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%-
Hypertensive emergency24.08.01.0040.000241%-
Negative thoughts19.15.02.0120.000820%-
Foot deformity15.10.03.0050.000772%-
Relapsing-remitting multiple sclerosis17.16.01.0070.000482%-
Secondary progressive multiple sclerosis17.16.01.0080.000844%-
Primary progressive multiple sclerosis17.16.01.0050.000362%-
Weight bearing difficulty15.03.05.0340.000241%-
Uhthoff's phenomenon06.02.07.008; 17.16.01.0090.000241%-
Band sensation17.16.01.0040.002700%-
Spinal pain08.01.08.030; 15.02.01.008; 17.10.01.0200.000892%-
Invasive ductal breast carcinoma16.10.01.013; 21.05.01.0210.000482%-
Small fibre neuropathy05.07.04.007; 14.07.04.007; 17.09.03.0210.000940%-
Eyelid rash06.04.04.017; 23.03.13.0200.000820%-
Skin texture abnormal23.03.03.0680.000530%-
Gastrointestinal wall thickening07.01.06.0320.000241%-
Fine motor skill dysfunction17.01.02.0200.001760%-
Gluten sensitivity07.17.01.009; 10.01.01.031; 14.02.01.0080.000820%-
Tongue discomfort07.14.02.0190.000530%-
Neuromyelitis optica spectrum disorder06.04.08.003; 10.04.10.015; 17.16.02.0050.000241%-
Automatic bladder20.03.03.0080.000241%-
Chronic cutaneous lupus erythematosus10.04.03.013; 15.06.02.013; 23.03.02.0220.000241%-
Clinically isolated syndrome17.16.02.0060.000241%-
Drug effect less than expected08.06.01.0360.003472%-
Electric shock sensation08.06.02.023; 17.02.07.0240.002411%-
Gait inability08.01.02.011; 17.02.05.0690.005329%-
Graves' disease05.02.02.009; 06.09.04.009; 10.04.08.0140.001206%-
Heavy menstrual bleeding21.01.03.005---
Hemihypoaesthesia17.02.06.044; 23.03.03.079---
Hepatic cytolysis09.01.07.0360.001085%-
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