Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Sapropterin
Drug ID BADD_D01987
Description Sapropterin (tetrahydrobiopterin or BH4) is a cofactor in the synthesis of nitric oxide. It is also essential in the conversion of phenylalanine to tyrosine by the enzyme phenylalanine-4-hydroxylase; the conversion of tyrosine to L-dopa by the enzyme tyrosine hydroxylase; and conversion of tryptophan to 5-hydroxytryptophan via tryptophan hydroxylase.
Indications and Usage For the treatment of tetrahydrobiopterin (BH4) deficiency.
Marketing Status approved; investigational
ATC Code A16AX07
DrugBank ID DB00360
KEGG ID D08505
MeSH ID C003402
PubChem ID 135398654
TTD Drug ID D0Q9YT
NDC Product Code Not Available
UNII EGX657432I
Synonyms sapropterin | 6R-BH4 | tetrahydrobiopterin | 5,6,7,8-erythro-tetrahydrobiopterin | tetrahydro-6-biopterin | phenylalanine hydroxylase cofactor | 5,6,7,8-tetrahydrodictyopterin | D-threo-tetrahydrobiopterin | 5,6,7,8-tetrahydro-L-erythrobiopterin | sapropterin dihydrochloride | 2,4,5-trihydroxybutyrophenone | THBP | 1-butanone, 1-(2,4,5-trihydroxyphenyl) | trihydroxybutyrophenone | 2',4',5'-trihydroxybutyrophenone | 6R-L-erythro-5,6,7,8-tetrahydrobiopterin | 5,6,7,8-tetrahydrobiopterin, (S-(R*,S*))-isomer | 5,6,7,8-tetrahydrobiopterin | kuvan
Chemical Information
Molecular Formula C9H15N5O3
CAS Registry Number 62989-33-7
SMILES CC(C(C1CNC2=C(N1)C(=O)NC(=N2)N)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)
Pyrexia08.05.02.0030.028462%
Rash23.03.13.001---
Respiration abnormal22.02.01.0410.009487%-
Respiratory failure14.01.04.003; 22.02.06.002--
Rhinorrhoea22.12.03.0210.014662%
Seizure17.12.03.0010.027599%
Upper respiratory tract infection11.01.13.009; 22.07.03.011--
Vertigo04.04.01.003; 17.02.12.0020.014662%
Vomiting07.01.07.0030.040968%
Post procedural haemorrhage12.02.05.004; 24.07.01.014--
Acute coronary syndrome02.02.02.015; 24.04.04.011---
Musculoskeletal stiffness15.03.05.0270.014662%-
Musculoskeletal discomfort15.03.04.001---
Urine output increased13.13.03.002---
Malnutrition14.03.02.004---
Mediastinal disorder22.09.03.001---
Mental disorder19.07.01.0020.004312%-
Abnormal behaviour19.01.01.0010.073310%-
Decreased appetite08.01.09.028; 14.03.01.0050.029324%
Low birth weight baby18.04.02.0030.006469%-
Oropharyngeal pain07.05.05.004; 22.12.03.016--
Foetal growth restriction18.03.01.0020.004312%
Attention deficit hyperactivity disorder19.21.04.0040.046142%-
Behaviour disorder19.01.01.0050.038811%-
Therapy non-responder08.06.01.0630.131959%-
Treatment noncompliance08.06.01.067; 12.09.02.0060.009487%-
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