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)
Urine phosphorus increased13.11.01.047--Not Available
Haemorrhage24.07.01.002--Not Available
Pulmonary mass22.02.07.0040.004070%Not Available
Pre-existing disease08.01.03.059--Not Available
Cutaneous lupus erythematosus23.03.02.008; 15.06.02.007; 10.04.03.0070.000643%Not Available
Colitis microscopic07.08.01.0110.001071%Not Available
Toxic skin eruption12.03.01.073; 23.03.05.003; 10.01.01.0080.000857%Not Available
Neutrophilic dermatosis01.02.01.013; 23.03.03.0590.000428%Not Available
Lung neoplasm malignant22.08.01.001; 16.19.02.0010.000643%Not Available
Vasodilation procedure25.03.01.001--Not Available
Restless legs syndrome17.02.07.008; 15.05.03.0120.000643%Not Available
Bicytopenia01.03.03.0100.000428%Not Available
Juvenile idiopathic arthritis15.01.03.004; 10.04.06.004--Not Available
Pleuropericarditis02.06.02.003; 22.05.01.0020.000643%Not Available
Hepatic enzyme increased13.03.04.028--Not Available
Adverse event08.06.01.010--Not Available
Breast disorder21.05.04.004--Not Available
Cardiac disorder02.11.01.003--Not Available
Connective tissue disorder10.04.04.026; 15.06.01.006--Not Available
Infarction24.04.02.0170.000428%Not Available
Infestation23.11.01.002; 11.09.01.001--Not Available
Inflammation10.02.01.089; 08.01.05.0070.002228%Not Available
Limb discomfort15.03.04.014--Not Available
Intervertebral disc degeneration15.10.01.0020.000643%Not Available
Malnutrition14.03.02.0040.000943%Not Available
Mediastinal disorder22.09.03.001--Not Available
Mental disorder19.07.01.002--Not Available
Decreased appetite08.01.09.028; 14.03.01.005--
Ill-defined disorder08.01.03.049--Not Available
Intervertebral disc disorder15.10.01.0030.000643%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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