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)
Bronchiectasis22.03.02.0050.001617%Not Available
Bronchiolitis11.05.04.008; 22.03.02.0040.003098%Not Available
Bronchitis22.07.01.001; 11.01.09.0010.004131%
Bronchopulmonary aspergillosis22.07.08.001; 11.03.01.0020.000539%Not Available
Burning sensation17.02.06.001; 08.01.09.0290.005164%Not Available
Bursitis15.04.01.0010.003098%Not Available
C-reactive protein increased13.09.01.0070.009295%Not Available
Cachexia14.03.02.001; 08.01.01.009; 16.32.03.0110.000539%Not Available
Cardiac failure02.05.01.0010.002964%
Cardiac failure acute02.05.01.0050.000808%Not Available
Cardiogenic shock24.06.02.006; 02.05.01.0030.002066%Not Available
Cardiomyopathy02.04.01.0010.003098%Not Available
Cardiovascular disorder24.03.02.009; 02.01.01.001--Not Available
Carpal tunnel syndrome17.09.02.0010.004131%Not Available
Cataract06.06.01.0010.003098%
Cellulitis23.09.01.001; 11.02.01.0010.005164%Not Available
Cerebral arteritis24.05.01.002; 17.08.02.0040.002066%Not Available
Cerebral haemorrhage24.07.04.001; 17.08.01.003--Not Available
Cerebrovascular accident24.03.05.001; 17.08.01.007--
Chest discomfort22.02.08.001; 08.01.08.019; 02.02.02.009--Not Available
Chest pain22.02.08.003; 08.01.08.002; 02.02.02.0110.010328%Not Available
Chills15.05.03.016; 08.01.09.0010.008263%
Cholecystitis09.03.01.0010.003098%
Cholelithiasis09.03.01.0020.003098%Not Available
Cholestasis09.01.01.0010.012394%Not Available
Chromaturia20.02.01.0020.003098%
Chronic lymphocytic leukaemia16.01.06.001; 01.10.06.0010.001078%Not Available
Chronic obstructive pulmonary disease22.03.01.0070.001617%Not Available
Coagulopathy01.01.02.0010.003098%Not Available
Cold sweat23.02.03.002; 08.01.03.0240.002066%Not Available
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