Albumin human
Accession Number
DB00062  (BTD00059, BTD00089, BTD00101, BIOD00059, BIOD00089, BIOD00101, DB00096, DB00064)
Biologic Classification
Protein Based Therapies
Blood factors

Human serum albumin is the primary protein present in human blood plasma. The main function of albumin is to maintain the oncotic pressure of blood 2. It binds to water, cations (such as Ca2+, Na+ and K+), fatty acids, hormones, bilirubin, thyroxine (T4) and pharmaceuticals (including barbiturates). Albumin represents approximately 50% of the total protein content in healthy humans 5.

Human albumin is a small globular protein (molecular weight: 66.5 kDa), consisting of a single chain of 585 amino acids organized in three repeated homolog domains (sites I, II, and III). Each domain comprises two separate sub-domains (A and B) 5.

There are various preparations of albumin that are well established and widely available in the clinical setting 9, 10, 6.

Also known as Albuminex 5% or 25%, one brand of human serum albumin is prepared from the pooled plasma of US donors in FDA-licensed facilities in the US 12. This is a biosimilar drug to existing human serum albumin and was approved for a biological license at both 5% and 25% concentrations by the FDA on June 21, 2018 6.

Protein structure
Protein chemical formula
Protein average weight
66472.2 Da
> Human Serum Albumin Sequence
Download FASTA Format
  • Albumin (human)
  • Albumin human
  • Albumin, blood
  • Albumin, human
  • Albumin, human-kjda
  • Human albumin
  • Human serum albumin
  • Serum albumin
Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing End
AlbukedSolution10 g/50mLIntravenousKedrion Biopharma, Inc.1981-07-28Not applicableUs
AlbukedSolution2.5 g/50mLIntravenousKedrion Biopharma, Inc.1976-08-26Not applicableUs
AlbukedSolution.05 g/1mLIntravenousKedrion Biopharma, Inc.1976-08-26Not applicableUs
AlbukedSolution10 g/50mLIntravenousKedrion Biopharma, Inc.1981-07-28Not applicableUs
AlbukedSolution5 g/20mLIntravenousKedrion Biopharma, Inc.1942-10-21Not applicableUs
AlbukedSolution5 g/20mLIntravenousKedrion Biopharma, Inc.1942-10-21Not applicableUs
Albumin (Human)Solution250 g/1000mLIntravenousOctapharma USA Inc2006-10-17Not applicableUs
Albumin (Human)Solution50 g/1000mLIntravenousOctapharma USA Inc2006-10-17Not applicableUs
Albumin (Human)Solution200 g/1000mLIntravenousOctapharma USA Inc2006-10-17Not applicableUs
Albumin (Human)Solution50 g/1000mLIntravenousOctapharma Pharmazeutika Produktionsgesellschaft M.B.H.2006-10-17Not applicableUs
Additional Data Available
  • Application Number
    Application Number

    A unique ID assigned by the FDA when a product is submitted for approval by the labeller.

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  • Product Code
    Product Code

    A governmentally-recognized ID which uniquely identifies the product within its regulatory market.

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Mixture Products
NameIngredientsDosageRouteLabellerMarketing StartMarketing End
Albumin Human DiluentAlbumin human (.3 mg) + Sodium chloride (9 mg)LiquidSubcutaneousOmega Laboratories Ltd1987-12-31Not applicableCanada
MacrotecAlbumin human (10 mg/1) + Albumin Aggregated (1.5 mg/1)Injection, powder, lyophilized, for suspensionIntravenousBracco Diagnostics, Inc1974-05-082008-04-20Us
Sterile Diluent for Allergenic ExtractAlbumin human (0.0003 mL/1mL) + Phenol (0.004 mL/1mL)Injection, solutionIntradermal; SubcutaneousAntigen Laboratories, Inc.1974-03-23Not applicableUs
CAS number



Albuminex solution is indicated for adults and children for hypovolemia, ascites, hypoalbuminemia including from burns, acute nephrosis, acute respiratory distress syndrome and cardipulmonary bypass 12.

Associated Conditions

Serum albumin is a soluble, monomeric protein essential for maintaining and regulating the colloidal osmotic pressure of blood. It is utilized to increase the circulating plasma volume, which reduces hemoconcentration and blood viscosity. Albumin is also used as a transport protein that binds naturally occurring, therapeutic and toxic materials and drugs in the circulation 12.

Human albumin makes up over 50% the total protein in the plasma and represents about 10% of protein synthesis activity by the liver. Human Albumin 25% has a corresponding hyper-oncotic effect 13.

Mechanism of action

The main function of albumin results from its contribution to plasma colloid oncotic pressure and transport function 13.

Albumin stabilizes circulating blood volume and carries hormones, enzymes, medicines, and toxins. Other physiological functions include antioxidant properties, free radical scavenging, in addition to maintenance capillary membrane integrity 13.

Exogenously administered albumin increases the oncotic pressure of the intravascular system, moving fluids from the interstitial space, thereby decreasing edema and increasing the circulating blood volume. The increase in volume reduces the concentration and viscosity of blood in patients with decreased circulating blood volume while maintaining cardiac output in shock. In dehydrated patients, negligible effects exist on circulating blood volume. In addition to the above albumin replaces protein in patients with hypoproteinemia until the cause of the deficiency can be determined 8.

This drug has thousands of endogenous and exogenous targets. Human albumin also binds and carries a plethora of hydrophobic molecules, such as endogenous (i.e., cholesterol, fatty acids, bilirubin, thyroxine) or exogenous substances (for example, drugs and toxins), transition metal ions, as well as gas (nitric oxide [NO]), with resulting implications for their solubilisation, transport, metabolism, and detoxification 5.

UNitric oxide
Additional Data Available
Adverse Effects

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Not Available
Volume of distribution

Albumin is distributed throughout the extracellular space and more than 60% of the body albumin pool is located in the extravascular fluid space 13.

In healthy adults, less than 10% of infused albumin leaves the intravascular compartment during the first 2 hours following infusion of albumin. There is considerable individual variation in the effect of albumin on plasma volume, however 12, 13.

In some patients, the plasma volume can remain elevated for several hours. In critically ill patients, however, albumin can leak out of the vascular space in substantial amounts at an unpredictable rate that is difficult to predict 13.

Protein binding
Not Available
Not Available
Route of elimination
Not Available
Half life
Not Available
Not Available

In general, human albumin solutions are well-tolerated and no specific, clinically relevant alterations in organ function or coagulopathy have been substantiated 12.

The most common adverse reactions are rigors, hypotension, tachycardia with increased heart rate, fever, chills, nausea, vomiting, dyspnea and/or bronchospasm, skin rash/pruritus. Stop the infusion immediately if anaphylaxis, with or without shock is observed 12.

Hypervolemia may occur if the dosage and rate of infusion are not adjusted to the volume status of the patient. When clinical signs of cardiovascular overload occur (headache, dyspnea, jugular venous distention, increased blood pressure), the infusion must be slowed or stopped immediately 13.

Affected organisms
  • Humans and other mammals
Not Available
Pharmacogenomic Effects/ADRs
Not Available


Drug Interactions
This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.
No interactions found.
Food Interactions
Not Available


Synthesis Reference

Robert A. Tenold, "Preparing essentially monomeric normal human serum albumin." U.S. Patent USRE0362590, issued July, 1976. Rene Fickat, Simon Benita, Francis Puisieux, "Preparation of biodegradable microcapsules based on serum albumin." U.S. Patent US4666641, issued June, 1958.

General References
  1. Zunszain PA, Ghuman J, Komatsu T, Tsuchida E, Curry S: Crystal structural analysis of human serum albumin complexed with hemin and fatty acid. BMC Struct Biol. 2003 Jul 7;3:6. Epub 2003 Jul 7. [PubMed:12846933]
  2. Moman RN, Bhimji SS: Albumin . [PubMed:29083605]
  3. Neumann E, Frei E, Funk D, Becker MD, Schrenk HH, Muller-Ladner U, Fiehn C: Native albumin for targeted drug delivery. Expert Opin Drug Deliv. 2010 Aug;7(8):915-25. doi: 10.1517/17425247.2010.498474. [PubMed:20586704]
  4. Schussler GC: The thyroxine-binding proteins. Thyroid. 2000 Feb;10(2):141-9. doi: 10.1089/thy.2000.10.141. [PubMed:10718550]
  5. Caraceni P, Tufoni M, Bonavita ME: Clinical use of albumin. Blood Transfus. 2013 Sep;11 Suppl 4:s18-25. doi: 10.2450/2013.005s. [PubMed:24333308]
  6. BLA APPROVAL [Link]
  7. ALBUMIN (HUMAN)- albumin human solution DailyMed [Link]
  8. PDR-Human Albumin [Link]
  9. Alburx [Link]
  10. Human Albumin [Link]
  11. Plasbumin [Link]
  12. Albuminex package insert [File]
  13. Albuminex 25 package insert [File]
  14. CSL Bhering Prescribing Information [File]
External Links
PubChem Substance
RxList Drug Page
AHFS Codes
  • 16:00.00 — Blood Derivatives
  • 36:18.00 — Cardiac Function
  • 40:50.00* — Diluents
FDA label
Download (265 KB)
Download (122 KB)

Clinical Trials

Clinical Trials
0RecruitingTreatmentAlbumin Supplementation / Albumin Therapy / Sepsis1
1Active Not RecruitingTreatmentCardiomyopathy Due to Anthracyclines1
1CompletedTreatmentHealthy Volunteers1
1RecruitingSupportive CareBlastocyst / Culture Media / Embryo Development / Poor Responder / Severe Male Infertility1
1RecruitingTreatmentHealthy Volunteers2
1RecruitingTreatmentHepatitis B Virus (HBV)1
1TerminatedTreatmentSubarachnoid Hemorrhage1
1, 2Active Not RecruitingTreatmentAllergic Rhinitis (AR)1
1, 2CompletedTreatmentHepatitis B Chronic Infection1
1, 2CompletedTreatmentHuman Immunodeficiency Virus (HIV) Infections1
1, 2CompletedTreatmentOsteoarthritis of the Knee1
1, 2Unknown StatusTreatmentGraft Versus Host Disease (GVHD)1
2Active Not RecruitingTreatmentIntermittent Claudication / Peripheral Artery Disease (PAD)1
2CompletedTreatmentAlpha 1-Antitrypsin Deficiency1
2CompletedTreatmentAlzheimer's Disease (AD)1
2CompletedTreatmentAmyotrophic Lateral Sclerosis (ALS)2
2CompletedTreatmentAnginal Pain / Chronic Ischemic Heart Disease / Ischaemic Cardiomyopathy / Left Ventricular Dysfunction1
2CompletedTreatmentChemotherapy Induced Neutropenia1
2CompletedTreatmentCommunity Acquired Pneumonia (CAP)1
2CompletedTreatmentDependence, Cocaine1
2CompletedTreatmentDiabetes Mellitus / Gastroparesis1
2CompletedTreatmentLeft Ventricular Dysfunction1
2CompletedTreatmentMacular Degeneration1
2CompletedTreatmentRelapsing Remitting Multiple Sclerosis (RRMS)1
2Not Yet RecruitingTreatmentHyponatremia With Excess Extracellular Fluid Volume / Liver Cirrhosis1
2RecruitingTreatmentChronic Myocardial Ischemia1
2RecruitingTreatmentNovel Coronavirus Infectious Disease (COVID-19)1
2TerminatedTreatmentCardiopulmonary Bypass / Systemic Inflammatory Response Syndrome (SIRS)1
2TerminatedTreatmentCerebral Hemorrhage1
2TerminatedTreatmentCerebral Infarctions1
2TerminatedTreatmentHemodynamic Stability1
2, 3Active Not RecruitingTreatmentRhinitis, Allergic, Seasonal1
2, 3CompletedTreatmentAllergic Rhinitis (AR)2
2, 3CompletedTreatmentAllergic Rhinitis Due to Grass Pollen1
2, 3CompletedTreatmentAllergies / Asthma / Rhinitis1
2, 3CompletedTreatmentAlzheimer's Disease (AD)1
2, 3TerminatedTreatmentGraft Versus Host Disease (GVHD)1
2, 3TerminatedTreatmentHepatorenal Syndrome / Liver Cirrhosis1
2, 3TerminatedTreatmentHypovolaemia1
2, 3Unknown StatusNot AvailableSevere Head Injury1
3Active Not RecruitingTreatmentPostoperative Kidney Injury1
3CompletedNot AvailableMumps / Rubeola / Varicella1
3CompletedPreventionMumps / Rubella / Rubeola / Varicella1
3CompletedTreatmentAlzheimer's Disease (AD)1
3CompletedTreatmentLiver Cirrhosis1
3CompletedTreatmentMultifocal Motor Neuropathy (MMN)1
3CompletedTreatmentOsteoarthritis of the Knee1
3CompletedTreatmentPolyradiculoneuropathy, Chronic Inflammatory Demyelinating1
3CompletedTreatmentSecondary Recurrent Miscarriage1
3Not Yet RecruitingTreatmentPostural Orthostatic Tachycardia Syndrome (POTS)1
3RecruitingTreatmentAcute on Chronic Liver Failure / Acute-On-Chronic Liver Failure1
3RecruitingTreatmentCommunity Acquired Pneumonia (CAP) / Hypoalbuminemia1
3RecruitingTreatmentDecompensated Cirrhosis and Ascites1
3RecruitingTreatmentShock, Septic1
3TerminatedTreatmentAlpha-1 Anti-trypsin Deficiency / Chronic Obstructive Pulmonary Disease (COPD)1
3TerminatedTreatmentAlzheimer's Disease (AD)1
3TerminatedTreatmentLiver Cirrhosis / Renal Failure / Sepsis1
3TerminatedTreatmentLung Injury, Acute (ALI) / Respiratory Distress Syndrome, Acute (ARDS)1
4CompletedPreventionHepatic Encephalopathy (HE)1
4CompletedTreatmentAscites / Liver Cirrhosis2
4CompletedTreatmentCardiopulmonary Bypass / Surgery, Cardiac1
4CompletedTreatmentHeart; Dysfunction Postoperative, Cardiac Surgery1
4CompletedTreatmentHypoalbuminemia / Peptic Ulcer Bleeding1
4RecruitingPreventionAcute Kidney Injury (AKI)1
4RecruitingTreatmentFluid Overload / Liver Cirrhosis / Volume Overload1
4RecruitingTreatmentHepatic Encephalopathy (HE) / Liver Cirrhosis1
4RecruitingTreatmentHypoalbuminemia / Shock / Systemic Inflammatory Response Syndrome (SIRS)1
4TerminatedTreatmentAdvanced Chronic Liver Disease / Cholangitis / Other Bacterial Diseases / Pneumonia / Urinary Tract Infection1
4TerminatedTreatmentSpontaneous Bacterial Peritonitis (SBP)1
4TerminatedTreatmentMinor burns1
4Unknown StatusTreatmentElective Cardiac Surgery1
4Unknown StatusTreatmentHemorrhage; Complicating Delivery, Coagulation Defect1
4Unknown StatusTreatmentSecond or Third Degree Burns1
Not AvailableActive Not RecruitingTreatmentAscites / Liver Cirrhosis1
Not AvailableCompletedDiagnosticTransesophageal Echocardiography Contrast Agents1
Not AvailableNot Yet RecruitingTreatmentBurn Injuries1
Not AvailableRecruitingNot AvailableCirrhosis, Decompensated1
Not AvailableRecruitingOtherEndothelial Dysfunction1
Not AvailableRecruitingTreatmentAortic Valve Disorder / Coronary Heart Disease (CHD) / Injuries, Brain / Renal Failure / Shock, Cardiogenic / Stroke1
Not AvailableSuspendedDiagnosticAscites / Liver Cirrhosis1
Not AvailableTerminatedTreatmentLiver Cirrhosis1
Not AvailableTerminatedTreatmentSubarachnoid Hemorrhage1
Not AvailableWithdrawnDiagnosticOvarian Hyperstimulation Syndrome1


Not Available
  • ALK-Abello Inc.
  • Alpha Therapeutic Corp.
  • Alpine Biologics Inc.
  • American Red Cross
  • Baxter International Inc.
  • CSL Behring LLC
  • Grifols SA
  • Massbiologics
  • Octapharma USA
  • Sanofi-Aventis Inc.
  • Talecris Biotherapeutics
Dosage forms
SolutionIntravenous.05 g/1mL
SolutionIntravenous10 g/50mL
SolutionIntravenous5 g/20mL
SolutionIntravenous200 g/1000mL
SolutionIntravenous250 g/1000mL
SolutionIntravenous50 g/1000mL
SolutionIntravenous20 g/100mL
SolutionIntravenous25 g
SolutionIntravenous25 g/100mL
SolutionIntravenous0.05 g/1mL
SolutionIntravenous12.5 g/250mL
SolutionIntravenous12.5 g/50mL
Injection, solutionIntravenous10 g/50mL
Injection, solutionIntravenous12.5 g/250mL
Injection, solutionIntravenous12.5 g/50mL
Injection, solutionIntravenous0.05 g/1mL
Injection, solutionIntravenous0.2 g/1mL
Injection, solutionIntravenous0.25 g/1mL
LiquidIntradermal; Subcutaneous
SolutionIntravenous0.20 g/1mL
SolutionIntravenous0.25 g/1mL
Injection, powder, lyophilized, for suspensionIntravenous
SolutionIntravenous2.5 g/50mL
Injection, solutionIntradermal; Subcutaneous
Unit descriptionCostUnit
Buminate 25% iv solution2.22USD ml
Albumin 25% iv solution1.97USD ml
Albutein 25% vial1.32USD ml
Buminate 5% iv solution0.44USD ml
Albutein 5% iv solution0.43USD ml
Albumin (human) 5% iv solution0.3USD ml
DrugBank does not sell nor buy drugs. Pricing information is supplied for informational purposes only.
Patent NumberPediatric ExtensionApprovedExpires (estimated)
Additional Data Available
  • Filed On
    Filed On

    The date on which a patent was filed with the relevant government.

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Experimental Properties
Not Available


Not Available
Organic Compounds
Super Class
Organic Acids
Carboxylic Acids and Derivatives
Sub Class
Amino Acids, Peptides, and Analogues
Direct Parent
Alternative Parents
Not Available
Not Available
Molecular Framework
Not Available
External Descriptors
Not Available


Small molecule
Pharmacological action
  1. Caraceni P, Tufoni M, Bonavita ME: Clinical use of albumin. Blood Transfus. 2013 Sep;11 Suppl 4:s18-25. doi: 10.2450/2013.005s. [PubMed:24333308]
  2. Ishima Y, Kragh-Hansen U, Maruyama T, Otagiri M: Albumin as a nitric oxide-traffic protein: characterization, biochemistry and possible future therapeutic applications. Drug Metab Pharmacokinet. 2009;24(4):308-17. [PubMed:19745558]
  3. Lee P, Wu X: Review: modifications of human serum albumin and their binding effect. Curr Pharm Des. 2015;21(14):1862-5. [PubMed:25732553]

Drug created on June 13, 2005 07:24 / Updated on May 30, 2020 00:22

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