ADReCS

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)
Oropharyngeal discomfort	07.05.05.008; 22.12.03.015	-	-	Not Available
Oropharyngeal pain	22.12.03.016; 07.05.05.004	-	-
Acute kidney injury	20.01.03.016	0.004285%
Foetal growth restriction	18.03.01.002	0.000428%
Acute yellow liver atrophy	09.01.07.026	-	-	Not Available
Sperm concentration	13.20.04.006	-	-	Not Available
Posterior reversible encephalopathy syndrome	17.13.02.007	0.001500%
Drug-induced liver injury	12.03.01.044; 09.01.07.023	0.006641%		Not Available
Drug reaction with eosinophilia and systemic symptoms	10.01.01.021; 12.03.01.064; 23.03.05.005	0.002999%		Not Available
Candida infection	11.03.03.021	-	-
Multiple organ dysfunction syndrome	08.01.03.057	0.001500%
Anal incontinence	17.05.01.021; 07.01.06.029	0.001371%
Liver function test increased	13.03.04.031	-	-	Not Available
Abnormal loss of weight	14.03.02.019	0.000428%		Not Available
Alopecia areata	23.02.02.008; 10.04.02.011	0.000643%		Not Available
Chronic gastritis	11.07.01.016; 10.04.04.011; 07.08.02.005	0.001071%		Not Available
Eczema asteatotic	23.03.04.025	0.000428%		Not Available
Enthesopathy	15.07.01.011	-	-	Not Available
Faeces pale	07.01.03.005	0.000428%		Not Available
Intraventricular haemorrhage neonatal	24.07.04.029; 18.04.16.002; 17.08.01.053	0.000428%		Not Available
Lymphangioma	16.18.01.009; 15.09.01.007; 01.09.01.026; 24.09.02.006	0.000428%		Not Available
Metatarsalgia	15.02.01.007	0.000428%		Not Available
Pulmonary artery thrombosis	24.01.06.005; 22.06.02.005	0.000428%		Not Available
Rectal adenocarcinoma	16.13.01.016; 07.21.05.005	0.000428%		Not Available
Rheumatoid lung	22.01.01.024; 15.01.03.005; 10.04.06.007	0.001285%		Not Available
Small for dates baby	18.04.02.002	0.000857%		Not Available
Superficial spreading melanoma stage unspecified	23.08.01.010; 16.03.01.010	0.000428%		Not Available
Pseudarthrosis	15.08.01.001; 12.04.02.010	0.000643%		Not Available
Atrial thrombosis	02.11.01.002; 24.01.05.005	0.000428%		Not Available
Urticarial vasculitis	24.12.04.025; 23.04.02.012; 10.01.06.012	0.000643%		Not Available

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