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)
Multiple sclerosis relapse17.16.01.0030.192842%Not Available
Musculoskeletal disorder15.03.05.0250.003303%Not Available
Poor venous access24.03.02.0170.000820%Not Available
Tooth infection11.01.04.004; 07.09.01.004--
Onychoclasis23.02.05.0050.005570%Not Available
Seasonal allergy22.04.04.008; 10.01.04.001; 06.04.01.0130.001760%Not Available
Weight fluctuation14.03.02.0020.000530%Not Available
Autoimmune thyroiditis10.04.08.006; 05.02.04.0020.000482%Not Available
Chapped lips07.05.01.0040.000940%Not Available
Nocturnal dyspnoea02.11.05.009; 22.02.01.0190.000241%Not Available
Onychomadesis23.02.05.0060.001230%
Lip blister07.05.01.007; 23.03.01.0160.000530%Not Available
General physical health deterioration08.01.03.018--Not Available
Muscle fatigue15.05.03.0060.000241%Not Available
Quadriparesis17.01.04.0120.000241%Not Available
Lhermitte's sign17.02.06.0140.000241%Not Available
Muscle tightness15.05.03.0070.004171%Not Available
Balance disorder08.01.03.081; 17.02.02.0070.072888%Not Available
Cardiac death08.04.01.007; 02.03.04.015--Not Available
Dysstasia15.03.05.011; 08.01.03.089; 17.02.02.0120.004244%Not Available
Intervertebral disc protrusion15.10.01.0040.002435%Not Available
Musculoskeletal chest pain22.09.01.001; 15.03.04.012--
Madarosis23.02.02.004; 06.06.04.0100.002411%Not Available
Dyschezia07.02.03.0050.000530%Not Available
Central nervous system lesion17.02.10.0110.008101%Not Available
Exercise tolerance decreased08.01.03.0360.000530%Not Available
Viral diarrhoea11.05.04.012; 07.19.02.008--Not Available
Acute coronary syndrome24.04.04.011; 02.02.02.015--Not Available
Ear discomfort04.03.01.005--Not Available
Ocular discomfort06.08.03.0080.000940%Not Available
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