Fludarabine

Common brands: Fludarabine, Cyclophosphamide, Frindovyx, Busulfex, Rituxan

Top reporter: Fresenius Kabi Usa, Llc

Alkylating Drug [EPC]Calcineurin Inhibitor Immunosuppressant [EPC]Corticosteroid [EPC]CD20-directed Cytolytic Antibody [EPC]Nucleoside Metabolic Inhibitor [EPC]
38,321
Total Reports
22,151
Serious Reports
11,767
Death Reports
30
Reported Reactions
Death Report Ratio: High (30.71%)

Patient Demographics

Male
17,440
Female
11,722

Reported Adverse Reactions (30)

Side effects reported in FDA adverse event reports for Fludarabine.

# Reaction Reports % of Total
1 OFF LABEL USE 4,199
9.1%
2 PYREXIA 2,897
6.3%
3 DRUG INEFFECTIVE 2,896
6.2%
4 CYTOKINE RELEASE SYNDROME 2,830
6.1%
5 FEBRILE NEUTROPENIA 2,780
6.0%
6 PRODUCT USE IN UNAPPROVED INDICATION 2,239
4.8%
7 NEUTROPENIA 1,974
4.3%
8 CYTOMEGALOVIRUS INFECTION 1,655
3.6%
9 THROMBOCYTOPENIA 1,575
3.4%
10 SEPSIS 1,506
3.2%
11 ACUTE GRAFT VERSUS HOST DISEASE 1,504
3.2%
12 PNEUMONIA 1,426
3.1%
13 MUCOSAL INFLAMMATION 1,371
3.0%
14 INFECTION 1,363
2.9%
15 PANCYTOPENIA 1,344
2.9%
16 GRAFT VERSUS HOST DISEASE 1,224
2.6%
17 CYTOMEGALOVIRUS INFECTION REACTIVATION 1,182
2.6%
18 DEATH 1,146
2.5%
19 ACUTE GRAFT VERSUS HOST DISEASE IN SKIN 1,104
2.4%
20 DISEASE PROGRESSION 1,045
2.3%
21 ANAEMIA 1,013
2.2%
22 DIARRHOEA 1,012
2.2%
23 RESPIRATORY FAILURE 957
2.1%
24 CHRONIC GRAFT VERSUS HOST DISEASE 922
2.0%
25 MYELODYSPLASTIC SYNDROME 917
2.0%
26 MULTIPLE ORGAN DYSFUNCTION SYNDROME 888
1.9%
27 ACUTE KIDNEY INJURY 887
1.9%
28 PLATELET COUNT DECREASED 844
1.8%
29 HYPOTENSION 826
1.8%
30 NAUSEA 823
1.8%

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.