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)
Intervertebral disc disorder15.10.01.0030.001881%-
Polyp08.01.06.010; 16.02.02.0050.000241%-
Blood disorder01.05.01.004---
Adverse drug reaction08.06.01.009---
Disease progression08.01.03.038--
Diverticular perforation07.04.04.0080.000241%-
Hepatic lesion09.01.08.0050.000362%-
Immunosuppression10.03.02.001---
Knee deformity15.10.03.0020.001230%-
Pigmentation disorder23.05.03.0010.001881%-
Sinus disorder22.04.06.0020.003183%
Nail ridging23.02.05.0200.000820%
Unevaluable event08.01.03.0510.025510%-
Haemorrhagic diathesis01.01.03.003; 24.07.01.0200.000241%-
Hyperamylasaemia14.11.01.003---
Cystitis noninfective20.03.02.001--
Bowel movement irregularity07.02.03.0030.000940%-
Lichenoid keratosis23.01.01.0040.000241%-
Joint instability15.01.08.0070.000241%-
Post-traumatic pain08.01.08.010; 12.01.08.016---
Bone loss15.02.04.0200.000530%-
Thyroid cancer05.02.05.001; 16.24.03.0010.000723%-
Treatment failure08.06.01.017---
Liver injury09.01.07.022; 12.01.17.0120.001206%-
Oral herpes07.05.07.002; 11.05.02.005---
Organising pneumonia22.01.02.0080.000362%-
Adverse reaction08.06.01.0180.002700%-
Type 2 diabetes mellitus05.06.01.003; 14.06.01.003---
Oral disorder07.05.01.0050.000772%-
Skin mass23.07.04.0140.001471%-
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