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%Not Available
Polyp16.02.02.005; 08.01.06.0100.000241%Not Available
Blood disorder01.05.01.004--Not Available
Adverse drug reaction08.06.01.009--Not Available
Disease progression08.01.03.038--
Diverticular perforation07.04.04.0080.000241%Not Available
Hepatic lesion09.01.08.0050.000362%Not Available
Immunosuppression10.03.02.001--Not Available
Knee deformity15.10.03.0020.001230%Not Available
Pigmentation disorder23.05.03.0010.001881%Not Available
Sinus disorder22.04.06.0020.003183%
Nail ridging23.02.05.0200.000820%
Unevaluable event08.01.03.0510.025510%Not Available
Haemorrhagic diathesis24.07.01.020; 01.01.03.0030.000241%Not Available
Hyperamylasaemia14.11.01.003--Not Available
Cystitis noninfective20.03.02.001--
Bowel movement irregularity07.02.03.0030.000940%Not Available
Lichenoid keratosis23.01.01.0040.000241%Not Available
Joint instability15.01.08.0070.000241%Not Available
Post-traumatic pain12.01.08.016; 08.01.08.010--Not Available
Bone loss15.02.04.0200.000530%Not Available
Thyroid cancer16.24.03.001; 05.02.05.0010.000723%Not Available
Treatment failure08.06.01.017--Not Available
Liver injury12.01.17.012; 09.01.07.0220.001206%Not Available
Oral herpes11.05.02.005; 07.05.07.002--Not Available
Organising pneumonia22.01.02.0080.000362%Not Available
Adverse reaction08.06.01.0180.002700%Not Available
Type 2 diabetes mellitus14.06.01.003; 05.06.01.003--Not Available
Oral disorder07.05.01.0050.000772%Not Available
Skin mass23.07.04.0140.001471%Not Available
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