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)
Ageusia17.02.07.001; 07.14.03.0030.105376%Not Available
Aggression19.05.01.001--Not Available
Agitation19.06.02.001; 17.02.05.012--
Agranulocytosis01.02.03.001--Not Available
Alanine aminotransferase abnormal13.03.01.0010.001737%Not Available
Alanine aminotransferase increased13.03.01.003--
Alopecia23.02.02.001--
Altered state of consciousness19.07.01.003; 17.02.04.001--Not Available
Alveolitis22.01.01.001--Not Available
Alveolitis allergic22.01.01.002; 10.01.03.0080.004632%Not Available
Amaurosis fugax24.04.06.006; 17.08.04.002; 06.02.02.0050.002316%Not Available
Amenorrhoea21.01.02.001; 05.05.01.002--
Ammonia increased13.03.01.023--Not Available
Amnesia19.20.01.001; 17.03.02.0010.105376%
Amylase increased13.05.01.009--
Amyloidosis10.02.05.0010.006193%Not Available
Anaemia01.03.02.0010.527461%
Anal fissure07.03.01.002--
Anaphylactic reaction24.06.03.006; 10.01.07.001--
Aneurysm24.02.01.001--Not Available
Anger19.04.02.001--Not Available
Angina pectoris24.04.04.002; 02.02.02.002--
Angina unstable24.04.04.004; 02.02.02.004--Not Available
Angioedema23.04.01.001; 10.01.05.009--Not Available
Angioimmunoblastic T-cell lymphoma16.17.05.001; 01.11.05.0010.000302%Not Available
Ankle fracture15.08.03.005; 12.04.01.0050.021423%
Anorectal disorder07.03.01.001--Not Available
Anosmia22.04.03.006; 17.04.04.0010.011580%
Anuria20.01.03.002--Not Available
Anxiety19.06.02.002--
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