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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

5-FLUOROURACIL: 547 Adverse Event Reports & Safety Profile

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547
Total FAERS Reports
291 (53.2%)
Deaths Reported
133
Hospitalizations
547
As Primary/Secondary Suspect
11
Life-Threatening
4
Disabilities

First Report: 199102 · Latest Report: 20140612

What Are the Most Common 5-FLUOROURACIL Side Effects?

#1 Most Reported
Breast cancer
137 reports (25.0%)
#2 Most Reported
Neoplasm progression
63 reports (11.5%)
#3 Most Reported
Death
37 reports (6.8%)

All 5-FLUOROURACIL Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Breast cancer 137 25.1% 137 0
Neoplasm progression 63 11.5% 63 0
Death 37 6.8% 37 4
Nausea 35 6.4% 4 29
Neutropenia 33 6.0% 5 11
Vomiting 32 5.9% 2 28
Diarrhoea 29 5.3% 2 22
Musculoskeletal disorder 25 4.6% 0 0
Pyrexia 24 4.4% 6 19
Toxicity to various agents 20 3.7% 2 4
Fatigue 19 3.5% 4 12
Interstitial lung disease 16 2.9% 2 7
Dehydration 15 2.7% 2 15
Malignant neoplasm progression 15 2.7% 7 4
Decreased appetite 14 2.6% 4 12
Dyspnoea 14 2.6% 4 9
Thrombocytopenia 12 2.2% 7 5
Drug effect incomplete 11 2.0% 3 3
Febrile neutropenia 11 2.0% 4 8
Breast cancer recurrent 10 1.8% 1 1

Who Reports 5-FLUOROURACIL Side Effects? Age & Gender Data

Average age: 59.7 years. Most reports from: US. View detailed demographics →

Is 5-FLUOROURACIL Getting Safer? Reports by Year

YearReportsDeathsHosp.
2007 1 0 1
2009 1 1 1
2010 4 0 2
2011 11 5 7
2012 13 6 9
2013 43 5 25
2014 41 3 35

View full timeline →

What Is 5-FLUOROURACIL Used For?

IndicationReports
Breast cancer 247
Breast cancer stage i 58
Colon cancer 27
Colorectal cancer metastatic 25
Chemotherapy 14
Colorectal cancer 11
Rectal cancer 10
Colon cancer metastatic 9
Pancreatic carcinoma 9
Invasive ductal breast carcinoma 6

5-FLUOROURACIL vs Alternatives: Which Is Safer?

5-FLUOROURACIL vs 5-FU 5-FLUOROURACIL vs 6-ACETYLMORPHINE 5-FLUOROURACIL vs ABACAVIR 5-FLUOROURACIL vs ABACAVIR\DOLUTEGRAVIR\LAMIVUDINE 5-FLUOROURACIL vs ABACAVIR\LAMIVUDINE 5-FLUOROURACIL vs ABACAVIR\LAMIVUDINE\ZIDOVUDINE 5-FLUOROURACIL vs ABALOPARATIDE 5-FLUOROURACIL vs ABATACEPT 5-FLUOROURACIL vs ABCIXIMAB 5-FLUOROURACIL vs ABEMACICLIB

Official FDA Label for 5-FLUOROURACIL

Official prescribing information from the FDA-approved drug label.