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IMATINIB MESYLATE

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Imatinib Mesylate Adverse Events Reported to the FDA Over Time

How are Imatinib Mesylate adverse event reports trending over time?

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

Most Common Imatinib Mesylate Adverse Events Reported to the FDA

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

Death
4169 (4.38%)
Nausea
1643 (1.73%)
Diarrhoea
1227 (1.29%)
Neoplasm Malignant
1150 (1.21%)
Vomiting
1147 (1.2%)
Pyrexia
1100 (1.16%)
Anaemia
1097 (1.15%)
Dyspnoea
1015 (1.07%)
Fatigue
971 (1.02%)
Oedema Peripheral
888 (.93%)
Rash
885 (.93%)
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Haemoglobin Decreased
795 (.84%)
Asthenia
708 (.74%)
Pleural Effusion
689 (.72%)
Platelet Count Decreased
630 (.66%)
Muscle Spasms
627 (.66%)
Abdominal Pain
613 (.64%)
Malignant Neoplasm Progression
595 (.62%)
White Blood Cell Count Decreased
564 (.59%)
Drug Ineffective
558 (.59%)
Pneumonia
554 (.58%)
Malaise
541 (.57%)
Thrombocytopenia
536 (.56%)
Oedema
519 (.55%)
Fluid Retention
476 (.5%)
Blood Creatinine Increased
474 (.5%)
Pancytopenia
466 (.49%)
Headache
453 (.48%)
Dizziness
417 (.44%)
Gastrointestinal Stromal Tumour
410 (.43%)
Decreased Appetite
407 (.43%)
Cough
401 (.42%)
Myalgia
399 (.42%)
Chronic Myeloid Leukaemia
395 (.41%)
Pain
384 (.4%)
Pruritus
365 (.38%)
Weight Increased
363 (.38%)
Ascites
361 (.38%)
Alanine Aminotransferase Increased
360 (.38%)
Pain In Extremity
359 (.38%)
Surgery
348 (.37%)
Weight Decreased
346 (.36%)
Arthralgia
345 (.36%)
Neutropenia
345 (.36%)
Aspartate Aminotransferase Increase...
342 (.36%)
Neoplasm Progression
340 (.36%)
Fall
339 (.36%)
Drug Exposure During Pregnancy
327 (.34%)
White Blood Cell Count Increased
325 (.34%)
Blast Crisis In Myelogenous Leukaem...
316 (.33%)
General Physical Health Deteriorati...
313 (.33%)
Renal Failure
312 (.33%)
Disease Progression
305 (.32%)
Red Blood Cell Count Decreased
299 (.31%)
Periorbital Oedema
292 (.31%)
Face Oedema
288 (.3%)
Sepsis
279 (.29%)
Haematocrit Decreased
277 (.29%)
Abdominal Pain Upper
276 (.29%)
Chest Pain
276 (.29%)
Back Pain
274 (.29%)
Interstitial Lung Disease
261 (.27%)
Bone Pain
260 (.27%)
Dehydration
255 (.27%)
Bone Marrow Failure
251 (.26%)
Renal Failure Acute
251 (.26%)
Cardiac Failure Congestive
250 (.26%)
Gait Disturbance
246 (.26%)
Drug Resistance
243 (.26%)
Blood Bilirubin Increased
242 (.25%)
Respiratory Failure
241 (.25%)
Metastases To Liver
239 (.25%)
Hypoaesthesia
237 (.25%)
Depression
236 (.25%)
Infection
236 (.25%)
Gastrointestinal Haemorrhage
235 (.25%)
Abdominal Discomfort
234 (.25%)
Cardiac Failure
233 (.24%)
Blood Alkaline Phosphatase Increase...
229 (.24%)
Abdominal Distension
228 (.24%)
Blood Lactate Dehydrogenase Increas...
228 (.24%)
Generalised Oedema
224 (.24%)
Eye Swelling
216 (.23%)
Hypotension
216 (.23%)
Blood Creatine Phosphokinase Increa...
214 (.22%)
Muscular Weakness
212 (.22%)
Erythema
210 (.22%)
Cerebrovascular Accident
202 (.21%)
Drug Intolerance
202 (.21%)
Myocardial Infarction
202 (.21%)
Drug Interaction
200 (.21%)
Eyelid Oedema
199 (.21%)
Liver Disorder
197 (.21%)
Hypertension
195 (.2%)
Renal Impairment
194 (.2%)
Cardiac Disorder
185 (.19%)
Constipation
184 (.19%)
Atrial Fibrillation
175 (.18%)
C-reactive Protein Increased
175 (.18%)
Pericardial Effusion
174 (.18%)
Leukopenia
172 (.18%)

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

What are the most common Imatinib Mesylate 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 Mesylate, 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 Mesylate 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 Mesylate According to Those Reporting Adverse Events

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

Chronic Myeloid Leukaemia
9523
Gastrointestinal Stromal Tumour
2865
Acute Lymphocytic Leukaemia
801
Gastric Cancer
194
Malignant Soft Tissue Neoplasm
135
Leukaemia
117
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Neoplasm Malignant
102
Glioblastoma Multiforme
89
Acute Myeloid Leukaemia
86
Pulmonary Arterial Hypertension
84
Blast Crisis In Myelogenous Leukaem...
75
Chromosome Analysis Abnormal
54
Myeloid Leukaemia
46
Hypereosinophilic Syndrome
39
Prostate Cancer
34
Chronic Myeloid Leukaemia (in Remis...
34
Gastrointestinal Carcinoma
31
Metastases To Liver
31
Drug Use For Unknown Indication
28
Neoplasm
26
Acute Lymphocytic Leukaemia Recurre...
22
Dermatofibrosarcoma
22
Chronic Eosinophilic Leukaemia
22
Sarcoma
21
Pancreatic Carcinoma
20
Malignant Melanoma
20
Pulmonary Hypertension
20
Myelodysplastic Syndrome
20
Acute Leukaemia
20
Soft Tissue Neoplasm
19
Interstitial Lung Disease
18
Acute Biphenotypic Leukaemia
17
Systemic Sclerosis
17
Breast Cancer Metastatic
17
Lymphocytic Leukaemia
17
Chronic Lymphocytic Leukaemia
17
Polycythaemia Vera
17
Non-small Cell Lung Cancer
16
Glioblastoma
16
Ureteric Cancer Metastatic
16
Acute Myeloid Leukaemia Recurrent
15
Renal Cell Carcinoma Stage Unspecif...
15
Lung Neoplasm Malignant
15
Chordoma
14
Mastocytosis
14
Eosinophilia
14
Astrocytoma
13
Gastrointestinal Neoplasm
13
Scleroderma
13
Product Used For Unknown Indication
13
Kaposis Sarcoma
12

Drug Labels

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

Imatinib Mesylate Case Reports

What Imatinib Mesylate 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 Mesylate. 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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