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)
Abdominal discomfort07.01.06.001--Not Available
Abdominal distension07.01.04.001--
Abdominal pain07.01.05.002--
Abdominal pain lower07.01.05.010--Not Available
Abdominal pain upper07.01.05.003--
Abdominal tenderness07.01.05.004--Not Available
Abnormal dreams19.02.03.001; 17.15.02.001--Not Available
Abnormal faeces07.01.03.001--Not Available
Abnormal sensation in eye06.01.01.001--Not Available
Abortion spontaneous18.01.04.001--Not Available
Abscess11.01.08.001--Not Available
Acidosis14.01.03.002--
Acne23.02.01.001--Not Available
Actinic keratosis23.01.06.001--Not Available
Acute abdomen07.01.06.015--Not Available
Acute febrile neutrophilic dermatosis23.03.03.033; 01.02.01.006--Not Available
Acute hepatic failure09.01.03.001--Not Available
Acute leukaemia16.01.02.001; 01.10.02.0010.003776%Not Available
Acute lymphocytic leukaemia16.01.01.001; 01.10.01.0010.007854%Not Available
Acute myeloid leukaemia16.01.05.001; 01.10.05.0010.030510%Not Available
Acute myocardial infarction24.04.04.001; 02.02.02.001--Not Available
Acute pulmonary oedema02.05.02.004; 22.01.03.005--Not Available
Acute respiratory distress syndrome22.01.03.001--
Acute respiratory failure22.02.06.001; 14.01.04.004--Not Available
Acute sinusitis22.07.03.013; 11.01.13.012--Not Available
Adenocarcinoma16.16.01.004--Not Available
Adenoma benign16.02.02.0010.001158%Not Available
Adrenal disorder05.01.03.0010.001158%Not Available
Adrenal insufficiency05.01.02.001; 14.11.01.004--
Affective disorder19.04.04.001--Not Available
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