Note: This document contains side effect information about teriflunomide. Some dosage forms listed on this page may not apply to the brand name Aubagio.
Summary
Common side effects of Aubagio 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. Continue reading for a comprehensive list of adverse effects.
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
- 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
- nausea
- runny or stuffy nose
- shivering
- sneezing
- sore throat
- sweating
- tightness in the chest
- trouble sleeping
- unusual tiredness or weakness
- vomiting
Less common
- 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
- stomach pain or tenderness
- 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
- sores, ulcers, or white spots in the mouth or on the lips
- swollen glands
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
- 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 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]
