Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Tetrahydrobiopterin
Drug ID BADD_D02185
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 D01798; D08505
MeSH ID C003402
PubChem ID 135402045
TTD Drug ID D0Q9YT
NDC Product Code Not Available
UNII KN729W3LR0
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 17528-72-2
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)
Skin disorder23.03.03.007---
Spinal cord injury12.01.13.002; 17.10.04.001---
Upper respiratory tract infection11.01.13.009; 22.07.03.011--
Urinary tract infection11.01.14.004; 20.08.02.001--
Vomiting07.01.07.003--
Contusion12.01.06.001; 15.03.05.007; 23.03.11.002; 24.07.06.001--
Post procedural haemorrhage12.02.05.004; 24.07.01.014--
Acute coronary syndrome02.02.02.015; 24.04.04.011---
Musculoskeletal discomfort15.03.04.001---
Testis cancer16.25.03.001; 21.13.02.001---
Urine output increased13.13.03.002---
Infestation11.09.01.001; 23.11.01.002---
Streptococcal infection11.02.06.003---
Tetrahydrobiopterin deficiency03.08.04.010; 14.14.04.010; 17.03.07.003; 19.21.06.003---
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ADReCS-Target
Drug Name ADR Term Target
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