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Buminate Adverse Events Reported to the FDA Over Time

How are Buminate adverse event reports trending over time?

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

Most Common Buminate Adverse Events Reported to the FDA

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

Sepsis
36 (5.35%)
Tachycardia
36 (5.35%)
Blood Pressure Fluctuation
30 (4.46%)
Hyperhidrosis
30 (4.46%)
Hyperthermia
30 (4.46%)
Pulmonary Oedema
30 (4.46%)
Chills
26 (3.86%)
Dyspnoea
17 (2.53%)
Hypotension
17 (2.53%)
Anaphylactic Reaction
16 (2.38%)
Myocardial Infarction
15 (2.23%)
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Tremor
15 (2.23%)
Pyrexia
14 (2.08%)
Paralysis
13 (1.93%)
Creutzfeldt-jakob Disease
12 (1.78%)
Blood Culture Positive
11 (1.63%)
Troponin Increased
11 (1.63%)
Atrial Fibrillation
10 (1.49%)
Hepatitis C Rna Positive
10 (1.49%)
Hypersensitivity
9 (1.34%)
Bacillus Infection
8 (1.19%)
Blood Pressure Decreased
8 (1.19%)
Blood Test Abnormal
8 (1.19%)
Hepatitis C
8 (1.19%)
Hypertension
8 (1.19%)
Death
7 (1.04%)
Acidosis
6 (.89%)
Anxiety
6 (.89%)
Diarrhoea
6 (.89%)
Electrolyte Imbalance
6 (.89%)
Hepatitis C Antibody Positive
6 (.89%)
Vascular Resistance Systemic Decrea...
6 (.89%)
Body Temperature Increased
5 (.74%)
C-reactive Protein Increased
5 (.74%)
Cardiac Failure
5 (.74%)
Heart Rate Increased
5 (.74%)
Wheezing
5 (.74%)
Blood Beta-d-glucan Increased
4 (.59%)
Circulatory Collapse
4 (.59%)
Eating Disorder
4 (.59%)
Fluid Retention
4 (.59%)
Gastrointestinal Haemorrhage
4 (.59%)
Hepatic Enzyme Increased
4 (.59%)
Hepatitis B Surface Antigen Positiv...
4 (.59%)
Hepatitis C Positive
4 (.59%)
Hypercalcaemia
4 (.59%)
Meningitis
4 (.59%)
Oxygen Saturation Decreased
4 (.59%)
Post Procedural Haemorrhage
4 (.59%)
Renal Failure
4 (.59%)
Respiratory Distress
4 (.59%)
Urinary Tract Infection
4 (.59%)
Weight Decreased
4 (.59%)
White Blood Cell Count Decreased
4 (.59%)
Alanine Aminotransferase Increased
3 (.45%)
Ammonia Increased
3 (.45%)
Anuria
3 (.45%)
Aspartate Aminotransferase Increase...
3 (.45%)
Bacterial Culture Positive
3 (.45%)
Blood Pressure Increased
3 (.45%)
Confusional State
3 (.45%)
Drug Ineffective
3 (.45%)
Eczema
3 (.45%)
Hepatorenal Syndrome
3 (.45%)
Infusion Related Reaction
3 (.45%)
Oedema
3 (.45%)
Poor Quality Drug Administered
3 (.45%)
Renal Impairment
3 (.45%)
Blood Creatinine Increased
2 (.3%)
Chest Pain
2 (.3%)
Condition Aggravated
2 (.3%)
Convulsion
2 (.3%)
Cyanosis
2 (.3%)
Feeling Hot
2 (.3%)
Hepatic Function Abnormal
2 (.3%)
Infusion Site Inflammation
2 (.3%)
Intestinal Polyp
2 (.3%)
Post Procedural Infection
2 (.3%)
Pruritus
2 (.3%)
Pseudomonas Infection
2 (.3%)
Shock
2 (.3%)
Urticaria
2 (.3%)
Abdominal Pain
1 (.15%)
Acute Myocardial Infarction
1 (.15%)
Anaphylactoid Reaction
1 (.15%)
Angiopathy
1 (.15%)
Arrhythmia Supraventricular
1 (.15%)
Bacteria Blood Identified
1 (.15%)
Blood Bilirubin Increased
1 (.15%)
Blood Creatine Increased
1 (.15%)
Blood Lactic Acid Abnormal
1 (.15%)
Blood Pressure Systolic Decreased
1 (.15%)
Cardiac Failure Congestive
1 (.15%)
Cardiac Hypertrophy
1 (.15%)
Dermatitis Exfoliative
1 (.15%)
Dermatitis Exfoliative Generalised
1 (.15%)
Device Related Infection
1 (.15%)
Eosinophil Count Increased
1 (.15%)
Erythema
1 (.15%)
Exfoliative Rash
1 (.15%)
Face Oedema
1 (.15%)

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

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

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

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

Prophylaxis
63
Product Used For Unknown Indication
23
Hypoalbuminaemia
22
Hypovolaemia
13
Ascites
11
Drug Use For Unknown Indication
10
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Plasmapheresis
8
Blood Albumin
8
Myasthenia Gravis
6
Nephrotic Syndrome
6
Hypoproteinaemia
5
Oedema
5
Hypotension
4
Exchange Blood Transfusion
4
Coronary Artery Surgery
4
Surgery
4
Cardiac Operation
4
Volume Blood Decreased
4
Shock
3
Guillain-barre Syndrome
3
Polyuria
3
Pulmonary Oedema
3
Spinal Laminectomy
2
Ovarian Cancer Recurrent
2
Vascular Graft
2
Protein Total Decreased
2
Cerebral Haemorrhage
2
Poems Syndrome
2
Hepatic Cirrhosis
2
Blood Albumin Decreased
2
Fluid Replacement
2
Blood Product Transfusion
2
Intraoperative Care
1
Toxic Epidermal Necrolysis
1
Blood Pressure Fluctuation
1
Coronary Artery Disease
1
Hepatorenal Syndrome
1
Liver Disorder
1

Drug Labels

LabelLabelerEffective
BuminateBaxter Healthcare Corporation25-MAR-12
BuminateBaxter Healthcare Corporation26-MAR-12

Buminate Case Reports

What Buminate 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 Buminate. 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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