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Side Effects of Arava (Leflunomide)


Arava (Leflunomide) Side Effects

Leflunomide, often referred to by brand name Arava, is an immunosuppressive drug. Arava is used in the treatment of autoimmune diseases including rheumatoid arthritis and psoriatic arthritis (PubMedHealth “Leflunomide” May 2017).

Serious Side Effects of Leflunomide

The adverse reactions reported by the FDA Arava Labeling are:

  • Hyperglycemia (excessive blood glucose concentration)
  • Abnormal liver enzymes
  • Gastritis (inflammation of the lining of the stomach)
  • Hypertension (high blood pressure)
  • Esophagitis (inflammation of the food pipe)
  • Pharyngitis (inflammation of the throat)
  • Bronchitis (inflammation of the lungs)
  • Dyspepsia (pain in upper middle part of stomach)
  • Cholethiasis (gall stones)
  • Esophagitis (inflammation of the food pipe)
  • Albuminuria (protein in urine)
  • Dysuria (painful urination)
  • Hematuria (blood in urine)
  • Asthma
  • Dyspnea (difficulty breathing)

Common Leuflunomide Side Effects

The Arava label as reported by theFDA also lists the common side effects:

  • Diarrhea
  • Respiratory infection (up to 30%)
  • Nausea/vomiting
  • Headache
  • Rash
  • Gastroenteritis (stomach flu)
  • Mouth ulcers (painful sores in mouth)
  • Constipation
  • Flatulence (gases in intestine or stomach)
  • Dry mouth
  • Cough
  • Sinusitis (inflammation of the sinuses)
  • Epistaxis (nosebleed)

Other common side effects include chest pain, alopecia (loss of hair), dry skin, acne, contact dermatitis (rash caused by contact with stimuli), headache (up to 21%), urinary tract infection, changes in urinary frequency, hypokalemia (low potassium), weight loss, and blurred vision. (Arava label as reported by the

How Does Pharmacogenetic Testing Work?

A number of enzymes have been indicated in the metabolism and therapeutic efficiacy of Arava. Polymorphism in the drugs target enzyme, DHODH, has been associated with reduced risk of toxicity of the drug. This study also identified a separate polymorphism on the cytochrome P450 enzyme, CYP1A2 that increased risk of toxicity compared to the general population (Arthiritis Research and Therapy “Polymorphisms in Cytochrome P450 2C19 Enzyme and Cessation of Leflunomide in Patients with Rheumatoid Arthritis” July 2012).

Know Your Risk for Side Effects with the Rxight® PGx Testing Program

Polymorphisms in a variety of enzymes have been associated with toxicity, such as in side effects of Arava. Genetic sequencing allows personalized dosing of the drug to be advantageous. MD Labs provides this with our pharmacogenetics testing service Rxight®, which sequences 18 genes for more than 60 alleles to identify how patients react to more than 200 drugs, including Arava.


Finding out your genetic variation is accurate, easy to understand, and reliable with Rxight®. By analyzing how Avara may affect you, your doctor and pharmacist will be able to determine the best dosage or a safer medication to use.


For more information about MD Labs, Rxight®, or pharmacogenetics, call us at 1-(888) 888-1932 or email us at support@Rxight.com..


Contributors to this Article:
Michael Sapko, MD, PhD; Deborah Kallick, PhD, Medicinal Chemistry

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