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)
Hepatic mass09.01.08.0150.000241%Not Available
Hypertensive emergency24.08.01.0040.000241%Not Available
Negative thoughts19.15.02.0120.000820%Not Available
Foot deformity15.10.03.0050.000772%Not Available
Relapsing-remitting multiple sclerosis17.16.01.0070.000482%Not Available
Secondary progressive multiple sclerosis17.16.01.0080.000844%Not Available
Primary progressive multiple sclerosis17.16.01.0050.000362%Not Available
Weight bearing difficulty15.03.05.0340.000241%Not Available
Uhthoff's phenomenon17.16.01.009; 06.02.07.0080.000241%Not Available
Band sensation17.16.01.0040.002700%Not Available
Spinal pain17.10.01.020; 15.02.01.008; 08.01.08.0300.000892%Not Available
Invasive ductal breast carcinoma21.05.01.021; 16.10.01.0130.000482%Not Available
Small fibre neuropathy17.09.03.021; 14.07.04.007; 05.07.04.0070.000940%Not Available
Eyelid rash06.04.04.017; 23.03.13.0200.000820%Not Available
Skin texture abnormal23.03.03.0680.000530%Not Available
Gastrointestinal wall thickening07.01.06.0320.000241%Not Available
Fine motor skill dysfunction17.01.02.0200.001760%Not Available
Gluten sensitivity14.02.01.008; 10.01.01.031; 07.17.01.0090.000820%Not Available
Tongue discomfort07.14.02.0190.000530%Not Available
Neuromyelitis optica spectrum disorder10.04.10.015; 17.16.02.005; 06.04.08.0030.000241%Not Available
Automatic bladder20.03.03.0080.000241%Not Available
Chronic cutaneous lupus erythematosus23.03.02.022; 15.06.02.013; 10.04.03.0130.000241%Not Available
Clinically isolated syndrome17.16.02.0060.000241%Not Available
Drug effect less than expected08.06.01.0360.003472%Not Available
Electric shock sensation17.02.07.024; 08.06.02.0230.002411%Not Available
Gait inability17.02.05.069; 08.01.02.0110.005329%Not Available
Graves' disease05.02.02.009; 10.04.08.014; 06.09.04.0090.001206%Not Available
Heavy menstrual bleeding21.01.03.005--Not Available
Hemihypoaesthesia23.03.03.079; 17.02.06.044--Not Available
Hepatic cytolysis09.01.07.0360.001085%Not Available
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