DrugCite
Search

SOTALOL

Adverse Events
Drug Profile
Learn More
Reference
About Results
Comments

Sotalol Adverse Events Reported to the FDA Over Time

How are Sotalol adverse event reports trending over time?

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

Most Common Sotalol Adverse Events Reported to the FDA

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

Atrial Fibrillation
200 (3.22%)
Bradycardia
167 (2.69%)
Drug Interaction
129 (2.08%)
Electrocardiogram Qt Prolonged
123 (1.98%)
Hypotension
118 (1.9%)
Torsade De Pointes
109 (1.75%)
Dyspnoea
96 (1.54%)
Dizziness
94 (1.51%)
Drug Ineffective
81 (1.3%)
Arrhythmia
76 (1.22%)
Ventricular Tachycardia
76 (1.22%)
Show More Show More
Renal Failure
72 (1.16%)
Fatigue
67 (1.08%)
Cardiac Arrest
60 (.97%)
Drug Toxicity
54 (.87%)
Asthenia
49 (.79%)
Depressed Level Of Consciousness
48 (.77%)
Nausea
47 (.76%)
Metabolic Acidosis
45 (.72%)
Syncope
45 (.72%)
Ventricular Fibrillation
45 (.72%)
Malaise
42 (.68%)
Overdose
41 (.66%)
Cough
40 (.64%)
Cardiac Failure
39 (.63%)
Renal Failure Acute
39 (.63%)
Loss Of Consciousness
38 (.61%)
Cardiogenic Shock
37 (.6%)
Heart Rate Increased
37 (.6%)
Abdominal Pain
34 (.55%)
Cardiomegaly
34 (.55%)
Condition Aggravated
34 (.55%)
Palpitations
34 (.55%)
Death
33 (.53%)
Hypokalaemia
33 (.53%)
Blood Creatinine Increased
32 (.51%)
Vomiting
32 (.51%)
Completed Suicide
31 (.5%)
Pruritus
31 (.5%)
Vision Blurred
31 (.5%)
Alopecia
30 (.48%)
Haemodialysis
30 (.48%)
Fall
29 (.47%)
Headache
29 (.47%)
Cardiac Failure Congestive
28 (.45%)
Diarrhoea
27 (.43%)
Pulse Absent
27 (.43%)
Blood Pressure Increased
26 (.42%)
Heart Rate Irregular
26 (.42%)
Abdominal Tenderness
25 (.4%)
Blood Glucose Increased
25 (.4%)
Cardioactive Drug Level Decreased
25 (.4%)
Heart Rate Decreased
25 (.4%)
Liver Function Test Abnormal
25 (.4%)
Blood Pressure Decreased
24 (.39%)
Anuria
23 (.37%)
Atrioventricular Block First Degree
23 (.37%)
Dehydration
23 (.37%)
International Normalised Ratio Incr...
23 (.37%)
Livedo Reticularis
23 (.37%)
No Adverse Event
23 (.37%)
Oedema Peripheral
23 (.37%)
Ventricular Extrasystoles
23 (.37%)
Chest Pain
22 (.35%)
Hepatic Enzyme Increased
22 (.35%)
Tachycardia
22 (.35%)
Confusional State
21 (.34%)
Abdominal Discomfort
19 (.31%)
Extrasystoles
19 (.31%)
Hyponatraemia
19 (.31%)
Pain
19 (.31%)
Suicide Attempt
19 (.31%)
Adverse Event
18 (.29%)
Amyotrophic Lateral Sclerosis
18 (.29%)
Medication Error
18 (.29%)
Pneumonia
18 (.29%)
Ventricular Arrhythmia
18 (.29%)
Weight Decreased
18 (.29%)
Decreased Appetite
17 (.27%)
Renal Impairment
17 (.27%)
Sinus Bradycardia
17 (.27%)
Supraventricular Tachycardia
17 (.27%)
Atrial Flutter
16 (.26%)
Disorientation
16 (.26%)
Hypoglycaemia
16 (.26%)
Aspartate Aminotransferase Increase...
15 (.24%)
Blood Potassium Decreased
15 (.24%)
Blood Urea Increased
15 (.24%)
Hyperhidrosis
15 (.24%)
Hypoaesthesia
15 (.24%)
Pyrexia
15 (.24%)
Rash
15 (.24%)
Somnolence
15 (.24%)
Supraventricular Extrasystoles
15 (.24%)
Thrombosis
15 (.24%)
Atrioventricular Block
14 (.23%)
Blood Sodium Decreased
14 (.23%)
Cardio-respiratory Arrest
14 (.23%)
Insomnia
14 (.23%)
Transient Ischaemic Attack
14 (.23%)
Multiple Drug Overdose
13 (.21%)

ExportShare/Embed GraphExport Export Data

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

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

Show More Show More

ExportShare/Embed Graph Export Export Data

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

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

Atrial Fibrillation
775
Drug Use For Unknown Indication
422
Product Used For Unknown Indication
275
Arrhythmia
238
Hypertension
235
Cardiac Disorder
113
Show More Show More
Ventricular Tachycardia
80
Atrial Flutter
59
Tachycardia
54
Supraventricular Tachycardia
44
Heart Rate Irregular
30
Ill-defined Disorder
26
Ventricular Arrhythmia
16
Coronary Artery Disease
15
Extrasystoles
14
Tachyarrhythmia
12
Blood Pressure
12
Heart Rate Abnormal
11
Essential Hypertension
11
Cardiovascular Disorder
10
Angina Pectoris
10
Prophylaxis
10
Heart Rate Increased
9
Palpitations
9
Ventricular Fibrillation
9
Ventricular Extrasystoles
8
Tachycardia Foetal
8
Cardiac Failure Congestive
8
Cardiac Fibrillation
7
Arrhythmia Supraventricular
7
Arrhythmia Prophylaxis
7
Atrial Tachycardia
6
Unevaluable Event
6
Cardiac Failure
6
Cardiomyopathy
5
Overdose
5
Blood Pressure Abnormal
5
Hypothyroidism
5
Cerebrovascular Accident
4
Blood Pressure Increased
4
Thyroid Disorder
4
Sinus Rhythm
4
Mitral Valve Prolapse
4
Heart Rate
4
Coronary Artery Insufficiency
4
Paroxysmal Arrhythmia
3
Intentional Overdose
3
Congestive Cardiomyopathy
3
Transient Ischaemic Attack
3
Myocardial Ischaemia
3
Acute Coronary Syndrome
3

Drug Labels

LabelLabelerEffective
Sotalol HydrochlorideBioniche Pharma USA LLC24-AUG-09
Sotalol HydrochlorideGlobal Pharmaceuticals10-SEP-10
Sotalol HydrochlorideRebel Distributors Corp01-DEC-10
Sotalol HydrochloridePD-Rx Pharmaceuticals, Inc.01-JAN-11
Sotalol HydrochlorideQualitest Pharmaceuticals06-OCT-11
Sotalol HydrochlorideAmerican Health Packaging07-NOV-11
Sotalol HydrochlorideMylan Pharmaceuticals Inc.15-DEC-11
Sotalol HydrochlorideGolden State Medical Supply, Inc.09-JAN-12
Sotalol HydrochlorideGolden State Medical Supply, Inc.09-JAN-12
Sotalol HydrochlorideApotex Corp.22-FEB-12
SorineUpsher-Smith Laboratories, Inc.12-MAR-12
Sotalol HydrochloridePhysicians Total Care, Inc.23-APR-12
SorineCardinal Health27-APR-12
Sotalol HydrochlorideEon Labs, Inc.15-MAY-12
Betapace AfBayer HealthCare Pharmaceuticals Inc.28-JUN-12
Sotalol HydrochlorideTeva Pharmaceuticals USA Inc31-JUL-12
Sotalol HydrochlorideNCS HealthCare of KY, Inc dba Vangard Labs14-NOV-12
Sotalol HydrochlorideApotex Corp.06-DEC-12
Sotalol HydrochlorideBryant Ranch Prepack17-JAN-13

Sotalol Case Reports

What Sotalol safety concerns are being reported by doctors and researchers in the medical literature?

Powered by Google

About Results

This report contains aggregated drug side effects and adverse events for Sotalol. 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.

Comments

Share your experience with Sotalol.