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 sensitisation23.03.03.052; 10.02.01.0380.002532%Not Available
Gastrointestinal tract irritation07.08.03.0080.001471%Not Available
Toxicity to various agents12.03.01.046--Not Available
Functional gastrointestinal disorder07.11.01.0160.005304%Not Available
Glassy eyes08.01.03.055; 06.08.03.0210.000820%Not Available
Muscle tone disorder17.05.02.014; 15.05.04.0170.001350%Not Available
Intraductal proliferative breast lesion21.05.01.014; 16.10.01.0060.001929%Not Available
Eye ulcer06.08.03.0180.001471%Not Available
Drug reaction with eosinophilia and systemic symptoms23.03.05.005; 10.01.01.021; 12.03.01.064--Not Available
Autoimmune haemolytic anaemia01.06.01.004; 10.04.01.005--Not Available
Candida infection11.03.03.021--
Faeces soft07.01.03.0080.011501%Not Available
Noninfective gingivitis07.09.13.0160.005280%Not Available
Mouth swelling23.04.01.020; 07.05.04.007; 10.01.05.0200.009042%Not Available
Respiratory symptom22.12.02.0130.005280%Not Available
Excessive cerumen production04.01.01.0040.001230%Not Available
Multiple organ dysfunction syndrome08.01.03.057--
Device related thrombosis24.01.01.027; 08.07.05.0010.000482%Not Available
Myeloproliferative neoplasm16.21.03.006; 01.13.03.0060.000362%Not Available
Gingival discomfort07.09.13.0030.001640%Not Available
Ureterolithiasis20.04.03.003--Not Available
Somatic symptom disorder19.24.01.006--Not Available
Abdominal mass07.01.01.0030.002532%Not Available
Acoustic neuroma17.18.02.002; 16.09.02.002; 04.04.04.0030.000241%Not Available
Adenocarcinoma gastric16.13.03.002; 07.21.02.0020.000723%Not Available
Adenocarcinoma of colon07.21.01.008; 16.13.01.0100.003617%Not Available
Adenocarcinoma of the cervix21.06.02.005; 16.12.01.0030.000241%Not Available
Adult T-cell lymphoma/leukaemia16.17.01.002; 01.11.01.0020.019048%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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