SPESOLIMAB-SBZO: 198 Adverse Event Reports & Safety Profile
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198
Total FAERS Reports
15 (7.6%)
Deaths Reported
34
Hospitalizations
198
As Primary/Secondary Suspect
13
Life-Threatening
2
Disabilities
Prescription
Status
FDA Application: 761244 ·
First Report: 20220101 · Latest Report: 20250819
What Are the Most Common SPESOLIMAB-SBZO Side Effects?
#1 Most Reported
Generalised pustular psoriasis
29 reports (14.6%)
#2 Most Reported
Drug ineffective
20 reports (10.1%)
#3 Most Reported
Rash
14 reports (7.1%)
All SPESOLIMAB-SBZO Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Generalised pustular psoriasis | 29 | 14.7% | 1 | 3 |
| Drug ineffective | 20 | 10.1% | 0 | 1 |
| Rash | 14 | 7.1% | 0 | 1 |
| Pruritus | 13 | 6.6% | 0 | 1 |
| Fatigue | 11 | 5.6% | 0 | 0 |
| Psoriasis | 10 | 5.1% | 0 | 2 |
| Pustule | 9 | 4.6% | 0 | 0 |
| Headache | 7 | 3.5% | 0 | 0 |
| Urinary tract infection | 7 | 3.5% | 1 | 4 |
| Arthralgia | 6 | 3.0% | 0 | 1 |
| Condition aggravated | 6 | 3.0% | 0 | 0 |
| Intentional product use issue | 6 | 3.0% | 0 | 0 |
| Maternal exposure during pregnancy | 6 | 3.0% | 0 | 0 |
| Off label use | 6 | 3.0% | 0 | 2 |
| Peripheral swelling | 6 | 3.0% | 0 | 1 |
| Sepsis | 6 | 3.0% | 4 | 4 |
| Asthenia | 5 | 2.5% | 0 | 0 |
| Erythema | 5 | 2.5% | 0 | 0 |
Who Reports SPESOLIMAB-SBZO Side Effects? Age & Gender Data
Gender: 72.7% female, 27.3% male. Average age: 58.7 years. Most reports from: US. View detailed demographics →
Is SPESOLIMAB-SBZO Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2022 | 5 | 0 | 2 |
| 2023 | 21 | 1 | 4 |
| 2024 | 59 | 5 | 12 |
| 2025 | 25 | 3 | 6 |
What Is SPESOLIMAB-SBZO Used For?
| Indication | Reports |
|---|---|
| Generalised pustular psoriasis | 80 |
| Pustular psoriasis | 70 |
| Product used for unknown indication | 36 |
| Psoriasis | 7 |
SPESOLIMAB-SBZO vs Alternatives: Which Is Safer?
SPESOLIMAB-SBZO vs SPIRAMYCIN
SPESOLIMAB-SBZO vs SPIRIVA
SPESOLIMAB-SBZO vs SPIRONOLACTONE
SPESOLIMAB-SBZO vs SPRYCEL
SPESOLIMAB-SBZO vs STALEVO
SPESOLIMAB-SBZO vs STANNOUS FLUORIDE
SPESOLIMAB-SBZO vs STANOZOLOL
SPESOLIMAB-SBZO vs STAVUDINE
SPESOLIMAB-SBZO vs STELARA
SPESOLIMAB-SBZO vs STIRIPENTOL
Official FDA Label for SPESOLIMAB-SBZO
Official prescribing information from the FDA-approved drug label.