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)
Abdominal pain07.01.05.002--
Anaphylactic reaction10.01.07.001; 24.06.03.006--
Anaphylactic shock10.01.07.002; 24.06.02.004--Not Available
Angioedema10.01.05.009; 23.04.01.001--Not Available
Anxiety19.06.02.002--
Arrhythmia02.03.02.001--Not Available
Arthralgia15.01.02.001--
Asthenia08.01.01.001--Not Available
Ataxia08.01.02.004; 17.02.02.001--
Auricular swelling04.01.01.002--Not Available
Back pain15.03.04.005--
Blood creatinine increased13.13.01.004--
Blood immunoglobulin G increased13.06.05.004--Not Available
Bradycardia02.03.02.002--Not Available
Burning sensation08.01.09.029; 17.02.06.001--Not Available
Cardiac arrest02.03.04.001--
Cardiac failure02.05.01.001--
Cardiac output decreased13.14.02.001--Not Available
Cardio-respiratory arrest02.03.04.002; 22.02.06.007--Not Available
Cerebrovascular accident17.08.01.007; 24.03.05.001--
Chest discomfort02.02.02.009; 08.01.08.019; 22.02.08.001--Not Available
Chest pain02.02.02.011; 08.01.08.002; 22.02.08.003--Not Available
Chills08.01.09.001; 15.05.03.016--
Cough22.02.03.001--
Depression19.15.01.001--
Diarrhoea07.02.01.001--
Dizziness02.01.02.004; 17.02.05.003; 24.06.02.007--
Dry mouth07.06.01.002--
Dysphagia07.01.06.003--
Dyspnoea02.01.03.002; 22.02.01.004--
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