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PACERONE

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Pacerone Adverse Events Reported to the FDA Over Time

How are Pacerone adverse event reports trending over time?

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

Most Common Pacerone Adverse Events Reported to the FDA

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

Drug Interaction
593 (2.22%)
Dyspnoea
498 (1.86%)
Atrial Fibrillation
455 (1.7%)
Ventricular Tachycardia
317 (1.19%)
Dizziness
292 (1.09%)
Hyperthyroidism
287 (1.07%)
Fatigue
278 (1.04%)
Asthenia
273 (1.02%)
Bradycardia
260 (.97%)
Torsade De Pointes
248 (.93%)
Interstitial Lung Disease
240 (.9%)
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Hypotension
237 (.89%)
Electrocardiogram Qt Prolonged
235 (.88%)
Hypothyroidism
227 (.85%)
Pulmonary Fibrosis
223 (.83%)
Nausea
221 (.83%)
Cardiac Arrest
220 (.82%)
Pneumonia
218 (.82%)
International Normalised Ratio Incr...
210 (.79%)
Pulmonary Toxicity
196 (.73%)
Renal Failure Acute
196 (.73%)
Syncope
186 (.7%)
Condition Aggravated
184 (.69%)
Drug Ineffective
183 (.69%)
Pleural Effusion
170 (.64%)
Cardiac Failure
164 (.61%)
Renal Failure
159 (.6%)
Drug Toxicity
157 (.59%)
Oedema Peripheral
155 (.58%)
Lung Disorder
153 (.57%)
Rhabdomyolysis
149 (.56%)
Alanine Aminotransferase Increased
147 (.55%)
Respiratory Failure
143 (.54%)
Fall
139 (.52%)
Paraesthesia
138 (.52%)
Vomiting
138 (.52%)
Cardiac Failure Congestive
133 (.5%)
Aspartate Aminotransferase Increase...
131 (.49%)
Feeling Abnormal
131 (.49%)
Ventricular Fibrillation
128 (.48%)
Weight Decreased
128 (.48%)
Tremor
127 (.48%)
Arrhythmia
118 (.44%)
Liver Function Test Abnormal
118 (.44%)
Hypokalaemia
115 (.43%)
Cough
110 (.41%)
Cardiac Murmur
109 (.41%)
Blood Creatinine Increased
105 (.39%)
Malaise
103 (.39%)
Pneumonitis
103 (.39%)
Anaemia
102 (.38%)
Oedema
96 (.36%)
Diarrhoea
95 (.36%)
Cardiogenic Shock
89 (.33%)
Loss Of Consciousness
89 (.33%)
Renal Impairment
89 (.33%)
Venous Pressure Jugular Increased
89 (.33%)
Dyspnoea Exertional
88 (.33%)
Multi-organ Failure
88 (.33%)
Acute Respiratory Distress Syndrome
87 (.33%)
Dehydration
87 (.33%)
Pyrexia
87 (.33%)
Pulmonary Oedema
86 (.32%)
Confusional State
85 (.32%)
Hepatotoxicity
81 (.3%)
General Physical Health Deteriorati...
80 (.3%)
Heart Rate Decreased
80 (.3%)
Pain
80 (.3%)
Haemoglobin Decreased
78 (.29%)
Left Ventricular Dysfunction
77 (.29%)
Muscular Weakness
77 (.29%)
Hyponatraemia
76 (.28%)
Chest Pain
75 (.28%)
Hyperhidrosis
75 (.28%)
Blood Creatine Phosphokinase Increa...
73 (.27%)
Liver Disorder
73 (.27%)
Gait Disturbance
72 (.27%)
Hepatic Failure
72 (.27%)
Blood Pressure Decreased
67 (.25%)
Hepatic Enzyme Increased
67 (.25%)
Hypoxia
67 (.25%)
Headache
66 (.25%)
Heart Rate Increased
66 (.25%)
Hyperkalaemia
65 (.24%)
Tachycardia
65 (.24%)
Blood Alkaline Phosphatase Increase...
64 (.24%)
Constipation
64 (.24%)
Skin Discolouration
64 (.24%)
Pericardial Effusion
62 (.23%)
Ventricular Extrasystoles
61 (.23%)
Thyroid Disorder
60 (.22%)
Vision Blurred
60 (.22%)
Death
59 (.22%)
Lung Infiltration
59 (.22%)
Myositis
59 (.22%)
Cardio-respiratory Arrest
58 (.22%)
Decreased Appetite
58 (.22%)
Dissociation
58 (.22%)
Palpitations
58 (.22%)
Sinus Bradycardia
58 (.22%)
Myocardial Infarction
57 (.21%)

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

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

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

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

Atrial Fibrillation
2744
Arrhythmia
794
Drug Use For Unknown Indication
705
Product Used For Unknown Indication
694
Ventricular Tachycardia
511
Cardiac Disorder
263
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Atrial Flutter
162
Supraventricular Tachycardia
161
Ventricular Fibrillation
140
Ventricular Arrhythmia
115
Heart Rate Irregular
92
Tachycardia
91
Ill-defined Disorder
82
Tachyarrhythmia
74
Hypertension
60
Cardiac Failure
54
Cardiac Failure Congestive
46
Arrhythmia Prophylaxis
38
Prophylaxis
36
Heart Rate Increased
35
Congestive Cardiomyopathy
31
Ventricular Extrasystoles
30
Cardioversion
28
Heart Rate Abnormal
22
Cardiac Fibrillation
22
Aortic Valve Replacement
21
Cardiomyopathy
20
Coronary Artery Disease
19
Palpitations
18
Torsade De Pointes
18
Arrhythmia Supraventricular
18
Hypertrophic Cardiomyopathy
18
Intentional Overdose
17
Atrial Tachycardia
17
Tachycardia Foetal
16
Cardiac Murmur
16
Cardio-respiratory Arrest
15
Cardiac Failure Chronic
14
Heart Rate
14
Coronary Artery Bypass
13
Hypotension
13
Ventricular Tachyarrhythmia
13
Cardiovascular Disorder
12
Myocardial Infarction
12
Supraventricular Tachyarrhythmia
10
Myocardial Ischaemia
9
Acute Myocardial Infarction
8
Sick Sinus Syndrome
7
Extrasystoles
7
Blood Pressure Abnormal
7
Post Procedural Complication
7

Drug Labels

LabelLabelerEffective
PaceronePhysicians Total Care, Inc.19-JAN-11
PaceroneCardinal Health26-JAN-12
PaceroneAphena Pharma Solutions - Tennessee, Inc.28-MAR-12
PaceroneUpsher-Smith Laboratories, Inc.31-AUG-12
PaceroneUpsher-Smith Laboratories, Inc.31-AUG-12

Pacerone Case Reports

What Pacerone 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 Pacerone. 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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