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VEMURAFENIB

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Vemurafenib Adverse Events Reported to the FDA Over Time

How are Vemurafenib adverse event reports trending over time?

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

Most Common Vemurafenib Adverse Events Reported to the FDA

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

Pyrexia
94 (2.81%)
Squamous Cell Carcinoma Of Skin
74 (2.21%)
Fatigue
64 (1.91%)
Anaemia
60 (1.79%)
Rash
60 (1.79%)
Pneumonia
59 (1.76%)
Dyspnoea
52 (1.55%)
Dehydration
51 (1.52%)
Disease Progression
46 (1.37%)
Headache
46 (1.37%)
General Physical Health Deteriorati...
41 (1.23%)
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Blood Creatinine Increased
37 (1.11%)
Squamous Cell Carcinoma
37 (1.11%)
Arthralgia
36 (1.08%)
Hypotension
36 (1.08%)
Malignant Melanoma
35 (1.05%)
Nausea
33 (.99%)
Dermatitis Exfoliative
31 (.93%)
Confusional State
30 (.9%)
Coma
28 (.84%)
Hepatitis
28 (.84%)
Neoplasm Progression
27 (.81%)
Alanine Aminotransferase Increased
26 (.78%)
Cellulitis
26 (.78%)
Diabetic Ketoacidosis
26 (.78%)
Rash Maculo-papular
26 (.78%)
Epilepsy
25 (.75%)
Keratoacanthoma
25 (.75%)
Neutropenia
25 (.75%)
Death
24 (.72%)
Leukopenia
24 (.72%)
Multi-organ Disorder
24 (.72%)
Diarrhoea
23 (.69%)
Aspartate Aminotransferase Increase...
22 (.66%)
Pulmonary Embolism
22 (.66%)
Renal Failure
22 (.66%)
Cerebral Haemorrhage
21 (.63%)
Fall
21 (.63%)
Pericarditis
21 (.63%)
Renal Failure Acute
21 (.63%)
Pancreatitis
20 (.6%)
Abdominal Pain Upper
19 (.57%)
Blood Uric Acid Increased
19 (.57%)
Abdominal Pain
18 (.54%)
Acute Myocardial Infarction
18 (.54%)
Chest Discomfort
18 (.54%)
Drug Eruption
18 (.54%)
Escherichia Sepsis
18 (.54%)
Haemorrhage Intracranial
18 (.54%)
Rash Erythematous
18 (.54%)
Vomiting
18 (.54%)
Haemoptysis
17 (.51%)
Malaise
17 (.51%)
Convulsion
16 (.48%)
Haemorrhage
16 (.48%)
Pleural Effusion
16 (.48%)
Dizziness
15 (.45%)
Pain
15 (.45%)
Vertigo
15 (.45%)
Asthenia
14 (.42%)
Erysipelas
14 (.42%)
Pericardial Haemorrhage
14 (.42%)
Weight Decreased
14 (.42%)
Brain Abscess
13 (.39%)
Hepatotoxicity
13 (.39%)
Hydrocephalus
13 (.39%)
Hyperthyroidism
13 (.39%)
Myalgia
13 (.39%)
Neutrophil Count Abnormal
13 (.39%)
Pruritus
13 (.39%)
Thrombocytopenia
13 (.39%)
Tremor
13 (.39%)
Atrial Fibrillation
12 (.36%)
Back Pain
12 (.36%)
Disseminated Intravascular Coagulat...
12 (.36%)
Hyperkeratosis
12 (.36%)
Lower Respiratory Tract Infection
12 (.36%)
Melanomatous Meningitis
12 (.36%)
Muscular Weakness
12 (.36%)
Osteomyelitis
12 (.36%)
Pain In Extremity
12 (.36%)
Pancreatitis Acute
12 (.36%)
Sunburn
12 (.36%)
Actinic Keratosis
11 (.33%)
Atrial Flutter
11 (.33%)
Chest Pain
11 (.33%)
Dysphagia
11 (.33%)
Gastroenteritis
11 (.33%)
Gastrointestinal Haemorrhage
11 (.33%)
Renal Impairment
11 (.33%)
Sepsis
11 (.33%)
Skin Ulcer
11 (.33%)
Tachycardia
11 (.33%)
Acanthosis
10 (.3%)
Decreased Appetite
10 (.3%)
Diabetes Mellitus
10 (.3%)
Face Oedema
10 (.3%)
Infection
10 (.3%)
Liver Function Test Abnormal
10 (.3%)
Otitis Externa
10 (.3%)
Pleuritic Pain
10 (.3%)

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

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

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

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

Metastatic Malignant Melanoma
562
Malignant Melanoma
411
Product Used For Unknown Indication
67
Thyroid Cancer
29
Neoplasm
12
Malignant Melanoma Stage Iv
4
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Metastases To Soft Tissue
1

Drug Labels

LabelLabelerEffective
ZelborafGenentech, Inc.01-APR-12

Vemurafenib Case Reports

What Vemurafenib 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 Vemurafenib. 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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