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)
Pustular psoriasis10.02.01.102; 23.03.14.0060.000530%Not Available
Radiculopathy17.10.01.0050.000530%
Rash23.03.13.0010.090490%Not Available
Rash macular23.03.13.0030.002821%Not Available
Rash pruritic23.03.13.0300.013623%Not Available
Rash vesicular23.03.13.0090.000940%Not Available
Raynaud's phenomenon24.04.03.0030.000892%Not Available
Renal colic20.02.03.0100.000362%
Renal disorder20.01.02.002--Not Available
Renal pain20.02.03.0030.001471%Not Available
Repetitive speech19.19.02.003; 17.02.08.0120.000530%Not Available
Respiration abnormal22.02.01.0410.000651%Not Available
Retinal vasculitis10.02.02.021; 06.04.06.0110.000241%Not Available
Rheumatoid arthritis10.04.06.001; 15.01.03.001--Not Available
Rhinitis22.07.03.006; 11.01.13.004--
Rhinorrhoea22.12.03.0210.008053%
Sarcoidosis10.02.06.0010.000844%Not Available
Scab23.03.03.0040.001591%Not Available
Sciatica17.10.03.001; 15.10.01.0010.002194%Not Available
Scoliosis15.10.04.0010.000820%
Seizure17.12.03.001--
Sensory disturbance17.02.07.0060.024979%Not Available
Sensory loss17.02.07.0070.002532%Not Available
Sexual dysfunction21.03.02.003; 19.08.05.0020.009862%Not Available
Sinusitis22.07.03.007; 11.01.13.005--
Skin atrophy23.01.05.0010.000772%
Skin disorder23.03.03.0070.003303%Not Available
Skin exfoliation23.03.07.0030.008584%Not Available
Skin fissures23.03.03.0080.002242%Not Available
Skin irritation23.03.04.0090.001181%Not Available
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