Drug Safety-related Labeling Changes (SrLC)

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MOUNJARO (NDA-215866)

(TIRZEPATIDE)

Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

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01/20/2026 (SUPPL-9)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.10 Never Share a MOUNJARO KwikPen Between Patients

Newly added section

Never share MOUNJARO KwikPen between patients, even if the pen needle is changed. Sharing poses a risk for transmission of blood-borne pathogens.

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

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Never Share a MOUNJARO KwikPen Between Patients

Advise patients that they must never share a MOUNJARO KwikPen with another person, even if the pen needle is changed, because doing so carries a risk for transmission of blood-borne pathogens [see Warnings and Precautions (5.10)].

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Administration

Instruct patients how to prepare and administer the correct dose of MOUNJARO and assess their ability to inject subcutaneously to ensure the proper administration of MOUNJARO. Instruct patients using MOUNJARO vials to always use a new syringe and needle for each injection. Use a syringe appropriate for dose administration (e.g., a 1 mL syringe capable of measuring a 0.5 mL or 0.6 mL dose). Notify the patient of which MOUNJARO presentation they will be receiving and ensure training is appropriate for the specific MOUNJARO presentation. Advise patients to refer to the IFU in case of any change in the presentation .Advise caregivers that MOUNJARO KwikPen is not recommended for self-administration by pediatric patients or those with visual impairment unless their healthcare provider determines the patient can properly administer. [see Dosage and Administration (2.2)].

 

MEDICATION GUIDE

Additions and/or revisions underlined:

Do not share your MOUNJARO KwikPen or needles with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.

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How should I use MOUNJARO?

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• Children should not inject themselves with MOUNJARO KwikPen. An adult caregiver should give a child his or her injections with MOUNJARO KwikPen.

• Self-injection is not recommended for people who are visually impaired.

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How should I store MOUNJARO?

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• Store multi-dose vial or single-patient-use KwikPen in the refrigerator between 36°F to 46°F (2°C to 8°C) or at room temperature [up to 86°F (30°C)]. Throw away the multi-dose vial or single-patient-use KwikPen after a total of 30 days at room temperature, 30 days after first use, or after taking 4 weekly doses, even if it still has medicine in it.

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What are the ingredients in MOUNJARO?

Active ingredient: tirzepatide

Inactive ingredients: sodium chloride, sodium phosphate dibasic heptahydrate, and water for injection. Benzyl alcohol, glycerin, and phenol are also inactive ingredients in the multi-dose vial and single-patient-use KwikPen. Hydrochloric acid solution and/or sodium hydroxide solution may have been added to adjust the pH.

01/07/2026 (SUPPL-41)

Approved Drug Label (PDF)

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

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Administration

Instruct patients how to prepare and administer the correct dose of MOUNJARO and assess their ability to inject subcutaneously to ensure the proper administration of MOUNJARO. Instruct patients using MOUNJARO vials to always use a new syringe and needle for each injection. Use a mL syringe appropriate for dose administration (e.g., a 1 mL syringe capable of measuring a 0.5 mL or 0.6 mL dose) [see Dosage and Administration (2.2)].

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MEDICATION GUIDE

Additions and/or revisions underlined:

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How should I use MOUNJARO?

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• If using MOUNJARO vials, always use a new syringe and needle for each injection.

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How should I store MOUNJARO?

• Store MOUNJARO in the original carton to protect it from light.

• Do not freeze MOUNJARO. Do not use MOUNJARO if frozen.

• Store each single-dose pen or single-dose vial in the refrigerator between 36?F to 46?F (2?C to 8?C). If needed, each single-dose pen or single-dose vial can be stored at room temperature up to 86?F (30?C) for up to 21 days.

• Store multi-dose vial in the refrigerator between 36°F to 46°F (2°C to 8°C) or at room temperature [up to 86°F (30°C)]. Throw away the multi-dose vial after a total of 30 days at room temperature, 30 days after first use, or after taking 4 weekly doses, even if it still has medicine in it.

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12/19/2025 (SUPPL-39)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.2 Acute Pancreatitis

Additions and/or revisions underlined:

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 (6)].

After initiation of MOUNJARO, 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 MOUNJARO and initiate appropriate management.

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5.6 Severe Gastrointestinal Adverse Reactions

Additions and/or revisions underlined:

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 gastrointestinal adverse reactions occurred more frequently among patients receiving MOUNJARO (5 mg 1.3%, 10 mg 0.4%, 15 mg 1.2%) than placebo (0.9%). Severe gastrointestinal adverse reactions have also been reported postmarketing with GLP-1 receptor agonists.

MOUNJARO is not recommended in patients with severe gastroparesis.

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5.8 Acute Gallbladder Disease

Additions and/or revisions underlined:

Acute events of gallbladder disease such as cholelithiasis or cholecystitis have been reported in GLP-1 receptor agonist trials and postmarketing.

In MOUNJARO placebo-controlled clinical trials in adults, acute gallbladder disease (cholelithiasis, biliary colic, and cholecystectomy) was reported by 0.6% of MOUNJARO-treated patients and 0% of placebo-treated patients. If cholelithiasis is suspected, gallbladder diagnostic studies and appropriate clinical follow-up are indicated.

6 Adverse Reactions

6.1 Clinical Trials Experience

Extensive changes; please refer to label for complete information

6.2 Postmarketing Experience

Additions and/or revisions underlined:

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Gastrointestinal: acute pancreatitis, hemorrhagic and necrotizing pancreatitis sometimes resulting in death, ileus, intestinal obstruction, severe constipation including fecal impaction

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8 Use in Specific Populations

Additions and/or revisions underlined:

The safety and effectiveness of MOUNJARO as an adjunct to diet and exercise to improve glycemic control in pediatric patients 10 years of age and older with type 2 diabetes mellitus have been established. Use of MOUNJARO for this indication is supported by a 30-week, randomized, double-blind, placebo-controlled trial with a 22-week open label extension in 99 pediatric patients [see Clinical Studies (14.5)].

Adverse reactions reported in pediatric patients 10 years of age and older treated with MOUNJARO were similar to those reported in adults with the exception of a higher incidence of vomiting, abdominal pain, and hypoglycemia [see Adverse Reactions (6.1)].

The safety and effectiveness of MOUNJARO have not been established in pediatric patients less than 10 years of age.

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

Acute Pancreatitis

Inform patients of the potential risk for acute pancreatitis and its symptoms: severe abdominal pain that sometimes radiates to the back, and which may or may not be accompanied by nausea or vomiting. Instruct patients to discontinue MOUNJARO promptly and contact their physician if pancreatitis is suspected [see Warnings and Precautions (5.2)].

MEDICATION GUIDE

Additions and/or revisions underlined:

What is MOUNJARO?

• MOUNJARO is an injectable prescription medicine that is used along with diet and exercise to improve blood sugar (glucose) in adults and children 10 years of age and older with type 2 diabetes mellitus.

• It is not known if MOUNJARO is safe and effective for use in children under 10 years of age.

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How should I use MOUNJARO?

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• A caregiver may give you MOUNJARO injections or you may self-inject if a healthcare provider determines that it is appropriate.

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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.

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• dehydration leading to kidney problems. Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration) which may cause kidney problems. It is important for you to drink fluids to help reduce your chance of dehydration. Tell your healthcare provider right away if you have nausea, vomiting, or diarrhea that does not go away.

09/25/2025 (SUPPL-34)

Approved Drug Label (PDF)

8 Use in Specific Populations

8.2 Lactation

Additions and/or revisions underlined:

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 MOUNJARO and any potential adverse effects on the breastfed infant from MOUNJARO 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

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

MEDICATION GUIDE

Additions and/or revisions underlined:

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Before using MOUNJARO, tell your healthcare provider about all of your medical conditions, including if you:

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• are breastfeeding or plan to breastfeed. MOUNJARO may pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby while using MOUNJARO.

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  How should I use MOUNJARO?

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• Inject MOUNJARO under the skin (subcutaneously) of your stomach (abdomen), thigh, or another person should inject in the back of the upper arm. Do not inject MOUNJARO into a muscle (intramuscularly) or vein (intravenously).

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05/28/2025 (SUPPL-31)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Acute Kidney Injury Due to Volume Depletion

Additions and/or revisions underlined:

There have been postmarketing reports of acute kidney injury, in some cases requiring hemodialysis, in patients treated with GLP-1 receptor agonists, or MOUNJARO [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 MOUNJARO that could lead to volume depletion, especially during dosage initiation and escalation of MOUNJARO.

6 Adverse Reactions

Additions and/or revisions underlined:

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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)]

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  6.1 Clinical Trials Experience

  Additions and/or revisions underlined:

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  Acute Pancreatitis

  In clinical studies, 14 events of acute pancreatitis were confirmed by adjudication in 13 MOUNJARO-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).

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  6.2 Postmarketing Experience

  Additions and/or revisions underlined:

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  Gastrointestinal: acute pancreatitis, hemorrhagic and necrotizing pancreatitis sometimes resulting in death, ileus

  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

  Skin and Subcutaneous Tissue: alopecia

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

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Acute Kidney Injury Due to Volume Depletion

Inform patients of the potential risk of acute kidney injury due to dehydration associated with gastrointestinal adverse reactions. Advise patients to take precautions to avoid fluid depletion. Inform patients of the signs and symptoms of acute kidney injury and instruct them to promptly report any of these signs or symptoms or persistent (or extended) nausea, vomiting, and diarrhea to their healthcare provider [see Warnings and Precautions (5.5)].

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Diabetic Retinopathy Complications in Patients with a History of Diabetic Retinopathy

Inform patients to contact their healthcare provider if changes in vision are experienced during treatment with MOUNJARO [see Warnings and Precautions (5.7)].

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MEDICATION GUIDE

Additions and/or revisions underlined:

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Before using MOUNJARO, talk to your healthcare provider about low blood sugar and how to manage it. Tell your healthcare provider if you are taking other medicines to treat diabetes including insulin or sulfonylureas.

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How should I use MOUNJARO?

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• Inject MOUNJARO under the skin (subcutaneously) of your stomach (abdomen), thigh, or upper arm. Do not inject MOUNJARO into a muscle (intramuscularly) or vein (intravenously).

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• If you take too much MOUNJARO, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.

 

What are the possible side effects of MOUNJARO?

MOUNJARO may cause serious side effects, including:

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• dehydration leading to kidney problems. Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration) which may cause kidney problems. It is important for you to drink fluids to help reduce your chance of dehydration.

  …

11/01/2024 (SUPPL-10)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.6 Severe Gastrointestinal Adverse Reactions

Additions and/or revisions underlined:

Use of MOUNJARO has been associated with gastrointestinal adverse reactions, sometimes severe [see Adverse Reactions 6.1]. In the pool of placebo-controlled trials, severe gastrointestinal adverse reactions occurred more frequently among patients receiving MOUNJARO (5 mg 1.3%, 10 mg 0.4%, 15 mg 1.2%) than placebo (0.9%).

MOUNJARO has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis, and is therefore not recommended in these patients.

6 Adverse Reactions

Addition of the following to the bulleted line listing:

• Severe Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.6)]

6.1 Clinical Trials Experience

Newly added information:

Dysgeusia

In the pool of placebo-controlled clinical trials, dysgeusia was reported by 0.1% of MOUNJARO-treated patients and 0% of placebo-treated patients.

11/01/2024 (SUPPL-15)

Approved Drug Label (PDF)

6 Adverse Reactions

6.1 Clinical Trials Experience

Newly added information:

Dysesthesia

In the pool of placebo-controlled clinical trials, dysesthesia was reported by 0.4%, 0.4%, and 0.4% of patients treated with MOUNJARO 5 mg, 10 mg, and 15 mg, respectively. No events were reported by patients receiving placebo.

11/01/2024 (SUPPL-22)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.9 Pulmonary Aspiration During General Anesthesia or Deep Sedation

Newly added subsection:

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 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 MOUNJARO, including whether modifying preoperative fasting recommendations or temporarily discontinuing MOUNJARO 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 MOUNJARO.

6 Adverse Reactions

Addition of the following to the bulleted line listing:

• Pulmonary Aspiration During General Anesthesia or Deep Sedation [see Warnings and Precautions (5.9)]

6.2 Postmarketing Experience

Newly added information:

Pulmonary: Pulmonary aspiration has occurred in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures requiring general anesthesia or deep sedation.

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

PATIENT COUNSELING INFORMATION

Newly added information:

Pulmonary Aspiration During General Anesthesia or Deep Sedation

Inform patients that MOUNJARO may cause their stomach to empty more slowly which may lead to complications with anesthesia or deep sedation during planned surgeries or procedures. Instruct patients to inform healthcare providers prior to any planned surgeries or procedures if they are taking MOUNJARO [see Warnings and Precautions (5.9)].

MEDICATION GUIDE

Additions and/or revisions underlined:

Before using MOUNJARO, tell your healthcare provider about all of your medical conditions, including if you:

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• are scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation).

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What are the possible side effects of MOUNJARO?

MOUNJARO may cause serious side effects, including:

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• food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). MOUNJARO may increase the chance of food getting into your lungs during surgery or other procedures. Tell all your healthcare providers that you are taking MOUNJARO before you are scheduled to have surgery or other procedures.

07/28/2023 (SUPPL-6)

Approved Drug Label (PDF)

4 Contraindications

(Additions and/or revisions underlined)

MOUNJARO is contraindicated in patients with:

• A personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) [see Warnings and Precautions (5.1)].

• Known serious hypersensitivity to tirzepatide or any of the excipients in MOUNJARO. Serious hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with MOUNJARO [see Warnings and Precautions (5.4)].

5 Warnings and Precautions

5.4 Hypersensitivity Reactions

(Additions and/or revisions underlined)

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 standard of care, and monitor until signs and symptoms resolve. Do not use in patients with a previous serious hypersensitivity reaction to tirzepatide or any of the excipients in MOUNJARO [see Contraindications (4), Adverse Reactions (6.2)].

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 MOUNJARO.

6 Adverse Reactions

(Additions and/or revisions underlined)

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)]
• 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 [see Warnings and Precautions (5.5)]
• Severe Gastrointestinal Disease [see Warnings and Precautions (5.6)]
• Diabetic Retinopathy Complications [see Warnings and Precautions (5.7)]
• Acute Gallbladder Disease [see Warnings and Precautions (5.8)]

6.2 Postmarketing Experience

(Newly added subsection)

The following adverse reactions have been reported during post-approval use of MOUNJARO. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Hypersensitivity: anaphylaxis, angioedema

Gastrointestinal: ileus

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

17 PATIENT COUNSELING INFORMATION

(Additions and/or revisions underlined)

Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).

Risk of Thyroid C-Cell Tumors

Inform patients that MOUNJARO causes thyroid C-cell tumors in rats and that the human relevance of this finding has not been determined. Counsel patients to report symptoms of thyroid tumors (e.g., a lump in the neck, persistent hoarseness, dysphagia, or dyspnea) to their healthcare provider [see Boxed Warning and Warnings and Precautions (5.1)].

Pancreatitis

Inform patients of the potential risk for pancreatitis. Instruct patients to discontinue MOUNJARO promptly and contact their healthcare provider if pancreatitis is suspected (severe abdominal pain that may radiate to the back, and which may or may not be accompanied by vomiting) [see Warnings and Precautions (5.2)].

Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin

Inform patients that the risk of hypoglycemia is increased when MOUNJARO is used with an insulin secretagogue (such as a sulfonylurea) or insulin. Educate patients on the signs and symptoms of hypoglycemia [see Warnings and Precautions (5.3)].

Hypersensitivity Reactions

Inform patients that serious hypersensitivity reactions have been reported with use of MOUNJARO. Advise patients on the symptoms of hypersensitivity reactions and instruct them to stop taking MOUNJARO and seek medical advice promptly if such symptoms occur [see Warnings and Precautions (5.4)].

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Administration

Instruct patients how to prepare and administer the correct dose of MOUNJARO and assess their ability to inject subcutaneously to ensure the proper administration of MOUNJARO. Instruct patients using the single-dose vial to use a syringe appropriate for dose administration (e.g., a 1 mL syringe capable of measuring a 0.5 mL dose) [see Dosage and Administration (2.2)].

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