BUDIGALIMAB: 38 Adverse Event Reports & Safety Profile
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38
Total FAERS Reports
1 (2.6%)
Deaths Reported
34
Hospitalizations
38
As Primary/Secondary Suspect
2
Life-Threatening
First Report: 201901 · Latest Report: 20250609
What Are the Most Common BUDIGALIMAB Side Effects?
#1 Most Reported
Dehydration
11 reports (28.9%)
#2 Most Reported
Anaemia
10 reports (26.3%)
#3 Most Reported
Vomiting
9 reports (23.7%)
All BUDIGALIMAB Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Dehydration | 11 | 29.0% | 0 | 11 |
| Anaemia | 10 | 26.3% | 0 | 10 |
| Vomiting | 9 | 23.7% | 0 | 8 |
| Back pain | 8 | 21.1% | 1 | 5 |
| Diarrhoea | 8 | 21.1% | 0 | 7 |
| Fatigue | 8 | 21.1% | 0 | 7 |
| Decreased appetite | 7 | 18.4% | 0 | 7 |
| Abdominal pain | 6 | 15.8% | 0 | 6 |
| Nausea | 6 | 15.8% | 0 | 6 |
| Immune-mediated hepatitis | 5 | 13.2% | 0 | 5 |
| Malaise | 5 | 13.2% | 0 | 5 |
| Pyrexia | 5 | 13.2% | 0 | 4 |
Who Reports BUDIGALIMAB Side Effects? Age & Gender Data
Gender: 76.1% female, 23.9% male. Average age: 64.1 years. Most reports from: US. View detailed demographics →
Is BUDIGALIMAB Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2019 | 1 | 0 | 1 |
| 2020 | 1 | 0 | 1 |
| 2021 | 11 | 0 | 11 |
| 2022 | 16 | 1 | 14 |
| 2023 | 5 | 0 | 3 |
| 2025 | 4 | 0 | 4 |
What Is BUDIGALIMAB Used For?
| Indication | Reports |
|---|---|
| Pancreatic carcinoma metastatic | 19 |
| Pancreatic carcinoma | 8 |
Official FDA Label for BUDIGALIMAB
Official prescribing information from the FDA-approved drug label.