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CLOFARABINE

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Clofarabine Adverse Events Reported to the FDA Over Time

How are Clofarabine adverse event reports trending over time?

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

Most Common Clofarabine Adverse Events Reported to the FDA

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

Febrile Neutropenia
320 (1.98%)
Hypotension
288 (1.78%)
Sepsis
208 (1.29%)
Diarrhoea
201 (1.24%)
Renal Failure Acute
185 (1.15%)
Pyrexia
166 (1.03%)
Pneumonia
165 (1.02%)
Pleural Effusion
162 (1%)
Neutropenia
159 (.98%)
Renal Failure
157 (.97%)
Nausea
154 (.95%)
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Pancytopenia
152 (.94%)
Vomiting
148 (.92%)
Multi-organ Failure
134 (.83%)
Platelet Count Decreased
133 (.82%)
Respiratory Failure
133 (.82%)
Haemoglobin Decreased
127 (.79%)
Staphylococcal Infection
122 (.76%)
Thrombocytopenia
114 (.71%)
Blood Bilirubin Increased
112 (.69%)
Pulmonary Oedema
109 (.67%)
Mucosal Inflammation
108 (.67%)
Septic Shock
107 (.66%)
Bone Marrow Failure
106 (.66%)
Blood Culture Positive
100 (.62%)
White Blood Cell Count Decreased
99 (.61%)
Dyspnoea
96 (.59%)
Alanine Aminotransferase Increased
92 (.57%)
General Physical Health Deteriorati...
92 (.57%)
Confusional State
89 (.55%)
Tachycardia
89 (.55%)
Haematocrit Decreased
88 (.54%)
Aspartate Aminotransferase Increase...
81 (.5%)
Atrial Fibrillation
81 (.5%)
Hypokalaemia
81 (.5%)
Hypoxia
81 (.5%)
Neutropenic Sepsis
81 (.5%)
Anaemia
80 (.5%)
Ascites
79 (.49%)
Headache
79 (.49%)
Abdominal Pain
77 (.48%)
Blood Creatinine Increased
75 (.46%)
Death
75 (.46%)
Hyperbilirubinaemia
74 (.46%)
Oedema Peripheral
73 (.45%)
Respiratory Distress
73 (.45%)
Infection
72 (.45%)
Cardiac Arrest
70 (.43%)
Dehydration
66 (.41%)
Enterococcal Infection
64 (.4%)
Asthenia
63 (.39%)
Atelectasis
63 (.39%)
Renal Impairment
63 (.39%)
Palmar-plantar Erythrodysaesthesia ...
62 (.38%)
Capillary Leak Syndrome
61 (.38%)
Disease Progression
61 (.38%)
Dialysis
60 (.37%)
Pancreatitis
60 (.37%)
Acute Myeloid Leukaemia
59 (.37%)
Fatigue
59 (.37%)
Haemodialysis
59 (.37%)
Aplasia
57 (.35%)
Fluid Overload
57 (.35%)
Rash
57 (.35%)
Bacterial Infection
56 (.35%)
Mental Status Changes
56 (.35%)
Fungal Infection
55 (.34%)
Caecitis
53 (.33%)
Blood Potassium Decreased
51 (.32%)
Fall
51 (.32%)
Oedema
51 (.32%)
Erythema
50 (.31%)
Pericardial Effusion
50 (.31%)
Transaminases Increased
50 (.31%)
Acute Respiratory Distress Syndrome
49 (.3%)
Hypertension
49 (.3%)
Cholelithiasis
48 (.3%)
Pain
48 (.3%)
Cardiac Failure Congestive
46 (.28%)
Metabolic Acidosis
46 (.28%)
Bacteraemia
45 (.28%)
Blood Alkaline Phosphatase Increase...
45 (.28%)
Chills
44 (.27%)
Hepatotoxicity
44 (.27%)
Bronchopulmonary Aspergillosis
43 (.27%)
Convulsion
43 (.27%)
Pulmonary Haemorrhage
42 (.26%)
Drug Toxicity
41 (.25%)
Heart Rate Increased
40 (.25%)
Lung Infection
40 (.25%)
Lymphadenopathy
40 (.25%)
Pain In Extremity
40 (.25%)
Gastrointestinal Haemorrhage
39 (.24%)
Neutropenic Colitis
39 (.24%)
Agitation
38 (.24%)
Cerebral Haemorrhage
38 (.24%)
Lipase Increased
38 (.24%)
Lung Consolidation
38 (.24%)
Pneumonia Fungal
38 (.24%)
Bk Virus Infection
37 (.23%)
Acidosis
36 (.22%)

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This graph shows the top adverse events submitted to the FDA for Clofarabine, 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 Clofarabine 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 Clofarabine

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

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This graph shows the top categories of adverse events submitted to the FDA for Clofarabine, 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 Clofarabine 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 Clofarabine According to Those Reporting Adverse Events

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

Acute Myeloid Leukaemia
732
Acute Lymphocytic Leukaemia
385
Acute Leukaemia
93
Myelodysplastic Syndrome
89
Myeloid Leukaemia
73
Bone Marrow Conditioning Regimen
58
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Stem Cell Transplant
38
Non-hodgkins Lymphoma
30
Chemotherapy
29
Acute Lymphocytic Leukaemia Recurre...
27
Acute Myeloid Leukaemia Recurrent
20
Lymphoma
17
Leukaemia Recurrent
16
Drug Use For Unknown Indication
13
Product Used For Unknown Indication
12
Leukaemia
10
Chronic Myelomonocytic Leukaemia
9
T-cell Type Acute Leukaemia
9
Bone Marrow Transplant
8
Chronic Myeloid Leukaemia
6
B Precursor Type Acute Leukaemia
5
Disease Recurrence
4
Chloroma
4
B-cell Type Acute Leukaemia
4
5q Minus Syndrome
3
Acute Myelomonocytic Leukaemia
3
Lymphocytic Leukaemia
3
T-cell Lymphoma
3
Non-hodgkins Lymphoma Recurrent
3
B-cell Lymphoma
2
Acute Biphenotypic Leukaemia
2
Pancreatic Carcinoma
2
Accidental Exposure
2
Haematological Malignancy
2
Precursor B-lymphoblastic Lymphoma
2
Non-small Cell Lung Cancer
2
Recurrent Cancer
1
Adult T-cell Lymphoma/leukaemia
1
Adrenoleukodystrophy
1
Acute Promyelocytic Leukaemia
1
Meningeal Disorder
1
Bone Sarcoma
1
Neoplasm Recurrence
1
Myeloproliferative Disorder
1
Hodgkins Disease
1
Adult T-cell Lymphoma/leukaemia Ref...
1
Diffuse Large B-cell Lymphoma
1
Sepsis
1
Multiple Myeloma
1
Central Nervous System Leukaemia
1
5q-syndrome
1

Drug Labels

LabelLabelerEffective
ClolarGenzyme Corporation18-JAN-13
Clolarsanofi-aventis U.S. LLC04-APR-13

Clofarabine Case Reports

What Clofarabine 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 Clofarabine. 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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