Teriflunomide (Aubagio) - Uses, Side Effects, and More

What are the most common side effects of teriflunomide?

The most common side effects of teriflunomide are listed below. Tell your health care provider if you have any of these side effects that bother you.

• Headache
• Stomach problems like nausea or diarrhea
• Hair thinning or hair loss, also known as alopecia
• Increases in liver function tests

There may be other side effects of teriflunomide that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of teriflunomide?

While less common, the most serious side effects of teriflunomide are described below, along with what to do if they happen.

Liver Damage. Liver damage, also called hepatotoxicity, can happen when taking teriflunomide. This medicine may cause serious liver problems, including liver failure that may be life-threatening and require a transplant. Your risk of liver damage may be higher if you already have liver problems or if you take certain medicines that affect your liver. Your health care provider will order blood tests to check your liver before you start taking teriflunomide and during treatment. Call your health care provider right away if you have any of the following symptoms of liver damage.

• Nausea or vomiting
• Stomach or belly pain
• Fever
• Weakness or unusual tiredness
• Itching
• Loss of appetite
• Light-colored poop
• Dark-colored urine (pee)
• Your skin or the whites of your eyes turning yellowish in color (also called jaundice)

Decreased White Blood Cells. Teriflunomide may cause decreased white blood cell counts. White blood cells help prevent infections. Having a low level of white blood cells increases your risk of infections, including serious infections. Your health care provider will check your white blood cell counts before treatment with teriflunomide. They will also test you for tuberculosis. Tell your health care provider right away if you have any of the following symptoms of an infection.

• Fever or chills
• Tiredness
• Body aches
• Nausea and vomiting

Severe Allergic Reactions. Teriflunomide may cause allergic reactions, including a specific type of allergic reaction called DRESS, which stands for drug reaction with eosinophilia and systemic symptoms. It is also sometimes called multi-organ hypersensitivity. This is a reaction that can affect multiple parts of the body, including your liver, kidneys, and heart. Stop taking the medicine and get help right away if you have any of the following symptoms of a serious allergic reaction.

• Breathing problems or wheezing
• Racing heart
• Itching, skin rash, or pale red bumps on the skin called hives
• Fever or general ill feeling
• Swollen lymph nodes
• Swelling of the face, lips, mouth, tongue, or throat
• Shortness of breath, trouble swallowing, or throat tightness
• Swelling in your feet, ankles, or legs
• Nausea or vomiting
• Dizziness, feeling lightheaded, or fainting
• Unusual bruising or bleeding
• Weakness or tiredness
• Stomach cramps
• Joint or muscle pain
• Dark-colored pee
• Your skin or the whites of your eyes turning yellowish in color (also called jaundice)

Severe Skin Reactions. Teriflunomide can cause severe skin reactions, called Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), that can lead to death if not treated. If you get a rash, stop teriflunomide and call your health care provider right away. Get emergency help if you have any of the following symptoms of SJS or TEN.

• Painful red or purple skin that looks burned and peels off
• Flat red rash or blisters on your skin, mouth, nose, and genitals
• Red, painful, watery eyes

Increased Blood Pressure (Hypertension). Teriflunomide may increase your blood pressure or make it worse if you have a history of high blood pressure. Call your health care provider if your blood pressure increases while taking this medicine.

Nerve Problems. Nerves are the fibers that carry sensations from your body to the brain. Damage to these nerves, called peripheral neuropathy, can happen in people who are taking teriflunomide. Your risk is higher if you are over 60 years old, take certain medicines that affect your nervous system, or have diabetes. Stop taking teriflunomide and call your health care provider if you develop pain, burning, tingling, numbness, or weakness in your arms, hands, legs, or feet that feels different from your multiple sclerosis symptoms.

Breathing Problems. Teriflunomide may cause new or worsened breathing problems. In some cases, these problems can be serious and lead to death. Call your health care provider right away or get emergency medical help if you have shortness of breath or coughing (with or without a fever).