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 Prescription
ATC Code L01EA03
DrugBank ID DB04868
KEGG ID D08953
MeSH ID C498826
PubChem ID 644241
TTD Drug ID D00STL
NDC Product Code 0078-0592; 0078-0951; 76302-015; 0078-0526; 54893-0069
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
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Cough22.02.03.0010.023444%
Crohn's disease10.02.01.005; 07.08.01.015--Not Available
Cyanosis24.03.01.007; 22.02.02.007; 02.01.02.002--
Cyst16.02.02.002; 08.03.05.0010.001332%Not Available
Cystitis20.03.02.002; 11.01.14.001--
Deafness04.02.01.0010.005328%Not Available
Deafness neurosensory17.04.07.001; 04.02.01.0020.001598%Not Available
Death08.04.01.0010.044618%
Decreased immune responsiveness10.02.01.0410.001332%Not Available
Decubitus ulcer23.03.11.0060.000533%Not Available
Dehydration14.05.05.001--
Delirium19.13.02.001--
Dementia19.20.02.001; 17.03.01.001--Not Available
Dementia Alzheimer's type19.20.03.001; 17.03.06.0010.000799%Not Available
Demyelination17.16.02.0010.000799%Not Available
Dental caries07.09.01.0010.002131%
Depressed level of consciousness17.02.04.002--
Depressed mood19.15.02.001--Not Available
Depression19.15.01.001--
Dermal cyst23.10.02.001; 16.26.02.001--Not Available
Dermatitis23.03.04.0020.001332%Not Available
Dermatitis acneiform23.02.01.0040.000799%
Dermatitis allergic10.01.03.014; 23.03.04.0030.002931%Not Available
Dermatitis atopic23.03.04.016; 10.01.04.0040.000533%Not Available
Dermatitis bullous23.03.01.002--
Dermatitis exfoliative23.03.07.001; 10.01.01.004--
Diabetes mellitus14.06.01.001; 05.06.01.0010.019448%Not Available
Diabetes mellitus inadequate control14.06.01.004; 05.06.01.0040.001865%Not Available
Diabetic neuropathy05.07.04.003; 17.09.04.002; 14.07.04.0030.000533%Not Available
Diabetic retinopathy24.03.07.004; 14.07.01.002; 06.10.02.002; 05.07.01.0020.000139%Not Available
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