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TASIGNA

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Tasigna Adverse Events Reported to the FDA Over Time

How are Tasigna adverse event reports trending over time?

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

Most Common Tasigna Adverse Events Reported to the FDA

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

Electrocardiogram Qt Prolonged
614 (1.87%)
Nausea
517 (1.57%)
Dyspnoea
501 (1.52%)
Fatigue
496 (1.51%)
Pyrexia
467 (1.42%)
Rash
448 (1.36%)
Death
435 (1.32%)
Headache
379 (1.15%)
Platelet Count Decreased
376 (1.14%)
Anaemia
349 (1.06%)
Chest Pain
349 (1.06%)
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Pruritus
341 (1.04%)
Neoplasm Malignant
289 (.88%)
Vomiting
282 (.86%)
Myocardial Infarction
271 (.82%)
Pneumonia
261 (.79%)
Thrombocytopenia
255 (.77%)
Pleural Effusion
250 (.76%)
Abdominal Pain
238 (.72%)
Asthenia
231 (.7%)
Angina Pectoris
228 (.69%)
Abdominal Pain Upper
222 (.67%)
Blood Bilirubin Increased
222 (.67%)
Haemoglobin Decreased
219 (.67%)
Pain
218 (.66%)
Pain In Extremity
216 (.66%)
Diarrhoea
214 (.65%)
Decreased Appetite
210 (.64%)
Cough
206 (.63%)
Blood Glucose Increased
204 (.62%)
Atrial Fibrillation
194 (.59%)
Malaise
189 (.57%)
Myalgia
182 (.55%)
Chronic Myeloid Leukaemia
181 (.55%)
Oedema Peripheral
181 (.55%)
Drug Ineffective
177 (.54%)
Coronary Artery Disease
176 (.53%)
White Blood Cell Count Decreased
176 (.53%)
Constipation
174 (.53%)
Dizziness
171 (.52%)
Lipase Increased
171 (.52%)
Acute Myocardial Infarction
168 (.51%)
Pancytopenia
152 (.46%)
Muscle Spasms
151 (.46%)
Blood Creatinine Increased
148 (.45%)
Back Pain
144 (.44%)
Coronary Artery Stenosis
141 (.43%)
Weight Decreased
138 (.42%)
Cardiac Failure
133 (.4%)
Arthralgia
128 (.39%)
Alopecia
126 (.38%)
Chest Discomfort
126 (.38%)
Peripheral Arterial Occlusive Disea...
124 (.38%)
Alanine Aminotransferase Increased
119 (.36%)
Malignant Neoplasm Progression
117 (.36%)
Incorrect Dose Administered
113 (.34%)
Cerebrovascular Accident
112 (.34%)
Aspartate Aminotransferase Increase...
110 (.33%)
General Physical Health Deteriorati...
108 (.33%)
Neutropenia
107 (.33%)
Cardiac Failure Congestive
104 (.32%)
White Blood Cell Count Increased
104 (.32%)
Sepsis
100 (.3%)
Loss Of Consciousness
97 (.29%)
Palpitations
97 (.29%)
Blast Crisis In Myelogenous Leukaem...
96 (.29%)
Bone Pain
96 (.29%)
Pancreatitis
96 (.29%)
Rash Generalised
96 (.29%)
Hypertension
95 (.29%)
Weight Increased
95 (.29%)
Diabetes Mellitus
92 (.28%)
Infection
92 (.28%)
Abdominal Distension
91 (.28%)
Liver Function Test Abnormal
90 (.27%)
Concomitant Disease Progression
89 (.27%)
Dry Skin
88 (.27%)
Pulmonary Oedema
88 (.27%)
Fall
85 (.26%)
Fluid Retention
85 (.26%)
Renal Failure
84 (.26%)
Gastrointestinal Haemorrhage
83 (.25%)
Abdominal Discomfort
82 (.25%)
Hyperglycaemia
81 (.25%)
Myocardial Ischaemia
81 (.25%)
Stent Placement
81 (.25%)
Hypoaesthesia
77 (.23%)
Renal Failure Acute
77 (.23%)
Blood Urea Increased
75 (.23%)
Intermittent Claudication
73 (.22%)
Hypotension
72 (.22%)
Drug Interaction
71 (.22%)
Oedema
71 (.22%)
Syncope
70 (.21%)
Neoplasm Progression
69 (.21%)
C-reactive Protein Increased
68 (.21%)
Hepatic Function Abnormal
68 (.21%)
Acute Coronary Syndrome
66 (.2%)
Ascites
66 (.2%)
Epistaxis
66 (.2%)
Gait Disturbance
66 (.2%)

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

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

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

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

Chronic Myeloid Leukaemia
4202
Gastrointestinal Stromal Tumour
280
Acute Lymphocytic Leukaemia
95
Leukaemia
58
Neoplasm Malignant
50
Acute Myeloid Leukaemia
36
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Chromosome Analysis Abnormal
33
Myeloid Leukaemia
24
Systemic Mastocytosis
24
Blast Crisis In Myelogenous Leukaem...
18
Gastric Cancer
18
Chronic Lymphocytic Leukaemia
14
Chronic Myeloid Leukaemia Transform...
12
Malignant Soft Tissue Neoplasm
11
Soft Tissue Neoplasm
11
Lymphocytic Leukaemia
10
Acute Lymphocytic Leukaemia Recurre...
10
Acute Myeloid Leukaemia (in Remissi...
8
Mastocytosis
7
Chronic Leukaemia
6
Neoplasm
5
Breast Cancer
5
Lymphoproliferative Disorder
4
Essential Thrombocythaemia
4
Gastrointestinal Carcinoma
3
Thrombocytopenia
3
Rectal Cancer
3
Small Intestine Carcinoma
3
Hypereosinophilic Syndrome
3
Product Used For Unknown Indication
3
B-cell Type Acute Leukaemia
3
Chronic Graft Versus Host Disease
2
Drug Resistance
2
Haematopoietic Neoplasm
2
Systemic Sclerosis
2
Acute Myeloid Leukaemia Recurrent
2
Chronic Myeloid Leukaemia (in Remis...
2
Lymphatic System Neoplasm
2
Anaemia
2
Leukaemia In Remission
2
Chronic Myelomonocytic Leukaemia
2
Lymphocytosis
2
Malignant Melanoma
2
Lymphatic Disorder
2
Gastrointestinal Neoplasm
2
Eosinophilia
2
Hepatic Neoplasm Malignant
2
Eosinophilic Leukaemia
2
Acute Leukaemia
2
Renal Failure Chronic
2
Acute Lymphocytic Leukaemia (in Rem...
1

Drug Labels

LabelLabelerEffective
TasignaNovartis Pharmaceuticals Corporation31-DEC-12

Tasigna Case Reports

What Tasigna 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 Tasigna. 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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