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)
Diarrhoea07.02.01.001--
Diffuse large B-cell lymphoma16.28.02.001; 01.15.02.0010.000278%Not Available
Dilatation ventricular02.04.02.0260.001066%Not Available
Diplopia17.17.01.005; 06.02.06.0020.002131%Not Available
Discomfort08.01.08.003--Not Available
Disorientation19.13.01.002; 17.02.05.015--Not Available
Disseminated intravascular coagulation24.01.01.010; 01.01.02.002--
Disturbance in attention19.21.02.002; 17.03.03.001--
Diverticulitis11.01.07.003; 07.10.02.0010.002398%Not Available
Diverticulum07.10.01.0010.002131%Not Available
Dizziness24.06.02.007; 17.02.05.003; 02.01.02.004--
Dizziness postural24.06.02.008; 17.02.05.004; 02.01.02.0050.000533%Not Available
Drug eruption23.03.05.001; 10.01.01.005; 08.01.06.0150.001598%Not Available
Drug hypersensitivity10.01.01.001--Not Available
Drug withdrawal syndrome08.06.02.004; 19.07.02.011--Not Available
Dry eye06.08.02.0010.004795%
Dry mouth07.06.01.002--
Dry skin23.03.03.0010.011456%
Duodenal ulcer07.04.02.0020.001066%
Dupuytren's contracture15.03.03.0030.000799%Not Available
Dysaesthesia17.02.06.0030.000533%
Dysarthria17.02.08.001; 19.19.03.0010.004795%
Dysgeusia17.02.07.003; 07.14.03.001--
Dyskinesia17.01.02.006--
Dysmenorrhoea21.01.01.002--
Dyspepsia07.01.02.0010.013321%
Dysphagia07.01.06.0030.011456%
Dysphonia22.02.05.005; 19.19.03.002; 17.02.08.004--
Dysphoria19.04.02.004--Not Available
Dyspnoea22.02.01.004; 02.01.03.0020.060742%
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