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)
Ocular surface disease06.08.03.016--Not Available
Liver injury12.01.17.012; 09.01.07.0220.000504%Not Available
Organising pneumonia22.01.02.0080.000168%Not Available
Head and neck cancer16.16.01.0030.000224%Not Available
Skin mass23.07.04.0140.000548%Not Available
Dementia with Lewy bodies19.20.02.003; 17.03.01.0040.000168%Not Available
Anorectal discomfort07.03.03.0030.000112%Not Available
Oropharyngeal pain22.12.03.016; 07.05.05.0040.002877%
Oral papilloma16.05.04.003; 11.05.07.003; 07.20.02.003--Not Available
Bone marrow reticulin fibrosis16.32.03.010; 01.05.01.0090.000224%Not Available
Upper-airway cough syndrome22.12.03.0360.000381%
Hypoxic-ischaemic encephalopathy22.02.02.011; 17.13.02.006; 24.04.06.0210.000112%Not Available
Nail bed disorder23.02.05.0170.000381%Not Available
Skin sensitisation23.03.03.052; 10.02.01.0380.000246%Not Available
Gastrointestinal tract irritation07.08.03.0080.000246%Not Available
Macular fibrosis06.09.03.0140.000112%Not Available
Peripheral artery stenosis24.04.03.0170.001679%Not Available
Peripheral artery thrombosis24.01.02.0100.000582%Not Available
Rheumatic disorder15.03.04.018; 10.02.01.0480.000302%Not Available
Diffuse alopecia23.02.02.0070.000112%Not Available
Autoimmune haemolytic anaemia10.04.01.005; 01.06.01.0040.000112%Not Available
Candida infection11.03.03.021--
Peripheral venous disease24.04.02.0220.000280%Not Available
Sinus node dysfunction02.03.03.0170.000224%
Stenosis08.01.03.0600.000672%Not Available
Multiple organ dysfunction syndrome08.01.03.0570.000951%
Frustration tolerance decreased19.04.02.0160.000381%Not Available
Adenocarcinoma of colon16.13.01.010; 07.21.01.0080.000112%Not Available
Blood blister23.03.01.028; 12.01.06.0130.000437%Not Available
Cardiac failure chronic02.05.01.0090.000112%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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