Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Nilotinib
Drug ID BADD_D01567
Description Nilotinib, also known as AMN107, is a tyrosine kinase inhibitor under investigation as a possible treatment for chronic myelogenous leukemia (CML). A Phase I clinical trial in 2006 showed that this drug was relatively safe and offered significant therapeutic benefits in cases of CML which were found to be resistant to treatment with imatinib (Gleevec), another tyrosine kinase inhibitor used as a first-line treatment for CML.
Indications and Usage For the potential treatment of various leukemias, including chronic myeloid leukemia (CML).
Marketing Status Prescription
ATC Code L01EA03
DrugBank ID DB04868
KEGG ID D08953
MeSH ID C498826
PubChem ID 644241
TTD Drug ID D00STL
NDC Product Code 0078-0592; 0078-0951; 76302-015; 0078-0526; 54893-0069
Synonyms nilotinib | 4-methyl-N-(3-(4-methylimidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-((4-pyridin-3-ylpyrimidin-2-yl)amino)benzamide | nilotinib hydrochloride dihydrate | benzamide, 4-methyl-N-(3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-((4-(3-pyridinyl)-2-pyrimidinyl)amino)-, hydrochloride, hydrate (1:1:2) | nilotinib hydrochloride anhydrous | benzamide, 4-methyl-N-(3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-((4-(3-pyridinyl)-2-pyrimidinyl)amino)-, hydrochloride (1:1) | nilotinib hydrochloride | nilotinib hydrochloride hydrate | Tasigna | nilotinib hydrochloride monohydrate | benzamide, 4-methyl-N-(3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-((4-(3-pyridinyl)-2-pyrimidinyl)amino)-, hydrochloride, hydrate | nilotinib hydrochloride sesquihydrate | benzamide, 4-methyl-N-(3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-((4-(3-pyridinyl)-2-pyrimidinyl)amino)-, hydrochloride, hydrate (2:2:3) | nilotinib dihydrochloride dihydrate | benzamide, 4-methyl-N-(3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-((4-(3-pyridinyl)-2-pyrimidinyl)amino)-, hydrochloride, hydrate (1:2:2) | AMN107 | AMN-107 | AMN 107
Chemical Information
Molecular Formula C28H22F3N7O
CAS Registry Number 641571-10-0
SMILES CC1=C(C=C(C=C1)C(=O)NC2=CC(=CC(=C2)C(F)(F)F)N3C=C(N=C3)C)NC4=NC=CC(=N4)C5=CN=CC= C5
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)
Kidney enlargement20.01.06.0030.000139%Not Available
Tumour marker increased13.22.01.0170.001066%Not Available
Concomitant disease progression08.01.03.0640.001320%Not Available
Basilar artery occlusion24.04.06.030; 17.08.01.0420.000208%Not Available
Vertebral artery occlusion24.04.06.043; 17.08.01.0640.000799%Not Available
C-reactive protein decreased13.09.01.0240.000533%Not Available
Subclavian artery stenosis24.04.03.0230.000533%Not Available
Blast crisis in myelogenous leukaemia01.10.08.002; 16.01.08.0020.003058%Not Available
Central nervous system inflammation17.06.01.0030.000533%Not Available
Bone marrow oedema01.05.01.019; 15.02.01.0050.000533%Not Available
Monocyte percentage increased13.01.06.0570.000799%Not Available
Full blood count increased13.01.07.0020.000347%Not Available
Brain natriuretic peptide increased13.02.04.0110.000799%Not Available
Bone swelling15.02.01.0060.000533%Not Available
Facet joint syndrome15.01.08.010; 17.10.01.0150.000533%Not Available
Breast cancer metastatic21.05.01.016; 16.10.01.008--Not Available
Hepatic infection09.01.08.014; 11.01.18.0080.000556%
Gastric infection11.01.07.008; 07.19.03.0030.000799%Not Available
Blast cells present13.01.03.0090.000533%Not Available
Cell death14.11.02.005; 08.03.03.0030.000799%Not Available
Aortic dilatation24.03.04.0070.000533%Not Available
Peripheral artery occlusion24.04.03.0220.005595%Not Available
Nephrogenic anaemia20.01.01.007; 01.03.04.0010.000533%Not Available
Aortic occlusion24.04.01.0050.000533%Not Available
Blood alkaline phosphatase decreased13.04.02.0030.000533%Not Available
Diabetic foot24.04.03.015; 23.07.03.008; 17.09.04.006; 14.07.06.001; 05.07.06.0010.000799%Not Available
Type V hyperlipidaemia14.08.02.002; 03.08.08.0020.001066%Not Available
Arterial stenosis24.04.02.0120.003730%Not Available
Corynebacterium infection11.02.24.0020.000533%Not Available
Traumatic intracranial haemorrhage24.07.04.034; 17.08.05.005; 12.01.10.0170.000139%Not Available
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