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ZELBORAF

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Zelboraf Adverse Events Reported to the FDA Over Time

How are Zelboraf adverse event reports trending over time?

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

Most Common Zelboraf Adverse Events Reported to the FDA

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

Death
257 (5.79%)
Fatigue
204 (4.6%)
Arthralgia
201 (4.53%)
Rash
187 (4.21%)
Nausea
138 (3.11%)
Decreased Appetite
124 (2.79%)
Myalgia
91 (2.05%)
Alopecia
89 (2%)
Disease Progression
77 (1.73%)
Diarrhoea
75 (1.69%)
Headache
74 (1.67%)
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Pruritus
71 (1.6%)
Mass
70 (1.58%)
Vomiting
70 (1.58%)
Sunburn
62 (1.4%)
Neoplasm
59 (1.33%)
Erythema
49 (1.1%)
Skin Papilloma
46 (1.04%)
Pyrexia
44 (.99%)
Malignant Melanoma
40 (.9%)
Squamous Cell Carcinoma
38 (.86%)
Constipation
37 (.83%)
Dehydration
35 (.79%)
Oedema Peripheral
35 (.79%)
Weight Decreased
35 (.79%)
Melanocytic Naevus
33 (.74%)
Vision Blurred
33 (.74%)
Asthenia
30 (.68%)
Neoplasm Progression
30 (.68%)
Dysgeusia
28 (.63%)
Swelling
28 (.63%)
Pain In Extremity
27 (.61%)
Visual Impairment
27 (.61%)
Blister
26 (.59%)
Rash Erythematous
26 (.59%)
Pneumonia
25 (.56%)
Blood Creatinine Increased
22 (.5%)
Dysphagia
22 (.5%)
Joint Swelling
22 (.5%)
Metastases To Central Nervous Syste...
21 (.47%)
Metastatic Malignant Melanoma
21 (.47%)
Photosensitivity Reaction
20 (.45%)
Skin Exfoliation
20 (.45%)
Brain Neoplasm
19 (.43%)
Renal Failure
19 (.43%)
Renal Failure Acute
19 (.43%)
Anaemia
18 (.41%)
Dyspnoea
18 (.41%)
Skin Mass
18 (.41%)
Hypotension
17 (.38%)
Liver Function Test Abnormal
17 (.38%)
Chills
16 (.36%)
Atrial Fibrillation
15 (.34%)
Stomatitis
15 (.34%)
Hepatic Enzyme Increased
14 (.32%)
Pain
14 (.32%)
Dry Skin
13 (.29%)
Squamous Cell Carcinoma Of Skin
13 (.29%)
Acne
12 (.27%)
Chest Pain
12 (.27%)
Swelling Face
12 (.27%)
Alanine Aminotransferase Increased
11 (.25%)
Dizziness
11 (.25%)
Eye Pain
11 (.25%)
Hyperkeratosis
11 (.25%)
Malaise
11 (.25%)
Metastasis
11 (.25%)
Neutropenia
11 (.25%)
Ocular Hyperaemia
11 (.25%)
Ageusia
10 (.23%)
Convulsion
10 (.23%)
Drug Ineffective
10 (.23%)
Haemorrhage
10 (.23%)
Hypoaesthesia
10 (.23%)
Myocardial Infarction
10 (.23%)
Nasopharyngitis
10 (.23%)
Neuropathy Peripheral
10 (.23%)
Photophobia
10 (.23%)
Rash Generalised
10 (.23%)
Skin Ulcer
10 (.23%)
White Blood Cell Count Decreased
10 (.23%)
Burning Sensation
9 (.2%)
Cellulitis
9 (.2%)
Cerebrovascular Accident
9 (.2%)
Chest Discomfort
9 (.2%)
Drug Eruption
9 (.2%)
Electrocardiogram Qt Prolonged
9 (.2%)
Infection
9 (.2%)
Insomnia
9 (.2%)
Keratoacanthoma
9 (.2%)
Leukopenia
9 (.2%)
Skin Toxicity
9 (.2%)
Urticaria
9 (.2%)
Cardiac Disorder
8 (.18%)
Dysphonia
8 (.18%)
Eosinophilia
8 (.18%)
Fall
8 (.18%)
Hiccups
8 (.18%)
Hyperhidrosis
8 (.18%)
Hypertension
8 (.18%)
Intestinal Perforation
8 (.18%)

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

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

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

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

Product Used For Unknown Indication
504
Malignant Melanoma
297
Metastatic Malignant Melanoma
176
Malignant Melanoma Stage Iv
6
Metastases To Lung
5
Neoplasm Malignant
5
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Thyroid Cancer
4
Metastases To Central Nervous Syste...
4
Bone Neoplasm Malignant
3
Non-small Cell Lung Cancer
3
Metastases To Lymph Nodes
2
Skin Cancer
2
Metastases To Skin
2
Metastasis
1
Basal Cell Carcinoma
1
Squamous Cell Carcinoma
1
Oesophageal Carcinoma
1
Bladder Cancer
1
Metastases To Liver
1
Breast Cancer
1
Respiratory Failure
1
Metastases To Nervous System
1

Drug Labels

LabelLabelerEffective
ZelborafGenentech, Inc.01-APR-12

Zelboraf Case Reports

What Zelboraf 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 Zelboraf. 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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