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 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)
Abdominal adhesions12.02.03.006; 07.07.03.0010.000428%Not Available
Abdominal discomfort07.01.06.001--Not Available
Abdominal distension07.01.04.0010.002528%
Abdominal pain07.01.05.0020.004585%
Abdominal pain upper07.01.05.0030.005184%
Abortion18.01.01.0010.000643%Not Available
Abortion spontaneous18.01.04.0010.009855%Not Available
Abscess11.01.08.001--Not Available
Acidosis14.01.03.0020.000428%
Acne23.02.01.001--Not Available
Acquired immunodeficiency syndrome11.05.17.007; 10.03.03.001--Not Available
Acute hepatic failure09.01.03.0010.000857%Not Available
Acute myocardial infarction24.04.04.001; 02.02.02.0010.001071%Not Available
Acute respiratory distress syndrome24.03.02.034; 10.02.01.067; 22.01.03.0010.000428%
Acute respiratory failure22.02.06.001; 14.01.04.0040.000428%Not Available
Ageusia17.02.07.001; 07.14.03.0030.000857%Not Available
Agranulocytosis01.02.03.0010.001500%Not Available
Alanine aminotransferase increased13.03.04.005--
Albuminuria20.02.01.001--Not Available
Alopecia23.02.02.0010.010840%
Alveolitis22.01.01.0010.000428%Not Available
Amblyopia06.02.01.001--Not Available
Anaemia01.03.02.0010.003856%
Anaemia megaloblastic14.12.01.003; 01.03.02.0030.000643%Not Available
Anaphylactic reaction24.06.03.006; 10.01.07.001--
Anaphylactic shock10.01.07.002; 24.06.02.004--Not Available
Anaphylactoid reaction24.06.03.007; 10.01.07.0030.000643%Not Available
Angina pectoris24.04.04.002; 02.02.02.0020.000428%
Angioedema22.04.02.008; 23.04.01.001; 10.01.05.009--Not Available
Ankylosing spondylitis15.01.09.001; 10.04.04.0040.000428%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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