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ROSIGLITAZONE MALEATE

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Rosiglitazone Maleate Adverse Events Reported to the FDA Over Time

How are Rosiglitazone Maleate adverse event reports trending over time?

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

Most Common Rosiglitazone Maleate Adverse Events Reported to the FDA

What are the most common Rosiglitazone Maleate adverse events reported to the FDA?

Myocardial Infarction
20989 (13.97%)
Cardiac Failure Congestive
12609 (8.39%)
Cerebrovascular Accident
7671 (5.11%)
Death
5646 (3.76%)
Coronary Artery Disease
5592 (3.72%)
Cardiac Disorder
4836 (3.22%)
Cardiovascular Disorder
3200 (2.13%)
Injury
2199 (1.46%)
Dyspnoea
2174 (1.45%)
Myocardial Ischaemia
2093 (1.39%)
Chest Pain
1893 (1.26%)
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Pain
1778 (1.18%)
Heart Injury
1685 (1.12%)
Weight Increased
1529 (1.02%)
Adverse Event
1383 (.92%)
Hypertension
1377 (.92%)
Transient Ischaemic Attack
1375 (.92%)
Atrial Fibrillation
1349 (.9%)
Cardiac Arrest
1196 (.8%)
Coronary Artery Bypass
1186 (.79%)
Oedema Peripheral
1177 (.78%)
Cardiac Failure
1138 (.76%)
Acute Myocardial Infarction
1120 (.75%)
Renal Failure
1068 (.71%)
Fatigue
971 (.65%)
Stent Placement
964 (.64%)
Oedema
897 (.6%)
Fluid Retention
855 (.57%)
Arteriosclerosis
837 (.56%)
Arrhythmia
810 (.54%)
Cardiomyopathy
743 (.49%)
Blood Glucose Increased
738 (.49%)
Asthenia
703 (.47%)
Ischaemic Cardiomyopathy
698 (.46%)
Dizziness
670 (.45%)
Anxiety
666 (.44%)
Depression
659 (.44%)
Acute Coronary Syndrome
616 (.41%)
Anaemia
569 (.38%)
Drug Ineffective
535 (.36%)
Angina Unstable
516 (.34%)
Hyperlipidaemia
513 (.34%)
Angina Pectoris
504 (.34%)
Nausea
493 (.33%)
Coronary Artery Occlusion
477 (.32%)
Arteriosclerosis Coronary Artery
472 (.31%)
Thrombosis
450 (.3%)
Pulmonary Oedema
447 (.3%)
Amnesia
441 (.29%)
Macular Oedema
432 (.29%)
Swelling
414 (.28%)
Cardio-respiratory Arrest
410 (.27%)
Blindness
407 (.27%)
Palpitations
401 (.27%)
Vision Blurred
397 (.26%)
Cardiomegaly
395 (.26%)
Diarrhoea
391 (.26%)
Headache
382 (.25%)
Condition Aggravated
367 (.24%)
Pain In Extremity
365 (.24%)
Heart Rate Irregular
353 (.24%)
Arterial Occlusive Disease
345 (.23%)
Hypoglycaemia
345 (.23%)
Pneumonia
338 (.23%)
Pleural Effusion
323 (.22%)
Gait Disturbance
321 (.21%)
Cardiac Pacemaker Insertion
313 (.21%)
Renal Failure Acute
312 (.21%)
Hypoaesthesia
307 (.2%)
Pulmonary Hypertension
307 (.2%)
Mitral Valve Incompetence
301 (.2%)
Respiratory Failure
301 (.2%)
Chronic Obstructive Pulmonary Disea...
297 (.2%)
Cardiac Operation
295 (.2%)
Malaise
295 (.2%)
Hepatic Failure
277 (.18%)
Sudden Cardiac Death
276 (.18%)
Joint Swelling
274 (.18%)
Fall
273 (.18%)
Fluid Overload
252 (.17%)
Visual Acuity Reduced
251 (.17%)
Weight Decreased
247 (.16%)
Ventricular Tachycardia
246 (.16%)
Diabetes Mellitus Inadequate Contro...
243 (.16%)
Coronary Arterial Stent Insertion
241 (.16%)
Blood Glucose Decreased
239 (.16%)
Heart Rate Increased
239 (.16%)
Renal Disorder
238 (.16%)
Implantable Defibrillator Insertion
236 (.16%)
Chest Discomfort
232 (.15%)
Ischaemic Stroke
229 (.15%)
Vomiting
229 (.15%)
Diabetes Mellitus
228 (.15%)
Intracardiac Thrombus
227 (.15%)
Liver Injury
224 (.15%)
Loss Of Consciousness
222 (.15%)
Pulmonary Embolism
222 (.15%)
Emotional Distress
216 (.14%)
Peripheral Vascular Disorder
215 (.14%)
Blood Cholesterol Increased
211 (.14%)
Muscular Weakness
208 (.14%)

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

What are the most common Rosiglitazone Maleate adverse events reported to the FDA?

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

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

Diabetes Mellitus
25575
Type 2 Diabetes Mellitus
3911
Drug Use For Unknown Indication
3303
Diabetes Mellitus Non-insulin-depen...
806
Product Used For Unknown Indication
484
Ill-defined Disorder
207
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Blood Glucose
41
Blood Glucose Increased
33
Insulin Resistance
21
Glucose Tolerance Impaired
19
Diabetes Mellitus Insulin-dependent
15
Type 1 Diabetes Mellitus
13
Hypertension
12
Blood Glucose Abnormal
12
Hyperglycaemia
9
Myocardial Infarction
9
Prophylaxis
8
Acne
6
Blood Pressure
6
Insulin-requiring Type 2 Diabetes M...
6
Diabetes Mellitus Inadequate Contro...
5
Psoriasis
4
Dementia Alzheimers Type
4
Blood Insulin Abnormal
4
Drug Dispensing Error
4
Diabetes Mellitus Management
3
Blood Glucose Fluctuation
3
Accidental Exposure
3
Insulin Resistance Syndrome
3
Insulin-requiring Type Ii Diabetes ...
3
Metabolic Syndrome
3
Hepatitis C
2
Medication Error
2
Cardiac Disorder
2
Blood Cholesterol Increased
2
Polycystic Ovaries
2
Menstruation Irregular
2
Unevaluable Event
2
Glycosylated Haemoglobin Increased
2
Drug Exposure During Pregnancy
2
Heart Injury
2
Oedema
1
Sarcoma
1
Asthma
1
Pain Management
1
Gestational Diabetes
1
Obesity
1
Cardiovascular Disorder
1
Colon Cancer
1
Immune System Disorder
1
Pruritus
1

Drug Labels

LabelLabelerEffective
Rosiglitazone MaleateWest-ward Pharmaceutical Corp22-JUL-09
AvandiaCardinal Health03-OCT-11
AvandiaGlaxoSmithKline LLC03-APR-12
AvandametGlaxoSmithKline LLC03-APR-12
AvandarylGlaxoSmithKline LLC04-APR-12
Avandamet Physicians Total Care, Inc.30-AUG-12

Rosiglitazone Maleate Case Reports

What Rosiglitazone Maleate 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 Rosiglitazone Maleate. 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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