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 Agalsidase beta is indicated in the treatment of Fabry disease.[L16383]
Marketing Status approved; investigational
ATC Code A16AB04
DrugBank ID DB00103
KEGG ID D03228
MeSH ID C459420
PubChem ID 52918379
TTD Drug ID Not Available
NDC Product Code 58468-0040; 58468-0041
UNII RZD65TSM9U
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
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
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
Flushing24.03.01.002; 23.06.05.003; 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 vasculitis01.01.04.008; 24.12.04.013; 23.06.02.005; 10.02.02.017--Not Available
Hypertension24.08.02.001--
Hypoaesthesia23.03.03.081; 17.02.06.023--Not Available
Hypotension24.06.03.002--
Hypoxia22.02.02.003--
Lacrimation increased06.08.02.004--
Lip swelling07.05.04.005; 23.04.01.007; 10.01.05.005--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--
Oedema14.05.06.010; 08.01.07.006--Not Available
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