Prescription medication · Dual GIP/GLP-1 Receptor Agonist
tirzepatide
Also sold as Mounjaro, Zepbound. Zepbound helps adults with obesity or who are overweight to lose weight.
Data updated 2026-05-15
- 120,921
- FDA reportsOften reported
- 1
- InteractionFew interactions
- 8
- Recall records
What the data shows
tirzepatide (Mounjaro) is a prescription Dual GIP/GLP-1 Receptor Agonist, more reported than most tracked drugs (120,921 FDA reports), with 1 documented drug interaction.
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
tirzepatide (Mounjaro) is a prescription Dual GIP/GLP-1 Receptor Agonist. Zepbound helps adults with obesity or who are overweight to lose weight.
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.
Verify with FDA → · CMS NADAC pricing →
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.
The sections below are summarized in plain English from tirzepatide's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
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.
This is a plain-language summary of tirzepatide's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
Zepbound may harm your unborn baby. Weight loss is not recommended during pregnancy. If you become pregnant, stop taking Zepbound.
This is a plain-language summary of tirzepatide's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
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.
This is a plain-language summary of tirzepatide's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store Zepbound in the refrigerator and protect it from heat and light; do not freeze.
Side Effects (from patient reports)
Based on 120,921 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for tirzepatide, by number of reports
- Wrong dose given
Wrong dose given
25,919 reports
- Pain where you injected the medicine
Pain where you injected the medicine
12,325 reports
- Feeling sick to your stomach
Feeling sick to your stomach
12,028 reports
- An extra dose was given 8,027
An extra dose was given
8,027 reports
- Loose stools 6,720
Loose stools
6,720 reports
- Throwing up 5,685
Throwing up
5,685 reports
- Bleeding where you injected the medicine 4,746
Bleeding where you injected the medicine
4,746 reports
- Accidentally taking too little medicine 4,444
Accidentally taking too little medicine
4,444 reports
- Redness where you injected the medicine 4,295
Redness where you injected the medicine
4,295 reports
- Having trouble passing stools 4,190
Having trouble passing stools
4,190 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for tirzepatide each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where tirzepatide sits
tirzepatide has more FDA adverse-event reports than 88% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is tirzepatide; the line is the median (50th percentile).
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
Reports Mentioning Death
652
0.5% of reports — not proof of cause
Hospitalization Reports
7,276
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
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 |
| 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 |
| 14 | FATIGUE | 3,179 |
| 15 | INJECTION SITE BRUISING | 3,002 |
| 16 | BLOOD GLUCOSE INCREASED | 2,598 |
| 17 | ABDOMINAL PAIN UPPER | 2,466 |
| 18 | DECREASED APPETITE | 2,392 |
Reactions in Death Reports
Reactions in Hospitalization Reports
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.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
Common Questions
What should I do if I experience severe nausea?
Can I take Zepbound if I have a history of pancreatitis?
Will Zepbound affect my other medications?
How long does it take to see results with Zepbound?
Can I drink alcohol while taking Zepbound?
What if I have side effects at the injection site?
How often will I see my doctor while taking Zepbound?
Can Zepbound cause low blood sugar?
What if I am planning to have surgery?
Is Zepbound safe for everyone?
What are the common side effects of tirzepatide?
Does tirzepatide interact with other medications?
What drug class is tirzepatide?
Is tirzepatide safe during pregnancy?
Has tirzepatide been recalled?
Active Recalls
Lack of Assurance of Sterility
New Life Pharma LLC
Lack of Assurance of Sterility
New Life Pharma LLC
Lack of Assurance of Sterility
ProRx LLC
Lack of Processing Controls.
AEQUITA PHARMACY
Lack of Processing Controls.
AEQUITA PHARMACY
Lack of Assurance of Sterility
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
Lack of Assurance of Sterility
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
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 120,921 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 8 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
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages