Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Nitisinone
Drug ID BADD_D01572
Description Nitisinone is a synthetic reversible inhibitor of 4-hydroxyphenylpyruvate dioxygenase. It is used in the treatment of hereditary tyrosinemia type 1. It is sold under the brand name Orfadin.
Indications and Usage Used as an adjunct to dietary restriction of tyrosine and phenylalanine in the treatment of hereditary tyrosinemia type 1.
Marketing Status Prescription
ATC Code A16AX04
DrugBank ID DB00348
KEGG ID D05177
MeSH ID C077073
PubChem ID 115355
TTD Drug ID D0V1UW
NDC Product Code 63629-2235; 55463-0034; 0254-3020; 43235-0016; 70709-000; 66658-110; 70709-005; 63629-2233; 63069-075; 24196-194; 63069-072; 0254-3022; 63069-071; 66658-105; 66658-120; 76438-004; 0254-3021; 76055-0043; 68022-7058; 66658-204; 66658-102; 70709-002; 58159-037; 63629-2234
Synonyms nitisinone | NTBC cpd | 2-(2-nitro-4-(trifluoromethyl)benzoyl)cyclohexane-1,3-dione | 2-(2-nitro-4-trifluoromethylbenzoyl)-1,3-cyclohexanedione | Orfadin
Chemical Information
Molecular Formula C14H10F3NO5
CAS Registry Number 104206-65-7
SMILES C1CC(=O)C(C(=O)C1)C(=O)C2=C(C=C(C=C2)C(F)(F)F)[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)
Tension19.06.02.005--Not Available
Thirst14.03.02.007; 08.01.09.021--Not Available
Thrombocytopenia01.08.01.0020.021361%Not Available
Tooth discolouration07.09.02.001--
Vomiting07.01.07.0030.027862%
Psychomotor skills impaired17.02.10.005; 19.22.01.0020.021361%Not Available
Lymphatic disorder01.09.01.003--Not Available
Haemorrhage24.07.01.0020.005572%Not Available
Cognitive disorder19.21.02.001; 17.03.03.0030.064083%
Hepatic enzyme increased13.03.01.019--Not Available
Brain neoplasm16.30.01.003; 17.20.01.003--Not Available
Learning disorder19.21.05.0010.021361%Not Available
Porphyrin metabolism disorder14.14.01.006; 09.01.10.004; 03.08.01.006--Not Available
Blood disorder01.05.01.004--Not Available
Hepatic lesion09.01.08.0050.021361%Not Available
Amino acid level increased13.09.01.0170.341775%Not Available
Autism spectrum disorder19.22.02.0020.021361%Not Available
Intellectual disability19.21.06.001; 17.03.07.0010.096124%Not Available
Foetal growth restriction18.03.01.0020.021361%
Hepatic cancer16.07.02.004; 09.04.02.0080.013931%Not Available
Hepatocellular carcinoma09.04.02.010; 16.07.02.0050.086373%Not Available
Alpha 1 foetoprotein increased13.09.01.0200.224290%Not Available
Speech disorder developmental17.02.08.011; 19.19.01.0030.021361%Not Available
Hepatic mass09.01.08.0150.021361%Not Available
Amino acid level decreased13.09.01.0140.160207%Not Available
Succinylacetone increased13.02.04.0130.267012%Not Available
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