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)
Skin sensitisation10.02.01.038; 23.03.03.0520.000596%Not Available
Infection reactivation11.01.08.048--Not Available
Posterior reversible encephalopathy syndrome17.13.02.0070.000382%
Slow speech19.19.02.004; 17.02.08.0160.000153%Not Available
Peripheral artery thrombosis24.01.02.0100.000153%Not Available
White matter lesion24.04.06.027; 17.11.01.0090.000153%Not Available
Hepatic cancer09.04.02.008; 16.07.02.004--Not Available
Hepatocellular carcinoma16.07.02.005; 09.04.02.010--Not Available
Eye ulcer06.08.03.0180.000153%Not Available
Candida infection11.03.03.021--
Aspergillus infection11.03.01.004--Not Available
Noninfective gingivitis07.09.13.0160.001269%Not Available
Mouth swelling23.04.01.020; 10.01.05.020; 07.05.04.0070.001636%Not Available
Respiratory symptom22.12.02.0130.000336%Not Available
Multiple organ dysfunction syndrome08.01.03.0570.002523%
Cornea verticillata06.06.03.0160.000535%Not Available
Anal incontinence17.05.01.021; 07.01.06.0290.000489%
Bone cancer16.29.02.002; 15.09.03.0120.000719%Not Available
Breast cancer recurrent21.05.01.017; 16.10.01.0090.000229%Not Available
Burning sensation mucosal17.02.06.031; 08.01.06.0200.000336%Not Available
Carcinoid syndrome16.32.02.004; 05.08.02.0050.000229%Not Available
Carcinoid tumour of the gastrointestinal tract16.24.04.005; 07.21.04.010; 05.08.01.0100.000153%Not Available
Central nervous system lymphoma01.12.01.005; 18.04.04.013; 17.02.10.028; 16.20.01.0050.000153%Not Available
Cholangitis acute09.02.01.0060.000382%Not Available
Chronic gastritis11.07.01.016; 10.04.04.011; 07.08.02.0050.000229%Not Available
Concomitant disease aggravated08.01.03.0630.002446%Not Available
Drowning12.01.18.003; 08.04.01.0140.000153%Not Available
Hypermetabolism14.11.01.0180.000153%Not Available
Infantile spasms19.21.02.011; 17.12.03.0270.000306%Not Available
Intracranial tumour haemorrhage24.07.04.028; 17.08.01.052; 16.32.03.0230.000153%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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