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)
Abdominal discomfort07.01.06.001--Not Available
Abdominal distension07.01.04.0010.003806%
Abdominal pain07.01.05.0020.011618%
Abdominal pain upper07.01.05.0030.011484%
Abdominal rigidity07.01.05.0110.000112%Not Available
Abdominal tenderness07.01.05.0040.000168%Not Available
Abortion18.01.01.0010.000392%Not Available
Acne23.02.01.0010.002686%Not Available
Acrochordon23.10.01.005; 16.26.01.0050.000246%Not Available
Acute leukaemia16.01.02.001; 01.10.02.0010.000112%Not Available
Acute lymphocytic leukaemia16.01.01.001; 01.10.01.0010.000862%Not Available
Acute myeloid leukaemia01.10.05.001; 16.01.05.0010.000783%Not Available
Acute myocardial infarction24.04.04.001; 02.02.02.0010.006716%Not Available
Acute promyelocytic leukaemia16.01.05.003; 01.10.05.0030.000112%Not Available
Acute pulmonary oedema22.01.03.005; 02.05.02.0040.000224%Not Available
Affective disorder19.04.04.0010.000302%Not Available
Ageusia17.02.07.001; 07.14.03.003--Not Available
Alanine aminotransferase increased13.03.04.005--
Alopecia23.02.02.0010.015357%
Amaurosis fugax06.02.10.002; 24.04.06.006; 17.08.04.0020.000112%Not Available
Amnesia19.20.01.001; 17.03.02.0010.001220%
Amylase increased13.05.01.009--
Anaemia01.03.02.0010.013196%
Anal fissure07.03.01.0020.000112%
Angina pectoris24.04.04.002; 02.02.02.0020.008585%
Angina unstable24.04.04.004; 02.02.02.0040.001511%Not Available
Angioimmunoblastic T-cell lymphoma16.17.05.001; 01.11.05.0010.000112%Not Available
Anorectal disorder07.03.01.0010.000112%Not Available
Anosmia22.04.03.006; 17.04.04.0010.000246%
Anxiety19.06.02.0020.019722%
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ADReCS-Target
Drug Name ADR Term Target
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