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)
Cardiopulmonary failure22.02.06.004; 02.05.01.0040.000112%Not Available
Blood pressure inadequately controlled24.06.01.0070.000246%Not Available
Madarosis23.02.02.004; 06.06.04.0100.000571%Not Available
Dyschezia07.02.03.0050.000112%Not Available
Facial paresis17.04.03.0020.000336%
Systemic inflammatory response syndrome24.06.03.008; 08.01.05.005; 10.02.01.0080.000168%Not Available
Malignant neoplasm progression16.16.01.0050.008193%Not Available
Prostatomegaly21.04.01.0020.000224%Not Available
Large intestine polyp16.05.02.006; 07.20.01.0100.000280%Not Available
Acute coronary syndrome02.02.02.015; 24.04.04.0110.002406%Not Available
Conjunctival hyperaemia06.04.01.004--Not Available
Bone erosion15.02.04.0190.000112%Not Available
Vascular calcification24.03.02.0130.000224%Not Available
Metabolic syndrome14.06.02.007; 05.06.02.007; 24.08.02.0140.000224%Not Available
Ear discomfort04.03.01.0050.000112%Not Available
Eye oedema06.08.03.0130.000112%Not Available
Eye pruritus06.04.05.0060.000929%Not Available
Lymphatic disorder01.09.01.003--Not Available
Diastolic dysfunction02.04.02.0220.000504%Not Available
Oedematous pancreatitis07.18.01.0060.000112%Not Available
Cardiac flutter02.03.02.0120.000246%Not Available
Coronary artery insufficiency24.04.04.016; 02.02.01.0080.000112%Not Available
Musculoskeletal stiffness15.03.05.027--Not Available
Epigastric discomfort07.01.02.0040.000168%Not Available
Musculoskeletal discomfort15.03.04.001--Not Available
Leukaemia cutis16.01.03.002; 01.10.03.0020.000112%Not Available
Secretion discharge08.01.03.0190.000246%Not Available
Vascular occlusion24.04.02.0150.000280%Not Available
Blast cell crisis16.01.02.002; 01.10.02.0020.000616%Not Available
Nodule08.03.05.0020.000470%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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