warnings

What is the most important information I should know about Methotrexate (Oral)(Oral)?

You should not use methotrexate if you are allergic to it. You may not be able to take methotrexate if you have:

alcoholism, cirrhosis, or chronic liver disease;
low blood cell counts;
a weak immune system or bone marrow disorder; or
if you are pregnant or breastfeeding.

Methotrexate is sometimes used to treat cancer in people who have a condition listed above. Your doctor will decide if this treatment is right for you.

Tell your doctor if you have ever had:

liver problems, especially fluid in your stomach (ascites);
kidney disease;
lung problems, especially fluid in the lungs (pleural effusion);
radiation treatments; or
a stomach ulcer or ulcerative colitis.

Tell your doctor if you are pregnant or plan to become pregnant. Methotrexate may cause injury or death to an unborn baby and should not be used during pregnancy to treat arthritis or psoriasis. However, methotrexate is sometimes used to treat cancer during pregnancy.

Methotrexate can harm an unborn baby if the mother or the father is using this medicine.

If you are a woman, you may need to have a negative pregnancy test before starting this treatment. Use effective birth control to prevent pregnancy while you are using methotrexate and for at least 6 months after your last dose.
If you are a man, use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 3 months after your last dose.
Tell your doctor right away if a pregnancy occurs while either the mother or the father is using methotrexate.

This medicine may affect fertility (ability to have children) in both men and women. However, it is important to use birth control to prevent pregnancy because methotrexate may harm the baby if a pregnancy does occur.

Do not breastfeed while using this medicine, and for at least 1 week after your last dose.

Do not give this medicine to a child without the advice of a doctor.

Side Effects

What are the side effects of Methotrexate (Oral)(Oral)?

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Methotrexate can cause serious or fatal side effects. Call your doctor at once if you have:

sudden chest pain, wheezing, dry cough, cough with mucus, chest pain, feeling short of breath;
fever, chills, swollen lymph glands, night sweats, weight loss;
blisters or ulcers in your mouth, red or swollen gums, trouble swallowing;
vomiting, diarrhea, blood in your urine or stools;
skin changes such as redness, warmth, swelling, or oozing;
low blood cell counts--fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath;
kidney problems--little or no urination, swelling in your feet or ankles;
liver problems--swelling around your midsection, right-sided upper stomach pain, nausea, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes);
nerve problems--confusion, weakness, drowsiness, coordination problems, feeling irritable, headache, neck stiffness, vision problems, loss of movement in any part of your body, seizure; or
signs of tumor cell breakdown--tiredness, weakness, muscle cramps, nausea, vomiting, diarrhea, fast or slow heart rate, tingling in your hands and feet or around your mouth.

Common side effects may include:

fever, chills, tiredness, not feeling well;
low blood cell counts;
mouth sores;
nausea, stomach pain;
abnormal liver function tests;
hair loss;
burning skin lesions; or
being more sensitive to light.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Pregnancy & Breastfeeding

Can I take Methotrexate (Oral)(Oral) if I’m pregnant or breastfeeding?

Contraindicated in pregnancy

Based on FDA pregnancy categories

Do not breastfeed while using this medicine, and for at least 1 week after your last dose.

Interactions

What drugs and food should I avoid while taking Methotrexate (Oral)(Oral)?

Avoid drinking alcohol. It may increase your risk of liver damage.

Do not receive a "live" vaccine while using methotrexate, or you could develop a serious infection. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Methotrexate could make you sunburn more easily. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Dosage Guidelines & Tips

How to take Methotrexate (Oral)(Oral)?

Use Methotrexate (Oral)(Oral) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

YOU MAY NOT NEED TO TAKE METHOTREXATE EVERY DAY. This medicine is sometimes taken only once per week, or 2 to 4 times per week. Some conditions are treated daily for just a few days followed by a rest period of 1 week or longer before taking the medicine again.

You must use the correct dose. Some people have died after incorrectly taking methotrexate every day.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Measure liquid medicine carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

Methotrexate can be toxic to your organs, and may lower your blood cell counts. You will need frequent medical tests, and you may need an occasional liver biopsy or chest X-ray. Your cancer treatments may be delayed based on the results.

If you need to be sedated for dental work, tell your dentist you currently use methotrexate.

Store methotrexate at room temperature away from moisture, heat, and light.

You may store Xatmep in a refrigerator or at room temperature. Avoid freezing or high heat. Throw away any unused Xatmep after 60 days if kept at room temperature.

What should I do if I missed a dose of Methotrexate (Oral)(Oral)?

Call your doctor for instructions if you miss a dose of methotrexate.

Overdose Signs

What happens if I overdose on Methotrexate (Oral)(Oral)?

Overdose symptoms may include bruising or unusual bleeding, mouth sores, vomiting, little or no urination, bloody or tarry stools, or coughing up blood or vomit that looks like coffee grounds.

If you think you or someone else may have overdosed on: Methotrexate (Oral)(Oral), call your doctor or the Poison Control center

(800) 222-1222

If someone collapses or isn't breathing after taking Methotrexate (Oral)(Oral), call 911

911