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)
Delusion19.10.01.001--
Diarrhoea07.02.01.001--
Dizziness02.11.04.006; 17.02.05.003; 24.06.02.007--
Dry eye06.08.02.001--
Dry mouth07.06.01.002--
Dry throat07.06.01.005; 22.12.03.005---
Duodenal ulcer07.04.02.002--
Dyskinesia17.01.02.006--
Dyspepsia07.01.02.001--
Dyspnoea02.11.05.003; 22.02.01.004--
Dyspnoea exertional02.11.05.005; 22.02.01.005---
Dystonia17.01.03.001---
Dysuria20.02.02.002--
Ejaculation failure21.03.01.003---
Enuresis19.07.04.001; 20.02.02.003---
Epistaxis22.04.03.001; 24.07.01.005--
Extrapyramidal disorder17.01.02.007--
Eye swelling06.08.03.003---
Eyelid oedema06.04.04.004; 10.01.05.001; 23.04.01.003---
Fatigue08.01.01.002--
Fluid retention14.05.06.002; 20.01.02.003---
Gait disturbance08.01.02.002; 15.03.05.013; 17.02.05.016--
Gastritis07.08.02.001--
Gastrooesophageal reflux disease07.02.02.003--
Gynaecomastia05.05.02.003; 21.05.04.003--
Haematocrit decreased13.01.05.001---
Haemoglobin decreased13.01.05.003---
Headache17.14.01.001--
Hiatus hernia07.16.01.001; 22.09.02.004---
Hostility19.05.01.003---
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