Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Sonidegib phosphate
Drug ID BADD_D02057
Description Sonidegib is a Hedgehog signaling pathway inhibitor (via smoothened antagonism) developed as an anticancer agent by Novartis. It was FDA approved in 2015 for the treatment of basal cell carcinoma.
Indications and Usage Sonidegib is approved for use in the US and EU for treatment of adults with locally advanced basal cell carcinoma (BCC) that has recurred post surgery or radiation therapy. It is also approved for adult patients with BCC who are not eligible for surgery or radiation therapy. (2)
Marketing Status approved; investigational
ATC Code L01XJ02
DrugBank ID DB09143
KEGG ID D10729
MeSH ID C561435
PubChem ID 45138699
TTD Drug ID D09BNZ
NDC Product Code 54893-0057; 63285-836
UNII W421AI34UW
Synonyms sonidegib | (1,1'-Biphenyl)-3-carboxamide, N-(6-((2R,6S)-2,6-dimethyl-4-morpholinyl)-3-pyridinyl)-2- methyl-4'-(trifluoromethoxy)-, rel- | Odomzo | N-(6-((2S,6R)-2,6-dimethylmorpholino)pyridin-3-yl)-2-methyl-4'-(trifluoromethoxy)biphenyl-3-carboxamide | LDE225 | NVP-LDE225
Chemical Information
Molecular Formula C26H32F3N3O11P2
CAS Registry Number 1218778-77-8
SMILES CC1CN(CC(O1)C)C2=NC=C(C=C2)NC(=O)C3=CC=CC(=C3C)C4=CC=C(C=C4)OC(F)(F)F.OP(=O)(O)O .OP(=O)(O)O
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 pain07.01.05.002--
Alanine aminotransferase increased13.03.04.005--
Alopecia23.02.02.001--
Amenorrhoea21.01.02.001; 05.05.01.002--
Amylase increased13.05.01.009--
Anaemia01.03.02.001--
Aspartate aminotransferase increased13.03.04.011--
Blood creatine phosphokinase increased13.04.01.001--
Blood creatinine increased13.13.01.004--
Diarrhoea07.02.01.001--
Dysgeusia07.14.03.001; 17.02.07.003--
Fatigue08.01.01.002--
Headache17.14.01.001--
Hyperglycaemia14.06.02.002; 05.06.02.002--
Lipase increased13.05.01.003--
Lymphopenia01.02.02.002--Not Available
Muscle spasms15.05.03.004--
Musculoskeletal pain15.03.04.007--
Myalgia15.05.02.001--
Nausea07.01.07.001--
Pain08.01.08.004--
Pruritus23.03.12.001--
Vomiting07.01.07.003--
Weight decreased13.15.01.005--
Musculoskeletal discomfort15.03.04.001--Not Available
Decreased appetite14.03.01.005; 08.01.09.028--
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