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)
Skin burning sensation23.03.03.021; 17.02.06.0090.000851%Not Available
Throat lesion22.12.03.0300.000302%Not Available
Vascular insufficiency24.04.02.0140.000112%Not Available
Foetal death08.04.01.011; 18.01.02.0030.000168%
Haemorrhage24.07.01.002--Not Available
Varices oesophageal24.10.02.004; 09.01.06.009; 07.15.05.0010.000112%Not Available
Fluid intake reduced14.05.10.0010.000246%Not Available
Pulmonary mass22.02.07.0040.000280%Not Available
Vulvovaginal pruritus21.08.02.004; 23.03.12.0090.000246%Not Available
Temperature intolerance08.01.09.0220.000112%Not Available
Urine odour abnormal20.02.01.0200.000381%Not Available
Daydreaming19.21.02.0050.000246%Not Available
Hypoaesthesia oral07.05.05.003; 17.02.06.0210.000280%Not Available
Vascular stenosis24.04.02.0200.000224%Not Available
Major depression19.15.01.0030.000168%Not Available
Reflux gastritis07.08.02.0040.000246%Not Available
Globulins decreased13.09.01.013--Not Available
Metabolic disorder14.11.01.0010.000168%Not Available
Dyslipidaemia14.08.04.0150.002339%Not Available
Ocular icterus09.01.01.007; 06.08.03.009; 01.06.04.0070.000246%Not Available
Troponin increased13.04.01.004--Not Available
Dysgraphia17.02.03.0060.000437%Not Available
Lung neoplasm malignant22.08.01.001; 16.19.02.0010.001287%Not Available
Dermatitis psoriasiform23.03.14.0040.000246%Not Available
Nipple swelling21.05.05.011--Not Available
Thyroid mass05.02.01.0030.000336%Not Available
Restless legs syndrome17.02.07.008; 15.05.03.0120.000940%Not Available
Bicytopenia01.03.03.0100.000112%Not Available
Venous occlusion24.04.02.0090.000168%Not Available
Gastrointestinal toxicity12.03.01.019; 07.08.03.0060.000302%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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