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)
Mental disorder19.07.01.002--Not Available
Motor dysfunction17.01.02.031; 15.05.06.0060.000336%Not Available
Paraproteinaemia16.23.01.001; 01.14.01.001--Not Available
Spinal disorder15.02.04.0230.000112%Not Available
Sudden hearing loss04.02.01.0090.000168%Not Available
Cardiac valve disease02.07.02.0010.000168%Not Available
White blood cell disorder01.02.05.0020.000302%Not Available
Decreased appetite08.01.09.028; 14.03.01.005--
Feeling of body temperature change08.01.09.012--Not Available
Erectile dysfunction21.03.01.007; 19.08.04.0010.001142%
Renal injury20.01.03.015; 12.01.05.0010.000168%Not Available
Renal neoplasm20.01.04.004; 16.08.03.0010.000168%Not Available
Ill-defined disorder08.01.03.049--Not Available
Intervertebral disc disorder15.10.01.0030.000224%Not Available
Lip and/or oral cavity cancer07.21.07.001; 16.13.07.0010.000168%Not Available
Inner ear disorder04.04.02.002--Not Available
Polyp16.02.02.005; 08.01.06.010--Not Available
Mitral valve disease02.07.01.0030.000112%
Parkinson's disease17.01.05.0100.000672%Not Available
Ulcer haemorrhage24.07.01.040; 08.03.06.0030.000168%Not Available
Blood disorder01.05.01.0040.000168%Not Available
Immunodeficiency10.03.02.0020.000112%Not Available
Bone marrow disorder01.05.01.0060.000112%Not Available
Disease progression08.01.03.038--
Disease recurrence08.01.03.0500.000806%Not Available
Drug intolerance08.06.01.0130.008730%Not Available
Neoplasm recurrence16.16.02.0040.000168%Not Available
Gastrointestinal ulcer perforation07.04.04.005--Not Available
Hepatic lesion09.01.08.0050.000112%Not Available
Hepatobiliary disease09.01.08.003--Not Available
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ADReCS-Target
Drug Name ADR Term Target
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