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 approved; investigational
ATC Code A16AX04
DrugBank ID DB00348
KEGG ID D05177
MeSH ID C077073
PubChem ID 115355
TTD Drug ID D0V1UW
NDC Product Code 43235-0016; 68022-7058; 66658-110; 70505-220; 63069-071; 76055-0043; 76438-004; 13668-632; 13668-631; 63629-2234; 70505-202; 66658-120; 58159-037; 0254-3022; 63629-2235; 63069-075; 66005-0046; 70505-210; 70709-002; 24196-194; 13668-629; 13668-630; 0254-3021; 66658-102; 66658-105; 70505-205; 70709-000; 55463-0034; 63629-2233; 66658-204; 70709-005; 63069-072; 0254-3020
UNII K5BN214699
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
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)
Somnolence19.02.05.003; 17.02.04.006--
Tachycardia02.03.02.0070.010781%Not Available
Tachypnoea22.02.01.0140.004312%Not Available
Tension19.06.02.005--Not Available
Thirst14.03.02.007; 08.01.09.021--Not Available
Thrombocytopenia01.08.01.0020.004312%Not Available
Tooth discolouration07.09.02.001--
Vision blurred17.17.01.010; 06.02.06.0070.004312%
Vomiting07.01.07.0030.034499%
Psychomotor skills impaired19.22.01.002; 17.02.10.0050.004312%Not Available
General physical health deterioration08.01.03.0180.004312%Not Available
Lymphatic disorder01.09.01.003--Not Available
Haemorrhage24.07.01.0020.004312%Not Available
Cognitive disorder19.21.02.001; 17.03.03.0030.012937%
Hepatic enzyme increased13.03.04.028--Not Available
Brain neoplasm17.20.01.003; 16.30.01.003--Not Available
Learning disorder19.21.05.0010.004312%Not Available
Porphyrin metabolism disorder14.14.01.006; 09.01.10.004; 03.08.01.006--Not Available
Conjunctival disorder06.06.02.0040.004312%Not Available
Blood disorder01.05.01.004--Not Available
Hepatic lesion09.01.08.0050.004312%Not Available
Hepatoblastoma16.07.04.001; 09.04.02.0030.006469%Not Available
Amino acid level increased13.09.01.017--Not Available
Hypophagia19.09.01.004; 14.03.01.006; 07.01.06.0100.004312%Not Available
Autism spectrum disorder17.03.05.003; 19.22.02.0020.004312%Not Available
Intellectual disability17.03.07.001; 19.21.06.0010.019406%Not Available
Foetal growth restriction18.03.01.0020.004312%
Hepatic cancer16.07.02.004; 09.04.02.0080.010781%Not Available
Hepatocellular carcinoma16.07.02.005; 09.04.02.0100.114278%Not Available
Speech disorder developmental19.19.01.003; 17.02.08.0110.009487%Not Available
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