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ARA C

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Ara C Adverse Events Reported to the FDA Over Time

How are Ara C adverse event reports trending over time?

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

Most Common Ara C Adverse Events Reported to the FDA

What are the most common Ara C adverse events reported to the FDA?

Neutropenia
69 (2.95%)
Sepsis
53 (2.27%)
Pyrexia
50 (2.14%)
Multi-organ Failure
40 (1.71%)
Pneumonia
39 (1.67%)
Renal Impairment
38 (1.63%)
Febrile Neutropenia
37 (1.58%)
Hypotension
35 (1.5%)
Septic Shock
31 (1.33%)
Thrombocytopenia
30 (1.28%)
Infection
29 (1.24%)
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Dyspnoea
23 (.98%)
Renal Failure Acute
22 (.94%)
Atrial Fibrillation
21 (.9%)
Diarrhoea
19 (.81%)
Respiratory Failure
19 (.81%)
Metabolic Acidosis
18 (.77%)
Neutropenic Sepsis
18 (.77%)
Acute Myeloid Leukaemia
17 (.73%)
Acute Respiratory Distress Syndrome
17 (.73%)
Pancytopenia
17 (.73%)
Cardiac Arrest
15 (.64%)
Respiratory Distress
15 (.64%)
Acute Respiratory Failure
13 (.56%)
Chills
13 (.56%)
Disease Progression
13 (.56%)
Hypophosphataemia
13 (.56%)
Staphylococcal Infection
13 (.56%)
Anaemia
12 (.51%)
Bone Marrow Failure
12 (.51%)
Hypoxia
12 (.51%)
Lung Infiltration
12 (.51%)
Haemoglobin Decreased
11 (.47%)
Headache
11 (.47%)
Nausea
11 (.47%)
Platelet Count Decreased
11 (.47%)
Tachycardia
11 (.47%)
Tumour Lysis Syndrome
11 (.47%)
White Blood Cell Count Decreased
11 (.47%)
Cerebral Haemorrhage
10 (.43%)
Chest Pain
10 (.43%)
Drug Toxicity
10 (.43%)
Fatigue
10 (.43%)
Fungal Infection
10 (.43%)
Loss Of Consciousness
10 (.43%)
Myocardial Infarction
10 (.43%)
Pericarditis
10 (.43%)
Asthenia
9 (.39%)
Bacteraemia
9 (.39%)
Bacterial Infection
9 (.39%)
Death
9 (.39%)
Lung Disorder
9 (.39%)
Oedema Peripheral
9 (.39%)
Pulmonary Haemorrhage
9 (.39%)
Pulmonary Oedema
9 (.39%)
Urinary Incontinence
9 (.39%)
Caecitis
8 (.34%)
Condition Aggravated
8 (.34%)
Drug Interaction
8 (.34%)
Graft Versus Host Disease
8 (.34%)
Renal Failure
8 (.34%)
Transaminases Increased
8 (.34%)
Abdominal Pain
7 (.3%)
Aspergillosis
7 (.3%)
Blood Culture Positive
7 (.3%)
Cardiac Failure
7 (.3%)
Electrocardiogram Qt Prolonged
7 (.3%)
Enterococcal Bacteraemia
7 (.3%)
Enterococcal Infection
7 (.3%)
Hypoalbuminaemia
7 (.3%)
Interstitial Lung Disease
7 (.3%)
Lymphoproliferative Disorder
7 (.3%)
Malignant Neoplasm Progression
7 (.3%)
Muscular Weakness
7 (.3%)
Pulmonary Alveolar Haemorrhage
7 (.3%)
Subdural Haematoma
7 (.3%)
Vomiting
7 (.3%)
Acidosis
6 (.26%)
Acute Myeloid Leukaemia Recurrent
6 (.26%)
Bronchopneumonia
6 (.26%)
C-reactive Protein Increased
6 (.26%)
Coagulopathy
6 (.26%)
Confusional State
6 (.26%)
Cytomegalovirus Infection
6 (.26%)
Encephalopathy
6 (.26%)
Fluid Overload
6 (.26%)
Hepatic Enzyme Increased
6 (.26%)
Hepatic Failure
6 (.26%)
Hypertension
6 (.26%)
Hypocalcaemia
6 (.26%)
Lung Infection
6 (.26%)
Mucosal Inflammation
6 (.26%)
Myelodysplastic Syndrome
6 (.26%)
Pleural Effusion
6 (.26%)
Pneumonia Bacterial
6 (.26%)
Shock
6 (.26%)
Stomatitis
6 (.26%)
Abdominal Distension
5 (.21%)
Anal Abscess
5 (.21%)
Arrhythmia
5 (.21%)
Atelectasis
5 (.21%)

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

What are the most common Ara C adverse events reported to the FDA?

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

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

Acute Myeloid Leukaemia
189
Acute Lymphocytic Leukaemia
32
Burkitts Lymphoma
31
Peripheral T-cell Lymphoma Unspecif...
28
Myeloid Leukaemia
10
Diffuse Large B-cell Lymphoma
10
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Acute Myeloid Leukaemia Recurrent
9
Drug Use For Unknown Indication
8
Bone Marrow Transplant
7
Non-hodgkins Lymphoma
7
B-cell Lymphoma
6
T-cell Lymphoma
6
Chronic Myeloid Leukaemia
5
Chemotherapy
5
Acute Leukaemia
5
Lymphoma
4
Prophylaxis
4
Hodgkins Disease
4
Cord Blood Transplant Therapy
3
Mantle Cell Lymphoma
3
Angioimmunoblastic T-cell Lymphoma
3
Product Used For Unknown Indication
3
Acute Promyelocytic Leukaemia
3
Hodgkins Disease Nodular Sclerosis ...
2
Leukaemia
2
Myelodysplastic Syndrome
2
Multiple Myeloma
2
Stem Cell Transplant
2
Chronic Lymphocytic Leukaemia
2
Diffuse Large B-cell Lymphoma Stage...
1
T-cell Lymphoma Recurrent
1
Non-hodgkins Lymphoma Recurrent
1
Central Nervous System Lymphoma
1
Haematopoietic Neoplasm
1
Leukaemic Infiltration Brain
1
Leukaemia Recurrent
1
Hodgkins Disease Nodular Sclerosis ...
1
Precursor T-lymphoblastic Lymphoma/...
1
Chronic Myelomonocytic Leukaemia
1

Ara C Case Reports

What Ara C 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 Ara C. 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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