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)
Leukopenia01.02.02.0010.015492%Not Available
Lip swelling23.04.01.007; 10.01.05.005; 07.05.04.0050.002066%Not Available
Liver abscess11.01.18.001; 09.01.11.0010.002066%Not Available
Liver disorder09.01.08.0010.009295%Not Available
Liver function test abnormal13.03.01.0130.017558%Not Available
Local swelling08.01.03.0130.004131%Not Available
Loss of consciousness17.02.04.004--Not Available
Lower respiratory tract infection22.07.01.002; 11.01.09.0020.002066%Not Available
Lung abscess22.07.01.006; 11.01.09.0060.002066%Not Available
Lung disorder22.02.07.0010.009295%Not Available
Lung infiltration22.01.02.0040.005164%Not Available
Lymphadenopathy01.09.01.0020.002066%Not Available
Lymphoma16.20.01.001; 01.12.01.0010.000539%Not Available
Malaise08.01.01.0030.024788%
Malignant hypertension24.08.01.0020.002066%Not Available
Malignant melanoma23.08.01.001; 16.03.01.0010.003098%Not Available
Melaena07.12.02.004; 24.07.02.013--Not Available
Memory impairment19.20.01.003; 17.03.02.003--
Menstrual disorder21.01.01.004--Not Available
Metabolic acidosis14.01.01.003--Not Available
Migraine24.03.05.003; 17.14.02.001--Not Available
Mouth ulceration07.05.06.0040.007230%Not Available
Mucosal inflammation08.01.06.0020.003098%Not Available
Muscle spasms15.05.03.004--
Muscular weakness17.05.03.005; 15.05.06.001--
Musculoskeletal pain15.03.04.0070.003098%
Myalgia15.05.02.001--
Myocardial infarction24.04.04.009; 02.02.02.007--
Myocardial ischaemia24.04.04.010; 02.02.02.0080.000808%Not Available
Nail disorder23.02.05.002--
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