Teriflunomide is a pyrimidine synthesis inhibitor indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. MedsAcross supplies Teriflunomide for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
AUBAGIO ® is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. AUBAGIO is a pyrimidine synthesis inhibitor indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
Source: US FDA prescribing information
Teriflunomide, an immunomodulatory agent with anti-inflammatory properties, inhibits dihydroorotate dehydrogenase, a mitochondrial enzyme involved in de novo pyrimidine synthesis. The exact mechanism by which teriflunomide exerts its therapeutic effect in multiple sclerosis is unknown but may involve a reduction in the number of activated lymphocytes in CNS.
Source: US FDA prescribing information
The recommended dose of AUBAGIO is 7 mg or 14 mg orally once daily. AUBAGIO can be taken with or without food. 7 mg or 14 mg orally once daily, with or without food. Monitoring to Assess Safety Obtain transaminase and bilirubin levels within 6 months before initiation of AUBAGIO therapy. Monitor ALT levels at least monthly for six months after starting AUBAGIO. Obtain a complete blood cell count (CBC) within 6 months before the initiation of treatment with AUBAGIO. Further monitoring should be based on signs and symptoms of infection. Prior to initiating AUBAGIO, screen patients for latent tuberculosis infection with a tuberculin skin test or blood test for mycobacterium tuberculosis infection. Exclude pregnancy prior to initiation of treatment with AUBAGIO in females of reproductive potential. Check blood pressure before start of AUBAGIO treatment and periodically thereafter.
Source: US FDA prescribing information
Severe hepatic impairment. Pregnancy. Hypersensitivity. Current leflunomide treatment. AUBAGIO is contraindicated in/with: Patients with severe hepatic impairment. Pregnant women and females of reproductive potential not using effective contraception. AUBAGIO may cause fetal harm. Patients with a history of a hypersensitivity reaction to teriflunomide, leflunomide, or to any of the inactive ingredients in AUBAGIO. Reactions have included anaphylaxis, angioedema, and serious skin reactions. Coadministration with leflunomide.
Source: US FDA prescribing information
Boxed 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 AUBAGIO in the postmarketing setting. Concomitant use of AUBAGIO with other hepatotoxic drugs may increase the risk of severe liver injury. Elimination of AUBAGIO can be accelerated by administration of cholestyramine or activated charcoal for 11 days. AUBAGIO may decrease WBC. A recent CBC should be available before starting AUBAGIO. Monitor for signs and symptoms of infection. Consider suspending treatment with AUBAGIO in case of serious infection. Do not start AUBAGIO in patients with active infections.
Source: US FDA prescribing information
The following clinically significant adverse reactions are described elsewhere in the prescribing information: Hepatotoxicity Bone Marrow Effects/Immunosuppression Potential/Infections Hypersensitivity Reactions Serious Skin Reactions Drug Reaction with Eosinophilia and Systemic Symptoms Cutaneous or Mucocutaneous Ulcers and Impaired Wound Healing Peripheral Neuropathy Increased Blood Pressure Respiratory Effects Pancreatitis in Pediatric Patients Most common adverse reactions (≥10% and ≥2% greater than placebo): headache, diarrhea, nausea, alopecia, increase in ALT.
Source: US FDA prescribing information
Drugs metabolized by CYP2C8 and OAT3 transporters: Monitor patients because teriflunomide may increase exposure of these drugs. Teriflunomide may increase exposure of ethinylestradiol and levonorgestrel. Choose an appropriate oral contraceptive. Drugs metabolized by CYP1A2: Monitor patients because teriflunomide may decrease exposure of these drugs. Warfarin: Monitor INR as teriflunomide may decrease INR. Drugs metabolized by BCRP and OATP1B1/B3 transporters: Monitor patients because teriflunomide may increase exposure of these drugs. Rosuvastatin: The dose of rosuvastatin should not exceed 10 mg once daily in patients taking AUBAGIO. Effect of AUBAGIO on CYP2C8 Substrates Teriflunomide is an inhibitor of CYP2C8 in vivo. In patients taking AUBAGIO, exposure of drugs metabolized by CYP2C8 (e.g., paclitaxel, pioglitazone, repaglinide, rosiglitazone) may be increased.
Source: US FDA prescribing information
Store at 68°F to 77°F (20°C to 25°C) with excursions permitted between 59°F and 86°F (15°C and 30°C).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
4 presentations of Teriflunomide, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Teriflunomide 14 mg tabletOralGeneric name | — | US FDA | Available on request |
| Teriflunomide 7 mg tabletOralGeneric name | — | US FDA | Available on request |
| Aubagio 14 mg tabletOral | Genzyme | US FDA | Available on request |
| Aubagio 7 mg tabletOral | Genzyme | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Conditions linked to Teriflunomide in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 4 presentations of Teriflunomide and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Teriflunomide, including Aubagio.
Yes. The US FDA first approved Teriflunomide on 12 September 2012, according to Drugs@FDA.
Yes. Teriflunomide has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
No listed presentation of Teriflunomide is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Teriflunomide is classified under ATC code L04AK02 (Teriflunomide).
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