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)
Keratitis06.04.02.002--
Lenticular opacities06.06.01.0030.010781%Not Available
Leukocytosis01.02.01.002--
Leukopenia01.02.02.001--Not Available
Liver disorder09.01.08.0010.008625%Not Available
Lymphadenopathy01.09.01.0020.004312%Not Available
Melaena24.07.02.013; 07.12.02.004--Not Available
Memory impairment19.20.01.003; 17.03.02.0030.008625%
Mental impairment19.21.02.003; 17.03.03.0020.006469%Not Available
Metabolic acidosis14.01.01.0030.004312%Not Available
Metastases to lung22.08.01.005; 16.22.02.0020.006469%Not Available
Muscular weakness17.05.03.005; 15.05.06.0010.006469%
Neoplasm malignant16.16.01.001--Not Available
Nervous system disorder17.02.10.0010.006469%Not Available
Nervousness19.06.02.003--Not Available
Neuropathy peripheral17.09.03.0030.004312%Not Available
Paralysis17.01.04.0040.004312%Not Available
Photophobia06.01.01.004; 17.17.02.0060.004312%
Pregnancy18.08.02.0040.011643%Not Available
Priapism24.04.12.007; 21.03.01.0050.004312%Not Available
Pruritus23.03.12.001--
Psychomotor hyperactivity19.11.02.003; 17.01.02.0110.009487%Not Available
Pyrexia08.05.02.0030.008625%
Rash erythematous23.03.13.029--Not Available
Rash maculo-papular23.03.13.004--
Respiratory distress22.02.01.0120.010781%Not Available
Respiratory failure22.02.06.002; 14.01.04.0030.006469%
Seizure17.12.03.0010.034499%
Sepsis11.01.11.003--
Skin disorder23.03.03.007--Not Available
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