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BISOPROLOL FUMARATE

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Bisoprolol Fumarate Adverse Events Reported to the FDA Over Time

How are Bisoprolol Fumarate adverse event reports trending over time?

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

Most Common Bisoprolol Fumarate Adverse Events Reported to the FDA

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

Bradycardia
242 (2.07%)
Drug Interaction
202 (1.73%)
Hypotension
198 (1.7%)
Fall
192 (1.64%)
Renal Failure Acute
175 (1.5%)
Dizziness
174 (1.49%)
Dyspnoea
165 (1.41%)
Atrial Fibrillation
137 (1.17%)
Fatigue
126 (1.08%)
Dehydration
125 (1.07%)
Syncope
116 (.99%)
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Nausea
114 (.98%)
Malaise
113 (.97%)
Hyperkalaemia
105 (.9%)
Drug Ineffective
104 (.89%)
Diarrhoea
100 (.86%)
Asthenia
92 (.79%)
Renal Failure
87 (.74%)
Vomiting
85 (.73%)
Loss Of Consciousness
79 (.68%)
Condition Aggravated
77 (.66%)
Oedema Peripheral
74 (.63%)
Blood Pressure Increased
73 (.63%)
Ventricular Tachycardia
70 (.6%)
General Physical Health Deteriorati...
66 (.57%)
Vertigo
66 (.57%)
Hypokalaemia
64 (.55%)
Feeling Abnormal
62 (.53%)
Atrioventricular Block Complete
61 (.52%)
Confusional State
61 (.52%)
Cardiac Failure
60 (.51%)
Hyponatraemia
56 (.48%)
Paraesthesia
54 (.46%)
Pruritus
53 (.45%)
Orthostatic Hypotension
52 (.45%)
Suicide Attempt
51 (.44%)
Vision Blurred
51 (.44%)
Rash
50 (.43%)
Blood Pressure Decreased
49 (.42%)
Cardiac Murmur
49 (.42%)
Coma
49 (.42%)
Hypertension
48 (.41%)
Dyspnoea Exertional
47 (.4%)
Weight Decreased
46 (.39%)
Visual Impairment
45 (.39%)
Anaemia
44 (.38%)
Venous Pressure Jugular Increased
44 (.38%)
Blood Creatinine Increased
42 (.36%)
Hypoglycaemia
42 (.36%)
International Normalised Ratio Incr...
42 (.36%)
Interstitial Lung Disease
41 (.35%)
Left Ventricular Dysfunction
41 (.35%)
Oedema
41 (.35%)
Sinus Bradycardia
41 (.35%)
Cerebrovascular Accident
40 (.34%)
Hypoaesthesia
39 (.33%)
Shock
39 (.33%)
Agitation
38 (.33%)
Chest Pain
38 (.33%)
Palpitations
38 (.33%)
Pyrexia
38 (.33%)
Rhabdomyolysis
38 (.33%)
Cardiac Arrest
37 (.32%)
Haemoglobin Decreased
37 (.32%)
Intentional Overdose
37 (.32%)
Thrombocytopenia
36 (.31%)
Alanine Aminotransferase Increased
35 (.3%)
Depression
35 (.3%)
Somnolence
35 (.3%)
Dissociation
34 (.29%)
Cardiogenic Shock
33 (.28%)
Drug Rash With Eosinophilia And Sys...
33 (.28%)
Myocardial Infarction
32 (.27%)
Neutropenia
32 (.27%)
Angina Pectoris
31 (.27%)
Arrhythmia
31 (.27%)
Cardio-respiratory Arrest
31 (.27%)
Electrocardiogram Qt Prolonged
31 (.27%)
Headache
31 (.27%)
Sepsis
31 (.27%)
Transaminases Increased
31 (.27%)
Abdominal Pain
30 (.26%)
Drug Exposure During Pregnancy
30 (.26%)
Drug Hypersensitivity
30 (.26%)
Eczema
30 (.26%)
Hypothermia
30 (.26%)
Overdose
30 (.26%)
Aspartate Aminotransferase Increase...
29 (.25%)
Bundle Branch Block Right
28 (.24%)
Cytolytic Hepatitis
28 (.24%)
Dialysis
28 (.24%)
Eosinophilia
28 (.24%)
Multiple Drug Overdose Intentional
28 (.24%)
Tachycardia
28 (.24%)
Gamma-glutamyltransferase Increased
27 (.23%)
Bundle Branch Block Left
26 (.22%)
Urinary Tract Infection
26 (.22%)
Electrocardiogram Qrs Complex Prolo...
25 (.21%)
Leukopenia
25 (.21%)
Muscle Spasms
25 (.21%)
Presyncope
25 (.21%)

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

What are the most common Bisoprolol Fumarate 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 Fumarate, 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 Fumarate 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 Fumarate According to Those Reporting Adverse Events

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

Hypertension
2538
Product Used For Unknown Indication
943
Drug Use For Unknown Indication
837
Atrial Fibrillation
261
Cardiac Failure
213
Myocardial Ischaemia
130
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Coronary Artery Disease
106
Cardiac Disorder
103
Blood Pressure
96
Myocardial Infarction
91
Essential Hypertension
78
Tachycardia
65
Arrhythmia
64
Cardiac Failure Congestive
61
Cardiac Failure Chronic
60
Ill-defined Disorder
48
Angina Pectoris
48
Blood Pressure Increased
40
Blood Pressure Abnormal
36
Palpitations
31
Cardiovascular Disorder
30
Congestive Cardiomyopathy
29
Acute Myocardial Infarction
27
Acute Coronary Syndrome
20
Cardiomyopathy
19
Ventricular Tachycardia
18
Ischaemic Cardiomyopathy
18
Prophylaxis
17
Hypertonia
16
Coronary Artery Bypass
15
Tachyarrhythmia
13
Supraventricular Tachycardia
12
Heart Rate
12
Cardiovascular Event Prophylaxis
11
Atrial Flutter
11
Heart Rate Increased
11
Arrhythmia Prophylaxis
11
Angina Unstable
11
Mitral Valve Prolapse
10
Drug Therapy
8
Renal Hypertension
8
Extrasystoles
7
Drug Exposure During Pregnancy
7
Atrial Tachycardia
7
Intentional Overdose
7
Migraine
6
Ventricular Arrhythmia
6
Maternal Exposure Timing Unspecifie...
6
Suicide Attempt
6
Infarction
5
Hypercholesterolaemia
5

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 Fumarate Case Reports

What Bisoprolol Fumarate 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 Fumarate. 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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