Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes Aubagio (Teriflunomide). If you are concerned about side effects, discuss the risks and benefits of Aubagio (Teriflunomide) with your doctor.

The following side effects have been reported by at least 1% of people taking Aubagio (Teriflunomide). Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• abdominal pain
• Diarrhea
• flu-like symptoms (sudden lack of energy, Fever, cough, sore throat)
• hair loss
• nausea
• sinus infection (e.g., sinus pain, congestion)
• upset stomach

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• numbness or tingling in hands and feet
• psoriasis (e.g., red patches covered in white scales)
• rash
• signs of bleeding (e.g., unusual nosebleeds, bruising, blood in urine, coughing blood, bleeding gums, cuts that don't stop bleeding)
• signs of infection (symptoms may include fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)
• signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
• signs of lung inflammation (interstitial lung disease; shortness of breath, difficulty breathing, cough)
• symptoms of high blood pressure (e.g., headache, vision changes, nausea, vomiting)

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
• signs of Heart Attack (e.g., sudden chest pain or pain radiating to back, down arm, jaw; sensation of fullness of the chest; nausea; vomiting; sweating; anxiety)
• signs of pancreatitis (e.g., abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, swollen abdomen)
• signs of a severe skin reaction such as blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Aubagio (Teriflunomide).

Each pale-blue-to-pastel-blue, pentagonal, film-coated tablet with "14" imprinted on one side and the company logo engraved on the other side, contains Aubagio (Teriflunomide) 14 mg. Nonmedicinal ingredients: lactose monohydrate, corn starch, hydroxypropylcellulose, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate. Film coating: hypromellose, titanium dioxide, talc, polyethylene glycol, and indigo carmine aluminum lake.

Do not take Aubagio (Teriflunomide) if you:

• are allergic to Aubagio (Teriflunomide) or any ingredients of the medication
• are allergic to Leflunomide
• are currently taking leflunomide
• have severely reduced liver function
• are pregnant or may become pregnant, unless you use reliable birth control
• have an immunodeficiency condition (e.g., AIDS, transplant recipients taking medications that suppress the immune system)
• have an impaired bone marrow function or other blood disorders
• have serious active infections

There may be an interaction between Aubagio (Teriflunomide) and any of the following:

• activated charcoal
• bacillus Calmette-Guérin (BCG)
• Baricitinib
• Bosentan
• caffeine and caffeine-containing products
• Cholestyramine
• ciprofloxacin
• Cladribine
• Colestipol
• Clomipramine
• Clozapine
• Dabrafenib
• Desloratadine
• Duloxetine
• echinacea
• Elagolix
• Eluxadoline
• Empagliflozin
• Enzalutamide
• Ezetimibe
• estrogens (Estradiol, conjugated/equine, esterified, Estropipate)
• Fingolimod
• Furosemide
• glecaprevir and pibrentasvir
• Irinotecan
• leflunomide
• lidocaine
• melatonin
• Methotrexate
• Mexiletine
• mycophenolate
• Natalizumab
• Ocrelizumab
• Olanzapine
• olmesartan
• Paclitaxel
• Pazopanib
• penicillin
• Pimecrolimus
• Pioglitazone
• Pirfenidone
• Propranolol
• Repaglinide
• rifampin
• Roflumilast
• Ropinirole
• Selexipag
• siponimod
• "statin" cholesterol mediations (e.g., Atorvastatin, Fluvastatin, Pravastatin, Rosuvastatin)
• Sulfasalazine
• Tacrolimus
• theophyllines (e.g., Aminophylline, Theophylline)
• Tizanidine
• Tofacitinib
• Topotecan
• vaccines (live and inactivated)
• Valsartan
• Warfarin
• zidovudine

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Aubagio (Teriflunomide). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Aubagio (Teriflunomide).

Alcohol use: Both alcohol and Aubagio (Teriflunomide) can cause liver damage. People who consume alcohol while taking Aubagio (Teriflunomide) may be at an increased risk of experiencing liver damage.

Birth defects: Medications similar to Aubagio (Teriflunomide) can cause major birth defects in a child whose father or mother was using it at the time of conception. If you or your partner could become pregnant, you must use a reliable method of birth control during and for up to two years after you stop taking Aubagio (Teriflunomide). Talk to your doctor about when it is safe for you or your partner to become pregnant.

Blood pressure: Aubagio (Teriflunomide) may cause increased blood pressure. If you have a history of high blood pressure, discuss with your doctor how Aubagio (Teriflunomide) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Aubagio (Teriflunomide), and whether any special monitoring is needed.

Infection: Aubagio (Teriflunomide) works on the immune system to help reduce the damage that parts of the immune system cause to the body. It can reduce the number of cells that fight infection in the body (white blood cells). As a result, Aubagio (Teriflunomide) may reduce the body's ability to fight severe infections.

Tell your doctor immediately if you notice signs of an infection, such as fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness. Your doctor will do regular blood tests to monitor the number of specific types of blood cells in your blood.

Avoid immunizations without your doctor's approval.

Lactose intolerance: Aubagio (Teriflunomide) contains lactose. If you have galactose intolerance (galactosemia, glucose-galactose malabsorption, or Lapp lactase deficiency) you should not take Aubagio (Teriflunomide). Talk to your doctor about other alternatives.

Liver function: Aubagio (Teriflunomide) can cause severe damage to the liver, including fatal liver failure. People with reduced liver function or liver disease may be more likely to experience additional liver problems. If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

If you have liver problems, discuss with your doctor how Aubagio (Teriflunomide) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Aubagio (Teriflunomide), and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking Aubagio (Teriflunomide).

Lung inflammation: Rarely, some people taking Aubagio (Teriflunomide) have experienced lung inflammation (interstitial lung disease), causing difficulty breathing. This complication can be serious and sometimes fatal. If you experience new or worsening shortness of breath or cough (with or without fever) at any time while you are taking Aubagio (Teriflunomide), contact your doctor immediately.

Pancreatitis: Rarely, pancreatitis (inflammation of the pancreas) has been reported with the use of Aubagio (Teriflunomide). If you experience signs of pancreatitis such as abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, or swollen abdomen, tell your doctor immediately.

Vaccines: You should not receive live vaccines (e.g., yellow fever, BCG, Cholera, typhoid, varicella) when you are taking Aubagio (Teriflunomide).

Pregnancy: Aubagio (Teriflunomide) is likely to cause serious harm and birth defects to the unborn baby if it is taken by a pregnant mother. It is important that Aubagio (Teriflunomide) is not used during pregnancy or by women who may become pregnant. If you become pregnant while taking Aubagio (Teriflunomide), contact your doctor immediately.

Breast-feeding: It is not known if Aubagio (Teriflunomide) passes into breast milk. If you are breast-feeding and are taking Aubagio (Teriflunomide), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Aubagio (Teriflunomide) have not been established for children.

Seniors: Seniors who use Aubagio (Teriflunomide) may be more likely to experience side effects. Discuss with your doctor whether Aubagio (Teriflunomide) is right for you.