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BUMETANIDE

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Bumetanide Adverse Events Reported to the FDA Over Time

How are Bumetanide adverse event reports trending over time?

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

Most Common Bumetanide Adverse Events Reported to the FDA

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

Renal Failure Acute
108 (4.74%)
Diarrhoea
53 (2.33%)
Bradycardia
52 (2.28%)
Renal Failure
48 (2.11%)
Hyperkalaemia
46 (2.02%)
Blood Creatinine Increased
39 (1.71%)
Dialysis
35 (1.54%)
Electrocardiogram Qrs Complex Prolo...
32 (1.41%)
Fluid Overload
28 (1.23%)
Hypotension
27 (1.19%)
Atrial Fibrillation
26 (1.14%)
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Shock
26 (1.14%)
Dehydration
25 (1.1%)
Oedema Peripheral
25 (1.1%)
Completed Suicide
24 (1.05%)
Dyspnoea
24 (1.05%)
Haemoglobin Decreased
24 (1.05%)
Toxic Epidermal Necrolysis
24 (1.05%)
Drug Interaction
23 (1.01%)
Hypokalaemia
23 (1.01%)
Pruritus
22 (.97%)
Erythema
21 (.92%)
Stevens-johnson Syndrome
21 (.92%)
Dry Skin
20 (.88%)
Medication Error
20 (.88%)
Pain
20 (.88%)
Rash Maculo-papular
20 (.88%)
Renal Impairment
20 (.88%)
Blister
19 (.83%)
Rash Generalised
19 (.83%)
Blood Potassium Increased
18 (.79%)
Eczema
18 (.79%)
Hypersensitivity
18 (.79%)
Scab
18 (.79%)
Circumstance Or Information Capable...
17 (.75%)
Exfoliative Rash
17 (.75%)
Petechiae
17 (.75%)
Rash Pruritic
17 (.75%)
Therapeutic Agent Toxicity
17 (.75%)
Loss Of Consciousness
16 (.7%)
Blood Pressure Diastolic Decreased
15 (.66%)
Coma
15 (.66%)
Fall
15 (.66%)
International Normalised Ratio Incr...
15 (.66%)
Malaise
15 (.66%)
Swelling
15 (.66%)
Asthenia
14 (.61%)
Condition Aggravated
14 (.61%)
Nausea
14 (.61%)
Vomiting
14 (.61%)
Blood Urea Increased
11 (.48%)
Cardiac Failure
11 (.48%)
Epilepsy
11 (.48%)
Hyponatraemia
11 (.48%)
Pulmonary Fibrosis
11 (.48%)
Thrombocytopenia
11 (.48%)
Alanine Aminotransferase Increased
10 (.44%)
Depressed Level Of Consciousness
10 (.44%)
Dizziness
10 (.44%)
Electrocardiogram P Wave Abnormal
10 (.44%)
Sinoatrial Block
10 (.44%)
Drug Ineffective
9 (.4%)
Encephalopathy
9 (.4%)
Hyperammonaemia
9 (.4%)
Overdose
9 (.4%)
Syncope
9 (.4%)
Blood Pressure Systolic Decreased
8 (.35%)
Electrocardiogram T Wave Abnormal
8 (.35%)
Headache
8 (.35%)
Melaena
8 (.35%)
Wrong Drug Administered
8 (.35%)
Cardiogenic Shock
7 (.31%)
Confusional State
7 (.31%)
Drug Rash With Eosinophilia And Sys...
7 (.31%)
Fatigue
7 (.31%)
Gamma-glutamyltransferase Increased
7 (.31%)
Haemodialysis
7 (.31%)
Lobar Pneumonia
7 (.31%)
Oedema
7 (.31%)
Pulmonary Embolism
7 (.31%)
Renal Tubular Necrosis
7 (.31%)
Toxic Skin Eruption
7 (.31%)
Unresponsive To Stimuli
7 (.31%)
Anaemia
6 (.26%)
Chest Pain
6 (.26%)
Constipation
6 (.26%)
Drug Dispensing Error
6 (.26%)
Dry Mouth
6 (.26%)
Gout
6 (.26%)
Hypothermia
6 (.26%)
Leukopenia
6 (.26%)
Metabolic Acidosis
6 (.26%)
Orthostatic Hypotension
6 (.26%)
Peritonitis
6 (.26%)
Rheumatoid Arthritis
6 (.26%)
Skin Exfoliation
6 (.26%)
Blood Bicarbonate Decreased
5 (.22%)
Blood Potassium Decreased
5 (.22%)
Blood Pressure Immeasurable
5 (.22%)
Death
5 (.22%)
Diabetes Mellitus
5 (.22%)

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

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

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

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

Product Used For Unknown Indication
158
Drug Use For Unknown Indication
131
Hypertension
130
Cardiac Failure
111
Diuretic Therapy
71
Fluid Retention
62
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Oedema
55
Cardiac Failure Congestive
52
Cardiovascular Disorder
24
Ill-defined Disorder
24
Cardiac Disorder
19
Oedema Peripheral
16
Cardiovascular Event Prophylaxis
15
Polyuria
12
Prophylaxis
11
Cardiac Failure Chronic
11
Renal Failure
8
Pulmonary Oedema
7
Fluid Replacement
7
Angiopathy
6
Fluid Overload
6
Blood Pressure
5
Swelling
5
Cardiomyopathy
5
Atrial Fibrillation
5
Unevaluable Event
4
Right Ventricular Failure
4
Coronary Artery Disease
4
Left Ventricular Dysfunction
3
Renal Failure Chronic
3
Generalised Oedema
3
Dyspnoea
3
Lupus Nephritis
3
Renal Disorder
2
Renal Impairment
2
Diastolic Dysfunction
2
Mitral Valve Replacement
2
Anxiety
2
Aortic Valve Repair
2
Ischaemic Cardiomyopathy
2
Suicide Attempt
1
Myocardial Infarction
1
Myocardial Ischaemia
1
Ascites
1
Hypovolaemia
1
Cerebrovascular Accident
1
Nephropathy
1
Hypertensive Heart Disease
1
Obesity
1
Asthma
1
Essential Hypertension
1

Drug Labels

LabelLabelerEffective
BumetanideMylan Pharmaceuticals Inc.13-APR-06
BumetanideBaxter Healthcare Corporation09-DEC-09
BumetanideBedford Laboratories08-FEB-10
BumetanideEon Labs, Inc.21-SEP-11
BumetanideWest-ward Pharmaceutical Corp.26-SEP-11
BumetanideHospira, Inc.16-NOV-11
BumetanideCardinal Health31-JAN-12
BumetanideCardinal Health31-JAN-12
BumetanideUnit Dose Services30-JUL-12
BumetanideTeva Pharmaceuticals USA Inc30-JUL-12
BumetanideUnit Dose Services30-JUL-12
BumetanideCardinal Health01-AUG-12
BumetanidePhysicians Total Care, Inc.13-SEP-12
BumetanideMylan Institutional Inc.05-OCT-12
BumetanideNCS HealthCare of KY, Inc dba Vangard Labs18-OCT-12
BumetanideCardinal Health17-APR-13

Bumetanide Case Reports

What Bumetanide 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 Bumetanide. 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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