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)
Cervical spinal stenosis17.10.02.006; 15.10.04.0060.000112%Not Available
Chloroma16.01.08.003; 01.10.08.0030.000336%Not Available
Cholangitis acute09.02.01.0060.000112%Not Available
Chronic gastritis10.04.04.011; 07.08.02.005; 11.07.01.0160.000358%Not Available
Chronic respiratory failure22.02.06.005; 14.01.04.0050.000168%Not Available
Concomitant disease aggravated08.01.03.0630.002474%Not Available
Dyslalia19.19.03.009; 17.02.08.0180.000224%Not Available
Enthesopathy15.07.01.0110.000112%Not Available
Lumbar spinal stenosis17.10.03.004; 15.10.04.0080.000168%Not Available
Lung adenocarcinoma22.08.01.007; 16.19.01.0020.000112%Not Available
Lymphadenopathy mediastinal22.09.03.006; 01.09.01.0250.000224%Not Available
Mitral valve prolapse02.07.01.0080.000112%Not Available
Mitral valve stenosis02.07.01.0090.000168%Not Available
Moyamoya disease24.01.04.016; 17.08.02.0230.000224%Not Available
Normal newborn18.08.06.0010.004712%Not Available
Oesophageal ulcer haemorrhage24.07.02.051; 07.04.05.0070.000112%Not Available
Overweight14.03.02.0210.000358%Not Available
Teeth brittle07.09.05.0150.000246%Not Available
Vertebral artery stenosis24.04.06.044; 17.08.02.0270.000504%Not Available
Vocal cord polyp22.04.01.009; 16.38.02.0010.000112%Not Available
Kidney enlargement20.01.06.0030.000246%Not Available
Concomitant disease progression08.01.03.0640.001119%Not Available
Basilar artery occlusion24.04.06.030; 17.08.01.0420.000224%Not Available
Vertebral artery occlusion24.04.06.043; 17.08.01.0640.000336%Not Available
Subclavian artery stenosis24.04.03.0230.000224%Not Available
Cervical radiculopathy17.10.02.0030.000168%Not Available
Blast crisis in myelogenous leukaemia16.01.08.002; 01.10.08.0020.003022%Not Available
Central nervous system inflammation17.06.01.0030.000112%Not Available
Gastric antral vascular ectasia24.03.03.028; 07.15.04.0030.000112%Not Available
Metastases to meninges17.02.10.012; 16.22.02.0030.000112%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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