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)
Arteritis24.05.01.0010.001598%Not Available
Arthralgia15.01.02.0010.039162%
Arthritis15.01.01.0010.005328%
Arthropathy15.01.01.003--Not Available
Ascites09.01.05.003; 07.07.01.001; 02.05.04.0020.003996%
Aspartate aminotransferase13.03.01.032--Not Available
Aspartate aminotransferase increased13.03.01.0060.013321%
Aspiration22.02.07.007--
Asthenia08.01.01.0010.034367%Not Available
Asthma22.03.01.002; 10.01.03.010--Not Available
Ataxia17.02.02.001; 08.01.02.004--
Atelectasis22.01.02.0010.001865%
Atrial fibrillation02.03.03.0020.023178%
Atrial flutter02.03.03.0030.001332%
Atrial septal defect03.07.02.002; 02.04.02.009--Not Available
Atrial tachycardia02.03.03.0040.000533%
Atrioventricular block02.03.01.0020.001865%Not Available
Atrioventricular block complete02.03.01.0030.001066%
Atrioventricular block first degree02.03.01.0040.001332%
B-cell lymphoma01.15.01.001; 16.28.01.0010.000208%Not Available
Back disorder15.03.01.0140.001066%Not Available
Back pain15.03.04.0050.024776%
Bacteraemia11.01.11.0010.000799%
Barrett's oesophagus07.11.03.0020.000799%Not Available
Basal cell carcinoma23.08.02.001; 16.03.02.0010.001598%Not Available
Basedow's disease10.04.08.004; 06.09.04.003; 05.02.02.0030.000533%Not Available
Basophil count increased13.01.06.0020.001066%Not Available
Benign prostatic hyperplasia21.04.02.0010.001598%Not Available
Bile duct cancer09.04.02.001; 16.07.01.0010.000208%Not Available
Bile duct stone09.02.02.0030.000533%Not Available
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