SUTIMLIMAB-JOME: 209 Adverse Event Reports & Safety Profile
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209
Total FAERS Reports
28 (13.4%)
Deaths Reported
37
Hospitalizations
209
As Primary/Secondary Suspect
7
Life-Threatening
3
Disabilities
Prescription
Status
FDA Application: 761164 ·
First Report: 20220101 · Latest Report: 20250801
What Are the Most Common SUTIMLIMAB-JOME Side Effects?
#1 Most Reported
Off label use
18 reports (8.6%)
#2 Most Reported
Haemoglobin decreased
15 reports (7.2%)
#3 Most Reported
Arthralgia
15 reports (7.2%)
All SUTIMLIMAB-JOME Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Off label use | 18 | 8.6% | 1 | 2 |
| Arthralgia | 15 | 7.2% | 0 | 3 |
| Haemoglobin decreased | 15 | 7.2% | 0 | 5 |
| Condition aggravated | 12 | 5.7% | 4 | 4 |
| Drug ineffective | 10 | 4.8% | 1 | 0 |
| Fatigue | 10 | 4.8% | 3 | 4 |
| Haemolysis | 10 | 4.8% | 3 | 1 |
| Headache | 9 | 4.3% | 0 | 2 |
| Inappropriate schedule of product administration | 8 | 3.8% | 0 | 0 |
| Covid-19 | 7 | 3.4% | 1 | 1 |
| Cyanosis | 7 | 3.4% | 0 | 1 |
| Lymphoma | 7 | 3.4% | 2 | 2 |
| Nausea | 7 | 3.4% | 0 | 0 |
| Anaemia | 6 | 2.9% | 1 | 2 |
| Dyspnoea | 6 | 2.9% | 3 | 4 |
| Pain | 6 | 2.9% | 0 | 1 |
| Pyrexia | 6 | 2.9% | 0 | 1 |
| Dizziness | 5 | 2.4% | 0 | 1 |
| Haematuria | 5 | 2.4% | 0 | 1 |
| Hypertension | 5 | 2.4% | 0 | 0 |
Who Reports SUTIMLIMAB-JOME Side Effects? Age & Gender Data
Gender: 69.9% female, 30.1% male. Average age: 72.1 years. Most reports from: US. View detailed demographics →
Is SUTIMLIMAB-JOME Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2022 | 22 | 2 | 10 |
| 2023 | 26 | 4 | 8 |
| 2024 | 39 | 6 | 4 |
| 2025 | 13 | 2 | 2 |
What Is SUTIMLIMAB-JOME Used For?
| Indication | Reports |
|---|---|
| Cold type haemolytic anaemia | 111 |
| Product used for unknown indication | 16 |
| Autoimmune haemolytic anaemia | 7 |
SUTIMLIMAB-JOME vs Alternatives: Which Is Safer?
SUTIMLIMAB-JOME vs SUVOREXANT
SUTIMLIMAB-JOME vs SUZETRIGINE
SUTIMLIMAB-JOME vs SYMBICORT
SUTIMLIMAB-JOME vs SYNAGIS
SUTIMLIMAB-JOME vs SYNTHROID
SUTIMLIMAB-JOME vs TACROLIMUS
SUTIMLIMAB-JOME vs TACROLIMUS\TACROLIMUS ANHYDROUS
SUTIMLIMAB-JOME vs TADALAFIL
SUTIMLIMAB-JOME vs TAFAMIDIS
SUTIMLIMAB-JOME vs TAFAMIDIS MEGLUMINE
Official FDA Label for SUTIMLIMAB-JOME
Official prescribing information from the FDA-approved drug label.