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Dacogen Adverse Events Reported to the FDA Over Time

How are Dacogen adverse event reports trending over time?

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

Most Common Dacogen Adverse Events Reported to the FDA

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

Off Label Use
39 (2.68%)
Platelet Count Decreased
34 (2.34%)
White Blood Cell Count Decreased
31 (2.13%)
Febrile Neutropenia
29 (1.99%)
Pneumonia
26 (1.79%)
Pyrexia
25 (1.72%)
Death
21 (1.44%)
Pancytopenia
20 (1.38%)
Haemoglobin Decreased
19 (1.31%)
Infection
18 (1.24%)
Asthenia
15 (1.03%)
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Bone Marrow Failure
15 (1.03%)
Neutropenia
15 (1.03%)
Respiratory Failure
15 (1.03%)
Thrombocytopenia
15 (1.03%)
Sepsis
14 (.96%)
Colitis
13 (.89%)
Oedema Peripheral
13 (.89%)
Anaemia
12 (.83%)
Confusional State
11 (.76%)
Dyspnoea
11 (.76%)
Hypotension
11 (.76%)
Peritonitis
11 (.76%)
Vomiting
11 (.76%)
Myelodysplastic Syndrome
10 (.69%)
Neutrophil Count Decreased
10 (.69%)
Pleural Effusion
10 (.69%)
Fatigue
9 (.62%)
Renal Failure Acute
9 (.62%)
Acute Myeloid Leukaemia
8 (.55%)
Blood Creatinine Increased
8 (.55%)
Cardiac Failure
8 (.55%)
Constipation
8 (.55%)
Cough
8 (.55%)
Diarrhoea
8 (.55%)
Muscular Weakness
8 (.55%)
Pain In Extremity
8 (.55%)
Rash
8 (.55%)
Renal Failure
8 (.55%)
Arthralgia
7 (.48%)
Cerebral Haemorrhage
7 (.48%)
Chills
7 (.48%)
Condition Aggravated
7 (.48%)
Disease Progression
7 (.48%)
Dizziness
7 (.48%)
Joint Swelling
7 (.48%)
Lung Infection
7 (.48%)
Neuropathy Peripheral
7 (.48%)
Splenic Infarction
7 (.48%)
Abdominal Distension
6 (.41%)
Aspartate Aminotransferase Increase...
6 (.41%)
Atrial Fibrillation
6 (.41%)
Blood Bilirubin Increased
6 (.41%)
Bronchopulmonary Aspergillosis
6 (.41%)
Hypophagia
6 (.41%)
Hypoxia
6 (.41%)
Mucosal Inflammation
6 (.41%)
Staphylococcal Infection
6 (.41%)
Stomatitis
6 (.41%)
Thrombotic Thrombocytopenic Purpura
6 (.41%)
Alanine Aminotransferase Increased
5 (.34%)
Arrhythmia
5 (.34%)
Cellulitis
5 (.34%)
Cerebral Infarction
5 (.34%)
Convulsion
5 (.34%)
Haematocrit Decreased
5 (.34%)
Haemolytic Anaemia
5 (.34%)
Hepatic Enzyme Increased
5 (.34%)
Intestinal Infarction
5 (.34%)
Liver Abscess
5 (.34%)
Malaise
5 (.34%)
Musculoskeletal Pain
5 (.34%)
Nausea
5 (.34%)
Pulmonary Fibrosis
5 (.34%)
Red Blood Cell Count Decreased
5 (.34%)
Renal Infarct
5 (.34%)
Somnolence
5 (.34%)
Splenomegaly
5 (.34%)
Vision Blurred
5 (.34%)
White Blood Cell Count Increased
5 (.34%)
Aspergillosis
4 (.28%)
Back Pain
4 (.28%)
Blood Alkaline Phosphatase Increase...
4 (.28%)
Blood Count Abnormal
4 (.28%)
Cardiac Arrest
4 (.28%)
Cardiac Failure Congestive
4 (.28%)
Contusion
4 (.28%)
Decubitus Ulcer
4 (.28%)
Extravasation
4 (.28%)
Gastrointestinal Disorder
4 (.28%)
Hemiparesis
4 (.28%)
Herpes Zoster
4 (.28%)
Hyperhidrosis
4 (.28%)
Infusion Site Extravasation
4 (.28%)
Malignant Neoplasm Progression
4 (.28%)
Multi-organ Failure
4 (.28%)
Myocardial Infarction
4 (.28%)
Myocardial Ischaemia
4 (.28%)
Neutropenic Sepsis
4 (.28%)
Pain
4 (.28%)
Pulmonary Oedema
4 (.28%)

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

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

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

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

Myelodysplastic Syndrome
233
Acute Myeloid Leukaemia
62
Drug Use For Unknown Indication
39
Myeloid Leukaemia
22
Product Used For Unknown Indication
18
Chronic Myelomonocytic Leukaemia
8
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Refractory Anaemia
5
Refractory Anaemia With An Excess O...
4
Leukaemia
4
Ill-defined Disorder
2
Colorectal Cancer Metastatic
2
Acute Myeloid Leukaemia Recurrent
2
Acute Myelomonocytic Leukaemia
2
Ovarian Cancer
2
Acute Lymphocytic Leukaemia
2
Chronic Myeloid Leukaemia
2
Bone Marrow Failure
1
Pancreatic Carcinoma
1
Anaemia
1
Non-hodgkins Lymphoma
1
Neoplasm Malignant
1
Gastrooesophageal Reflux Disease
1
Accidental Exposure
1
Anaemia Macrocytic
1
Idiopathic Thrombocytopenic Purpura
1

Drug Labels

LabelLabelerEffective
DacogenEisai Inc.30-MAR-10

Dacogen Case Reports

What Dacogen 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 Dacogen. 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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