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)
Hot flush21.02.02.001; 08.01.03.027; 24.03.01.0050.009500%
Appetite disorder19.09.01.002; 14.03.01.0040.001350%Not Available
Bladder disorder20.03.01.0020.029922%Not Available
Breast disorder21.05.04.004--Not Available
Cardiac disorder02.11.01.003--Not Available
Connective tissue disorder10.04.04.026; 15.06.01.006--Not Available
Cranial nerve disorder17.04.01.0010.000241%Not Available
Eye movement disorder17.02.05.025; 06.05.02.0080.001591%Not Available
Eyelid disorder06.08.03.010; 23.03.03.0280.000530%Not Available
Feeding disorder14.03.02.003; 19.09.01.0030.001302%Not Available
Foetal disorder18.03.02.0010.000241%Not Available
Gastrointestinal motility disorder07.02.03.0010.000530%Not Available
Infestation23.11.01.002; 11.09.01.001--Not Available
Inflammation10.02.01.089; 08.01.05.0070.003086%Not Available
Limb discomfort15.03.04.0140.016661%Not Available
Intervertebral disc degeneration15.10.01.0020.000940%Not Available
Joint lock15.01.08.0040.000530%Not Available
Malnutrition14.03.02.004--Not Available
Mediastinal disorder22.09.03.001--Not Available
Mental disorder19.07.01.002--Not Available
Metastatic neoplasm16.16.01.0070.000241%Not Available
Motor dysfunction17.01.02.031; 15.05.06.006--Not Available
Optic nerve disorder17.04.05.004; 06.02.08.0010.000362%
Optic neuropathy17.04.05.005; 06.02.08.0020.000241%Not Available
Spinal cord disorder17.10.01.0100.000241%Not Available
White blood cell disorder01.02.05.0020.000940%Not Available
Decreased appetite14.03.01.005; 08.01.09.028--
Feeling of body temperature change08.01.09.0120.000530%Not Available
Gastrointestinal ulcer07.04.04.0020.000940%Not Available
Ill-defined disorder08.01.03.049--Not Available
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