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)
Ventricular dysfunction02.04.02.0050.000112%Not Available
Scleral hyperaemia06.04.07.003--Not Available
Angiopathy24.03.02.0070.001511%Not Available
Extremity necrosis24.04.03.0120.000168%Not Available
Skin toxicity23.03.03.032; 12.03.01.0200.000336%Not Available
Blood alkaline phosphatase increased13.04.02.004--
Drug resistance08.06.01.0050.003985%Not Available
Induration08.01.03.0200.000302%Not Available
Abdominal hernia07.16.06.0050.000302%Not Available
Appetite disorder19.09.01.002; 14.03.01.0040.000437%Not Available
Arterial disorder24.03.02.0200.001757%Not Available
Brain neoplasm17.20.01.003; 16.30.01.0030.000224%Not Available
Breast disorder21.05.04.004--Not Available
Cardiac disorder02.11.01.0030.004645%Not Available
Connective tissue disorder10.04.04.026; 15.06.01.006--Not Available
Cranial nerve disorder17.04.01.0010.000112%Not Available
Diabetic complication14.07.03.002; 05.07.03.0020.000358%Not Available
Feeding disorder19.09.01.003; 14.03.02.0030.000660%Not Available
Embolism24.01.01.0090.000224%
Gastrointestinal motility disorder07.02.03.001--Not Available
Haematotoxicity12.03.01.025; 01.05.01.0070.001836%Not Available
Infarction24.04.02.0170.001623%Not Available
Infestation23.11.01.002; 11.09.01.001--Not Available
Inflammation10.02.01.089; 08.01.05.0070.001153%Not Available
Limb discomfort15.03.04.0140.000750%Not Available
Intervertebral disc degeneration15.10.01.0020.000806%Not Available
Ischaemia24.04.02.0040.000895%Not Available
Ischaemic stroke24.04.06.010; 17.08.01.0180.001287%Not Available
Malnutrition14.03.02.004--Not Available
Mediastinal disorder22.09.03.001--Not Available
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ADReCS-Target
Drug Name ADR Term Target
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