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)
Upper-airway cough syndrome22.12.03.0360.012393%
Foetal growth restriction18.03.01.002--
Skin sensitisation10.02.01.038; 23.03.03.0520.002532%-
Gastrointestinal tract irritation07.08.03.0080.001471%-
Toxicity to various agents12.03.01.046---
Functional gastrointestinal disorder07.11.01.0160.005304%-
Glassy eyes06.08.03.021; 08.01.03.0550.000820%-
Muscle tone disorder15.05.04.017; 17.05.02.0140.001350%-
Intraductal proliferative breast lesion16.10.01.006; 21.05.01.0140.001929%-
Eye ulcer06.08.03.0180.001471%-
Drug reaction with eosinophilia and systemic symptoms10.01.01.021; 12.03.01.064; 23.03.05.005---
Autoimmune haemolytic anaemia01.06.01.004; 10.04.01.005---
Candida infection11.03.03.021--
Faeces soft07.01.03.0080.011501%-
Noninfective gingivitis07.09.13.0160.005280%-
Mouth swelling07.05.04.007; 10.01.05.020; 23.04.01.0200.009042%-
Respiratory symptom22.12.02.0130.005280%-
Excessive cerumen production04.01.01.0040.001230%-
Multiple organ dysfunction syndrome08.01.03.057--
Device related thrombosis08.07.05.001; 24.01.01.0270.000482%-
Myeloproliferative neoplasm01.13.03.006; 16.21.03.0060.000362%-
Gingival discomfort07.09.13.0030.001640%-
Ureterolithiasis20.04.03.003---
Somatic symptom disorder19.24.01.006---
Abdominal mass07.01.01.0030.002532%-
Acoustic neuroma04.04.04.003; 16.09.02.002; 17.18.02.0020.000241%-
Adenocarcinoma gastric07.21.02.002; 16.13.03.0020.000723%-
Adenocarcinoma of colon07.21.01.008; 16.13.01.0100.003617%-
Adenocarcinoma of the cervix16.12.01.003; 21.06.02.0050.000241%-
Adult T-cell lymphoma/leukaemia01.11.01.002; 16.17.01.0020.019048%-
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ADReCS-Target
Drug Name ADR Term Target
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