5-FU: 159 Adverse Event Reports & Safety Profile
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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
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2007 | 1 | 0 | 1 |
| 2010 | 2 | 0 | 2 |
| 2011 | 8 | 3 | 5 |
| 2012 | 12 | 2 | 7 |
| 2013 | 44 | 7 | 28 |
| 2014 | 54 | 10 | 37 |
What Is 5-FU Used For?
| Indication | Reports |
|---|---|
| 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.