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Oncaspar Adverse Events Reported to the FDA Over Time

How are Oncaspar adverse event reports trending over time?

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

Most Common Oncaspar Adverse Events Reported to the FDA

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

Pyrexia
65 (2.3%)
Vomiting
56 (1.98%)
Hypotension
55 (1.95%)
Urticaria
55 (1.95%)
Hyperglycaemia
51 (1.81%)
Anaphylactic Reaction
50 (1.77%)
Hyperbilirubinaemia
42 (1.49%)
Hypersensitivity
41 (1.45%)
Pancreatitis
38 (1.35%)
Dyspnoea
35 (1.24%)
Hypertriglyceridaemia
32 (1.13%)
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Nausea
32 (1.13%)
Rash
29 (1.03%)
Pleural Effusion
27 (.96%)
Pruritus
26 (.92%)
Swelling Face
23 (.81%)
Abdominal Pain
22 (.78%)
Headache
22 (.78%)
Neutropenia
22 (.78%)
Blood Bilirubin Increased
21 (.74%)
Cough
20 (.71%)
Drug Hypersensitivity
19 (.67%)
Mucosal Inflammation
19 (.67%)
Respiratory Distress
19 (.67%)
Thrombocytopenia
19 (.67%)
Ascites
18 (.64%)
Constipation
18 (.64%)
Platelet Count Decreased
17 (.6%)
Asthenia
16 (.57%)
Infusion Related Reaction
16 (.57%)
Lip Swelling
16 (.57%)
Back Pain
15 (.53%)
Disseminated Intravascular Coagulat...
15 (.53%)
Alanine Aminotransferase Increased
14 (.5%)
Anaemia
14 (.5%)
Aspartate Aminotransferase Increase...
14 (.5%)
Cardiac Arrest
14 (.5%)
Hypertension
14 (.5%)
Renal Failure
14 (.5%)
Tachycardia
14 (.5%)
Activated Partial Thromboplastin Ti...
13 (.46%)
Blood Glucose Increased
13 (.46%)
Blood Pressure Decreased
13 (.46%)
Blood Triglycerides Increased
13 (.46%)
Dehydration
13 (.46%)
Hepatic Steatosis
13 (.46%)
Hypocalcaemia
13 (.46%)
Oropharyngeal Pain
13 (.46%)
Pulmonary Embolism
13 (.46%)
Sepsis
13 (.46%)
White Blood Cell Count Decreased
13 (.46%)
Blood Cholesterol Increased
12 (.43%)
Convulsion
12 (.43%)
Dizziness
12 (.43%)
Erythema
12 (.43%)
Hepatic Failure
12 (.43%)
Hypercholesterolaemia
12 (.43%)
Mental Status Changes
12 (.43%)
Oxygen Saturation Decreased
12 (.43%)
Septic Shock
12 (.43%)
Diarrhoea
11 (.39%)
Hypoalbuminaemia
11 (.39%)
International Normalised Ratio Incr...
11 (.39%)
Prothrombin Time Prolonged
11 (.39%)
Wheezing
11 (.39%)
Anxiety
10 (.35%)
Cerebral Haemorrhage
10 (.35%)
Chills
10 (.35%)
Drug Specific Antibody Present
10 (.35%)
Osteonecrosis
10 (.35%)
Pancytopenia
10 (.35%)
Eye Swelling
9 (.32%)
Fall
9 (.32%)
Febrile Neutropenia
9 (.32%)
General Physical Health Deteriorati...
9 (.32%)
Hypoxia
9 (.32%)
Neutrophil Count Decreased
9 (.32%)
Throat Tightness
9 (.32%)
Abdominal Pain Upper
8 (.28%)
Arthralgia
8 (.28%)
Blood Fibrinogen Decreased
8 (.28%)
Cardio-respiratory Arrest
8 (.28%)
Cerebrovascular Accident
8 (.28%)
Chest Discomfort
8 (.28%)
Depressed Level Of Consciousness
8 (.28%)
Flushing
8 (.28%)
Haemoglobin Decreased
8 (.28%)
Hepatomegaly
8 (.28%)
Hypophagia
8 (.28%)
Infection
8 (.28%)
Leukopenia
8 (.28%)
Pallor
8 (.28%)
Pharyngeal Oedema
8 (.28%)
Pneumomediastinum
8 (.28%)
Abasia
7 (.25%)
Agitation
7 (.25%)
Blood Creatinine Increased
7 (.25%)
Blood Culture Positive
7 (.25%)
Brain Death
7 (.25%)
Coagulopathy
7 (.25%)
Death
7 (.25%)

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

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

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

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

Acute Lymphocytic Leukaemia
304
Drug Use For Unknown Indication
48
B Precursor Type Acute Leukaemia
16
Leukaemia
12
Non-hodgkins Lymphoma
7
Chemotherapy
5
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T-cell Type Acute Leukaemia
5
Neoplasm
3
Acute Lymphocytic Leukaemia Recurre...
3
Multiple Myeloma
3
Acute Leukaemia
2
Precursor B-lymphoblastic Lymphoma
2
T-cell Lymphoma
2
Diffuse Large B-cell Lymphoma
2
Natural Killer-cell Lymphoblastic L...
2
Lymphocytic Leukaemia
1
Metastatic Neoplasm
1
Acute Myeloid Leukaemia
1
Transitional Cell Carcinoma
1
Colon Cancer Metastatic
1
B-cell Type Acute Leukaemia
1
Hepatosplenic T-cell Lymphoma
1
Peritoneal Carcinoma
1
Ovarian Cancer
1
Leukaemia Recurrent
1

Drug Labels

LabelLabelerEffective
OncasparSigma-Tau Pharmaceuticals, Inc.08-JUN-12

Oncaspar Case Reports

What Oncaspar 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 Oncaspar. 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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