Do not use Arava if:

• you are allergic to any ingredient in Arava;
• you are pregnant or planning to become pregnant.

• Drinking alcohol while you are taking Arava may increase the risk of liver problems. Talk with your doctor before drinking alcohol while taking Arava.
• Avoid receiving vaccines while taking Arava.
• Contact your doctor immediately if you develop a skin rash, small blisters over a large portion of the body, or lesions around the eyes, mouth, or throat.
• Arava is not recommended for use in children younger than 18 years of age. Safety and effectiveness in this age group have not been confirmed.
• Arava may cause harm to the fetus. Arava must not be used during pregnancy, or by women who are able to become pregnant unless they are using reliable forms of birth control. A negative pregnancy test must be obtained before the start of treatment with Arava . Contact your health care provider at once if your menstrual flow is delayed or if you suspect that you are pregnant. After completing therapy, women of childbearing potential who plan to become pregnant must undergo a procedure to flush any remaining medicine out of the body system. It is unknown if Arava is excreted in breast milk. Do not breast-feed while taking Arava.

Safety information

Check with your doctor if any of these most common side effects persist or become bothersome:

• back pain; bronchitis; diarrhea; dizziness; dry skin; hair loss; headache; increased cough; indigestion; joint disorder; loss of appetite; muscle aches; nausea; runny nose; sinus infection; upper respiratory tract infection; urinary tract infection; vomiting; weakness; weight loss.

• severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blistering or peeling skin; blisters on the inside of eyes, nose, or mouth; chest pain; dark urine; easy bruising/bleeding; feelings of numbness or tingling; fever; infection; muscle cramps, including leg cramps; pale skin; pale stools; sore throat; stomach pain; unusual tiredness; vomiting; yellowing of the eyes or skin.

Arava is to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.