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ALKERAN

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Alkeran Adverse Events Reported to the FDA Over Time

How are Alkeran adverse event reports trending over time?

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

Most Common Alkeran Adverse Events Reported to the FDA

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

Pyrexia
614 (2.13%)
Diarrhoea
487 (1.69%)
Febrile Neutropenia
446 (1.55%)
Sepsis
412 (1.43%)
Pneumonia
405 (1.4%)
Mucosal Inflammation
360 (1.25%)
Neutropenia
326 (1.13%)
Thrombocytopenia
290 (1%)
Nausea
287 (.99%)
Vomiting
244 (.85%)
Multi-organ Failure
236 (.82%)
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Renal Failure
236 (.82%)
Dyspnoea
235 (.81%)
Infection
233 (.81%)
Anaemia
231 (.8%)
Pancytopenia
229 (.79%)
Renal Failure Acute
228 (.79%)
Hypotension
209 (.72%)
Graft Versus Host Disease
206 (.71%)
Death
201 (.7%)
Respiratory Failure
200 (.69%)
Drug Toxicity
180 (.62%)
Fatigue
180 (.62%)
Myelodysplastic Syndrome
178 (.62%)
Acute Myeloid Leukaemia
174 (.6%)
Asthenia
167 (.58%)
Stem Cell Transplant
165 (.57%)
Acute Graft Versus Host Disease
157 (.54%)
Septic Shock
156 (.54%)
General Physical Health Deteriorati...
155 (.54%)
Pleural Effusion
141 (.49%)
Dehydration
140 (.48%)
Platelet Count Decreased
135 (.47%)
Blood Creatinine Increased
130 (.45%)
Stomatitis
130 (.45%)
Atrial Fibrillation
129 (.45%)
Rash
127 (.44%)
Cardiac Failure
121 (.42%)
Multiple Myeloma
121 (.42%)
Haemoglobin Decreased
117 (.41%)
Disease Progression
110 (.38%)
Neuropathy Peripheral
109 (.38%)
Venoocclusive Liver Disease
109 (.38%)
Cytomegalovirus Infection
107 (.37%)
White Blood Cell Count Decreased
105 (.36%)
Cough
104 (.36%)
Abdominal Pain
103 (.36%)
Hypoxia
102 (.35%)
C-reactive Protein Increased
101 (.35%)
Gastrointestinal Haemorrhage
96 (.33%)
Dizziness
95 (.33%)
Chronic Graft Versus Host Disease
94 (.33%)
Anorexia
93 (.32%)
Pain
91 (.32%)
Renal Impairment
91 (.32%)
Confusional State
90 (.31%)
Acute Respiratory Distress Syndrome
88 (.3%)
Herpes Zoster
88 (.3%)
Deep Vein Thrombosis
87 (.3%)
Mucous Membrane Disorder
87 (.3%)
Cardiac Failure Congestive
85 (.29%)
Adenovirus Infection
84 (.29%)
Bone Marrow Failure
84 (.29%)
Pulmonary Embolism
84 (.29%)
Colitis
82 (.28%)
Interstitial Lung Disease
82 (.28%)
Thrombotic Microangiopathy
81 (.28%)
Aspartate Aminotransferase Increase...
80 (.28%)
Constipation
80 (.28%)
Alanine Aminotransferase Increased
78 (.27%)
Decreased Appetite
78 (.27%)
Leukopenia
77 (.27%)
Cardiac Arrest
76 (.26%)
Oedema Peripheral
75 (.26%)
Syncope
72 (.25%)
Hepatotoxicity
71 (.25%)
Venoocclusive Disease
71 (.25%)
Convulsion
70 (.24%)
Pulmonary Oedema
69 (.24%)
Staphylococcal Infection
69 (.24%)
Fall
66 (.23%)
Tachycardia
64 (.22%)
Condition Aggravated
63 (.22%)
Pneumonitis
63 (.22%)
Blood Bilirubin Increased
62 (.21%)
Neutrophil Count Decreased
62 (.21%)
Atelectasis
61 (.21%)
Chest Pain
61 (.21%)
Hypokalaemia
61 (.21%)
Gastrointestinal Inflammation
60 (.21%)
Hypertension
60 (.21%)
Ascites
59 (.2%)
Neoplasm Malignant
58 (.2%)
Urinary Tract Infection
58 (.2%)
Vitreous Haemorrhage
58 (.2%)
Back Pain
57 (.2%)
Hepatic Function Abnormal
55 (.19%)
Jaundice
55 (.19%)
Staphylococcal Sepsis
55 (.19%)
Blood Lactate Dehydrogenase Increas...
54 (.19%)
Cystitis Haemorrhagic
54 (.19%)

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

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

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

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

Multiple Myeloma
3353
Stem Cell Transplant
857
Bone Marrow Conditioning Regimen
458
Drug Use For Unknown Indication
227
Cord Blood Transplant Therapy
182
Acute Myeloid Leukaemia
178
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Allogenic Bone Marrow Transplantati...
171
Amyloidosis
170
Product Used For Unknown Indication
156
Non-hodgkins Lymphoma
130
Bone Marrow Transplant
128
Retinoblastoma
124
Malignant Melanoma
88
Acute Lymphocytic Leukaemia
83
Neuroblastoma
69
Chemotherapy
62
Mantle Cell Lymphoma
60
Myelodysplastic Syndrome
50
Retinoblastoma Unilateral
47
Hodgkins Disease
47
Lymphoma
45
B-cell Lymphoma
44
Plasmacytoma
38
Diffuse Large B-cell Lymphoma
36
Acute Leukaemia
32
Haematological Malignancy
31
Transplant
29
Medulloblastoma
28
Intraocular Retinoblastoma
27
Neoplasm Malignant
25
Aplastic Anaemia
22
Chronic Lymphocytic Leukaemia
22
Premedication
21
Primary Amyloidosis
18
Ewings Sarcoma
17
Retinoblastoma Bilateral
17
Metastases To Liver
14
Epstein-barr Virus Infection
14
Autologous Bone Marrow Transplantat...
13
Metastatic Malignant Melanoma
13
Malignant Melanoma Stage Iii
12
Acute Lymphocytic Leukaemia Recurre...
12
Coeliac Disease
11
Prophylaxis Against Graft Versus Ho...
11
Neoplasm
10
Sarcoma
10
Rheumatoid Arthritis
10
T-cell Lymphoma
9
Mantle Cell Lymphoma Stage Iv
9
Immunosuppression
8
Leukaemia Plasmacytic
8

Drug Labels

LabelLabelerEffective
AlkeranApo-Pharma USA, Inc04-OCT-11
AlkeranApo-Pharma USA, Inc15-FEB-12

Alkeran Case Reports

What Alkeran 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 Alkeran. 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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