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 multiple myeloma in combination with dexamethasone. It is also indicated for the treatment of patients with transfusion-dependent anemia due to low- or intermediate- risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.
Marketing Status Prescription
ATC Code L04AX04
DrugBank ID DB00480
KEGG ID D04687
MeSH ID D000077269
PubChem ID 216326
NDC Product Code 59572-415; 59572-402; 55488-0700; 0480-1242; 0480-1244; 14096-131; 65727-084; 0480-1246; 59572-420; 59116-4710; 59572-425; 53104-7720; 59572-410; 55111-911; 68554-0090; 71796-026; 0480-1243; 46708-927; 59572-405; 53104-7726; 54893-0061; 82245-0101; 65015-772
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
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Atrial fibrillation02.03.03.0020.249545%
Atrial flutter02.03.03.0030.018528%
Atrioventricular block02.03.01.002--Not Available
Atrioventricular block complete02.03.01.003--
Atrioventricular block second degree02.03.01.005--
Atypical pneumonia11.01.09.012; Available
Auditory disorder04.02.03.0020.005790%Not Available
Aura17.02.07.011--Not Available
Azotaemia20.01.01.001--Not Available
B-cell lymphoma16.28.01.001; Available
B-cell type acute leukaemia16.01.01.002; Available
Back disorder15.03.01.0140.105955%Not Available
Back pain15.03.04.005--
Barrett's oesophagus07.11.03.0020.001737%Not Available
Basal cell carcinoma16.03.02.001; Available
Basedow's disease10.04.08.004;; Available
Benign prostatic hyperplasia21.04.02.001--Not Available
Bile duct cancer16.07.01.001; Available
Bile duct stone09.02.02.003--Not Available
Biliary colic09.02.01.0010.002316%Not Available
Bipolar I disorder19.16.01.002--Not Available
Bladder cancer20.03.04.001; Available
Bladder neoplasm20.03.04.002; Available
Bladder pain20.02.02.001--Not Available
Bleeding time prolonged13.01.02.0020.004053%Not Available
Blepharitis23.03.04.012; Available
Blepharospasm17.17.02.001; Available
Blindness17.17.01.003; Available
Blindness transient17.17.01.004; Available
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