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)
Gastrointestinal haemorrhage24.07.02.009; 07.12.02.0010.006469%Not Available
Gastrointestinal pain07.01.05.0050.004312%
Generalised tonic-clonic seizure17.12.01.0020.004312%Not Available
Headache17.14.01.0010.156108%
Hiatus hernia22.09.02.004; 07.16.01.0010.006469%Not Available
Hyperkinesia17.01.02.008--Not Available
Hypersensitivity10.01.03.003--
Insomnia19.02.01.002; 17.15.03.0020.036655%
Irritability08.01.03.011; 19.04.02.0130.053473%
Jaundice23.03.03.030; 09.01.01.004; 01.06.04.0040.004312%Not Available
Laryngeal pain22.12.03.010--
Malaise08.01.01.0030.051317%
Memory impairment19.20.01.003; 17.03.02.0030.095303%
Mood altered19.04.02.0070.051317%Not Available
Mood swings19.04.03.0010.031480%Not Available
Myalgia15.05.02.0010.021993%
Myocardial infarction24.04.04.009; 02.02.02.007--
Nasal congestion22.04.04.0010.014662%
Nasopharyngitis22.07.03.002; 11.01.13.002--Not Available
Nausea07.01.07.001--
Neoplasm malignant16.16.01.0010.004312%Not Available
Nervous system disorder17.02.10.001--Not Available
Nervousness19.06.02.0030.014662%Not Available
Oedema peripheral14.05.06.011; 08.01.07.007; 02.05.04.007--
Oesophageal pain07.01.05.012--
Pharyngitis22.07.03.004; 11.01.13.003; 07.05.07.004--
Polyuria20.02.03.002--Not Available
Pregnancy18.08.02.0040.016818%Not Available
Premature baby18.04.02.0010.010781%Not Available
Psychomotor hyperactivity19.11.02.003; 17.01.02.0110.102634%Not Available
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