Arava is used to treat rheumatoid arthritis by reducing symptoms, improving physical functions and preventing the development of further damage to joints. It is classified as a pyrimidine synthesis inhibitor and works by blocking certain enzymes responsible for abnormal tissue growth.

Arava has recently been linked to dangerous side effects such as liver damage, lymphoma and Stevens-Johnsons Syndrome.

In 2010, the FDA issued a drug safety alert adding a black box warning to Arava. The FDA warned that after reviewing Arava from 2002 to 2009, there were 14 deaths and at least 49 cases of severe liver injury linked to the use of the drug.

In addition to risks of liver injury, Arava has also been liked to Stevens-Johnson Syndrome (SJS). SJS is a skin disease that can cause rash, skin peeling and sores on the mucous membranes. It is an immune-complex-mediated hypersensitivity disorder that could be caused by many drugs, viral infections and malignancies. SJS is potentially fatal.

Lastly, Arava has also been linked to fetal harm or fetal death. Women who are pregnant or could potentially become pregnant have been warned not to take Arava. Women have also been advised to use an effective form of birth control while on the drug and to continue the birth control for two years after stopping an Arava regiment. After patients stop taking Arava, a doctor may prescribe another medicine to remove the drug from the patients system.
Side effects may include:

  • Back pain
  • Diarrhea
  • Dizziness
  • Hair loss
  • Headache
  • Indigestion
  • Muscle aches
  • Nausea
  • Runny nose
  • Weakness
  • Weight loss

More severe side effects may include:

  • Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue)
  • Blisters on the inside of the eyes, nose, or mouth
  • Burning, numbness, or tingling
  • Chest pain
  • Fast or irregular heartbeat
  • Muscle cramps, including leg cramps
  • New or worsening breathing problems (such as cough or shortness of breath, with or without fever)
    Red, swollen, blistered, or peeling skin
  • Severe or persistent vomiting
  • Symptoms of high blood pressure (such as severe or persistent headache or dizziness, vision changes)
  • Symptoms of infection (such as fever, chills, sore throat, cough, increased or painful urination)
  • Symptoms of liver problems (such as dark urine, pale stools, yellowing of the skin or eyes, stomach
    pain, severe or persistent nausea or loss of appetite)
  • Unusual or easy bruising or bleeding
  • Unusual tiredness
  • Unusually pale skin
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