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AZACITIDINE

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Azacitidine Adverse Events Reported to the FDA Over Time

How are Azacitidine adverse event reports trending over time?

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

Most Common Azacitidine Adverse Events Reported to the FDA

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

Febrile Neutropenia
147 (4.63%)
Pneumonia
123 (3.87%)
Pyrexia
57 (1.79%)
Sepsis
56 (1.76%)
Acute Myeloid Leukaemia
52 (1.64%)
Neutropenia
51 (1.61%)
Hypotension
50 (1.57%)
Thrombocytopenia
43 (1.35%)
Haemoglobin Decreased
42 (1.32%)
Pleural Effusion
39 (1.23%)
Dyspnoea
34 (1.07%)
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Nausea
33 (1.04%)
Platelet Count Decreased
32 (1.01%)
Death
31 (.98%)
Hypoxia
31 (.98%)
Renal Failure
31 (.98%)
Fatigue
30 (.94%)
Diarrhoea
29 (.91%)
Infection
29 (.91%)
Disease Progression
28 (.88%)
Pancytopenia
28 (.88%)
Respiratory Failure
28 (.88%)
White Blood Cell Count Decreased
28 (.88%)
Anaemia
27 (.85%)
Rash
25 (.79%)
Cellulitis
24 (.76%)
Atrial Fibrillation
23 (.72%)
Constipation
21 (.66%)
Hepatic Failure
21 (.66%)
Renal Failure Acute
20 (.63%)
Asthenia
19 (.6%)
General Physical Health Deteriorati...
19 (.6%)
Hyponatraemia
19 (.6%)
Caecitis
18 (.57%)
Fall
18 (.57%)
Multi-organ Failure
17 (.54%)
Neutrophil Count Decreased
17 (.54%)
Pain
17 (.54%)
Cough
16 (.5%)
Lung Infection
16 (.5%)
Oedema Peripheral
16 (.5%)
Abdominal Pain
15 (.47%)
Clostridium Difficile Colitis
15 (.47%)
Confusional State
15 (.47%)
Haemorrhage
15 (.47%)
Myelodysplastic Syndrome
15 (.47%)
Blood Creatinine Increased
14 (.44%)
Cardiac Failure
14 (.44%)
Cerebral Haemorrhage
14 (.44%)
Pulmonary Fibrosis
14 (.44%)
Septic Shock
14 (.44%)
Chest Pain
13 (.41%)
Pneumonia Fungal
13 (.41%)
Pulmonary Embolism
13 (.41%)
Red Blood Cell Count Decreased
13 (.41%)
Bacteraemia
12 (.38%)
Dehydration
12 (.38%)
Hypernatraemia
12 (.38%)
Myocardial Ischaemia
12 (.38%)
Neutropenic Sepsis
12 (.38%)
Urinary Tract Infection
12 (.38%)
Deep Vein Thrombosis
11 (.35%)
Epistaxis
11 (.35%)
Myelodysplastic Syndrome Transforma...
11 (.35%)
Myocardial Infarction
11 (.35%)
Neutropenic Colitis
11 (.35%)
Pulmonary Haemorrhage
11 (.35%)
Respiratory Distress
11 (.35%)
Blood Urea Increased
10 (.31%)
No Therapeutic Response
10 (.31%)
Acute Respiratory Distress Syndrome
9 (.28%)
Blood Bilirubin Increased
9 (.28%)
Blood Sodium Decreased
9 (.28%)
Chills
9 (.28%)
Graft Versus Host Disease
9 (.28%)
Haematoma
9 (.28%)
Malignant Neoplasm Progression
9 (.28%)
Pancreatitis Acute
9 (.28%)
Pneumonitis
9 (.28%)
Pulmonary Oedema
9 (.28%)
Subileus
9 (.28%)
Syncope
9 (.28%)
Vomiting
9 (.28%)
Abdominal Distension
8 (.25%)
Acute Myocardial Infarction
8 (.25%)
Ascites
8 (.25%)
Aspartate Aminotransferase Increase...
8 (.25%)
Colitis
8 (.25%)
Erythroblast Count Decreased
8 (.25%)
Haematocrit Decreased
8 (.25%)
Hepatic Function Abnormal
8 (.25%)
Interstitial Lung Disease
8 (.25%)
Intestinal Obstruction
8 (.25%)
Mental Status Changes
8 (.25%)
Skin Lesion
8 (.25%)
Somnolence
8 (.25%)
Splenic Infarction
8 (.25%)
Anxiety
7 (.22%)
Blood Culture Positive
7 (.22%)
Bronchopulmonary Aspergillosis
7 (.22%)
Device Related Infection
7 (.22%)

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

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

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

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

Myelodysplastic Syndrome
174
Acute Myeloid Leukaemia
164
Product Used For Unknown Indication
6
Multiple Myeloma
6
Refractory Anaemia With An Excess O...
5
Mycosis Fungoides
5
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Sarcoma
4
Non-small Cell Lung Cancer
4
Chronic Myeloid Leukaemia
4
Chronic Lymphocytic Leukaemia
4
Uterine Cancer
3
Neoplasm
3
Chronic Myelomonocytic Leukaemia
3
Diffuse Large B-cell Lymphoma
2
Colorectal Cancer
2
Neoplasm Malignant
2
Juvenile Chronic Myelomonocytic Leu...
2
Acute Lymphocytic Leukaemia
2
Non-hodgkins Lymphoma
2
Nasopharyngeal Cancer
2
Drug Use For Unknown Indication
2
Lymphoma
2
T-cell Lymphoma
1
Acute Leukaemia
1
Myelofibrosis
1
Myelodysplastic Syndrome Transforma...
1
Lung Disorder
1
Laryngeal Cancer
1
Refractory Cytopenia With Multiline...
1
Crohns Disease
1
Prophylaxis Against Transplant Reje...
1
Thrombocytopenia
1
Metastatic Malignant Melanoma
1
Chemotherapy
1

Drug Labels

LabelLabelerEffective
VidazaCelgene Corporation31-DEC-12

Azacitidine Case Reports

What Azacitidine 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 Azacitidine. 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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