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%-
Nasal sinus cancer16.19.09.003; 22.08.02.0140.000482%-
Obstructive sleep apnoea syndrome17.15.05.003; 19.02.05.012; 22.02.01.038---
Ophthalmic migraine06.02.07.009; 17.14.02.0050.000820%-
Optic nerve sheath haemorrhage06.07.03.006; 24.07.05.0190.000241%-
Oral blood blister07.05.02.004; 12.01.17.016; 23.03.01.0390.000530%-
Paget's disease of the vulva16.12.08.003; 21.08.03.0070.000362%-
Paranasal sinus neoplasm16.19.04.002; 22.08.02.0150.000241%-
Perineal ulceration15.03.02.023; 21.10.05.028; 23.07.03.0310.000241%-
Periorbital swelling06.08.03.032; 10.01.05.025; 23.04.01.0250.006510%-
Peripheral T-cell lymphoma unspecified refractory01.11.06.002; 16.17.06.0020.000241%-
Pharyngeal cancer16.19.12.001; 22.08.02.0160.000241%-
Physical deconditioning08.01.03.0960.004099%-
Plasma cell myeloma in remission01.14.02.007; 16.23.02.0070.002580%-
Plasma cell myeloma refractory01.14.02.008; 16.23.02.0080.000964%-
Pleural mesothelioma malignant16.39.01.004; 22.05.04.0040.000241%-
Polyneuropathy in malignant disease10.02.01.100; 16.32.01.014; 17.09.04.0100.000362%-
Primary amyloidosis10.02.05.0090.000241%-
Primary mediastinal large B-cell lymphoma01.15.11.001; 16.28.11.0010.000482%-
Pseudostroke17.08.01.073; 24.03.05.0180.000241%-
Pubic pain15.02.01.0090.000530%-
Pulmonary amyloidosis10.02.05.010; 22.01.02.0340.000241%-
Sacral pain15.03.04.0230.000241%-
Sensitive skin23.03.03.0970.006582%-
Skin laceration12.01.06.016; 23.03.11.041---
Sleep deficit17.15.04.0100.001471%-
Soft tissue neoplasm15.09.02.008; 16.33.08.0040.000241%-
Spinal ligament ossification15.07.02.0100.000241%-
Spinal stenosis15.10.04.014; 17.10.01.0310.007884%-
Spindle cell sarcoma15.09.03.036; 16.33.01.0060.000362%-
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ADReCS-Target
Drug Name ADR Term Target
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