Teriflunomide: uses, dosing, side effects & brands
Teriflunomide is a pyrimidine synthesis inhibitor sold in the U.S. under 2 brand and generic names, for relapsing-remitting multiple sclerosis. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Pyrimidine Synthesis Inhibitor
- Treats
- Relapsing-Remitting Multiple Sclerosis
- Available as
- Tablet
- Sold as
- 2 products — Aubagio and Teriflunomide
- Prescription?
- Prescription only
- Generic available?
- Yes
- What the pharmacy pays
- about $16 for a 30-count supply — not your price
- Boxed warning
- Boxed warning
How teriflunomide is dosed
From the FDA label for Aubagio (application NDA202992). Other teriflunomide products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
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. ( 2 ) 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 [see Warnings and Precautions (5.1) ] . 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 [see Warnings and Precautions (5.4) ] . Prior to initiating AUBAGIO, screen patients for latent tuberculosis infection with a tuberculin skin test or blood test for mycobacterium tuberculosis infection [see Warnings and Precautions (5.4) ] . Exclude pregnancy prior to initiation of treatment with AUBAGIO in females of reproductive potential [see Warnings and Precautions (5.2) ] . Check blood pressure before start of AUBAGIO treatment and periodically thereafter [see Warnings and Precautions (5.10) ] .
Teriflunomide side effects
The following clinically significant adverse reactions are described elsewhere in the prescribing information: Hepatotoxicity [see Contraindications (4) and Warnings and Precautions (5.1) ] Bone Marrow Effects/Immunosuppression Potential/Infections [see Warnings and Precautions (5.4) ] Hypersensitivity Reactions [see Contraindications (4) and Warnings and Precautions (5.5) ] Serious Skin Reactions [see Warnings and Precautions (5.6) ] Drug Reaction with Eosinophilia and Systemic Symptoms [see Warnings and Precautions (5.7) ] Cutaneous or Mucocutaneous Ulcers and Impaired Wound Healing [see Warnings and Precautions (5.8) ] Peripheral Neuropathy [see Warnings and Precautions (5.9) ] Increased Blood Pressure [see Warnings and Precautions (5.10) ] Respiratory Effects [see Warnings and Precautions (5.11) ] Pancreatitis in Pediatric Patients [see Warnings and Precautions (5.12) ] Most common adverse reactions (≥10% and ≥2% greater than placebo): headache, diarrhea, nausea, alopecia, increase in ALT. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Genzyme Corporation at 1-800-745-4447 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and…
Who shouldn’t take teriflunomide
Severe hepatic impairment ( 4 , 5.1 ) Pregnancy ( 4 , 5.2 , 8.1 ) Hypersensitivity ( 4 , 5.5 ) Current leflunomide treatment ( 4 ) AUBAGIO is contraindicated in/with: Patients with severe hepatic impairment [see Warnings and Precautions (5.1) ] . Pregnant women and females of reproductive potential not using effective contraception. AUBAGIO may cause fetal harm [see Warnings and Precautions (5.2 , 5.3) and Use in Specific Populations (8.1) ] . 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 [see Warnings and Precautions (5.5) ]. Coadministration with leflunomide [see Clinical Pharmacology (12.3) ].
Teriflunomide drug interactions
Drugs metabolized by CYP2C8 and OAT3 transporters: Monitor patients because teriflunomide may increase exposure of these drugs. ( 7 ) Teriflunomide may increase exposure of ethinylestradiol and levonorgestrel. Choose an appropriate oral contraceptive. ( 7 ) Drugs metabolized by CYP1A2: Monitor patients because teriflunomide may decrease exposure of these drugs. ( 7 ) Warfarin: Monitor INR as teriflunomide may decrease INR. ( 7 ) Drugs metabolized by BCRP and OATP1B1/B3 transporters: Monitor patients because teriflunomide may increase exposure of these drugs. ( 7 ) Rosuvastatin: The dose of rosuvastatin should not exceed 10 mg once daily in patients taking AUBAGIO. ( 7 ) 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. Monitor these patients and adjust the dose of the concomitant drug(s) metabolized by CYP2C8 as required [see Clinical Pharmacology (12.3) ] . Effect of AUBAGIO on Warfarin Coadministration of AUBAGIO with warfarin requires close monitoring of the international normalized ratio (INR) because AUBAGIO may decrease peak INR by approximately 25%. Effect of AUBAGIO on Oral Contraceptives AUBAGIO may increase the systemic exposures of ethinylestradiol and levonorgestrel. Consideration should be given to the type or dose of contraceptives used in combination with AUBAGIO [see Clinical Pharmacology (12.3) ] . Effect of AUBAGIO on CYP1A2 Substrates Teriflunomide may be a weak inducer of CYP1A2 in vivo . In patients taking AUBAGIO, exposure of drugs metabolized by CYP1A2 (e.g., alosetron, duloxetine, theophylline, tizanidine) may be reduced. Monitor these patients and adjust the dose of the concomitant drug(s) metabolized by CYP1A2 as required [see Clinical Pharmacology (12.3) ] . Effect of AUBAGIO on Organic Anion Transporter 3 (OAT3) Substrates Teriflunomide inhibits the activity of OAT3 in vivo . In patients taking AUBAGIO, exposure of drugs which are OAT3 substrates (e.g., cefaclor, cimetidine, ciprofloxacin, penicillin G, ketoprofen, furosemide, methotrexate, zidovudine) may be increased. Monitor these patients and adjust the dose of the concomitant drug(s) which are OAT3 substrates as required [see Clinical Pharmacology (12.3) ] . Effect of AUBAGIO on BCRP and Organic Anion Transporting Polypeptide B1 and B3 (OATP1B1/1B3) Substrates Teriflunomide inhibits the activity of BCRP and OATP1B1/1B3 in vivo . For a patient taking AUBAGIO, the dose of rosuvastatin should not exceed 10 mg once daily. For other substrates of BCRP (e.g., mitoxantrone) and drugs in the OATP family (e.g., methotrexate, rifampin), especially HMG-Co reductase inhibitors (e.g., atorvastatin, nateglinide, pravastatin, repaglinide, and simvastatin), consider reducing the dose of these drugs and monitor patients closely for signs and symptoms of increased exposures to the drugs while patients are taking AUBAGIO [see Clinical Pharmacology (12.3) ] .
Every teriflunomide product we track (2)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Pharmacy pays | |
|---|---|---|---|---|---|---|---|
| 1 | 70/100 | Prescription | Tablet | Generic | $16 | View → | |
| 2 | 56/100 | Prescription | Tablet | Generic | $16 | View → |
What teriflunomide pills look like
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
Teriflunomide recalls
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
How long teriflunomide keeps
No teriflunomide label we read sets a separate limit for after opening, but they do specify how it must be stored — and the stability behind any date assumes those conditions.
Does teriflunomide expire? The in-use limits and storage rules from its labelsTeriflunomide and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for teriflunomide: levels in milk, effects in breastfed infants, and the drugs it would consider insteadBecause there is no published experience with teriflunomide during breastfeeding, most sources recommend that it should be avoided during breastfeeding, especially while nursing a newborn or preterm infant.[1–4]
National Institute of Child Health and Human Development, record revised June 15, 2025. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about teriflunomide
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 5,306 reports naming teriflunomide, and the FDA flagged 68% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- fatigue840 reports
- alopecia832 reports
- diarrhoea774 reports
- multiple sclerosis relapse653 reports
- hypoaesthesia608 reports
- fall570 reports
- headache557 reports
- paraesthesia516 reports
Read these as a signal, not a rate. A report does not mean teriflunomide caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved August 26, 2026.
Related calculators
Frequently asked questions
What is teriflunomide?
Aubagio (Teriflunomide) is a pyrimidine synthesis inhibitor used to treat Relapsing-Remitting Multiple Sclerosis.
What kind of drug is teriflunomide?
The FDA classifies teriflunomide as a pyrimidine synthesis inhibitor. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take teriflunomide with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run teriflunomide against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is teriflunomide sold under?
We track 2 teriflunomide-containing products in the U.S.: Aubagio and Teriflunomide. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does teriflunomide come in?
Across the brands we track, teriflunomide is currently marketed as tablet, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic teriflunomide?
Yes. Our catalog lists 1 generic teriflunomide product alongside the brand versions. A generic has the same active ingredient and must meet the FDA's bioequivalence standard; it usually costs less. Ask your pharmacist which one your plan covers.
Has teriflunomide been recalled?
The FDA's Enforcement database lists 1 recall record whose product description mentions teriflunomide. The most recent: Teriflunomide Tablets (Mar 13, 2025). A recall applies to specific lots, not to the drug as a whole — check the record for the affected lot numbers.
Cite this page
- APA
- pharmaranks. (2026, July 24). Teriflunomide: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/teriflunomide
- MLA
- “Teriflunomide: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/teriflunomide.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for teriflunomide on DailyMed (NIH) ↗ — including its boxed warning in full.