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%Not Available
Cholelithiasis09.03.01.0020.002339%Not Available
Chromaturia20.02.01.0020.003183%
Clumsiness17.01.02.0050.000820%Not Available
Cold sweat23.02.03.002; 08.01.03.0240.001181%Not Available
Colitis07.08.01.0010.004943%
Condition aggravated08.01.03.0040.069440%Not Available
Conjunctivitis11.01.06.012; 06.04.01.002--
Coronary artery occlusion02.02.01.006; 12.02.01.036; 24.04.04.0130.000362%Not Available
Cough22.02.03.0010.022520%
Crying08.01.03.005; 19.04.02.002; 17.02.05.013; 12.02.11.001--Not Available
Cyst16.02.02.002; 08.03.05.0010.000603%Not Available
Cystitis20.03.02.002; 11.01.14.001--
Cystitis haemorrhagic20.03.02.0030.000241%Not Available
Decreased activity19.11.01.002; 08.01.01.0060.001013%Not Available
Decreased interest19.15.02.0040.009403%Not Available
Decubitus ulcer23.03.11.0060.001013%Not Available
Defaecation urgency07.02.04.0010.001760%Not Available
Demyelination17.16.02.0010.000844%Not Available
Dental caries07.09.01.0010.001423%
Depressed mood19.15.02.0010.028861%Not Available
Depression19.15.01.0010.075396%
Dermatitis23.03.04.002--Not Available
Dermatitis atopic23.03.04.016; 10.01.04.0040.000820%Not Available
Dermatitis bullous23.03.01.0020.000603%
Dermatitis contact23.03.04.004; 12.03.01.040; 10.01.01.0030.001181%Not Available
Diabetes insipidus14.05.07.003; 05.03.03.0040.000241%Not Available
Diarrhoea07.02.01.0010.264669%
Diarrhoea haemorrhagic07.02.01.002; 24.07.02.0040.001085%Not Available
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