When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to azathioprine, or if you are pregnant.

How to Use This Medicine:
Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine if you have received other medicines for arthritis in the past such as chlorambucil, cyclophosphamide, or melphalan.
• Some foods and medicines can affect how azathioprine works. Tell your doctor if you are using allopurinol, cotrimoxazole, mercaptopurine, mesalamine, olsalazine, ribavirin, sulfasalazine, a blood thinner (such as warfarin), or certain blood pressure medicines (ACE inhibitors).
• This medicine may interfere with vaccines. Ask your doctor before you get a flu shot or any other vaccines.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant.
• Tell your doctor if you are breastfeeding, or if you have kidney disease, Crohn disease or bowel problems, blood or bone marrow problems (such as anemia, low white blood cells, or low platelets in the blood), or any type of infection.
• This medicine may cause the following problems:
  
  • Higher risk of skin cancer or lymphoma
  • Higher risk of infection, including progressive multifocal leukoencephalopathy (PML)
  • Serious intestinal allergic reactions
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• Use sunscreen with a sun protection factor (SPF) of at least 15 when you are outdoors. Wear protective clothing and hats, and stay out of direct sunlight between the hours of 10 a.m. and 3 p.m. Avoid sunlamps and tanning beds.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Fever, chills, cough, sore throat, and body aches
• Lightheadedness or fainting
• Severe stomach pain, nausea, vomiting, or diarrhea
• Sores on the skin
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Hair loss
• Joint or muscle pain
• Sores or white patches on your lips, mouth, or throat

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088