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
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
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 reaction24.06.03.006;
Anaphylactic shock24.06.02.004; Available
Angioedema23.04.01.001; Available
Arrhythmia02.03.02.001--Not Available
Asthenia08.01.01.001--Not Available
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 sensation17.02.06.001; 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; Available
Cerebrovascular accident24.03.05.001;
Chest discomfort22.02.08.001;; Available
Chest pain22.02.08.003;; Available
Dry mouth07.06.01.002--
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