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OFATUMUMAB

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Ofatumumab Adverse Events Reported to the FDA Over Time

How are Ofatumumab adverse event reports trending over time?

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

Most Common Ofatumumab Adverse Events Reported to the FDA

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

Febrile Neutropenia
144 (7.83%)
Pneumonia
54 (2.93%)
Pyrexia
51 (2.77%)
Neutropenia
38 (2.07%)
Fatigue
33 (1.79%)
Nausea
30 (1.63%)
Dyspnoea
27 (1.47%)
Asthenia
26 (1.41%)
Neutropenic Sepsis
26 (1.41%)
Thrombocytopenia
26 (1.41%)
Sepsis
24 (1.3%)
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Cytomegalovirus Infection
23 (1.25%)
Failure To Thrive
22 (1.2%)
Renal Failure Acute
21 (1.14%)
Anaemia
20 (1.09%)
Hypercalcaemia
19 (1.03%)
Vomiting
19 (1.03%)
Confusional State
18 (.98%)
Infection
18 (.98%)
Hypotension
17 (.92%)
Blood Creatinine Increased
16 (.87%)
Respiratory Failure
16 (.87%)
Tumour Lysis Syndrome
16 (.87%)
Diarrhoea
15 (.82%)
Platelet Count Decreased
15 (.82%)
Atrial Fibrillation
13 (.71%)
Headache
13 (.71%)
Cough
12 (.65%)
Dizziness
12 (.65%)
Renal Failure
12 (.65%)
Infusion Related Reaction
11 (.6%)
Malaise
11 (.6%)
Pulmonary Embolism
11 (.6%)
Dehydration
10 (.54%)
Haemoglobin Decreased
10 (.54%)
Hypokalaemia
10 (.54%)
Hypoxia
10 (.54%)
Alanine Aminotransferase Increased
9 (.49%)
Anaphylactic Reaction
9 (.49%)
Progressive Multifocal Leukoencepha...
9 (.49%)
Rash
9 (.49%)
Tremor
9 (.49%)
Hyperglycaemia
8 (.43%)
Leukopenia
8 (.43%)
Lung Disorder
8 (.43%)
Oxygen Saturation Decreased
8 (.43%)
Septic Shock
8 (.43%)
Urinary Tract Infection
8 (.43%)
Urticaria
8 (.43%)
Abdominal Pain
7 (.38%)
Altered State Of Consciousness
7 (.38%)
Chronic Obstructive Pulmonary Disea...
7 (.38%)
Diabetes Mellitus
7 (.38%)
Disease Progression
7 (.38%)
Hyperuricaemia
7 (.38%)
Neoplasm Progression
7 (.38%)
Respiratory Tract Infection
7 (.38%)
White Blood Cell Count Decreased
7 (.38%)
Agranulocytosis
6 (.33%)
Chronic Lymphocytic Leukaemia
6 (.33%)
Circulatory Collapse
6 (.33%)
Faeces Discoloured
6 (.33%)
Haemolysis
6 (.33%)
Hydronephrosis
6 (.33%)
Hyperkalaemia
6 (.33%)
Red Blood Cell Count Decreased
6 (.33%)
Syncope
6 (.33%)
Vertigo Labyrinthine
6 (.33%)
Acute Pulmonary Oedema
5 (.27%)
Anaemia Haemolytic Autoimmune
5 (.27%)
Bacteraemia
5 (.27%)
Balance Disorder
5 (.27%)
Depression
5 (.27%)
Diffuse Large B-cell Lymphoma
5 (.27%)
Fungal Infection
5 (.27%)
Hyponatraemia
5 (.27%)
Ill-defined Disorder
5 (.27%)
Lower Respiratory Tract Infection
5 (.27%)
Lymphoma
5 (.27%)
Myasthenia Gravis
5 (.27%)
Oedema Peripheral
5 (.27%)
Productive Cough
5 (.27%)
Renal Colic
5 (.27%)
Upper Respiratory Tract Infection
5 (.27%)
Anxiety
4 (.22%)
Arthritis
4 (.22%)
Ataxia
4 (.22%)
Blunted Affect
4 (.22%)
Bronchitis
4 (.22%)
Cardiac Failure
4 (.22%)
Chills
4 (.22%)
Condition Aggravated
4 (.22%)
Convulsion
4 (.22%)
Deafness Unilateral
4 (.22%)
Decreased Appetite
4 (.22%)
Disturbance In Attention
4 (.22%)
Flushing
4 (.22%)
General Physical Health Deteriorati...
4 (.22%)
Haematocrit Decreased
4 (.22%)
Herpes Zoster
4 (.22%)
Hypoglycaemia
4 (.22%)

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

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

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

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

Chronic Lymphocytic Leukaemia
282
Diffuse Large B-cell Lymphoma Recur...
63
Lymphoma
39
B-cell Lymphoma
34
Rheumatoid Arthritis
33
Diffuse Large B-cell Lymphoma
30
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Non-hodgkins Lymphoma
27
Mantle Cell Lymphoma
23
Chronic Lymphocytic Leukaemia Refra...
21
Chronic Lymphocytic Leukaemia Recur...
8
Richters Syndrome
8
Malignant Melanoma
4
Product Used For Unknown Indication
4
Hodgkins Disease
3
Diffuse Large B-cell Lymphoma Refra...
3
Drug Dispensing Error
2
Leukaemia
2
Lymphocytic Leukaemia
1
Pneumonitis
1
Non-hodgkins Lymphoma Refractory
1
Waldenstroms Macroglobulinaemia
1
Stem Cell Transplant
1
Osteochondrosis
1
Immunoglobulins Normal
1
B-cell Small Lymphocytic Lymphoma
1
Disseminated Large Cell Lymphoma
1

Drug Labels

LabelLabelerEffective
ArzerraGlaxoSmithKline LLC12-SEP-11

Ofatumumab Case Reports

What Ofatumumab 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 Ofatumumab. 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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