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)
Haemolysis01.06.04.0020.000448%
Haemolytic anaemia01.06.03.0020.000336%Not Available
Haemoptysis02.11.04.009; 24.07.01.006; 22.02.03.0040.001153%Not Available
Haemorrhage intracranial24.07.04.003; 17.08.01.008--
Haemorrhage subcutaneous24.07.06.010; 23.06.07.0020.000168%Not Available
Haemorrhagic disorder24.07.01.021; 01.01.03.0040.000224%Not Available
Haemorrhagic stroke17.08.01.011; 24.07.04.014--Not Available
Haemorrhoids24.10.02.002; 07.15.03.0010.001354%
Haemothorax12.01.18.005; 24.07.01.008; 22.05.02.0010.000224%
Hair colour changes23.02.06.0010.000604%
Hair growth abnormal23.02.06.0060.000246%Not Available
Hair texture abnormal23.02.06.0040.000795%
Head discomfort17.02.05.0270.000492%Not Available
Headache17.14.01.0010.024199%
Hemiparesis17.01.04.0010.001231%
Hemiplegia17.01.04.0020.000783%Not Available
Hepatic cirrhosis09.01.04.0010.000616%Not Available
Hepatic fibrosis24.08.06.002; 09.01.04.0020.000112%Not Available
Hepatic function abnormal09.01.02.0010.003414%Not Available
Hepatic pain09.01.05.0050.000246%
Hepatic steatosis14.08.04.005; 09.01.07.0030.001030%Not Available
Hepatitis09.01.07.0040.000616%Not Available
Hepatitis toxic12.03.01.016; 09.01.07.0170.000112%Not Available
Hepatomegaly09.01.05.0010.001108%Not Available
Hepatosplenomegaly09.01.05.002; 01.09.03.0010.000280%Not Available
Hepatotoxicity12.03.01.008; 09.01.07.0090.001343%Not Available
Herpes simplex23.11.05.004; 11.05.02.001--Not Available
Herpes virus infection11.05.02.008--Not Available
Hiatus hernia22.09.02.004; 07.16.01.0010.000336%Not Available
Hiccups22.12.01.001; 07.01.06.0090.000437%
The 11th Page    First    Pre   11 12 13 14 15    Next   Last    Total 35 Pages
ADReCS-Target
Drug Name ADR Term Target
Tip:  Drug Name  ADR Term  Protein  Variation  Gene