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%Not Available
Subacute cutaneous lupus erythematosus23.03.02.020; 15.06.02.012; 10.04.03.0120.000857%Not Available
Gastrointestinal oedema07.11.01.0120.000428%Not Available
Foot deformity15.10.03.0050.001071%Not Available
Hand deformity15.10.03.0070.000943%Not Available
Oral cavity fistula07.11.05.0140.000428%
Trichodysplasia spinulosa23.03.08.015; 10.03.02.0040.000428%Not Available
Invasive ductal breast carcinoma16.10.01.013; 21.05.01.0210.000428%Not Available
Clear cell renal cell carcinoma16.08.02.004; 20.01.04.0080.000428%Not Available
Granulomatous dermatitis23.03.15.006; 10.04.02.0150.000643%Not Available
Bone marrow infiltration01.05.01.0180.000428%Not Available
Blood loss anaemia01.03.02.018; 24.07.01.0880.000428%Not Available
Central nervous system vasculitis24.12.04.005; 17.08.02.029; 10.02.02.0300.000643%Not Available
Cholangiolitis09.02.01.0080.000428%Not Available
Dyscalculia19.21.01.013; 17.02.03.0200.000428%Not Available
Eosinophilic bronchitis22.03.02.013; 01.02.04.0200.001157%Not Available
Gait inability17.02.05.069; 08.01.02.011--Not Available
Haemophagocytic lymphohistiocytosis10.02.01.077; 01.05.01.026; 16.32.03.0380.000428%Not Available
Hypersensitivity pneumonitis22.01.01.027; 10.01.03.0560.000428%Not Available
Illness08.01.03.091--Not Available
Joint space narrowing15.01.08.021--Not Available
Myelosuppression01.03.03.0150.000857%Not Available
Spinal stenosis17.10.01.031; 15.10.04.0140.000643%Not Available
Therapeutic product effect decreased08.06.01.0500.003342%Not Available
Therapeutic product effect incomplete08.06.01.0520.002828%Not Available
Therapeutic product ineffective08.06.01.057--Not Available
Therapeutic response shortened08.06.01.062--Not Available
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ADReCS-Target
Drug Name ADR Term Target
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