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)
Mobility decreased15.03.05.023; 17.02.05.018; 08.01.03.0300.000857%Not Available
Fibromyalgia15.05.02.0020.000943%Not Available
Joint range of motion decreased15.01.02.0060.000428%
Poor venous access24.03.02.017--Not Available
Hypoacusis04.02.01.0060.000428%
Performance status decreased08.01.03.0420.000428%Not Available
Retinal toxicity12.03.01.036; 06.09.03.0130.000857%Not Available
Peripheral swelling08.01.03.053; 02.05.04.0150.004028%Not Available
Brain oedema17.07.02.003; 12.01.10.0100.000643%
Weight fluctuation14.03.02.002--Not Available
General physical health deterioration08.01.03.0180.001500%Not Available
Dysstasia08.01.03.089; 17.02.02.012; 15.03.05.0110.001285%Not Available
Intervertebral disc protrusion15.10.01.0040.001285%Not Available
Lupus-like syndrome23.03.02.004; 15.06.02.004; 10.04.03.0030.001500%Not Available
Contusion12.01.06.001; 15.03.05.007; 24.07.06.001; 23.03.11.002--
Musculoskeletal chest pain22.09.01.001; 15.03.04.012--
Puncture site haemorrhage12.07.04.006; 08.02.04.007; 24.07.01.0340.000643%Not Available
Chylothorax22.05.02.0060.000643%
Central nervous system lesion17.02.10.0110.000428%Not Available
Systemic inflammatory response syndrome24.06.03.008; 10.02.01.008; 08.01.05.0050.000428%Not Available
Bone erosion15.02.04.019--Not Available
Ear discomfort04.03.01.0050.000428%Not Available
Respiratory tract congestion22.02.07.003--Not Available
Lymphatic disorder01.09.01.003--Not Available
Foetor hepaticus09.01.05.006; 07.01.06.026--Not Available
Musculoskeletal stiffness15.03.05.0270.002099%Not Available
Musculoskeletal discomfort15.03.04.001--Not Available
Secretion discharge08.01.03.019--Not Available
Nodule08.03.05.0020.001285%Not Available
Skin burning sensation23.03.03.021; 17.02.06.0090.000428%Not Available
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ADReCS-Target
Drug Name ADR Term Target
Tip:  Drug Name  ADR Term  Protein  Variation  Gene