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CYTARABINE

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Cytarabine Adverse Events Reported to the FDA Over Time

How are Cytarabine adverse event reports trending over time?

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

Most Common Cytarabine Adverse Events Reported to the FDA

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

Febrile Neutropenia
1175 (2.4%)
Pyrexia
848 (1.73%)
Sepsis
798 (1.63%)
Neutropenia
736 (1.5%)
Hypotension
582 (1.19%)
Thrombocytopenia
550 (1.12%)
Pneumonia
536 (1.09%)
Septic Shock
447 (.91%)
Pancytopenia
426 (.87%)
Platelet Count Decreased
414 (.85%)
Diarrhoea
397 (.81%)
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Respiratory Failure
396 (.81%)
Multi-organ Failure
377 (.77%)
Nausea
372 (.76%)
Vomiting
372 (.76%)
Infection
360 (.74%)
Renal Failure Acute
355 (.73%)
Mucosal Inflammation
329 (.67%)
White Blood Cell Count Decreased
329 (.67%)
Dyspnoea
326 (.67%)
Anaemia
322 (.66%)
Pleural Effusion
315 (.64%)
Haemoglobin Decreased
311 (.64%)
Renal Failure
303 (.62%)
Aspartate Aminotransferase Increase...
279 (.57%)
Blood Bilirubin Increased
275 (.56%)
Bone Marrow Failure
270 (.55%)
Acute Myeloid Leukaemia
263 (.54%)
Alanine Aminotransferase Increased
260 (.53%)
Blood Culture Positive
258 (.53%)
Abdominal Pain
239 (.49%)
Acute Respiratory Distress Syndrome
223 (.46%)
Hypoxia
223 (.46%)
Death
220 (.45%)
General Physical Health Deteriorati...
220 (.45%)
Staphylococcal Infection
220 (.45%)
Headache
218 (.45%)
Convulsion
217 (.44%)
Tachycardia
217 (.44%)
Respiratory Distress
209 (.43%)
Pulmonary Oedema
206 (.42%)
Hypokalaemia
194 (.4%)
Cardiac Arrest
193 (.39%)
Fatigue
178 (.36%)
Atrial Fibrillation
177 (.36%)
Disease Progression
166 (.34%)
Fungal Infection
164 (.33%)
Hyperbilirubinaemia
164 (.33%)
Myelodysplastic Syndrome
163 (.33%)
Neutrophil Count Decreased
162 (.33%)
Cerebral Haemorrhage
159 (.32%)
Asthenia
158 (.32%)
Drug Toxicity
156 (.32%)
Lung Infiltration
155 (.32%)
Tumour Lysis Syndrome
146 (.3%)
Confusional State
145 (.3%)
Cardiac Failure
144 (.29%)
Disseminated Intravascular Coagulat...
144 (.29%)
Encephalopathy
142 (.29%)
Cardio-respiratory Arrest
141 (.29%)
Hypertension
140 (.29%)
Stomatitis
140 (.29%)
Caecitis
139 (.28%)
Gastrointestinal Haemorrhage
138 (.28%)
Neutropenic Sepsis
138 (.28%)
Blood Creatinine Increased
136 (.28%)
Pulmonary Haemorrhage
134 (.27%)
Bronchopulmonary Aspergillosis
132 (.27%)
Chills
132 (.27%)
Ascites
129 (.26%)
Enterococcal Infection
128 (.26%)
Aplasia
125 (.26%)
Bacteraemia
125 (.26%)
Rash
124 (.25%)
Colitis
120 (.25%)
Dehydration
120 (.25%)
Mental Status Changes
120 (.25%)
Haemodialysis
119 (.24%)
Neurotoxicity
117 (.24%)
Sinus Tachycardia
117 (.24%)
Hepatic Failure
116 (.24%)
Venoocclusive Liver Disease
115 (.23%)
Bacterial Infection
112 (.23%)
Hepatotoxicity
112 (.23%)
Depressed Level Of Consciousness
110 (.22%)
Condition Aggravated
109 (.22%)
Leukopenia
109 (.22%)
No Therapeutic Response
109 (.22%)
Pain
109 (.22%)
Oedema
107 (.22%)
Leukoencephalopathy
106 (.22%)
Cough
105 (.21%)
Hepatic Function Abnormal
105 (.21%)
Hyperglycaemia
104 (.21%)
Cardiac Failure Congestive
102 (.21%)
Febrile Bone Marrow Aplasia
102 (.21%)
Palmar-plantar Erythrodysaesthesia ...
102 (.21%)
Haemorrhage
101 (.21%)
Oxygen Saturation Decreased
101 (.21%)
Fluid Overload
99 (.2%)
Neutropenic Colitis
99 (.2%)

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

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

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

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

Acute Myeloid Leukaemia
2935
Acute Lymphocytic Leukaemia
1114
Non-hodgkins Lymphoma
317
Myelodysplastic Syndrome
242
Burkitts Lymphoma
242
Mantle Cell Lymphoma
240
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Lymphoma
193
Diffuse Large B-cell Lymphoma
183
Drug Use For Unknown Indication
156
Chemotherapy
154
Bone Marrow Conditioning Regimen
152
Acute Leukaemia
148
Product Used For Unknown Indication
132
B-cell Lymphoma
120
Acute Myeloid Leukaemia Recurrent
111
Acute Promyelocytic Leukaemia
106
Stem Cell Transplant
106
B Precursor Type Acute Leukaemia
103
Myeloid Leukaemia
92
Leukaemia
80
Central Nervous System Lymphoma
75
Chronic Myeloid Leukaemia
74
Diffuse Large B-cell Lymphoma Recur...
64
Chronic Lymphocytic Leukaemia
60
Hodgkins Disease
55
T-cell Type Acute Leukaemia
53
Prophylaxis
47
Precursor T-lymphoblastic Lymphoma/...
36
Neoplasm Malignant
35
T-cell Lymphoma
33
Malignant Lymphoid Neoplasm
32
Bone Marrow Transplant
32
Adult T-cell Lymphoma/leukaemia
30
Lymphocytic Leukaemia
30
Acute Myelomonocytic Leukaemia
28
Multiple Myeloma
26
B-cell Type Acute Leukaemia
26
Burkitts Leukaemia
26
Langerhans Cell Histiocytosis
25
Peripheral T-cell Lymphoma Unspecif...
24
Acute Monocytic Leukaemia
24
Non-hodgkins Lymphoma Unspecified H...
23
Cord Blood Transplant Therapy
22
Haematological Malignancy
20
Acute Lymphocytic Leukaemia Recurre...
20
Allogenic Bone Marrow Transplantati...
17
Leukaemia Recurrent
16
Metastases To Meninges
16
Anaplastic Large Cell Lymphoma T- A...
14
Mantle Cell Lymphoma Stage Iv
13
Medulloblastoma
12

Drug Labels

LabelLabelerEffective
CytarabineBedford Laboratories12-AUG-09
CytarabineBedford Laboratories24-MAY-10
DepocytSigma-Tau Pharmaceuticals, Inc.14-SEP-11
CytarabinePfizer Laboratories Div Pfizer Inc.20-APR-12
CytarabinePfizer Laboratories Div Pfizer Inc.20-APR-12
CytarabinePfizer Laboratories Div Pfizer Inc.20-APR-12
CytarabinePfizer Laboratories Div Pfizer Inc.15-MAY-12
CytarabineHospira Worldwide, Inc.27-JUN-12
CytarabineHospira Worldwide, Inc.28-JUN-12
CytarabineHospira Worldwide, Inc.02-JUL-12
CytarabineAPP Pharmaceuticals, LLC20-AUG-12

Cytarabine Case Reports

What Cytarabine 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 Cytarabine. 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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