Busulfan

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

Top reporter: Otsuka America Pharmaceutical, Inc.

Alkylating Drug [EPC]Calcineurin Inhibitor Immunosuppressant [EPC]Folate Analog Metabolic Inhibitor [EPC]Corticosteroid [EPC]Nucleoside Metabolic Inhibitor [EPC]
18,029
Total Reports
10,274
Serious Reports
5,582
Death Reports
30
Reported Reactions
Death Report Ratio: High (30.96%)

Patient Demographics

Male
7,501
Female
5,589

Reported Adverse Reactions (30)

Side effects reported in FDA adverse event reports for Busulfan.

# Reaction Reports % of Total
1 OFF LABEL USE 2,095
9.2%
2 PRODUCT USE IN UNAPPROVED INDICATION 1,827
8.0%
3 MUCOSAL INFLAMMATION 1,200
5.3%
4 DRUG INEFFECTIVE 1,072
4.7%
5 GRAFT VERSUS HOST DISEASE 1,052
4.6%
6 ACUTE GRAFT VERSUS HOST DISEASE 1,036
4.5%
7 VENOOCCLUSIVE LIVER DISEASE 1,034
4.5%
8 CYTOMEGALOVIRUS INFECTION 979
4.3%
9 FEBRILE NEUTROPENIA 971
4.3%
10 PYREXIA 904
4.0%
11 CHRONIC GRAFT VERSUS HOST DISEASE 763
3.3%
12 SEPSIS 723
3.2%
13 ACUTE GRAFT VERSUS HOST DISEASE IN SKIN 667
2.9%
14 DIARRHOEA 652
2.9%
15 INFECTION 621
2.7%
16 VENOOCCLUSIVE DISEASE 611
2.7%
17 THROMBOCYTOPENIA 608
2.7%
18 CYTOMEGALOVIRUS INFECTION REACTIVATION 593
2.6%
19 PNEUMONIA 588
2.6%
20 RESPIRATORY FAILURE 523
2.3%
21 CYSTITIS HAEMORRHAGIC 496
2.2%
22 THROMBOTIC MICROANGIOPATHY 484
2.1%
23 PANCYTOPENIA 476
2.1%
24 NEUTROPENIA 455
2.0%
25 NAUSEA 423
1.9%
26 STOMATITIS 403
1.8%
27 BK VIRUS INFECTION 396
1.7%
28 CYTOMEGALOVIRUS VIRAEMIA 380
1.7%
29 MULTIPLE ORGAN DYSFUNCTION SYNDROME 377
1.7%
30 DEATH 372
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.