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)
Onychoclasis23.02.05.0050.000246%Not Available
Anal abscess11.01.07.015; 07.19.04.004--Not Available
Peripheral swelling08.01.03.053; 02.05.04.015--Not Available
Localised oedema14.05.06.009; 08.01.07.011; 02.05.04.0060.000112%
Brain oedema17.07.02.003; 12.01.10.010--
Carotid artery occlusion24.04.06.008; 17.08.01.0120.001231%Not Available
Weight fluctuation14.03.02.0020.000381%Not Available
Autoimmune thyroiditis10.04.08.006; 05.02.04.0020.000828%Not Available
Brain death17.02.03.003; 08.04.01.0040.000112%Not Available
Osteopenia15.02.03.003; 14.04.04.0040.000302%Not Available
Oesophagitis ulcerative07.04.05.003--Not Available
Emotional distress19.04.02.0080.015726%Not Available
Onychomadesis23.02.05.0060.000246%
Sudden cardiac death08.04.01.008; 02.03.04.0160.000224%Not Available
General physical health deterioration08.01.03.0180.002059%Not Available
Blood phosphorus decreased13.11.01.015--Not Available
Quadriparesis17.01.04.0120.000112%Not Available
Left ventricular dysfunction02.04.02.0110.000560%
Shock haemorrhagic24.06.02.014; 14.05.05.003--Not Available
Left ventricular hypertrophy02.04.02.0140.000783%Not Available
Dry gangrene24.04.03.018; 23.06.06.0030.000224%Not Available
Lumbar radiculopathy17.10.03.0030.000168%Not Available
Dysstasia15.03.05.011; 08.01.03.089; 17.02.02.0120.000683%Not Available
Intervertebral disc protrusion15.10.01.0040.000940%Not Available
Cerumen impaction04.01.01.0010.000168%Not Available
Subileus07.13.01.004--Not Available
Ejection fraction decreased13.14.02.003--
Contusion15.03.05.007; 24.07.06.001; 23.03.11.002; 12.01.06.001--
Musculoskeletal chest pain22.09.01.001; 15.03.04.0120.000627%
Gastrointestinal stromal tumour16.13.04.008; 07.21.04.0030.000336%Not Available
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ADReCS-Target
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