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 Prescription; Discontinued
ATC Code L04AA13
DrugBank ID DB01097
KEGG ID D00749
MeSH ID D000077339
PubChem ID 3899
TTD Drug ID D08ROP
NDC Product Code 46708-436; 59651-348; 71052-260; 46708-848; 66499-0001; 70771-1492; 42291-421; 35573-448; 46708-437; 60505-2503; 0955-1735; 62332-062; 60505-2502; 14593-911; 70748-130; 70771-1491; 10702-278; 23155-044; 42291-420; 50268-478; 23155-043; 51927-0170; 53104-7557; 0088-2160; 70710-1157; 70710-1158; 72969-037; 10702-277; 0088-2162; 70748-129; 0088-2161; 62332-061; 35573-447; 51927-4520; 70518-3240; 59651-349; 57741-3600; 50268-477; 0955-1737
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
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Superficial spreading melanoma stage unspecified23.08.01.010; 16.03.01.0100.002066%Not Available
Pseudarthrosis15.08.01.001; 12.04.02.0100.003098%Not Available
Atrial thrombosis24.01.05.005; 02.01.01.0130.002066%Not Available
Urticarial vasculitis10.01.06.012; 24.05.02.027; 23.04.02.0120.004131%Not Available
Mycobacterium fortuitum infection11.04.02.0060.000808%Not Available
Carbohydrate antigen 125 increased13.22.01.0050.003098%Not Available
Pulmonary cavitation22.01.02.0220.010328%Not Available
Clostridium difficile infection11.02.02.0090.002066%Not Available
Tubo-ovarian abscess21.14.03.005; 11.01.10.0230.002066%Not Available
Psoas abscess15.05.01.008; 11.01.17.0080.000539%Not Available
Infective exacerbation of chronic obstructive airways disease22.03.01.022; 11.01.09.0150.002066%Not Available
Subacute cutaneous lupus erythematosus23.03.02.020; 15.06.02.012; 10.04.03.0120.002066%Not Available
Escherichia infection11.02.10.0040.005164%Not Available
Foot deformity15.10.03.0050.005164%Not Available
Hand deformity15.10.03.0070.002066%Not Available
Nerve root compression17.10.01.0160.002066%Not Available
Congenital nose malformation22.10.02.003; 03.16.04.0010.003098%Not Available
Ligament rupture15.07.02.008; 12.01.07.0140.003098%Not Available
Oral cavity fistula07.11.05.0140.002066%
Inflammatory marker increased13.09.02.0030.002066%Not Available
Infectious pleural effusion22.05.01.004; 11.01.09.0110.002066%Not Available
Trichodysplasia spinulosa23.03.08.015; 10.03.02.0040.002066%Not Available
Meniscus injury12.04.03.008; 15.07.03.0060.004131%Not Available
Invasive ductal breast carcinoma21.05.01.021; 16.10.01.0130.002066%Not Available
Clear cell renal cell carcinoma20.01.04.008; 16.08.02.0040.002066%Not Available
Granulomatous dermatitis23.03.15.006; 10.04.02.0150.004131%Not Available
Bone marrow infiltration01.05.01.0180.002066%Not Available
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