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ROSIGLITAZONE

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Rosiglitazone Adverse Events Reported to the FDA Over Time

How are Rosiglitazone adverse event reports trending over time?

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

Most Common Rosiglitazone Adverse Events Reported to the FDA

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

Myocardial Infarction
21141 (13.77%)
Cardiac Failure Congestive
12774 (8.32%)
Cerebrovascular Accident
7751 (5.05%)
Death
5776 (3.76%)
Coronary Artery Disease
5620 (3.66%)
Cardiac Disorder
4862 (3.17%)
Cardiovascular Disorder
3254 (2.12%)
Dyspnoea
2247 (1.46%)
Injury
2229 (1.45%)
Myocardial Ischaemia
2227 (1.45%)
Chest Pain
1934 (1.26%)
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Pain
1788 (1.16%)
Heart Injury
1693 (1.1%)
Weight Increased
1566 (1.02%)
Hypertension
1405 (.92%)
Atrial Fibrillation
1389 (.9%)
Adverse Event
1386 (.9%)
Transient Ischaemic Attack
1385 (.9%)
Oedema Peripheral
1252 (.82%)
Cardiac Arrest
1207 (.79%)
Coronary Artery Bypass
1191 (.78%)
Cardiac Failure
1166 (.76%)
Acute Myocardial Infarction
1151 (.75%)
Renal Failure
1086 (.71%)
Fatigue
985 (.64%)
Stent Placement
970 (.63%)
Oedema
920 (.6%)
Fluid Retention
867 (.56%)
Arteriosclerosis
844 (.55%)
Arrhythmia
823 (.54%)
Blood Glucose Increased
749 (.49%)
Cardiomyopathy
747 (.49%)
Asthenia
719 (.47%)
Ischaemic Cardiomyopathy
699 (.46%)
Dizziness
680 (.44%)
Anxiety
668 (.44%)
Depression
663 (.43%)
Acute Coronary Syndrome
630 (.41%)
Anaemia
586 (.38%)
Drug Ineffective
536 (.35%)
Angina Unstable
525 (.34%)
Angina Pectoris
519 (.34%)
Hyperlipidaemia
514 (.33%)
Nausea
508 (.33%)
Coronary Artery Occlusion
486 (.32%)
Arteriosclerosis Coronary Artery
476 (.31%)
Pulmonary Oedema
473 (.31%)
Thrombosis
452 (.29%)
Macular Oedema
444 (.29%)
Amnesia
441 (.29%)
Cardio-respiratory Arrest
418 (.27%)
Swelling
414 (.27%)
Blindness
410 (.27%)
Palpitations
407 (.27%)
Vision Blurred
405 (.26%)
Condition Aggravated
402 (.26%)
Diarrhoea
402 (.26%)
Cardiomegaly
400 (.26%)
Headache
391 (.25%)
Hypoglycaemia
390 (.25%)
Pain In Extremity
375 (.24%)
Heart Rate Irregular
357 (.23%)
Pneumonia
352 (.23%)
Arterial Occlusive Disease
346 (.23%)
Pleural Effusion
334 (.22%)
Gait Disturbance
324 (.21%)
Renal Failure Acute
319 (.21%)
Pulmonary Hypertension
317 (.21%)
Cardiac Pacemaker Insertion
314 (.2%)
Hypoaesthesia
309 (.2%)
Mitral Valve Incompetence
309 (.2%)
Respiratory Failure
306 (.2%)
Chronic Obstructive Pulmonary Disea...
300 (.2%)
Malaise
300 (.2%)
Fall
297 (.19%)
Cardiac Operation
295 (.19%)
Hepatic Failure
295 (.19%)
Sudden Cardiac Death
282 (.18%)
Joint Swelling
277 (.18%)
Visual Acuity Reduced
258 (.17%)
Weight Decreased
258 (.17%)
Fluid Overload
257 (.17%)
Diabetes Mellitus Inadequate Contro...
253 (.16%)
Vomiting
249 (.16%)
Ventricular Tachycardia
247 (.16%)
Heart Rate Increased
244 (.16%)
Chest Discomfort
243 (.16%)
Blood Glucose Decreased
242 (.16%)
Coronary Arterial Stent Insertion
242 (.16%)
Renal Disorder
239 (.16%)
Loss Of Consciousness
237 (.15%)
Implantable Defibrillator Insertion
236 (.15%)
Ischaemic Stroke
233 (.15%)
Diabetes Mellitus
232 (.15%)
Intracardiac Thrombus
227 (.15%)
Liver Injury
226 (.15%)
Pulmonary Embolism
223 (.15%)
Peripheral Vascular Disorder
219 (.14%)
Blood Cholesterol Increased
216 (.14%)
Emotional Distress
216 (.14%)
Muscular Weakness
213 (.14%)

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

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

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

Diabetes Mellitus
25944
Type 2 Diabetes Mellitus
4015
Drug Use For Unknown Indication
3465
Diabetes Mellitus Non-insulin-depen...
861
Product Used For Unknown Indication
535
Ill-defined Disorder
210
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Blood Glucose
42
Blood Glucose Increased
34
Insulin Resistance
24
Hyperglycaemia
22
Glucose Tolerance Impaired
20
Dementia Alzheimers Type
16
Diabetes Mellitus Insulin-dependent
15
Type 1 Diabetes Mellitus
15
Hypertension
14
Blood Glucose Abnormal
14
Myocardial Infarction
9
Prophylaxis
8
Diabetes Mellitus Inadequate Contro...
6
Insulin-requiring Type 2 Diabetes M...
6
Acne
6
Blood Pressure
6
Metabolic Syndrome
5
Insulin-requiring Type Ii Diabetes ...
5
Blood Insulin Abnormal
4
Drug Dispensing Error
4
Psoriasis
4
Cardiac Failure Congestive
3
Diabetes Mellitus Management
3
Blood Glucose Fluctuation
3
Accidental Exposure
3
Insulin Resistance Syndrome
3
Cardiac Disorder
2
Medication Error
2
Completed Suicide
2
Unevaluable Event
2
Glycosylated Haemoglobin Increased
2
Drug Exposure During Pregnancy
2
Lipoatrophy
2
Hepatitis C
2
Menstruation Irregular
2
Rheumatoid Arthritis
2
Polycystic Ovaries
2
Blood Cholesterol Increased
2
Heart Injury
2
Oedema
1
Diabetic Vascular Disorder
1
In-stent Arterial Restenosis
1
Asthma
1
Pain Management
1
Gestational Diabetes
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 Case Reports

What Rosiglitazone 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. 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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