VONICOG ALFA: 99 Adverse Event Reports & Safety Profile
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99
Total FAERS Reports
4 (4.0%)
Deaths Reported
43
Hospitalizations
99
As Primary/Secondary Suspect
1
Life-Threatening
First Report: 20200101 · Latest Report: 20250807
What Are the Most Common VONICOG ALFA Side Effects?
#1 Most Reported
Off label use
27 reports (27.3%)
#2 Most Reported
Epistaxis
17 reports (17.2%)
#3 Most Reported
Haemorrhage
16 reports (16.2%)
All VONICOG ALFA Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Off label use | 27 | 27.3% | 0 | 13 |
| Epistaxis | 17 | 17.2% | 1 | 6 |
| Haemorrhage | 16 | 16.2% | 0 | 5 |
| Gastrointestinal haemorrhage | 12 | 12.1% | 1 | 6 |
| No adverse event | 11 | 11.1% | 0 | 8 |
| Fall | 9 | 9.1% | 0 | 5 |
| Haemarthrosis | 9 | 9.1% | 0 | 6 |
| Pain | 8 | 8.1% | 0 | 1 |
| Drug ineffective | 7 | 7.1% | 0 | 3 |
| Fatigue | 7 | 7.1% | 0 | 7 |
| Gait disturbance | 7 | 7.1% | 1 | 3 |
| Haemoglobin decreased | 7 | 7.1% | 1 | 6 |
| Heavy menstrual bleeding | 7 | 7.1% | 0 | 1 |
| Incorrect dose administered | 7 | 7.1% | 1 | 5 |
| Product dose omission issue | 7 | 7.1% | 0 | 3 |
| Covid-19 | 6 | 6.1% | 0 | 4 |
| Depression | 6 | 6.1% | 0 | 0 |
| Discomfort | 6 | 6.1% | 0 | 0 |
| Asthenia | 5 | 5.1% | 1 | 4 |
| General physical health deterioration | 5 | 5.1% | 1 | 5 |
Who Reports VONICOG ALFA Side Effects? Age & Gender Data
Gender: 60.1% female, 39.9% male. Average age: 52.9 years. Most reports from: DE. View detailed demographics →
Is VONICOG ALFA Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2020 | 7 | 1 | 5 |
| 2021 | 9 | 0 | 4 |
| 2022 | 10 | 0 | 4 |
| 2023 | 17 | 1 | 6 |
| 2024 | 9 | 0 | 2 |
| 2025 | 10 | 0 | 8 |
What Is VONICOG ALFA Used For?
| Indication | Reports |
|---|---|
| Von willebrand's disease | 48 |
| Haemorrhage | 19 |
| Product used for unknown indication | 18 |
| Haemostasis | 12 |
| Haemorrhage prophylaxis | 7 |
| Prophylaxis | 6 |
Official FDA Label for VONICOG ALFA
Official prescribing information from the FDA-approved drug label.