Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Idursulfase
Drug ID BADD_D01132
Description Idursulfase is a purified form of human iduronate-2-sulfatase, a lysosomal enzyme. Idursulfase is produced by recombinant DNA technology in a human cell line. Idursulfase is an enzyme that hydrolyzes the 2-sulfate esters of terminal iduronate sulfate residues from the glycosaminoglycans dermatan sulfate and heparan sulfate in the lysosomes of various cell types. Idursulfase is a 525-amino acid glycoprotein with a molecular weight of approximately 76 kilodaltons. The enzyme contains eight asparagine-linked glycosylation sites occupied by complex oligosaccharide structures. The enzyme activity of idursulfase is dependent on the post-translational modification of a specific cysteine to formylglycine.
Indications and Usage For the treatment of Hunter syndrome in adults and children ages 5 and older.
Marketing Status approved
ATC Code A16AB09
DrugBank ID DB01271
KEGG ID D04499
MeSH ID C517982
PubChem ID Not Available
TTD Drug ID D06CZJ
NDC Product Code 54092-700
UNII 5W8JGG2651
Synonyms idursulfase | Elaprase
Chemical Information
Molecular Formula Not Available
CAS Registry Number 50936-59-9
SMILES Not Available
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)
Tremor17.01.06.002--
Upper respiratory tract infection22.07.03.011; 11.01.13.009--
Urinary incontinence20.02.02.010; 17.05.01.008--
Urinary retention20.02.02.011--
Urticaria23.04.02.001; 10.01.06.001--
Vertigo17.02.12.002; 04.04.01.003--
Vision blurred17.17.01.010; 06.02.06.007--
Visual impairment06.02.10.013--Not Available
Weight decreased13.15.01.005--
Weight increased13.15.01.006--
Wheezing22.03.01.009--
Musculoskeletal disorder15.03.05.025--Not Available
Musculoskeletal chest pain15.03.04.012; 22.09.01.001--
Conjunctival hyperaemia06.04.01.004--Not Available
Musculoskeletal stiffness15.03.05.027--Not Available
Infusion site oedema12.07.05.013; 08.02.05.012--Not Available
Postmenopausal haemorrhage24.07.03.002; 21.02.01.002--Not Available
Major depression19.15.01.003--Not Available
Restless legs syndrome17.02.07.008; 15.05.03.012--Not Available
Adverse event08.06.01.010--Not Available
Impulse-control disorder19.18.01.002--Not Available
Erectile dysfunction21.03.01.007; 19.08.04.001--
Skin abrasion23.03.11.018; 12.01.06.010--Not Available
Acute kidney injury20.01.03.016--
Anal incontinence17.05.01.021; 07.01.06.029--
Heavy menstrual bleeding21.01.03.005--Not Available
Intermenstrual bleeding21.01.01.015--Not Available
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