Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Cobimetinib
Drug ID BADD_D00513
Description Cobimetinib is an orally active, potent and highly selective small molecule inhibiting mitogen-activated protein kinase kinase 1 (MAP2K1 or MEK1), and central components of the RAS/RAF/MEK/ERK signal transduction pathway. It has been approved in Switzerland and the US, in combination with vemurafenib for the treatment of patients with unresectable or metastatic BRAF V600 mutation-positive melanoma.
Indications and Usage For the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation. Cobimetinib is used in combination with vemurafenib, a BRAF inhibitor.
Marketing Status Not Available
ATC Code L01EE02
DrugBank ID DB05239
KEGG ID D10405
MeSH ID C574276
PubChem ID 16222096
TTD Drug ID D0FJ9I
NDC Product Code 50242-717; 72969-098
Synonyms cobimetinib | (3,4-difluoro-2-(2-fluoro-4-iodophenylamino)phenyl)(3-hydroxy-3-(piperidin-2-yl)azetidin-1-yl)methanone | Cotellic | GDC-0973 | XL518
Chemical Information
Molecular Formula C21H21F3IN3O2
CAS Registry Number 934660-93-2
SMILES C1CCNC(C1)C2(CN(C2)C(=O)C3=C(C(=C(C=C3)F)F)NC4=C(C=C(C=C4)I)F)O
Chemical Structure
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Acne23.02.01.0010.000533%Not Available
Alanine aminotransferase increased13.03.01.003--
Alopecia23.02.02.0010.000533%
Anaemia01.03.02.001--
Arthralgia15.01.02.0010.000533%
Aspartate aminotransferase increased13.03.01.006--
Asthenia08.01.01.0010.000533%Not Available
Blood creatine phosphokinase increased13.04.01.0010.000533%
Blood creatinine increased13.13.01.004--
Cardiac failure02.05.01.0010.000139%
Cardiomyopathy02.04.01.001--Not Available
Chills08.01.09.001; 15.05.03.016--
Death08.04.01.0010.000625%
Dermatitis acneiform23.02.01.004--
Diarrhoea07.02.01.0010.002131%
Dysphagia07.01.06.0030.000799%
Erythema23.03.06.001--Not Available
Gamma-glutamyltransferase increased13.03.01.011--
Hepatotoxicity09.01.07.009; 12.03.01.008--Not Available
Hyperkalaemia14.05.03.001--
Hyperkeratosis23.01.01.001--
Hypertension24.08.02.001--
Hypoalbuminaemia09.01.02.003; 14.10.01.002--
Hypocalcaemia14.04.01.004--
Hypokalaemia14.05.03.002--
Hyponatraemia14.05.04.002--
Hypophosphataemia14.04.03.001--
Lymphopenia01.02.02.002--Not Available
Myalgia15.05.02.0010.000799%
Nausea07.01.07.001--
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