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)
Somnolence17.02.04.006; 19.02.05.003--
Tachycardia02.03.02.0070.010781%-
Tachypnoea22.02.01.0140.004312%-
Tension19.06.02.005---
Thirst08.01.09.021; 14.03.02.007---
Thrombocytopenia01.08.01.0020.004312%-
Tooth discolouration07.09.02.001--
Vision blurred06.02.06.007; 17.17.01.0100.004312%
Vomiting07.01.07.0030.034499%
Psychomotor skills impaired17.02.10.005; 19.22.01.0020.004312%-
General physical health deterioration08.01.03.0180.004312%-
Lymphatic disorder01.09.01.003---
Haemorrhage24.07.01.0020.004312%-
Cognitive disorder17.03.03.003; 19.21.02.0010.012937%
Hepatic enzyme increased13.03.04.028---
Brain neoplasm16.30.01.003; 17.20.01.003---
Learning disorder19.21.05.0010.004312%-
Porphyrin metabolism disorder03.08.01.006; 09.01.10.004; 14.14.01.006---
Conjunctival disorder06.06.02.0040.004312%-
Blood disorder01.05.01.004---
Hepatic lesion09.01.08.0050.004312%-
Hepatoblastoma09.04.02.003; 16.07.04.0010.006469%-
Amino acid level increased13.09.01.017---
Hypophagia07.01.06.010; 14.03.01.006; 19.09.01.0040.004312%-
Autism spectrum disorder17.03.05.003; 19.22.02.0020.004312%-
Intellectual disability17.03.07.001; 19.21.06.0010.019406%-
Foetal growth restriction18.03.01.0020.004312%
Hepatic cancer09.04.02.008; 16.07.02.0040.010781%-
Hepatocellular carcinoma09.04.02.010; 16.07.02.0050.114278%-
Speech disorder developmental17.02.08.011; 19.19.01.0030.009487%-
The 4th Page    First    Pre   4 5    Next   Last    Total 5 Pages