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Description A piperidinyl isoindole originally introduced as a non-barbiturate hypnotic, but withdrawn from the market due to teratogenic effects.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Marketing Status approved; investigational; withdrawn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)
Bronchial wall thickening22.03.02.006---
Adverse reaction08.06.01.0180.002990%-
Genital swelling21.10.01.0100.000651%-
Acute kidney injury20.01.03.016--
Posterior reversible encephalopathy syndrome17.13.02.007--
Application site haemorrhage08.02.01.040; 12.07.01.040; 24.07.01.0480.000241%-
Lacrimal structural disorder06.06.04.013---
Pneumocystis jirovecii pneumonia11.03.07.005; 22.07.08.009---
Candida infection11.03.03.021--
Sinus node dysfunction02.03.03.017--
Multiple organ dysfunction syndrome08.01.03.0570.001326%
Device related thrombosis08.07.05.001; 24.01.01.0270.000241%-
Anal incontinence07.01.06.029; 17.05.01.0210.000241%
Liver function test increased13.03.04.031---
Abdominal mass07.01.01.0030.000241%-
Adenocarcinoma of colon07.21.01.008; 16.13.01.0100.000241%-
Anal ulcer07.04.01.0010.000241%
Behcet's syndrome06.04.05.017; 07.05.06.008; 10.02.02.015; 15.01.01.009; 21.10.03.009; 23.06.02.004; 24.12.04.0030.000241%-
Brain neoplasm malignant16.30.04.002; 17.20.04.0020.001808%-
Ewing's sarcoma15.09.03.015; 16.29.03.0040.000241%-
Jugular vein thrombosis24.01.02.0070.000241%-
Medulloblastoma16.30.02.006; 17.20.02.0060.000241%-
Normal newborn18.08.06.0010.000964%-
Live birth18.08.02.0070.000482%-
Small intestinal haemorrhage07.12.03.002; 24.07.02.0190.000530%
Ovarian epithelial cancer16.12.04.006; 21.11.01.0170.000241%-
Abdominal wall haematoma07.16.05.005; 24.07.02.0390.000362%-
Apparent death08.01.03.0620.000530%-
Plasma cell myeloma recurrent01.14.02.006; 16.23.02.0060.002146%-
Internal haemorrhage24.07.01.0720.000241%-
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ADReCS-Target
Drug Name ADR Term Target
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