RAVULIZUMAB-CWVZ: 10,229 Adverse Event Reports & Safety Profile
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10,229
Total FAERS Reports
551 (5.4%)
Deaths Reported
1,663
Hospitalizations
10,229
As Primary/Secondary Suspect
78
Life-Threatening
24
Disabilities
Prescription
Status
FDA Application: 761108 ·
First Report: 20080101 · Latest Report: 20250925
What Are the Most Common RAVULIZUMAB-CWVZ Side Effects?
#1 Most Reported
Fatigue
1,472 reports (14.4%)
#2 Most Reported
Asthenia
727 reports (7.1%)
#3 Most Reported
Headache
639 reports (6.2%)
All RAVULIZUMAB-CWVZ Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Fatigue | 1,472 | 14.4% | 2 | 127 |
| Asthenia | 727 | 7.1% | 1 | 94 |
| Headache | 639 | 6.3% | 3 | 73 |
| Drug ineffective | 570 | 5.6% | 6 | 73 |
| Off label use | 451 | 4.4% | 9 | 44 |
| Muscular weakness | 422 | 4.1% | 2 | 38 |
| Dyspnoea | 414 | 4.1% | 5 | 89 |
| Malaise | 353 | 3.5% | 3 | 53 |
| Haemoglobin decreased | 346 | 3.4% | 6 | 70 |
| Myasthenia gravis | 338 | 3.3% | 8 | 139 |
| Back pain | 326 | 3.2% | 1 | 35 |
| Pain | 318 | 3.1% | 0 | 50 |
| Therapeutic response shortened | 316 | 3.1% | 1 | 30 |
| Death | 313 | 3.1% | 313 | 9 |
| Feeling abnormal | 307 | 3.0% | 1 | 24 |
| Diplopia | 294 | 2.9% | 0 | 17 |
| Diarrhoea | 279 | 2.7% | 1 | 44 |
| Nausea | 278 | 2.7% | 1 | 36 |
| Arthralgia | 251 | 2.5% | 1 | 27 |
| Haemolysis | 242 | 2.4% | 3 | 66 |
Who Reports RAVULIZUMAB-CWVZ Side Effects? Age & Gender Data
Gender: 53.8% female, 46.2% male. Average age: 55.5 years. Most reports from: US. View detailed demographics →
Is RAVULIZUMAB-CWVZ Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2008 | 1 | 0 | 0 |
| 2010 | 2 | 0 | 0 |
| 2013 | 3 | 0 | 2 |
| 2014 | 2 | 0 | 2 |
| 2015 | 5 | 0 | 1 |
| 2016 | 6 | 1 | 2 |
| 2017 | 4 | 0 | 1 |
| 2018 | 9 | 0 | 2 |
| 2019 | 277 | 9 | 50 |
| 2020 | 166 | 16 | 48 |
| 2021 | 134 | 14 | 52 |
| 2022 | 241 | 27 | 64 |
| 2023 | 638 | 39 | 168 |
| 2024 | 957 | 75 | 215 |
| 2025 | 490 | 81 | 186 |
What Is RAVULIZUMAB-CWVZ Used For?
| Indication | Reports |
|---|---|
| Myasthenia gravis | 3,781 |
| Paroxysmal nocturnal haemoglobinuria | 2,175 |
| Product used for unknown indication | 1,815 |
| Atypical haemolytic uraemic syndrome | 1,121 |
| Neuromyelitis optica spectrum disorder | 403 |
| Off label use | 259 |
| Haemolytic uraemic syndrome | 93 |
| Thrombotic microangiopathy | 62 |
| C3 glomerulopathy | 59 |
| Renal transplant | 11 |
RAVULIZUMAB-CWVZ vs Alternatives: Which Is Safer?
RAVULIZUMAB-CWVZ vs REBAMIPIDE
RAVULIZUMAB-CWVZ vs REBETOL
RAVULIZUMAB-CWVZ vs REBIF
RAVULIZUMAB-CWVZ vs REBOXETINE
RAVULIZUMAB-CWVZ vs RECLAST
RAVULIZUMAB-CWVZ vs RECOMBINANT VARICELLA ZOSTER VIRUS GLYCOPROTEIN E
RAVULIZUMAB-CWVZ vs REGADENOSON
RAVULIZUMAB-CWVZ vs REGORAFENIB
RAVULIZUMAB-CWVZ vs REGORAFENIB\REGORAFENIB
RAVULIZUMAB-CWVZ vs RELATLIMAB
Official FDA Label for RAVULIZUMAB-CWVZ
Official prescribing information from the FDA-approved drug label.