Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Teriflunomide
Drug ID BADD_D02165
Description Teriflunomide is the active metabolite of leflunomide, and it acts as an immunomodulatory agent by inhibiting pyrimidine synthesis. It is marketed under the name Aubagio® and is indicated for the treatment of multiple sclerosis, specifically relapsing forms. The FDA label states an important warning about the risk of hepatoxicity and teratogenicity for patients using teriflunomide.
Indications and Usage Used in the treatment of relapsing forms of multiple sclerosis (MS).
Marketing Status Prescription
ATC Code L04AA31
DrugBank ID DB08880
KEGG ID D10172
MeSH ID C527525
PubChem ID 54684141
TTD Drug ID Not Available
NDC Product Code 69238-1303; 65727-058; 12579-186; 69238-1304; 66499-0059; 59285-001; 69539-032; 47621-049; 17337-0070; 69037-0016; 58468-0211; 63850-8081; 12579-185; 46708-888; 12579-191; 53747-061; 69539-033; 14501-0086; 58468-0210; 59651-036; 66039-916; 0115-1565; 12579-190
Synonyms teriflunomide | (Z)-2-cyano-3-hydroxy-N-(4-(trifluoromethyl)phenyl)-2-butenamide | (2Z)-2-cyano-3-hydroxy-N-(4-(trifluoromethyl)phenyl)-2-butenamide | 2-cyano-3-hydroxy-N-(4-(trifluoromethyl)phenyl)-2-butenamide | 2-hydroxyethylidene-cyanoacetic acid-4-trifluoromethyl anilide | RS 61980 | Aubagio | HMR1726 | HMR-1726 | A 771726 | A 1726 | A771726 | A-771726 | A77 1726
Chemical Information
Molecular Formula C12H9F3N2O2
CAS Registry Number 163451-81-8
SMILES CC(=C(C#N)C(=O)NC1=CC=C(C=C1)C(F)(F)F)O
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)
Flank pain15.03.04.003; 08.01.08.007; 20.02.03.0060.003474%
Flatulence07.01.04.0020.006948%
Flushing24.03.01.002; 23.06.05.003; 08.01.03.025--
Foot fracture15.08.03.012; 12.04.01.012--Not Available
Formication19.10.02.010; 17.02.06.0180.001158%Not Available
Frequent bowel movements07.02.04.0020.005211%Not Available
Fungal infection11.03.05.001--Not Available
Furuncle23.09.01.004; 11.02.05.0080.004053%Not Available
Gait disturbance17.02.05.016; 08.01.02.0020.039950%
Gallbladder disorder09.03.02.001--Not Available
Gamma-glutamyltransferase increased13.03.01.0110.008106%
Gastric haemorrhage24.07.02.007; 07.12.01.001--
Gastric ulcer07.04.03.0020.003474%
Gastritis07.08.02.0010.002895%
Gastritis erosive07.04.03.0030.001158%Not Available
Gastrooesophageal reflux disease07.02.02.0030.005790%
Gastroenteritis07.19.03.001; 11.01.07.004--Not Available
Gastroenteritis viral11.05.04.005; 07.19.03.005--Not Available
Gastrointestinal carcinoma16.13.04.001; 07.21.03.0010.000453%Not Available
Gastrointestinal disorder07.11.01.0010.024897%Not Available
Gastrointestinal haemorrhage24.07.02.009; 07.12.02.001--Not Available
Generalised tonic-clonic seizure17.12.01.0020.001208%Not Available
Genital herpes21.10.03.008; 11.05.02.0120.001158%Not Available
Gingival bleeding24.07.02.010; 07.09.07.001--Not Available
Gingival pain07.09.04.0010.001158%
Gingivitis07.09.03.003; 11.01.04.0130.001737%
Glaucoma06.03.01.002--
Glioblastoma multiforme16.30.02.001; 17.20.02.0010.001158%Not Available
Goitre14.11.01.008; 05.02.01.0010.001158%Not Available
Granuloma annulare23.03.15.0050.001737%Not Available
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