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NEBIVOLOL

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Nebivolol Adverse Events Reported to the FDA Over Time

How are Nebivolol adverse event reports trending over time?

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

Most Common Nebivolol Adverse Events Reported to the FDA

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

Bradycardia
117 (2.89%)
Renal Failure Acute
82 (2.02%)
Drug Interaction
63 (1.56%)
Hypotension
56 (1.38%)
Loss Of Consciousness
56 (1.38%)
Dyspnoea
54 (1.33%)
Orthostatic Hypotension
51 (1.26%)
Hyperkalaemia
48 (1.19%)
Fall
44 (1.09%)
Asthenia
43 (1.06%)
Malaise
42 (1.04%)
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Syncope
40 (.99%)
Oedema Peripheral
39 (.96%)
Blood Pressure Increased
38 (.94%)
Blood Creatinine Increased
35 (.86%)
Dizziness
33 (.81%)
Atrial Fibrillation
32 (.79%)
Renal Failure
29 (.72%)
Fatigue
28 (.69%)
Cardiac Arrest
27 (.67%)
General Physical Health Deteriorati...
26 (.64%)
Multiple Drug Overdose Intentional
26 (.64%)
Bundle Branch Block Left
23 (.57%)
Diarrhoea
23 (.57%)
Headache
23 (.57%)
Abdominal Pain Upper
21 (.52%)
Interstitial Lung Disease
21 (.52%)
Pyrexia
21 (.52%)
Vomiting
21 (.52%)
Condition Aggravated
20 (.49%)
Drug Ineffective
20 (.49%)
Hyponatraemia
20 (.49%)
Blood Urea Increased
19 (.47%)
Cardiac Failure
19 (.47%)
Dehydration
19 (.47%)
Electrocardiogram Qt Prolonged
19 (.47%)
Hypokalaemia
19 (.47%)
Pneumonia
19 (.47%)
Pruritus
19 (.47%)
Hepatitis
18 (.44%)
Suicide Attempt
18 (.44%)
White Blood Cell Count Increased
18 (.44%)
Decreased Appetite
17 (.42%)
Disorientation
17 (.42%)
Nausea
17 (.42%)
Pulmonary Oedema
17 (.42%)
Rhabdomyolysis
17 (.42%)
Weight Decreased
17 (.42%)
C-reactive Protein Increased
16 (.4%)
Heart Rate Increased
16 (.4%)
Pleural Effusion
16 (.4%)
Abdominal Distension
15 (.37%)
Cardio-respiratory Arrest
15 (.37%)
Chest Pain
15 (.37%)
Ventricular Tachycardia
15 (.37%)
Haematoma
14 (.35%)
Hypoglycaemia
14 (.35%)
Hypothyroidism
14 (.35%)
Pulmonary Congestion
14 (.35%)
Confusional State
13 (.32%)
Cough
13 (.32%)
Haemoglobin Decreased
13 (.32%)
Hepatitis Cholestatic
13 (.32%)
Inflammation
13 (.32%)
Sinus Bradycardia
13 (.32%)
Skin Discolouration
13 (.32%)
Somnolence
13 (.32%)
Abdominal Pain
12 (.3%)
Alanine Aminotransferase Increased
12 (.3%)
Burning Sensation
12 (.3%)
Epistaxis
12 (.3%)
Erythema
12 (.3%)
Extrasystoles
12 (.3%)
Heart Rate Decreased
12 (.3%)
Hypertension
12 (.3%)
Jaundice
12 (.3%)
Palpitations
12 (.3%)
Presyncope
12 (.3%)
Arteriosclerosis Coronary Artery
11 (.27%)
Blood Creatine Increased
11 (.27%)
Cytolytic Hepatitis
11 (.27%)
Dyskinesia
11 (.27%)
Hepatomegaly
11 (.27%)
International Normalised Ratio Incr...
11 (.27%)
Lactic Acidosis
11 (.27%)
Renal Impairment
11 (.27%)
Tremor
11 (.27%)
Arrhythmia
10 (.25%)
Arthralgia
9 (.22%)
Aspartate Aminotransferase Increase...
9 (.22%)
Balance Disorder
9 (.22%)
Blood Potassium Increased
9 (.22%)
Blood Pressure Decreased
9 (.22%)
Bone Marrow Failure
9 (.22%)
Cardiomegaly
9 (.22%)
Completed Suicide
9 (.22%)
Intentional Overdose
9 (.22%)
Lung Disorder
9 (.22%)
Muscle Spasms
9 (.22%)
Neutropenia
9 (.22%)
Psychomotor Retardation
9 (.22%)

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

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

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

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

Hypertension
802
Product Used For Unknown Indication
195
Drug Use For Unknown Indication
128
Cardiac Failure
50
Atrial Fibrillation
23
Essential Hypertension
22
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Blood Pressure
18
Tachycardia
15
Coronary Artery Disease
15
Acute Coronary Syndrome
13
Myocardial Ischaemia
12
Arrhythmia
10
Myocardial Infarction
9
Blood Pressure Increased
7
Heart Rate Decreased
7
Hypertonia
6
Cardiac Failure Congestive
6
Hypertensive Heart Disease
6
Renal Hypertension
5
Blood Pressure Abnormal
5
Cardiomyopathy
5
Intentional Overdose
5
Cardiac Disorder
5
Unevaluable Event
4
Heart Rate Abnormal
4
Heart Rate Increased
4
Atrial Flutter
3
Palpitations
3
Ventricular Tachyarrhythmia
3
Bradycardia
2
Iron Deficiency Anaemia
2
Ischaemic Cardiomyopathy
2
Pericarditis
2
Drug Exposure During Pregnancy
2
Portal Hypertension
2
Accidental Exposure
2
Self Injurious Behaviour
2
Supraventricular Tachycardia
2
Sinus Tachycardia
2
Peripheral Vascular Disorder
2
Joint Arthroplasty
1
Cardiac Failure Chronic
1
Aortic Valve Incompetence
1
Liver Injury
1
Ill-defined Disorder
1
Hypertensive Crisis
1
Ventricular Extrasystoles
1
Constipation
1
Blood Pressure Management
1
Cardiovascular Disorder
1
Diabetes Mellitus
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

Nebivolol Case Reports

What Nebivolol 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 Nebivolol. 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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