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)
Spleen disorder01.09.02.0030.000112%-
Splenic infarction01.09.02.004; 24.04.08.0240.000112%-
Splenomegaly01.09.02.0010.002675%-
Sputum discoloured22.02.03.0100.000246%-
Squamous cell carcinoma16.16.01.0020.000582%-
Stomatitis07.05.06.005--
Stress19.06.02.0040.001701%-
Stridor22.04.02.0030.000112%
Subcutaneous abscess11.01.12.007; 23.11.04.008---
Sudden death02.03.04.013; 08.04.01.0030.000728%
Supraventricular extrasystoles02.03.03.0110.000392%-
Swelling08.01.03.015---
Swelling face08.01.03.100; 10.01.05.018; 23.04.01.018---
Swollen tongue07.14.02.003; 10.01.05.015; 23.04.01.014---
Syncope02.11.04.015; 17.02.04.008; 24.06.02.0120.003492%
Systemic lupus erythematosus10.04.03.004; 15.06.02.003; 23.03.02.0060.000224%-
Tachycardia02.03.02.007---
Tendonitis12.01.07.007; 15.07.01.0030.000168%-
Tenosynovitis15.07.01.0040.000246%-
Testicular pain21.13.01.0050.000437%
Testicular swelling21.13.01.0030.000246%-
Therapeutic response decreased08.06.01.0160.002653%-
Throat irritation07.05.05.037; 22.12.03.029---
Thrombocytopenia01.08.01.0020.012021%-
Thrombocytosis01.08.02.0010.001030%-
Thrombophlebitis24.01.02.0010.000224%-
Thrombosis24.01.01.006---
Thrombotic thrombocytopenic purpura01.08.01.005; 23.06.01.011; 24.07.06.0140.000168%
Thyroid disorder05.02.01.0020.000985%-
Thyroid neoplasm05.02.05.002; 16.24.01.0020.000492%-
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ADReCS-Target
Drug Name ADR Term Target
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