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CORDARONE

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Cordarone Adverse Events Reported to the FDA Over Time

How are Cordarone adverse event reports trending over time?

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

Most Common Cordarone Adverse Events Reported to the FDA

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

Drug Interaction
954 (2.42%)
Atrial Fibrillation
597 (1.51%)
Dyspnoea
588 (1.49%)
Bradycardia
483 (1.23%)
Hyperthyroidism
477 (1.21%)
Interstitial Lung Disease
420 (1.07%)
International Normalised Ratio Incr...
403 (1.02%)
Asthenia
359 (.91%)
Ventricular Tachycardia
358 (.91%)
Electrocardiogram Qt Prolonged
346 (.88%)
Renal Failure Acute
345 (.88%)
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Hypothyroidism
344 (.87%)
Torsade De Pointes
344 (.87%)
Dizziness
326 (.83%)
Renal Failure
323 (.82%)
Pulmonary Fibrosis
321 (.81%)
Condition Aggravated
313 (.79%)
Fatigue
312 (.79%)
Hypotension
306 (.78%)
Fall
298 (.76%)
Cardiac Arrest
289 (.73%)
Nausea
283 (.72%)
Cardiac Failure
281 (.71%)
Pneumonia
277 (.7%)
Lung Disorder
257 (.65%)
Syncope
255 (.65%)
Drug Ineffective
230 (.58%)
Pleural Effusion
224 (.57%)
Rhabdomyolysis
218 (.55%)
Vomiting
218 (.55%)
Malaise
213 (.54%)
Pulmonary Toxicity
211 (.54%)
Alanine Aminotransferase Increased
205 (.52%)
Oedema Peripheral
204 (.52%)
Anaemia
196 (.5%)
Weight Decreased
182 (.46%)
Tremor
181 (.46%)
Aspartate Aminotransferase Increase...
180 (.46%)
General Physical Health Deteriorati...
180 (.46%)
Respiratory Failure
177 (.45%)
Arrhythmia
174 (.44%)
Drug Toxicity
166 (.42%)
Pyrexia
161 (.41%)
Hypokalaemia
157 (.4%)
Cough
153 (.39%)
Paraesthesia
152 (.39%)
Blood Creatinine Increased
151 (.38%)
Diarrhoea
151 (.38%)
Ventricular Fibrillation
150 (.38%)
Pneumonitis
148 (.38%)
Cardiogenic Shock
147 (.37%)
Hyponatraemia
147 (.37%)
Loss Of Consciousness
147 (.37%)
Acute Respiratory Distress Syndrome
145 (.37%)
Dehydration
143 (.36%)
Cardiac Failure Congestive
140 (.36%)
Hyperkalaemia
137 (.35%)
Confusional State
133 (.34%)
Multi-organ Failure
131 (.33%)
Feeling Abnormal
130 (.33%)
Liver Function Test Abnormal
129 (.33%)
Pulmonary Oedema
127 (.32%)
Haemoglobin Decreased
123 (.31%)
Thrombocytopenia
123 (.31%)
Muscular Weakness
121 (.31%)
Cytolytic Hepatitis
119 (.3%)
Hepatic Failure
117 (.3%)
Cardiac Murmur
114 (.29%)
Cholestasis
114 (.29%)
Gait Disturbance
114 (.29%)
Sinus Bradycardia
112 (.28%)
Overdose
109 (.28%)
Oedema
108 (.27%)
Gamma-glutamyltransferase Increased
105 (.27%)
Hypoxia
105 (.27%)
Blood Alkaline Phosphatase Increase...
104 (.26%)
Cardio-respiratory Arrest
102 (.26%)
Chest Pain
102 (.26%)
Headache
102 (.26%)
Renal Impairment
101 (.26%)
Ventricular Extrasystoles
101 (.26%)
Jaundice
100 (.25%)
Hyperhidrosis
96 (.24%)
Pain
96 (.24%)
Blood Creatine Phosphokinase Increa...
95 (.24%)
Dyspnoea Exertional
95 (.24%)
Hepatotoxicity
93 (.24%)
Liver Disorder
91 (.23%)
Tachycardia
91 (.23%)
Coma
90 (.23%)
Hepatic Enzyme Increased
90 (.23%)
Venous Pressure Jugular Increased
90 (.23%)
Death
89 (.23%)
Abdominal Pain
85 (.22%)
Constipation
84 (.21%)
Left Ventricular Dysfunction
82 (.21%)
Myocardial Infarction
82 (.21%)
Septic Shock
82 (.21%)
Lung Infiltration
81 (.21%)
Vision Blurred
80 (.2%)
Haematoma
78 (.2%)

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

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

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

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

Atrial Fibrillation
4011
Arrhythmia
1209
Drug Use For Unknown Indication
1006
Product Used For Unknown Indication
825
Ventricular Tachycardia
593
Atrial Flutter
378
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Cardiac Disorder
325
Supraventricular Tachycardia
192
Ventricular Fibrillation
150
Tachycardia
141
Ventricular Arrhythmia
132
Ill-defined Disorder
117
Cardiac Failure
109
Tachyarrhythmia
96
Heart Rate Irregular
91
Hypertension
79
Arrhythmia Prophylaxis
57
Ventricular Extrasystoles
54
Prophylaxis
47
Cardiac Failure Congestive
45
Arrhythmia Supraventricular
43
Cardiomyopathy
41
Atrial Tachycardia
38
Congestive Cardiomyopathy
33
Heart Rate Increased
31
Coronary Artery Disease
30
Cardioversion
29
Hypertrophic Cardiomyopathy
25
Extrasystoles
24
Cardiac Fibrillation
24
Heart Rate Abnormal
23
Aortic Valve Replacement
21
Torsade De Pointes
19
Acute Myocardial Infarction
19
Conduction Disorder
19
Intentional Overdose
18
Tachycardia Foetal
17
Myocardial Ischaemia
17
Palpitations
17
Myocardial Infarction
17
Heart Rate
17
Cardiac Murmur
16
Cardiac Failure Chronic
16
Supraventricular Tachyarrhythmia
16
Cardio-respiratory Arrest
15
Cardiovascular Disorder
14
Coronary Artery Bypass
14
Hypertensive Heart Disease
14
Supraventricular Extrasystoles
13
Ventricular Tachyarrhythmia
13
Ischaemic Cardiomyopathy
13

Drug Labels

LabelLabelerEffective
CordaroneWyeth Pharmaceuticals Company, a subsidiary of Pfizer Inc.15-JAN-13

Cordarone Case Reports

What Cordarone 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 Cordarone. 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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