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RYTHMOL SR

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Rythmol Sr Adverse Events Reported to the FDA Over Time

How are Rythmol Sr adverse event reports trending over time?

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

Most Common Rythmol Sr Adverse Events Reported to the FDA

What are the most common Rythmol Sr adverse events reported to the FDA?

Atrial Fibrillation
52 (5.9%)
Drug Ineffective
30 (3.41%)
Fatigue
26 (2.95%)
Dizziness
24 (2.72%)
Asthenia
22 (2.5%)
Dyspnoea
20 (2.27%)
Nausea
15 (1.7%)
Headache
14 (1.59%)
Dysgeusia
12 (1.36%)
Malaise
12 (1.36%)
Muscular Weakness
12 (1.36%)
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Product Quality Issue
12 (1.36%)
Tremor
11 (1.25%)
Arrhythmia
10 (1.14%)
Balance Disorder
10 (1.14%)
Constipation
10 (1.14%)
Drug Interaction
10 (1.14%)
Palpitations
10 (1.14%)
Heart Rate Increased
9 (1.02%)
Blood Pressure Increased
8 (.91%)
Heart Rate Decreased
8 (.91%)
International Normalised Ratio Incr...
8 (.91%)
Fall
7 (.79%)
Rash
7 (.79%)
Cerebrovascular Accident
6 (.68%)
Cough
6 (.68%)
Dyskinesia
6 (.68%)
Hypotension
6 (.68%)
Atrial Flutter
5 (.57%)
Blood Glucose Decreased
5 (.57%)
Dry Mouth
5 (.57%)
Erythema
5 (.57%)
Feeling Abnormal
5 (.57%)
Heart Rate Irregular
5 (.57%)
Neuropathy Peripheral
5 (.57%)
Oedema
5 (.57%)
Overdose
5 (.57%)
Vision Blurred
5 (.57%)
Vomiting
5 (.57%)
Weight Increased
5 (.57%)
Abdominal Pain
4 (.45%)
Adverse Event
4 (.45%)
Alopecia
4 (.45%)
Back Pain
4 (.45%)
Cardiac Ablation
4 (.45%)
Cardioversion
4 (.45%)
Chest Discomfort
4 (.45%)
Chest Pain
4 (.45%)
Condition Aggravated
4 (.45%)
Death
4 (.45%)
Diarrhoea
4 (.45%)
Dry Eye
4 (.45%)
Dyspepsia
4 (.45%)
Eye Pain
4 (.45%)
Hyperhidrosis
4 (.45%)
Hypersensitivity
4 (.45%)
Hypoaesthesia
4 (.45%)
Off Label Use
4 (.45%)
Pelvic Fracture
4 (.45%)
Prothrombin Time Prolonged
4 (.45%)
Pruritus
4 (.45%)
Somnolence
4 (.45%)
Therapeutic Response Decreased
4 (.45%)
Visual Acuity Reduced
4 (.45%)
Abasia
3 (.34%)
Alanine Aminotransferase Increased
3 (.34%)
Anxiety
3 (.34%)
Aspartate Aminotransferase Increase...
3 (.34%)
Blood Alkaline Phosphatase Increase...
3 (.34%)
Blood Creatinine Increased
3 (.34%)
Blood Potassium Increased
3 (.34%)
Blood Sodium Decreased
3 (.34%)
Blood Urea Increased
3 (.34%)
Bradycardia
3 (.34%)
Cardiac Arrest
3 (.34%)
Cardiac Disorder
3 (.34%)
Cardiac Failure Congestive
3 (.34%)
Cardiac Flutter
3 (.34%)
Cellulitis
3 (.34%)
Cognitive Disorder
3 (.34%)
Contusion
3 (.34%)
Drug Administration Error
3 (.34%)
Drug Effect Decreased
3 (.34%)
Dysphagia
3 (.34%)
Dysphonia
3 (.34%)
Ecchymosis
3 (.34%)
Haemorrhage Urinary Tract
3 (.34%)
Hyperkalaemia
3 (.34%)
Ill-defined Disorder
3 (.34%)
Neck Pain
3 (.34%)
Respiratory Disorder
3 (.34%)
Sensory Loss
3 (.34%)
Sinus Disorder
3 (.34%)
Skin Ulcer
3 (.34%)
Systemic Lupus Erythematosus
3 (.34%)
Tinnitus
3 (.34%)
Treatment Noncompliance
3 (.34%)
Ventricular Extrasystoles
3 (.34%)
Weight Decreased
3 (.34%)
Abdominal Distension
2 (.23%)
Abdominal Tenderness
2 (.23%)

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

What are the most common Rythmol Sr adverse events reported to the FDA?

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

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

Atrial Fibrillation
149
Drug Use For Unknown Indication
19
Arrhythmia
14
Product Used For Unknown Indication
11
Atrial Flutter
5
Ventricular Arrhythmia
3
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Atrial Tachycardia
3
Tachycardia
1
Heart Rate Irregular
1
Investigation
1
Heart Rate Increased
1
Cardioversion
1
Supraventricular Tachycardia
1
Cardiac Disorder
1

Drug Labels

LabelLabelerEffective
RythmolsrGlaxoSmithKline LLC18-MAR-11
RythmolsrGlaxoSmithKline LLC14-FEB-13

Rythmol Sr Case Reports

What Rythmol Sr 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 Rythmol Sr. 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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