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

Get emergency medical help if you have any of these signs of an allergic reaction while taking teriflunomide (the active ingredient contained in Aubagio) hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using teriflunomide and call your doctor at once if you have:

• fever, chills, body aches, flu symptoms, sores in your mouth and throat;

• nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• fast or racing heartbeats;

• numbness or tingling in your hands or feet that feels different from your regular MS symptoms;

• pain in your side or lower back, confusion, little or no urinating;

• chest pain, dry cough, wheezing, feeling short of breath;

• skin redness or peeling;

• swelling, rapid weight gain; or

• severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

• diarrhea;

• thinning hair; or

• burning or prickly feeling in your skin.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

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%)

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