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
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Anaemia01.03.02.0010.042892%
Anal fissure07.03.01.0020.000533%
Anaphylactic reaction10.01.07.001; 24.06.03.006--
Anger19.04.02.001--Not Available
Angina pectoris02.02.02.002; 24.04.04.0020.033301%
Angina unstable02.02.02.004; 24.04.04.0040.006127%Not Available
Angioedema10.01.05.009; 23.04.01.001--Not Available
Angioimmunoblastic T-cell lymphoma01.11.05.001; 16.17.05.0010.000533%Not Available
Ankle fracture12.04.01.005; 15.08.03.005--
Anorectal disorder07.03.01.0010.000533%Not Available
Anosmia17.04.04.001; 22.04.03.0060.000533%
Anuria20.01.03.002--Not Available
Anxiety19.06.02.002--
Aortic aneurysm24.02.03.0010.001066%Not Available
Aortic stenosis24.04.01.0010.002664%Not Available
Aortic thrombosis24.01.09.0010.000533%Not Available
Aortic valve incompetence02.07.03.0010.001066%Not Available
Aortic valve sclerosis02.07.03.0030.001332%Not Available
Apathy19.04.04.002--Not Available
Aphasia17.02.03.001; 19.21.01.0010.004795%
Aphonia17.02.08.009; 19.19.01.002; 22.02.05.0240.000533%
Aphthous ulcer07.05.06.002--Not Available
Aplasia03.02.01.002; 08.03.04.0030.001598%Not Available
Aplastic anaemia01.03.03.0020.000625%Not Available
Appendicitis07.19.01.001; 11.01.07.001--
Arrhythmia02.03.02.0010.012255%Not Available
Arterial injury12.01.11.008; 24.11.02.0020.000533%
Arteriosclerosis24.04.02.0010.002988%Not Available
Arteriosclerosis coronary artery02.02.01.011; 24.04.04.0120.000764%Not Available
Arteriospasm coronary02.02.02.005; 24.04.04.0050.001598%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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