Aubagio Side Effects

Generic name: teriflunomide

Medically reviewed by Philip Thornton, DipPharm. Last updated on Nov 15, 2024.

Note: This document provides detailed information about Aubagio Side Effects associated with teriflunomide. Some dosage forms listed on this page may not apply specifically to the brand name Aubagio.

Applies to teriflunomide: oral tablet.

Precautions

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Women will receive a pregnancy test before starting this medicine. Use an effective form of birth control to keep from getting pregnant during treatment and after 2 years of stopping treatment with this medicine. If you think you have become pregnant while using the medicine, tell your doctor right away.

Teriflunomide may also cause birth defects if the father is using it when his sexual partner becomes pregnant. Men taking teriflunomide (the active ingredient contained in Aubagio) should use condoms as a form of birth control during sexual intercourse. A man intending to father a child should Stop taking teriflunomide and check with his doctor right away.

Do not use this medicine together with leflunomide (Arava®). Using these medicines together may cause serious unwanted effects.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Teriflunomide can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

You will need to have a skin test for tuberculosis before you start using this medicine. Tell your doctor if you or anyone in your home has ever had a positive reaction to a tuberculosis test.

While you are being treated with teriflunomide, for at least 6 months you stop using it, do not have any immunizations (vaccinations) without your doctor's approval. Live virus vaccines should not be given while receiving this medicine.

Using this medicine may increase your risk of getting cancers, including blood cancer. Talk to your doctor if you have concerns about this risk.

Check with your doctor right away if you are having burning, numbness, tingling, or painful sensations in the arms, hands, legs, or feet. These could be symptoms of a condition called peripheral neuropathy.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, trouble breathing, trouble swallowing, fever or chills.

This medicine may cause serious skin reactions (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis). Check with your doctor right away if you have a black, tarry stools, blistering, peeling or loosening of the skin, chest pain, chills, cough, diarrhea, fever, itching, joint or muscle pain, red irritated eyes, red skin lesions, often with a purple center, painful or difficult urination, sore throat, sores, ulcers, or white spots in the mouth or on the lips, swollen glands, unusual bleeding or bruising, or unusual tiredness or weakness.

Tell your doctor right away if you or your child develop a fever, rash, swollen, painful, or tender lymph glands in the neck, armpit, or groin, unusual bleeding or bruising, or yellow eyes or skin after using this medicine. These may be symptoms of a serious and life-threatening condition called drug reaction with eosinophilia and systemic symptoms (DRESS).

Check with your doctor right away if you have a cough with or without a fever or trouble breathing while taking this medicine.

You will need to have your blood pressure measured before starting this medicine and while you are using it. If you notice any change to your recommended blood pressure, call your doctor right away. If you have questions about this, talk to your doctor.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Serious side effects of Aubagio

Along with its needed effects, teriflunomide 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 while taking teriflunomide:

Other side effects of Aubagio

Some side effects of teriflunomide 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:

For healthcare professionals

Applies to teriflunomide: oral tablet.

General adverse events

The most commonly reported side effects were increased ALT, alopecia, diarrhea, influenza, nausea and paresthesia.^[Ref]

Hematologic

• Common (1% to 10%): Neutropenia, leukopenia, decreased neutrophil count, decreased WBC count
• Uncommon (0.1% to 1%): Anemia, mild thrombocytopenia, lymphopenia
• Frequency not reported: Decreased platelet count^[Ref]

Hepatic

• Very common (10% or more): Increased ALT levels (up to 14%)
• Common (1% to 10%): Increased AST and GGT levels
• Frequency not reported: Fatal liver failure and dysfunction, hepatotoxicity^[Ref]

Cardiovascular

• Common (1% to 10%): Hypertension, palpitations, tachycardia^[Ref]

Dermatologic

• Very common (10% or more): Alopecia (up to 13%)
• Common (1% to 10%): Acne, pruritus, tinea pedis, rash
• Uncommon (0.1% to 1%): Generalized pruritus
• Frequency not reported: Stevens-Johnson syndrome, toxic epidermal necrolysis^[Ref]

Gastrointestinal

• Very common (10% or more): Diarrhea (Up to 18%), nausea (up to 14%)
• Common (1% to 10%): Upper abdominal pain, toothache, tooth infection, oral herpes, viral gastroenteritis, abdominal distention, vomiting, inguinal hernia
• Very rare (less than 0.01%): Pancreatitis^[Ref]

Genitourinary

• Very common (10% or more): Urinary tract infection
• Common (1% to 10%): Cystitis, menorrhagia^[Ref]

Immunologic

• Very common (10% or more): Influenza
• Common (1% to 10%): Seasonal allergy, oral herpes, mild allergic reactions
• Frequency not reported: Bone marrow effects/Immunosuppression potential/Infections^[Ref]

Metabolic

• Very common (10% or more): Hypophosphatemia
• Common (1% to 10%): Decreased weight, hyperkalemia
• Uncommon (0.1% to 1%): Hyperamylasemia^[Ref]

Musculoskeletal

• Common (1% to 10%): Musculoskeletal pain, myalgia^[Ref]

Nervous system

• Very common (10% or more): Headache (up to 22%), paresthesia (up to 10%)
• Common (1% to 10%): Sciatica, burning sensation, carpal tunnel syndrome, peripheral neuropathy (both polyneuropathy and mononeuropathy), multiple sclerosis, neuralgia, hyperesthesia
• Uncommon (0.1% to 1%): Dysgeusia^[Ref]

Ocular

• Common (1% to 10%): Blurred vision, conjunctivitis^[Ref]

Psychiatric

• Common (1% to 10%): Anxiety, depression^[Ref]

Respiratory

• Very common (10% or more): Influenza (up to 12%)
• Common (1% to 10%): Upper respiratory infection, lower respiratory tract infection, bronchitis, sinusitis, laryngitis, pharyngitis
• Very rare (less than 0.01%): Interstitial lung disease^[Ref]

Renal

• Common (1% to 10%): Transient acute renal failure, pollakiuria
• Uncommon (0.1% to 1%): Increased blood creatinine^[Ref]

Other

• Common (1% to 10%): Pain^[Ref]

See also:

Frequently asked questions

• Does Aubagio cause weight gain or loss?
• Who makes Aubagio and where is it made?
• Does Aubagio help with fatigue?
• Should I take Aubagio in the morning or night?
• What are the new drugs used for multiple sclerosis (MS)?
• Ocrevus vs Aubagio: How do they compare for MS?
• Does Aubagio suppress the immune system?
• How long do Aubagio side effects last?
• Can Aubagio cause PML as a side effect?

Further information

Aubagio side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer