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)
Gastric ulcer perforation07.04.03.0060.000428%Not Available
Gastritis07.08.02.0010.000643%
Gastroenteritis11.01.07.004; 07.19.03.001--Not Available
Gastrointestinal disorder07.11.01.0010.004242%Not Available
Gastrointestinal pain07.01.05.005--
Generalised oedema14.05.06.007; 08.01.07.0040.000428%
Gingivitis07.09.10.002; 11.01.04.013--
Glomerulonephritis membranous20.05.01.0070.000428%Not Available
Granuloma23.03.15.001; 08.01.05.0010.000428%Not Available
Groin pain15.03.02.0040.000428%Not Available
Haemangioma of liver16.06.01.003; 24.03.06.006; 09.04.01.0030.000428%Not Available
Haematemesis24.07.02.011; 07.12.02.002--Not Available
Haematochezia24.07.02.012; 07.12.02.0030.000857%Not Available
Haematoma24.07.01.0010.000643%
Haematuria21.10.01.018; 24.07.01.047; 20.02.01.0060.001714%
Haemoglobin13.01.05.018--Not Available
Haemolytic anaemia01.06.03.0020.000643%Not Available
Hair colour changes23.02.06.001--
Headache17.14.01.001--
Hemiparesis17.01.04.001--
Hepatic cirrhosis09.01.04.0010.000428%Not Available
Hepatic encephalopathy17.13.01.003; 09.01.03.0060.000428%Not Available
Hepatic failure09.01.03.0020.001714%
Hepatic function abnormal09.01.02.001--Not Available
Hepatic necrosis09.01.07.002--
Hepatic steatosis14.08.04.005; 09.01.07.0030.000428%Not Available
Hepatitis09.01.07.0040.003428%Not Available
Hepatitis acute09.01.07.0050.000428%Not Available
Hepatitis cholestatic09.01.01.0020.000643%Not Available
Hepatocellular injury09.01.07.0080.004070%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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