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)
Rales22.12.01.0110.000112%Not Available
Rash23.03.13.0010.059926%Not Available
Rash erythematous23.03.13.0290.001511%Not Available
Rash macular23.03.13.003--Not Available
Rash papular23.03.13.0170.000548%Not Available
Rash pruritic23.03.13.0300.003750%Not Available
Raynaud's phenomenon24.04.03.0030.000638%Not Available
Rectal cancer16.13.01.003; 07.21.05.0020.000168%Not Available
Rectal haemorrhage24.07.02.018; 07.12.03.001--
Renal artery stenosis24.04.11.001; 20.01.07.0050.000672%Not Available
Renal colic20.02.03.0100.000112%
Renal disorder20.01.02.0020.001332%Not Available
Renal failure20.01.03.0050.003470%Not Available
Renal pain20.02.03.0030.000470%Not Available
Respiration abnormal22.02.01.0410.000112%Not Available
Respiratory disorder22.02.07.0020.000884%Not Available
Retinal artery occlusion24.01.07.003; 06.10.01.0050.000168%Not Available
Retinal artery thrombosis24.01.07.005; 06.10.01.0070.000168%Not Available
Retinal detachment06.09.03.003; 12.01.04.0040.000392%
Retinal haemorrhage06.10.01.001; 24.07.05.0030.000336%Not Available
Retinal ischaemia24.04.10.005; 06.10.01.0090.000112%Not Available
Retinal vein occlusion24.01.07.006; 06.10.01.0100.000168%Not Available
Retroperitoneal haemorrhage12.01.17.018; 24.07.01.017; 07.07.02.002--
Rhabdomyolysis15.05.05.0020.001175%
Rheumatoid arthritis15.01.03.001; 10.04.06.0010.000828%Not Available
Rhinitis22.07.03.006; 11.01.13.004--
Rhinitis allergic10.01.04.003; 22.04.04.0030.000526%
Rhinorrhoea22.12.03.0210.002295%
Rosacea23.02.08.0010.000358%Not Available
Sarcoidosis10.02.06.0010.000168%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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