TIRZEPATIDE: 99,893 Adverse Event Reports & Safety Profile
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99,893
Total FAERS Reports
455 (0.5%)
Deaths Reported
5,527
Hospitalizations
99,893
As Primary/Secondary Suspect
718
Life-Threatening
629
Disabilities
Jan 20, 2026
FDA Approved
Eli Lilly and Company
Manufacturer
Prescription
Status
Drug Class: G-Protein-linked Receptor Interactions [MoA] · Manufacturer: Eli Lilly and Company · FDA Application: 215866 ·
Patent Expires: Jun 14, 2039 · First Report: 19620530 · Latest Report: 20250930
What Are the Most Common TIRZEPATIDE Side Effects?
#1 Most Reported
Incorrect dose administered
23,301 reports (23.3%)
#2 Most Reported
Injection site pain
10,989 reports (11.0%)
#3 Most Reported
Nausea
10,018 reports (10.0%)
All TIRZEPATIDE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Incorrect dose administered | 23,301 | 23.3% | 1 | 67 |
| Injection site pain | 10,989 | 11.0% | 0 | 33 |
| Nausea | 10,018 | 10.0% | 20 | 867 |
| Off label use | 7,007 | 7.0% | 21 | 425 |
| Extra dose administered | 6,774 | 6.8% | 1 | 32 |
| Diarrhoea | 5,463 | 5.5% | 22 | 725 |
| Vomiting | 4,635 | 4.6% | 27 | 1,004 |
| Injection site haemorrhage | 4,389 | 4.4% | 0 | 12 |
| Accidental underdose | 3,897 | 3.9% | 0 | 7 |
| Injection site erythema | 3,844 | 3.9% | 0 | 14 |
| Constipation | 3,417 | 3.4% | 6 | 341 |
| Product dose omission issue | 3,211 | 3.2% | 0 | 47 |
| Injection site bruising | 2,665 | 2.7% | 0 | 14 |
| Drug ineffective | 2,648 | 2.7% | 0 | 44 |
| Fatigue | 2,301 | 2.3% | 5 | 123 |
| Blood glucose increased | 2,240 | 2.2% | 1 | 97 |
| Abdominal pain upper | 2,045 | 2.1% | 6 | 229 |
| Decreased appetite | 2,041 | 2.0% | 18 | 284 |
| Injection site pruritus | 1,947 | 2.0% | 0 | 14 |
| Headache | 1,766 | 1.8% | 2 | 96 |
Who Reports TIRZEPATIDE Side Effects? Age & Gender Data
Gender: 75.6% female, 24.4% male. Average age: 53.9 years. Most reports from: US. View detailed demographics →
Is TIRZEPATIDE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2001 | 1 | 0 | 0 |
| 2002 | 4 | 0 | 0 |
| 2003 | 3 | 0 | 0 |
| 2005 | 1 | 0 | 0 |
| 2006 | 2 | 0 | 0 |
| 2010 | 1 | 0 | 0 |
| 2011 | 1 | 0 | 0 |
| 2012 | 2 | 0 | 0 |
| 2013 | 1 | 0 | 0 |
| 2014 | 1 | 0 | 0 |
| 2015 | 2 | 0 | 0 |
| 2016 | 3 | 0 | 2 |
| 2017 | 2 | 0 | 0 |
| 2018 | 13 | 0 | 3 |
| 2019 | 12 | 0 | 11 |
| 2020 | 25 | 0 | 10 |
| 2021 | 56 | 0 | 29 |
| 2022 | 3,538 | 4 | 215 |
| 2023 | 9,139 | 44 | 601 |
| 2024 | 14,149 | 75 | 1,004 |
| 2025 | 14,173 | 65 | 1,224 |
What Is TIRZEPATIDE Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 56,075 |
| Weight control | 17,354 |
| Type 2 diabetes mellitus | 14,571 |
| Diabetes mellitus | 5,209 |
| Weight decreased | 2,625 |
| Glucose tolerance impaired | 2,452 |
| Obesity | 700 |
| Sleep apnoea syndrome | 654 |
| Insulin resistance | 572 |
| Glycosylated haemoglobin increased | 564 |
TIRZEPATIDE vs Alternatives: Which Is Safer?
TIRZEPATIDE vs TISAGENLECLEUCEL
TIRZEPATIDE vs TISLELIZUMAB
TIRZEPATIDE vs TISOTUMAB VEDOTIN
TIRZEPATIDE vs TISOTUMAB VEDOTIN-TFTV
TIRZEPATIDE vs TITANIUM DIOXIDE\ZINC
TIRZEPATIDE vs TIVICAY
TIRZEPATIDE vs TIVOZANIB
TIRZEPATIDE vs TIXOCORTOL PIVALATE
TIRZEPATIDE vs TIZANIDINE
TIRZEPATIDE vs TOBACCO LEAF
Official FDA Label for TIRZEPATIDE
Official prescribing information from the FDA-approved drug label.