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)
Lymphatic disorder01.09.01.003--Not Available
Paranasal sinus discomfort22.12.03.0180.000820%Not Available
Adenocarcinoma pancreas16.13.10.002; 07.21.09.0030.000241%Not Available
Musculoskeletal stiffness15.03.05.0270.052828%Not Available
Musculoskeletal discomfort15.03.04.0010.001832%Not Available
Organ failure08.01.03.0410.000241%Not Available
Skin swelling23.03.03.0390.001061%Not Available
Secretion discharge08.01.03.0190.000940%Not Available
Depressive symptom19.15.02.0030.003641%Not Available
Nodule08.03.05.0020.000940%Not Available
Skin burning sensation23.03.03.021; 17.02.06.0090.003641%Not Available
Cerebral disorder17.02.10.0170.002242%Not Available
Dysphemia19.19.03.005; 17.02.08.0100.001881%Not Available
Postmenopausal haemorrhage24.07.03.002; 21.02.01.0020.000241%Not Available
Peripheral sensorimotor neuropathy17.09.03.0090.000820%Not Available
Colitis microscopic07.08.01.0110.001808%Not Available
Temperature intolerance08.01.09.0220.004774%Not Available
Urine odour abnormal20.02.01.0200.001013%Not Available
Hypoaesthesia oral17.02.06.021; 07.05.05.003--Not Available
Paraesthesia oral07.05.05.035; 17.02.06.008--Not Available
Breast cancer female16.10.01.004; 21.05.01.0110.001326%Not Available
Cognitive disorder19.21.02.001; 17.03.03.0030.029536%
Toxic skin eruption12.03.01.073; 23.03.05.003; 10.01.01.0080.000844%Not Available
Ocular icterus01.06.04.007; 09.01.01.007; 06.08.03.0090.000241%Not Available
Cystoid macular oedema06.04.06.010; 12.02.02.0050.000362%Not Available
Dysplasia08.03.04.0070.000241%Not Available
Dysgraphia17.02.03.0060.001181%Not Available
Thyroid mass05.02.01.0030.000603%Not Available
Restless legs syndrome17.02.07.008; 15.05.03.0120.002893%Not Available
Angiopathy24.03.02.007--Not Available
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