Aubagio (teriflunomide) for multiple sclerosis

Last updated July 16, 2025, by Lindsey Shapiro, PhD
Fact-checked by Inês Martins, PhD

What is Aubagio for MS?

Aubagio (teriflunomide) is an approved oral treatment for relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), and active secondary progressive MS (SPMS).

The disease-modifying therapy has been shown in clinical trials to reduce the risk of relapses and disability progression, while also lessening measures of brain damage on MRI scans. It is taken once daily as oral tablets.

Aubagio works to limit the replication of activated immune cells implicated in the inflammatory attacks that drive MS. It does so by inhibiting an enzyme these cells need to grow called dihydroorotate dehydrogenase. Its active ingredient, teriflunomide, is a metabolite of leflunomide, a medication approved to treat rheumatoid arthritis.

The brand name medication is marketed by Sanofi, but several generic versions are also available.

Therapy snapshot

Who can take Aubagio?

Aubagio is approved in the U.S. for treating adults with CIS, RRMS, and active SPMS.

It is similarly approved in more than 80 countries, but indications vary. In the European Union, for example, it can be used for children and adults, ages 10 and older, with RRMS.

In the U.S., the medication is contraindicated for:

• people with severe liver problems
• pregnant patients or women of reproductive potential who aren’t using effective contraception
• people with a history of hypersensitivity reactions (harmful immune responses, including allergic reactions) to teriflunomide, leflunomide, or any of Aubagio’s ingredients
• those already using leflunomide.

Aubagio is also generally not recommended, although not specifically contraindicated, for people with severe immunodeficiency, bone marrow disease, or severe and uncontrolled infections.

How is Aubagio administered?

Aubagio is available in film-coated tablets that are taken by mouth once per day, with or without food. The recommended dose is 7 mg or 14 mg.

Aubagio in clinical trials

A number of Phase 2 and Phase 3 trials have demonstrated Aubagio’s ability to reduce disease activity and lower the risk of disease progression in people with relapsing forms of MS, but its approval was primarily supported by four Phase 3 trials:

• The TEMSO trial (NCT00134563) enrolled 1,088 adults with relapsing MS and randomly assigned them to receive Aubagio or a placebo for about two years. Results showed that Aubagio significantly reduced relapse rates, lowered the risk of disability progression, and reduced MRI-based indicators of disease activity. Benefits were sustained for up to nine years in an extension study (NCT00803049), with the risk of relapses and disability progression remaining significantly lower among those who started Aubagio in the main trial.
• The TOWER trial (NCT00751881) compared up to 40 months of treatment with Aubagio or a placebo in 1,165 adults with relapsing forms of MS. Results generally confirmed TEMSO’s findings, with Aubagio reducing relapse rates and disability progression and benefits being sustained in the long term.

Aubagio was also shown in a Phase 3 trial called TOPIC (NCT00622700) to reduce the risk of conversion to clinically definite MS in adults with CIS.

The Phase 3 TERIKIDS clinical trial (NCT02201108) also showed that the treatment tended to reduce the risk of relapse and significantly reduced the number of brain lesions in children with relapsing MS, ages 10-17. The findings supported Aubagio’s clearance for pediatric populations in Europe, but U.S. regulators found the data insufficient to support a regulatory approval in that population.

Aubagio side effects

The most common side effects of Aubagio in clinical trials included:

• headache
• diarrhea
• nausea
• hair loss (alopecia)
• elevated levels of liver enzymes, indicating liver damage.

Aubagio’s prescribing information also comes with two specific boxed warnings about its use in certain populations:

• The medication can lead to clinically significant and possibly life-threatening liver injury, with the risk being particularly high in people using other medications that are toxic to the liver, or in those with pre-existing liver problems.
• Aubagio is known to cause fetal harm and should not be started or continued in pregnant people, or in those of childbearing potential who are not using an effective mode of contraception.

Pregnancy must be ruled out before Aubagio starts. Should a person become pregnant while taking Aubagio or within two years after the last dose, they should immediately inform their healthcare team.

Aubagio leaves the body slowly, so people who need to stop using it for safety reasons may be given medications to more quickly remove the treatment from the body.

Other possible complications that may occur while on treatment with Aubagio include:

• reduced immune cell counts and increased risk of infection
• hypersensitivity reactions, including severe allergic reactions and anaphylaxis
• serious skin or systemic reactions related to high blood levels of immune cells called eosinophils
• damage to nerves outside the brain and spinal cord
• elevated blood pressure
• new or worsening lung problems.

Multiple Sclerosis News Today is strictly a news and information website about the disease. It does not provide medical advice, diagnosis, or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website.