EVINACUMAB-DGNB: 92 Adverse Event Reports & Safety Profile
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92
Total FAERS Reports
5 (5.4%)
Deaths Reported
12
Hospitalizations
92
As Primary/Secondary Suspect
Prescription
Status
FDA Application: 761181 ·
First Report: 20210101 · Latest Report: 20250414
What Are the Most Common EVINACUMAB-DGNB Side Effects?
#1 Most Reported
Nausea
14 reports (15.2%)
#2 Most Reported
Fatigue
12 reports (13.0%)
#3 Most Reported
Pain
9 reports (9.8%)
All EVINACUMAB-DGNB Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Nausea | 14 | 15.2% | 0 | 1 |
| Fatigue | 12 | 13.0% | 0 | 2 |
| Pain | 9 | 9.8% | 0 | 1 |
| Hepatic steatosis | 7 | 7.6% | 0 | 0 |
| Diarrhoea | 6 | 6.5% | 0 | 0 |
| Dizziness | 6 | 6.5% | 0 | 0 |
| Drug ineffective | 6 | 6.5% | 0 | 1 |
| International normalised ratio increased | 6 | 6.5% | 0 | 0 |
| Product dose omission issue | 6 | 6.5% | 0 | 0 |
| Death | 5 | 5.4% | 5 | 0 |
| Headache | 5 | 5.4% | 0 | 0 |
Who Reports EVINACUMAB-DGNB Side Effects? Age & Gender Data
Gender: 71.3% female, 28.7% male. Average age: 45.8 years. Most reports from: US. View detailed demographics →
Is EVINACUMAB-DGNB Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2021 | 10 | 0 | 1 |
| 2022 | 11 | 0 | 0 |
| 2023 | 10 | 0 | 1 |
| 2024 | 10 | 4 | 0 |
| 2025 | 4 | 0 | 3 |
What Is EVINACUMAB-DGNB Used For?
| Indication | Reports |
|---|---|
| Type iia hyperlipidaemia | 50 |
| Product used for unknown indication | 33 |
| Hypercholesterolaemia | 8 |
Official FDA Label for EVINACUMAB-DGNB
Official prescribing information from the FDA-approved drug label.