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)
Cholecystitis09.03.01.0010.001567%
Cholecystitis acute09.03.01.0030.000362%-
Cholelithiasis09.03.01.0020.002339%-
Chromaturia20.02.01.0020.003183%
Clumsiness17.01.02.0050.000820%-
Cold sweat08.01.03.024; 23.02.03.0020.001181%-
Colitis07.08.01.0010.004943%
Condition aggravated08.01.03.0040.069440%-
Conjunctivitis06.04.01.002; 11.01.06.012--
Coronary artery occlusion02.02.01.006; 12.02.01.036; 24.04.04.0130.000362%-
Cough22.02.03.0010.022520%
Crying08.01.03.005; 12.02.11.001; 17.02.05.013; 19.04.02.002---
Cyst08.03.05.001; 16.02.02.0020.000603%-
Cystitis11.01.14.001; 20.03.02.002--
Cystitis haemorrhagic20.03.02.0030.000241%-
Decreased activity08.01.01.006; 19.11.01.0020.001013%-
Decreased interest19.15.02.0040.009403%-
Decubitus ulcer23.03.11.0060.001013%-
Defaecation urgency07.02.04.0010.001760%-
Demyelination17.16.02.0010.000844%-
Dental caries07.09.01.0010.001423%
Depressed mood19.15.02.0010.028861%-
Depression19.15.01.0010.075396%
Dermatitis23.03.04.002---
Dermatitis atopic10.01.04.004; 23.03.04.0160.000820%-
Dermatitis bullous23.03.01.0020.000603%
Dermatitis contact10.01.01.003; 12.03.01.040; 23.03.04.0040.001181%-
Diabetes insipidus05.03.03.004; 14.05.07.0030.000241%-
Diarrhoea07.02.01.0010.264669%
Diarrhoea haemorrhagic07.02.01.002; 24.07.02.0040.001085%-
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