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)
Abdominal discomfort07.01.06.001---
Abscess11.01.08.001---
Aggression19.05.01.001---
Akathisia17.01.02.002; 19.06.02.006--
Amenorrhoea05.05.01.002; 21.01.02.001--
Amnesia17.03.02.001; 19.20.01.001--
Anaemia01.03.02.001--
Anorgasmia19.08.01.001--
Anxiety19.06.02.002--
Aphthous ulcer07.05.06.002---
Arrhythmia02.03.02.001---
Arthralgia15.01.02.001--
Asthma10.01.03.010; 22.03.01.002---
Atrial fibrillation02.03.03.002--
Atrioventricular block first degree02.03.01.004--
Blepharitis06.04.04.001; 23.03.04.012---
Bradykinesia17.01.02.004---
Breast pain21.05.05.003--
Bulimia nervosa14.03.03.001; 19.09.01.006---
Cardiac failure02.05.01.001--
Cardiac failure acute02.05.01.005---
Cardiac failure congestive02.05.01.002---
Cataract06.06.01.001--
Catatonia19.11.01.001---
Cholelithiasis09.03.01.002---
Confusional state17.02.03.005; 19.13.01.001--
Conjunctivitis06.04.01.002; 11.01.06.012--
Conjunctivitis allergic06.04.01.003; 10.01.04.002---
Dehydration14.05.05.001--
Delirium19.13.02.001--
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