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Description A piperidinyl isoindole originally introduced as a non-barbiturate hypnotic, but withdrawn from the market due to teratogenic effects.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Marketing Status approved; investigational; withdrawn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)
Bone pain15.02.01.0010.002291%
Bradycardia02.03.02.0020.002508%-
Breast mass21.05.04.0020.000530%-
Bronchitis11.01.09.001; 22.07.01.001--
Bronchospasm10.01.03.012; 22.03.01.004--
Burning sensation08.01.09.029; 17.02.06.001---
Cardiac arrest02.03.04.001--
Cardiac failure02.05.01.0010.002773%
Cardiac failure congestive02.05.01.0020.002652%-
Cardiac murmur13.14.01.001---
Cardiovascular disorder02.11.01.010; 24.03.02.0090.001326%-
Carnitine decreased13.12.02.003---
Carpal tunnel syndrome17.09.02.001---
Cataract06.06.01.0010.001206%
CD4 lymphocytes decreased13.01.06.016--
Cellulitis11.02.01.001; 23.11.02.004---
Cerebral ischaemia17.08.01.005; 24.04.06.003--
Cerebrovascular accident17.08.01.007; 24.03.05.0010.005184%
Chest pain02.02.02.011; 08.01.08.002; 22.12.02.0030.004533%-
Chills08.01.09.001; 15.05.03.016--
Cholangitis09.02.01.002---
Cholecystitis09.03.01.0010.000241%
Cholestasis09.01.01.001---
Chronic myeloid leukaemia01.10.07.001; 16.01.07.0010.000241%-
Chronic obstructive pulmonary disease22.03.01.0070.001567%-
Colitis07.08.01.001--
Confusional state17.02.03.005; 19.13.01.001--
Congenital anomaly03.02.01.001---
Conjunctivitis06.04.01.002; 11.01.06.012--
Constipation07.02.02.0010.024714%
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ADReCS-Target
Drug Name ADR Term Target
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