Last reviewed 2026-04-20 · How we verify

Aubagio (TERIFLUNOMIDE)

Teriflunomide inhibits dihydroorotate dehydrogenase, reducing activated lymphocytes in the CNS.

At a glance

Mechanism of action

Teriflunomide is an immunomodulatory agent that primarily works by inhibiting dihydroorotate dehydrogenase, a key enzyme in the synthesis of pyrimidines. This inhibition likely reduces the number of activated lymphocytes in the central nervous system, which may help in managing multiple sclerosis.

Approved indications

• Multiple sclerosis
• Relapsing remitting multiple sclerosis

Boxed warnings

• WARNING: HEPATOTOXICITY and EMBRYOFETAL TOXICITY • Hepatotoxicity: Clinically significant and potentially life-threatening liver injury, including acute liver failure requiring transplant, has been reported in patients treated with teriflunomide tablets in the postmarketing setting [see Warnings and Precautions (5.1) ] . Concomitant use of teriflunomide tablets with other hepatotoxic drugs may increase the risk of severe liver injury. Obtain transaminase and bilirubin levels within 6 months before initiation of teriflunomide tablets therapy. Monitor ALT levels at least monthly for six months after starting teriflunomide tablets [see Warnings and Precautions (5.1) ]. If drug induced liver injury is suspected, discontinue teriflunomide tablets and start an accelerated elimination procedure with cholestyramine or charcoal [see Warnings and Precautions (5.3) ] . Teriflunomide tablets are contraindicated in patients with severe hepatic impairment [see Contraindications (4) ] . Patients with pre-existing liver disease may be at increased risk of developing elevated serum transaminases when taking teriflunomide tablets. • Embryofetal Toxicity: Teriflunomide tablets are contraindicated for use in pregnant women and in females of reproductive potential who are not using effective contraception because of the potential for fetal harm. Teratogenicity and embryolethality occurred in animals at plasma teriflunomide exposures lower than that in humans. Exclude pregnancy before the start of treatment with teriflunomide tablets in females of reproductive potential. Advise females of reproductive potential to use effective contraception during teriflunomide tablets treatment and during an accelerated drug elimination procedure after teriflunomide tablets treatment. Stop teriflunomide tablets and use an accelerated drug elimination procedure if the patient becomes pregnant [see Contraindications (4) , Warnings and Precautions (5.2 , 5.3) , Use in Specific Populations (8.1 , 8.3) , and Clinical Pharmacology (12.3) ] . WARNING: HEPATOTOXICITY and EMBRYOFETAL TOXICITY See full prescribing information for complete boxed warning. • Hepatotoxicity: Clinically significant and potentially life-threatening liver injury, including acute liver failure requiring transplant, has been reported in patients treated with teriflunomide tablets in the postmarketing setting ( 5.1 ). Concomitant use of teriflunomide tablets with other hepatotoxic drugs may increase the risk of severe liver injury. Obtain transaminase and bilirubin levels within 6 months before initiation of teriflunomide tablets and monitor ALT levels at least monthly for six months ( 5.1 ). If drug induced liver injury is suspected, discontinue teriflunomide tablets and start accelerated elimination procedure ( 5.3 ). • Embryofetal Toxicity: Teratogenicity and embryolethality occurred in animals administered teriflunomide ( 5.2 , 8.1 ). Exclude pregnancy prior to initiating teriflunomide tablets therapy ( 4 , 5.2 , 8.1 , 8.3 ). Advise use of effective contraception in females of reproductive potential during treatment and during an accelerated drug elimination procedure ( 4 , 5.2 , 5.3 , 8.1 , 8.3 ). Stop teriflunomide tablets and use an accelerated drug elimination procedure if the patient becomes pregnant ( 5.2 , 5.3 , 8.1 ).

Common side effects

• Headache
• Increase in Alanine aminotransferase
• Diarrhea
• Alopecia
• Nausea
• Paresthesia
• Arthralgia
• Hypertension
• Neutropenia
• Acute Renal Failure
• Hypophosphatemia
• Severe skin reactions

Drug interactions

• SLCO1B1 Substrates

Key clinical trials

• Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS) (PHASE3)
• Leflunomide in Previously Treated Metastatic Triple Negative Cancers (PHASE1,PHASE2)
• Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS) (PHASE3)
• Teriflunomide in HTLV-1 Associated Myelopathy/Tropical Spastic Paraparesis (PHASE1,PHASE2)
• Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS) (PHASE3)
• A Non-interventional Study Evaluating Clinical Utility and Implications on Improved Patient Management of Serum Neurofilament as a Prognostic Marker for Disease Activity in Patients With Relapsing Multiple Sclerosis
• A NIS Evaluating Various Injectable and Oral Treatments in Patients With Relapsing Multiple Sclerosis
• Efficacy and Safety Studies of Frexalimab (SAR441344) in Adults With Relapsing Forms of Multiple Sclerosis (PHASE3)

Patents

Primary sources

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