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XALKORI

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Xalkori Adverse Events Reported to the FDA Over Time

How are Xalkori adverse event reports trending over time?

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

Most Common Xalkori Adverse Events Reported to the FDA

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

Nausea
142 (6.59%)
Disease Progression
127 (5.89%)
Death
117 (5.43%)
Vomiting
111 (5.15%)
Diarrhoea
83 (3.85%)
Constipation
80 (3.71%)
Lung Neoplasm Malignant
66 (3.06%)
Oedema Peripheral
56 (2.6%)
Fatigue
55 (2.55%)
Visual Impairment
52 (2.41%)
Decreased Appetite
46 (2.13%)
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Vision Blurred
38 (1.76%)
Dizziness
34 (1.58%)
Dysgeusia
27 (1.25%)
Malaise
26 (1.21%)
Non-small Cell Lung Cancer
24 (1.11%)
Asthenia
23 (1.07%)
Dyspnoea
23 (1.07%)
Dyspepsia
22 (1.02%)
Photopsia
22 (1.02%)
Pulmonary Embolism
21 (.97%)
Neoplasm Malignant
19 (.88%)
Rash
19 (.88%)
Back Pain
18 (.83%)
Interstitial Lung Disease
18 (.83%)
Pleural Effusion
18 (.83%)
Stomatitis
18 (.83%)
Thrombosis
18 (.83%)
Dehydration
17 (.79%)
Oedema
15 (.7%)
Photophobia
15 (.7%)
Headache
14 (.65%)
Pneumonitis
14 (.65%)
Cough
13 (.6%)
Gastrooesophageal Reflux Disease
13 (.6%)
Joint Swelling
13 (.6%)
Dysphagia
12 (.56%)
Liver Function Test Abnormal
12 (.56%)
Oesophageal Pain
12 (.56%)
Pain
12 (.56%)
Pain In Extremity
12 (.56%)
Pneumonia
12 (.56%)
Chest Pain
10 (.46%)
Feeling Abnormal
10 (.46%)
Arthralgia
9 (.42%)
Influenza Like Illness
9 (.42%)
Abdominal Discomfort
8 (.37%)
Diverticular Perforation
8 (.37%)
Haemoglobin Decreased
8 (.37%)
Heart Rate Decreased
8 (.37%)
Hepatic Enzyme Increased
8 (.37%)
Mobility Decreased
8 (.37%)
Paraesthesia
8 (.37%)
Respiratory Distress
8 (.37%)
Burning Sensation
7 (.32%)
Dry Mouth
7 (.32%)
Haematocrit Decreased
7 (.32%)
International Normalised Ratio Incr...
7 (.32%)
Oesophagitis
7 (.32%)
Pericardial Effusion
7 (.32%)
Visual Acuity Reduced
7 (.32%)
Abdominal Pain
6 (.28%)
Abscess
6 (.28%)
Ageusia
6 (.28%)
Confusional State
6 (.28%)
Lung Infiltration
6 (.28%)
Oropharyngeal Pain
6 (.28%)
Pneumocystis Jiroveci Pneumonia
6 (.28%)
Productive Cough
6 (.28%)
Weight Decreased
6 (.28%)
Weight Increased
6 (.28%)
Abdominal Pain Upper
5 (.23%)
Atrial Fibrillation
5 (.23%)
Blood Creatinine Increased
5 (.23%)
Dizziness Postural
5 (.23%)
Dysuria
5 (.23%)
Fluid Retention
5 (.23%)
Lacrimation Increased
5 (.23%)
Micturition Disorder
5 (.23%)
Non-small Cell Lung Cancer Metastat...
5 (.23%)
Red Blood Cell Count Decreased
5 (.23%)
Red Cell Distribution Width Increas...
5 (.23%)
Respiratory Disorder
5 (.23%)
Retching
5 (.23%)
Amnesia
4 (.19%)
Blood Bilirubin Increased
4 (.19%)
Blood Glucose Increased
4 (.19%)
Breath Sounds Abnormal
4 (.19%)
Cellulitis
4 (.19%)
Choking Sensation
4 (.19%)
Conjunctival Haemorrhage
4 (.19%)
Dreamy State
4 (.19%)
Drug Intolerance
4 (.19%)
Dry Skin
4 (.19%)
Electrocardiogram Qt Prolonged
4 (.19%)
Erythema
4 (.19%)
Gait Disturbance
4 (.19%)
Haemoptysis
4 (.19%)
Hepatitis
4 (.19%)
Hypersensitivity
4 (.19%)
Lung Cancer Metastatic
4 (.19%)

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

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

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

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

Lung Neoplasm Malignant
328
Non-small Cell Lung Cancer
79
Bronchial Carcinoma
17
Tracheal Cancer
13
Lung Carcinoma Cell Type Unspecifie...
8
Lung Neoplasm
8
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Lung Cancer Metastatic
8
Non-small Cell Lung Cancer Stage Iv
8
Neoplasm Malignant
7
Lung Adenocarcinoma
6
Lung Carcinoma Cell Type Unspecifie...
5
Anaplastic Lymphoma Kinase Gene Mut...
3
Anaplastic Lymphoma Receptor Tyrosi...
3
Lung Disorder
3
Tracheal Neoplasm
3
Malignant Respiratory Tract Neoplas...
3
Non-small Cell Lung Cancer Metastat...
2
Metastases To Liver
2
Malignant Pleural Effusion
2
Pancreatic Carcinoma
2
Bronchial Neoplasm
2
Non-hodgkins Lymphoma
2
Metastases To Adrenals
1
Anaplastic Astrocytoma
1
Brain Neoplasm Malignant
1
Lung Carcinoma Cell Type Unspecifie...
1
Tyrosine Kinase Mutation
1
Colon Cancer
1
Lymphoma
1
Metastases To Central Nervous Syste...
1
Blood Alkaline Phosphatase Increase...
1
Lung Adenocarcinoma Metastatic
1
Hepatic Neoplasm Malignant
1
Malignant Soft Tissue Neoplasm
1
Medulloblastoma
1
Metastases To Lung
1
Adenocarcinoma
1

Drug Labels

LabelLabelerEffective
XalkoriPfizer Laboratories Div Pfizer Inc12-FEB-13

Xalkori Case Reports

What Xalkori 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 Xalkori. 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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