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CLOLAR

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Clolar Adverse Events Reported to the FDA Over Time

How are Clolar adverse event reports trending over time?

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

Most Common Clolar Adverse Events Reported to the FDA

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

Febrile Neutropenia
127 (2.16%)
Hypotension
123 (2.1%)
Neutropenia
118 (2.01%)
Sepsis
108 (1.84%)
Death
100 (1.7%)
Thrombocytopenia
94 (1.6%)
Multi-organ Failure
85 (1.45%)
Renal Failure
75 (1.28%)
Pancytopenia
70 (1.19%)
Pyrexia
67 (1.14%)
Infection
66 (1.12%)
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Pneumonia
61 (1.04%)
Renal Failure Acute
59 (1%)
Hypoxia
58 (.99%)
Respiratory Failure
57 (.97%)
Hypokalaemia
54 (.92%)
Nausea
50 (.85%)
Pleural Effusion
48 (.82%)
Pulmonary Oedema
46 (.78%)
Bone Marrow Failure
45 (.77%)
Diarrhoea
44 (.75%)
Dyspnoea
44 (.75%)
Acute Lymphocytic Leukaemia
43 (.73%)
Tumour Lysis Syndrome
43 (.73%)
Tachycardia
41 (.7%)
Pain
40 (.68%)
Vomiting
40 (.68%)
Atrial Fibrillation
37 (.63%)
Hyperbilirubinaemia
36 (.61%)
Alanine Aminotransferase Increased
35 (.6%)
Aspartate Aminotransferase Increase...
35 (.6%)
Neoplasm Malignant
35 (.6%)
Acute Myeloid Leukaemia
34 (.58%)
Disease Progression
34 (.58%)
Haemoglobin Decreased
34 (.58%)
Leukopenia
33 (.56%)
Palmar-plantar Erythrodysaesthesia ...
32 (.55%)
Neutropenic Infection
31 (.53%)
Abdominal Pain
30 (.51%)
Anaemia
30 (.51%)
Hepatotoxicity
29 (.49%)
Mucosal Inflammation
29 (.49%)
Transaminases Increased
28 (.48%)
Agitation
27 (.46%)
Blood Bilirubin Increased
27 (.46%)
Lung Infiltration
27 (.46%)
Mental Status Changes
27 (.46%)
Respiratory Distress
26 (.44%)
Acute Respiratory Distress Syndrome
25 (.43%)
Dehydration
24 (.41%)
Hypertension
24 (.41%)
Enterococcal Infection
23 (.39%)
Gastrointestinal Haemorrhage
23 (.39%)
Pain In Extremity
23 (.39%)
Device Related Infection
22 (.37%)
Pericardial Effusion
22 (.37%)
Platelet Count Decreased
22 (.37%)
Septic Shock
22 (.37%)
White Blood Cell Count Decreased
22 (.37%)
Blood Culture Positive
21 (.36%)
Cardiac Failure Congestive
21 (.36%)
Cellulitis
21 (.36%)
Constipation
21 (.36%)
Fungal Infection
21 (.36%)
Haemodialysis
21 (.36%)
Malignant Neoplasm Progression
21 (.36%)
Lipase Increased
20 (.34%)
Blood Creatinine Increased
19 (.32%)
Capillary Leak Syndrome
19 (.32%)
Cardiac Failure
19 (.32%)
Cardio-respiratory Arrest
19 (.32%)
Coagulopathy
19 (.32%)
Dialysis
19 (.32%)
Drug Toxicity
19 (.32%)
Encephalopathy
19 (.32%)
Hepatic Function Abnormal
19 (.32%)
Pneumonitis
19 (.32%)
Cardiac Arrest
18 (.31%)
Confusional State
18 (.31%)
Graft Versus Host Disease
18 (.31%)
Insomnia
18 (.31%)
Liver Function Test Abnormal
18 (.31%)
Lymphopenia
18 (.31%)
Staphylococcal Infection
18 (.31%)
Venoocclusive Liver Disease
18 (.31%)
Acute Graft Versus Host Disease In ...
17 (.29%)
Aplasia
17 (.29%)
Convulsion
17 (.29%)
Fatigue
17 (.29%)
Pancreatitis
17 (.29%)
Pulmonary Haemorrhage
17 (.29%)
Sinus Tachycardia
17 (.29%)
Staphylococcal Bacteraemia
17 (.29%)
Acute Leukaemia
16 (.27%)
Bradycardia
16 (.27%)
Cardiomegaly
16 (.27%)
Epistaxis
16 (.27%)
General Physical Health Deteriorati...
16 (.27%)
Headache
16 (.27%)
Venoocclusive Disease
16 (.27%)
Cerebral Haemorrhage
15 (.26%)

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

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

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

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

Acute Myeloid Leukaemia
317
Acute Lymphocytic Leukaemia
286
Acute Leukaemia
95
Myelodysplastic Syndrome
48
Haematological Malignancy
25
Bone Marrow Conditioning Regimen
23
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Non-hodgkins Lymphoma
21
Stem Cell Transplant
21
Acute Lymphocytic Leukaemia Recurre...
18
Myeloid Leukaemia
16
Product Used For Unknown Indication
14
Leukaemia
12
Drug Use For Unknown Indication
11
Acute Myeloid Leukaemia Recurrent
9
Acute Promyelocytic Leukaemia
7
B-cell Lymphoma
6
Lymphoma
5
T-cell Lymphoma Refractory
5
Acute Biphenotypic Leukaemia
5
Chronic Lymphocytic Leukaemia
5
Multiple Myeloma
3
T-cell Lymphoma
3
Acute Monocytic Leukaemia
3
B-cell Type Acute Leukaemia
2
Non-hodgkins Lymphoma Refractory
2
Disease Recurrence
2
B Precursor Type Acute Leukaemia
1
Leukaemia Recurrent
1
Myeloproliferative Disorder
1
Adult T-cell Lymphoma/leukaemia
1
Adrenoleukodystrophy
1
Acute Megakaryocytic Leukaemia
1
Neuroblastoma
1
Langerhans Cell Histiocytosis
1
Rhabdomyosarcoma
1
Chronic Myeloid Leukaemia
1
Angioimmunoblastic T-cell Lymphoma
1

Drug Labels

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

Clolar Case Reports

What Clolar 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 Clolar. 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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