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)
Intracranial aneurysm24.02.04.001; 17.08.06.0010.000414%Not Available
Intracranial pressure increased17.07.02.0020.000168%Not Available
Intraventricular haemorrhage24.07.04.008; 17.08.01.0170.000112%Not Available
Iron deficiency14.13.02.0020.000470%Not Available
Iron deficiency anaemia01.03.01.002; 14.13.02.0010.000728%Not Available
Jaundice09.01.01.004; 01.06.04.004; 23.03.03.0300.001679%Not Available
Joint effusion15.01.02.0050.000381%
Joint swelling15.01.02.004--Not Available
Keratitis06.04.02.0020.000224%
Lacrimation increased06.08.02.0040.000526%
Laryngeal oedema23.04.01.005; 22.04.02.001; 10.01.05.0030.000224%
Laryngeal pain22.12.03.010--
Left ventricular failure02.05.02.0010.000112%Not Available
Lethargy19.04.04.004; 17.02.04.003; 08.01.01.008--
Leukaemia16.01.03.001; 01.10.03.0010.000672%
Leukocytosis01.02.01.0020.002171%
Leukoencephalopathy17.13.02.0030.000112%
Leukopenia01.02.02.0010.001959%Not Available
Lichen planus23.03.08.0010.000246%Not Available
Lipase increased13.05.01.003--
Lipoma16.18.01.001; 15.09.01.0010.000112%Not Available
Livedo reticularis24.03.04.003; 23.06.05.0010.000112%Not Available
Liver disorder09.01.08.0010.003190%Not Available
Long QT syndrome02.03.01.0170.000246%Not Available
Loss of consciousness17.02.04.004--Not Available
Lung consolidation22.01.02.0100.000168%Not Available
Lung disorder22.02.07.0010.001444%Not Available
Lung infiltration22.01.02.0040.000448%Not Available
Lymphadenitis01.09.01.0010.000280%Not Available
Lymphadenopathy01.09.01.0020.001354%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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