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IMATINIB

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Imatinib Adverse Events Reported to the FDA Over Time

How are Imatinib adverse event reports trending over time?

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

Most Common Imatinib Adverse Events Reported to the FDA

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

Death
4182 (4.24%)
Nausea
1697 (1.72%)
Diarrhoea
1254 (1.27%)
Vomiting
1180 (1.2%)
Neoplasm Malignant
1159 (1.17%)
Pyrexia
1143 (1.16%)
Anaemia
1117 (1.13%)
Dyspnoea
1050 (1.06%)
Fatigue
999 (1.01%)
Oedema Peripheral
920 (.93%)
Rash
891 (.9%)
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Haemoglobin Decreased
813 (.82%)
Pleural Effusion
719 (.73%)
Asthenia
717 (.73%)
Abdominal Pain
650 (.66%)
Platelet Count Decreased
645 (.65%)
Malignant Neoplasm Progression
640 (.65%)
Muscle Spasms
631 (.64%)
White Blood Cell Count Decreased
581 (.59%)
Drug Ineffective
575 (.58%)
Thrombocytopenia
568 (.58%)
Pneumonia
560 (.57%)
Malaise
549 (.56%)
Oedema
529 (.54%)
Pancytopenia
506 (.51%)
Blood Creatinine Increased
487 (.49%)
Fluid Retention
486 (.49%)
Headache
483 (.49%)
Gastrointestinal Stromal Tumour
428 (.43%)
Decreased Appetite
422 (.43%)
Dizziness
417 (.42%)
Chronic Myeloid Leukaemia
414 (.42%)
Cough
408 (.41%)
Myalgia
403 (.41%)
Pain
390 (.4%)
Neutropenia
376 (.38%)
Alanine Aminotransferase Increased
373 (.38%)
Weight Increased
373 (.38%)
Ascites
372 (.38%)
Pruritus
370 (.38%)
Pain In Extremity
369 (.37%)
Arthralgia
366 (.37%)
Surgery
358 (.36%)
Drug Exposure During Pregnancy
355 (.36%)
Aspartate Aminotransferase Increase...
353 (.36%)
Weight Decreased
352 (.36%)
Fall
346 (.35%)
Neoplasm Progression
341 (.35%)
Blast Crisis In Myelogenous Leukaem...
336 (.34%)
General Physical Health Deteriorati...
331 (.34%)
White Blood Cell Count Increased
331 (.34%)
Renal Failure
327 (.33%)
Disease Progression
320 (.32%)
Sepsis
305 (.31%)
Red Blood Cell Count Decreased
302 (.31%)
Chest Pain
299 (.3%)
Periorbital Oedema
297 (.3%)
Face Oedema
296 (.3%)
Abdominal Pain Upper
282 (.29%)
Back Pain
282 (.29%)
Haematocrit Decreased
279 (.28%)
Interstitial Lung Disease
272 (.28%)
Drug Resistance
269 (.27%)
Dehydration
267 (.27%)
Bone Marrow Failure
266 (.27%)
Renal Failure Acute
264 (.27%)
Bone Pain
262 (.27%)
Infection
256 (.26%)
Cardiac Failure Congestive
254 (.26%)
Respiratory Failure
253 (.26%)
Gait Disturbance
252 (.26%)
Metastases To Liver
247 (.25%)
Gastrointestinal Haemorrhage
246 (.25%)
Blood Bilirubin Increased
245 (.25%)
Blood Alkaline Phosphatase Increase...
241 (.24%)
Cardiac Failure
241 (.24%)
Hypoaesthesia
239 (.24%)
Depression
238 (.24%)
Abdominal Discomfort
234 (.24%)
Abdominal Distension
233 (.24%)
Blood Lactate Dehydrogenase Increas...
232 (.24%)
Hypotension
227 (.23%)
Generalised Oedema
225 (.23%)
Blood Creatine Phosphokinase Increa...
218 (.22%)
Drug Interaction
218 (.22%)
Eye Swelling
218 (.22%)
Muscular Weakness
218 (.22%)
Erythema
215 (.22%)
Myocardial Infarction
208 (.21%)
Drug Intolerance
207 (.21%)
Hypertension
204 (.21%)
Liver Disorder
203 (.21%)
Cerebrovascular Accident
202 (.2%)
Eyelid Oedema
201 (.2%)
Renal Impairment
195 (.2%)
Constipation
189 (.19%)
Cardiac Disorder
186 (.19%)
C-reactive Protein Increased
185 (.19%)
Pericardial Effusion
185 (.19%)
Leukopenia
183 (.19%)
Atrial Fibrillation
178 (.18%)

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

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

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

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

Chronic Myeloid Leukaemia
9801
Gastrointestinal Stromal Tumour
2952
Acute Lymphocytic Leukaemia
865
Gastric Cancer
195
Malignant Soft Tissue Neoplasm
135
Leukaemia
121
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Neoplasm Malignant
103
Glioblastoma Multiforme
90
Acute Myeloid Leukaemia
90
Pulmonary Arterial Hypertension
87
Blast Crisis In Myelogenous Leukaem...
85
Chromosome Analysis Abnormal
54
Myeloid Leukaemia
48
Hypereosinophilic Syndrome
47
Prostate Cancer
46
Drug Use For Unknown Indication
35
Chronic Myeloid Leukaemia (in Remis...
34
Metastases To Liver
32
Gastrointestinal Carcinoma
31
Neoplasm
27
Dermatofibrosarcoma
26
Acute Lymphocytic Leukaemia Recurre...
23
Chronic Eosinophilic Leukaemia
22
Sarcoma
21
Pulmonary Hypertension
21
Malignant Melanoma
20
Myelodysplastic Syndrome
20
Pancreatic Carcinoma
20
Acute Leukaemia
20
Soft Tissue Neoplasm
19
Interstitial Lung Disease
18
Acute Biphenotypic Leukaemia
18
Systemic Sclerosis
17
Lymphocytic Leukaemia
17
Breast Cancer Metastatic
17
Chronic Lymphocytic Leukaemia
17
Polycythaemia Vera
17
Non-small Cell Lung Cancer
16
Glioblastoma
16
Ureteric Cancer Metastatic
16
Renal Cell Carcinoma Stage Unspecif...
15
Lung Neoplasm Malignant
15
Acute Myeloid Leukaemia Recurrent
15
Product Used For Unknown Indication
15
Chordoma
14
Eosinophilia
14
Mastocytosis
14
Scleroderma
13
Gastrointestinal Neoplasm
13
Astrocytoma
13
Myeloproliferative Disorder
12

Drug Labels

LabelLabelerEffective
GleevecPhysicians Total Care, Inc.01-MAR-12
GleevecNovartis Pharmaceuticals Corporation22-FEB-13

Imatinib Case Reports

What Imatinib 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 Imatinib. 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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