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Dasatinib Adverse Events Reported to the FDA Over Time

How are Dasatinib adverse event reports trending over time?

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

Most Common Dasatinib Adverse Events Reported to the FDA

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

Pleural Effusion
246 (4.42%)
Dyspnoea
164 (2.95%)
Pyrexia
125 (2.25%)
Dehydration
124 (2.23%)
Diarrhoea
111 (2%)
Pneumonia
110 (1.98%)
Malignant Neoplasm Progression
103 (1.85%)
Nausea
94 (1.69%)
Febrile Neutropenia
88 (1.58%)
Vomiting
88 (1.58%)
Anaemia
69 (1.24%)
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Respiratory Failure
63 (1.13%)
Neutropenia
58 (1.04%)
Haemoglobin Decreased
52 (.94%)
Thrombocytopenia
52 (.94%)
Asthenia
50 (.9%)
Fatigue
50 (.9%)
Headache
49 (.88%)
Hypoxia
48 (.86%)
Abdominal Pain
43 (.77%)
Pulmonary Embolism
43 (.77%)
Sepsis
43 (.77%)
Pain
40 (.72%)
Rash
40 (.72%)
Cardiac Failure Congestive
39 (.7%)
Renal Failure Acute
39 (.7%)
Pericardial Effusion
38 (.68%)
Infection
37 (.67%)
Disease Progression
36 (.65%)
Gastrointestinal Haemorrhage
36 (.65%)
Oedema Peripheral
34 (.61%)
Atrial Fibrillation
33 (.59%)
Hyponatraemia
33 (.59%)
Urinary Tract Infection
32 (.58%)
Chest Pain
31 (.56%)
Constipation
31 (.56%)
Death
31 (.56%)
Hypotension
31 (.56%)
Hypertension
30 (.54%)
Pulmonary Hypertension
30 (.54%)
Anxiety
29 (.52%)
Anorexia
28 (.5%)
Hypokalaemia
28 (.5%)
Decreased Appetite
26 (.47%)
Renal Failure
25 (.45%)
Cough
24 (.43%)
Neoplasm Malignant
24 (.43%)
Platelet Count Decreased
23 (.41%)
Acute Respiratory Failure
22 (.4%)
Chronic Myeloid Leukaemia
22 (.4%)
Chronic Obstructive Pulmonary Disea...
22 (.4%)
Hyperkalaemia
22 (.4%)
Pancytopenia
22 (.4%)
Subdural Haematoma
22 (.4%)
Cardiac Arrest
20 (.36%)
Malignant Pleural Effusion
20 (.36%)
Drug Ineffective
19 (.34%)
Hypocalcaemia
19 (.34%)
Mental Status Changes
19 (.34%)
Cardiac Failure
18 (.32%)
Cellulitis
18 (.32%)
Alanine Aminotransferase Increased
17 (.31%)
Atelectasis
17 (.31%)
Pneumonitis
17 (.31%)
Pulmonary Mass
17 (.31%)
Weight Decreased
17 (.31%)
Arthralgia
16 (.29%)
Blood Creatinine Increased
16 (.29%)
Musculoskeletal Pain
16 (.29%)
Myocardial Infarction
16 (.29%)
Tumour Lysis Syndrome
16 (.29%)
White Blood Cell Count Decreased
16 (.29%)
General Physical Health Deteriorati...
15 (.27%)
Aspartate Aminotransferase Increase...
14 (.25%)
Back Pain
14 (.25%)
Blast Crisis In Myelogenous Leukaem...
14 (.25%)
Deep Vein Thrombosis
14 (.25%)
Fall
14 (.25%)
Hypomagnesaemia
14 (.25%)
Lethargy
14 (.25%)
Multi-organ Failure
14 (.25%)
Septic Shock
14 (.25%)
Acute Myocardial Infarction
13 (.23%)
Confusional State
13 (.23%)
Depression
13 (.23%)
Muscular Weakness
13 (.23%)
Thrombosis
13 (.23%)
Bronchopneumonia
12 (.22%)
Cardiogenic Shock
12 (.22%)
Musculoskeletal Chest Pain
12 (.22%)
Neutrophil Count Decreased
12 (.22%)
Rectal Haemorrhage
12 (.22%)
Respiratory Distress
12 (.22%)
Stomatitis
12 (.22%)
Sudden Death
12 (.22%)
Acute Myeloid Leukaemia
11 (.2%)
Ascites
11 (.2%)
Bone Pain
11 (.2%)
Cardio-respiratory Arrest
11 (.2%)
Cerebrovascular Accident
11 (.2%)
Convulsion
11 (.2%)

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

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

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

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

Chronic Myeloid Leukaemia
369
Non-small Cell Lung Cancer
122
Leukaemia
108
Acute Lymphocytic Leukaemia
94
Prostate Cancer
72
Breast Cancer
55
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Malignant Melanoma
53
Sarcoma
34
Breast Cancer Metastatic
33
Acute Myeloid Leukaemia
29
Glioblastoma Multiforme
16
Colorectal Cancer Metastatic
16
Multiple Myeloma
15
Gastrointestinal Stromal Tumour
12
Non-small Cell Lung Cancer Metastat...
12
Glioblastoma
11
Chordoma
10
Myelodysplastic Syndrome
10
Neoplasm Malignant
9
Ovarian Cancer
8
Pancreatic Carcinoma
8
Blast Crisis In Myelogenous Leukaem...
8
Neoplasm
8
Bladder Cancer
6
Non-small Cell Lung Cancer Stage Iv
5
Lung Neoplasm Malignant
5
Chemotherapy
5
Prostate Cancer Metastatic
5
Non-hodgkins Lymphoma
5
Chronic Lymphocytic Leukaemia
5
Glioma
5
Malignant Fibrous Histiocytoma
4
Bone Sarcoma
4
Colon Cancer
4
Haemangiopericytoma
4
Chromosome Analysis Abnormal
4
Chronic Myeloid Leukaemia Transform...
4
Polycythaemia Vera
3
Colorectal Cancer
3
Adenocarcinoma Pancreas
3
Salivary Gland Cancer
3
Hepatic Neoplasm Malignant
3
B Precursor Type Acute Leukaemia
3
Breast Cancer Stage Iv
3
Ovarian Epithelial Cancer
3
Chondrosarcoma
3
Metastatic Neoplasm
3
Leiomyosarcoma
3
Chronic Lymphocytic Leukaemia Refra...
3
Blast Cell Crisis
3
Pleural Mesothelioma Malignant
3

Drug Labels

LabelLabelerEffective
Sprycel Physicians Total Care, Inc.01-JUN-12
SprycelE.R. Squibb & Sons, L.L.C.01-NOV-12

Dasatinib Case Reports

What Dasatinib 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 Dasatinib. 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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