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Teriflunomide
Specialty Drug

Aubagio

TERIFLUNOMIDE treats multiple sclerosis. It can decrease the number of flare-ups. This medicine is not a cure. Compare pyrimidine synthesis inhibitors.
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Teriflunomide Side Effects

What should I watch for?

Visit your healthcare professional for regular checks on your progress. Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse. You may need blood work done while you are taking this medicine.

This medicine may stay in your body for up to 2 years after your last dose. Tell your doctor about any unusual side effects or symptoms. A medicine can be given to help lower your blood levels of teriflunomide quickly.

Women must use effective birth control with this medicine. There is a potential for serious side effects to an unborn child. Do not become pregnant while taking this medicine or for 2 years after stopping it. Inform your doctor if you wish to become pregnant. This medicine remains in your blood after you stop taking it. You must continue using effective birth control until the blood levels have been checked and they are low enough. Immediately talk to your doctor if you think you may be pregnant. You may need a pregnancy test. A medicine can be given to help lower your blood levels of this medicine more quickly. Talk to your health care professional or pharmacist for more information.

For men, your partner should not become pregnant while you are taking this medicine. There is a potential for serious side effects to an unborn child. You and your female partner should use effective birth control during your treatment. This medicine is found in the semen of men. This medicine remains in your blood after you stop taking it. Men who wish to father a child should continue using effective birth control until the blood levels of this medicine have been checked and they are low enough.

You should not receive certain vaccines during your treatment and for 6 months after your treatment with this medication ends.

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Common and Rare Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Body aches or pain

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

chills

cough

cough producing mucus

diarrhea

difficulty breathing

ear congestion

fever

general feeling of discomfort or illness

headache

joint pain

loss of appetite

loss of voice

muscle aches and pains

nasal congestion

nausea

runny nose

shivering

sneezing

sore throat

sweating

tightness in the chest

trouble sleeping

unusual tiredness or weakness

vomiting

Less common

Abdominal or stomach pain or tenderness

agitation

black, tarry stools

bloody or cloudy urine

blurred vision

burning, numbness, pain, or tingling in all fingers except smallest finger

clay colored stools

coma

confusion

dark urine

decreased appetite

decreased urine output

depression

diarrhea

difficult, burning, or painful urination

dizziness

fast, irregular, pounding, or racing heartbeat or pulse

frequent urge to urinate

hostility

irritability

itching or skin rash

lethargy

loss of appetite

lower back or side pain

muscle twitching

pale skin

pounding in the ears

rapid weight gain

seizures

slow or fast heartbeat

stupor

swelling of the feet or lower legs

ulcers, sores, or white spots in the mouth

unusual bleeding or bruising

weakness or heaviness of the legs

yellow eyes or skin

Rare

Blistering, peeling, or loosening of the skin

joint pain

red skin lesions, often with a purple center

red, irritated eyes

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Hair loss or thinning of the hair

Less common

Blemishes on the skin

bone pain

burning, dry, or itching eyes

difficulty with moving

discharge or excessive tearing

full or bloated feeling

muscle cramping or stiffness

pain in the lower back, bottom, or hips

pain in the upper leg

pimples

pressure in the stomach

redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid

swelling of the abdominal or stomach area

swollen joints

toothache

weight loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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