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)
Chills15.05.03.016; 08.01.09.0010.006927%
Choking22.02.05.0010.001598%Not Available
Cholangitis09.02.01.002--Not Available
Cholecystitis09.03.01.0010.003996%
Cholecystitis acute09.03.01.0030.001865%Not Available
Cholelithiasis09.03.01.0020.006127%Not Available
Cholestasis09.01.01.001--Not Available
Chromaturia20.02.01.0020.003996%
Chronic hepatitis B11.05.06.005; 09.01.09.0080.000533%Not Available
Chronic lymphocytic leukaemia01.10.06.001; 16.01.06.0010.000417%Not Available
Chronic myeloid leukaemia16.01.07.001; 01.10.07.0010.008270%Not Available
Chronic obstructive pulmonary disease22.03.01.0070.001946%Not Available
Chronic sinusitis22.07.03.018; 11.01.13.0160.001066%Not Available
Circulatory collapse24.06.02.001--Not Available
Coagulopathy01.01.02.001--Not Available
Cold sweat23.02.03.002; 08.01.03.0240.001598%Not Available
Colitis07.08.01.001--
Colitis ischaemic24.04.08.012; 07.08.01.0040.000799%Not Available
Colon cancer16.13.01.001; 07.21.01.0010.000625%Not Available
Coma17.02.09.001--Not Available
Completed suicide19.12.01.001; 08.04.01.010--Not Available
Confusional state17.02.03.005; 19.13.01.001--
Conjunctival haemorrhage24.07.05.001; 06.07.01.0010.001332%Not Available
Conjunctivitis11.01.06.012; 06.04.01.0020.001598%
Conjunctivitis allergic10.01.04.002; 06.04.01.003--Not Available
Constipation07.02.02.0010.017583%
Coronary artery disease24.04.04.006; 02.02.01.0010.028506%Not Available
Coronary artery occlusion24.04.04.013; 02.02.01.0060.006660%Not Available
Coronary artery stenosis24.04.04.017; 02.02.01.0100.009324%Not Available
Coronary artery thrombosis24.01.05.002; 02.02.01.0070.000347%Not Available
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