Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Lenalidomide
Drug ID BADD_D01253
Description Lenalidomide (previously referred to as CC-5013) is an immunomodulatory drug with potent antineoplastic, anti-angiogenic, and anti-inflammatory properties.[A228553] It is a 4-amino-glutamyl analogue of [thalidomide] [A228543] and like thalidomide, lenalidomide exists as a racemic mixture of the active S(-) and R(+) forms.[A228708] However, lenalidomide is much safer and potent than thalidomide, with fewer adverse effects and toxicities.[A714, A228543] Thalidomide and its analogues, including lenalidomide, are referred to as immunomodulatory imide drugs (also known as cereblon modulators), which are a class of immunomodulatory drugs that contain an imide group. Lenalidomide works through various mechanisms of actions that promote malignant cell death and enhance host immunity.[A228708] Available as oral capsules, lenalidomide is approved by the FDA and EU for the treatment of multiple myeloma, myelodysplastic syndromes, mantle cell lymphoma, follicular lymphoma, and marginal zone lymphoma in selected patients.[L16028] Lenalidomide is available only under a special restricted distribution program.[A228708]
Indications and Usage Lenalidomide is indicated for the treatment of adult patients with multiple myeloma (MM) in combination with dexamethasone. It is also indicated as maintenance therapy in multiple myeloma following autologous hematopoietic stem cell transplantation (auto-HSCT). It is indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. Lenalidomide is indicated for the treatment of adult patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib. In combination with a rituximab product, lenalidomide is indicated for the treatment of adult patients with previously treated follicular lymphoma (FL) or previously treated marginal zone lymphoma (MZL).[L16028]
Marketing Status approved
ATC Code L04AX04
DrugBank ID DB00480
KEGG ID D04687
MeSH ID D000077269
PubChem ID 216326
TTD Drug ID D0Q5NX
NDC Product Code 54893-0061; 65015-772; 82991-402; 31722-257; 43598-512; 59572-410; 59572-425; 60505-4534; 0378-1941; 70710-1033; 53104-7720; 68554-0090; 82245-0101; 43598-516; 47781-486; 63304-044; 0378-1936; 70710-1032; 70710-1034; 70710-1035; 14096-131; 55111-911; 59651-733; 31722-260; 31722-262; 43598-514; 43598-515; 59572-420; 59651-342; 63304-042; 63304-043; 70771-1676; 0378-1935; 0480-1241; 0480-1242; 65727-084; 71796-026; 31722-261; 43598-511; 47781-484; 47781-487; 47781-488; 59572-405; 59651-346; 59651-347; 63304-045; 0378-1937; 0480-1246; 70771-1681; 0378-1942; 0480-1244; 70710-1031; 76282-697; 76282-699; 76282-701; 59116-4710; 31722-258; 59572-402; 59651-344; 0378-1940; 69097-604; 0480-1245; 70710-1030; 76282-698; 43598-513; 47781-483; 59572-415; 59651-345; 60505-4533; 63304-041; 69097-381; 69097-382; 69097-383; 69097-384; 69097-385; 70771-1680; 59651-343; 60505-4536; 63304-046; 0480-1243; 70771-1679; 55488-0700; 47781-485; 60505-4532; 60505-4535; 60505-4537; 70771-1677; 70771-1678; 53104-7726; 31722-259
UNII F0P408N6V4
Synonyms Lenalidomide | 3-(4-Amino-1-oxoisoindolin-2-yl)piperidine-2,6-dione | 2,6-Piperidinedione, 3-(4-amino-1,3-dihydro-1-oxo-2H- isoindol-2-yl)- | IMiD3 Cpd | CC 5013 | CC5013 | CC-5013 | Revlimid | Revimid
Chemical Information
Molecular Formula C13H13N3O3
CAS Registry Number 191732-72-6
SMILES C1CC(=O)NC(=O)C1N2CC3=C(C2=O)C=CC=C3N
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)
Refractory cancer16.16.01.0160.000241%Not Available
Lip pruritus07.05.05.0210.000820%Not Available
Cerebral small vessel ischaemic disease24.04.06.034; 17.08.02.0200.000241%Not Available
Bone deformity15.10.03.0060.000530%Not Available
Neuroendocrine carcinoma metastatic16.24.01.008; 05.08.01.0120.000241%Not Available
Spinal pain17.10.01.020; 15.02.01.008; 08.01.08.0300.009379%Not Available
Protein deficiency14.03.02.0230.000651%Not Available
Invasive ductal breast carcinoma21.05.01.021; 16.10.01.0130.002291%Not Available
Plasma cell myeloma recurrent16.23.02.006; 01.14.02.0060.086656%Not Available
Anal squamous cell carcinoma16.13.05.002; 07.21.05.0040.000603%Not Available
Appendix cancer16.13.01.011; 07.21.01.0090.000241%Not Available
Small intestine adenocarcinoma16.13.13.001; 07.21.01.0150.000241%Not Available
Myeloma cast nephropathy20.05.03.018; 16.32.03.0240.000964%Not Available
Splenic thrombosis24.01.08.006; 01.09.02.0180.000241%Not Available
Eyelid rash23.03.13.020; 06.04.04.0170.000820%Not Available
Pulmonary pain22.12.01.0100.002821%Not Available
Internal haemorrhage24.07.01.072--Not Available
Skin texture abnormal23.03.03.0680.001640%Not Available
Lower respiratory tract congestion22.12.01.0040.001230%Not Available
Urinary tract discomfort20.02.03.0170.000820%Not Available
Increased viscosity of upper respiratory secretion22.12.03.0080.000820%Not Available
Mental fatigue19.21.02.012; 17.03.03.0060.001061%Not Available
Vein rupture24.03.02.032; 12.01.11.0110.000940%Not Available
Critical illness08.01.03.0650.000651%Not Available
Tongue discomfort07.14.02.0190.005980%Not Available
Abdominal hernia obstructive07.16.06.0080.000362%Not Available
Acute biphenotypic leukaemia16.01.02.003; 01.10.02.0030.000241%Not Available
Acute cardiac event02.11.01.0010.000241%Not Available
Allergy to animal10.01.03.0510.000820%Not Available
Allergy to arthropod bite10.01.03.0350.000530%Not Available
The 36th Page    First    Pre   36 37 38 39 40    Next   Last    Total 40 Pages
ADReCS-Target
Drug Name ADR Term Target
Tip:  Drug Name  ADR Term  Protein  Variation  Gene