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ELTROMBOPAG

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Eltrombopag Adverse Events Reported to the FDA Over Time

How are Eltrombopag adverse event reports trending over time?

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

Most Common Eltrombopag Adverse Events Reported to the FDA

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

Drug Ineffective
451 (4.73%)
Death
436 (4.57%)
Platelet Count Decreased
241 (2.53%)
Thrombocytopenia
160 (1.68%)
Liver Disorder
158 (1.66%)
Anaemia
114 (1.19%)
Ascites
108 (1.13%)
Disease Progression
101 (1.06%)
Pyrexia
96 (1.01%)
Pneumonia
93 (.97%)
Fatigue
92 (.96%)
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Nausea
90 (.94%)
Platelet Count Increased
89 (.93%)
Haemorrhage
88 (.92%)
Asthenia
80 (.84%)
Myelodysplastic Syndrome
79 (.83%)
Haematological Malignancy
78 (.82%)
Haemoglobin Decreased
75 (.79%)
Dyspnoea
69 (.72%)
Myocardial Infarction
69 (.72%)
Oedema Peripheral
68 (.71%)
Headache
67 (.7%)
Liver Function Test Abnormal
67 (.7%)
Epistaxis
64 (.67%)
Idiopathic Thrombocytopenic Purpura
64 (.67%)
Pulmonary Embolism
64 (.67%)
Deep Vein Thrombosis
59 (.62%)
Sepsis
59 (.62%)
Vomiting
57 (.6%)
Aspartate Aminotransferase Increase...
55 (.58%)
Thrombosis
55 (.58%)
Pancytopenia
53 (.56%)
Alanine Aminotransferase Increased
50 (.52%)
Acute Myeloid Leukaemia
49 (.51%)
Myalgia
49 (.51%)
Blood Bilirubin Increased
48 (.5%)
Abdominal Pain
47 (.49%)
Pain In Extremity
47 (.49%)
Pleural Effusion
47 (.49%)
Chronic Lymphocytic Leukaemia
45 (.47%)
Diarrhoea
45 (.47%)
Gastrointestinal Haemorrhage
45 (.47%)
Cataract
44 (.46%)
Hepatic Failure
44 (.46%)
Portal Vein Thrombosis
44 (.46%)
Chest Pain
43 (.45%)
Splenomegaly
43 (.45%)
White Blood Cell Count Increased
42 (.44%)
Abdominal Distension
41 (.43%)
Pruritus
41 (.43%)
Dizziness
40 (.42%)
Cerebral Infarction
39 (.41%)
Arthralgia
37 (.39%)
Renal Failure Acute
37 (.39%)
Hepatic Enzyme Increased
36 (.38%)
Hypotension
36 (.38%)
Cardiac Disorder
35 (.37%)
Hepatic Cirrhosis
35 (.37%)
Malaise
35 (.37%)
Myelofibrosis
34 (.36%)
Respiratory Failure
34 (.36%)
Blood Alkaline Phosphatase Increase...
33 (.35%)
Febrile Neutropenia
33 (.35%)
Infection
33 (.35%)
Pain
33 (.35%)
Cerebrovascular Accident
32 (.34%)
Jaundice
31 (.32%)
Leukocytosis
30 (.31%)
Hepatic Neoplasm Malignant
29 (.3%)
Hypoaesthesia
29 (.3%)
International Normalised Ratio Incr...
29 (.3%)
Petechiae
29 (.3%)
Rash
29 (.3%)
Weight Decreased
29 (.3%)
Hepatic Function Abnormal
28 (.29%)
Oedema
27 (.28%)
Cardiac Failure Congestive
26 (.27%)
Fall
26 (.27%)
Lymphadenopathy
26 (.27%)
Abdominal Pain Upper
25 (.26%)
Cardiac Arrest
25 (.26%)
Contusion
25 (.26%)
Gamma-glutamyltransferase Increased
25 (.26%)
Neutropenia
25 (.26%)
Cardio-respiratory Arrest
24 (.25%)
Decreased Appetite
24 (.25%)
Gingival Bleeding
24 (.25%)
Acute Myocardial Infarction
23 (.24%)
Cough
23 (.24%)
Drug Interaction
23 (.24%)
Blood Creatinine Increased
22 (.23%)
Bone Pain
22 (.23%)
Condition Aggravated
22 (.23%)
Renal Failure
22 (.23%)
Visual Acuity Reduced
22 (.23%)
White Blood Cell Count Decreased
22 (.23%)
Coma
21 (.22%)
Lymphoma
21 (.22%)
Multi-organ Failure
21 (.22%)
Urinary Tract Infection
21 (.22%)
Blood Lactate Dehydrogenase Increas...
20 (.21%)

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

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

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

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

Idiopathic Thrombocytopenic Purpura
1660
Thrombocytopenia
582
Product Used For Unknown Indication
166
Autoimmune Thrombocytopenia
77
Drug Use For Unknown Indication
40
Myelodysplastic Syndrome
40
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Hepatitis C
23
Platelet Count Decreased
11
Gastric Ulcer
9
Prophylaxis
9
Acute Myeloid Leukaemia
9
Evans Syndrome
8
Multiple Myeloma
8
Gastritis
8
Non-hodgkins Lymphoma
7
Thrombocytopenic Purpura
6
Aplastic Anaemia
6
Abdominal Discomfort
5
Pancytopenia
5
Hepatic Cirrhosis
5
Ill-defined Disorder
5
Chronic Lymphocytic Leukaemia
4
Platelet Count
4
Myelofibrosis
4
Neoplasm Malignant
4
Zinc Deficiency
4
Lymphoma
3
Gastritis Prophylaxis
3
Refractory Cytopenia With Multiline...
3
Immune System Disorder
3
Dysgeusia
3
Lymphohistiocytosis
3
Coagulopathy
3
Liver Disorder
2
Thrombosis
2
Duodenal Ulcer
2
Blood Disorder
2
Myeloproliferative Disorder
2
B-cell Lymphoma
1
Cns Germinoma
1
Gastritis Erosive
1
Chemotherapy
1
Haemorrhagic Disorder
1
Acute Leukaemia
1
Purpura
1
Small Intestine Carcinoma
1
Skin Ulcer
1
Central Nervous System Neoplasm
1
Gastrooesophageal Reflux Disease
1
Glioblastoma
1
Sjogrens Syndrome
1

Drug Labels

LabelLabelerEffective
PromactaGlaxoSmithKline LLC16-NOV-12

Eltrombopag Case Reports

What Eltrombopag 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 Eltrombopag. 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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