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Leflunomide Side Effects

Common Side Effects

Leflunomide has been studied extensively in clinical trials. In these studies, the side effects that occurred in a group of people taking leflunomide were documented and then compared to the side effects that occurred in a similar group of people taking either a placebo (a "sugar pill" that does not contain any active ingredients) or other medicines used to treat rheumatoid arthritis.
In these studies, the most common leflunomide side effects included:
  • Diarrhea -- in up to 27 percent of people
  • Respiratory infections -- up to 21 percent
  • A rash -- up to 12 percent
  • Nausea -- up to 13 percent
  • Headaches -- up to 13 percent
  • Indigestion or heartburn -- up to 10 percent
  • Elevated liver enzymes (found using a standard blood test) -- up to 10 percent
  • Increased blood pressure (hypertension) -- up to 10 percent
  • Hair loss (alopecia) -- up to 10 percent.
Other common side effects, occurring in 1 to 5 percent of people, included:
  • Back pain
  • Abdominal (stomach) pain
  • Infections, including urinary tract infections, bronchitis, pneumonia, and sinus infections
  • Weight loss
  • Weakness
  • Joint problems, such as joint inflammation and pain
  • Dizziness
  • Increased coughing
  • A sore throat
  • A stuffy nose
  • Flu-like symptoms
  • Decreased appetite
  • Skin reactions, such as a rash, itching, and dry skin
  • Irritation and inflammation of the gastrointestinal (GI) tract ("stomach flu")
  • Mouth ulcers
  • Vomiting
  • Tingling, pricking, or numbness of the skin
  • Chest pain
  • A decrease in blood potassium levels (hypokalemia)
  • Leg cramps.
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Leflunomide Drug Information

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