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)
Blood potassium decreased13.11.01.010--Not Available
Blood pressure increased13.14.03.005--Not Available
Blood triglycerides increased13.12.03.001--Not Available
Blood urea increased13.13.01.006--Not Available
Blood uric acid increased13.02.04.001--Not Available
Body temperature increased13.15.01.001--Not Available
Bone pain15.02.01.0010.009671%
Bradycardia02.03.02.002--Not Available
Brain stem infarction24.04.06.014; 17.08.01.0240.000224%Not Available
Breast hyperplasia21.05.01.0070.000112%Not Available
Breast induration21.05.05.010--Not Available
Breast mass21.05.04.0020.000168%Not Available
Breast pain21.05.05.0030.000414%
Breast tenderness21.05.05.0040.000571%Not Available
Bronchitis22.07.01.001; 11.01.09.001--
Bronchitis chronic22.03.01.0190.000112%Not Available
Bruxism19.11.03.001; 07.01.06.0080.000381%Not Available
Bundle branch block02.03.01.0090.000358%Not Available
Bundle branch block left02.03.01.0070.000168%Not Available
Bundle branch block right02.03.01.0110.000336%Not Available
Burning sensation17.02.06.001; 08.01.09.029--Not Available
Bursitis12.04.03.010; 15.04.01.0010.000392%Not Available
Cachexia16.32.03.011; 14.03.02.001; 08.01.01.0090.000168%Not Available
Calculus urinary20.04.03.0020.000112%Not Available
Cardiac arrest02.03.04.0010.002798%
Cardiac failure02.05.01.0010.004667%
Cardiac failure congestive02.05.01.0020.002429%Not Available
Cardiac murmur13.14.01.001--Not Available
Cardiac tamponade02.06.01.0010.000448%
Cardiogenic shock24.06.02.006; 02.05.01.0030.000336%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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