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)
Pancreatitis acute07.18.01.002--Not Available
Pancytopenia01.03.03.003--Not Available
Papule23.03.03.0380.000489%Not Available
Paraesthesia23.03.03.094; 17.02.06.005--
Paralysis17.01.04.0040.000459%Not Available
Parosmia22.04.03.007; 17.04.04.0020.000336%Not Available
Pathological fracture16.32.03.007; 15.08.02.008; 12.04.02.0060.000306%Not Available
Pericardial effusion02.06.01.0020.003134%
Pericarditis02.06.02.0010.000688%
Periorbital oedema06.08.03.017; 23.04.01.002; 10.01.05.0100.000489%
Peripheral sensory neuropathy17.09.03.0050.000153%
Peripheral vascular disorder24.03.01.0030.000153%Not Available
Peritonitis11.01.07.007; 07.19.05.004--
Peroneal nerve palsy17.09.02.0030.000153%Not Available
Pharyngeal oedema23.04.01.016; 22.04.05.003; 10.01.05.0160.001269%Not Available
Pharyngeal ulceration22.04.05.0040.000673%Not Available
Pharyngitis22.07.03.004; 11.01.13.003; 07.05.07.004--
Pharyngitis streptococcal22.07.04.001; 11.02.06.002--Not Available
Phlebitis24.12.03.004; 12.02.01.0020.000459%
Platelet count decreased13.01.04.001--
Pleural disorder22.05.03.0020.000153%Not Available
Pleural effusion22.05.02.0020.010442%
Pleural fibrosis22.05.03.0030.000153%Not Available
Pleurisy22.05.01.0010.000459%Not Available
Pneumonia22.07.01.003; 11.01.09.003--Not Available
Pneumonitis22.01.01.0060.037946%
Pneumothorax22.05.02.0030.001330%
Pollakiuria20.02.02.007--
Polydipsia14.05.02.001; 05.03.03.0020.000229%Not Available
Polyneuropathy17.09.03.0120.000306%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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