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)
Eyelid ptosis17.17.02.004; 06.05.01.0020.004131%Not Available
Face oedema23.04.01.004; 10.01.05.002; 08.01.07.0030.002066%
Fatigue08.01.01.002--
Feeling abnormal08.01.09.014--Not Available
Feeling cold08.01.09.0080.002066%Not Available
Feeling hot08.01.09.0090.004131%Not Available
Femur fracture15.08.03.003; 12.04.01.0030.006197%Not Available
Flatulence07.01.04.002--
Flushing24.03.01.002; 23.06.05.003; 08.01.03.025--
Foot fracture12.04.01.012; 15.08.03.0120.004131%Not Available
Fungal skin infection23.09.02.001; 11.03.05.002--Not Available
Gait disturbance17.02.05.016; 08.01.02.002--
Gamma-glutamyltransferase increased13.03.01.0110.012394%
Gastric ulcer07.04.03.0020.003098%
Gastritis07.08.02.0010.003098%
Gastrooesophageal reflux disease07.02.02.003--
Gastroenteritis11.01.07.004; 07.19.03.0010.003098%Not Available
Gastrointestinal disorder07.11.01.0010.011361%Not Available
Gastrointestinal infection11.01.07.012; 07.19.02.0050.003098%Not Available
Gastrointestinal pain07.01.05.005--
Generalised oedema14.05.06.007; 08.01.07.0040.002066%
Gingivitis11.01.04.013; 07.09.03.003--
Guillain-Barre syndrome11.07.01.001; 10.04.10.005; 17.09.01.0010.003098%
Haemangioma of liver24.03.06.006; 16.06.01.003; 09.04.01.0030.002066%Not Available
Haematochezia24.07.02.012; 07.12.02.0030.003098%Not Available
Haematoma24.07.01.001--
Haematuria20.02.01.006; 24.07.01.0470.007230%
Haemoglobin13.01.05.018--Not Available
Haemoglobin decreased13.01.05.003--Not Available
Haemolytic anaemia01.06.03.0020.003098%Not Available
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