VORETIGENE NEPARVOVEC: 38 Adverse Event Reports & Safety Profile
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38
Total FAERS Reports
0
Deaths Reported
0
Hospitalizations
38
As Primary/Secondary Suspect
2
Disabilities
First Report: 20190901 · Latest Report: 20220315
What Are the Most Common VORETIGENE NEPARVOVEC Side Effects?
#1 Most Reported
Retinal degeneration
25 reports (65.8%)
#2 Most Reported
Injection site atrophy
15 reports (39.5%)
#3 Most Reported
Intraocular pressure increased
8 reports (21.1%)
All VORETIGENE NEPARVOVEC Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Retinal degeneration | 25 | 65.8% | 0 | 0 |
| Injection site atrophy | 15 | 39.5% | 0 | 0 |
| Intraocular pressure increased | 8 | 21.1% | 0 | 0 |
| Metamorphopsia | 6 | 15.8% | 0 | 0 |
| Migraine | 6 | 15.8% | 0 | 0 |
| Pharyngitis | 6 | 15.8% | 0 | 0 |
| Urticaria | 6 | 15.8% | 0 | 0 |
| Chronic spontaneous urticaria | 5 | 13.2% | 0 | 0 |
| Headache | 5 | 13.2% | 0 | 0 |
Who Reports VORETIGENE NEPARVOVEC Side Effects? Age & Gender Data
Gender: 50.0% female, 50.0% male. Average age: 19.0 years. Most reports from: COUNTRY NOT SPECIFIED. View detailed demographics →
Is VORETIGENE NEPARVOVEC Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2019 | 4 | 0 | 0 |
| 2020 | 9 | 0 | 0 |
| 2021 | 16 | 0 | 0 |
| 2022 | 6 | 0 | 0 |
What Is VORETIGENE NEPARVOVEC Used For?
| Indication | Reports |
|---|---|
| Retinal dystrophy | 32 |
| Rpe65 gene mutation | 32 |
| Leber's congenital amaurosis | 6 |
Official FDA Label for VORETIGENE NEPARVOVEC
Official prescribing information from the FDA-approved drug label.