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
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)
Erythema23.03.06.001--Not Available
Eye swelling06.08.03.003--Not Available
Fabry's disease23.06.03.002; 17.02.06.013; 14.14.02.001; 03.08.02.001--Not Available
Face oedema10.01.05.002; 08.01.07.003; 23.04.01.004--
Fall12.01.08.002--
Fatigue08.01.01.002--
Feeling cold08.01.09.008--Not Available
Feeling hot08.01.09.009--Not Available
Flushing23.06.05.003; 24.03.01.002; 08.01.03.025--
Fungal infection11.03.05.001--Not Available
Headache17.14.01.001--
Hyperhidrosis23.02.03.004; 08.01.03.028--
Hypersensitivity10.01.03.003--
Hypersensitivity vasculitis24.05.02.012; 23.06.02.005; 10.02.02.017; 01.01.04.008--Not Available
Hypertension24.08.02.001--
Hypoaesthesia17.02.06.023--Not Available
Hypotension24.06.03.002--
Hypoxia22.02.02.003--
Lacrimation increased06.08.02.004--
Lip swelling23.04.01.007; 10.01.05.005; 07.05.04.005--Not Available
Localised infection11.01.08.006--Not Available
Lower respiratory tract infection22.07.01.002; 11.01.09.002--Not Available
Lymphadenopathy01.09.01.002--Not Available
Muscle spasms15.05.03.004--
Myalgia15.05.02.001--
Myocardial infarction24.04.04.009; 02.02.02.007--
Nasal congestion22.04.04.001--
Nausea07.01.07.001--
Nephrotic syndrome20.05.01.002--
Oedema08.01.07.006; 14.05.06.010--Not Available
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