Aubagio Side Effects

Generic name: teriflunomide

Medically reviewed by Philip Thornton, DipPharm. Last updated on Aug 11, 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.

Important warnings This medicine can cause some serious health issues

Oral route (tablet)

Hepatotoxicity. Clinically significant and potentially life-threatening liver injury, including acute liver failure requiring transplant, has been reported in patients treated with teriflunomide in the postmarketing setting.

Concomitant use of teriflunomide with other hepatotoxic drugs may increase the risk of severe liver injury.

Obtain transaminase and bilirubin levels within 6 months before initiation of teriflunomide and monitor ALT levels at least monthly for six months.

If drug induced liver injury is suspected, discontinue teriflunomide and start accelerated elimination procedure.Embryofetal Toxicity. Teratogenicity and embryolethality occurred in animals administered teriflunomide.

Exclude pregnancy prior to initiating teriflunomide therapy.

Advise use of effective contraception in females of reproductive potential during treatment and during an accelerated drug elimination procedure.

Stop teriflunomide and use an accelerated drug elimination procedure if the patient becomes pregnant.

Serious side effects of Aubagio

Along with its needed effects, teriflunomide (the active ingredient contained in Aubagio) 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:

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
• nausea
• runny or stuffy nose
• shivering
• sneezing
• sore throat
• sweating
• tightness in the chest
• trouble sleeping
• unusual tiredness or weakness
• vomiting

Less common

• 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
• stomach pain or tenderness
• 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
• sores, ulcers, or white spots in the mouth or on the lips
• swollen glands

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:

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 stomach area
• swollen joints
• toothache
• weight loss

For healthcare professionals

Applies to teriflunomide: oral tablet.

General

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]

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.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer