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.

Some side effects of Aubagio may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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
  • lethargy
  • loss of appetite
  • lower back or side pain
  • muscle twitching
  • pale skin
  • pounding in the ears
  • rapid weight gain
  • seizures
  • skin rash
  • 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 frequently reported side effects were increased ALT, alopecia, diarrhea, influenza, nausea and paresthesia. Alopecia was the most common side effect resulting in treatment discontinuation.

Cardiovascular

Common (1% to 10%): Hypertension (up to 4%), palpitations (up to 3%)

Dermatologic

Very common (10% or more): Alopecia (up to 13%)
Common (1% to 10%): Acne (up to 3%), pruritus (up to 4%)

Gastrointestinal

Very common (10% or more): Diarrhea (Up to 18%), nausea (up to 14%)
Common (1% to 10%): upper abdominal pain (up to 6%), toothache (up to 4%), oral herpes (up to 4%), viral gastroenteritis (up to 4%), abdominal distention (up to 2%)

Genitourinary

Common (1% to 10%): Cystitis (up to 4%)

Hematologic

Common (1% to 10%): Neutropenia (up to 4%), leukopenia (up to 2%)
Frequency not reported: Decreased platelet count

Immunologic

Common (1% to 10%): Seasonal allergy (up to 3%)

Metabolic

Very common (10% or more): Increased alanine aminotransferase (up to 14%), hypophosphatemia
Common (1% to 10%): Increased gamma-glutamyltransferase (up to 5%), increased aspartate aminotransferase (up to 3%), decreased weight (up to 3%), decreased neutrophil count (up to 3%), decreased white blood cell count (up to 3%), hyperkalemia (1%)

Musculoskeletal

Common (1% to 10%): Musculoskeletal pain (up to 5%), myalgia (up to 4%)

Nervous system

Very common (10% or more): Headache (up to 22%), paresthesia (up to 10%)
Common (1% to 10%): Sciatica (up to 3%), burning sensation (up to 3%), carpal tunnel syndrome (up to 3%), peripheral neuropathy (both polyneuropathy and mononeuropathy) (up to 1.9%)

Ocular

Common (1% to 10%): Blurred vision (up to 3%), conjunctivitis (up to 3%)

Psychiatric

Common (1% to 10%): Anxiety (up to 4%)

Respiratory

Very common (10% or more): Influenza (up to 12%)
Common (1% to 10%): Upper respiratory infection (up to 9%), bronchitis (up to 8%), sinusitis (up to 6%)

Hepatic

Frequency not reported: Fatal liver failure and dysfunction

Renal

Common (1% to 10%): Transient acute renal failure (1.2%)

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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