VUDALIMAB: 66 Adverse Event Reports & Safety Profile
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66
Total FAERS Reports
17 (25.8%)
Deaths Reported
51
Hospitalizations
66
As Primary/Secondary Suspect
10
Life-Threatening
First Report: 20180101 · Latest Report: 20250716
What Are the Most Common VUDALIMAB Side Effects?
#1 Most Reported
Anaemia
21 reports (31.8%)
#2 Most Reported
C-reactive protein increased
20 reports (30.3%)
#3 Most Reported
Pyrexia
18 reports (27.3%)
All VUDALIMAB Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Anaemia | 21 | 31.8% | 3 | 19 |
| C-reactive protein increased | 20 | 30.3% | 7 | 20 |
| Pyrexia | 18 | 27.3% | 0 | 16 |
| Malignant neoplasm progression | 13 | 19.7% | 5 | 11 |
| Pneumonia | 13 | 19.7% | 2 | 13 |
| Dyspnoea | 12 | 18.2% | 1 | 11 |
| Nausea | 12 | 18.2% | 6 | 11 |
| Platelet count decreased | 12 | 18.2% | 1 | 10 |
| Hypoxia | 10 | 15.2% | 2 | 10 |
| Vomiting | 10 | 15.2% | 0 | 10 |
| Abdominal pain | 9 | 13.6% | 7 | 9 |
| Asthenia | 9 | 13.6% | 0 | 8 |
| Fatigue | 9 | 13.6% | 1 | 6 |
| Hypotension | 9 | 13.6% | 1 | 9 |
| Blood creatinine increased | 8 | 12.1% | 0 | 8 |
| Chromaturia | 8 | 12.1% | 0 | 8 |
| Infusion related reaction | 8 | 12.1% | 0 | 7 |
| Abdominal distension | 7 | 10.6% | 7 | 7 |
| Abdominal pain lower | 7 | 10.6% | 0 | 7 |
| Ascites | 7 | 10.6% | 0 | 1 |
Who Reports VUDALIMAB Side Effects? Age & Gender Data
Gender: 26.0% female, 74.0% male. Average age: 66.2 years. Most reports from: ES. View detailed demographics →
Is VUDALIMAB Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2018 | 1 | 0 | 0 |
| 2023 | 12 | 4 | 11 |
| 2024 | 40 | 9 | 33 |
| 2025 | 8 | 4 | 4 |
What Is VUDALIMAB Used For?
| Indication | Reports |
|---|---|
| Non-small cell lung cancer | 37 |
| Adenocarcinoma | 18 |
| Prostate cancer | 5 |
Official FDA Label for VUDALIMAB
Official prescribing information from the FDA-approved drug label.