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)
Pleurisy22.05.01.0010.000224%Not Available
Pleuritic pain22.12.01.007--
Pneumonia22.07.01.003; 11.01.09.003--Not Available
Pollakiuria20.02.02.0070.000940%
Polyarteritis nodosa15.06.01.003; 10.02.02.001; 24.12.04.019; 20.01.02.0040.000112%Not Available
Polycystic ovaries21.11.01.006; 05.05.01.0140.000168%Not Available
Polycythaemia01.07.01.0010.000168%Not Available
Polymyalgia rheumatica15.06.01.001; 10.04.05.0030.000168%Not Available
Polyneuropathy17.09.03.0120.000616%Not Available
Poor peripheral circulation24.04.03.0130.000336%Not Available
Portal vein thrombosis24.01.03.003; 09.01.06.0070.000112%
Postpartum haemorrhage18.06.01.001; 24.07.03.0030.000112%Not Available
Premature labour18.07.01.0020.000168%Not Available
Presbyopia06.02.04.0070.000112%Not Available
Prinzmetal angina24.04.04.015; 02.02.02.0190.000616%Not Available
Proctalgia07.03.02.0010.000414%
Productive cough22.02.03.0050.000963%
Pruritus23.03.12.0010.024949%
Psoriasis23.03.14.002; 10.02.01.036--Not Available
Psychomotor retardation19.15.02.0020.000112%Not Available
Pulmonary congestion24.03.08.001; 22.01.03.002; 02.05.02.0020.000884%Not Available
Pulmonary fibrosis22.01.02.0060.000728%
Pulmonary haemorrhage22.12.01.009; 24.07.01.0160.000168%
Pulmonary hypertension22.06.01.001; 24.08.03.0020.001030%
Pulmonary oedema22.01.03.003; 02.05.02.0030.002485%
Pulmonary valve incompetence02.07.04.0010.000336%Not Available
Punctate keratitis06.04.02.0030.000112%Not Available
Pyrexia08.05.02.0030.012189%
Quadriplegia17.01.04.0130.000112%Not Available
Radiculopathy17.10.01.0050.000112%
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ADReCS-Target
Drug Name ADR Term Target
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