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BISOPROLOL

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Bisoprolol Adverse Events Reported to the FDA Over Time

How are Bisoprolol adverse event reports trending over time?

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

Most Common Bisoprolol Adverse Events Reported to the FDA

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

Bradycardia
339 (2.14%)
Drug Interaction
315 (1.98%)
Dizziness
281 (1.77%)
Hypotension
280 (1.76%)
Dyspnoea
249 (1.57%)
Renal Failure Acute
248 (1.56%)
Fall
236 (1.49%)
Atrial Fibrillation
219 (1.38%)
Fatigue
202 (1.27%)
Syncope
176 (1.11%)
Dehydration
167 (1.05%)
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Hyperkalaemia
149 (.94%)
Nausea
149 (.94%)
Diarrhoea
145 (.91%)
Malaise
142 (.89%)
Drug Ineffective
134 (.84%)
Oedema Peripheral
118 (.74%)
Asthenia
114 (.72%)
Ventricular Tachycardia
114 (.72%)
Paraesthesia
113 (.71%)
Vomiting
109 (.69%)
Loss Of Consciousness
106 (.67%)
Renal Failure
105 (.66%)
Feeling Abnormal
104 (.65%)
Confusional State
100 (.63%)
Blood Pressure Increased
96 (.6%)
Condition Aggravated
96 (.6%)
Cardiac Murmur
91 (.57%)
Cardiac Failure
90 (.57%)
Vertigo
83 (.52%)
Venous Pressure Jugular Increased
82 (.52%)
Left Ventricular Dysfunction
79 (.5%)
Dyspnoea Exertional
76 (.48%)
Hyponatraemia
76 (.48%)
General Physical Health Deteriorati...
75 (.47%)
Vision Blurred
75 (.47%)
Oedema
74 (.47%)
Suicide Attempt
74 (.47%)
Shock
73 (.46%)
Atrioventricular Block Complete
70 (.44%)
Hypokalaemia
70 (.44%)
Pruritus
69 (.43%)
Orthostatic Hypotension
66 (.42%)
International Normalised Ratio Incr...
65 (.41%)
Sinus Bradycardia
64 (.4%)
Hypoglycaemia
63 (.4%)
Blood Pressure Decreased
60 (.38%)
Dissociation
60 (.38%)
Hypoaesthesia
60 (.38%)
Visual Impairment
60 (.38%)
Somnolence
59 (.37%)
Hypertension
56 (.35%)
Coma
55 (.35%)
Blood Creatinine Increased
53 (.33%)
Rash
53 (.33%)
Intentional Overdose
51 (.32%)
Pyrexia
51 (.32%)
Palpitations
50 (.31%)
Weight Decreased
50 (.31%)
Anaemia
48 (.3%)
Agitation
47 (.3%)
Cerebrovascular Accident
47 (.3%)
Interstitial Lung Disease
47 (.3%)
Drug Hypersensitivity
46 (.29%)
Thrombocytopenia
46 (.29%)
Depression
45 (.28%)
Alanine Aminotransferase Increased
44 (.28%)
Chest Pain
44 (.28%)
Depressed Level Of Consciousness
44 (.28%)
Dialysis
44 (.28%)
Electrocardiogram Qrs Complex Prolo...
44 (.28%)
Headache
44 (.28%)
Haemoglobin Decreased
43 (.27%)
Overdose
43 (.27%)
Rhabdomyolysis
43 (.27%)
Aspartate Aminotransferase Increase...
42 (.26%)
Circulatory Collapse
42 (.26%)
Electrocardiogram Qt Prolonged
42 (.26%)
Left Ventricular Failure
42 (.26%)
Transaminases Increased
42 (.26%)
Cardio-respiratory Arrest
41 (.26%)
Cardiogenic Shock
41 (.26%)
Abdominal Pain
40 (.25%)
Multiple Drug Overdose Intentional
40 (.25%)
Angina Pectoris
39 (.25%)
Arrhythmia
39 (.25%)
Cardiac Arrest
39 (.25%)
Cytolytic Hepatitis
38 (.24%)
Drug Rash With Eosinophilia And Sys...
38 (.24%)
Presyncope
38 (.24%)
Tachycardia
38 (.24%)
Drug Exposure During Pregnancy
37 (.23%)
Gait Disturbance
37 (.23%)
Sepsis
37 (.23%)
Muscle Spasms
36 (.23%)
Myocardial Infarction
36 (.23%)
Gamma-glutamyltransferase Increased
35 (.22%)
Hallucination
33 (.21%)
Neutropenia
33 (.21%)
Bradyarrhythmia
32 (.2%)
Atrioventricular Block
31 (.2%)

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

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

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

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

Hypertension
3779
Drug Use For Unknown Indication
1293
Product Used For Unknown Indication
1281
Atrial Fibrillation
375
Cardiac Failure
322
Coronary Artery Disease
226
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Myocardial Ischaemia
192
Cardiac Disorder
160
Blood Pressure
142
Myocardial Infarction
127
Essential Hypertension
102
Arrhythmia
97
Cardiac Failure Congestive
92
Angina Pectoris
90
Tachycardia
85
Cardiac Failure Chronic
72
Ill-defined Disorder
69
Blood Pressure Increased
68
Cardiovascular Disorder
46
Palpitations
40
Blood Pressure Abnormal
39
Acute Myocardial Infarction
35
Congestive Cardiomyopathy
34
Acute Coronary Syndrome
31
Prophylaxis
27
Ischaemic Cardiomyopathy
26
Cardiovascular Event Prophylaxis
25
Cardiomyopathy
24
Ventricular Tachycardia
23
Hypertonia
22
Tachyarrhythmia
19
Supraventricular Tachycardia
18
Coronary Artery Bypass
17
Heart Rate Increased
16
Heart Rate Irregular
16
Heart Rate
16
Paraesthesia
16
Venous Pressure Jugular
16
Renal Hypertension
15
Atrial Flutter
15
Arrhythmia Prophylaxis
12
Extrasystoles
11
Mitral Valve Prolapse
11
Angina Unstable
11
Left Ventricular Failure
10
Intentional Overdose
10
Drug Therapy
10
Angiopathy
10
Diuretic Therapy
10
Suicide Attempt
10
Long Qt Syndrome
9

Drug Labels

LabelLabelerEffective
Bisoprolol FumaratePhysicians Total Care, Inc.25-SEP-09
ZebetaDuramed Pharmaceuticals, Inc.16-NOV-10
Bisoprolol FumarateRebel Distributors Corp10-DEC-10
Bisoprolol Fumarate And HydrochlorothiazideRebel Distributors Corp10-DEC-10
ZiacTeva Women's Health, Inc.30-MAR-11
Bisoprolol Fumarate And HydrochlorothiazideMylan Pharmaceuticals Inc.01-SEP-11
Bisoprolol Fumarate And HydrochlorothiazidePD-Rx Pharmaceuticals, Inc.01-SEP-11
Bisoprolol Fumarate And HydrochlorothiazideUnichem Pharmaceuticals (USA), Inc.09-SEP-11
Bisoprolol FumarateUnichem Pharmaceuticals (USA), Inc.23-SEP-11
Bisoprolol Fumarate And HydrochlorothiazidePhysicians Total Care, Inc.15-DEC-11
Bisoprolol Fumarate And HydrochlorothiazideEon Labs, Inc.20-DEC-11
Bisoprolol FumarateAurobindo Pharma Limited11-JAN-12
Bisoprolol FumarateGreenstone LLC21-FEB-12
Bisoprolol FumarateAmerican Health Packaging09-JUL-12
Bisoprolol FumarateTeva Pharmaceuticals USA Inc17-JUL-12
Bisoprolol FumarateMylan Pharmaceuticals Inc.31-AUG-12
Bisoprolol Fumarate And HydrochlorothiazideBryant Ranch Prepack12-OCT-12
Bisoprolol FumarateEon Labs, Inc.06-DEC-12
Bisoprolol Fumarate And HydrochlorothiazideBryant Ranch Prepack17-JAN-13
Bisoprolol Fumarate And HydrochlorothiazideBryant Ranch Prepack18-JAN-13

Bisoprolol Case Reports

What Bisoprolol 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 Bisoprolol. 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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