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)
Dyspraxia17.02.03.0070.021361%Not Available
Ear infection11.01.05.001; 04.03.01.006--Not Available
Enanthema08.01.06.007--Not Available
Encephalopathy17.13.02.001--
Enuresis20.02.02.003; 19.07.04.0010.021361%Not Available
Epilepsy17.12.03.0020.042722%Not Available
Epistaxis24.07.01.005; 22.04.03.001--
Eye disorder06.08.03.001--Not Available
Eye irritation06.04.05.0030.021361%Not Available
Eye pain06.08.03.002--
Gastritis07.08.02.001--
Gastroenteritis11.01.07.004; 07.19.03.001--Not Available
Gastrointestinal haemorrhage24.07.02.009; 07.12.02.0010.013931%Not Available
Gastrointestinal pain07.01.05.005--
Granulocytopenia01.02.03.003--Not Available
Haemoglobin13.01.05.018--Not Available
Headache17.14.01.001--
Hepatic cirrhosis09.01.04.0010.019503%Not Available
Hepatic encephalopathy17.13.01.003; 09.01.03.0060.008359%Not Available
Hepatic failure09.01.03.0020.027862%
Hepatic function abnormal09.01.02.0010.021361%Not Available
Hepatic neoplasm16.07.03.001; 09.04.03.0010.022290%Not Available
Hepatitis09.01.07.0040.021361%Not Available
Hepatomegaly09.01.05.0010.021361%Not Available
Hyperkinesia17.01.02.008--Not Available
Hypertension24.08.02.0010.042722%
Hypoglycaemia14.06.03.001; 05.06.03.001--
Infection11.01.08.002--Not Available
Irritability19.04.02.013; 08.01.03.0110.021361%
Keratitis06.04.02.002--
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