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Avandia Adverse Events Reported to the FDA Over Time

How are Avandia adverse event reports trending over time?

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

Most Common Avandia Adverse Events Reported to the FDA

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

Myocardial Infarction
18204 (14.38%)
Cardiac Failure Congestive
10956 (8.65%)
Cerebrovascular Accident
6737 (5.32%)
Death
5406 (4.27%)
Coronary Artery Disease
4601 (3.63%)
Cardiac Disorder
4193 (3.31%)
Cardiovascular Disorder
2780 (2.2%)
Injury
2036 (1.61%)
Dyspnoea
1779 (1.41%)
Myocardial Ischaemia
1716 (1.36%)
Pain
1535 (1.21%)
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Chest Pain
1528 (1.21%)
Heart Injury
1482 (1.17%)
Adverse Event
1334 (1.05%)
Weight Increased
1219 (.96%)
Transient Ischaemic Attack
1189 (.94%)
Hypertension
1158 (.91%)
Atrial Fibrillation
1121 (.89%)
Coronary Artery Bypass
1021 (.81%)
Cardiac Arrest
1016 (.8%)
Oedema Peripheral
959 (.76%)
Renal Failure
947 (.75%)
Cardiac Failure
941 (.74%)
Acute Myocardial Infarction
921 (.73%)
Stent Placement
818 (.65%)
Fatigue
761 (.6%)
Oedema
747 (.59%)
Fluid Retention
741 (.59%)
Arrhythmia
699 (.55%)
Arteriosclerosis
683 (.54%)
Ischaemic Cardiomyopathy
596 (.47%)
Cardiomyopathy
586 (.46%)
Anxiety
580 (.46%)
Asthenia
553 (.44%)
Blood Glucose Increased
552 (.44%)
Depression
548 (.43%)
Dizziness
506 (.4%)
Acute Coronary Syndrome
490 (.39%)
Anaemia
469 (.37%)
Angina Pectoris
431 (.34%)
Hyperlipidaemia
428 (.34%)
Coronary Artery Occlusion
407 (.32%)
Angina Unstable
403 (.32%)
Drug Ineffective
391 (.31%)
Thrombosis
391 (.31%)
Arteriosclerosis Coronary Artery
386 (.3%)
Amnesia
377 (.3%)
Pulmonary Oedema
369 (.29%)
Macular Oedema
365 (.29%)
Cardio-respiratory Arrest
358 (.28%)
Swelling
343 (.27%)
Blindness
339 (.27%)
Cardiomegaly
330 (.26%)
Palpitations
327 (.26%)
Nausea
322 (.25%)
Vision Blurred
315 (.25%)
Condition Aggravated
308 (.24%)
Heart Rate Irregular
303 (.24%)
Pain In Extremity
297 (.23%)
Headache
295 (.23%)
Arterial Occlusive Disease
284 (.22%)
Pneumonia
280 (.22%)
Pleural Effusion
278 (.22%)
Cardiac Pacemaker Insertion
270 (.21%)
Hypoglycaemia
270 (.21%)
Cardiac Operation
265 (.21%)
Pulmonary Hypertension
264 (.21%)
Gait Disturbance
259 (.2%)
Chronic Obstructive Pulmonary Disea...
254 (.2%)
Hypoaesthesia
253 (.2%)
Mitral Valve Incompetence
252 (.2%)
Renal Failure Acute
251 (.2%)
Respiratory Failure
250 (.2%)
Sudden Cardiac Death
245 (.19%)
Hepatic Failure
234 (.18%)
Malaise
229 (.18%)
Fall
228 (.18%)
Joint Swelling
225 (.18%)
Fluid Overload
222 (.18%)
Renal Disorder
216 (.17%)
Diarrhoea
205 (.16%)
Coronary Arterial Stent Insertion
204 (.16%)
Ischaemic Stroke
204 (.16%)
Visual Acuity Reduced
204 (.16%)
Implantable Defibrillator Insertion
203 (.16%)
Liver Injury
202 (.16%)
Ventricular Tachycardia
202 (.16%)
Blood Glucose Decreased
196 (.15%)
Intracardiac Thrombus
196 (.15%)
Diabetes Mellitus
193 (.15%)
Diabetes Mellitus Inadequate Contro...
193 (.15%)
Heart Rate Increased
189 (.15%)
Chest Discomfort
187 (.15%)
Weight Decreased
187 (.15%)
Emotional Distress
180 (.14%)
Vascular Graft
178 (.14%)
Visual Impairment
177 (.14%)
Peripheral Vascular Disorder
175 (.14%)
Congestive Cardiomyopathy
171 (.14%)
Loss Of Consciousness
171 (.14%)
Renal Failure Chronic
168 (.13%)

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

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

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

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

Diabetes Mellitus
22589
Type 2 Diabetes Mellitus
3342
Drug Use For Unknown Indication
2855
Diabetes Mellitus Non-insulin-depen...
656
Product Used For Unknown Indication
421
Ill-defined Disorder
152
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Blood Glucose
35
Blood Glucose Increased
31
Insulin Resistance
18
Glucose Tolerance Impaired
16
Diabetes Mellitus Insulin-dependent
15
Type 1 Diabetes Mellitus
12
Myocardial Infarction
9
Hypertension
9
Prophylaxis
8
Blood Glucose Abnormal
7
Hyperglycaemia
7
Blood Pressure
6
Insulin-requiring Type 2 Diabetes M...
6
Diabetes Mellitus Inadequate Contro...
4
Dementia Alzheimers Type
4
Psoriasis
4
Blood Insulin Abnormal
4
Drug Dispensing Error
3
Insulin Resistance Syndrome
3
Insulin-requiring Type Ii Diabetes ...
3
Metabolic Syndrome
3
Glycosylated Haemoglobin Increased
2
Drug Exposure During Pregnancy
2
Heart Injury
2
Hepatitis C
2
Blood Glucose Fluctuation
2
Accidental Exposure
2
Diabetes Mellitus Management
2
Unevaluable Event
2
Cardiac Disorder
2
Menstruation Irregular
2
Blood Cholesterol Increased
2
Polycystic Ovaries
2
Oedema
1
Diabetic Vascular Disorder
1
Asthma
1
Pain Management
1
Gestational Diabetes
1
Obesity
1
Cardiovascular Disorder
1
Immune System Disorder
1
Pruritus
1
Injury
1
Restless Legs Syndrome
1
Product Contamination
1

Drug Labels

LabelLabelerEffective
AvandiaPhysicians Total Care, Inc.19-JAN-10
AvandiaCardinal Health03-OCT-11
AvandiaGlaxoSmithKline LLC03-APR-12

Avandia Case Reports

What Avandia 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 Avandia. 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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