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)
Colitis07.08.01.0010.009295%
Colitis ulcerative07.08.01.005; 10.02.01.0040.002066%Not Available
Colon cancer16.13.01.001; 07.21.01.0010.000539%Not Available
Conduction disorder02.03.01.0080.002066%
Confusional state17.02.03.005; 19.13.01.001--
Congenital anomaly03.02.01.001--Not Available
Conjunctivitis11.01.06.012; 06.04.01.002--
Constipation07.02.02.001--
Cough22.02.03.0010.022722%
Crohn's disease10.02.01.005; 07.08.01.0150.002066%Not Available
Cryptococcosis11.03.04.0010.002066%Not Available
Cutaneous vasculitis24.05.02.004; 23.06.02.001; 10.02.02.003--Not Available
Cyst16.02.02.002; 08.03.05.001--Not Available
Cystitis20.03.02.002; 11.01.14.0010.002066%
Death08.04.01.001--
Dehydration14.05.05.001--
Delirium19.13.02.0010.003098%
Depressed mood19.15.02.001--Not Available
Depression19.15.01.001--
Dermatitis23.03.04.0020.003098%Not Available
Dermatitis allergic23.03.04.003; 10.01.03.0140.002066%Not Available
Dermatitis contact23.03.04.004; 12.03.01.040; 10.01.01.003--Not Available
Developmental delay08.01.03.037--Not Available
Diabetes mellitus14.06.01.001; 05.06.01.001--Not Available
Diabetic ketoacidosis14.07.03.001; 05.07.03.0010.007230%Not Available
Diarrhoea07.02.01.0010.049575%
Diarrhoea haemorrhagic24.07.02.004; 07.02.01.0020.002066%Not Available
Diffuse large B-cell lymphoma16.28.02.001; 01.15.02.0010.002066%Not Available
Diplopia17.17.01.005; 06.02.06.0020.003098%Not Available
Discomfort08.01.08.0030.004131%Not Available
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