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Description A piperidinyl isoindole originally introduced as a non-barbiturate hypnotic, but withdrawn from the market due to teratogenic effects.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Marketing Status approved; investigational; withdrawn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--Not Available
Adverse reaction08.06.01.0180.002990%Not Available
Genital swelling21.10.01.0100.000651%Not Available
Acute kidney injury20.01.03.016--
Posterior reversible encephalopathy syndrome17.13.02.007--
Application site haemorrhage24.07.01.048; 12.07.01.040; 08.02.01.0400.000241%Not Available
Lacrimal structural disorder06.06.04.013--Not Available
Pneumocystis jirovecii pneumonia22.07.08.009; 11.03.07.005--Not Available
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%Not Available
Anal incontinence17.05.01.021; 07.01.06.0290.000241%
Liver function test increased13.03.04.031--Not Available
Abdominal mass07.01.01.0030.000241%Not Available
Adenocarcinoma of colon16.13.01.010; 07.21.01.0080.000241%Not Available
Anal ulcer07.04.01.0010.000241%
Behcet's syndrome24.12.04.003; 23.06.02.004; 21.10.03.009; 15.01.01.009; 10.02.02.015; 07.05.06.008; 06.04.05.0170.000241%Not Available
Brain neoplasm malignant17.20.04.002; 16.30.04.0020.001808%Not Available
Ewing's sarcoma16.29.03.004; 15.09.03.0150.000241%Not Available
Jugular vein thrombosis24.01.02.0070.000241%Not Available
Medulloblastoma17.20.02.006; 16.30.02.0060.000241%Not Available
Normal newborn18.08.06.0010.000964%Not Available
Live birth18.08.02.0070.000482%Not Available
Small intestinal haemorrhage24.07.02.019; 07.12.03.0020.000530%
Ovarian epithelial cancer21.11.01.017; 16.12.04.0060.000241%Not Available
Abdominal wall haematoma24.07.02.039; 07.16.05.0050.000362%Not Available
Apparent death08.01.03.0620.000530%Not Available
Plasma cell myeloma recurrent01.14.02.006; 16.23.02.0060.002146%Not Available
Internal haemorrhage24.07.01.0720.000241%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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