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Aubagio Side Effects

Generic Name: teriflunomide

Note: This document contains side effect information about teriflunomide. Some of the dosage forms listed on this page may not apply to the brand name Aubagio.

For the Consumer

Applies to teriflunomide: oral tablet

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

Less Common

  • 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 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
  • 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

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

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 abdominal or 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]

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. Cerner Multum, Inc. "Australian Product Information." O 0

3. "Product Information. Aubagio (teriflunomide)." Genzyme Corporation, Cambridge, MA.

Further information

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.

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