Fluorouracil

Common brands: Efudex, Tolak, Oxaliplatin, Avastin, Leucovorin Calcium

Top reporter: Bausch Health Us, Llc

Nucleoside Metabolic Inhibitor [EPC]Platinum-based Drug [EPC]Vascular Endothelial Growth Factor Inhibitor [EPC]Epidermal Growth Factor Receptor Antagonist [EPC]Microtubule Inhibitor [EPC]
75,128
Total Reports
33,864
Serious Reports
10,682
Death Reports
30
Reported Reactions
Death Report Ratio: High (14.22%)

Patient Demographics

Male
35,313
Female
29,010

Reported Adverse Reactions (30)

Side effects reported in FDA adverse event reports for Fluorouracil.

# Reaction Reports % of Total
1 DIARRHOEA 6,841
9.1%
2 NEUTROPENIA 5,076
6.7%
3 NAUSEA 4,853
6.4%
4 VOMITING 3,904
5.2%
5 OFF LABEL USE 3,475
4.6%
6 NEUROPATHY PERIPHERAL 3,239
4.3%
7 DISEASE PROGRESSION 3,197
4.2%
8 FATIGUE 3,089
4.1%
9 PYREXIA 3,007
4.0%
10 THROMBOCYTOPENIA 2,917
3.9%
11 FEBRILE NEUTROPENIA 2,837
3.8%
12 ASTHENIA 2,533
3.4%
13 ANAEMIA 2,480
3.3%
14 DRUG INEFFECTIVE 2,165
2.9%
15 MALIGNANT NEOPLASM PROGRESSION 2,089
2.8%
16 DECREASED APPETITE 2,013
2.7%
17 DYSPNOEA 2,001
2.6%
18 DEATH 1,993
2.6%
19 ABDOMINAL PAIN 1,883
2.5%
20 MUCOSAL INFLAMMATION 1,781
2.4%
21 DEHYDRATION 1,692
2.2%
22 LEUKOPENIA 1,588
2.1%
23 RASH 1,523
2.0%
24 STOMATITIS 1,514
2.0%
25 GENERAL PHYSICAL HEALTH DETERIORATION 1,402
1.9%
26 PULMONARY EMBOLISM 1,387
1.8%
27 SEPSIS 1,378
1.8%
28 PNEUMONIA 1,255
1.7%
29 MYELOSUPPRESSION 1,240
1.6%
30 HYPERTENSION 1,197
1.6%

Important Disclaimer

FDA adverse event reports are submitted voluntarily and do not prove causation. A reported reaction does not mean the drug caused it. Drugs with more users naturally have more reports. Always consult your doctor or pharmacist before making medication decisions.