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)
Erythema23.03.06.001--Not Available
Eye swelling06.08.03.003--Not Available
Fabry's disease03.08.02.001; 14.14.02.001; 17.02.06.013; 23.06.03.002--Not Available
Face oedema08.01.07.003; 10.01.05.002; 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
Flushing08.01.03.025; 23.06.05.003; 24.03.01.002--
Fungal infection11.03.05.001--Not Available
Headache17.14.01.001--
Hyperhidrosis08.01.03.028; 23.02.03.004--
Hypersensitivity10.01.03.003--
Hypersensitivity vasculitis01.01.04.008; 10.02.02.017; 23.06.02.005; 24.05.02.012--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 swelling07.05.04.005; 10.01.05.005; 23.04.01.007--Not Available
Localised infection11.01.08.006--Not Available
Lower respiratory tract infection11.01.09.002; 22.07.01.002--Not Available
Lymphadenopathy01.09.01.002--Not Available
Muscle spasms15.05.03.004--
Myalgia15.05.02.001--
Myocardial infarction02.02.02.007; 24.04.04.009--
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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