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)
Oropharyngeal pain22.02.05.022; 07.05.05.004--
Acute kidney injury20.01.03.0160.020656%
Foetal growth restriction18.03.01.0020.002066%
Acute yellow liver atrophy09.01.07.026--Not Available
Sperm concentration13.20.01.012--Not Available
Posterior reversible encephalopathy syndrome17.13.02.0070.007230%
Drug-induced liver injury12.03.01.044; 09.01.07.0230.021689%Not Available
Drug reaction with eosinophilia and systemic symptoms23.03.05.005; 10.01.01.0210.012394%Not Available
Candida infection11.03.03.0210.002066%
Aspergillus infection11.03.01.0040.000539%Not Available
Peripheral venous disease24.04.02.0220.002066%Not Available
Multiple organ dysfunction syndrome08.01.03.0570.001617%
Anal incontinence17.05.01.021; 07.01.06.0290.003098%
Liver function test increased13.03.01.0440.003098%Not Available
Abnormal loss of weight14.03.02.0190.004131%Not Available
Dengue fever23.09.03.011; 11.05.23.0010.002066%Not Available
Eczema asteatotic23.03.04.0250.002066%Not Available
Encephalomyelitis17.06.05.003; 11.01.03.0120.000539%
Faeces pale07.01.03.0050.002066%Not Available
Heart block congenital03.07.07.003; 02.03.01.0210.000539%Not Available
Intraventricular haemorrhage neonatal24.07.04.029; 18.04.16.002; 17.08.01.0530.000539%Not Available
Lymphangioma15.09.01.007; 24.09.02.006; 16.18.01.009; 01.09.01.0260.000539%Not Available
Meningitis pneumococcal17.06.10.004; 11.02.06.0120.000808%Not Available
Metatarsalgia15.02.01.0070.002066%Not Available
Pierre Robin syndrome15.11.05.009; 03.11.05.0090.002066%Not Available
Pulmonary artery thrombosis24.01.06.005; 22.06.02.0050.002066%Not Available
Rectal adenocarcinoma07.21.05.005; 16.13.01.0160.002066%Not Available
Rheumatoid lung10.04.06.007; 22.01.01.024; 15.01.03.0050.001617%Not Available
Small for dates baby18.04.02.0020.004131%Not Available
Spinal column stenosis17.10.01.011; 15.10.04.0030.003098%Not Available
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