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PROPAFENONE

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Propafenone Adverse Events Reported to the FDA Over Time

How are Propafenone adverse event reports trending over time?

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

Most Common Propafenone Adverse Events Reported to the FDA

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

Atrial Fibrillation
260 (3.42%)
Dizziness
159 (2.09%)
Drug Ineffective
150 (1.97%)
Hypotension
144 (1.89%)
Nausea
112 (1.47%)
Bradycardia
100 (1.31%)
Asthenia
96 (1.26%)
Dyspnoea
91 (1.2%)
Product Quality Issue
89 (1.17%)
Fall
88 (1.16%)
Fatigue
86 (1.13%)
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Cardiac Arrest
80 (1.05%)
Drug Interaction
77 (1.01%)
Vomiting
75 (.99%)
Headache
73 (.96%)
Palpitations
73 (.96%)
Malaise
70 (.92%)
Syncope
64 (.84%)
Arrhythmia
63 (.83%)
Heart Rate Increased
61 (.8%)
Electrocardiogram Qrs Complex Prolo...
60 (.79%)
Completed Suicide
59 (.78%)
Chest Pain
58 (.76%)
Overdose
56 (.74%)
Loss Of Consciousness
54 (.71%)
Heart Rate Irregular
50 (.66%)
International Normalised Ratio Incr...
50 (.66%)
Tremor
49 (.64%)
Ventricular Tachycardia
46 (.6%)
Hyperhidrosis
44 (.58%)
Dysgeusia
43 (.57%)
Diarrhoea
41 (.54%)
Atrial Flutter
39 (.51%)
Convulsion
38 (.5%)
Suicide Attempt
37 (.49%)
Vision Blurred
35 (.46%)
Blood Pressure Increased
34 (.45%)
Coma
33 (.43%)
Constipation
33 (.43%)
Heart Rate Decreased
33 (.43%)
Chest Discomfort
32 (.42%)
Condition Aggravated
32 (.42%)
Drug Toxicity
31 (.41%)
Sinus Bradycardia
30 (.39%)
Tachycardia
30 (.39%)
Abdominal Pain
29 (.38%)
Confusional State
29 (.38%)
Feeling Abnormal
29 (.38%)
Pallor
28 (.37%)
Blood Pressure Decreased
27 (.35%)
Bundle Branch Block Left
27 (.35%)
Electrocardiogram Qt Prolonged
27 (.35%)
Treatment Noncompliance
27 (.35%)
Cardiac Failure Congestive
26 (.34%)
Cardio-respiratory Arrest
26 (.34%)
Hypertension
25 (.33%)
Somnolence
25 (.33%)
Dyspepsia
24 (.32%)
Intentional Overdose
24 (.32%)
Muscular Weakness
24 (.32%)
Pain
24 (.32%)
Abdominal Pain Upper
23 (.3%)
Anxiety
23 (.3%)
Balance Disorder
23 (.3%)
Brugada Syndrome
23 (.3%)
Cholestasis
23 (.3%)
Dry Mouth
23 (.3%)
Ventricular Extrasystoles
23 (.3%)
Vertigo
23 (.3%)
Death
22 (.29%)
Eye Irritation
22 (.29%)
Hyperkalaemia
22 (.29%)
Oedema Peripheral
22 (.29%)
Hypoaesthesia
21 (.28%)
Prothrombin Time Prolonged
21 (.28%)
Atrioventricular Block First Degree
20 (.26%)
Cold Sweat
20 (.26%)
Depressed Level Of Consciousness
20 (.26%)
Incorrect Dose Administered
20 (.26%)
Ventricular Arrhythmia
20 (.26%)
Weight Decreased
20 (.26%)
Blood Creatinine Increased
19 (.25%)
Blood Glucose Decreased
19 (.25%)
Blood Sodium Decreased
19 (.25%)
Myocardial Infarction
19 (.25%)
Pneumonia
19 (.25%)
Ventricular Fibrillation
19 (.25%)
Aspartate Aminotransferase Increase...
18 (.24%)
Blood Bilirubin Increased
18 (.24%)
Decreased Appetite
18 (.24%)
Hypoxia
18 (.24%)
Oedema
18 (.24%)
Extrasystoles
17 (.22%)
Grand Mal Convulsion
17 (.22%)
Conduction Disorder
16 (.21%)
Contusion
16 (.21%)
Multiple Drug Overdose Intentional
16 (.21%)
Rash
16 (.21%)
Respiratory Failure
16 (.21%)
Alopecia
15 (.2%)
Amnesia
15 (.2%)

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

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

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

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

Atrial Fibrillation
771
Arrhythmia
255
Product Used For Unknown Indication
192
Drug Use For Unknown Indication
184
Cardiac Disorder
49
Heart Rate Irregular
38
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Tachycardia
35
Supraventricular Tachycardia
30
Atrial Flutter
29
Extrasystoles
19
Hypertension
16
Suicide Attempt
16
Palpitations
15
Ventricular Arrhythmia
14
Ventricular Extrasystoles
12
Cardiac Fibrillation
10
Arrhythmia Supraventricular
8
Atrial Tachycardia
8
Arrhythmia Prophylaxis
8
Multiple Drug Overdose Intentional
8
Supraventricular Extrasystoles
7
Wolff-parkinson-white Syndrome
7
Heart Rate Increased
7
Unevaluable Event
6
Heart Rate
5
Cardiac Failure Congestive
5
Ventricular Tachycardia
4
Prophylaxis
4
Investigation
3
Tachyarrhythmia
3
Blood Pressure
3
Drug Abuse
3
Bundle Branch Block
2
Poisoning Deliberate
2
Overdose
2
Dyspnoea
2
Coronary Artery Disease
2
Accidental Overdose
2
Ill-defined Disorder
2
Cardiac Flutter
2
Ischaemia
1
Dyslipidaemia
1
Tremor
1
Cardiac Valve Disease
1
Vascular Graft
1
Nodal Arrhythmia
1
Essential Hypertension
1
Sinus Tachycardia
1
Intentional Overdose
1
Ventricular Fibrillation
1
Cardiac Ablation
1

Drug Labels

LabelLabelerEffective
Propafenone HydrochlorideMutual Pharmaceutical Co., Inc.13-JUL-09
Propafenone HydrochloridePhysicians Total Care, Inc.13-JUL-09
Propafenone HydrochlorideUDL Laboratories, Inc.05-FEB-10
Propafenone HydrochlorideNCS HealthCare of KY, Inc dba Vangard Labs27-MAY-10
RythmolsrGlaxoSmithKline LLC18-MAR-11
PropafenoneRebel Distributors Corp13-APR-11
Propafenone HydrochlorideCardinal Health25-MAY-11
Propafenone HydrochlorideQualitest Pharmaceuticals30-DEC-11
Propafenone HclAmerican Health Packaging17-JUL-12
Propafenone HclMcKesson Packaging Services a business unit of McKesson Corporation21-AUG-12
Propafenone HclWatson Laboratories, Inc.11-JAN-13
RythmolsrGlaxoSmithKline LLC14-FEB-13
RythmolGlaxoSmithKline LLC20-MAR-13
Propafenone HydrochloridePar Pharmaceutical, Inc.15-APR-13

Propafenone Case Reports

What Propafenone 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 Propafenone. 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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