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)
Nasal crusting22.04.03.0230.000820%Not Available
Nasal sinus cancer22.08.02.014; 16.19.09.0030.000482%Not Available
Obstructive sleep apnoea syndrome19.02.05.012; 17.15.05.003; 22.02.01.038--Not Available
Ophthalmic migraine17.14.02.005; 06.02.07.0090.000820%Not Available
Optic nerve sheath haemorrhage24.07.05.019; 06.07.03.0060.000241%Not Available
Oral blood blister23.03.01.039; 12.01.17.016; 07.05.02.0040.000530%Not Available
Paget's disease of the vulva21.08.03.007; 16.12.08.0030.000362%Not Available
Paranasal sinus neoplasm22.08.02.015; 16.19.04.0020.000241%Not Available
Perineal ulceration23.07.03.031; 21.10.05.028; 15.03.02.0230.000241%Not Available
Periorbital swelling06.08.03.032; 23.04.01.025; 10.01.05.0250.006510%Not Available
Peripheral T-cell lymphoma unspecified refractory16.17.06.002; 01.11.06.0020.000241%Not Available
Pharyngeal cancer22.08.02.016; 16.19.12.0010.000241%Not Available
Physical deconditioning08.01.03.0960.004099%Not Available
Plasma cell myeloma in remission16.23.02.007; 01.14.02.0070.002580%Not Available
Plasma cell myeloma refractory16.23.02.008; 01.14.02.0080.000964%Not Available
Pleural mesothelioma malignant22.05.04.004; 16.39.01.0040.000241%Not Available
Polyneuropathy in malignant disease17.09.04.010; 16.32.01.014; 10.02.01.1000.000362%Not Available
Primary amyloidosis10.02.05.0090.000241%Not Available
Primary mediastinal large B-cell lymphoma01.15.11.001; 16.28.11.0010.000482%Not Available
Pseudostroke24.03.05.018; 17.08.01.0730.000241%Not Available
Pubic pain15.02.01.0090.000530%Not Available
Pulmonary amyloidosis22.01.02.034; 10.02.05.0100.000241%Not Available
Sacral pain15.03.04.0230.000241%Not Available
Sensitive skin23.03.03.0970.006582%Not Available
Skin laceration12.01.06.016; 23.03.11.041--Not Available
Sleep deficit17.15.04.0100.001471%Not Available
Soft tissue neoplasm16.33.08.004; 15.09.02.0080.000241%Not Available
Spinal ligament ossification15.07.02.0100.000241%Not Available
Spinal stenosis17.10.01.031; 15.10.04.0140.007884%Not Available
Spindle cell sarcoma16.33.01.006; 15.09.03.0360.000362%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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