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)
Anorectal discomfort07.03.03.0030.000820%-
Oropharyngeal pain07.05.05.004; 22.12.03.016--
Acute kidney injury20.01.03.016--
Bladder dysfunction20.03.03.0020.000820%-
Upper-airway cough syndrome22.12.03.0360.000820%
Functional gastrointestinal disorder07.11.01.0160.003761%-
Slow speech17.02.08.016; 19.19.02.0040.000820%-
Intraductal proliferative breast lesion16.10.01.006; 21.05.01.0140.000362%-
Faeces soft07.01.03.0080.002291%-
Mouth swelling07.05.04.007; 10.01.05.020; 23.04.01.0200.000772%-
Invasive breast carcinoma16.10.01.005; 21.05.01.0130.000241%-
Anal incontinence07.01.06.029; 17.05.01.0210.006341%
Frustration tolerance decreased19.04.02.0160.001712%-
Abnormal loss of weight14.03.02.0190.000651%-
Alopecia areata10.04.02.011; 23.02.02.0080.000530%-
Coeliac disease07.17.01.008; 10.04.04.012; 14.02.01.0070.000362%-
Fallopian tube cancer16.12.07.001; 21.11.01.0090.000241%-
Hilar lymphadenopathy01.09.01.023; 22.09.03.0050.000241%-
Lateral medullary syndrome17.08.01.055; 24.04.06.0380.000241%-
Leiomyosarcoma15.09.03.016; 16.33.07.0010.000241%-
Lichen sclerosus21.10.03.010; 23.03.08.0060.001230%-
Lung adenocarcinoma16.19.01.002; 22.08.01.0070.000241%-
Metastases to lymph nodes01.09.01.015; 16.22.02.0060.000362%-
Overweight14.03.02.0210.000241%-
Post-traumatic stress disorder19.06.06.0020.000241%-
Slow response to stimuli17.02.05.0630.000241%-
Teeth brittle07.09.05.0150.000820%-
Progressive multiple sclerosis17.16.01.0060.000844%-
IIIrd nerve paresis06.05.02.019; 17.04.02.0060.000241%-
Splenic lesion01.09.02.0170.000241%-
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