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)
Cardiomegaly02.04.02.0010.001310%Not Available
Cardiomyopathy02.04.01.0010.000951%Not Available
Cardiovascular disorder02.11.01.010; 24.03.02.0090.003168%Not Available
Carotid artery stenosis24.04.06.001; 17.08.02.0010.004141%Not Available
Carotid artery thrombosis24.01.04.007; 17.08.01.0250.000168%Not Available
Carpal tunnel syndrome17.09.02.0010.000414%Not Available
Cataract06.06.01.0010.001533%
Cerebellar infarction24.04.06.007; 17.08.01.0130.000112%Not Available
Cerebral artery occlusion24.04.06.020; 17.08.01.0280.000280%Not Available
Cerebral atrophy17.11.01.0010.000112%Not Available
Cerebral haemorrhage17.08.01.003; 24.07.04.0010.001511%Not Available
Cerebral infarction24.04.06.002; 17.08.01.0040.003134%Not Available
Cerebral ischaemia24.04.06.003; 17.08.01.0050.000504%
Cerebral thrombosis17.08.01.006; 24.01.04.0030.000112%Not Available
Cerebrovascular accident24.03.05.001; 17.08.01.0070.011473%
Cerebrovascular disorder24.03.05.002; 17.08.02.0020.000392%Not Available
Cervix carcinoma21.06.02.001; 16.12.01.0010.000112%Not Available
Chest discomfort08.01.08.019; 02.02.02.009; 22.12.02.0020.004555%Not Available
Chest pain22.12.02.003; 08.01.08.002; 02.02.02.0110.012849%Not Available
Chills15.05.03.016; 08.01.09.001--
Choking22.12.03.0030.000336%Not Available
Cholangitis09.02.01.0020.000168%Not Available
Cholangitis sclerosing10.04.09.002; 09.02.01.0030.000112%Not Available
Cholecystitis09.03.01.0010.000895%
Cholecystitis acute09.03.01.0030.000392%Not Available
Cholecystitis chronic09.03.01.0040.000112%Not Available
Cholelithiasis09.03.01.0020.002216%Not Available
Cholestasis09.01.01.001--Not Available
Chromaturia20.02.01.0020.001489%
Chronic lymphocytic leukaemia16.01.06.001; 01.10.06.0010.000336%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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