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)
Immune system disorder10.02.01.001--Not Available
Impaired gastric emptying07.02.02.0040.000241%
Impaired healing08.03.02.0010.002532%Not Available
Incontinence17.05.01.006; 07.01.06.011; 20.02.02.0040.007523%Not Available
Infection11.01.08.002--Not Available
Influenza22.07.02.001; 11.05.03.001--Not Available
Influenza like illness08.01.03.0100.009138%
Inguinal hernia07.16.02.001--Not Available
Initial insomnia19.02.01.005; 17.15.03.0050.000892%Not Available
Interstitial lung disease22.01.02.003; 10.02.01.033--Not Available
Intestinal ulcer07.04.06.0030.000241%Not Available
Iridocyclitis06.04.03.0010.000482%Not Available
Iron deficiency14.13.02.0020.000241%Not Available
Irritable bowel syndrome19.24.01.003; 07.02.04.0030.003014%Not Available
Keratitis06.04.02.0020.000241%
Laryngeal oedema23.04.01.005; 10.01.05.003; 22.04.02.0010.000482%
Laryngitis22.07.03.001; 11.01.13.001--
Lethargy19.04.04.004; 17.02.04.003; 08.01.01.008--
Leukopenia01.02.02.0010.003906%Not Available
Libido increased21.03.02.007; 19.08.03.0020.000820%
Lip pain07.05.05.0290.000940%
Listless19.04.04.003; 08.01.01.0120.000651%Not Available
Liver disorder09.01.08.0010.006944%Not Available
Loss of consciousness17.02.04.004--Not Available
Lower respiratory tract infection22.07.01.002; 11.01.09.002--Not Available
Lymphadenopathy01.09.01.0020.004364%Not Available
Lymphoedema24.09.01.001; 01.09.01.0060.000820%
Lymphoma01.12.01.001; 16.20.01.0010.000723%Not Available
Lymphopenia01.02.02.0020.006558%Not Available
Macular oedema06.04.06.0050.000482%Not Available
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