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 [FDA]. In May 2018, it was approved for use with [DB08912] for the treatment of treat anaplastic thyroid cancer caused by an abnormal BRAF V600E gene [L2726].
Marketing Status approved
ATC Code L01EE01
DrugBank ID DB08911
KEGG ID D10175
MeSH ID C560077
PubChem ID 11707110
TTD Drug ID D04XVN
NDC Product Code 0078-1105; 73309-005; 0078-1112; 12064-021; 52482-014; 0078-0668; 12064-022; 54893-0062; 86036-018; 0078-0666; 0078-1161
UNII 33E86K87QN
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
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)
Oropharyngeal pain22.12.03.016; 07.05.05.004--
Neurological decompensation17.02.05.0300.000112%Not Available
Acute kidney injury20.01.03.016--
Langerhans' cell histiocytosis16.21.04.003; 15.09.03.008; 01.13.04.003; 09.01.08.018; 22.01.01.0160.000168%Not Available
Nail bed disorder23.02.05.0170.000246%Not Available
Posterior reversible encephalopathy syndrome17.13.02.0070.000224%
Autoimmune haemolytic anaemia10.04.01.005; 01.06.01.0040.000112%Not Available
Respiratory symptom22.12.02.0130.000112%Not Available
Multiple organ dysfunction syndrome08.01.03.0570.000280%
Brain neoplasm malignant17.20.04.002; 16.30.04.0020.000358%Not Available
Coeliac disease14.02.01.007; 10.04.04.012; 07.17.01.0080.000112%Not Available
Dermatitis exfoliative generalised23.03.07.002; 10.01.01.0290.000112%Not Available
Lung adenocarcinoma16.19.01.002; 22.08.01.0070.000224%Not Available
Metastases to bone16.22.02.005; 15.09.03.0060.000112%Not Available
Metastases to lymph nodes16.22.02.006; 01.09.01.0150.000112%Not Available
Metastases to meninges17.02.10.012; 16.22.02.0030.000112%Not Available
Astrocytoma, low grade16.09.04.001; 17.18.04.0010.000280%Not Available
Cardiac dysfunction02.11.01.0040.000112%Not Available
Disease complication08.01.03.0870.000168%Not Available
Drug ineffective for unapproved indication12.09.02.002; 08.06.01.0380.000627%Not Available
Ganglioglioma17.20.01.011; 16.30.01.0110.000112%Not Available
Hepatic cytolysis09.01.07.0360.000112%Not Available
Histiocytic sarcoma01.13.04.004; 16.21.04.0040.000168%Not Available
Illness08.01.03.0910.000548%Not Available
Neurofibrosarcoma15.09.03.033; 16.33.11.0010.000112%Not Available
Serous retinopathy06.10.02.0130.000112%Not Available
Skin weeping23.03.03.1010.000437%Not Available
Therapy partial responder08.06.01.0640.000392%Not Available
Trichomegaly23.02.04.003; 06.06.04.0280.000112%Not Available
Uveal melanoma16.34.04.003; 06.12.04.0030.000392%Not Available
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