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)
Abdominal distension07.01.04.0010.008625%
Abdominal pain07.01.05.0020.035361%
Abortion spontaneous18.01.04.0010.020268%Not Available
Acute hepatic failure09.01.03.0010.010781%Not Available
Agitation19.06.02.001; 17.02.05.0120.004312%
Agranulocytosis01.02.03.001--Not Available
Alopecia23.02.02.001--
Amenorrhoea21.01.02.001; 05.05.01.002--
Anaemia01.03.02.0010.006469%
Blepharitis23.03.04.012; 06.04.04.001--Not Available
Bronchitis22.07.01.001; 11.01.09.001--
Cataract06.06.01.0010.032343%
Chest pain22.12.02.003; 08.01.08.002; 02.02.02.0110.006469%Not Available
Coagulopathy01.01.02.0010.004312%Not Available
Condition aggravated08.01.03.0040.017249%Not Available
Confusional state19.13.01.001; 17.02.03.0050.006469%
Conjunctivitis11.01.06.012; 06.04.01.002--
Constipation07.02.02.0010.018974%
Corneal opacity06.06.03.005--Not Available
Cyanosis23.06.04.005; 02.11.04.004; 24.03.01.007; 22.02.02.007--
Deafness04.02.01.0010.004312%Not Available
Death08.04.01.0010.043124%
Dehydration14.05.05.001--
Dermatitis exfoliative10.01.01.004; 23.03.07.001--
Developmental delay19.07.05.003; 08.01.03.0370.004312%Not Available
Diarrhoea07.02.01.001--
Dry skin23.03.03.001--
Dyspraxia17.02.03.0070.004312%Not Available
Ear infection11.01.05.001; 04.03.01.006--Not Available
Enanthema08.01.06.007--Not Available
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