What the label lists and what reports show
Tirzepatide side effects
Tirzepatide's FDA label: “The most common adverse reactions, reported in ≥5% of patients treated with MOUNJARO are nausea, diarrhea, decreased appetite, vomiting, constipation, dyspepsia, and abdominal pain.” FAERS holds 160,663 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is nausea (17,092 reports).
- No generic listed
- Boxed warning
Check it at the source: the tirzepatide FDA label on DailyMed (effective July 29, 2026, A-S Medication Solutions); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of MOUNJARO?MOUNJARO may cause serious side effects, including: See “ What is the most important information I should know about MOUNJARO? ” inflammation of your pancreas (pancreatitis). Stop using MOUNJARO and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without nausea or vomiting. Sometimes you may feel the pain from your abdomen to your back. low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use MOUNJARO with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. Signs and symptoms of low blood sugar may include: dizziness or light-headedness sweating confusion or drowsiness headache blurred vision slurred speech shakiness fast heartbeat anxiety, irritability, or mood changes hunger weakness feeling jittery serious allergic reactions. […]
Source: FDA drug label, NDA215866 (Eli Lilly And Co), as published by A-S Medication Solutions, effective July 29, 2026 (SPL set 78aad975-4971-49fa-b4b0-6aa39f76d2e7), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions, reported in ≥5% of patients treated with MOUNJARO are nausea, diarrhea, decreased appetite, vomiting, constipation, dyspepsia, and abdominal pain.
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)
This table is printed in the Zepbound label published by Eli Lilly and Company of August 28, 2026; the label quoted above does not print one.
| 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 a | 8 | 19 | 21 | 23 |
| Vomiting | 2 | 8 | 11 | 13 |
| Constipation b | 5 | 17 | 14 | 11 |
| Abdominal Pain c | 5 | 9 | 9 | 10 |
| Dyspepsia | 4 | 9 | 9 | 10 |
| Injection Site Reactions d | 2 | 6 | 8 | 8 |
| Fatigue e | 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 f | 0 | 1 | 1 | 2 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe 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 )] Acute Pancreatitis [see Warnings and Precautions ( 5.2 )] Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin [see Warnings and Precautions ( 5.3 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.4 )] Acute Kidney Injury Due to Volume Depletion [see Warnings and Precautions ( 5.5 )] Severe Gastrointestinal Adverse Reactions [see Warnings and Precautions ( 5.6 )] Diabetic Retinopathy Complications in Patients with a History of Diabetic Retinopathy [see Warnings and Precautions ( 5.7 )] Acute Gallbladder Disease [see Warnings and Precautions ( 5.8 )] Pulmonary Aspiration During General Anesthesia or Deep Sedation [see Warnings and Precautions ( 5.9 )] The most common adverse reactions, reported in ≥5% of patients treated with MOUNJARO are nausea, diarrhea, decreased appetite, vomiting, constipation, dyspepsia, and abdominal pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …
Source: FDA drug label, NDA215866 (Eli Lilly And Co), as published by A-S Medication Solutions, effective July 29, 2026 (SPL set 78aad975-4971-49fa-b4b0-6aa39f76d2e7), via openFDA; the full label on DailyMed
What do FAERS reports show?
160,663 reports list tirzepatide among the medicines taken, each a report of something that happened, not proof the medicine caused it; 889 are coded as a death and 10,233 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2025 (62,302, against a median of 33 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 20 reactions below, 10 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Tirzepatide: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions