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)
Leukocytosis01.02.01.002--
Leukopenia01.02.02.001--Not Available
Liver disorder09.01.08.0010.032041%Not Available
Melaena24.07.02.013; 07.12.02.004--Not Available
Memory impairment19.20.01.003; 17.03.02.0030.042722%
Mental impairment19.21.02.003; 17.03.03.0020.032041%Not Available
Metabolic acidosis14.01.01.0030.021361%Not Available
Metastases to lung22.08.01.005; 16.22.02.0020.008359%Not Available
Neoplasm malignant16.16.01.001--Not Available
Nervousness19.06.02.003--Not Available
Pain08.01.08.0040.064083%
Paraesthesia17.02.06.0050.021361%
Paralysis17.01.04.0040.021361%Not Available
Photophobia17.17.02.006; 06.01.01.0040.021361%
Pneumonia22.07.01.003; 11.01.09.003--Not Available
Porphyria acute03.08.01.002; 19.07.03.003; 17.19.01.001; 14.14.01.002; 09.01.10.0010.032041%Not Available
Portal hypertension24.08.06.001; 09.01.06.0060.021361%
Priapism21.03.01.0050.021361%Not Available
Pruritus23.03.12.001--
Pyrexia08.05.02.0030.032041%
Rash erythematous23.03.06.003--Not Available
Rash maculo-papular23.03.13.004--
Respiratory distress22.02.01.0120.008359%Not Available
Respiratory failure22.02.06.002; 14.01.04.003--
Seizure17.12.03.0010.033435%
Sepsis11.01.11.0030.013931%
Skin disorder23.03.03.007--Not Available
Somnolence19.02.05.003; 17.02.04.006--
Tachycardia02.03.02.0070.021361%Not Available
Tachypnoea22.02.01.0140.005572%Not Available
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