Zepbound side effects
In Zepbound's FDA label (revised Aug 28, 2026), the most common side effects at 15 mg were nausea (28% vs 8% on placebo), diarrhea (23% vs 8%) and vomiting (13% vs 2%).
Source: FDA label on DailyMed (Eli Lilly and Company), revised , version 40. Read every day: a new FDA version updates this page by itself.
How often Zepbound side effects happened
Table 1: Adverse Reactions (≥2% and Greater than Placebo) in ZEPBOUND-Treated Adults with Obesity or Overweight in Weight Reduction and Long-term Maintenance Trials (Study 1 and Study 2)
| Side effect | Zepbound 15 mg | Placebo |
|---|---|---|
| Nausea | 28% | 8% |
| Diarrhea | 23% | 8% |
| Vomiting | 13% | 2% |
| Constipation | 11% | 5% |
| Abdominal pain | 10% | 5% |
| Indigestion | 10% | 4% |
| Injection site reactions | 8% | 2% |
| Fatigue | 7% | 3% |
| Burping | 5% | 1% |
| Reflux | 5% | 2% |
| Hair loss | 5% | 1% |
| Dizziness | 4% | 2% |
| Gas | 4% | 2% |
| Bloating | 4% | 2% |
People in the trial reporting each side effect, as FDA prints it. The placebo column is the rate among people given no medication, which is why a side effect can be common on both.
Boxed warning
- In rats, tirzepatide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures. It is unknown whether ZEPBOUND causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of tirzepatide-induced rodent thyroid C-cell tumors has not been determined [see Warnings and Precautions (5.1) and Nonclinical Toxicology (13.1)].
- ZEPBOUND is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) [see Contraindications (4)] . Counsel patients regarding the potential risk for MTC with the use of ZEPBOUND and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with ZEPBOUND [see Contraindications (4) and Warnings and Precautions (5.1)].
Source: Zepbound prescribing information (FDA label on DailyMed), revised 2026-08-28
What the label warns about
Section 5 of the label, word for word.
Risk of Thyroid C-Cell Tumors
In rats, tirzepatide caused a dose-dependent and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) in a 2-year study at clinically relevant plasma exposures [see Nonclinical Toxicology (13.1)] . It is unknown whether ZEPBOUND causes thyroid C-cell tumors, including MTC, in humans as human relevance of tirzepatide-induced rodent thyroid C-cell tumors has not been determined.
ZEPBOUND is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2. Counsel patients regarding the potential risk for MTC with the use of ZEPBOUND and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness).
Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with ZEPBOUND. Such monitoring may increase the risk of unnecessary procedures, due to the low test specificity for serum calcitonin and a high background incidence of thyroid disease. Significantly elevated serum calcitonin values may indicate MTC and patients with MTC usually have calcitonin values >50 ng/L. If serum calcitonin is measured and found to be elevated, the patient should be further evaluated. Patients with thyroid nodules noted on physical examination or neck imaging should also be further evaluated.
Source: Zepbound prescribing information (FDA label on DailyMed), revised 2026-08-28
Severe Gastrointestinal Adverse Reactions
Use of ZEPBOUND has been associated with gastrointestinal adverse reactions, sometimes severe [see Adverse Reactions (6)] . In a pool of two ZEPBOUND clinical trials for weight reduction (Studies 1 and 2), severe gastrointestinal adverse reactions were reported more frequently among patients receiving ZEPBOUND (5 mg 1.7%, 10 mg 2.5%, 15 mg 3.1%) than placebo (1%). Similar rates of severe gastrointestinal adverse reactions were observed in ZEPBOUND clinical trials for weight reduction and in ZEPBOUND clinical trials for OSA. Severe gastrointestinal adverse reactions have also been reported postmarketing with GLP-1 receptor agonists.
ZEPBOUND is not recommended in patients with severe gastroparesis.
Source: Zepbound prescribing information (FDA label on DailyMed), revised 2026-08-28
Acute Kidney Injury Due to Volume Depletion
There have been postmarketing reports of acute kidney injury, in some cases requiring hemodialysis, in patients treated with GLP-1 receptor agonists, or ZEPBOUND [see Adverse Reactions (6.2)] . The majority of the reported events occurred in patients who experienced gastrointestinal adverse reactions leading to dehydration such as nausea, vomiting, or diarrhea [see Adverse Reactions (6.1)] . Monitor renal function in patients reporting adverse reactions to ZEPBOUND that could lead to volume depletion, especially during dosage initiation and escalation of ZEPBOUND.
Source: Zepbound prescribing information (FDA label on DailyMed), revised 2026-08-28
Acute Gallbladder Disease
Treatment with ZEPBOUND and GLP-1 receptor agonists is associated with an increased occurrence of acute gallbladder disease.
In a pool of two ZEPBOUND clinical trials for weight reduction (Studies 1 and 2), cholelithiasis was reported in 1.1% of ZEPBOUND-treated patients and 1% of placebo-treated patients, cholecystitis was reported in 0.7% of ZEPBOUND-treated patients and 0.2% of placebo-treated patients, and cholecystectomy was reported in 0.2% of ZEPBOUND-treated patients and no placebo-treated patients. Acute gallbladder events were associated with weight reduction. Similar rates of cholelithiasis were reported in ZEPBOUND clinical trials for weight reduction and in ZEPBOUND trials for OSA. If cholecystitis is suspected, gallbladder diagnostic studies and appropriate clinical follow-up are indicated.
Source: Zepbound prescribing information (FDA label on DailyMed), revised 2026-08-28
Acute Pancreatitis
Acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with GLP-1 receptor agonists, or ZEPBOUND [see Adverse Reactions (6)] .
After initiation of ZEPBOUND, observe patients carefully for signs and symptoms of acute pancreatitis which may include persistent or severe abdominal pain (sometimes radiating to the back) and which may or may not be accompanied by nausea or vomiting. If pancreatitis is suspected, discontinue ZEPBOUND and initiate appropriate management.
Source: Zepbound prescribing information (FDA label on DailyMed), revised 2026-08-28
Hypersensitivity Reactions
There have been postmarketing reports of serious hypersensitivity reactions (e.g., anaphylaxis, angioedema) in patients treated with tirzepatide. In a pool of two ZEPBOUND clinical studies for weight reduction (Studies 1 and 2), 0.1% of ZEPBOUND-treated patients had severe hypersensitivity reactions compared to no placebo-treated patients. Similar rates of severe hypersensitivity reactions were observed in ZEPBOUND clinical trials for weight reduction and in ZEPBOUND trials for OSA. If hypersensitivity reactions occur, advise patients to promptly seek medical attention and discontinue use of ZEPBOUND. Do not use in patients with a previous serious hypersensitivity reaction to tirzepatide or any of the excipients in ZEPBOUND [see Contraindications (4) and Adverse Reactions (6.2)] .
Serious hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with GLP-1 receptor agonists. Use caution in patients with a history of angioedema or anaphylaxis with a GLP-1 receptor agonist because it is unknown whether such patients will be predisposed to these reactions with ZEPBOUND.
Source: Zepbound prescribing information (FDA label on DailyMed), revised 2026-08-28
Hypoglycemia
ZEPBOUND lowers blood glucose and can cause hypoglycemia.
In a trial of patients with type 2 diabetes mellitus and BMI ≥27 kg/m 2 (Study 2), hypoglycemia (plasma glucose <54 mg/dL) was reported in 4.2% of ZEPBOUND-treated patients versus 1.3% of placebo-treated patients. In this trial, patients taking ZEPBOUND in combination with an insulin secretagogue (e.g., sulfonylurea) had increased risk of hypoglycemia (10.3%) compared to ZEPBOUND-treated patients not taking a sulfonylurea (2.1%). There is also increased risk of hypoglycemia in patients treated with tirzepatide in combination with insulin [see Drug Interactions (7.1)] .
Hypoglycemia has also been associated with ZEPBOUND and GLP-1 receptor agonists in adults without type 2 diabetes mellitus [see Adverse Reactions (6.1)] .
Inform patients of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia. In patients with diabetes mellitus, monitor blood glucose prior to starting ZEPBOUND and during ZEPBOUND treatment. The risk of hypoglycemia may be lowered by a reduction in the dose of insulin or sulfonylurea (or other concomitantly administered insulin secretagogue).
Source: Zepbound prescribing information (FDA label on DailyMed), revised 2026-08-28
Diabetic Retinopathy Complications in Patients with Type 2 Diabetes Mellitus
Temporary worsening of diabetic retinopathy has been reported with rapid improvement in glucose control. Patients with a history of diabetic retinopathy should be monitored for progression of diabetic retinopathy.
Source: Zepbound prescribing information (FDA label on DailyMed), revised 2026-08-28
Pulmonary Aspiration During General Anesthesia or Deep Sedation
ZEPBOUND delays gastric emptying [see Clinical Pharmacology (12.2)] . There have been rare postmarketing reports of pulmonary aspiration in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures requiring general anesthesia or deep sedation who had residual gastric contents despite reported adherence to preoperative fasting recommendations.
Available data are insufficient to inform recommendations to mitigate the risk of pulmonary aspiration during general anesthesia or deep sedation in patients taking ZEPBOUND, including whether modifying preoperative fasting recommendations or temporarily discontinuing ZEPBOUND could reduce the incidence of retained gastric contents. Instruct patients to inform healthcare providers prior to any planned surgeries or procedures if they are taking ZEPBOUND.
Source: Zepbound prescribing information (FDA label on DailyMed), revised 2026-08-28
Never Share a ZEPBOUND KwikPen Between Patients
Never share ZEPBOUND KwikPen between patients, even if the pen needle is changed. Sharing poses a risk for transmission of blood-borne pathogens.
Source: Zepbound prescribing information (FDA label on DailyMed), revised 2026-08-28
Who should not take Zepbound
ZEPBOUND is contraindicated in patients with:
- A personal or family history of MTC or in patients with MEN 2 [see Warnings and Precautions (5.1)] .
- Known serious hypersensitivity to tirzepatide or any of the excipients in ZEPBOUND. Serious hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with tirzepatide [see Warnings and Precautions (5.6) and Adverse Reactions (6.2)] .
Source: Zepbound prescribing information (FDA label on DailyMed), revised 2026-08-28
Zepbound, pregnancy and breastfeeding
Pregnancy
Pregnancy Exposure Registry
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ZEPBOUND (tirzepatide) during pregnancy. Pregnant patients exposed to ZEPBOUND and healthcare providers are encouraged to register by calling 1-844-524-0039 or emailing at MILEregistry@thermofisher.com. To learn more please call or visit https://pregnancyregistry.lilly.com/zepbound.
Risk Summary
Weight loss offers no benefit to a pregnant patient and may cause fetal harm. Advise pregnant patients that weight loss is not recommended during pregnancy and to discontinue ZEPBOUND when a pregnancy is recognized (see Clinical Considerations) . Available data with tirzepatide in pregnant patients are insufficient to evaluate for a drug-related risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Based on animal reproduction studies, there may be risks to the fetus from exposure to tirzepatide during pregnancy.
In pregnant rats administered tirzepatide during organogenesis, fetal growth reductions and fetal abnormalities occurred at clinical exposure in maternal rats based on AUC. In rabbits administered tirzepatide during organogenesis, fetal growth reductions were observed at clinically relevant exposures based on AUC. These adverse embryo/fetal effects in animals coincided with pharmacological effects on maternal weight and food consumption (see Data) .
The estimated background risk of major birth defects and miscarriage for the indicated population is increased when compared to the general population. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
Clinical Considerations
Disease-Associated Maternal and/or Embryo/Fetal Risk
Appropriate weight gain based on pre-pregnancy weight is currently recommended for all pregnant patients, including those with obesity or overweight, due to the obligatory weight gain that occurs in maternal tissues during pregnancy.
Data
Animal Data
In pregnant rats given twice weekly subcutaneous doses of 0.02, 0.1, and 0.5 mg/kg tirzepatide [0.03-, 0.07-, and 0.5-fold the maximum recommended human dose (MRHD) of 15 mg once weekly based on AUC] during organogenesis, increased incidences of external, visceral, and skeletal malformations, increased incidences of visceral and skeletal developmental variations, and decreased fetal weights coincided with pharmacologically-mediated reductions in maternal body weights and food consumption at 0.5 mg/kg. In pregnant rabbits given once weekly subcutaneous doses of 0.01, 0.03, or 0.1 mg/kg tirzepatide (0.01-, 0.06-, and 0.2-fold the MRHD) during organogenesis, pharmacologically mediated effects on the gastrointestinal system resulting in maternal mortality or abortion in a few rabbits occurred at all dose levels. Reduced fetal weights associated with decreased maternal food consumption and body weights were observed at 0.1 mg/kg. In a pre- and post-natal study in rats administered subcutaneous doses of 0.02, 0.10, or 0.25 mg/kg tirzepatide twice weekly from implantation through lactation, F 1 pups from F 0 maternal rats given 0.25 mg/kg tirzepatide had statistically significant lower mean body weight when compared to controls from post-natal day 7 through post-natal day 126 for males and post-natal day 56 for females.
Source: Zepbound prescribing information (FDA label on DailyMed), revised 2026-08-28
Breastfeeding
Risk Summary
In a single-dose clinical lactation study, the concentration of tirzepatide in breast milk was found to be either undetectable or low compared to the maternal administered dose (see Data) . There are no available data on the effects of tirzepatide on the breastfed infant or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for ZEPBOUND and any potential adverse effects on the breastfed infant from ZEPBOUND or from the underlying maternal condition.
Data
Following subcutaneous administration of a single 5 mg dose to 11 healthy lactating adult females, the concentration of tirzepatide in breast milk was found to be undetectable (limit of detection in breast milk 4 ng/mL) in 164/171 samples assayed. The cumulative amount of tirzepatide detected in the remaining 7 breast milk samples over the 28-day sampling window was equivalent to less than 0.02% of the maternal administered dose, with the last measurable concentrations occurring 5 days post-dose. The AUC of tirzepatide in breast milk could not be calculated, due to insufficient quantifiable concentrations.
Source: Zepbound prescribing information (FDA label on DailyMed), revised 2026-08-28
What Zepbound interacts with
Concomitant Use with Insulin or an Insulin Secretagogue (e.g., Sulfonylurea)
ZEPBOUND lowers blood glucose. When initiating ZEPBOUND, consider reducing the dose of concomitantly administered insulin or insulin secretagogues (e.g., sulfonylureas) to reduce the risk of hypoglycemia [see Warnings and Precautions (5.7)] .
Oral Medications
ZEPBOUND delays gastric emptying and thereby has the potential to impact the absorption of concomitantly administered oral medications. Caution should be exercised when oral medications are concomitantly administered with ZEPBOUND.
Monitor patients on oral medications dependent on threshold concentrations for efficacy and those with a narrow therapeutic index (e.g., warfarin) when concomitantly administered with ZEPBOUND.
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. Hormonal contraceptives that are not administered orally should not be affected [see Use in Specific Populations (8.3) and Clinical Pharmacology (12.2, 12.3)] .
Source: Zepbound prescribing information (FDA label on DailyMed), revised 2026-08-28
All side-effect tables and trial data in the label
Everything the label reports under adverse reactions, in its own order.
The following serious adverse reactions are described below or elsewhere in the prescribing information:
- Risk of Thyroid C-cell Tumors [see Warnings and Precautions (5.1)]
- Severe Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.2)]
- Acute Kidney Injury Due to Volume Depletion [see Warnings and Precautions (5.3)]
- Acute Gallbladder Disease [see Warnings and Precautions (5.4)]
- Acute Pancreatitis [see Warnings and Precautions (5.5)]
- Hypersensitivity Reactions [see Warnings and Precautions (5.6)]
- Hypoglycemia [see Warnings and Precautions (5.7)]
- Diabetic Retinopathy Complications in Patients with Type 2 Diabetes Mellitus [see Warnings and Precautions (5.8)]
- Pulmonary Aspiration During General Anesthesia or Deep Sedation [see Warnings and Precautions (5.9)]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Adverse Reactions in Patients for Weight Reduction and Long-Term Maintenance
Pool of Placebo - Controlled Weight Reduction Trials in Adults with Obesity or Overweight, with or without Type 2 Diabetes (Study 1 and Study 2)
ZEPBOUND was evaluated for safety in a pool of two randomized, double-blind, placebo-controlled trials that included 2,519 adult patients with obesity or overweight treated with ZEPBOUND for up to 72 weeks and a 4-week off drug follow-up period (Study 1 and Study 2) [see Clinical Studies (14.1)] . The mean age of patients was 47 years and 37% were male. The population was 72% White, 12% Asian, 8% Black or African American, and 7% American Indian or Alaska Native; 51% identified as Hispanic or Latino ethnicity. Baseline characteristics included an average BMI of 37.4 kg/m 2 , 29% with a BMI ≥40 kg/m 2 , 41% with hypertension, 37% with dyslipidemia, 25% with type 2 diabetes mellitus, 7% with obstructive sleep apnea, and 4% with cardiovascular (CV) disease.
Across both trials, 4.8%, 6.3%, and 6.7% of patients treated with 5 mg, 10 mg, and 15 mg of ZEPBOUND, respectively, permanently discontinued treatment as a result of adverse reactions compared to 3.4% of patients treated with placebo. 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.
Common Adverse Reactions
Table 1 shows common adverse reactions associated with the use of ZEPBOUND in the pool of two placebo-controlled trials for weight reduction (Study 1 and Study 2). These adverse reactions occurred more commonly with ZEPBOUND than with placebo and occurred in at least 2% of patients treated with ZEPBOUND.
| Adverse Reaction | Placebo (N=958) % | ZEPBOUND 5 mg (N=630) % | ZEPBOUND 10 mg (N=948) % | ZEPBOUND 15 mg (N=941) % |
|---|---|---|---|---|
| Nausea | 8 | 25 | 29 | 28 |
| Diarrhea | 8 | 19 | 21 | 23 |
| Vomiting | 2 | 8 | 11 | 13 |
| Constipation | 5 | 17 | 14 | 11 |
| Abdominal Pain | 5 | 9 | 9 | 10 |
| Dyspepsia | 4 | 9 | 9 | 10 |
| Injection Site Reactions | 2 | 6 | 8 | 8 |
| Fatigue | 3 | 5 | 6 | 7 |
| Hypersensitivity Reactions | 3 | 5 | 5 | 5 |
| Eructation | 1 | 4 | 5 | 5 |
| Hair Loss | 1 | 5 | 4 | 5 |
| Gastroesophageal Reflux Disease | 2 | 4 | 4 | 5 |
| Flatulence | 2 | 3 | 3 | 4 |
| Abdominal Distension | 2 | 3 | 3 | 4 |
| Dizziness | 2 | 4 | 5 | 4 |
| Hypotension | 0 | 1 | 1 | 2 |
a Includes diarrhea, frequent bowel movements.
b Includes constipation, feces hard.
c Includes abdominal discomfort, abdominal pain, abdominal pain lower, abdominal pain upper, abdominal tenderness.
d Includes multiple related adverse event terms, such as injection site bruising, injection site erythema, injection site pruritus, injection site pain, injection site rash, injection site reaction.
e Includes asthenia, fatigue, lethargy, malaise.
f Includes blood pressure decreased, hypotension, orthostatic hypotension.
In a clinical trial for weight reduction that included an intensive lifestyle intervention lead-in period (Study 3), 287 patients were treated with ZEPBOUND for up to 72 weeks. In a randomized withdrawal trial (Study 4), 783 patients were treated with ZEPBOUND for up to 36 weeks, and 335 of these patients were treated for up to 88 weeks [see Clinical Studies (14.1)] . In Study 3, 10% of ZEPBOUND-treated patients and 2% of placebo-treated patients discontinued drug due to adverse reactions. In Study 4, 7% of patients discontinued ZEPBOUND treatment before randomized withdrawal at Week 36 due to adverse reactions. In Study 3 and Study 4, adverse reactions were similar to those reported in the two pooled ZEPBOUND clinical trials (Study 1 and Study 2).
Gastrointestinal Adverse Reactions
In a pool of Study 1 and 2, gastrointestinal adverse reactions occurred more frequently among patients receiving ZEPBOUND (5 mg 56%, 10 mg 56%, 15 mg 56%) than placebo (30%). More patients receiving ZEPBOUND 5 mg (1.9%), ZEPBOUND 10 mg (3.3%), and ZEPBOUND 15 mg (4.3%) discontinued treatment due to gastrointestinal adverse reactions than patients receiving placebo (0.5%). The majority of nausea, vomiting, and/or diarrhea events occurred during dose escalation and decreased over time.
Acute Pancreatitis
In clinical trials of tirzepatide for a different indication, 14 events of acute pancreatitis were confirmed by adjudication in 13 tirzepatide-treated patients (0.23 patients per 100 years of exposure) versus 3 events in 3 comparator-treated patients (0.11 patients per 100 years of exposure). In a pool of two ZEPBOUND clinical trials for weight reduction (Studies 1 and 2), 0.2% of ZEPBOUND-treated patients had acute pancreatitis confirmed by adjudication (0.14 patients per 100 years of exposure) versus 0.2% of placebo-treated patients (0.15 patients per 100 years of exposure). The exposure-adjusted incidence rate for treatment-emergent adjudication-confirmed pancreatitis in the pooled clinical studies for OSA (Studies 5 and 6) was 0.84 patients per 100 years for ZEPBOUND and 0 for placebo-treated patients.
Hypotension
In a pool of Study 1 and 2, hypotension occurred more frequently among patients taking ZEPBOUND (1.6%) than patients taking placebo (0.1%). Hypotension was more frequently seen in ZEPBOUND-treated patients on concomitant antihypertensive therapy (2.2%) compared to ZEPBOUND-treated patients not on antihypertensive therapy (1.2%). Hypotension also occurred in association with gastrointestinal adverse events and dehydration.
Hypersensitivity Reactions
In a pool of Study 1 and 2, immediate hypersensitivity reactions (within one day after drug administration) occurred in 2.1% of ZEPBOUND-treated patients compared to 0.4% of placebo-treated patients, while non-immediate hypersensitivity reactions occurred in 3.5% of ZEPBOUND-treated patients compared to 2.7% of placebo-treated patients. Among ZEPBOUND-treated patients, hypersensitivity reactions were more frequent in those with anti-tirzepatide antibodies (6.2%) compared to those who did not develop anti-tirzepatide antibodies (3%) [see Clinical Pharmacology (12.6)] . The majority of the hypersensitivity reactions in trials were skin reactions (e.g., rash, itching).
Injection Site Reactions
In ZEPBOUND-treated patients in a pool of Study 1 and 2, injection site reactions were more frequent in those with anti-tirzepatide antibodies (11.3%) compared to those who did not develop anti-tirzepatide antibodies (1%) [see Clinical Pharmacology (12.6)] .
Hair Loss
Hair loss adverse reactions in ZEPBOUND-treated patients were associated with weight reduction. In a pool of Study 1 and 2, hair loss was reported more frequently in female than male patients in the ZEPBOUND (7.1% female versus 0.5% male) and placebo (1.3% female versus 0% male) treatment groups. No ZEPBOUND-treated patients and one placebo-treated patient discontinued study treatment due to hair loss.
Other Adverse Reactions
Acute Kidney Injury
In a pool of Study 1 and 2, acute kidney injury was reported in 0.5% of ZEPBOUND-treated patients compared to 0.2% of placebo-treated patients.
Acute Gallbladder Disease
In a pool of Study 1 and 2, cholelithiasis was reported in 1.1% of ZEPBOUND-treated patients and 1% of placebo-treated patients, cholecystitis was reported in 0.7% of ZEPBOUND-treated patients and 0.2% of placebo-treated patients, and cholecystectomy was reported in 0.2% of ZEPBOUND-treated patients and no placebo-treated patients.
Hypoglycemia
In Study 2, a trial of patients with type 2 diabetes mellitus and BMI ≥27 kg/m 2 , hypoglycemia (plasma glucose <54 mg/dL) was reported in 4.2% of ZEPBOUND-treated patients versus 1.3% of placebo-treated patients.
In Study 1, a trial of ZEPBOUND in adults with obesity/overweight without type 2 diabetes mellitus, there was no systematic capturing of hypoglycemia, but plasma glucose <54 mg/dL was reported in 0.3% of ZEPBOUND-treated patients versus no placebo-treated patients.
Heart Rate Increase
In a pool of Study 1 and 2, treatment with ZEPBOUND resulted in a mean increase in heart rate of 1 to 3 beats per minute compared to no increase in placebo-treated patients.
Dysesthesia
In a pool of Study 1 and 2, dysesthesia occurred more frequently among patients receiving ZEPBOUND (5 mg 0.2%, 10 mg 0.2%, 15 mg 0.4%) than placebo (0.1%).
Dysgeusia
In a pool of Study 1 and 2, dysgeusia was reported by 0.4% of ZEPBOUND-treated patients and no placebo-treated patients.
Dry Mouth
In a pool of Study 1 and 2, dry mouth or dry throat was reported by 1% of ZEPBOUND-treated patients and 0.1% of placebo-treated patients.
Laboratory Abnormalities
Amylase and Lipase Increase
In a pool of Study 1 and 2, treatment with ZEPBOUND resulted in mean increases from baseline in serum pancreatic amylase concentrations of 20% to 25% and serum lipase concentrations of 28% to 35%, compared to mean increases from baseline in pancreatic amylase of 2.1% and serum lipase of 5.8% in placebo-treated patients. The clinical significance of elevations in amylase or lipase with ZEPBOUND is unknown in the absence of other signs and symptoms of pancreatitis.
Adverse Reactions in Patients with Obstructive Sleep Apnea
ZEPBOUND was evaluated in 2 randomized, double-blind, placebo-controlled trials (Study 5 and Study 6) that included a total of 467 adult patients with moderate to severe OSA and obesity [see Clinical Studies (14.2)] . Study 5 enrolled 234 patients who were unable or unwilling to use Positive Airway Pressure (PAP) therapy and Study 6 enrolled 235 patients who were on PAP therapy. The adverse reactions observed with ZEPBOUND 10 mg or 15 mg administered subcutaneously once weekly were similar to those reported in the two pooled placebo controlled clinical trials for weight reduction (Study 1 and Study 2).
Postmarketing Experience
The following adverse reactions have been reported during post-approval use of tirzepatide, the active ingredient in ZEPBOUND. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or to establish a causal relationship to drug exposure.
Gastrointestinal: acute pancreatitis, hemorrhagic and necrotizing pancreatitis sometimes resulting in death, ileus, intestinal obstruction, severe constipation including fecal impaction
Hypersensitivity: anaphylaxis, angioedema
Pulmonary: Pulmonary aspiration has occurred in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures requiring general anesthesia or deep sedation.
Renal: acute renal failure or worsening of chronic renal failure, sometimes requiring hemodialysis
Source: Zepbound prescribing information (FDA label on DailyMed), revised 2026-08-28
What changed for Tirzepatide
- RecallRecall: Tirzepatide/Niacinamide 2mL vial (40 MG per Vial) Inj 20mg/2mg/mL
- RecallRecall: TIRZEPATIDE/CYANOCOBALAMIN 26/2 MG/ML INJECTABLE, Packaged in single-use dosage…
- RecallRecall: TIRZEPATIDE 26 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL…
- RecallRecall: Tirzepatide Injection, 18mg/mL, 4 mL Sterile Multi-Dose Vial
- RecallRecall: TIRZEPATIDE/CYANOCOBALAMIN 85/2 MG/ML INJECTABLE, Packaged in single-use dosage…
- RecallRecall: TIRZEPATIDE/CYANOCOBALAMIN 76/2 MG/ML INJECTABLE, Packaged in single-use dosage…
Written from each source's own record as it changes. Every change on GLPcompare
What people have reported to FDA about Zepbound
80,835 reports name Zepbound, 5,835 of them marked serious, in FDA's file of Oct 28, 2026. Anyone can file a report and a report names every medicine the person took, so these counts cannot show that Zepbound caused a problem or how often it happens. For how often, use the trial rates above.
Symptoms reported most
- Nausea9,576
- Injection site pain5,130
- Diarrhea4,973
- Vomiting3,895
- Constipation3,740
- Fatigue2,973
- Redness at the injection site2,417
- Weight increased2,351
- Upper abdominal pain1,912
- Bleeding at the injection site1,906
- Hair loss (alopecia)1,893
- Headache1,828
Pen, dose and use problems reported most
- Incorrect dose administered14,733
- Drug ineffective5,552
- Extra dose administered5,025
- Accidental underdose2,606
- Therapeutic response changed2,261
- Product dose omission issue1,991
- Off label use1,885
- Intentional product misuse894
- Wrong technique in product usage process755
- Accidental overdose695
- Intercepted product selection error579
- Intercepted product dispensing error539
Counted through openFDA from FDA's Adverse Event Reporting System. One report can list several problems.
Zepbound side effects: common questions
What are the most common side effects of Zepbound?
In Zepbound's FDA label (revised Aug 28, 2026), the most common side effects at 15 mg were nausea (28% vs 8% on placebo), diarrhea (23% vs 8%) and vomiting (13% vs 2%). These come from FDA's table of placebo-controlled trials (Table 1: Adverse Reactions (≥2% and Greater than Placebo) in ZEPBOUND-Treated Adults with Obesity or Overweight in Weight Reduction and Long-term Maintenance Trials (Study 1 and Study 2)).
Does Zepbound cause hair loss?
In its FDA label, 5% of people taking Zepbound at 15 mg reported hair loss, against 1% on placebo.
Does Zepbound cause burping?
In its FDA label, 5% of people taking Zepbound at 15 mg reported burping, against 1% on placebo.
Does Zepbound cause acid reflux?
In its FDA label, 5% of people taking Zepbound at 15 mg reported acid reflux, against 2% on placebo.
Does Zepbound cause fatigue?
In its FDA label, 7% of people taking Zepbound at 15 mg reported fatigue, against 3% on placebo.
Does Zepbound cause dizziness?
In its FDA label, 4% of people taking Zepbound at 15 mg reported dizziness, against 2% on placebo.
Does Zepbound cause constipation?
In its FDA label, 11% of people taking Zepbound at 15 mg reported constipation, against 5% on placebo.
Does Zepbound cause gas?
In its FDA label, 4% of people taking Zepbound at 15 mg reported gas, against 2% on placebo.
What serious side effects does the Zepbound label warn about?
Its Warnings and Precautions section covers Risk of Thyroid C-Cell Tumors; Severe Gastrointestinal Adverse Reactions; Acute Kidney Injury Due to Volume Depletion; Acute Gallbladder Disease; Acute Pancreatitis; Hypersensitivity Reactions; Hypoglycemia; Diabetic Retinopathy Complications in Patients with Type 2 Diabetes Mellitus; Pulmonary Aspiration During General Anesthesia or Deep Sedation; and Never Share a ZEPBOUND KwikPen Between Patients.
Does Zepbound have a boxed warning?
Yes. In rats, tirzepatide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures. It is unknown whether ZEPBOUND causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of tirzepatide-induced rodent thyroid C-cell tumors has not been determined [see Warnings and Precautions (5.1) and Nonclinical Toxicology (13.1)]....
Can you take Zepbound while pregnant?
Weight loss offers no benefit to a pregnant patient and may cause fetal harm. Advise pregnant patients that weight loss is not recommended during pregnancy and to discontinue ZEPBOUND when a pregnancy is recognized (see Clinical Considerations).
Can you take Zepbound while breastfeeding?
In a single-dose clinical lactation study, the concentration of tirzepatide in breast milk was found to be either undetectable or low compared to the maternal administered dose (see Data).
Should you stop Zepbound before surgery?
Available data are insufficient to inform recommendations to mitigate the risk of pulmonary aspiration during general anesthesia or deep sedation in patients taking ZEPBOUND, including whether modifying preoperative fasting recommendations or temporarily discontinuing ZEPBOUND could reduce the incidence of retained gastric contents.
Does Zepbound cause withdrawal symptoms?
The warnings and side effect sections of its FDA label do not list any. What trials do show after people stop a GLP-1 is weight coming back. What happens when you stop a GLP-1
Who should not take Zepbound?
ZEPBOUND is contraindicated in patients with: A personal or family history of MTC or in patients with MEN 2. Known serious hypersensitivity to tirzepatide or any of the excipients in ZEPBOUND. Serious hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with tirzepatide.
How many side effect reports has FDA received about Zepbound?
FDA's adverse event system holds 80,835 reports that name Zepbound, 5,835 of them marked serious. The most reported symptoms are nausea, injection site pain, diarrhea. Anyone can file a report and a report names every medicine the person took, so these cannot show that Zepbound caused a problem or how often it happens. The trial rates in its label do that.
Trial rates describe groups, not what one person will feel. Talk to your clinician before starting, stopping or changing a medicine. Label revised Aug 28, 2026.