Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Thalidomide
Drug ID BADD_D02192
Description A piperidinyl isoindole originally introduced as a non-barbiturate hypnotic, but withdrawn from the market due to teratogenic effects. It has been reintroduced and used for a number of immunological and inflammatory disorders. Thalidomide displays immunosuppresive and anti-angiogenic activity. It inhibits release of tumor necrosis factor-alpha from monocytes, and modulates other cytokine action. [PubChem]
Indications and Usage For the acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL). Also for use as maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrence.
Marketing Status approved; investigational; withdrawn
ATC Code L04AX02
DrugBank ID DB01041
KEGG ID D00754
MeSH ID D013792
PubChem ID 5426
TTD Drug ID D0U7GK
NDC Product Code 17205-205; 59572-215; 68554-0011; 82991-205; 59572-220; 17337-0301; 59572-210; 59572-205; 63818-0424
UNII 4Z8R6ORS6L
Synonyms Thalidomide | Sedoval | Thalomid
Chemical Information
Molecular Formula C13H10N2O4
CAS Registry Number 50-35-1
SMILES C1CC(=O)NC(=O)C1N2C(=O)C3=CC=CC=C3C2=O
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)
Mental status changes19.07.01.001---
Musculoskeletal disorder15.03.05.0250.000844%-
Hypoacusis04.02.01.0060.002266%
Seasonal allergy06.04.01.013; 10.01.04.001; 22.04.04.0080.000820%-
Peripheral swelling02.05.04.015; 08.01.03.0530.020543%-
Red blood cell sedimentation rate decreased13.01.03.003---
General physical health deterioration08.01.03.0180.003086%-
Blood phosphorus decreased13.11.01.015---
Muscle tightness15.05.03.0070.000820%-
Balance disorder08.01.03.081; 17.02.02.0070.005256%-
Lung cancer metastatic16.19.02.003; 22.08.01.0040.000241%-
Deep vein thrombosis24.01.02.0030.006872%-
Cardiopulmonary failure02.05.01.004; 22.02.06.0040.000362%-
Acute coronary syndrome02.02.02.015; 24.04.04.0110.000241%-
Respiratory tract congestion22.02.07.0030.000940%-
Lymphatic disorder01.09.01.003---
Foetor hepaticus07.01.06.026; 09.01.05.006---
Musculoskeletal stiffness15.03.05.027---
Protein urine present13.13.02.006---
Musculoskeletal discomfort15.03.04.0010.000530%-
Inappropriate antidiuretic hormone secretion05.03.03.001; 14.05.07.001---
Tracheal disorder22.04.07.0050.000241%-
Bronchopneumopathy22.02.07.010---
Affect lability19.04.01.001---
Pulmonary mass22.02.07.0040.000241%-
Cutaneous lupus erythematosus10.04.03.007; 15.06.02.007; 23.03.02.0080.000820%-
Hypoaesthesia oral07.05.05.003; 17.02.06.0210.000651%-
Paraesthesia oral07.05.05.035; 17.02.06.0080.001230%-
Spleen palpable13.15.01.011---
Toxic skin eruption10.01.01.008; 12.03.01.073; 23.03.05.003---
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ADReCS-Target
Drug Name ADR Term Target
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