CROVALIMAB-AKKZ: 38 Adverse Event Reports & Safety Profile
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38
Total FAERS Reports
4 (10.5%)
Deaths Reported
24
Hospitalizations
38
As Primary/Secondary Suspect
1
Life-Threatening
Prescription
Status
FDA Application: 761388 ·
First Report: 20240101 · Latest Report: 20250908
What Are the Most Common CROVALIMAB-AKKZ Side Effects?
#1 Most Reported
Pyrexia
12 reports (31.6%)
#2 Most Reported
Type iii immune complex mediated reaction
10 reports (26.3%)
#3 Most Reported
Anaemia
8 reports (21.1%)
All CROVALIMAB-AKKZ Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Pyrexia | 12 | 31.6% | 2 | 10 |
| Type iii immune complex mediated reaction | 10 | 26.3% | 1 | 9 |
| Anaemia | 8 | 21.1% | 0 | 5 |
| Off label use | 7 | 18.4% | 0 | 3 |
| Haemolysis | 6 | 15.8% | 0 | 3 |
| Infection | 5 | 13.2% | 1 | 5 |
Who Reports CROVALIMAB-AKKZ Side Effects? Age & Gender Data
Gender: 43.7% female, 56.3% male. Average age: 69.0 years. Most reports from: JP. View detailed demographics →
Is CROVALIMAB-AKKZ Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2024 | 18 | 4 | 12 |
| 2025 | 18 | 0 | 12 |
What Is CROVALIMAB-AKKZ Used For?
| Indication | Reports |
|---|---|
| Paroxysmal nocturnal haemoglobinuria | 36 |
Official FDA Label for CROVALIMAB-AKKZ
Official prescribing information from the FDA-approved drug label.