Prescription medicine
Teriflunomide Brand names: Aubagio
Teriflunomide (Aubagio) is a prescription medicine with an FDA approval on record since 2012. FDA's NDC Directory lists it from 15 generic labelers, and pharmacies paid $0.233 per teriflunomide 14 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the teriflunomide FDA label on DailyMed (effective February 20, 2026, Genzyme Corporation); the NDA 202992 record on Drugs@FDA; every teriflunomide label on DailyMed.
Highlights of the record
FDA label of February 20, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
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 [see Warnings and Precautions (5.1) ]. Concomitant use of AUBAGIO with other hepatotoxic drugs may increase the risk of severe liver injury. 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) ]. If drug induced liver injury is suspected, discontinue AUBAGIO and start an accelerated elimination procedure with cholestyramine or charcoal [see Warnings and Precautions (5.3) ]. AUBAGIO is 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 AUBAGIO. Embryofetal Toxicity AUBAGIO is 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. […]
Used for
From the label: indications and usageAUBAGIO ® 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.
Forms and strengths
- 7 mg
- 14 mg
- 14 mg/141
Film-coated tablet; tablet.
On the market
- Earliest approval on file
- September 12, 2012 Aubagio, Sanofi Aventis Us; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 19 first July 27, 2018; 13 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 16 of which 15 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- August 4, 2034 Aubagio tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.233 per tablet Teriflunomide 14 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2025 0 Class I among all firms' recalls; latest March 13, 2025
- FAERS reports
- 44,957 through July 30, 2026
What is teriflunomide used for?
From the label: indications and usageAUBAGIO ® 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.
Conditions named in the indications of teriflunomide's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Pyrimidine Synthesis Inhibitor.
Source: FDA drug label (Aubagio), NDA202992 (Sanofi Aventis Us), as published by Genzyme Corporation, effective February 20, 2026 (SPL set 4650d12c-b9c8-4525-b07f-a2d773eca155), via openFDA; the full label on DailyMed
What does the patient leaflet for teriflunomide say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about AUBAGIO?AUBAGIO may cause serious side effects, including: Liver problems: AUBAGIO may cause serious liver problems, including liver failure that can be life-threatening and may require a liver transplant. Your risk of developing serious liver problems may be higher if you already have liver problems or take other medicines that also affect your liver. Your healthcare provider should do blood tests to check your liver: within 6 months before you start taking AUBAGIO 1 time a month for 6 months after you start taking AUBAGIO Call your healthcare provider right away if you have any of the following symptoms of liver problems: nausea vomiting stomach pain loss of appetite tiredness your skin or the whites of your eyes turn yellow dark urine Harm to your unborn baby: AUBAGIO may cause harm to your unborn baby. Do not take AUBAGIO if you are pregnant. Do not take AUBAGIO unless you are using effective birth control. If you are a female, you should have a pregnancy test before you start taking AUBAGIO. Use effective birth control during your treatment with AUBAGIO. After stopping AUBAGIO, continue using effective birth control until you have blood tests to make sure your blood levels of AUBAGIO are low enough. If you become pregnant while taking AUBAGIO or within 2 years after you stop taking it, tell your healthcare provider right away. There is a pregnancy safety surveillance program for females who are exposed to AUBAGIO during pregnancy or who become pregnant within 2 years after their last dose of AUBAGIO. The purpose of the program is to collect information about the health of pregnant females exposed to AUBAGIO and their babies. If you become pregnant, talk to your healthcare provider about how you can take part in the program or call 1-800-745-4447, option 2. […]
From the patient leaflet: How should I store AUBAGIO?Store AUBAGIO at room temperature between 68°F to 77°F (20°C to 25°C). Keep AUBAGIO and all medicines out of the reach of children.
Source: FDA drug label (Aubagio), NDA202992 (Sanofi Aventis Us), as published by Genzyme Corporation, effective February 20, 2026 (SPL set 4650d12c-b9c8-4525-b07f-a2d773eca155), via openFDA; the full label on DailyMed
Is there a generic for teriflunomide (Aubagio)?
The FDA approved the first generic teriflunomide on July 27, 2018. 19 generic applications are approved; 13 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists teriflunomide from 15 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 3 patents for Aubagio tablets, the last expiring on August 4, 2034. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2012 earliest approval on file
- 2018 first generic approved
- 2034 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for teriflunomide (Aubagio)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.233 per Teriflunomide 14 mg tablet, down 68% from $0.737 on October 8, 2025. The survey records the price, not the reason for a change; large moves often follow a new generic or a list-price change. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Teriflunomide 14 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Teriflunomide 14 mg tablet | Generic | $0.233 per tablet | $7.00 | -68% |
| Teriflunomide 7 mg tablet | Generic | $0.292 per tablet | $8.76 | -47% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has teriflunomide been recalled?
The FDA's Enforcement Report lists 1 recall naming teriflunomide since 2025: 0 Class I (the most serious), 1 Class II, 0 Class III; 1 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| March 13, 2025 | Class II | Glenmark Pharmaceuticals Inc., USA | CGMP Deviations |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the teriflunomide label say about other medicines?
The teriflunomide label names 27 other medicines in its interaction, contraindication or warning sections. The labels of 11 other medicines name teriflunomide. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Alosetron | drug interactions | In patients taking AUBAGIO, exposure of drugs metabolized by CYP1A2 (e.g., alosetron, duloxetine, theophylline, tizanidine) may be reduced. |
| Atorvastatin | drug interactions | 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 … |
| Cefaclor | drug interactions | 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. |
| Cholestyramine | boxed warning | If drug induced liver injury is suspected, discontinue AUBAGIO and start an accelerated elimination procedure with cholestyramine or charcoal [see Warnings and Precautions (5.3) ]. |
| Cimetidine | drug interactions | 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. |
| Ciprofloxacin | drug interactions | 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. |
| Duloxetine | drug interactions | In patients taking AUBAGIO, exposure of drugs metabolized by CYP1A2 (e.g., alosetron, duloxetine, theophylline, tizanidine) may be reduced. |
| Furosemide | drug interactions | 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. |
| Glatiramer | warnings and precautions | Safety studies in which AUBAGIO was concomitantly administered with other immune modulating therapies for up to one year (interferon beta, glatiramer acetate) did not reveal any specific safety concerns. |
| Ketoprofen | drug interactions | 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. |
| Leflunomide | contraindications | CONTRAINDICATIONS 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: |
| Levonorgestrel | drug interactions | 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. |
| Methotrexate | drug interactions | 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. |
| Mitoxantrone | drug interactions | 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 … |
Every other medicine the teriflunomide label names
| Medicine named | Section | What the label says |
|---|---|---|
| Nateglinide | drug interactions | … 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 … |
| Paclitaxel | drug interactions | In patients taking AUBAGIO, exposure of drugs metabolized by CYP2C8 (e.g., paclitaxel, pioglitazone, repaglinide, rosiglitazone) may be increased. |
| Penicillin g | drug interactions | 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. |
| Pioglitazone | drug interactions | In patients taking AUBAGIO, exposure of drugs metabolized by CYP2C8 (e.g., paclitaxel, pioglitazone, repaglinide, rosiglitazone) may be increased. |
| Pravastatin | drug interactions | … 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 … |
| Repaglinide | drug interactions | In patients taking AUBAGIO, exposure of drugs metabolized by CYP2C8 (e.g., paclitaxel, pioglitazone, repaglinide, rosiglitazone) may be increased. |
| Rifampin | drug interactions | 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 … |
| Rosuvastatin | drug interactions | 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. |
| Simvastatin | drug interactions | … 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 … |
| Theophylline | drug interactions | In patients taking AUBAGIO, exposure of drugs metabolized by CYP1A2 (e.g., alosetron, duloxetine, theophylline, tizanidine) may be reduced. |
| Tizanidine | drug interactions | In patients taking AUBAGIO, exposure of drugs metabolized by CYP1A2 (e.g., alosetron, duloxetine, theophylline, tizanidine) may be reduced. |
| Warfarin | drug interactions | 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 … |
| Zidovudine | drug interactions | 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. |
Other labels that name teriflunomide
Source: FDA drug label (Aubagio), NDA202992 (Sanofi Aventis Us), as published by Genzyme Corporation, effective February 20, 2026 (SPL set 4650d12c-b9c8-4525-b07f-a2d773eca155), via openFDA; the full label on DailyMed
What do FAERS reports show for teriflunomide?
The FDA Adverse Event Reporting System holds 44,957 reports that list teriflunomide among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 726 are coded as a death and 6,374 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as teriflunomide?
8 other medicines are given the same way (oral) and in the same FDA class as teriflunomide or labeled mainly for the same use (multiple sclerosis), the same class first. Multiple sclerosis lists all 23 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Dimethyl fumarate | Multiple sclerosis | 19 labelers | $0.467 per capsule 240 mg capsule | No current entry |
| Fingolimod | Multiple sclerosis | 21 labelers | $1.58 per capsule 0.5 mg capsule | No current entry |
| Dalfampridine | Multiple sclerosis | 9 labelers | $0.399 per tablet 10 mg tablet | No current entry |
| Cladribine | Multiple sclerosis | 3 labelers | n/a | No current entry |
| Siponimod | Multiple sclerosis | none listed | n/a | No current entry |
| Ponesimod | Multiple sclerosis | none listed | n/a | No current entry |
| Diroximel fumarate | Multiple sclerosis | none listed | n/a | No current entry |
| Monomethyl fumarate | Multiple sclerosis | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as teriflunomide
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to teriflunomide
- 8 medicines for the same use
- Teriflunomide side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other