ADReCS

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)
Ataxia	17.02.02.001; 08.01.02.004	0.001784%
Autoimmune hepatitis	10.04.09.001; 09.01.07.019	0.000603%		Not Available
B-cell lymphoma	16.28.01.001; 01.15.01.001	0.000964%		Not Available
Back disorder	15.03.05.003	0.002242%		Not Available
Back pain	15.03.04.005	0.031321%
Basal cell carcinoma	16.03.02.001; 23.08.02.001	0.000964%		Not Available
Bladder discomfort	20.02.02.019	0.002411%		Not Available
Bladder pain	20.02.02.001	-	-	Not Available
Blepharospasm	17.17.02.001; 06.05.01.001	0.001760%		Not Available
Blindness	17.17.01.003; 06.02.10.003	0.001808%		Not Available
Blindness transient	06.02.10.006; 17.17.01.004	0.000362%		Not Available
Blindness unilateral	06.02.10.007; 17.17.01.016	0.001495%		Not Available
Blister	23.03.01.001; 12.01.06.002	0.009307%		Not Available
Blood creatinine increased	13.13.01.004	-	-
Breast cancer	21.05.01.003; 16.10.01.001	0.006751%		Not Available
Breast cyst	21.05.01.006; 16.14.01.004	0.000241%		Not Available
Breast mass	21.05.04.002	0.000651%		Not Available
Breast neoplasm	21.05.01.004; 16.10.02.001	0.000241%		Not Available
Bronchitis	22.07.01.001; 11.01.09.001	-	-
Bruxism	19.11.03.001; 07.01.06.008	0.000530%		Not Available
Burning sensation	08.01.09.029; 17.02.06.001	0.018879%		Not Available
Bursitis	12.04.03.010; 15.04.01.001	0.001881%		Not Available
Calculus urinary	20.04.03.002	0.000241%		Not Available
Carpal tunnel syndrome	17.09.02.001	0.003062%		Not Available
Cerebellar syndrome	17.02.02.002	0.000241%		Not Available
Cerebral atrophy	17.11.01.001	0.000241%		Not Available
Cervical dysplasia	21.06.01.002	0.000362%		Not Available
Cervicobrachial syndrome	17.10.02.001; 15.01.04.002	0.000241%		Not Available
Cervix carcinoma	16.12.01.001; 21.06.02.001	0.000844%		Not Available
Chills	15.05.03.016; 08.01.09.001	-	-

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