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Aubagio

Generic Name: teriflunomide (ter i FLOO noe mide)
Brand Names: Aubagio
Aubagio (teriflunomide) is used to reduce flare-ups in people with relapsing multiple sclerosis (MS). Includes Aubagio side effects, interactions and indications.
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Drug Information:
Aubagio (teriflunomide) affects the immune system and reduces swelling and inflammation in the nervous system. Aubagio is used to reduce flare-ups in people with relapsing multiple sclerosis (MS). Aubagio is not a cure for MS. Teriflunomide can cause severe liver problems. You should not use this medicine if you have severe liver disease or if you are also taking leflunomide (Arava). Tell your doctor if you have a history of liver disease. Call your doctor at once if you have signs of liver problems: upper stomach pain, loss of appetite, dark urine, or jaundice (yellowing of the skin or eyes). Learn more

Aubagio Side Effects

Aubagio Side Effects

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.

In Summary

Common side effects of Aubagio include: alopecia, decreased neutrophils, decreased white blood cell count, diarrhea, increased serum alanine aminotransferase, nausea, decreased platelet count, hyperkalemia, and lymphocytopenia. Other side effects include: cystitis, increased gamma-glutamyl transferase, neutropenia, hypertension, and viral gastroenteritis. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to teriflunomide: oral tablet

Warning

Oral route (Tablet)

Severe liver injury, including fatal liver failure, has been reported in patients receiving leflunomide, and a similar risk is expected with teriflunomide. Teriflunomide use is contraindicated in patients with severe hepatic impairment. Concomitant use with other hepatotoxic drugs may increase the risk of liver injury. Monitoring is recommended and discontinuation of therapy, including an accelerated elimination procedure, is advised if liver injury is suspected. Teriflunomide may cause major birth defects if used during pregnancy. Pregnancy must be excluded before starting treatment with teriflunomide. Teriflunomide is contraindicated in pregnant women or women of childbearing potential who are not using reliable contraception. Pregnancy must be avoided during teriflunomide treatment or prior to the completion of the drug elimination procedure after treatment; advise women to use reliable contraception. Discontinue teriflunomide and use an accelerated drug elimination procedure if pregnancy occurs.

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

  • 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 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.

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

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

Cardiovascular

Common (1% to 10%): Hypertension, palpitations, tachycardia

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

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

Genitourinary

Very common (10% or more): Urinary tract infection

Common (1% to 10%): Cystitis, menorrhagia

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

Metabolic

Very common (10% or more): Hypophosphatemia

Common (1% to 10%): Decreased weight, hyperkalemia

Uncommon (0.1% to 1%): Hyperamylasemia

Musculoskeletal

Common (1% to 10%): Musculoskeletal pain, myalgia

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

Ocular

Common (1% to 10%): Blurred vision, conjunctivitis

Psychiatric

Common (1% to 10%): Anxiety, depression

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

Renal

Common (1% to 10%): Transient acute renal failure, pollakiuria

Uncommon (0.1% to 1%): Increased blood creatinine

Other

Common (1% to 10%): Pain

Editorial References and Review

Medically reviewed by BestRx Medical Team Last updated on 1/1/2020.

Source: Drugs.com Aubagio