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Aubagio Side Effects

Generic name: teriflunomide

Medically reviewed by Philip Thornton, DipPharm. Last updated on Oct 20, 2023.

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

Applies to teriflunomide: oral tablet.

Warning

Oral route (Tablet)

HepatotoxicityClinically 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 ToxicityTeratogenicity 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

Less common

Rare

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

Less common

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

References

1. Product Information. Aubagio (teriflunomide). Genzyme Corporation. 2012.

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.