Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Galsulfase
Drug ID BADD_D01001
Description Galsufase is a variant form of the polymorphic human enzyme N-acetylgalactosamine 4-sulfatase of recombinant DNA origin. Galsulfase is a glycoprotein with a molecular weight of approximately 56 kD. The recombinant protein is comprised of 495 amino acids and contains six asparagine-linked glycosylation sites, four of which carry a bis mannose-6-phosphate manose7 oligosaccharide for specific cellular recognition. Post-translational modification of Cys53 produces the catalytic amino acid residue Ca-formylglycine, which is required for enzyme activity and is conserved in all members of the sulfatase enzyme family.
Indications and Usage For the treatment of adults and children with Mucopolysaccharidosis VI.
Marketing Status approved; investigational
ATC Code A16AB08
DrugBank ID DB01279
KEGG ID D06565
MeSH ID C508864
PubChem ID Not Available
TTD Drug ID D05UHF
NDC Product Code 68135-020
UNII 59UA429E5G
Synonyms galsulfase | Naglazyme
Chemical Information
Molecular Formula Not Available
CAS Registry Number 552858-79-4
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 pain07.01.05.002--
Anaphylactic reaction24.06.03.006; 10.01.07.001--
Angioedema22.04.02.008; 23.04.01.001; 10.01.05.009--Not Available
Areflexia17.02.01.001--Not Available
Arthralgia15.01.02.001--
Bradycardia02.03.02.002--Not Available
Bronchospasm22.03.01.004; 10.01.03.012--
Chest pain22.12.02.003; 08.01.08.002; 02.02.02.011--Not Available
Chills15.05.03.016; 08.01.09.001--
Conjunctivitis06.04.01.002; 11.01.06.012--
Corneal opacity06.06.03.005--Not Available
Cyanosis23.06.04.005; 02.11.04.004; 24.03.01.007; 22.02.02.007--
Dyspnoea02.11.05.003; 22.02.01.004--
Ear pain04.03.01.003--
Erythema23.03.06.001--Not Available
Gastroenteritis11.01.07.004; 07.19.03.001--Not Available
Headache17.14.01.001--
Hypertension24.08.02.001--
Hypotension24.06.03.002--
Hypoxia22.02.02.003--
Laryngeal oedema23.04.01.005; 22.04.02.001; 10.01.05.003--
Malaise08.01.01.003--
Nasal congestion22.04.04.001--
Nausea07.01.07.001--
Pain08.01.08.004--
Pallor24.03.04.001; 23.03.03.031; 08.01.03.032--Not Available
Paraesthesia23.03.03.094; 17.02.06.005--
Pharyngitis11.01.13.003; 07.05.07.004; 22.07.03.004--
Pruritus23.03.12.001--
Pyrexia08.05.02.003--
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