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)
C-reactive protein increased13.09.01.0070.005861%Not Available
Cachexia16.32.03.011; 14.03.02.001; 08.01.01.0090.000208%Not Available
Calculus urinary20.04.02.0010.000533%Not Available
Cardiac arrest02.03.04.0010.002849%
Cardiac failure02.05.01.0010.005282%
Cardiac failure acute02.05.01.0050.000533%Not Available
Cardiac failure congestive02.05.01.002--Not Available
Cardiac murmur13.14.01.0010.001598%Not Available
Cardiac tamponade02.06.01.0010.001066%
Cardio-respiratory arrest22.02.06.007; 02.03.04.002--Not Available
Cardiogenic shock24.06.02.006; 02.05.01.003--Not Available
Cardiomegaly02.04.02.0010.001112%Not Available
Cardiomyopathy02.04.01.0010.003730%Not Available
Cardiovascular disorder24.03.02.009; 02.01.01.0010.002432%Not Available
Carotid artery stenosis24.04.06.001; 17.08.02.0010.011456%Not Available
Carotid artery thrombosis24.01.04.007; 17.08.01.0250.000799%Not Available
Carpal tunnel syndrome17.09.02.0010.001332%Not Available
Cataract06.06.01.0010.006394%
Cellulitis23.09.01.001; 11.02.01.0010.006127%Not Available
Cerebellar infarction17.08.01.013; 24.04.06.0070.000799%Not Available
Cerebral artery occlusion24.04.06.020; 17.08.01.0280.001066%Not Available
Cerebral atrophy17.11.01.0010.000533%Not Available
Cerebral haemorrhage24.07.04.001; 17.08.01.0030.001668%Not Available
Cerebral infarction24.04.06.002; 17.08.01.0040.011456%Not Available
Cerebral ischaemia24.04.06.003; 17.08.01.0050.002131%
Cerebrovascular accident17.08.01.007; 24.03.05.0010.035699%
Cerebrovascular disorder24.03.05.002; 17.08.02.0020.000417%Not Available
Cervix carcinoma21.06.02.001; 16.12.01.0010.000533%Not Available
Chest discomfort08.01.08.019; 02.02.02.009; 22.02.08.0010.014386%Not Available
Chest pain08.01.08.002; 22.02.08.003; 02.02.02.0110.045556%Not Available
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