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 hypertension24.08.03.002; 22.06.01.0010.001071%
Purpura24.07.06.005; 23.06.01.004; 01.01.04.0030.000428%
Pustular psoriasis10.02.01.102; 23.03.14.0060.000428%Not Available
Pyoderma gangrenosum23.07.03.001; 16.32.03.005; 10.04.02.0090.000643%Not Available
Pyrexia08.05.02.0030.009598%
Radiculopathy17.10.01.0050.000428%
Rash23.03.13.0010.012340%Not Available
Rash erythematous23.03.13.0290.000857%Not Available
Rash macular23.03.13.0030.000857%Not Available
Rash maculo-papular23.03.13.0040.001500%
Rash papular23.03.13.0170.000428%Not Available
Rash pruritic23.03.13.0300.002142%Not Available
Renal failure20.01.03.0050.003428%Not Available
Respiratory disorder22.02.07.0020.000857%Not Available
Respiratory failure22.02.06.002; 14.01.04.0030.002142%
Retinal vein occlusion24.01.07.006; 06.10.01.0100.000428%Not Available
Rheumatoid arthritis15.01.03.001; 10.04.06.0010.013539%Not Available
Rhinitis11.01.13.004; 22.07.03.006--
Rhinorrhoea22.12.03.021--
Salivary gland enlargement07.06.03.002--Not Available
Scab23.03.03.0040.000428%Not Available
Sciatica17.10.03.001; 15.10.01.0010.000428%Not Available
Sensory disturbance17.02.07.0060.000643%Not Available
Sepsis11.01.11.003--
Serotonin syndrome12.03.01.041; 17.05.02.004; 15.05.04.0160.000428%Not Available
Shock24.06.02.0020.000428%Not Available
Sinusitis22.07.03.007; 11.01.13.005--
Sjogren's syndrome15.06.01.015; 10.04.04.009; 07.06.01.010; 06.08.02.0110.001157%Not Available
Skin atrophy23.01.05.0010.000643%
Skin cancer23.08.02.002; 16.03.02.0020.000857%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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