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ELSPAR

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Elspar Adverse Events Reported to the FDA Over Time

How are Elspar adverse event reports trending over time?

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

Most Common Elspar Adverse Events Reported to the FDA

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

Infection
72 (1.92%)
Neutropenia
71 (1.89%)
Convulsion
63 (1.68%)
Pyrexia
53 (1.41%)
Embolism
52 (1.39%)
Sepsis
51 (1.36%)
Superior Sagittal Sinus Thrombosis
41 (1.09%)
Cerebral Infarction
39 (1.04%)
Osteonecrosis
36 (.96%)
Cerebral Haemorrhage
35 (.93%)
Febrile Neutropenia
34 (.91%)
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Pneumonia
32 (.85%)
Encephalopathy
31 (.83%)
White Blood Cell Count Decreased
30 (.8%)
Headache
26 (.69%)
Hypotension
26 (.69%)
Septic Shock
26 (.69%)
Leukoencephalopathy
24 (.64%)
Pancreatic Pseudocyst
24 (.64%)
Vomiting
24 (.64%)
Blood Fibrinogen Decreased
23 (.61%)
Abdominal Pain
22 (.59%)
Antithrombin Iii Decreased
22 (.59%)
Pancytopenia
22 (.59%)
Platelet Count Decreased
22 (.59%)
Thrombosis
21 (.56%)
Blood Culture Positive
20 (.53%)
Hyperglycaemia
20 (.53%)
Pulmonary Embolism
20 (.53%)
Deep Vein Thrombosis
19 (.51%)
Dehydration
19 (.51%)
Dyspnoea
19 (.51%)
Grand Mal Convulsion
19 (.51%)
Haemoglobin Decreased
19 (.51%)
Neutrophil Count Decreased
19 (.51%)
Pancreatitis Acute
19 (.51%)
Death
18 (.48%)
Mucosal Inflammation
18 (.48%)
Multi-organ Failure
18 (.48%)
Neuropathy Peripheral
18 (.48%)
Neurotoxicity
17 (.45%)
Pancreatitis
17 (.45%)
Thrombocytopenia
17 (.45%)
Bone Marrow Failure
16 (.43%)
Drug Toxicity
16 (.43%)
Hyponatraemia
16 (.43%)
Coagulopathy
15 (.4%)
Fungal Infection
15 (.4%)
Haemorrhage Intracranial
15 (.4%)
Haemorrhagic Infarction
15 (.4%)
Hemiparesis
15 (.4%)
Hepatotoxicity
15 (.4%)
Off Label Use
15 (.4%)
Alanine Aminotransferase Increased
14 (.37%)
Nausea
14 (.37%)
Respiratory Failure
14 (.37%)
Cerebral Venous Thrombosis
13 (.35%)
Leukaemia Recurrent
13 (.35%)
Renal Failure Acute
13 (.35%)
Staphylococcal Infection
13 (.35%)
Blood Bilirubin Increased
12 (.32%)
Blood Pressure Increased
12 (.32%)
Coma
12 (.32%)
Embolism Venous
12 (.32%)
Gastrointestinal Haemorrhage
12 (.32%)
Hypertension
12 (.32%)
Hypocoagulable State
12 (.32%)
Hypoxia
12 (.32%)
Simple Partial Seizures
12 (.32%)
Bacterial Infection
11 (.29%)
Cellulitis
11 (.29%)
Cerebral Thrombosis
11 (.29%)
Cough
11 (.29%)
Diabetic Ketoacidosis
11 (.29%)
Disseminated Intravascular Coagulat...
11 (.29%)
Fatigue
11 (.29%)
Pleural Effusion
11 (.29%)
Renal Failure
11 (.29%)
Reversible Posterior Leukoencephalo...
11 (.29%)
Aspartate Aminotransferase Increase...
10 (.27%)
Candidiasis
10 (.27%)
Drug Ineffective
10 (.27%)
Leukopenia
10 (.27%)
Pain
10 (.27%)
Prothrombin Time Prolonged
10 (.27%)
Tumour Lysis Syndrome
10 (.27%)
Activated Partial Thromboplastin Ti...
9 (.24%)
Acute Lymphocytic Leukaemia
9 (.24%)
Brain Oedema
9 (.24%)
Caecitis
9 (.24%)
Cerebrovascular Accident
9 (.24%)
Diarrhoea
9 (.24%)
Hepatic Steatosis
9 (.24%)
Hypertriglyceridaemia
9 (.24%)
Nervous System Disorder
9 (.24%)
Anaemia
8 (.21%)
Anorexia
8 (.21%)
Asthenia
8 (.21%)
Bone Marrow Transplant
8 (.21%)
Diabetes Mellitus
8 (.21%)
Dialysis
8 (.21%)

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

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

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

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

Acute Lymphocytic Leukaemia
754
T-cell Lymphoma Stage Iv
41
Product Used For Unknown Indication
26
Chemotherapy
22
B Precursor Type Acute Leukaemia
21
Drug Use For Unknown Indication
11
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Non-hodgkins Lymphoma
11
Leukaemia
11
T-cell Lymphoma
10
Acute Lymphocytic Leukaemia Recurre...
9
Neoplasm Malignant
9
Acute Myeloid Leukaemia
9
Extranodal Nk/t-cell Lymphoma, Nasa...
7
Lymphoma
7
Lymphocytic Leukaemia
7
T-cell Type Acute Leukaemia
6
B-cell Type Acute Leukaemia
6
Precursor B-lymphoblastic Lymphoma
5
Precursor T-lymphoblastic Lymphoma/...
5
Diffuse Large B-cell Lymphoma
3
Acute Leukaemia
3
Bone Marrow Leukaemic Cell Infiltra...
3
Anaplastic Large Cell Lymphoma T- A...
2
Epstein-barr Virus Infection
2
Stem Cell Transplant
2
Chronic Myeloid Leukaemia
2
Peripheral T-cell Lymphoma Unspecif...
2
Mediastinum Neoplasm
2
Chemotherapy Multiple Agents System...
2
Haematopoietic Neoplasm
2
Carcinoma
1
Mediastinal Mass
1
Aplasia Pure Red Cell
1
Burkitts Lymphoma
1
Myeloid Leukaemia
1
Ataxia Telangiectasia
1
Ill-defined Disorder
1
Natural Killer-cell Leukaemia
1
Acute Myeloid Leukaemia Recurrent
1
Bone Marrow Conditioning Regimen
1
Leukaemia Recurrent
1
Metastases To Bone Marrow
1

Drug Labels

LabelLabelerEffective
ElsparLundbeck LLC14-JAN-13

Elspar Case Reports

What Elspar 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 Elspar. 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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