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Teriflunomide Side Effects

In Summary

Commonly reported side effects of teriflunomide 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

As well as its needed effects, teriflunomide may cause unwanted side effects that require medical attention.

Major Side Effects

If any of the following side effects occur while taking teriflunomide, check with your doctor immediately:

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

Minor Side Effects

Some teriflunomide side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned 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.[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]

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. Cerner Multum, Inc. "Australian Product Information." O 0

3. "Product Information. Aubagio (teriflunomide)." Genzyme Corporation, Cambridge, MA.

It is possible that some side effects of teriflunomide may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

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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