Skip to content
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-FU: 159 Adverse Event Reports & Safety Profile

Boost Your Natural Energy & Metabolism

Mitolyn — 6 exotic plants to unlock your body's fat-burning power. 90-day guarantee.

Try Mitolyn Now
159
Total FAERS Reports
31 (19.5%)
Deaths Reported
87
Hospitalizations
159
As Primary/Secondary Suspect
12
Life-Threatening
2
Disabilities

First Report: 20070404 · Latest Report: 20140626

What Are the Most Common 5-FU Side Effects?

#1 Most Reported
Diarrhoea
21 reports (13.2%)
#2 Most Reported
Disease progression
14 reports (8.8%)
#3 Most Reported
Nausea
13 reports (8.2%)

All 5-FU Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Diarrhoea 21 13.2% 2 16
Disease progression 14 8.8% 8 2
Nausea 13 8.2% 2 8
Stomatitis 12 7.6% 2 6
Vomiting 12 7.6% 0 9
Dehydration 11 6.9% 0 11
Neutropenia 11 6.9% 4 6
Fatigue 9 5.7% 0 8
Hypertension 9 5.7% 0 3
Mucosal inflammation 9 5.7% 1 5
Pneumonia 9 5.7% 2 6
Pyrexia 8 5.0% 1 7
Interstitial lung disease 7 4.4% 2 1
Decreased appetite 6 3.8% 2 5
Leukopenia 6 3.8% 1 3
Dyspnoea 5 3.1% 0 4
Febrile neutropenia 5 3.1% 1 5
Neutrophil count decreased 5 3.1% 1 3
Pulmonary embolism 5 3.1% 0 4

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

Average age: 65.2 years. Most reports from: JP. View detailed demographics →

Is 5-FU Getting Safer? Reports by Year

YearReportsDeathsHosp.
2007 1 0 1
2010 2 0 2
2011 8 3 5
2012 12 2 7
2013 44 7 28
2014 54 10 37

View full timeline →

What Is 5-FU Used For?

IndicationReports
Colorectal cancer metastatic 37
Colon cancer 22
Pancreatic carcinoma 12
Colon cancer metastatic 9
Rectal cancer 9
Breast cancer 8
Oesophageal carcinoma 7
Product used for unknown indication 7

5-FU vs Alternatives: Which Is Safer?

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

Official FDA Label for 5-FU

Official prescribing information from the FDA-approved drug label.