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 approved
ATC Code L04AA31
DrugBank ID DB08880
KEGG ID D10172
MeSH ID C527525
PubChem ID 54684141
TTD Drug ID Not Available
NDC Product Code 47621-049; 51991-882; 58468-0211; 59651-054; 62332-314; 69339-169; 70377-017; 70710-1114; 12579-185; 12579-190; 59651-036; 65727-058; 0378-0628; 69238-1303; 69238-1304; 51991-881; 0480-3157; 69539-315; 69539-316; 70512-851; 66499-0059; 16729-400; 70710-1115; 70771-1011; 53747-061; 66039-916; 59651-055; 0378-0627; 70771-1010; 59285-001; 63850-8081; 69037-0016; 16729-399; 46708-314; 0480-3156; 69339-170; 69539-033; 70377-018; 12579-191; 42291-831; 60505-4478; 69025-129; 69025-130; 69539-032; 31722-247; 46708-313; 62332-313; 12579-186; 14501-0086; 17337-0070; 43598-281; 43598-282; 60505-4477; 68462-423; 68462-424; 0781-5747; 0781-5755; 31722-246; 42291-830; 58468-0210
UNII 1C058IKG3B
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
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)
Facial pain08.01.08.0120.002821%
Faeces discoloured07.01.03.0020.002532%-
Fatigue08.01.01.0020.223511%
Feeling abnormal08.01.09.0140.034142%-
Feeling cold08.01.09.0080.004412%-
Feeling drunk08.01.09.0150.001350%-
Feeling hot08.01.09.009---
Flank pain08.01.08.007; 15.03.04.003; 20.02.03.0060.002001%
Flatulence07.01.04.0020.005232%
Food poisoning07.11.01.007; 11.07.02.001; 12.03.01.0240.001350%-
Formication17.02.06.018; 19.10.04.0020.000651%-
Frequent bowel movements07.02.04.0020.003954%-
Gait disturbance08.01.02.002; 15.03.05.013; 17.02.05.0160.057746%
Gallbladder disorder09.03.02.0010.001591%-
Gamma-glutamyltransferase increased13.03.04.024--
Gastric ulcer07.04.03.0020.001447%
Gastritis erosive07.04.03.0030.000362%-
Gastrooesophageal reflux disease07.02.02.003--
Gastroenteritis07.19.03.001; 11.01.07.004---
Gastroenteritis viral07.19.03.005; 11.05.04.005---
Gastrointestinal carcinoma07.21.03.001; 16.13.04.0010.000362%-
Gastrointestinal disorder07.11.01.0010.031972%-
Gastrointestinal pain07.01.05.0050.000651%
Gingival pain07.09.13.0100.000362%
Gingival swelling07.09.13.0130.000241%-
Glioblastoma multiforme16.30.02.001; 17.20.02.0010.000241%-
Goitre05.02.01.001; 14.11.01.0080.000241%-
Granuloma annulare23.03.15.0050.001230%-
Haematochezia07.12.02.003; 24.07.02.012---
Hair disorder23.02.06.0030.001230%-
The 5th Page    First    Pre   5 6 7 8 9    Next   Last    Total 20 Pages