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Description A piperidinyl isoindole originally introduced as a non-barbiturate hypnotic, but withdrawn from the market due to teratogenic effects.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Marketing Status approved; investigational; withdrawn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)
Infection11.01.08.002--Not Available
Influenza22.07.02.001; 11.05.03.001--Not Available
Injury12.01.08.004--Not Available
Insomnia19.02.01.002; 17.15.03.002--
Interstitial lung disease22.01.02.003; 10.02.01.033--Not Available
Intestinal obstruction07.13.01.0020.000964%Not Available
Intestinal perforation07.04.06.0020.000241%Not Available
Iron deficiency anaemia01.03.01.002; 14.13.02.0010.000241%Not Available
Jaundice cholestatic09.01.01.005--Not Available
Joint stiffness15.01.02.0030.000940%Not Available
Joint swelling15.01.02.0040.009669%Not Available
Lacrimation increased06.08.02.0040.000772%
Large intestine perforation12.02.03.005; 07.04.06.0050.000482%
Lethargy19.04.04.004; 17.02.04.003; 08.01.01.008--
Leukaemia16.01.03.001; 01.10.03.0010.000362%
Leukocytosis01.02.01.002--
Leukopenia01.02.02.001--Not Available
Libido decreased21.03.02.005; 19.08.03.001--
Limb reduction defect15.11.07.004; 03.11.07.004--Not Available
Lipase increased13.05.01.003--
Liver disorder09.01.08.0010.000964%Not Available
Liver function test abnormal13.03.04.030--Not Available
Loss of consciousness17.02.04.004--Not Available
Loss of control of legs08.01.02.0030.000241%Not Available
Lung disorder22.02.07.0010.001423%Not Available
Lymphadenopathy01.09.01.002--Not Available
Lymphoedema24.09.01.001; 01.09.01.006--
Lymphoma01.12.01.001; 16.20.01.0010.000482%Not Available
Lymphopenia01.02.02.002--Not Available
Malaise08.01.01.003--
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ADReCS-Target
Drug Name ADR Term Target
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