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)
Abdominal pain07.01.05.002--
Agitation17.02.05.012; 19.06.02.001--
Arthralgia15.01.02.001--
Body temperature increased13.15.01.001---
Cardiovascular disorder02.11.01.010; 24.03.02.009---
Cough22.02.03.001--
Dermatitis23.03.04.002---
Diarrhoea07.02.01.001--
Dizziness02.11.04.006; 17.02.05.003; 24.06.02.007--
Gastritis07.08.02.001--
Gastrointestinal disorder07.11.01.001---
Gastrointestinal haemorrhage07.12.02.001; 24.07.02.009---
Gastrointestinal pain07.01.05.005--
Headache17.14.01.001--
Hypersensitivity10.01.03.003--
Infection11.01.08.002---
Irritability08.01.03.011; 19.04.02.013--
Laryngeal pain22.12.03.010--
Myocardial infarction02.02.02.007; 24.04.04.009--
Nasal congestion22.04.04.001--
Nasopharyngitis11.01.13.002; 22.07.03.002---
Nausea07.01.07.001--
Nervous system disorder17.02.10.001---
Neutropenia01.02.03.004---
Oedema peripheral02.05.04.007; 08.01.07.007; 14.05.06.011--
Polyuria20.02.03.002---
Rash23.03.13.001---
Respiratory failure14.01.04.003; 22.02.06.002--
Rhinorrhoea22.12.03.021--
Seizure17.12.03.001--
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ADReCS-Target
Drug Name ADR Term Target
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