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)
Hepatic artery thrombosis24.01.03.002; 09.01.06.005--Not Available
Hepatic cirrhosis09.01.04.0010.000994%Not Available
Hepatic cyst09.01.08.008; 16.06.02.0010.000306%Not Available
Hepatic failure09.01.03.0020.002247%
Hepatic fibrosis24.08.06.002; 09.01.04.0020.000153%Not Available
Hepatic function abnormal09.01.02.0010.003807%Not Available
Hepatic necrosis09.01.07.0020.000382%
Hepatic neoplasm16.07.03.001; 09.04.03.0010.000841%Not Available
Hepatic pain09.01.05.0050.000153%
Hepatic steatosis14.08.04.005; 09.01.07.0030.000688%Not Available
Hepatitis09.01.07.0040.000917%Not Available
Hepatitis B11.05.28.003; 09.01.09.003--
Hepatitis C11.05.28.004; 09.01.09.005--Not Available
Hepatitis fulminant11.07.01.003; 09.01.07.0070.000229%Not Available
Hepatitis toxic12.03.01.016; 09.01.07.0170.000229%Not Available
Hepatocellular injury09.01.07.0080.001223%Not Available
Hepatomegaly09.01.05.0010.000306%Not Available
Hepatorenal syndrome09.01.03.007; 20.01.03.0120.000153%Not Available
Hernia08.01.04.0010.000642%Not Available
Herpes virus infection11.05.02.008--Not Available
Herpes zoster23.11.05.005; 17.09.03.026; 11.05.02.003--
Hirsutism23.02.04.001; 05.05.01.005--
Histiocytosis16.21.04.002; 01.13.04.002--Not Available
Hydrocephalus17.07.01.0010.000413%
Hydronephrosis20.01.05.0010.000382%Not Available
Hypercalcaemia14.04.01.003; 05.04.01.0020.001177%
Hyperchlorhydria07.11.03.0010.000153%Not Available
Hypercholesterolaemia14.08.01.0010.001850%Not Available
Hyperglycaemia14.06.02.002; 05.06.02.0020.010381%
Hyperhidrosis08.01.03.028; 23.02.03.004--
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ADReCS-Target
Drug Name ADR Term Target
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