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)
Oedema peripheral14.05.06.011; 08.01.07.007; 02.05.04.007--
Oxygen saturation decreased13.02.01.004--Not Available
Pain08.01.08.004--
Pain in extremity15.03.04.010--
Pallor24.03.04.001; 23.03.03.031; 08.01.03.032--Not Available
Palpitations02.11.04.012--
Paraesthesia17.02.06.005; 23.03.03.094--
Pharyngeal oedema23.04.01.016; 22.04.05.003; 10.01.05.016--Not Available
Pharyngitis22.07.03.004; 11.01.13.003; 07.05.07.004--
Pneumonia22.07.01.003; 11.01.09.003--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--
Rhinorrhoea22.12.03.021--
Sepsis11.01.11.003--
Sinusitis22.07.03.007; 11.01.13.005--
Skin test positive13.06.04.003--Not Available
Somnolence19.02.05.003; 17.02.04.006--
Swelling face08.01.03.100; 23.04.01.018; 10.01.05.018--Not Available
Swollen tongue10.01.05.015; 07.14.02.003; 23.04.01.014--Not Available
Tachycardia02.03.02.007--Not Available
Throat tightness22.12.03.031; 19.01.02.005--Not Available
Tinnitus17.04.07.004; 04.04.01.002--
Toothache07.09.06.001--
Upper respiratory tract infection22.07.03.011; 11.01.13.009--
Urticaria23.04.02.001; 10.01.06.001--
Ventricular hypertrophy02.04.02.012--Not Available
Vertigo17.02.12.002; 04.04.01.003--
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