exists to reduce the risk of gastrointestinal adverse reactions, which is the same point from the other direction: the body adapts to each level of the medication, and the label’s steps are spaced to allow it. A 2026 narrative review of adverse events with incretin-based therapies in Drug Design, Development and Therapy, found through PubMed, reached the same conclusion from sixty studies and safety reports: the common adverse events are predominantly gastrointestinal, they are the principal cause of discontinuation, and in the authors’ assessment they reflect predictable pharmacological effects rather than off-target toxicity, with tolerability improved by aligning dose escalation with the individual patient.
Some of the other common effects follow from the gastrointestinal ones. The labels link kidney injury to dehydration from nausea, vomiting and diarrhea. Fatigue, dizziness and hypotension can accompany reduced intake of food and fluid. Hair loss appears in both labels’ tables without an explanation.
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
Both labels open with a boxed warning and carry a list of warnings and precautions. Each is given here as the label states it.
Thyroid C-cell tumours. Both labels state that the medication caused thyroid C-cell tumours in rodents at clinically relevant exposures and that it is unknown whether it does so, including medullary thyroid carcinoma, in humans. Both are contraindicated in people with a personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2.
Acute pancreatitis. Both labels warn that pancreatitis has been reported and direct that the medication be discontinued if pancreatitis is suspected. The Zepbound® label reports acute pancreatitis confirmed by adjudication in 0.2 percent of treated and 0.2 percent of placebo patients in its weight reduction trials.
Acute gallbladder disease. The Wegovy® label reports gallstones in 1.6 percent of treated adults against 0.7 percent on placebo and cholecystitis in 0.6 percent against 0.2 percent. Both labels advise gallbladder studies and appropriate follow-up if gallbladder disease is suspected.
Hypoglycemia. Both labels warn that the risk of low blood sugar is increased when the medication is combined with insulin or an insulin secretagogue such as a sulfonylurea. The Zepbound® label reports hypoglycemia 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.
Acute kidney injury. Both labels report postmarketing cases of acute kidney injury, some requiring dialysis, most in patients who became dehydrated from gastrointestinal reactions, and advise monitoring kidney function in patients reporting reactions that could lead to dehydration, especially during initiation and escalation.
Severe gastrointestinal reactions. Both labels warn of these and state that the medication is not recommended in patients with severe gastroparesis. Both list ileus, intestinal obstruction and severe constipation among postmarketing reports.
Hypersensitivity. Both labels report serious reactions including anaphylaxis and angioedema, and a known serious hypersensitivity to the medication is a contraindication.
Diabetic retinopathy complications. Both labels warn of these in patients with type 2 diabetes and advise monitoring in patients with a history of retinopathy.
Pulmonary aspiration. Both labels warn that aspiration has occurred in patients on GLP-1 receptor agonists undergoing procedures under general anesthesia or deep sedation, and advise telling every healthcare provider about the medication before a procedure.
Heart rate. The Wegovy® label warns of an increase in resting heart rate and asks patients to tell their provider about palpitations or a racing heartbeat while at rest.
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 labels say a provider may do
The labels give a provider room to respond. The Wegovy® label says that if a patient does not tolerate a dose during escalation, a provider may consider delaying the next step by four weeks, and that treatment response and tolerability should guide the choice of maintenance dose. The Zepbound® label says that if a maintenance dose is not tolerated, a lower maintenance dose should be considered. Both say the medication should be stopped promptly if pancreatitis is suspected, and both direct that patients on insulin or a sulfonylurea may need those doses reduced when the medication is started.
With a compounded prescription, those are your provider’s decisions and they are the reason the care team exists. Do not change your own dose, skip doses to manage symptoms without asking, or stop the medication without telling your provider, except where the label directs stopping and seeking care, as in suspected pancreatitis or a serious allergic reaction.
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 labels support
The labels’ patient counselling sections and medication guides support a short list of practical steps. Drink fluids: both medication guides say that diarrhea, nausea and vomiting may cause dehydration that can lead to kidney problems and that it is important to drink fluids to reduce that chance. Report persistent gastrointestinal symptoms promptly, since the labels tie kidney injury to dehydration and ask patients to report persistent nausea, vomiting or diarrhea. Know that the escalation is gradual on purpose, and tell your provider rather than pushing through a step that is not tolerable. Tell every clinician who treats you, especially before any procedure under anesthesia, that you take the medication. And if you take an oral medication that depends on steady absorption, tell your provider, because both labels say delayed gastric emptying can affect it.
The nausea guide on this site goes further into what the label and the published literature support for the most common effect.
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 labels’ counselling sections name the symptoms that need prompt attention. Severe abdominal pain that does not go away, sometimes radiating to the back, with or without nausea or vomiting, which may signal pancreatitis: stop the medication and contact your provider. Symptoms of a serious allergic reaction, such as swelling of the face, lips, tongue or throat, trouble breathing or swallowing, severe rash, or fainting: stop the medication and get medical help right away. A lump or swelling in the neck, hoarseness, trouble swallowing or shortness of breath, which the labels list as possible symptoms of thyroid tumours. Nausea, vomiting or diarrhea that does not go away, because of the risk of dehydration and kidney injury. Pain in the upper abdomen, fever, yellowing of the skin or eyes, or clay-colored stools, which the labels list as symptoms of gallbladder problems. Changes in vision, for patients with type 2 diabetes. And the signs of low blood sugar, for anyone also taking insulin or a sulfonylurea.
For anything severe, seek emergency care first and tell your provider afterwards.
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 ongoing messaging with your care team through the patient portal, and side effects are the main reason it is there. Message your care team when a step is not tolerable, when a symptom is persistent, when you have missed doses because of symptoms, when you are unsure whether a symptom matters, or when a new medication or diagnosis changes your picture. A licensed provider, through Wasef Health, PC for applicable programs, makes the clinical decisions and can adjust your plan. 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 semaglutide and tirzepatide are not FDA-approved, the figures in this guide describe the branded products in their trials, and the FDA has noted that adverse events for compounded products are likely underreported. This is general information and not medical advice, and your licensed provider is the person to ask.