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Description A piperidinyl isoindole originally introduced as a non-barbiturate hypnotic, but withdrawn from the market due to teratogenic effects.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Marketing Status approved; investigational; withdrawn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)
Thrombosis24.01.01.0060.009283%-
Thyroid disorder05.02.01.0020.000651%-
Thyroid function test abnormal13.10.06.001---
Tinnitus04.04.01.002; 17.04.07.004--
Tongue discolouration07.14.02.006---
Tooth disorder07.09.05.0010.003641%-
Toothache07.09.06.001--
Toxic epidermal necrolysis10.01.01.006; 11.07.01.006; 12.03.01.015; 23.03.01.0080.000362%
Transient ischaemic attack17.08.04.001; 24.04.06.0050.000964%
Tremor17.01.06.0020.007209%
Tumour lysis syndrome14.05.01.004; 16.32.03.0020.000530%
Ulcer08.03.06.0010.001230%-
Unresponsive to stimuli17.02.05.0310.000723%-
Upper respiratory tract infection11.01.13.009; 22.07.03.011--
Urethral disorder20.07.01.002---
Urinary tract disorder20.08.01.001---
Urticaria10.01.06.001; 23.04.02.001--
Uterine cancer16.12.05.001; 21.07.02.0030.000362%-
Vascular purpura01.01.04.007; 23.06.01.008; 24.07.06.011---
Vasodilatation23.06.05.006; 24.03.02.003---
Venous thrombosis24.01.01.008---
Vertigo04.04.01.003; 17.02.12.002--
Viral infection11.05.04.001---
Vision blurred06.02.06.007; 17.17.01.010--
Visual acuity reduced06.02.10.012; 17.17.01.0110.001350%
Visual impairment06.02.10.013---
Vomiting07.01.07.003--
Weight decreased13.15.01.005--
Weight increased13.15.01.006--
White blood cell count decreased13.01.06.012--
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ADReCS-Target
Drug Name ADR Term Target
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