Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Leflunomide
Drug ID BADD_D01252
Description Leflunomide is a pyrimidine synthesis inhibitor belonging to the DMARD (disease-modifying antirheumatic drug) class of drugs, which are chemically and pharmacologically very heterogeneous. Leflunomide was approved by FDA and in many other countries (e.g., Canada, Europe) in 1999.
Indications and Usage For the management of the signs and symptoms of active rheumatoid arthritis (RA) to improve physical function and to slow the progression of structural damage associated with the disease. Has also been used for the prevention of acute and chronic rejection in recipients of solid organ trasnplants and is designated by the FDA as an orphan drug for this use.
Marketing Status approved; investigational
ATC Code L04AA13
DrugBank ID DB01097
KEGG ID D00749
MeSH ID D000077339
PubChem ID 3899
TTD Drug ID D08ROP
NDC Product Code 23155-044; 35573-447; 59651-349; 35573-448; 12579-510; 0088-2161; 59651-348; 60505-2502; 70748-130; 72266-133; 60505-2503; 0088-2160; 23155-043; 50268-478; 62332-061; 70771-1491; 70771-1492; 12579-509; 0955-1737; 71052-260; 10702-278; 46708-437; 0955-1735; 51927-4520; 10702-277; 0088-2162; 50268-477; 62332-062; 70518-3240; 70748-129; 14593-911; 46708-436; 70710-1157; 70710-1158; 72266-132; 53104-7557; 57741-3600; 66499-0001; 42291-420; 42291-421; 50090-5992
UNII G162GK9U4W
Synonyms Leflunomide | N-(4-Trifluoromethyphenyl)-5-methylisoxazole-4-carboxamide | HWA 486 | HWA-486 | HWA486 | SU101 | Arava
Chemical Information
Molecular Formula C12H9F3N2O2
CAS Registry Number 75706-12-6
SMILES CC1=C(C=NO1)C(=O)NC2=CC=C(C=C2)C(F)(F)F
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)
Pulmonary cavitation22.01.02.0220.002142%-
Subacute cutaneous lupus erythematosus10.04.03.012; 15.06.02.012; 23.03.02.0200.000857%-
Gastrointestinal oedema07.11.01.0120.000428%-
Foot deformity15.10.03.0050.001071%-
Hand deformity15.10.03.0070.000943%-
Oral cavity fistula07.11.05.0140.000428%
Trichodysplasia spinulosa10.03.02.004; 23.03.08.0150.000428%-
Invasive ductal breast carcinoma16.10.01.013; 21.05.01.0210.000428%-
Clear cell renal cell carcinoma16.08.02.004; 20.01.04.0080.000428%-
Granulomatous dermatitis10.04.02.015; 23.03.15.0060.000643%-
Bone marrow infiltration01.05.01.0180.000428%-
Blood loss anaemia01.03.02.018; 24.07.01.0880.000428%-
Central nervous system vasculitis10.02.02.030; 17.08.02.029; 24.12.04.0050.000643%-
Cholangiolitis09.02.01.0080.000428%-
Dyscalculia17.02.03.020; 19.21.01.0130.000428%-
Eosinophilic bronchitis01.02.04.020; 22.03.02.0130.001157%-
Gait inability08.01.02.011; 17.02.05.069---
Haemophagocytic lymphohistiocytosis01.05.01.026; 10.02.01.077; 16.32.03.0380.000428%-
Hypersensitivity pneumonitis10.01.03.056; 22.01.01.0270.000428%-
Illness08.01.03.091---
Joint space narrowing15.01.08.021---
Myelosuppression01.03.03.0150.000857%-
Spinal stenosis15.10.04.014; 17.10.01.0310.000643%-
Therapeutic product effect decreased08.06.01.0500.003342%-
Therapeutic product effect incomplete08.06.01.0520.002828%-
Therapeutic product ineffective08.06.01.057---
Therapeutic response shortened08.06.01.062---
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ADReCS-Target
Drug Name ADR Term Target
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