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FLUDARABINE PHOSPHATE

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Fludarabine Phosphate Adverse Events Reported to the FDA Over Time

How are Fludarabine Phosphate adverse event reports trending over time?

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

Most Common Fludarabine Phosphate Adverse Events Reported to the FDA

What are the most common Fludarabine Phosphate adverse events reported to the FDA?

Pyrexia
752 (2.06%)
Febrile Neutropenia
655 (1.8%)
Acute Graft Versus Host Disease
607 (1.66%)
Neutropenia
572 (1.57%)
Graft Versus Host Disease
459 (1.26%)
Pneumonia
458 (1.26%)
Sepsis
435 (1.19%)
Chronic Graft Versus Host Disease
374 (1.03%)
Pancytopenia
373 (1.02%)
Multi-organ Failure
365 (1%)
Infection
353 (.97%)
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Diarrhoea
349 (.96%)
Thrombocytopenia
343 (.94%)
Myelodysplastic Syndrome
330 (.9%)
Cytomegalovirus Infection
327 (.9%)
Death
311 (.85%)
Nausea
294 (.81%)
Respiratory Failure
278 (.76%)
Renal Failure
264 (.72%)
Acute Graft Versus Host Disease In ...
255 (.7%)
Anaemia
250 (.69%)
Renal Failure Acute
250 (.69%)
Acute Myeloid Leukaemia
240 (.66%)
Mucosal Inflammation
233 (.64%)
Platelet Count Decreased
232 (.64%)
Vomiting
214 (.59%)
Septic Shock
212 (.58%)
Dyspnoea
211 (.58%)
Progressive Multifocal Leukoencepha...
192 (.53%)
Bone Marrow Failure
184 (.5%)
Pleural Effusion
172 (.47%)
Rash
169 (.46%)
White Blood Cell Count Decreased
169 (.46%)
Disease Progression
165 (.45%)
Hypotension
164 (.45%)
Haemoglobin Decreased
158 (.43%)
Histiocytosis Haematophagic
156 (.43%)
Acute Graft Versus Host Disease In ...
152 (.42%)
Leukopenia
150 (.41%)
Convulsion
143 (.39%)
Venoocclusive Liver Disease
142 (.39%)
Thrombotic Microangiopathy
139 (.38%)
Cystitis Haemorrhagic
136 (.37%)
Asthenia
135 (.37%)
General Physical Health Deteriorati...
133 (.36%)
Neutrophil Count Decreased
132 (.36%)
Epstein-barr Virus Infection
130 (.36%)
Cytomegalovirus Viraemia
123 (.34%)
Hepatic Failure
123 (.34%)
Renal Impairment
122 (.33%)
Alanine Aminotransferase Increased
121 (.33%)
Fatigue
119 (.33%)
Cardiac Failure
117 (.32%)
Confusional State
117 (.32%)
Anaemia Haemolytic Autoimmune
113 (.31%)
Aspartate Aminotransferase Increase...
113 (.31%)
Fungal Infection
113 (.31%)
Epstein-barr Virus Associated Lymph...
110 (.3%)
Interstitial Lung Disease
108 (.3%)
Blood Bilirubin Increased
107 (.29%)
Acute Respiratory Distress Syndrome
106 (.29%)
Stomatitis
105 (.29%)
Hypoxia
104 (.29%)
Hyperbilirubinaemia
103 (.28%)
Adenovirus Infection
102 (.28%)
Bronchopulmonary Aspergillosis
102 (.28%)
Hepatic Function Abnormal
102 (.28%)
Pulmonary Oedema
101 (.28%)
Disseminated Intravascular Coagulat...
100 (.27%)
Transplant Failure
100 (.27%)
Neoplasm Malignant
98 (.27%)
Lymphopenia
97 (.27%)
Chills
92 (.25%)
Tumour Lysis Syndrome
92 (.25%)
Bacterial Infection
91 (.25%)
Blood Creatinine Increased
90 (.25%)
Haemolytic Anaemia
90 (.25%)
Neutropenic Sepsis
90 (.25%)
Cytomegalovirus Test Positive
88 (.24%)
Gastrointestinal Haemorrhage
88 (.24%)
Encephalopathy
87 (.24%)
Herpes Zoster
87 (.24%)
Drug Toxicity
85 (.23%)
Blood Lactate Dehydrogenase Increas...
84 (.23%)
Abdominal Pain
83 (.23%)
Hypertension
83 (.23%)
Aspergillosis
82 (.22%)
Cerebral Haemorrhage
82 (.22%)
Hepatotoxicity
82 (.22%)
Cough
81 (.22%)
Liver Disorder
81 (.22%)
Malignant Neoplasm Progression
81 (.22%)
Headache
80 (.22%)
Stem Cell Transplant
80 (.22%)
Chronic Lymphocytic Leukaemia
76 (.21%)
Dizziness
76 (.21%)
Drug Ineffective
75 (.21%)
Pneumocystis Jiroveci Pneumonia
75 (.21%)
Ascites
73 (.2%)
Lymphadenopathy
72 (.2%)
Lung Infection
71 (.19%)

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

What are the most common Fludarabine Phosphate adverse events reported to the FDA?

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

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

Chronic Lymphocytic Leukaemia
2526
Bone Marrow Conditioning Regimen
1118
Stem Cell Transplant
1064
Acute Myeloid Leukaemia
586
Non-hodgkins Lymphoma
348
B-cell Lymphoma
325
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Cord Blood Transplant Therapy
260
Lymphoma
214
Allogenic Bone Marrow Transplantati...
207
Drug Use For Unknown Indication
194
Myelodysplastic Syndrome
139
Bone Marrow Transplant
128
Product Used For Unknown Indication
124
Acute Lymphocytic Leukaemia
121
Mantle Cell Lymphoma
119
Waldenstroms Macroglobulinaemia
98
Aplastic Anaemia
83
B-cell Small Lymphocytic Lymphoma
71
Haematological Malignancy
68
Multiple Myeloma
67
Chemotherapy
56
Malignant Melanoma
44
Metastatic Malignant Melanoma
44
Combined Immunodeficiency
39
Premedication
38
Peripheral T-cell Lymphoma Unspecif...
36
Chronic Lymphocytic Leukaemia Recur...
34
Surgical Preconditioning
34
Leukaemia
32
Follicle Centre Lymphoma, Follicula...
31
Chronic Myeloid Leukaemia
30
Hodgkins Disease
29
Acute Myeloid Leukaemia Recurrent
29
Myelofibrosis
27
Lymphocytic Lymphoma
23
Prophylaxis Against Graft Versus Ho...
23
Lymphocytic Leukaemia
22
T-cell Prolymphocytic Leukaemia
22
Immunosuppression
21
Congenital Aplastic Anaemia
21
Acute Leukaemia
21
Follicle Centre Lymphoma, Follicula...
21
Therapeutic Procedure
20
Non-hodgkins Lymphoma Recurrent
20
Unrelated Donor Bone Marrow Transpl...
20
Prophylaxis Against Transplant Reje...
19
Myeloid Leukaemia
18
Neuroblastoma
17
Chronic Lymphocytic Leukaemia Refra...
17
Chronic Granulomatous Disease
17
Epstein-barr Virus Infection
17

Drug Labels

LabelLabelerEffective
Ofortasanofi-aventis U.S. LLC30-JUL-09
FludarabineAPP Pharmaceuticals, LLC11-DEC-09
Fludarabine PhosphateSandoz Inc25-MAY-10
Fludarabine PhosphateTeva Parenteral Medicines, Inc.24-FEB-11
FludarabineAPP Pharmaceuticals, LLC10-MAY-11
Fludarabine PhosphateSagent Pharmaceutical, Inc.28-OCT-11
Fludarabine PhosphatePfizer Laboratories Div Pfizer Inc.16-APR-12
Fludarabine PhosphateTeva Parenteral Medicines, Inc.13-AUG-12
Fludarabine PhosphateTeva Parenteral Medicines, Inc.13-AUG-12
Fludarabine PhosphateHospira Worldwide, Inc.30-OCT-12
Fludarabine PhosphateMylan Institutional LLC30-NOV-12

Fludarabine Phosphate Case Reports

What Fludarabine Phosphate 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 Fludarabine Phosphate. 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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