Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Trametinib
Drug ID BADD_D02257
Description Trametinib dimethyl sulfoxide is a kinase inhibitor. Each 1-mg tablet contains 1.127 mg trametinib dimethyl sulfoxide equivalent to 1 mg of trametinib non-solvated parent. FDA approved on May 29, 2013 [L2727]. The U.S. Food and Drug Administration approved [DB08912](Tafilnar) and Mekinist (trametinib), administered together, for the treatment of anaplastic thyroid cancer (ATC) that cannot be removed by surgery or has spread to other parts of the body (metastatic), and has a type of abnormal gene, BRAF V600E (BRAF V600E mutation-positive) [L2726]. Thyroid cancer is a disease in which cancer cells form in the tissues of the thyroid. Anaplastic thyroid cancer is a rare, aggressive type of thyroid cancer. The National Institutes of Health (NIH) estimates there will be 53,990 new cases of thyroid cancer and an estimated 2,060 deaths from the disease in the United States in 2018. Anaplastic thyroid cancer accounts for approximately 1 to 2 percent of all thyroid cancers [L2726].
Indications and Usage Trametinib is indicated for the treatment of unresectable or metastatic melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test.
Marketing Status Not Available
ATC Code L01EE01
DrugBank ID DB08911
KEGG ID D10175
MeSH ID C560077
PubChem ID 11707110
TTD Drug ID D04XVN
NDC Product Code 0078-0666; 0078-0668; 12064-022; 0078-1105; 54893-0062; 52482-014; 43744-572; 73309-020; 0078-1112; 12064-021; 73309-005
Synonyms trametinib | JTP 74057 | JTP74057 | JTP-74057 | GSK 1120212 | GSK1120212 | GSK-1120212
Chemical Information
Molecular Formula C26H23FIN5O4
CAS Registry Number 871700-17-3
SMILES CC1=C2C(=C(N(C1=O)C)NC3=C(C=C(C=C3)I)F)C(=O)N(C(=O)N2C4=CC=CC(=C4)NC(=O)C)C5CC5
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal discomfort07.01.06.001--Not Available
Abdominal distension07.01.04.0010.001066%
Abdominal pain07.01.05.0020.002931%
Abdominal pain lower07.01.05.010--Not Available
Abdominal pain upper07.01.05.0030.001865%
Abdominal tenderness07.01.05.004--Not Available
Acne23.02.01.0010.006127%Not Available
Actinic keratosis23.01.06.001--Not Available
Adenocarcinoma16.16.01.0040.000208%Not Available
Alanine aminotransferase increased13.03.01.0030.001598%
Alopecia23.02.02.0010.004263%
Amnesia19.20.01.001; 17.03.02.001--
Amylase increased13.05.01.0090.000139%
Anaemia01.03.02.001--
Angina pectoris24.04.04.002; 02.02.02.0020.000533%
Angular cheilitis11.01.04.014; 07.05.07.013; 23.03.03.0540.001066%Not Available
Aphasia19.21.01.001; 17.02.03.0010.001066%
Aphthous ulcer07.05.06.002--Not Available
Arrhythmia02.03.02.001--Not Available
Arthralgia15.01.02.0010.002931%
Aspartate aminotransferase increased13.03.01.0060.001332%
Asthenia08.01.01.001--Not Available
Atrial fibrillation02.03.03.0020.001598%
Back pain15.03.04.005--
Blindness17.17.01.003; 06.02.02.0010.000533%Not Available
Blindness transient17.17.01.004; 06.02.02.002--Not Available
Blister23.03.01.001; 12.01.06.0020.000533%Not Available
Blood creatine phosphokinase increased13.04.01.0010.001598%
Blood creatinine increased13.13.01.0040.000799%
Blood lactate dehydrogenase increased13.04.02.0020.000533%
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