Prescription medicine

Tirzepatide Brand names: Mounjaro, Zepbound

Tirzepatide (Zepbound) is a prescription medicine with an FDA approval on record since 2022. No generic is listed; pharmacies paid $538.68 per mL (Mounjaro 10 mg/0.5 mL pen) in the October 7, 2026 NADAC survey.

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 NDA 215866 record on Drugs@FDA; every tirzepatide label on DailyMed.

Highlights of the record

FDA label of July 29, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026

Boxed warning

RISK OF THYROID C-CELL TUMORS.

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 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 )]. MOUNJARO 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 MOUNJARO 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 MOUNJARO [see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 )]. WARNING: RISK OF THYROID C-CELL TUMORS See full prescribing information for complete boxed warning. Tirzepatide causes thyroid C-cell tumors in rats. […]

Used for

From the label: indications and usage
MOUNJARO ® is indicated 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 diabetes mellitus.

Forms and strengths

2.5 mg/.5ml
4.17 mg/ml
5 mg/.5ml
7.5 mg/.5ml
8.33 mg/ml
10 mg/.5ml
12.5 mg/.5ml
12.5 mg/ml
15 mg/.5ml
16.7 mg/ml
20.8 mg/ml
25 mg/ml

Injection (solution).

On the market

Earliest approval on file: May 13, 2022 Mounjaro, Eli Lilly And Co; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals: No generic approved
Labelers listed (NDC): 2 of which 0 under generic applications, 2 under brand applications, repackagers included
Last listed patent: July 22, 2039 Zepbound injection; not a generic launch date

Supply and safety

Pharmacy cost (NADAC): $538.68 per mL Mounjaro 10 mg/0.5 mL pen
Shortage (FDA): No current entry resolved earlier; see below
Recalls by its makers (FDA): 0 since 2023 1 Class I among all firms' recalls; 7 more by firms not listed as its makers
FAERS reports: 160,663 through July 30, 2026

What is tirzepatide used for?

From the label: indications and usage
MOUNJARO ® is indicated 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 diabetes mellitus. MOUNJARO ® is a glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist indicated 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 diabetes mellitus.

Conditions named in the indications of tirzepatide's FDA labels, with every medicine labeled for each:

From other tirzepatide labels
Weight management: ZEPBOUND ® is indicated in combination with a reduced-calorie diet and increased physical activity: to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at …

FDA pharmacologic class: GLP-1 Receptor Agonist and Glucose-dependent Insulinotropic Polypeptide Receptor Agonist.

Source: FDA drug label (MOUNJARO), 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 patient leaflet for tirzepatide say first?

The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.

From the patient leaflet: What is the most important information I should know about MOUNJARO?
MOUNJARO may cause serious side effects, including: Possible thyroid tumors, including cancer. Tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rats, MOUNJARO and medicines that work like MOUNJARO caused thyroid tumors, including thyroid cancer. It is not known if MOUNJARO will cause thyroid tumors, or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people. Do not use MOUNJARO if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC), or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

From the patient leaflet: 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 36⁰F to 46⁰F (2⁰C to 8⁰C). If needed, each single-dose pen or single-dose vial can be stored at room temperature up to 86⁰F (30⁰C) for up to a total of 21 days. Throw away single-dose pen or single-dose vial after a total of 21 days at room temperature. 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. Keep MOUNJARO and all medicines out of the reach of children.

Is there a generic for tirzepatide (Zepbound)?

No generic tirzepatide is approved (Drugs@FDA, October 8, 2026).

The Orange Book lists 8 patents for Zepbound injection: the compound patent runs to May 13, 2036, and the last listed entry to July 22, 2039; a patent listed only for Mounjaro injection runs to December 30, 2041. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.

2022 earliest approval on file
2039 last listed patent
red ticks recalls

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What do pharmacies pay for tirzepatide (Zepbound)?

In CMS's NADAC survey of October 7, 2026, pharmacies paid $538.68 per mL (Mounjaro 10 mg/0.5 mL pen), up 3% from $522.94 on October 8, 2025. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.

NADAC per unit, October 7, 2026
Strength and form	Brand or generic	Pharmacy cost	30 tablets, or one pen or vial	12-month change
Mounjaro 10 mg/0.5 mL pen	Brand	$538.68 per mL	$269.34 per single-dose pen	+3%
Mounjaro 12.5 mg/0.5 mL pen	Brand	$538.53 per mL	$269.26 per single-dose pen	+3%
Mounjaro 15 mg/0.5 mL pen	Brand	$538.52 per mL	$269.26 per single-dose pen	+3%
Mounjaro 2.5 mg/0.5 mL pen	Brand	$538.69 per mL	$269.34 per single-dose pen	+3%
Mounjaro 5 mg/0.5 mL pen	Brand	$538.63 per mL	$269.32 per single-dose pen	+3%
Mounjaro 7.5 mg/0.5 mL pen	Brand	$538.68 per mL	$269.34 per single-dose pen	+3%
Zepbound 10 mg/0.5 mL pen	Brand	$526.05 per mL	$263.02 per single-dose pen	no change
Zepbound 10 mg/dose (40 mg/2.4 mL) kwikpen	Brand	$281.62 per mL	n/a	n/a
Zepbound 12.5 mg/0.5 mL pen	Brand	$525.85 per mL	$262.92 per single-dose pen	-0.1%
Zepbound 12.5 mg/dose (50 mg/2.4 mL) kwikpen	Brand	$281.99 per mL	n/a	n/a
Zepbound 15 mg/0.5 mL pen	Brand	$525.92 per mL	$262.96 per single-dose pen	no change
Zepbound 15 mg/dose (60 mg/2.4 mL) kwikpen	Brand	$281.43 per mL	n/a	n/a
Zepbound 2.5 mg/0.5 mL pen	Brand	$526.20 per mL	$263.10 per single-dose pen	no change
Zepbound 2.5 mg/dose (10 mg/2.4 mL) kwikpen	Brand	$201.26 per mL	n/a	n/a

Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price

Has tirzepatide been in shortage before?

The FDA determined that the shortage of tirzepatide injection was resolved on October 2, 2024; reaffirmed after re-evaluation on December 19, 2024; the shortage had been listed since December 2022.

The shortage file openFDA publishes does not keep every shortage the FDA resolved before it; this history is from the FDA's own page on it. Status checked October 8, 2026.

Source: the FDA's page on the GLP-1 shortage and compounding, which records the resolution of October 2, 2024

Has tirzepatide been recalled?

The FDA's Enforcement Report lists 7 recalls naming tirzepatide since 2023: 1 Class I (the most serious), 6 Class II, 0 Class III; 7 still ongoing. 7 of them are by firms that FDA's NDC Directory does not list as a maker of tirzepatide and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.

Started	Class	Company	Reason
October 15, 2025	Class II	ProRx LLC not a listed maker	Lack of Assurance of Sterility
July 30, 2025	Class II	GenoGenix LLC not a listed maker	Lack of Assurance of Sterility
August 22, 2024	Class II	ProRx LLC not a listed maker	Lack of Assurance of Sterility
April 20, 2024	Class I	Revive Rx LLC dba Revive Rx Pharmacy not a listed maker	Labeling: Label Mix-up - product labeled as tirzepatide contains testosterone cypionate
May 11, 2023	Class II	Revive Rx LLC dba Revive Rx Pharmacy not a listed maker	Sub-potent Drug

Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026

What does the tirzepatide label say about other medicines?

The tirzepatide label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.

Medicine named	Section	What the label says
Warfarin	drug interactions	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.

Check tirzepatide against other medicines

What do FAERS reports show for tirzepatide?

The FDA Adverse Event Reporting System holds 160,663 reports that list tirzepatide among the medicines taken, through July 30, 2026, 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.

Reports received each year

The most reported reactions

Incorrect Dose Administered (a use or a product term, not a reaction)29,672
Nausea (named in the label)17,092
Injection Site Pain13,906
Diarrhoea (named in the label)10,006
Extra Dose Administered9,608
Off Label Use (a use or a product term, not a reaction)8,941
Vomiting (named in the label)8,267
Drug Ineffective (a use or a product term, not a reaction)6,965

Side effects: the label's list and every FAERS reaction

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What else is labeled for the same conditions as tirzepatide?

14 other medicines are given the same way (subcutaneous) and in the same FDA class as tirzepatide or labeled mainly for the same use (type 2 diabetes), the same class first. Type 2 diabetes lists all 52 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.

Medicine	Shared indication	Generic labelers (subcutaneous)	Pharmacy cost	Shortage
Liraglutide	Heart attack and coronary artery disease, Type 2 diabetes, Weight management	9 labelers	$31.41 per mL 2-pak 18 mg/3 mL	In shortage
Semaglutide	Heart attack and coronary artery disease, Type 2 diabetes, Weight management	none listed	$331.99 per mL 0.25-0.5 mg/dose (2 mg/3 mL) pen	A presentation being discontinued
Dulaglutide	Heart attack and coronary artery disease, Type 2 diabetes	none listed	$487.57 per mL 0.75 mg/0.5 mL pen	No current entry
Exenatide	Type 2 diabetes	1 labeler	$300.17 per mL 10 mcg dose pen injection	No current entry
Insulin degludec and liraglutide	Type 2 diabetes	none listed	$85.89 per mL 100 unit-3.6 mg/mL pen	No current entry
Insulin glargine and lixisenatide	Type 2 diabetes	none listed	$57.06 per mL 100 unit-33 mcg/mL pen	No current entry
Insulin glargine	Type 2 diabetes	none listed	$2.90 per mL 100 pen	A presentation being discontinued
Insulin aspart	Type 2 diabetes	none listed	$6.95 per mL 100 unit/mL vial	No current entry

Every medicine labeled for the same conditions as tirzepatide

Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)

How does tirzepatide compare with medicines for the same use?

3 side-by-side pages set tirzepatide beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.

What next?

Alternatives to tirzepatide: 14 medicines for the same use
Other GLP-1 receptor agonists: the pharmacologic class, with prices and generics
Tirzepatide side effects: the label's list beside FAERS reports
Check an interaction: what two or more labels say about each other