When This Medicine Should Not Be Used:
You should not use this medicine if you have had an allergic reaction to methotrexate or if you are breastfeeding. You should not use this medicine for arthritis or psoriasis if you are pregnant, or if you have liver disease or certain problems with your blood or immune system. Make sure your doctor knows if you drink alcohol of any kind on a regular basis.

How to Use This Medicine:
Tablet

• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• Your doctor will tell you how much medicine to use. Do not use more than directed. The correct schedule for this medicine is different for arthritis, psoriasis, and different kinds of cancer. For example, people who have arthritis or psoriasis often take this medicine only once a week.
• Make sure you understand your personal dosing schedule. Ask your doctor and pharmacist if you are not sure when or how often to take your medicine.
• If you take the medicine only once a week, it is best to take it on the same day each week.
• Write down on a calendar or piece of paper when you are supposed to use your medicine. Keep the calendar or paper where you can see it. After you take your dose of medicine, cross off that date on your calendar or paper. This will help you remember if you took the medicine or if you still need to take it. If you need other ideas to help you keep track of your schedule, ask your pharmacist or other healthcare provider.

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

• There are many drugs that can interact with methotrexate. Some of these drugs are aspirin, phenytoin (Dilantin®), theophylline (Theo-Dur®), antibiotics (such as penicillin, tetracycline, Bactrim®, Septra®), and vitamin supplements that contain folic acid. Make sure your doctor knows about ALL other medicines you are using.
• If you have bone cancer, ask your doctor if you need to avoid using pain or arthritis medicine (such as aspirin, diclofenac, ibuprofen, indomethacin, Advil®, Aleve®, Bextra®, Celebrex®) or steroid medicines (such as prednisone).
• If you have arthritis, make sure your doctor knows about all other medicines you are using to treat arthritis (such as aspirin, gold, ibuprofen, prednisone, sulfasalazine, Azulfidine®, Celebrex®, Plaquenil®).
• Make sure your doctor knows about any cancer treatments you are using, including cisplatin (Platinol®) or radiation.
• Tell your doctor if you have used methotrexate before for any reason.
• Talk to your doctor before getting flu shots or other vaccines while you are receiving methotrexate. Vaccines may not work as well while you are using this medicine.

Warnings While Using This Medicine:

• Using this medicine while you are pregnant can harm your unborn baby. The medicine may also cause birth defects if the father is using it when his sexual partner becomes pregnant. Use an effective form of birth control during treatment with methotrexate. For a man, continue birth control for at least 3 months after stopping treatment. For a woman, continue birth control until you have had two menstrual periods after stopping treatment. If a pregnancy occurs while you are using this medicine, tell your doctor right away.
• Make sure your doctor knows if you have kidney disease, liver disease, a stomach ulcer, colitis, diabetes, hepatitis, HIV or AIDS, problems with your immune system, or any kind of problem with your blood (such as anemia). Tell your doctor if you get an infection of any kind.
• This medicine may make your skin more sensitive to sunlight. Wear sunscreen. Do not use sunlamps or tanning beds. Tell your doctor if you have increased skin redness or other problems.
• You may get infections more easily while you are using this medicine. Stay away from people with colds, flu, or other infections. Wash your hands often.
• Your doctor will need to check your progress at regular visits while you are using this medicine. You may need to have blood tests or other kinds of medical tests. Be sure to keep all appointments.
• Call your doctor right away if you think you have taken too much of this medicine.

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
• Blistering, peeling, red skin rash
• Cough, fever, chest pain, trouble breathing, blue lips or fingers
• Eyes or skin turn yellow, or dark-colored urine or pale stools
• Fever
• Nausea, vomiting, diarrhea, loss of appetite, stomach pain
• Sores or white patches on your lips, mouth, or throat
• Unusual bleeding, bruising, or weakness

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

• Hair loss, headache, dizziness

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