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BUSULFEX

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Busulfex Adverse Events Reported to the FDA Over Time

How are Busulfex adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Busulfex, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Busulfex is flagged as the suspect drug causing the adverse event.

Most Common Busulfex Adverse Events Reported to the FDA

What are the most common Busulfex adverse events reported to the FDA?

Stomatitis
187 (2.84%)
Acute Graft Versus Host Disease
184 (2.79%)
Diarrhoea
172 (2.61%)
Anorexia
166 (2.52%)
Nausea
160 (2.43%)
Malaise
156 (2.37%)
Vomiting
115 (1.75%)
Graft Versus Host Disease
110 (1.67%)
Chronic Graft Versus Host Disease
98 (1.49%)
Thrombotic Microangiopathy
98 (1.49%)
Venoocclusive Liver Disease
96 (1.46%)
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Sepsis
95 (1.44%)
Cytomegalovirus Infection
91 (1.38%)
Acute Graft Versus Host Disease In ...
85 (1.29%)
Febrile Neutropenia
71 (1.08%)
Stem Cell Transplant
67 (1.02%)
Bone Marrow Transplant
63 (.96%)
Bone Marrow Transplant Rejection
62 (.94%)
Pneumonia
59 (.9%)
Pyrexia
58 (.88%)
Acute Graft Versus Host Disease In ...
56 (.85%)
Acute Myeloid Leukaemia Recurrent
55 (.83%)
Mucosal Inflammation
55 (.83%)
Convulsion
54 (.82%)
Infection
54 (.82%)
Blood Bilirubin Increased
53 (.8%)
Staphylococcal Sepsis
53 (.8%)
Cytomegalovirus Viraemia
49 (.74%)
Leukaemia Recurrent
47 (.71%)
Renal Failure
44 (.67%)
Multi-organ Failure
43 (.65%)
Malignant Neoplasm Progression
42 (.64%)
Cystitis Haemorrhagic
41 (.62%)
Alanine Aminotransferase Increased
38 (.58%)
Thrombocytopenia
38 (.58%)
Disease Recurrence
37 (.56%)
Respiratory Failure
37 (.56%)
Acute Graft Versus Host Disease In ...
36 (.55%)
Acute Myeloid Leukaemia
35 (.53%)
Aspartate Aminotransferase Increase...
35 (.53%)
Venoocclusive Disease
35 (.53%)
Disease Progression
34 (.52%)
Liver Disorder
33 (.5%)
Neutropenia
33 (.5%)
Renal Failure Acute
31 (.47%)
Cardiac Failure
30 (.46%)
Rash
30 (.46%)
Gamma-glutamyltransferase Increased
29 (.44%)
Hepatic Function Abnormal
29 (.44%)
Platelet Count Decreased
28 (.42%)
Recurrent Cancer
28 (.42%)
Acute Respiratory Distress Syndrome
27 (.41%)
Hyperbilirubinaemia
26 (.39%)
Hepatotoxicity
25 (.38%)
Hypokalaemia
25 (.38%)
Transplant Failure
25 (.38%)
Ascites
24 (.36%)
Renal Impairment
24 (.36%)
Blood Lactate Dehydrogenase Increas...
23 (.35%)
Cord Blood Transplant Therapy
23 (.35%)
Weight Increased
23 (.35%)
Hypertension
22 (.33%)
Interstitial Lung Disease
22 (.33%)
Gastrointestinal Haemorrhage
21 (.32%)
Pleural Effusion
21 (.32%)
Jaundice
20 (.3%)
Myelodysplastic Syndrome
20 (.3%)
Pulmonary Oedema
19 (.29%)
Bk Virus Infection
18 (.27%)
Epstein-barr Virus Infection
18 (.27%)
Histiocytosis Haematophagic
18 (.27%)
Hyponatraemia
18 (.27%)
Septic Shock
18 (.27%)
Acute Lymphocytic Leukaemia Recurre...
17 (.26%)
Cerebral Haemorrhage
17 (.26%)
Condition Aggravated
17 (.26%)
Encephalitis Viral
17 (.26%)
Gastrointestinal Toxicity
17 (.26%)
Hypotension
17 (.26%)
No Therapeutic Response
17 (.26%)
Anaemia
16 (.24%)
Enterococcal Sepsis
16 (.24%)
General Physical Health Deteriorati...
16 (.24%)
Hypoalbuminaemia
16 (.24%)
Pancytopenia
16 (.24%)
Bone Marrow Failure
15 (.23%)
Cardiac Arrest
15 (.23%)
Death
15 (.23%)
Haematuria
15 (.23%)
Adenovirus Infection
14 (.21%)
Bacterial Sepsis
14 (.21%)
Blood Creatinine Increased
14 (.21%)
Fungal Infection
14 (.21%)
Headache
14 (.21%)
Hepatic Failure
14 (.21%)
Hypoxia
14 (.21%)
Oedema
14 (.21%)
Pulmonary Haemorrhage
14 (.21%)
Stenotrophomonas Sepsis
14 (.21%)
Blood Pressure Decreased
13 (.2%)
Bronchopulmonary Aspergillosis
13 (.2%)

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This graph shows the top adverse events submitted to the FDA for Busulfex, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Busulfex is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Busulfex

What are the most common Busulfex adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Busulfex, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Busulfex is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Common Uses of Busulfex According to Those Reporting Adverse Events

Why are people taking Busulfex, according to those reporting adverse events to the FDA?

Stem Cell Transplant
851
Bone Marrow Conditioning Regimen
126
Bone Marrow Transplant
60
Acute Myeloid Leukaemia
42
Cord Blood Transplant Therapy
32
Drug Use For Unknown Indication
15
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Acute Lymphocytic Leukaemia
15
Myelodysplastic Syndrome
13
Leukaemia
9
Allogenic Bone Marrow Transplantati...
9
Transplant Evaluation
7
Chronic Myeloid Leukaemia
7
Chemotherapy
6
Essential Thrombocythaemia
6
Multiple Myeloma
5
Prophylaxis Against Transplant Reje...
5
Myeloid Leukaemia
4
Preoperative Care
4
Product Used For Unknown Indication
3
Haematological Malignancy
3
Prophylaxis Against Graft Versus Ho...
3
Mycosis Fungoides
2
Follicle Centre Lymphoma, Follicula...
2
T-cell Lymphoma Stage Iv
2
Premedication
2
B-cell Lymphoma Refractory
1
Transplant
1
Acute Leukaemia
1
Nasopharyngitis
1
Chronic Myeloid Leukaemia Transform...
1
Chronic Myelomonocytic Leukaemia
1
Lymphoma
1
Non-hodgkins Lymphoma
1
Bone Marrow Disorder
1
Accidental Exposure
1

Drug Labels

LabelLabelerEffective
BusulfexOtsuka America Pharmaceutical Inc.16-SEP-10

Busulfex Case Reports

What Busulfex safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Busulfex. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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