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ALEMTUZUMAB

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Alemtuzumab Adverse Events Reported to the FDA Over Time

How are Alemtuzumab adverse event reports trending over time?

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

Most Common Alemtuzumab Adverse Events Reported to the FDA

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

Cytomegalovirus Infection
131 (2.41%)
Pyrexia
116 (2.13%)
Neutropenia
94 (1.73%)
Sepsis
70 (1.29%)
Pancytopenia
68 (1.25%)
Pneumonia
68 (1.25%)
Febrile Neutropenia
67 (1.23%)
Multi-organ Failure
67 (1.23%)
Thrombocytopenia
55 (1.01%)
Suicidal Ideation
53 (.97%)
Graft Versus Host Disease
52 (.96%)
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Headache
51 (.94%)
Renal Failure
45 (.83%)
Dyspnoea
44 (.81%)
Diarrhoea
40 (.74%)
Nausea
40 (.74%)
Infection
39 (.72%)
Hyperthyroidism
38 (.7%)
Respiratory Failure
38 (.7%)
Renal Failure Acute
37 (.68%)
Adenovirus Infection
35 (.64%)
Epstein-barr Virus Infection
35 (.64%)
Anaemia
33 (.61%)
Epstein-barr Virus Associated Lymph...
31 (.57%)
Vomiting
30 (.55%)
Fatigue
28 (.51%)
Hepatic Failure
28 (.51%)
Hypothyroidism
28 (.51%)
Dehydration
27 (.5%)
Transplant Rejection
27 (.5%)
Anaemia Haemolytic Autoimmune
26 (.48%)
Drug Ineffective
26 (.48%)
Fungal Infection
25 (.46%)
Pleurisy
25 (.46%)
Rash
25 (.46%)
Urinary Tract Infection
25 (.46%)
Hepatitis
24 (.44%)
Tachycardia
24 (.44%)
Breast Cancer
23 (.42%)
Hypotension
23 (.42%)
Tuberculosis
23 (.42%)
Multiple Sclerosis Relapse
22 (.4%)
Pulmonary Tuberculosis
22 (.4%)
Septic Shock
22 (.4%)
Asthenia
21 (.39%)
Blood Creatinine Increased
21 (.39%)
Cervical Dysplasia
21 (.39%)
Hysterectomy
21 (.39%)
Leukopenia
21 (.39%)
Oedema Peripheral
21 (.39%)
Pneumonitis
21 (.39%)
Acute Graft Versus Host Disease In ...
20 (.37%)
Encephalitis
20 (.37%)
Renal Impairment
20 (.37%)
Bronchopulmonary Aspergillosis
19 (.35%)
Dizziness
19 (.35%)
General Physical Health Deteriorati...
19 (.35%)
Abdominal Pain
18 (.33%)
Abortion Spontaneous
18 (.33%)
Autoimmune Thrombocytopenia
18 (.33%)
Confusional State
18 (.33%)
Convulsion
18 (.33%)
Death
18 (.33%)
Herpes Simplex
18 (.33%)
Infusion Related Reaction
18 (.33%)
Progressive Multifocal Leukoencepha...
18 (.33%)
Aspergillosis
17 (.31%)
Bone Marrow Failure
17 (.31%)
Pneumocystis Jiroveci Pneumonia
17 (.31%)
Chronic Graft Versus Host Disease
16 (.29%)
Diffuse Large B-cell Lymphoma
16 (.29%)
Gastrointestinal Haemorrhage
16 (.29%)
Lung Infection
16 (.29%)
Lung Infiltration
16 (.29%)
Lymphopenia
16 (.29%)
Ascites
15 (.28%)
Cardiac Failure Congestive
15 (.28%)
Haemolytic Anaemia
15 (.28%)
Hypertension
15 (.28%)
Myelodysplastic Syndrome
15 (.28%)
Pleural Effusion
15 (.28%)
Pneumonia Cytomegaloviral
15 (.28%)
Respiratory Distress
15 (.28%)
Urine Output Decreased
15 (.28%)
Weight Decreased
15 (.28%)
Acute Graft Versus Host Disease
14 (.26%)
Acute Myeloid Leukaemia
14 (.26%)
Dysfunctional Uterine Bleeding
14 (.26%)
Gastritis
14 (.26%)
Gastroenteritis
14 (.26%)
Haemoglobin Decreased
14 (.26%)
Herpes Zoster
14 (.26%)
Mycobacterium Avium Complex Infecti...
14 (.26%)
Oxygen Saturation Decreased
14 (.26%)
Bradycardia
13 (.24%)
C-reactive Protein Increased
13 (.24%)
Chills
13 (.24%)
Cytomegalovirus Viraemia
13 (.24%)
Gastrointestinal Disorder
13 (.24%)
Histiocytosis Haematophagic
13 (.24%)
Mucosal Inflammation
13 (.24%)

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

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

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

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

Multiple Sclerosis
361
Chronic Lymphocytic Leukaemia
197
Stem Cell Transplant
75
T-cell Lymphoma
52
Bone Marrow Conditioning Regimen
37
Prophylaxis Against Graft Versus Ho...
35
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Immunosuppression
34
Chronic Lymphocytic Leukaemia Recur...
19
Acute Myeloid Leukaemia
19
Prophylaxis Against Transplant Reje...
17
Peripheral T-cell Lymphoma Unspecif...
16
T-cell Prolymphocytic Leukaemia
16
Haematological Malignancy
14
Graft Versus Host Disease
13
Drug Use For Unknown Indication
12
Renal Transplant
12
Myelodysplastic Syndrome
8
Angioimmunoblastic T-cell Lymphoma ...
7
Mycosis Fungoides Refractory
6
Product Used For Unknown Indication
6
Immunosuppressant Drug Therapy
6
Bone Marrow Failure
6
Bone Marrow Transplant
6
T-cell Depletion
6
Refractory Anaemia With An Excess O...
5
Prophylaxis
5
Acute Graft Versus Host Disease
5
Adult T-cell Lymphoma/leukaemia
5
Aplastic Anaemia
5
B-cell Small Lymphocytic Lymphoma
4
Precursor T-lymphoblastic Lymphoma/...
4
B-cell Small Lymphocytic Lymphoma R...
4
Transplant
4
Immunoblastic Lymphoma
4
Aplasia Pure Red Cell
4
Lymphocytic Leukaemia
4
Large Granular Lymphocytosis
4
Allogenic Bone Marrow Transplantati...
3
Lymphoma
3
T-cell Lymphoma Recurrent
3
Angioimmunoblastic T-cell Lymphoma ...
3
Transplant Rejection
3
Acute Lymphocytic Leukaemia
3
B-cell Small Lymphocytic Lymphoma R...
3
Anti-neutrophil Cytoplasmic Antibod...
3
Drug Therapy
3
Extranodal Nk/t-cell Lymphoma, Nasa...
3
Anaplastic Large Cell Lymphoma T- A...
2
Ill-defined Disorder
2
Mycosis Fungoides
2
Unrelated Donor Bone Marrow Transpl...
2

Drug Labels

LabelLabelerEffective
CampathGenzyme Corporation18-DEC-12

Alemtuzumab Case Reports

What Alemtuzumab 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 Alemtuzumab. 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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