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)
Skin lesion23.03.03.0100.004412%Not Available
Skin reaction10.01.03.019; 23.03.03.0130.003231%Not Available
Skin ulcer24.04.03.007; 23.07.03.0030.001905%
Skin warm23.03.03.0140.001061%Not Available
Sleep apnoea syndrome22.02.01.013; 19.02.05.002; 17.15.05.001--
Sleep disorder19.02.04.0010.013936%Not Available
Sluggishness08.01.01.0040.000772%Not Available
Somnambulism19.02.03.006; 17.15.02.0040.001230%Not Available
Speech disorder22.12.03.027; 19.19.02.002; 17.02.08.0030.008270%Not Available
Spinal cord compression17.10.01.0060.000241%
Squamous cell carcinoma16.16.01.0020.000603%Not Available
Stress19.06.02.0040.014539%Not Available
Synovial cyst16.18.01.004; 15.04.02.0020.000651%Not Available
Tachycardia02.03.02.007--Not Available
Tenderness08.01.08.005--Not Available
Testicular swelling21.13.01.0030.000820%Not Available
Therapeutic response decreased08.06.01.0160.008897%Not Available
Thinking abnormal19.10.03.001; 17.02.05.0230.002242%Not Available
Throat irritation22.12.03.029; 07.05.05.0370.004750%Not Available
Thrombocytopenia01.08.01.002--Not Available
Thrombocytosis01.08.02.0010.000362%Not Available
Thrombosis24.01.01.006--Not Available
Thyroid disorder05.02.01.0020.000772%Not Available
Thyroiditis05.02.04.0010.000603%Not Available
Tinea pedis23.11.03.012; 11.03.08.004--Not Available
Tinnitus17.04.07.004; 04.04.01.002--
Tongue disorder07.14.01.0020.000820%Not Available
Tooth loss07.09.09.001; 12.01.17.0260.002363%Not Available
Toothache07.09.06.0010.002363%
Transient global amnesia19.20.01.004; 17.03.02.0040.000241%Not Available
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