What are the side effects of Aubagio (teriflunomide) and what monitoring and precautions are required?

Medical Advisory BoardAll articles are reviewed for accuracy by our Medical Advisory Board
Educational purpose only • Exercise caution as content is pending human review
Article Review Status
Submitted
Under Review
Approved

Last updated: February 17, 2026 • View editorial policy

Personalize

Help us tailor your experience

Which best describes you? Your choice helps us use language that's most understandable for you.

Side Effects of Aubagio (Teriflunomide)

Aubagio carries serious risks of hepatotoxicity (including acute liver failure requiring transplant) and is absolutely contraindicated in pregnancy due to teratogenicity, requiring strict monitoring protocols and immediate discontinuation if liver injury or pregnancy occurs. 1

Boxed Warning: Life-Threatening Risks

Hepatotoxicity

  • Clinically significant and potentially life-threatening liver injury, including acute liver failure requiring transplant, has been reported in the postmarketing setting 1
  • Patients with pre-existing liver disease and those taking other hepatotoxic drugs face increased risk when taking teriflunomide 1
  • Liver injury can occur at any time during treatment 1
  • Aubagio is contraindicated in patients with severe hepatic impairment 1

Embryofetal Toxicity

  • Aubagio is contraindicated in pregnant women and females of reproductive potential not using effective contraception 1
  • Teratogenicity and embryolethality occurred in animals at plasma exposures lower than human therapeutic levels 1
  • The drug has a long half-life (approximately 19 days), complicating management for patients wishing to have children 2
  • Fetal toxicity via semen cannot be ruled out 2

Common Adverse Effects (≥2% and ≥2% Higher Than Placebo)

The following adverse events occurred in pooled safety data from clinical trials 3:

  • Headache 3
  • Alanine aminotransferase (ALT) increase 3
  • Diarrhea 3
  • Alopecia (hair thinning) 3
  • Nausea 3
  • Paresthesia 3
  • Arthralgia 3
  • Neutropenia 3
  • Hypertension 3

Specific Organ System Toxicities

Hepatic Effects

  • ALT greater than three times the upper limit of normal (ULN) occurred in 5.8% of patients receiving 7 mg and 6.2% receiving 14 mg, compared to 3.8% with placebo 1
  • Hepatotoxicity is similar to that seen with leflunomide, the parent compound 2

Hematologic Effects

  • Leukopenia and neutropenia can occur 3, 2
  • The drug is cytostatic but not cytotoxic, not affecting resting or slowly dividing lymphocytes 4

Cardiovascular Effects

  • Arterial hypertension is a recognized adverse effect 2
  • Blood pressure should be checked before starting treatment and periodically thereafter 1

Neurologic Effects

  • Peripheral neuropathy has been reported 2
  • Paresthesia occurs more frequently than with placebo 3

Infectious Complications

  • Increased risk of infections due to immunosuppressive effects 2
  • Screening for latent tuberculosis is required before initiation 1

Dermatologic Effects

  • Alopecia (hair thinning) is a common adverse effect 3, 2
  • Serious skin reactions including anaphylaxis and angioedema have been reported 1

Required Monitoring Protocol

Before Starting Treatment

  • Obtain transaminase and bilirubin levels within 6 months before initiation 1
  • Obtain complete blood cell count (CBC) within 6 months before initiation 1
  • Screen for latent tuberculosis infection with tuberculin skin test or blood test 1
  • Exclude pregnancy in females of reproductive potential 1
  • Check baseline blood pressure 1

During Treatment

  • Monitor ALT levels at least monthly for the first six months after starting teriflunomide 1
  • Further CBC monitoring should be based on signs and symptoms of infection 1
  • Blood pressure should be checked periodically 1

Critical Management Considerations

When to Discontinue Immediately

  • If drug-induced liver injury is suspected, discontinue teriflunomide and start an accelerated elimination procedure with cholestyramine or charcoal 1
  • If the patient becomes pregnant, stop teriflunomide and use an accelerated drug elimination procedure 1

Contraindications to Therapy

  • Patients with severe hepatic impairment 1
  • Patients with serum ALT greater than two times ULN before initiating treatment should not normally be treated 1
  • History of hypersensitivity reaction to teriflunomide or leflunomide 1
  • Co-administration with leflunomide is contraindicated 1

Common Pitfalls to Avoid

  • Do not overlook the need for effective contraception in females of reproductive potential throughout treatment and during the accelerated elimination period 1
  • Do not underestimate the long half-life (19 days), which complicates management of adverse effects and drug interactions 2
  • Do not fail to obtain monthly ALT monitoring during the first six months, as liver injury can occur at any time 1
  • Do not use in patients with pre-existing acute or chronic liver disease without careful consideration 1

References

Related Questions

What is the appropriate treatment approach for a patient with multiple sclerosis who is considering or already taking Aubagio (teriflunomide)?
What is the most appropriate medication to manage diffuse body aches in a patient with Multiple Sclerosis (MS) on teriflunomide therapy?
In a neurologically stable multiple sclerosis patient on teriflunomide who reports generalized body pain, which medication should be added to her regimen?
What medication should be given to a Multiple Sclerosis (MS) patient on teriflunomide for diffuse body aches?
Is teriflunomide safe to take with Augmentin (amoxicillin/clavulanate) and fluticasone nasal spray?
In an adult cirrhotic patient who has undergone endoscopic variceal band ligation for prior variceal hemorrhage, should non‑selective beta‑blockers be started as secondary prophylaxis?
Can a person with a BMI of 19.8 develop type 2 diabetes mellitus?
In a 23‑year‑old woman with total cholesterol 216 mg/dL, low‑density lipoprotein cholesterol (LDL‑C) 145 mg/dL, high‑density lipoprotein cholesterol (HDL‑C) 41 mg/dL, triglycerides 161 mg/dL, cholesterol/HDL ratio 5.3, non‑high‑density lipoprotein cholesterol (non‑HDL‑C) 175 mg/dL, and a calculated lifetime atherosclerotic cardiovascular disease (ASCVD) risk of approximately 39 %, should statin therapy be initiated?
What are the five cardiovascular effects of taking SGLT2 inhibitors (sodium‑glucose co‑transporter‑2 inhibitors)?
Can I add tirzepatide to Jardiance (empagliflozin) in an adult patient with type 2 diabetes who is already tolerating empagliflozin at a stable dose and has adequate renal function (estimated glomerular filtration rate ≥ 45 mL/min/1.73 m²)?
What are the five adverse effects associated with SGLT2 inhibitor therapy?

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

Have a follow-up question?

Our Medical A.I. is used by practicing medical doctors at top research institutions around the world. Ask any follow up question and get world-class guideline-backed answers instantly.

Ask Question