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VORINOSTAT

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Vorinostat Adverse Events Reported to the FDA Over Time

How are Vorinostat adverse event reports trending over time?

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

Most Common Vorinostat Adverse Events Reported to the FDA

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

Thrombocytopenia
225 (2.53%)
Nausea
175 (1.97%)
Febrile Neutropenia
166 (1.87%)
Diarrhoea
145 (1.63%)
Pneumonia
145 (1.63%)
Haemoglobin Decreased
142 (1.6%)
Dehydration
141 (1.59%)
Vomiting
131 (1.48%)
Asthenia
124 (1.4%)
Anaemia
102 (1.15%)
Pleural Effusion
102 (1.15%)
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Fatigue
96 (1.08%)
Platelet Count Decreased
93 (1.05%)
Pyrexia
85 (.96%)
White Blood Cell Count Decreased
82 (.92%)
General Physical Health Deteriorati...
76 (.86%)
Disease Progression
74 (.83%)
Neutropenia
66 (.74%)
Decreased Appetite
63 (.71%)
Sepsis
63 (.71%)
Hypotension
59 (.66%)
Confusional State
58 (.65%)
Renal Failure Acute
58 (.65%)
Dyspnoea
56 (.63%)
Hypertension
55 (.62%)
Hypokalaemia
55 (.62%)
Weight Decreased
55 (.62%)
Pulmonary Embolism
54 (.61%)
Constipation
50 (.56%)
Fall
50 (.56%)
Renal Failure
48 (.54%)
Staphylococcal Infection
48 (.54%)
Haematocrit Decreased
46 (.52%)
Chills
43 (.48%)
Infection
43 (.48%)
Leukopenia
43 (.48%)
Malignant Neoplasm Progression
43 (.48%)
Condition Aggravated
42 (.47%)
Hyperglycaemia
42 (.47%)
Syncope
42 (.47%)
Abdominal Pain
41 (.46%)
Electrocardiogram Qt Prolonged
41 (.46%)
Cellulitis
40 (.45%)
Septic Shock
39 (.44%)
Dizziness
38 (.43%)
Muscular Weakness
38 (.43%)
Headache
37 (.42%)
Respiratory Failure
37 (.42%)
Urinary Tract Infection
35 (.39%)
Pulmonary Oedema
33 (.37%)
Alanine Aminotransferase Increased
32 (.36%)
Anorexia
32 (.36%)
Hyponatraemia
32 (.36%)
Red Blood Cell Count Decreased
32 (.36%)
Somnolence
31 (.35%)
Aspartate Aminotransferase Increase...
30 (.34%)
Blood Creatinine Increased
30 (.34%)
Lymphopenia
30 (.34%)
Tachycardia
30 (.34%)
Drug Toxicity
29 (.33%)
Multiple Myeloma
29 (.33%)
Myocardial Infarction
29 (.33%)
Blood Albumin Decreased
28 (.32%)
Blood Lactate Dehydrogenase Increas...
28 (.32%)
Mental Status Changes
28 (.32%)
Blood Glucose Increased
27 (.3%)
Clostridial Infection
27 (.3%)
Insomnia
27 (.3%)
Neutrophil Count Decreased
27 (.3%)
Oedema Peripheral
27 (.3%)
Urinary Retention
27 (.3%)
Acute Myeloid Leukaemia
26 (.29%)
Bronchopneumonia
26 (.29%)
Epistaxis
26 (.29%)
Haemoptysis
26 (.29%)
Hypophagia
26 (.29%)
Hypoxia
25 (.28%)
Cardiac Failure
24 (.27%)
Pancytopenia
24 (.27%)
Arthralgia
23 (.26%)
Atrial Fibrillation
23 (.26%)
Cough
23 (.26%)
International Normalised Ratio Incr...
23 (.26%)
Agitation
22 (.25%)
Deep Vein Thrombosis
22 (.25%)
Lung Infection
22 (.25%)
Mucosal Inflammation
22 (.25%)
Pain
22 (.25%)
Abdominal Pain Upper
21 (.24%)
Atelectasis
21 (.24%)
Blood Culture Positive
21 (.24%)
Chest Pain
21 (.24%)
Lobar Pneumonia
21 (.24%)
Neoplasm Progression
21 (.24%)
Respiratory Distress
21 (.24%)
Sinus Tachycardia
21 (.24%)
Hypoalbuminaemia
20 (.23%)
Inappropriate Antidiuretic Hormone ...
20 (.23%)
Lung Infiltration
20 (.23%)
Neuropathy Peripheral
20 (.23%)
Phlebitis
20 (.23%)

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

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

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

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

Multiple Myeloma
268
Acute Myeloid Leukaemia
160
Non-small Cell Lung Cancer
128
Myelodysplastic Syndrome
65
Mycosis Fungoides
58
Breast Cancer
42
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Glioblastoma Multiforme
40
B-cell Lymphoma
27
Lung Neoplasm Malignant
20
Diffuse Large B-cell Lymphoma
20
Breast Cancer Metastatic
13
Pancreatic Carcinoma
13
Lymphoma
11
Mesothelioma
11
Product Used For Unknown Indication
11
Nodal Marginal Zone B-cell Lymphoma
10
Metastases To Central Nervous Syste...
9
Sarcoma Metastatic
8
Myeloma Recurrence
8
Chronic Lymphocytic Leukaemia
7
Neuroblastoma
7
Neoplasm
7
Glioblastoma
6
Medulloblastoma
6
Non-hodgkins Lymphoma
6
Peripheral T-cell Lymphoma Unspecif...
5
Bile Duct Cancer
5
Brain Stem Glioma
5
Drug Use For Unknown Indication
5
Malignant Melanoma
5
Hodgkins Disease
5
Neoplasm Malignant
5
Mantle Cell Lymphoma
5
Adenocarcinoma
4
Ovarian Cancer
4
Lung Adenocarcinoma
4
Oesophageal Adenocarcinoma
4
Bladder Cancer
4
Oesophageal Cancer Metastatic
3
Colon Cancer Metastatic
3
Renal Cancer Metastatic
3
Ovarian Epithelial Cancer Recurrent
3
Gastric Cancer
3
Acute Lymphocytic Leukaemia
2
Leukaemia
2
Diffuse Large B-cell Lymphoma Recur...
2
Metastasis
2
Renal Cell Carcinoma
2
Non-hodgkins Lymphoma Recurrent
2
Nasopharyngeal Cancer
2
Ovarian Cancer Metastatic
2

Drug Labels

LabelLabelerEffective
ZolinzaMerck Sharp & Dohme Corp.14-NOV-11
ZolinzaMerck Sharp & Dohme Corp.24-APR-13

Vorinostat Case Reports

What Vorinostat 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 Vorinostat. 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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