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ASPARAGINASE

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Asparaginase Adverse Events Reported to the FDA Over Time

How are Asparaginase adverse event reports trending over time?

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

Most Common Asparaginase Adverse Events Reported to the FDA

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

Pyrexia
173 (1.61%)
Hypotension
156 (1.46%)
Neutropenia
133 (1.24%)
Vomiting
118 (1.1%)
Febrile Neutropenia
117 (1.09%)
Thrombosis
94 (.88%)
Abdominal Pain
89 (.83%)
Hyperglycaemia
85 (.79%)
Deep Vein Thrombosis
82 (.77%)
Nausea
79 (.74%)
Sepsis
78 (.73%)
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Blood Bilirubin Increased
76 (.71%)
Convulsion
74 (.69%)
Diarrhoea
71 (.66%)
Headache
71 (.66%)
Coagulopathy
66 (.62%)
Pleural Effusion
66 (.62%)
Septic Shock
66 (.62%)
Cerebral Artery Thrombosis
65 (.61%)
Hepatic Steatosis
65 (.61%)
Intracranial Venous Sinus Thrombosi...
64 (.6%)
Haemorrhage
63 (.59%)
Pneumonia
63 (.59%)
Multi-organ Failure
61 (.57%)
Blood Culture Positive
60 (.56%)
Portal Vein Thrombosis
60 (.56%)
Renal Vein Thrombosis
59 (.55%)
Renal Failure
57 (.53%)
Thrombocytopenia
56 (.52%)
General Physical Health Deteriorati...
54 (.5%)
Tachycardia
54 (.5%)
Dyspnoea
53 (.49%)
Hyperbilirubinaemia
53 (.49%)
Ascites
52 (.49%)
Hypoxia
52 (.49%)
Catheter Thrombosis
51 (.48%)
Staphylococcal Infection
51 (.48%)
Mucosal Inflammation
50 (.47%)
Haemoglobin Decreased
48 (.45%)
Platelet Count Decreased
48 (.45%)
Cardio-respiratory Arrest
47 (.44%)
Pancreatitis
47 (.44%)
Alanine Aminotransferase Increased
46 (.43%)
Cardiac Arrest
46 (.43%)
Respiratory Distress
46 (.43%)
Adenoviral Hepatitis
44 (.41%)
Hepatomegaly
44 (.41%)
Hypertension
44 (.41%)
Hyponatraemia
44 (.41%)
Pancytopenia
42 (.39%)
Caecitis
41 (.38%)
Respiratory Failure
41 (.38%)
Aspartate Aminotransferase Increase...
40 (.37%)
Pancreatitis Acute
40 (.37%)
Reversible Posterior Leukoencephalo...
40 (.37%)
Constipation
39 (.36%)
Dehydration
39 (.36%)
Hepatic Failure
39 (.36%)
Renal Failure Acute
39 (.36%)
Asthenia
38 (.35%)
Loss Of Consciousness
38 (.35%)
White Blood Cell Count Decreased
38 (.35%)
Hemiplegia
37 (.35%)
Blood Glucose Increased
36 (.34%)
Depressed Level Of Consciousness
36 (.34%)
Hepatic Encephalopathy
36 (.34%)
Pseudomonas Infection
36 (.34%)
Abdominal Distension
35 (.33%)
Acute Respiratory Distress Syndrome
35 (.33%)
Neutrophil Count Decreased
35 (.33%)
Oxygen Saturation Decreased
35 (.33%)
Disseminated Intravascular Coagulat...
34 (.32%)
Fatigue
34 (.32%)
Infection
34 (.32%)
Mental Status Changes
34 (.32%)
No Therapeutic Response
34 (.32%)
Back Pain
32 (.3%)
Blood Triglycerides Increased
32 (.3%)
Cough
32 (.3%)
Encephalopathy
32 (.3%)
Activated Partial Thromboplastin Ti...
31 (.29%)
Anaemia
31 (.29%)
Glioma
31 (.29%)
Heart Rate Increased
31 (.29%)
Hypertriglyceridaemia
31 (.29%)
Renal Impairment
31 (.29%)
Fungal Infection
30 (.28%)
Metabolic Acidosis
30 (.28%)
Pain In Extremity
30 (.28%)
Coma
29 (.27%)
Confusional State
29 (.27%)
Hepatotoxicity
29 (.27%)
Pulmonary Embolism
29 (.27%)
Grand Mal Convulsion
28 (.26%)
Muscular Weakness
28 (.26%)
Blood Cholesterol Increased
26 (.24%)
Blood Pressure Decreased
26 (.24%)
Brain Oedema
26 (.24%)
Drug Toxicity
26 (.24%)
Tachypnoea
26 (.24%)
Candidiasis
25 (.23%)

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

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

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

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

Acute Lymphocytic Leukaemia
608
Product Used For Unknown Indication
62
T-cell Type Acute Leukaemia
42
B Precursor Type Acute Leukaemia
37
Non-hodgkins Lymphoma
22
Chemotherapy
18
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Precursor T-lymphoblastic Lymphoma/...
15
Acute Myeloid Leukaemia
13
Leukaemia
12
Lymphocytic Leukaemia
12
Lymphoma
12
Drug Use For Unknown Indication
11
Acute Leukaemia
9
B-cell Type Acute Leukaemia
8
Ill-defined Disorder
7
Malignant Histiocytosis
4
Acute Lymphocytic Leukaemia Recurre...
4
Neoplasm Malignant
3
Leukaemia Recurrent
2
Natural Killer-cell Lymphoblastic L...
2
Precursor B-lymphoblastic Lymphoma
2
Haematological Malignancy
2
Natural Killer-cell Leukaemia
2
Acute Myeloid Leukaemia Recurrent
1
Anaplastic Large Cell Lymphoma T- A...
1
Chronic Myeloid Leukaemia
1
Lymphoproliferative Disorder
1
Systemic Lupus Erythematosus
1
B-cell Lymphoma
1
Peripheral T-cell Lymphoma Unspecif...
1
Intestinal T-cell Lymphoma Recurren...
1
Extranodal Nk/t-cell Lymphoma, Nasa...
1
T-cell Lymphoma
1
Precursor T-lymphoblastic Lymphoma/...
1
Langerhans Cell Granulomatosis
1
Non-hodgkins Lymphoma Stage Iii
1
White Blood Cell Count Decreased
1
Drug Therapy
1
Diffuse Large B-cell Lymphoma
1
Adult T-cell Lymphoma/leukaemia
1

Drug Labels

LabelLabelerEffective
ElsparLundbeck LLC14-JAN-13
ErwinazeJazz Pharmaceuticals, Inc.28-JAN-13

Asparaginase Case Reports

What Asparaginase 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 Asparaginase. 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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