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)
Hair colour changes23.02.06.001--
Headache17.14.01.001--
Hepatic cirrhosis09.01.04.0010.000539%Not Available
Hepatic encephalopathy17.13.01.003; 09.01.03.0060.000539%Not Available
Hepatic failure09.01.03.0020.002155%
Hepatic necrosis09.01.07.002--
Hepatic steatosis14.08.04.005; 09.01.07.0030.002066%Not Available
Hepatitis09.01.07.0040.013427%Not Available
Hepatitis acute09.01.07.0050.003098%Not Available
Hepatitis cholestatic09.01.01.0020.003098%Not Available
Hepatocellular injury09.01.07.0080.012394%Not Available
Hepatomegaly09.01.05.0010.003098%Not Available
Hepatotoxicity12.03.01.008; 09.01.07.0090.012394%Not Available
Hernia08.01.04.001--Not Available
Herpes simplex23.09.03.001; 11.05.02.001--Not Available
Herpes zoster23.09.03.002; 11.05.02.0030.004131%
Hydrocephalus17.07.01.0010.000539%
Hyperbilirubinaemia14.11.01.010; 09.01.01.003; 01.06.04.0030.002066%Not Available
Hypercalcaemia14.04.01.003; 05.04.01.0020.002066%
Hyperglycaemia14.06.02.002; 05.06.02.002--
Hyperhidrosis23.02.03.004; 08.01.03.0280.007230%
Hyperkeratosis23.01.01.0010.002066%
Hypersensitivity10.01.03.0030.018591%
Hypertension24.08.02.0010.023755%
Hypertensive crisis24.08.01.0010.007230%Not Available
Hyperthyroidism14.11.01.011; 05.02.02.0010.007230%
Hypertriglyceridaemia14.08.02.0010.003098%
Hypoaesthesia17.02.06.0230.020656%Not Available
Hypogammaglobulinaemia10.03.01.0010.004131%Not Available
Hypogeusia17.02.07.004; 07.14.03.0020.002066%Not Available
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