USTEKINUMAB-STBA: 184 Adverse Event Reports & Safety Profile
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184
Total FAERS Reports
16 (8.7%)
Deaths Reported
33
Hospitalizations
184
As Primary/Secondary Suspect
2
Life-Threatening
6
Disabilities
Prescription
Status
FDA Application: 761338 ·
First Report: 20211006 · Latest Report: 20250911
What Are the Most Common USTEKINUMAB-STBA Side Effects?
#1 Most Reported
Intentional product use issue
46 reports (25.0%)
#2 Most Reported
Off label use
43 reports (23.4%)
#3 Most Reported
Intentional dose omission
21 reports (11.4%)
All USTEKINUMAB-STBA Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Intentional product use issue | 46 | 25.0% | 2 | 6 |
| Off label use | 43 | 23.4% | 3 | 7 |
| Intentional dose omission | 21 | 11.4% | 1 | 9 |
| Crohn's disease | 20 | 10.9% | 1 | 5 |
| Death | 15 | 8.2% | 15 | 2 |
| Haematochezia | 13 | 7.1% | 0 | 3 |
| Condition aggravated | 12 | 6.5% | 0 | 3 |
| Diarrhoea | 10 | 5.4% | 0 | 2 |
| Colitis ulcerative | 8 | 4.4% | 0 | 1 |
| Psoriasis | 8 | 4.4% | 0 | 0 |
| Abdominal pain | 6 | 3.3% | 0 | 3 |
| Frequent bowel movements | 6 | 3.3% | 0 | 1 |
| Surgery | 6 | 3.3% | 0 | 2 |
| Symptom recurrence | 6 | 3.3% | 0 | 0 |
| Drug dose omission by device | 5 | 2.7% | 0 | 0 |
| Loss of therapeutic response | 5 | 2.7% | 0 | 1 |
| Needle issue | 5 | 2.7% | 0 | 0 |
| Pain | 5 | 2.7% | 0 | 0 |
| Product dose omission issue | 5 | 2.7% | 2 | 0 |
| Therapeutic response changed | 5 | 2.7% | 0 | 0 |
Who Reports USTEKINUMAB-STBA Side Effects? Age & Gender Data
Gender: 22.2% female, 77.8% male. Average age: 49.7 years. Most reports from: CA. View detailed demographics →
Is USTEKINUMAB-STBA Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2021 | 1 | 0 | 0 |
| 2024 | 29 | 1 | 3 |
| 2025 | 112 | 10 | 22 |
What Is USTEKINUMAB-STBA Used For?
| Indication | Reports |
|---|---|
| Crohn's disease | 79 |
| Psoriasis | 66 |
| Colitis ulcerative | 28 |
| Product used for unknown indication | 13 |
| Psoriatic arthropathy | 6 |
USTEKINUMAB-STBA vs Alternatives: Which Is Safer?
USTEKINUMAB-STBA vs VADADUSTAT
USTEKINUMAB-STBA vs VALACYCLOVIR
USTEKINUMAB-STBA vs VALBENAZINE
USTEKINUMAB-STBA vs VALBENAZINE DITOSYLATE
USTEKINUMAB-STBA vs VALDECOXIB
USTEKINUMAB-STBA vs VALERIAN
USTEKINUMAB-STBA vs VALGANCICLOVIR
USTEKINUMAB-STBA vs VALIUM
USTEKINUMAB-STBA vs VALPROATE
USTEKINUMAB-STBA vs VALPROIC ACID
Official FDA Label for USTEKINUMAB-STBA
Official prescribing information from the FDA-approved drug label.