AUBAGIO® (teriflunomide) is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS).

Do not take AUBAGIO if you have severe liver problems, are pregnant or of childbearing potential and not using effective birth control, have had an allergic reaction to AUBAGIO or leflunomide, or are taking a medicine called leflunomide for rheumatoid arthritis. View IMPORTANT SAFETY INFORMATION

AUBAGIO® (teriflunomide) 14 mg tablet image

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Our Safety Profile. Demonstrated Over Time.

Over 13 years of ongoing clinical studies and real-world patient experience – FDA approval of AUBAGIO in 2012

Possible Serious Side Effects of AUBAGIO.

If you experience any of the following side effects while taking AUBAGIO, speak with your healthcare provider right away.

In addition to the risk of liver problems and the risk of harm to an unborn baby, other serious side effects include:

  • Reduced white blood cell count — this may cause you to have more infections
  • Numbness or tingling in your hands or feet that is different from your MS symptoms
  • Allergic reactions, including serious skin problems
  • Breathing problems (new or worsening)
  • High blood pressure
  • Patients with low white blood cell count should not receive certain vaccinations during AUBAGIO treatment and 6 months after

Tell your doctor if you have any side effect that bothers you or does not go away.

Real people. Real Results.

The most common side effects of AUBAGIO.

AUBAGIO was associated with some side effects. Here are some of the most common side effects seen in clinical trials. These are not all of the side effects. Of course, not every individual reacts the same to medicine. So your healthcare provider is a great person to discuss your concerns about side effects with you. You can also call the MS One to One® Nurses at 1-855-MSOne2One (1-855-676-6326).

SIDE EFFECTS AUBAGIO
14 mg (n=1002)
7 mg (n=1045)
PLACEBO
(n=997)
Headache 16% 18% 15%
Diarrhea 14% 13% 8%
Nausea 11% 8% 7%
Hair thinning or loss 13% 10% 5%
Abnormal liver test results 15% 13% 9%

Tell your doctor if you have any side effect that bothers you or does not go away.

n = number of people in trial

Discontinuation due to common side effects. In clinical trials, only a small percentage of people stopped taking AUBAGIO due to side effects.

Discontinuation Rates Due to Common Side Effects
SIDE EFFECTS AUBAGIO
14 mg (n=1002)
7 mg (n=1045)
PLACEBO
(n=997)
Diarrhea 0.4% 0.5% 0.1%
Nausea 0.3% 0.1% 0%
Hair thinning
or loss
1.3% 0.2% 0.1%
Abnormal liver
test results
2.6% 3.3% 2.3%
Headache 0% 0% 0.3%

The facts about possible hair thinning or hair loss.

Hair thinning or hair loss was a side effect of AUBAGIO reported in clinical trials. 87% of patients on AUBAGIO 14 mg and 90% of patients on AUBAGIO 7 mg did not report hair thinning or hair loss. That means that nearly 9 out of 10 people on AUBAGIO didn’t report this problem.
In most cases, hair thinning or hair loss was mild to moderate, had a median time to onset of 99 days, and improved without corrective therapy while patients remained in the clinical trials.

Sure, I was worried about hair thinning. But I talked to my doctor so I was ready when it happened. For me, it lasted 3 months.”

-Mary Ellen

On AUBAGIO 14 mg.
Individual experiences may vary.

Information
for women Of childbearing 
potential.

Women who are pregnant or not using effective birth control should not take AUBAGIO because it’s possible that AUBAGIO may harm your unborn baby.

If you’re not pregnant and are using effective birth control, you can take AUBAGIO. Always talk to your healthcare provider about all your medications if you are planning to become pregnant.

If you become pregnant while taking AUBAGIO, tell your healthcare provider right away. A process called accelerated elimination helps remove AUBAGIO from your blood if needed. It is recommended that you continue using birth control until the level of AUBAGIO is lower than 0.02 mg/L in your blood.

It is not known if AUBAGIO passes into breast milk. Your healthcare provider can help you decide if you should take AUBAGIO or breastfeed—you should not do both at the same time.

If you become pregnant while taking AUBAGIO or within 2 years after stopping, tell your healthcare provider right away and enroll in the AUBAGIO Pregnancy Registry at 1-800-745-4447, option 2. The purpose of this registry is to collect information about your health and your baby’s health.

Men considering or taking AUBAGIO should also talk to their healthcare provider about family planning.

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INDICATION

AUBAGIO® (teriflunomide) is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS).

IMPORTANT SAFETY INFORMATION

DO NOT TAKE AUBAGIO IF YOU:
  • Have severe liver problems. AUBAGIO may cause serious liver problems, which can be life-threatening. Your risk may be higher if you take other medicines that affect your liver. Your healthcare provider should do blood tests to check your liver within 6 months before you start AUBAGIO and monthly for 6 months after starting AUBAGIO. Tell your healthcare provider right away if you develop any of these symptoms of liver problems: nausea, vomiting, stomach pain, loss of appetite, tiredness, yellowing of your skin or whites of your eyes, or dark urine.
  • Are pregnant. AUBAGIO may harm an unborn baby. You should have a pregnancy test before starting AUBAGIO. After stopping AUBAGIO, continue to use effective birth control until you have made sure your blood levels of AUBAGIO are lowered. If you become pregnant while taking AUBAGIO or within 2 years after stopping, tell your healthcare provider right away and enroll in the AUBAGIO Pregnancy Registry at 1‑800‑745‑4447, option 2.
  • Are of childbearing potential and not using effective birth control.

    It is not known if AUBAGIO passes into breast milk. Your healthcare provider can help you decide if you should take AUBAGIO or breastfeed — you should not do both at the same time.

    If you are a man whose partner plans to become pregnant, you should stop taking AUBAGIO and talk with your healthcare provider about reducing the levels of AUBAGIO in your blood. If your partner does not plan to become pregnant, use effective birth control while taking AUBAGIO.

  • Have had an allergic reaction to AUBAGIO or a medicine called leflunomide.
  • Take a medicine called leflunomide for rheumatoid arthritis.

AUBAGIO may stay in your blood for up to 2 years after you stop taking it. Your healthcare provider can prescribe a medicine that can remove AUBAGIO from your blood quickly.

Before taking AUBAGIO, talk with your healthcare provider if you have: liver or kidney problems; a fever or infection, or if you are unable to fight infections; numbness or tingling in your hands or feet that is different from your MS symptoms; diabetes; serious skin problems when taking other medicines; breathing problems; or high blood pressure. Your healthcare provider will check your blood cell count and TB test before you start AUBAGIO. Talk with your healthcare provider if you take or are planning to take other medicines (especially medicines for treating cancer or controlling your immune system), vitamins or herbal supplements.

AUBAGIO may cause serious side effects, including: reduced white blood cell count — this may cause you to have more infections; numbness or tingling in your hands or feet that is different from your MS symptoms; allergic reactions, including serious skin problems; breathing problems (new or worsening); and high blood pressure. Patients with low white blood cell count should not receive certain vaccinations during AUBAGIO treatment and 6 months after.

Tell your doctor if you have any side effect that bothers you or does not go away.

The most common side effects when taking AUBAGIO include: headache; diarrhea; nausea; hair thinning or loss; and abnormal liver test results. These are not all the side effects of AUBAGIO. Tell your healthcare provider about any side effect that bothers you.

Consult your healthcare provider if you have questions about your health or any medications you may be taking, including AUBAGIO.

You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1‑800‑FDA‑1088.

Please click here for full Prescribing Information, including boxed WARNING and Medication Guide.

IMPORTANT SAFETY INFORMATION
Do not take AUBAGIO if you have severe liver problems. AUBAGIO may cause serious liver problems, which can be life-threatening. Your risk may be higher if you take other medicines that affect your liver. View More