Tirzepatide Prescribing Information: Both Labels
Tirzepatide is sold under 2 labels: Mounjaro, Zepbound. Each carries the same boxed warning for thyroid C-cell tumors but lists different approved uses.
- Boxed warning
- Thyroid C-cell tumors
- Approved uses
- 2
- Warnings
- 9
- First approved
- 2022
Zepbound in brief
The half-life ranges from 5 to 6 days: after 5.5 d, half is gone, and five half-lives (27.5 d) leave about 3%
In SURMOUNT-1 over 72 weeks, body weight dropped 20.9%, compared with 3.1% on placebo.
Monthly prices in US dollars: the list price and self-pay offers, each taken from the maker's price page.
Sources: FDA label (DailyMed), Eli Lilly 1 2, cnbc.com.
The 2 tirzepatide labels
| Label | Main approved use | Form | Full label |
|---|---|---|---|
 Mounjaro | When combined with diet and exercise, this treatment lowers blood sugar in people with type 2 diabetes who are 10 or older | weekly injection | DailyMed |
 Zepbound | For adults with obesity, or who are overweight with a weight-related condition, this treatment supports weight loss and long-term weight maintenance with diet and activity | weekly injection | DailyMed |
Sources: FDA label (DailyMed), FDA label.
Mounjaro boxed warning
Boxed warning: thyroid C-cell tumors in rodents were caused by it; whether it causes them in people is not known. Do not use it if you or a family member has had medullary thyroid cancer (MTC), or if you have MEN 2.
Words in the label
“In both male and female rats, tirzepatide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures. It is unknown whether MOUNJARO causes thyroid”
Source: FDA label (DailyMed).
Indications
When combined with diet and exercise, this treatment lowers blood sugar in people with type 2 diabetes who are 10 or older
Words in the label
“as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2”
Source: FDA label (DailyMed).
For adults with type 2 diabetes at high risk, this treatment reduces the chance of a heart attack, stroke, or death related to the heart
Words in the label
“to reduce the risk of major adverse cardiovascular (CV) events (CV death, non-fatal myocardial infarction (MI), or non-fatal stroke) in adults with type 2 diabetes”
Source: FDA label (DailyMed).
Contraindications
Medullary thyroid cancer (MTC) in your own or family history, or MEN 2.
Words in the label
“personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)”
Source: FDA label (DailyMed).
A past serious allergic reaction to tirzepatide or any product ingredient
Words in the label
“serious hypersensitivity to tirzepatide or any of the excipients in MOUNJARO. Serious hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with MOUNJARO”
Source: FDA label (DailyMed).
Warnings and precautions
Thyroid C-cell tumors. In rodents it caused thyroid C-cell tumors, and whether it does the same in people is not known. Do not use it if your own history or your family's history includes medullary thyroid cancer (MTC), or if you have MEN 2.
Words in the label
“In both sexes of 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”
Source: FDA label (DailyMed).
Inflammation of the pancreas. It may lead to inflammation of the pancreas. Severe stomach pain that does not stop, and sometimes spreads to the back, calls for stopping it and getting care.
Words in the label
“Acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with GLP-1 receptor agonists, or MOUNJARO [see Adverse Reactions”
Source: FDA label (DailyMed).
Low blood sugar. When you take it with insulin or a sulfonylurea, low blood sugar becomes more likely, so those doses may need to be lowered.
Words in the label
“Patients receiving MOUNJARO in combination with an insulin secretagogue (e.g., sulfonylurea) or insulin may have an increased risk of hypoglycemia, including severe hypoglycemia [see Adverse”
Source: FDA label (DailyMed).
Allergic reactions can be severe. Reports include serious allergic reactions, such as swelling affecting the face, lips, or throat. If they occur, stop it and get help right away.
Words in the label
“Serious hypersensitivity reactions (e.g., anaphylaxis, angioedema) have been reported in patients treated with MOUNJARO. If hypersensitivity reactions occur, discontinue use of MOUNJARO; treat promptly per”
Source: FDA label (DailyMed).
Kidney injury from fluid loss. Vomiting or diarrhea can cause fluid loss, which can lead to kidney injury If fluid loss is heavy, report it
Words in the label
“There have been postmarketing reports of acute kidney injury, in some cases requiring hemodialysis, in patients treated with GLP-1 receptor agonists, or MOUNJARO. The majority”
Source: FDA label (DailyMed).
Stomach and gut reactions that are severe. Stomach and gut problems are common side effects, and some can be severe. Not recommended if you have severe gastroparesis.
Words in the label
“Use of MOUNJARO has been associated with gastrointestinal adverse reactions, sometimes severe [see Adverse Reactions (6)]. In the pool of placebo-controlled trials in adults, severe”
Source: FDA label (DailyMed).
Diabetic eye disease getting worse. Diabetic eye disease may worsen in type 2 diabetes, particularly when blood sugar drops quickly. If you already have it, that is when eye checks matter.
Words in the label
“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”
Source: FDA label (DailyMed).
Gallbladder disease. You may get gallstones or gallbladder inflammation. Report pain in the upper right of the belly. Also report fever, or yellow skin or eyes.
Words in the label
“Acute events of gallbladder disease such as cholelithiasis or cholecystitis have been reported in GLP-1 receptor agonist trials and postmarketing.”
Source: FDA label (DailyMed).
During anesthesia or sedation, food can enter the lungs. Food may remain in your stomach longer, and that matters during anesthesia or deep sedation. Before any procedure, tell the care team.
Words in the label
“MOUNJARO 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”
Source: FDA label (DailyMed).
Source: FDA label (DailyMed).
Adverse reactions table
The label trials show the side effects seen most often, listed by dose, next to placebo.
| Side effect | Placebo | Mounjaro 5 mg | Mounjaro 10 mg | Mounjaro 15 mg | More than placebo, 15 mg |
|---|---|---|---|---|---|
| Nausea | 4% | 12% | 15% | 18% | +14 points |
| Diarrhea | 9% | 12% | 13% | 17% | +8 points |
| Decreased Appetite | 1% | 5% | 10% | 11% | +10 points |
| Vomiting | 2% | 5% | 5% | 9% | +7 points |
| Dyspepsia | 3% | 8% | 8% | 5% | +2 points |
| Constipation | 1% | 6% | 6% | 7% | +6 points |
| Abdominal Pain | 4% | 6% | 5% | 5% | +1 points |
From: Mounjaro label (DailyMed).
Drug interactions
Taking it alongside insulin or a sulfonylurea, including glipizide or glimepiride, increases the risk of low blood sugar; your doctor may reduce those doses.
Words in the label
“When initiating MOUNJARO, consider reducing the dose of concomitantly administered insulin secretagogues (e.g., sulfonylureas) or insulin to reduce the risk of hypoglycemia [see Warnings and”
Source: FDA label (DailyMed).
Stomach emptying slows, and that can change the way your body takes in other pills.
Words in the label
“MOUNJARO delays gastric emptying and thereby has the potential to impact the absorption of concomitantly administered oral medications. Caution should be exercised when oral medications”
Source: FDA label (DailyMed).
For a while, birth control pills can be less effective. Use a non-oral method instead, or add a barrier method, after you begin and any time the dose goes up.
Words in the label
“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”
Source: FDA label (DailyMed).
Drugs such as warfarin need closer monitoring, because small changes in their levels matter.
Words in the label
“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 MOUNJARO.”
Source: FDA label (DailyMed).
Pregnancy and breastfeeding
There are too few pregnancy data to judge the risk. Speak with your doctor before trying to conceive.
Words in the label
“Available data with MOUNJARO use in pregnant women are insufficient to evaluate for a drug-related risk of major birth defects, miscarriage, or other adverse maternal”
Source: FDA label (DailyMed).
A small study found that breast milk levels were undetectable or low.
Words in the label
“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”
Source: FDA label (DailyMed).
Storage and patient counselling
For up to 21 days, a single-dose pen or vial may remain at temperatures up to 86°F. Do not freeze it. Do not freeze.
Words in the label
“pen or single-dose vial can be stored unrefrigerated at temperatures not to exceed 30°C (86°F) for up to a total of 21 days. Discard the”
Source: FDA label (DailyMed).
Other GLP-1 labels compared with this one
| Label | Boxed warning | Warnings | Interaction lines | Named beyond insulin and pills |
|---|---|---|---|---|
 Ozempic | Yes | 9 | 2 | Not listed |
 Wegovy | Yes | 10 | 3 | Levothyroxine |
 Rybelsus | Yes | 9 | 3 | Levothyroxine |
| Mounjaro | Yes | 9 | 4 | Birth control pills, Warfarin and narrow-range drugs |
| Zepbound | Yes | 9 | 4 | Birth control pills, Warfarin and narrow-range drugs |
 Foundayo | Yes | 9 | 6 | Strong CYP3A4 inhibitors and Strong CYP3A4 inducers, along with Birth control pills and Simvastatin |
 Trulicity | Yes | 9 | 3 | Warfarin and narrow-range drugs |
 Saxenda | Yes | 9 | 2 | Not listed |
 Victoza | Yes | 8 | 2 | Not listed |
| Byetta | No | 9 | 4 | Warfarin and narrow-range drugs, as well as Birth control pills and antibiotics |
Sources for these labels: Ozempic label (DailyMed), Wegovy label (DailyMed), Rybelsus label (DailyMed), Mounjaro label (DailyMed), Zepbound label (DailyMed), Foundayo label (DailyMed), Trulicity label (DailyMed), Saxenda label (DailyMed), Victoza label (DailyMed), Byetta label (DailyMed).
Read the full Mounjaro label
The full prescribing information is on DailyMed, the National Library of Medicine label site.