Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Everolimus
Drug ID BADD_D00858
Description Everolimus is a derivative of Rapamycin (sirolimus), and works similarly to Rapamycin as an mTOR (mammalian target of rapamycin) inhibitor. It is currently used as an immunosuppressant to prevent rejection of organ transplants. In a similar fashion to other mTOR inhibitors Everolimus' effect is solely on the mTORC1 protein and not on the mTORC2 protein.
Indications and Usage Everolimus is indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer (advanced HR+ BC) in combination with exemestane, after failure of treatment with letrozole or anastrozole. Indicated for the treatment of adult patients with progressive neuroendocrine tumors of pancreatic origin (PNET) with unresectable, locally advanced or metastatic disease. Indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) after failure of treatment with sunitinib or sorafenib. Indicated for the treatment of adult patients with renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery. Indicated in pediatric and adult patients with tuberous sclerosis complex (TSC) for the treatment of subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected.
Marketing Status approved
ATC Code L01EG02; L04AA18
DrugBank ID DB01590
KEGG ID D02714
MeSH ID D000068338
PubChem ID 6442177
TTD Drug ID D0K3QS
NDC Product Code 52076-6247; 62227-019; 68254-6234; 71052-559; 49884-283; 0054-0480; 0078-0566; 0078-0620; 0078-0627; 0378-3096; 0378-3097; 67877-721; 0054-0472; 70377-012; 65129-1324; 71796-012; 0078-0422; 0093-7767; 0093-7768; 49884-119; 51991-821; 63850-0062; 63850-0064; 70377-010; 70377-011; 63850-0059; 67877-718; 0054-0470; 17404-1027; 65727-064; 0078-0567; 51991-824; 63850-0058; 0378-0007; 0378-3098; 0054-0497; 65727-063; 0078-0594; 0078-0628; 49884-158; 0378-0005; 0378-3099; 67877-720; 0054-0471; 52076-6253; 62227-013; 70225-1103; 0078-0415; 0078-0417; 0078-0626; 0054-0482; 52076-6234; 63850-0063; 67877-719; 63850-0061; 0054-0481; 0054-0604; 49884-160; 51991-822; 63850-0060; 0378-0006; 70377-013; 65727-046; 0078-0414; 0093-7766; 49884-125; 49884-127; 49884-128; 49884-159; 51991-823
UNII 9HW64Q8G6G
Synonyms Everolimus | SDZ RAD | RAD, SDZ | SDZ-RAD | 40-O-(2-hydroxyethyl)-rapamycin | RAD 001 | 001, RAD | RAD001 | Certican | Afinitor
Chemical Information
Molecular Formula C53H83NO14
CAS Registry Number 159351-69-6
SMILES CC1CCC2CC(C(=CC=CC=CC(CC(C(=O)C(C(C(=CC(C(=O)CC(OC(=O)C3CCCCN3C(=O)C(=O)C1(O2)O) C(C)CC4CCC(C(C4)OC)OCCO)C)C)O)OC)C)C)C)OC
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)
Exposed bone in jaw15.02.04.0340.000382%Not Available
Spinal pain17.10.01.020; 15.02.01.008; 08.01.08.0300.000382%Not Available
Eye colour change06.06.06.0080.000153%Not Available
Prerenal failure24.06.02.025; 20.01.03.0220.000153%Not Available
Clear cell renal cell carcinoma20.01.04.008; 16.08.02.0040.000459%Not Available
Oedematous kidney20.01.02.0170.000153%Not Available
Abdominal lymphadenopathy07.11.01.018; 01.09.01.0200.000153%Not Available
Gastrointestinal wall thickening07.01.06.0320.000382%Not Available
Unmasking of previously unidentified disease08.01.03.0800.000153%Not Available
Tongue discomfort07.14.02.0190.001116%Not Available
Biliary obstruction09.02.02.0050.000382%Not Available
Breast ulceration21.05.04.017; 23.07.03.0220.000153%Not Available
Carcinoid heart disease02.07.02.009; 16.32.02.005; 05.08.02.0060.000306%Not Available
Carcinoid tumour of the small bowel16.24.04.007; 07.21.04.012; 05.08.01.0170.000153%Not Available
Carcinoid tumour pulmonary22.08.01.023; 16.24.04.008; 05.08.01.0180.000229%Not Available
Cardiac dysfunction02.11.01.0040.000306%Not Available
Cystic lung disease22.01.02.0290.000153%Not Available
Diabetic ketosis05.07.03.004; 14.07.03.0040.000229%Not Available
Dilated cardiomyopathy02.04.01.0170.000306%Not Available
Disease complication08.01.03.0870.000382%Not Available
Endometrial cancer recurrent21.07.02.015; 16.12.02.0050.000153%Not Available
Epithelioid mesothelioma16.39.01.002; 15.09.03.0240.000153%Not Available
Epithelioid sarcoma15.09.03.025; 16.33.09.0010.000153%Not Available
Gait inability08.01.02.011; 17.02.05.0690.002049%Not Available
Haemangioblastoma17.18.01.006; 16.09.01.0060.000153%Not Available
Heart transplant rejection12.02.01.039; 10.02.03.009; 02.11.01.0150.000153%Not Available
Heavy menstrual bleeding21.01.03.005--Not Available
Hyper HDL cholesterolaemia14.08.04.0170.000520%Not Available
Hyperaesthesia teeth07.09.06.0050.000596%Not Available
Hypersensitivity pneumonitis10.01.03.056; 22.01.01.0270.000153%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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