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Description A piperidinyl isoindole originally introduced as a non-barbiturate hypnotic, but withdrawn from the market due to teratogenic effects.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Marketing Status approved; investigational; withdrawn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)
Face oedema23.04.01.004; 10.01.05.002; 08.01.07.003--
Facial pain08.01.08.0120.000530%
Facial paralysis17.04.03.0080.000362%Not Available
Faeces hard07.01.03.0030.000820%Not Available
Failure to thrive19.07.05.001; 18.04.01.003; 14.03.02.0080.000241%Not Available
Fatigue08.01.01.0020.038313%
Febrile neutropenia08.05.02.004; 01.02.03.0020.001857%
Feeling abnormal08.01.09.014--Not Available
Feeling jittery08.01.09.0160.000820%Not Available
Flatulence07.01.04.002--
Fluid retention20.01.02.003; 14.05.06.0020.003207%Not Available
Fungal skin infection23.11.03.006; 11.03.05.002--Not Available
Gait disturbance08.01.02.002; 15.03.05.013; 17.02.05.016--
Galactorrhoea21.05.02.002; 05.03.04.002--Not Available
Gallbladder disorder09.03.02.0010.000844%Not Available
Gastric ulcer07.04.03.002--
Gastritis07.08.02.0010.001181%
Gastroenteritis11.01.07.004; 07.19.03.001--Not Available
Gastrointestinal disorder07.11.01.0010.005329%Not Available
Gastrointestinal haemorrhage24.07.02.009; 07.12.02.0010.005425%Not Available
Gastrointestinal pain07.01.05.005--
Gastrointestinal perforation07.04.04.001--Not Available
Gastrointestinal stenosis07.13.01.0070.000241%Not Available
Generalised oedema14.05.06.007; 08.01.07.0040.000530%
Generalised tonic-clonic seizure17.12.01.002--Not Available
Gingival disorder07.09.13.004--Not Available
Glioblastoma17.20.02.002; 16.30.02.0020.000241%Not Available
Glossitis07.14.01.0010.000241%Not Available
Glossodynia07.14.02.0010.000530%Not Available
Gout15.01.06.001; 14.09.01.0010.001061%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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