Teriflunomide (Oral Route)

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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:

• 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

• 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
• Lethargy
• Loss of appetite
• Lower back or side pain
• Muscle twitching
• Pale skin
• Pounding in the ears
• Rapid weight gain
• Seizures
• Skin rash
• 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

• 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:

• Hair loss or thinning of the hair

• 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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