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Description A piperidinyl isoindole originally introduced as a non-barbiturate hypnotic, but withdrawn from the market due to teratogenic effects.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Marketing Status approved; investigational; withdrawn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)
Sjogren's syndrome06.08.02.011; 07.06.01.010; 10.04.04.009; 15.06.01.0150.000241%-
Skin cancer16.03.02.002; 23.08.02.0020.000603%-
Skin discolouration23.03.03.005---
Skin disorder23.03.03.0070.003520%-
Skin exfoliation23.03.07.003---
Skin irritation23.03.04.0090.001640%-
Skin lesion23.03.03.0100.003520%-
Skin necrosis23.03.03.011---
Skin reaction10.01.03.019; 23.03.03.0130.000772%-
Skin ulcer23.07.03.003; 24.04.03.007--
Small intestinal obstruction07.13.06.0010.000241%
Somnolence17.02.04.006; 19.02.05.0030.013382%
Spinal cord compression17.10.01.0060.000241%
Splenomegaly01.09.02.0010.000482%-
Squamous cell carcinoma of skin16.03.02.005; 23.08.02.0050.000964%-
Status epilepticus17.12.03.005---
Stevens-Johnson syndrome10.01.01.045; 11.07.01.005; 12.03.01.014; 23.03.01.007--
Stomatitis07.05.06.005--
Stupor17.02.04.007; 19.02.05.004---
Suicide attempt19.12.01.004--
Swelling08.01.03.0150.004485%-
Syncope02.11.04.015; 17.02.04.008; 24.06.02.0120.003520%
Systemic lupus erythematosus10.04.03.004; 15.06.02.003; 23.03.02.0060.001953%-
Tachycardia02.03.02.007---
Tension19.06.02.005---
Teratogenicity03.02.01.004; 12.03.01.032---
Therapeutic response decreased08.06.01.0160.002291%-
Thinking abnormal17.02.05.023; 19.10.03.001---
Thrombocytopenia01.08.01.002---
Thrombophlebitis24.01.02.0010.000241%-
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ADReCS-Target
Drug Name ADR Term Target
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