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 approved; investigational
ATC Code L01EA03
DrugBank ID DB04868
KEGG ID D08953
MeSH ID C498826
PubChem ID 644241
TTD Drug ID D00STL
NDC Product Code 71796-047; 54893-0069; 0078-0526; 0078-0592; 0078-0951
UNII F41401512X
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
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)
Bone marrow oedema15.02.01.005; 01.05.01.0190.000112%Not Available
Bone swelling15.02.01.0060.000112%Not Available
Facet joint syndrome17.10.01.015; 15.01.08.0100.000112%Not Available
Cell death14.11.02.005; 08.03.03.0030.000358%Not Available
Aortic dilatation24.03.04.0070.000112%Not Available
Peripheral artery occlusion24.04.03.0220.001735%Not Available
Nephrogenic anaemia20.01.01.007; 01.03.04.0010.000112%Not Available
Aortic occlusion24.04.01.0050.000246%Not Available
Diabetic foot24.04.03.015; 23.07.03.008; 17.09.04.006; 14.07.06.001; 05.07.06.0010.000168%Not Available
Arterial stenosis24.04.02.0120.000951%Not Available
Carotid artery disease17.08.02.016; 24.03.05.0090.000448%Not Available
Cerebrovascular stenosis17.08.02.021; 24.04.06.0360.000112%Not Available
Gastric cancer stage IV16.13.03.003; 07.21.02.0030.000112%Not Available
Leukaemia recurrent01.10.03.005; 16.01.03.0050.000448%Not Available
Spider vein24.10.04.003; 23.06.03.0060.000381%Not Available
Spondylolisthesis12.04.04.008; 15.10.04.0040.000168%Not Available
Acute lymphocytic leukaemia recurrent16.01.01.003; 01.10.01.0030.000392%Not Available
Central nervous system leukaemia17.02.10.019; 16.01.03.004; 01.10.03.0040.000112%Not Available
Carotid arteriosclerosis24.04.06.031; 17.08.02.0150.000392%Not Available
Right atrial dilatation02.04.02.0320.000112%Not Available
Left atrial dilatation02.04.02.0250.000280%Not Available
Coeliac artery stenosis24.04.08.015; 07.15.02.0120.000224%Not Available
Apparent death08.01.03.0620.000168%Not Available
Delivery18.08.02.0060.000929%Not Available
Hyperlipasaemia14.11.01.0230.000112%Not Available
Oncologic complication16.32.03.0250.000728%Not Available
Haemorrhagic hepatic cyst24.07.01.070; 16.06.02.003; 09.01.08.0130.000112%Not Available
Chronic myeloid leukaemia transformation16.01.07.004; 01.10.07.0040.001231%Not Available
Cerebral small vessel ischaemic disease24.04.06.034; 17.08.02.0200.000168%Not Available
Systolic dysfunction02.04.02.0350.000112%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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