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)
Encephalopathy17.13.02.001--
Enuresis20.02.02.003; 19.07.04.0010.004312%Not Available
Epilepsy17.12.03.0020.010781%Not Available
Epistaxis24.07.01.005; 22.04.03.001--
Eye disorder06.08.03.001--Not Available
Eye irritation06.04.05.0030.006469%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; 07.12.02.0010.010781%Not Available
Gastrointestinal pain07.01.05.005--
Generalised tonic-clonic seizure17.12.01.0020.006469%Not Available
Granulocytopenia01.02.03.003--Not Available
Haemoglobin13.01.05.018--Not Available
Headache17.14.01.001--
Hepatic cirrhosis09.01.04.0010.030187%Not Available
Hepatic encephalopathy17.13.01.003; 09.01.03.0060.006469%Not Available
Hepatic failure09.01.03.0020.043124%
Hepatic function abnormal09.01.02.0010.006469%Not Available
Hepatic neoplasm16.07.03.001; 09.04.03.0010.017249%Not Available
Hepatic steatosis14.08.04.005; 09.01.07.0030.004312%Not Available
Hepatitis09.01.07.0040.004312%Not Available
Hepatomegaly09.01.05.0010.010781%Not Available
Hyperkinesia17.01.02.008--Not Available
Hypertension24.08.02.0010.022424%
Hypoglycaemia14.06.03.001; 05.06.03.001--
Hyponatraemia14.05.04.0020.006469%
Hypovolaemia14.05.05.0020.004312%Not Available
Infection11.01.08.002--Not Available
Irritability19.04.02.013; 08.01.03.0110.016818%
The 2th Page    First    Pre   2 3 4 5    Next   Last    Total 5 Pages