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BYSTOLIC

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Bystolic Adverse Events Reported to the FDA Over Time

How are Bystolic adverse event reports trending over time?

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

Most Common Bystolic Adverse Events Reported to the FDA

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

Fatigue
127 (3.39%)
Dizziness
111 (2.96%)
Headache
101 (2.69%)
Dyspnoea
85 (2.27%)
Blood Pressure Increased
80 (2.13%)
Heart Rate Decreased
72 (1.92%)
Oedema Peripheral
71 (1.89%)
Bradycardia
68 (1.81%)
Insomnia
61 (1.63%)
Rash
61 (1.63%)
Nausea
59 (1.57%)
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Palpitations
48 (1.28%)
Chest Pain
47 (1.25%)
Asthenia
42 (1.12%)
Diarrhoea
42 (1.12%)
Drug Ineffective
42 (1.12%)
Abdominal Distension
37 (.99%)
Pruritus
37 (.99%)
Weight Increased
37 (.99%)
Hypotension
35 (.93%)
Drug Interaction
34 (.91%)
Chest Discomfort
33 (.88%)
Loss Of Consciousness
33 (.88%)
Pain In Extremity
33 (.88%)
Alopecia
32 (.85%)
Depression
32 (.85%)
Erythema
26 (.69%)
Hypoaesthesia
26 (.69%)
Vision Blurred
26 (.69%)
Hypertension
25 (.67%)
Paraesthesia
25 (.67%)
Weight Decreased
25 (.67%)
Abdominal Discomfort
23 (.61%)
Blood Pressure Decreased
23 (.61%)
Syncope
23 (.61%)
Vomiting
23 (.61%)
Anxiety
22 (.59%)
Cough
22 (.59%)
Muscle Spasms
22 (.59%)
Fall
21 (.56%)
Abdominal Pain Upper
20 (.53%)
Arthralgia
20 (.53%)
Heart Rate Increased
20 (.53%)
Joint Swelling
20 (.53%)
Burning Sensation
19 (.51%)
Malaise
19 (.51%)
Atrial Fibrillation
18 (.48%)
Abnormal Dreams
17 (.45%)
Blood Glucose Increased
17 (.45%)
Condition Aggravated
17 (.45%)
Cystitis
17 (.45%)
Flatulence
17 (.45%)
Myalgia
17 (.45%)
Oedema
17 (.45%)
Unevaluable Event
17 (.45%)
Cardiac Arrest
16 (.43%)
Constipation
16 (.43%)
Renal Failure Acute
16 (.43%)
Urticaria
16 (.43%)
Cardiac Failure
15 (.4%)
Hyperhidrosis
15 (.4%)
Tremor
15 (.4%)
Abdominal Pain
14 (.37%)
Cholecystectomy
14 (.37%)
Ingrowing Nail
14 (.37%)
Migraine
14 (.37%)
Blood Count Abnormal
13 (.35%)
Cardiac Failure Congestive
13 (.35%)
Hypersensitivity
13 (.35%)
Lethargy
13 (.35%)
Pain
13 (.35%)
Somnolence
13 (.35%)
Toe Operation
13 (.35%)
Blood Triglycerides Increased
12 (.32%)
Dysgeusia
12 (.32%)
Feeling Abnormal
12 (.32%)
Heart Rate Irregular
12 (.32%)
Angioedema
11 (.29%)
Asthma
11 (.29%)
Blood Pressure Inadequately Control...
11 (.29%)
Cerebrovascular Accident
11 (.29%)
Convulsion
11 (.29%)
Drug Hypersensitivity
11 (.29%)
Throat Tightness
11 (.29%)
Visual Impairment
11 (.29%)
Alanine Aminotransferase Increased
10 (.27%)
Chills
10 (.27%)
Decreased Appetite
10 (.27%)
Dyspepsia
10 (.27%)
Erectile Dysfunction
10 (.27%)
Gait Disturbance
10 (.27%)
Swelling Face
10 (.27%)
Wheezing
10 (.27%)
Arteriosclerosis Coronary Artery
9 (.24%)
Blood Pressure Fluctuation
9 (.24%)
Suicidal Ideation
9 (.24%)
Swollen Tongue
9 (.24%)
Amnesia
8 (.21%)
Atrioventricular Block
8 (.21%)
Balance Disorder
8 (.21%)
Blister
8 (.21%)

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

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

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

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

Hypertension
1101
Product Used For Unknown Indication
326
Drug Use For Unknown Indication
80
Blood Pressure
78
Cardiac Disorder
47
Blood Pressure Increased
34
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Atrial Fibrillation
30
Tachycardia
25
Blood Pressure Abnormal
19
Arrhythmia
15
Heart Rate Irregular
15
Palpitations
11
Heart Rate Increased
9
Heart Rate Abnormal
8
Coronary Artery Disease
5
Ventricular Tachycardia
4
Cardiovascular Event Prophylaxis
4
Atrial Flutter
4
Sinus Tachycardia
4
Blood Cholesterol Increased
4
Extrasystoles
4
Ventricular Extrasystoles
3
Cardiac Failure Congestive
3
Essential Tremor
3
Blood Pressure Fluctuation
3
Angina Pectoris
3
Dyspnoea
3
Malignant Hypertension
2
Heart Rate
2
Blood Pressure Management
2
Central Nervous System Lesion
2
Gastric Disorder
2
Long Qt Syndrome
2
Supraventricular Tachycardia
2
Systolic Hypertension
2
Mitral Valve Prolapse
2
Migraine
2
Aortic Valve Stenosis
1
Bundle Branch Block
1
Oedema
1
Systemic Lupus Erythematosus
1
Cardiac Failure
1
Myocardial Infarction
1
Supraventricular Extrasystoles
1
Angioplasty
1
Phaeochromocytoma
1
Pain In Extremity
1
Exercise Adequate
1
Aortic Valve Disease
1
Silent Myocardial Infarction
1
Anxiety
1

Drug Labels

LabelLabelerEffective
BystolicCardinal Health26-APR-11
BystolicForest laboratories, Inc.20-DEC-11
BystolicPhysicians Total Care, Inc.03-JAN-12
BystolicCardinal Health17-APR-13

Bystolic Case Reports

What Bystolic 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 Bystolic. 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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