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
TTD Drug ID D0Q5NX
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
SMILES C1CC(=O)NC(=O)C1N2CC3=C(C2=O)C=CC=C3N
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)
Blood potassium increased13.11.01.011--Not Available
Blood pressure abnormal13.14.03.0010.031266%Not Available
Blood pressure decreased13.14.03.002--Not Available
Blood pressure fluctuation24.06.01.002--Not Available
Blood pressure increased13.14.03.005--Not Available
Blood pressure systolic decreased13.14.03.007--Not Available
Blood pressure systolic increased13.14.03.006--Not Available
Blood sodium abnormal13.11.01.0250.002895%Not Available
Blood sodium decreased13.11.01.0120.027213%Not Available
Blood testosterone decreased13.10.05.004--Not Available
Blood thyroid stimulating hormone increased13.10.03.006--
Blood triglycerides increased13.12.03.001--Not Available
Blood urea increased13.13.01.006--Not Available
Blood uric acid increased13.02.04.0010.008685%Not Available
Body temperature decreased13.15.01.010--Not Available
Body temperature increased13.15.01.0010.028950%Not Available
Bone disorder15.02.04.0040.038213%Not Available
Bone pain15.02.01.0010.100166%
Bowen's disease23.08.02.004; 16.03.02.004--Not Available
Bradycardia02.03.02.002--Not Available
Brain abscess17.06.07.001; 11.01.03.003--Not Available
Brain herniation12.01.10.001; 17.11.01.002--Not Available
Breast cancer21.05.01.003; 16.10.01.001--Not Available
Breast cyst21.05.01.006; 16.14.01.004--Not Available
Breast disorder female21.05.04.0070.001158%Not Available
Breast enlargement21.05.04.001--Not Available
Breast mass21.05.04.0020.008685%Not Available
Breast neoplasm21.05.01.004; 16.10.02.0010.001158%Not Available
Breast pain21.05.05.003--
Breast swelling21.05.05.008--Not Available
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