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Description A piperidinyl isoindole originally introduced as a non-barbiturate hypnotic, but withdrawn from the market due to teratogenic effects.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Marketing Status approved; investigational; withdrawn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 syndrome15.06.01.015; 10.04.04.009; 07.06.01.010; 06.08.02.0110.000241%Not Available
Skin cancer23.08.02.002; 16.03.02.0020.000603%Not Available
Skin discolouration23.03.03.005--Not Available
Skin disorder23.03.03.0070.003520%Not Available
Skin exfoliation23.03.07.003--Not Available
Skin irritation23.03.04.0090.001640%Not Available
Skin lesion23.03.03.0100.003520%Not Available
Skin necrosis23.03.03.011--Not Available
Skin reaction23.03.03.013; 10.01.03.0190.000772%Not Available
Skin ulcer24.04.03.007; 23.07.03.003--
Small intestinal obstruction07.13.06.0010.000241%
Somnolence19.02.05.003; 17.02.04.0060.013382%
Spinal cord compression17.10.01.0060.000241%
Splenomegaly01.09.02.0010.000482%Not Available
Squamous cell carcinoma of skin23.08.02.005; 16.03.02.0050.000964%Not Available
Status epilepticus17.12.03.005--Not Available
Stevens-Johnson syndrome11.07.01.005; 10.01.01.045; 23.03.01.007; 12.03.01.014--
Stomatitis07.05.06.005--
Stupor17.02.04.007; 19.02.05.004--Not Available
Suicide attempt19.12.01.004--
Swelling08.01.03.0150.004485%Not Available
Syncope17.02.04.008; 02.11.04.015; 24.06.02.0120.003520%
Systemic lupus erythematosus23.03.02.006; 15.06.02.003; 10.04.03.0040.001953%Not Available
Tachycardia02.03.02.007--Not Available
Tension19.06.02.005--Not Available
Teratogenicity03.02.01.004; 12.03.01.032--Not Available
Therapeutic response decreased08.06.01.0160.002291%Not Available
Thinking abnormal19.10.03.001; 17.02.05.023--Not Available
Thrombocytopenia01.08.01.002--Not Available
Thrombophlebitis24.01.02.0010.000241%Not Available
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ADReCS-Target
Drug Name ADR Term Target
Tip:  Drug Name  ADR Term  Protein  Variation  Gene