USTEKINUMAB-TTWE: 83 Adverse Event Reports & Safety Profile
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83
Total FAERS Reports
0
Deaths Reported
25
Hospitalizations
83
As Primary/Secondary Suspect
2
Life-Threatening
3
Disabilities
Prescription
Status
FDA Application: 761373 ·
First Report: 20240801 · Latest Report: 20250814
What Are the Most Common USTEKINUMAB-TTWE Side Effects?
#1 Most Reported
Off label use
8 reports (9.6%)
#2 Most Reported
Crohn's disease
8 reports (9.6%)
#3 Most Reported
Fatigue
7 reports (8.4%)
All USTEKINUMAB-TTWE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Crohn's disease | 8 | 9.6% | 0 | 1 |
| Off label use | 8 | 9.6% | 0 | 3 |
| Fatigue | 7 | 8.4% | 0 | 0 |
| Drug ineffective | 6 | 7.2% | 0 | 2 |
| Lower respiratory tract infection | 6 | 7.2% | 0 | 2 |
| Dyspnoea | 5 | 6.0% | 0 | 2 |
| Headache | 5 | 6.0% | 0 | 0 |
| Infection | 5 | 6.0% | 0 | 4 |
| Pruritus | 5 | 6.0% | 0 | 1 |
Who Reports USTEKINUMAB-TTWE Side Effects? Age & Gender Data
Gender: 53.9% female, 46.1% male. Average age: 53.8 years. Most reports from: GB. View detailed demographics →
Is USTEKINUMAB-TTWE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2024 | 7 | 0 | 1 |
| 2025 | 11 | 0 | 4 |
What Is USTEKINUMAB-TTWE Used For?
| Indication | Reports |
|---|---|
| Crohn's disease | 52 |
| Psoriasis | 15 |
| Product used for unknown indication | 8 |
| Colitis ulcerative | 6 |
Official FDA Label for USTEKINUMAB-TTWE
Official prescribing information from the FDA-approved drug label.