NATALIZUMAB-SZTN: 188 Adverse Event Reports & Safety Profile
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188
Total FAERS Reports
2 (1.1%)
Deaths Reported
18
Hospitalizations
188
As Primary/Secondary Suspect
5
Life-Threatening
40
Disabilities
Prescription
Status
FDA Application: 761322 ·
First Report: 20231216 · Latest Report: 20250730
What Are the Most Common NATALIZUMAB-SZTN Side Effects?
#1 Most Reported
Fatigue
63 reports (33.5%)
#2 Most Reported
Mobility decreased
52 reports (27.7%)
#3 Most Reported
Balance disorder
31 reports (16.5%)
All NATALIZUMAB-SZTN Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Fatigue | 63 | 33.5% | 0 | 3 |
| Mobility decreased | 52 | 27.7% | 0 | 0 |
| Balance disorder | 31 | 16.5% | 0 | 2 |
| Headache | 18 | 9.6% | 0 | 3 |
| Product substitution issue | 17 | 9.0% | 2 | 3 |
| Multiple sclerosis relapse | 16 | 8.5% | 0 | 1 |
| Muscular weakness | 16 | 8.5% | 0 | 0 |
| Cognitive disorder | 13 | 6.9% | 0 | 0 |
| Gait disturbance | 13 | 6.9% | 0 | 0 |
| Dizziness | 11 | 5.9% | 0 | 1 |
| Nausea | 9 | 4.8% | 0 | 0 |
| Urinary incontinence | 9 | 4.8% | 0 | 0 |
| Arthralgia | 7 | 3.7% | 0 | 2 |
| Dysphagia | 7 | 3.7% | 0 | 0 |
| Musculoskeletal stiffness | 7 | 3.7% | 0 | 2 |
| Paraesthesia | 7 | 3.7% | 0 | 0 |
| Progressive multifocal leukoencephalopathy | 7 | 3.7% | 2 | 5 |
| Rash | 7 | 3.7% | 0 | 1 |
| Abdominal distension | 6 | 3.2% | 0 | 0 |
| Alopecia | 6 | 3.2% | 0 | 0 |
Who Reports NATALIZUMAB-SZTN Side Effects? Age & Gender Data
Gender: 84.7% female, 15.3% male. Average age: 47.0 years. Most reports from: GB. View detailed demographics →
Is NATALIZUMAB-SZTN Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2023 | 1 | 0 | 1 |
| 2024 | 140 | 0 | 8 |
| 2025 | 10 | 0 | 2 |
What Is NATALIZUMAB-SZTN Used For?
| Indication | Reports |
|---|---|
| Multiple sclerosis | 142 |
| Product used for unknown indication | 33 |
| Relapsing-remitting multiple sclerosis | 10 |
NATALIZUMAB-SZTN vs Alternatives: Which Is Safer?
NATALIZUMAB-SZTN vs NATAMYCIN
NATALIZUMAB-SZTN vs NATEGLINIDE
NATALIZUMAB-SZTN vs NAVITOCLAX
NATALIZUMAB-SZTN vs NAXITAMAB-GQGK
NATALIZUMAB-SZTN vs NEBIVOLOL
NATALIZUMAB-SZTN vs NECITUMUMAB
NATALIZUMAB-SZTN vs NEDAPLATIN
NATALIZUMAB-SZTN vs NEFAZODONE
NATALIZUMAB-SZTN vs NEFOPAM
NATALIZUMAB-SZTN vs NEISSERIA MENINGITIDIS GROUP B FHBP FUSION PROTEIN ANTIGEN\NEISSERIA MENINGITIDIS GROUP B NADA PROTEIN ANTIGEN\NEISSERIA MENINGITIDIS GROUP B NHBA FUSION PROTEIN ANTIGEN\NEISSERIA MENINGITIDIS GROUP B STRAIN NZ98/254 OUTER MEMBRANE VESICLE\NEISSERIA MENINGITIDIS SEROGROUP B FHBP FUSION PROTEIN ANTIG
Official FDA Label for NATALIZUMAB-SZTN
Official prescribing information from the FDA-approved drug label.