Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Sapropterin dihydrochloride
Drug ID BADD_D01988
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
MeSH ID C003402
PubChem ID 135409471
TTD Drug ID D0Q9YT
NDC Product Code 51846-1057; 43598-749; 49884-873; 49884-948; 68135-301; 69037-0048; 31722-045; 68135-482; 43598-477; 31722-047; 43598-097; 46438-0660; 31722-048; 66652-2103; 49884-720; 54864-872; 72643-026; 73435-017; 43598-096; 68135-300; 43598-162
UNII RG277LF5B3
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 C9H17Cl2N5O3
CAS Registry Number 69056-38-8
SMILES CC(C(C1CNC2=C(N1)C(=O)NC(=N2)N)O)O.Cl.Cl
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--
Agitation19.06.02.001; 17.02.05.012--
Arthralgia15.01.02.001--
Cough22.02.03.001--
Diarrhoea07.02.01.001--
Dizziness02.11.04.006; 24.06.02.007; 17.02.05.003--
Gamma-glutamyltransferase increased13.03.04.024--
Gastrointestinal haemorrhage24.07.02.009; 07.12.02.001--Not Available
Headache17.14.01.001--
Irritability19.04.02.013; 08.01.03.011--
Laryngeal pain22.12.03.010--
Myocardial infarction24.04.04.009; 02.02.02.007--
Nasal congestion22.04.04.001--
Oedema peripheral14.05.06.011; 08.01.07.007; 02.05.04.007--
Polyuria20.02.03.002--Not Available
Pyrexia08.05.02.003--
Rash23.03.13.001--Not Available
Respiratory failure14.01.04.003; 22.02.06.002--
Rhinorrhoea22.12.03.021--
Seizure17.12.03.001--
Upper respiratory tract infection22.07.03.011; 11.01.13.009--
Vomiting07.01.07.003--
Contusion24.07.06.001; 23.03.11.002; 12.01.06.001; 15.03.05.007--
Post procedural haemorrhage24.07.01.014; 12.02.05.004--
Device stimulation issue27.01.02.005--Not Available
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