Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Albumin microspheres (human)
Drug ID BADD_D00055
Description 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 [A33706]. 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 [A40060]. 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) [A40060]. There are various preparations of albumin that are well established and widely available in the clinical setting [L3108], [L3109], [L3101]. 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 [F229]. 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 [L3101].
Indications and Usage Albuminex solution is indicated for adults and children for hypovolemia, ascites, hypoalbuminemia including from burns, acute nephrosis, acute respiratory distress syndrome and cardipulmonary bypass [F229].
Marketing Status approved
ATC Code Not Available
DrugBank ID DB00062
KEGG ID Not Available
MeSH ID D012709
PubChem ID Not Available
TTD Drug ID Not Available
NDC Product Code 64208-2512; 68982-633; 0944-0493; 68982-623; 68982-643; 64208-2510; 0944-0495
UNII Not Available
Synonyms Serum Albumin | Albumin, Serum | Plasma Albumin
Chemical Information
Molecular Formula Not Available
CAS Registry Number 9048-46-8
SMILES Not Available
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice.
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Arrhythmia supraventricular02.03.03.001---
Arthralgia15.01.02.001--
Asthenia08.01.01.001---
Back pain15.03.04.005--
Cardiac arrest02.03.04.001--
Chest pain22.12.02.003; 08.01.08.002; 02.02.02.011---
Chills15.05.03.016; 08.01.09.001--
Dizziness02.11.04.006; 24.06.02.007; 17.02.05.003--
Dry mouth07.06.01.002--
Dysgeusia17.02.07.003; 07.14.03.001--
Dyspnoea02.11.05.003; 22.02.01.004--
Eosinophilia01.02.04.001--
Erythema23.03.06.001---
Eye irritation06.04.05.003---
Fatigue08.01.01.002--
Flushing24.03.01.002; 23.06.05.003; 08.01.03.025--
Headache17.14.01.001--
Hypersensitivity10.01.03.003--
Hypotension24.06.03.002--
Influenza11.05.03.001; 22.07.02.001---
Irritability19.04.02.013; 08.01.03.011--
Loss of consciousness17.02.04.004---
Malaise08.01.01.003--
Myalgia15.05.02.001--
Nausea07.01.07.001--
Oxygen saturation decreased13.02.01.004---
Pain08.01.08.004--
Palpitations02.11.04.012--
Paraesthesia23.03.03.094; 17.02.06.005--
Photophobia06.01.01.004; 17.17.02.006--
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