ALBUMIN

Albumin Adverse Events Reported to the FDA Over Time

How are Albumin adverse event reports trending over time?

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

Most Common Albumin Adverse Events Reported to the FDA

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

Hepatitis C	56 (2.38%)
Dyspnoea	52 (2.21%)
Pyrexia	48 (2.04%)
Sepsis	38 (1.61%)
Pulmonary Oedema	35 (1.49%)
Hypotension	33 (1.4%)
Blood Pressure Decreased	29 (1.23%)
Multi-organ Failure	29 (1.23%)
Tremor	28 (1.19%)
Factor Viii Inhibition	26 (1.1%)
Chills	25 (1.06%)
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Hypersensitivity	25 (1.06%)
Infusion Related Reaction	24 (1.02%)
Cardiac Arrest	23 (.98%)
Feeling Abnormal	20 (.85%)
Hypertension	20 (.85%)
Respiratory Distress	20 (.85%)
Respiratory Failure	20 (.85%)
Anaphylactic Reaction	19 (.81%)
Platelet Count Decreased	19 (.81%)
Tachycardia	19 (.81%)
Transmission Of An Infectious Agent...	19 (.81%)
Pleural Effusion	18 (.76%)
Stenotrophomonas Infection	18 (.76%)
Thrombocytopenia	18 (.76%)
Convulsion	17 (.72%)
Hepatitis B	17 (.72%)
Coma	16 (.68%)
Erythema	16 (.68%)
Medication Error	16 (.68%)
Pain	15 (.64%)
Anaphylactic Shock	14 (.59%)
Blood Culture Positive	14 (.59%)
Condition Aggravated	14 (.59%)
Death	14 (.59%)
Haemoglobin Decreased	14 (.59%)
Haemorrhage	14 (.59%)
Urticaria	14 (.59%)
Anaemia	13 (.55%)
Stevens-johnson Syndrome	13 (.55%)
Toxic Epidermal Necrolysis	13 (.55%)
Dizziness	12 (.51%)
Cardio-respiratory Arrest	11 (.47%)
Chest Discomfort	11 (.47%)
Fatigue	11 (.47%)
Hepatitis C Antibody Positive	11 (.47%)
Loss Of Consciousness	11 (.47%)
Pruritus	11 (.47%)
Rash	11 (.47%)
Renal Failure	11 (.47%)
Transfusion-related Acute Lung Inju...	11 (.47%)
Tumour Lysis Syndrome	11 (.47%)
Acute Pulmonary Oedema	10 (.42%)
Blood Alkaline Phosphatase Increase...	10 (.42%)
Pneumonia	10 (.42%)
Post Procedural Complication	10 (.42%)
Cachexia	9 (.38%)
Cerebral Infarction	9 (.38%)
Hyperhidrosis	9 (.38%)
Malaise	9 (.38%)
Nausea	9 (.38%)
Neutrophil Count Decreased	9 (.38%)
Ascites	8 (.34%)
Bradycardia	8 (.34%)
Culture Urine Positive	8 (.34%)
Heart Rate Increased	8 (.34%)
Hepatitis E	8 (.34%)
Hyperuricaemia	8 (.34%)
Metabolic Acidosis	8 (.34%)
Renal Failure Acute	8 (.34%)
Renal Impairment	8 (.34%)
Respiratory Arrest	8 (.34%)
Thrombotic Microangiopathy	8 (.34%)
Vomiting	8 (.34%)
White Blood Cell Count Decreased	8 (.34%)
Abdominal Pain	7 (.3%)
Acute Respiratory Distress Syndrome	7 (.3%)
Aspartate Aminotransferase Increase...	7 (.3%)
Brain Oedema	7 (.3%)
Bronchospasm	7 (.3%)
Cardiac Failure	7 (.3%)
Chest Pain	7 (.3%)
Dermatitis Exfoliative	7 (.3%)
Disseminated Intravascular Coagulat...	7 (.3%)
Escherichia Sepsis	7 (.3%)
Haemodynamic Instability	7 (.3%)
Haemolysis	7 (.3%)
Hepatitis C Positive	7 (.3%)
Infection	7 (.3%)
Liver Disorder	7 (.3%)
Neuropathy Peripheral	7 (.3%)
Neutropenia	7 (.3%)
Oedema Peripheral	7 (.3%)
Oxygen Saturation Decreased	7 (.3%)
Postoperative Renal Failure	7 (.3%)
Allergic Transfusion Reaction	6 (.25%)
Anxiety	6 (.25%)
Body Temperature Increased	6 (.25%)
Diarrhoea	6 (.25%)
Drug Physiologic Incompatibility	6 (.25%)
Headache	6 (.25%)

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

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

Respiratory	153 (6.5%)
Epidermal And Dermal Conditions	109 (4.63%)
Infections - Pathogen Unspecified	90 (3.82%)
Viral Infectious	88 (3.74%)
Hematology Investigations	77 (3.27%)
Cardiac Arrhythmias	75 (3.19%)
Allergic Conditions	66 (2.8%)
Cardiac And Vascular Investigations	66 (2.8%)
Lower Respiratory Tract Disorders	66 (2.8%)
Neurological	62 (2.63%)
Bacterial Infectious	59 (2.51%)
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Procedural And Device Related Injur...	56 (2.38%)
Body Temperature Conditions	54 (2.29%)
Microbiology And Serology	52 (2.21%)
Decreased And Nonspecific Blood Pre...	49 (2.08%)
Coagulopathies And Bleeding Diathes...	45 (1.91%)
Gastrointestinal Signs	39 (1.66%)
Renal Disorders	37 (1.57%)
Hepatic And Hepatobiliary	36 (1.53%)
Medication Errors	35 (1.49%)
Movement Disorders	34 (1.44%)
Electrolyte And Fluid Balance Condi...	33 (1.4%)
Administration Site Reactions	27 (1.15%)
Platelet	25 (1.06%)
Vascular Hypertensive	21 (.89%)
Hepatobiliary	20 (.85%)
Ancillary Infectious Topics	19 (.81%)
Physical Examination Topics	18 (.76%)
Pleural	18 (.76%)
Seizures	17 (.72%)
Urinary Tract Signs	17 (.72%)
Metabolic, Nutritional And Blood Ga...	16 (.68%)
Therapeutic And Nontherapeutic Effe...	16 (.68%)
Angiedema And Urticaria	15 (.64%)
Central Nervous System Vascular	15 (.64%)
Enzyme	15 (.64%)
Fatal Outcomes	15 (.64%)
Heart Failures	15 (.64%)
Vascular Hemorrhagic	15 (.64%)
Anemias Nonhemolytic And Marrow Dep...	14 (.59%)
Gastrointestinal Hemorrhages	14 (.59%)
Vascular	14 (.59%)
Increased Intracranial Pressure And...	13 (.55%)
Oral Soft Tissue Conditions	13 (.55%)
Peritoneal And Retroperitoneal Cond...	13 (.55%)
Anxiety Disorders	12 (.51%)
Appetite And General Nutritional	12 (.51%)
Gastrointestinal Motility And Defec...	12 (.51%)
Injuries	12 (.51%)
Product Quality Issues	12 (.51%)
Acid-base	11 (.47%)
Bronchial Disorders	11 (.47%)
Peripheral Neuropathies	11 (.47%)
Skin Appendage Conditions	11 (.47%)
White Blood Cell	11 (.47%)
Encephalopathies	10 (.42%)
Hemolyses And Related Conditions	10 (.42%)
Immunology And Allergy	10 (.42%)
Renal And Urinary Tract Investigati...	9 (.38%)
Cardiac Disorder Signs	8 (.34%)
Purine And Pyrimidine Metabolism	8 (.34%)
Upper Respiratory Tract Disorders	8 (.34%)
Chemical Injury And Poisoning	7 (.3%)
Fungal Infectious	7 (.3%)
Headaches	7 (.3%)
Hematological And Lymphoid Tissue T...	7 (.3%)
Immune	7 (.3%)
Muscle	7 (.3%)
Embolism And Thrombosis	6 (.25%)
Gastrointestinal Inflammatory Condi...	6 (.25%)
Ocular Infections, Irritations And ...	6 (.25%)
Protein And Chemistry Analyses	6 (.25%)
Skin Vascular Abnormalities	6 (.25%)
Bone, Calcium, Magnesium And Phosph...	5 (.21%)
Coronary Artery	5 (.21%)
Neuromuscular	5 (.21%)
Pulmonary Vascular	5 (.21%)
Spleen, Lymphatic And Reticulendoth...	5 (.21%)
Tongue Conditions	5 (.21%)
Water, Electrolyte And Mineral	5 (.21%)
Bone Disorders	4 (.17%)
Deliria	4 (.17%)
Gastrointestinal Vascular Condition...	4 (.17%)
Hematological	4 (.17%)
Hematopoietic Neoplasms	4 (.17%)
Investigations, Imaging And Histopa...	4 (.17%)
Joint	4 (.17%)
Mood Disorders	4 (.17%)
Renal And Urinary Tract Therapeutic...	4 (.17%)
Synovial And Bursal	4 (.17%)
Arteriosclerosis, Stenosis, Vascula...	3 (.13%)
Gastrointestinal Conditions	3 (.13%)
Lifestyle Issues	3 (.13%)
Myocardial	3 (.13%)
Therapeutic Procedures And Supporti...	3 (.13%)
Tissue	3 (.13%)
Cardiac Valve	2 (.08%)
Disturbances In Thinking	2 (.08%)
Environmental Issues	2 (.08%)
Gastrointestinal	2 (.08%)
Glucose Metabolism Disorders	2 (.08%)

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This graph shows the top categories of adverse events submitted to the FDA for Albumin, 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 Albumin 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.