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)
Influenza22.07.02.001; 11.05.03.001--Not Available
Influenza like illness08.01.03.010--
Injection site bruising24.07.06.017; 23.03.11.015; 12.07.03.042; 08.02.03.042--Not Available
Injection site erythema23.03.06.015; 12.07.03.001; 08.02.03.0010.000643%Not Available
Injection site haemorrhage24.07.01.010; 12.07.03.005; 08.02.03.005--Not Available
Injection site pain12.07.03.011; 08.02.03.0100.004499%Not Available
Injection site reaction12.07.03.015; 08.02.03.0140.002614%
Injury12.01.08.004--Not Available
Insomnia19.02.01.002; 17.15.03.002--
Interstitial lung disease22.01.02.003; 10.02.01.0330.002785%Not Available
Intestinal ischaemia24.04.08.001; 07.15.02.0010.000428%Not Available
Iron deficiency anaemia14.13.02.001; 01.03.01.002--Not Available
Jaundice23.03.03.030; 09.01.01.004; 01.06.04.0040.003213%Not Available
Jaundice cholestatic09.01.01.0050.000428%Not Available
Joint effusion15.01.02.0050.000857%
Joint stiffness15.01.02.0030.001371%Not Available
Joint swelling15.01.02.0040.006127%Not Available
Kaposi's sarcoma16.33.02.001; 11.05.17.0010.000643%Not Available
Keratoacanthoma23.08.02.007; 16.03.02.0070.000428%Not Available
Laryngeal oedema23.04.01.005; 22.04.02.001; 10.01.05.0030.000643%
Laryngospasm22.04.02.0020.000428%
Leukocytosis01.02.01.0020.001285%
Leukoencephalopathy17.13.02.0030.000643%
Leukopenia01.02.02.0010.005441%Not Available
Lip swelling23.04.01.007; 10.01.05.005; 07.05.04.0050.000643%Not Available
Livedo reticularis24.03.04.003; 23.06.05.0010.000428%Not Available
Liver disorder09.01.08.0010.002656%Not Available
Liver function test abnormal13.03.04.030--Not Available
Lung disorder22.02.07.0010.003599%Not Available
Lung infiltration22.01.02.0040.001285%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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