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tirzepatide

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Brand names: Mounjaro, Zepbound

Dual GIP/GLP-1 Receptor Agonist Rx

Zepbound is a medicine that can help adults with obesity or overweight lose weight and keep it off. It can also treat moderate to severe sleep apnea in adults with obesity.

Drug Pricing (NADAC)

Brand Price

$515.85/unit

Generic Available

No

ELI LILLY AND CO

Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →

What it does

Zepbound helps adults with obesity or who are overweight to lose weight.

Common side effects

Nausea, Diarrhea, Vomiting

Key warnings

Zepbound may cause thyroid C-cell tumors in rats.

How It Works

Zepbound works by activating two receptors in your body: GIP and GLP-1. These receptors help control your blood sugar and appetite. By activating these receptors, Zepbound can help you feel fuller, eat less, and lose weight.

How to Take It

Zepbound is given as a shot under the skin (subcutaneously) once a week. The starting dose is 2.5 mg for 4 weeks. Your doctor will then increase the dose by 2.5 mg every 4 weeks until you reach the right maintenance dose. The maximum dose is 15 mg per week.

Pregnancy & Breastfeeding

Zepbound may harm your unborn baby. Weight loss is not recommended during pregnancy. If you become pregnant, stop taking Zepbound.

Missed Dose

If you miss a dose, take it as soon as you remember if it is within 4 days (96 hours) of the missed dose. If it is more than 4 days, skip the missed dose and take your next dose on your regular day.

Storage

Store Zepbound in the refrigerator and protect it from heat and light; do not freeze.

Side Effects (from patient reports)

Based on 91,915 FDA adverse event reports.

Wrong dose given
25,919
Pain where you injected the medicine
12,325
Feeling sick to your stomach
12,028
An extra dose was given
8,027
Using the medicine for something it's not approved for
7,726
Loose stools
6,720
Throwing up
5,685
Bleeding where you injected the medicine
4,746
Accidentally taking too little medicine
4,444
Redness where you injected the medicine
4,295

FDA Adverse Event Report Analysis

Detailed analysis of 120,921 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2015–2025.

Total Reports

120,921

Death-Related Reports

652

Hospitalization Reports

7,276

Top Indication

Product Used For Unknown Indication

Gender Distribution

Female 74,456 (75%)
Male 24,157 (24%)

Age Distribution

0–17 60
18–44 21,550
45–64 42,427
65–74 14,844
75+ 5,159

Most Reported Adverse Reactions (FAERS)

# Reaction Reports
1 INCORRECT DOSE ADMINISTERED 25,919
2 INJECTION SITE PAIN 12,325
3 NAUSEA 12,028
4 EXTRA DOSE ADMINISTERED 8,027
5 OFF LABEL USE 7,726
6 DIARRHOEA 6,720
7 VOMITING 5,685
8 INJECTION SITE HAEMORRHAGE 4,746
9 ACCIDENTAL UNDERDOSE 4,444
10 INJECTION SITE ERYTHEMA 4,295
11 CONSTIPATION 4,190
12 DRUG INEFFECTIVE 3,850
13 PRODUCT DOSE OMISSION ISSUE 3,819
14 FATIGUE 3,179
15 INJECTION SITE BRUISING 3,002

Reactions in Death Reports

DEATH 261
VOMITING 39
CARDIAC ARREST 34
OFF LABEL USE 33
DIARRHOEA 32
NAUSEA 31
MULTIPLE ORGAN DYSFUNCTION SYNDROME 26
MYOCARDIAL INFARCTION 25
DECREASED APPETITE 22
ACUTE KIDNEY INJURY 20

Reactions in Hospitalization Reports

VOMITING 1,287
NAUSEA 1,147
DIARRHOEA 932
DEHYDRATION 726
ABDOMINAL PAIN 622
IMPAIRED GASTRIC EMPTYING 577
OFF LABEL USE 575
CONSTIPATION 478
PANCREATITIS 429
DECREASED APPETITE 373

Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation

Serious Warnings

Zepbound may cause thyroid C-cell tumors in rats. It is not known if Zepbound causes thyroid tumors in humans. You should not take Zepbound if you or your family have a history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Tell your doctor if you have a lump in your neck, trouble swallowing, trouble breathing, or a hoarse voice that doesn't go away.

Known 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 ZEPBOUND.

Mechanism: Tirzepatide can change how your body absorbs oral medicines like warfarin by affecting how fast your stomach empties. This can make the effects of the blood thinner less predictable.

What to do: Your doctor should closely monitor your blood clotting levels when you start or change your dose of tirzepatide.

Common Questions

What should I do if I experience severe nausea?
Contact your doctor. They may recommend ways to manage the nausea or adjust your dose.
Can I take Zepbound if I have a history of pancreatitis?
Tell your doctor if you have a history of pancreatitis, as Zepbound may cause pancreatitis.
Will Zepbound affect my other medications?
Zepbound can slow down stomach emptying, which may affect how your body absorbs other oral medications. Talk to your doctor about all the medicines you take.
How long does it take to see results with Zepbound?
Weight loss varies from person to person. Continue with your diet and exercise plan while taking Zepbound.
Can I drink alcohol while taking Zepbound?
Talk to your doctor about drinking alcohol while taking Zepbound.
What if I have side effects at the injection site?
Injection site reactions are common. If you have redness, itching, or pain, talk to your doctor.
How often will I see my doctor while taking Zepbound?
Your doctor will want to see you regularly to monitor your progress and check for any side effects.
Can Zepbound cause low blood sugar?
Zepbound can cause low blood sugar, especially if you also take insulin or other diabetes medicines. Know the signs of low blood sugar.
What if I am planning to have surgery?
Tell your doctor if you are planning to have surgery, as Zepbound can increase the risk of lung problems during anesthesia.
Is Zepbound safe for everyone?
Zepbound is not right for everyone. Talk to your doctor to see if it is a good choice for you.
What are the common side effects of tirzepatide?
The most commonly reported side effects of tirzepatide include Nausea, Diarrhea, Vomiting, Constipation, Abdominal pain. Based on 91,915 FDA adverse event reports. Always consult your healthcare provider about potential side effects.
Does tirzepatide interact with other medications?
Yes, tirzepatide has 1 known drug interactions. Notable interactions include warfarin. Always inform your doctor about all medications you are taking.
What drug class is tirzepatide?
tirzepatide belongs to the Dual GIP/GLP-1 Receptor Agonist drug class. It requires a prescription (Rx). Zepbound helps adults with obesity or who are overweight to lose weight.
Is tirzepatide safe during pregnancy?
Zepbound may harm your unborn baby. Weight loss is not recommended during pregnancy. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.
Has tirzepatide been recalled?
There are 6 recalls associated with tirzepatide products. Lack of Assurance of Sterility. Check the recalls section below for full details and affected products.

Active Recalls

Class II October 15, 2025

Lack of Assurance of Sterility

ProRx LLC

Class II July 18, 2025

Lack of Processing Controls.

AEQUITA PHARMACY

Class II July 18, 2025

Lack of Processing Controls.

AEQUITA PHARMACY

Class II May 21, 2025

Lack of Assurance of Sterility

Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)

Class II May 21, 2025

Lack of Assurance of Sterility

Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)

Class II August 22, 2024

Lack of Assurance of Sterility

ProRx LLC

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What the FDA Data Shows for tirzepatide

The FDA label for tirzepatide (sold under brand names such as Mounjaro, Zepbound) classifies it as a prescription-only medication in the Dual GIP/GLP-1 Receptor Agonist class. Zepbound helps adults with obesity or who are overweight to lose weight. Official labeling lists 12 commonly reported side effects, including Nausea, Diarrhea, Vomiting.

Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 91,915 voluntary reports. The database also lists 1 documented drug interaction derived from FDA labeling, with the top-flagged interaction rated minor severity. NADAC pricing from CMS.

Report counts do not establish causation — a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history (currently 6 recall records on file), and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.

Data Sources

Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).

FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.

Last updated: January 20, 2026

All federal data sources used on this page