Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Agalsidase beta
Drug ID BADD_D00049
Description Agalsidase beta is a recombinant human α-galactosidase A similar to [agalsidase alfa]. While patients generally do not experience a clinically significant difference in outcomes between the two drugs, some patients may experience greater benefit with agalsidase beta.[A220228,A220233] Use of agalsidase beta has decreased in Europe, in favor of agalsidase alfa, after a contamination event in 2009.[A220343] Agalsidase beta was granted FDA approval on 24 April 2003.[L16383]
Indications and Usage For treatment of Fabry's disease (alpha-galactosidase A deficiency)
Marketing Status Prescription
ATC Code A16AB04
DrugBank ID DB00103
KEGG ID D03228
MeSH ID C459420
PubChem ID 52918379
TTD Drug ID Not Available
NDC Product Code 58468-0041; 58468-0040
Synonyms agalsidase beta | Fabrazyme
Chemical Information
Molecular Formula C50H78N4O14
CAS Registry Number 928659-70-5
SMILES CCCCCCCC(=O)NC(CN1CCCC1)C(C2=CC3=C(C=C2)OCCO3)O.CCCCCCCC(=O)NC(CN1CCCC1)C(C2=CC3 =C(C=C2)OCCO3)O.C(C(C(=O)O)O)(C(=O)O)O
Chemical Structure
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Viral infection11.05.04.001--Not Available
Vomiting07.01.07.003--
Wheezing22.03.01.009--
Hypoacusis04.02.01.006--
Excoriation12.01.06.007; 23.03.11.003--Not Available
Contusion12.01.06.001; 15.03.01.008; 23.03.11.002; 24.07.06.001--
Infusion related reaction08.01.03.002; 10.01.01.017; 12.02.05.009--
Respiratory tract congestion22.02.07.003--Not Available
Thermal burn12.05.04.001--
Infusion site reaction08.02.05.005; 12.07.05.006--Not Available
Hypoaesthesia oral07.05.05.003; 17.02.06.021--Not Available
Post procedural complication12.02.05.018--Not Available
Hot flush08.01.03.027; 21.02.02.001; 24.03.01.005--
Adverse event08.06.01.010--Not Available
Procedural pain08.01.08.009; 12.02.05.007--Not Available
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