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)
Oedema peripheral02.05.04.007; 08.01.07.007; 14.05.06.011--
Oxygen saturation decreased13.02.01.004--Not Available
Pain08.01.08.004--
Pain in extremity15.03.04.010--
Pallor08.01.03.032; 23.03.03.031; 24.03.04.001--Not Available
Palpitations02.01.02.003--
Paraesthesia17.02.06.005--
Pharyngeal oedema10.01.05.016; 22.04.05.003; 23.04.01.016--Not Available
Pharyngitis07.05.07.004; 11.01.13.003; 22.07.03.004--
Pneumonia11.01.09.003; 22.07.01.003--Not Available
Pruritus23.03.12.001--
Pyrexia08.05.02.003--
Rash23.03.13.001--Not Available
Renal failure20.01.03.005--Not Available
Respiratory failure14.01.04.003; 22.02.06.002--
Rhinorrhoea22.02.05.010--
Sepsis11.01.11.003--
Sinusitis11.01.13.005; 22.07.03.007--
Skin test positive13.06.04.003--Not Available
Somnolence17.02.04.006; 19.02.05.003--
Swelling face10.01.05.018; 23.04.01.018--Not Available
Swollen tongue07.14.02.003; 10.01.05.015; 23.04.01.014--Not Available
Tachycardia02.03.02.007--Not Available
Throat tightness19.01.02.005; 22.02.05.015--Not Available
Tinnitus04.04.01.002; 17.04.07.004--
Toothache07.09.06.001--
Upper respiratory tract infection11.01.13.009; 22.07.03.011--
Urticaria10.01.06.001; 23.04.02.001--
Ventricular hypertrophy02.04.02.012--Not Available
Vertigo04.04.01.003; 17.02.12.002--
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