FLUOROURACIL\LEUCOVORIN: 28 Adverse Event Reports & Safety Profile
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28
Total FAERS Reports
4 (14.3%)
Deaths Reported
5
Hospitalizations
28
As Primary/Secondary Suspect
5
Life-Threatening
First Report: 2019 · Latest Report: 20250526
What Are the Most Common FLUOROURACIL\LEUCOVORIN Side Effects?
#1 Most Reported
Neutropenia
9 reports (32.1%)
#2 Most Reported
Neuropathy peripheral
7 reports (25.0%)
#3 Most Reported
Skin toxicity
6 reports (21.4%)
All FLUOROURACIL\LEUCOVORIN Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Neutropenia | 9 | 32.1% | 0 | 0 |
| Neuropathy peripheral | 7 | 25.0% | 0 | 0 |
| Skin toxicity | 6 | 21.4% | 0 | 0 |
| Diarrhoea | 5 | 17.9% | 0 | 0 |
| Thrombocytopenia | 5 | 17.9% | 2 | 0 |
Who Reports FLUOROURACIL\LEUCOVORIN Side Effects? Age & Gender Data
Gender: 28.1% female, 71.9% male. Average age: 59.7 years. Most reports from: RO. View detailed demographics →
Is FLUOROURACIL\LEUCOVORIN Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2019 | 4 | 2 | 2 |
| 2020 | 2 | 0 | 2 |
| 2022 | 1 | 0 | 0 |
| 2023 | 3 | 0 | 0 |
| 2024 | 2 | 0 | 0 |
| 2025 | 1 | 0 | 1 |
What Is FLUOROURACIL\LEUCOVORIN Used For?
| Indication | Reports |
|---|---|
| Colorectal cancer metastatic | 10 |
| Adenocarcinoma of colon | 5 |
Official FDA Label for FLUOROURACIL\LEUCOVORIN
Official prescribing information from the FDA-approved drug label.