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 Prescription
ATC Code A16AX07
DrugBank ID DB00360
KEGG ID D08505
MeSH ID C003402
PubChem ID 135398654
TTD Drug ID D0Q9YT
NDC Product Code Not Available
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
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal discomfort07.01.06.0010.032041%Not Available
Abdominal pain07.01.05.0020.032041%
Abdominal pain upper07.01.05.003--
Abortion spontaneous18.01.04.0010.032041%Not Available
Affective disorder19.04.04.0010.021361%Not Available
Aggression19.05.01.0010.021361%Not Available
Agitation19.06.02.001; 17.02.05.012--
Anaphylactic shock10.01.07.002; 24.06.02.004--Not Available
Anxiety19.06.02.0020.064083%
Arthralgia15.01.02.001--
Atrial septal defect03.07.02.002; 02.04.02.0090.021361%Not Available
Attention deficit/hyperactivity disorder19.21.04.0010.032041%Not Available
Cardiovascular disorder24.03.02.009; 02.01.01.001--Not Available
Cough22.02.03.001--
Death08.04.01.001--
Depressed mood19.15.02.0010.021361%Not Available
Depression19.15.01.0010.032041%
Dermatitis23.03.04.002--Not Available
Diarrhoea07.02.01.001--
Dizziness02.01.02.004; 24.06.02.007; 17.02.05.0030.042722%
Dyspepsia07.01.02.0010.021361%
Gastritis07.08.02.001--
Gastroenteritis viral11.05.04.005; 07.19.03.0050.021361%Not Available
Gastrointestinal disorder07.11.01.001--Not Available
Gastrointestinal haemorrhage24.07.02.009; 07.12.02.0010.032041%Not Available
Gastrointestinal pain07.01.05.005--
Generalised tonic-clonic seizure17.12.01.0020.021361%Not Available
Headache17.14.01.0010.074763%
Hyperkinesia17.01.02.008--Not Available
Hypersensitivity10.01.03.003--
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