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)
Abdominal distension07.01.04.0010.032041%
Abdominal pain07.01.05.0020.053402%
Abortion spontaneous18.01.04.0010.074763%Not Available
Acute hepatic failure09.01.03.0010.008359%Not Available
Agitation19.06.02.001; 17.02.05.012--
Agranulocytosis01.02.03.001--Not Available
Alopecia23.02.02.001--
Amenorrhoea21.01.02.001; 05.05.01.002--
Anaemia01.03.02.0010.032041%
Anxiety19.06.02.002--
Asthenia08.01.01.001--Not Available
Attention deficit/hyperactivity disorder19.21.04.0010.064083%Not Available
Blepharitis23.03.04.012; 06.04.04.001--Not Available
Bronchitis22.07.01.001; 11.01.09.001--
Cataract06.06.01.001--
Chest pain22.02.08.003; 08.01.08.002; 02.02.02.0110.032041%Not Available
Coagulopathy01.01.02.0010.005572%Not Available
Conjunctivitis06.04.01.002; 11.01.06.012--
Constipation07.02.02.0010.021361%
Corneal opacity06.06.03.005--Not Available
Cyanosis24.03.01.007; 22.02.02.007; 02.01.02.002--
Deafness04.02.01.0010.021361%Not Available
Death08.04.01.0010.036221%
Dehydration14.05.05.001--
Depression19.15.01.0010.032041%
Dermatitis exfoliative10.01.01.004; 23.03.07.001--
Developmental delay08.01.03.0370.021361%Not Available
Diarrhoea07.02.01.001--
Dry skin23.03.03.001--
Dyspnoea22.02.01.004; 02.01.03.002--
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