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)
Diplopia17.17.01.005; 06.02.06.0020.003785%Not Available
Discomfort08.01.08.003--Not Available
Disturbance in attention19.21.02.002; 17.03.03.0010.006293%
Drug ineffective08.06.01.0060.175771%Not Available
Dry skin23.03.03.0010.010874%
Dry throat22.12.03.005; 07.06.01.0050.000530%Not Available
Duodenal perforation07.04.02.0010.000241%
Duodenal ulcer haemorrhage24.07.02.020; 07.04.02.0040.000362%Not Available
Duodenitis07.08.03.0010.000241%Not Available
Dysaesthesia23.03.03.077; 17.02.06.0030.002652%
Dysarthria17.02.08.001; 19.19.03.001--
Dysgeusia17.02.07.003; 07.14.03.001--
Dysphagia07.01.06.003--
Dysuria20.02.02.0020.004774%
Ear infection11.01.05.001; 04.03.01.006--Not Available
Ear pain04.03.01.0030.001591%
Ectopic pregnancy18.02.02.0020.000362%Not Available
Eczema23.03.04.0060.004364%
Eczema nummular23.03.04.0350.000651%Not Available
Emphysema22.01.02.0020.000651%Not Available
Enanthema08.01.06.0070.000241%Not Available
Endometrial cancer21.07.02.002; 16.12.02.0010.000241%Not Available
Enteritis07.08.03.0020.000362%
Eosinophilia01.02.04.0010.002194%
Epilepsy17.12.03.002--Not Available
Erythema multiforme23.03.01.003; 10.01.03.0150.000723%
Erythema nodosum23.07.02.001; 10.02.01.0200.000772%Not Available
Eye disorder06.08.03.0010.003834%Not Available
Eye inflammation06.04.05.0020.000482%Not Available
Eye pain06.08.03.0020.003785%
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