Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Sonidegib
Drug ID BADD_D02472
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 D10119
MeSH ID C561435
PubChem ID 24775005
TTD Drug ID D09BNZ
NDC Product Code 47335-303
UNII 0RLU3VTK5M
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 C26H26F3N3O3
CAS Registry Number 956697-53-3
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
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 discomfort07.01.06.0010.000627%Not Available
Abdominal pain07.01.05.0020.000168%
Abdominal pain upper07.01.05.0030.000381%
Ageusia17.02.07.001; 07.14.03.0030.000739%Not Available
Alopecia23.02.02.0010.001063%
Amenorrhoea21.01.02.001; 05.05.01.0020.000381%
Anxiety19.06.02.0020.000246%
Arthralgia15.01.02.0010.000381%
Asthenia08.01.01.0010.000492%Not Available
Atrial fibrillation02.03.03.0020.000604%
Basal cell carcinoma23.08.02.001; 16.03.02.0010.000448%Not Available
Cerebrovascular accident24.03.05.001; 17.08.01.0070.000246%
Chills15.05.03.016; 08.01.09.0010.000168%
Condition aggravated08.01.03.0040.000112%Not Available
Death08.04.01.0010.001164%
Dehydration14.05.05.0010.000246%
Diarrhoea07.02.01.0010.001175%
Dizziness17.02.05.003; 02.11.04.006; 24.06.02.0070.000548%
Dysgeusia17.02.07.003; 07.14.03.0010.000828%
Dyspepsia07.01.02.0010.000112%
Dysphagia07.01.06.0030.000246%
Dyspnoea02.11.05.003; 22.02.01.0040.000492%
Fatigue08.01.01.0020.001231%
Gastric ulcer07.04.03.0020.000246%
Gastrointestinal haemorrhage24.07.02.009; 07.12.02.0010.000112%Not Available
Hyperkalaemia14.05.03.0010.000168%
Hypotension24.06.03.0020.000246%
Muscle spasms15.05.03.0040.002642%
Muscular weakness17.05.03.005; 15.05.06.0010.000168%
Myalgia15.05.02.0010.000358%
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