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Methotrexate tablets

Pronunciation

Generic Name: methotrexate (METH-oh-TREX-ate)
Brand Name: Examples include Rheumatrex and Trexall

Methotrexate tablets may cause severe and sometimes fatal side effects. These may include bone marrow, blood, liver, lung, kidney, or skin problems. For this reason, methotrexate tablets is only used to treat certain patients who have life-threatening cancer or who have severe psoriasis or rheumatoid arthritis that is not relieved by other treatments. Your doctor will perform lab tests to check for side effects while you take methotrexate tablets. Keep all doctor and laboratory appointments. Talk with your doctor and be sure you understand the risks and benefits of using methotrexate tablets.

Methotrexate tablets may cause birth defects or fetal death. Do not use methotrexate tablets to treat psoriasis or rheumatoid arthritis if you are pregnant. Tell your doctor before you take methotrexate tablets if you are pregnant or think you may be pregnant. Do not become pregnant or father a child while using methotrexate tablets. Talk to your doctor about using an effective form of birth control.

Certain medicines and conditions may increase your risk for side effects. Tell your doctor if you take a nonsteroidal anti-inflammatory drug (NSAID) (eg, ibuprofen, celecoxib) or salicylate (eg, aspirin), or if you receive radiation therapy. Tell your doctor if you have excess fluid in your stomach or around your lungs, or if you have any liver, kidney, lung, blood, bone marrow, stomach, bowel, or immune system problems. Tell your doctor right away if you develop any new or worsening symptoms, including black, tarry stools; dry, nonproductive cough; mouth sores; red, swollen, blistered, or peeling skin; severe or persistent diarrhea or vomiting; shortness of breath or trouble breathing; signs of infection (eg, fever, chills, persistent sore throat); stomach pain; unusual bruising or bleeding; unusual tiredness or weakness; or yellowing of the skin or eyes.

Methotrexate tablets may cause a serious and possibly fatal condition called tumor lysis syndrome (TLS) in certain patients with cancer. Contact your doctor right away if you develop symptoms such as fast or irregular heartbeat; fainting; decreased urination; muscle weakness or cramps; nausea, vomiting, diarrhea, or loss of appetite; or sluggishness.

Methotrexate tablets may increase the risk of developing a certain type of cancer (lymphoma). Discuss any questions or concerns with your doctor.


Methotrexate tablets is used for:

Treating certain types of cancer. It is also used to control severe psoriasis and severe rheumatoid arthritis in certain patients. It may be used alone or with other medicines. It may also be used for other conditions as determined by your doctor.

Methotrexate tablets is an antimetabolite. It works to treat cancer and psoriasis by slowing the growth of cancer cells and abnormal skin cells. Exactly how methotrexate tablets works to treat rheumatoid arthritis is unknown. It reduces symptoms of inflammation (eg, pain, swelling, stiffness) caused by rheumatoid arthritis.

Do NOT use methotrexate tablets if:

  • you are allergic to any ingredient in methotrexate tablets
  • you are breast-feeding
  • you are treating psoriasis or rheumatoid arthritis and any of the following apply to you:
    • you are pregnant
    • you have alcoholism, liver problems caused by alcohol, or chronic liver problems
    • you have a weakened immune system or certain blood problems (eg, anemia, bone marrow depression, low white blood cell count, low blood platelet count)
  • you are taking acitretin
  • you have taken or will be taking palifermin within 24 hours of taking methotrexate tablets

Contact your doctor or health care provider right away if any of these apply to you.

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Before using methotrexate tablets:

Some medical conditions may interact with methotrexate tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breastfeeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you are able to become pregnant or father a child
  • if you have a history of lung problems, immune system problems, nervous system problems (eg, seizures), liver problems (eg, hepatitis), kidney problems, diabetes, or blood problems (eg, anemia, low white blood cell levels, low blood platelet levels)
  • if you have an active infection, severe vomiting or diarrhea, or dehydration
  • if you have mouth sores, excess fluid in your stomach or around your lungs, stomach or bowel ulcers, bowel inflammation (eg, ulcerative colitis), or a blockage of your stomach or bowel
  • if you have a folic acid deficiency, are in very poor health or are very overweight, or have a history of alcohol abuse
  • if you are receiving chemotherapy or radiation

Some MEDICINES MAY INTERACT with methotrexate tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Palifermin because if mouth or tongue sores develop, they may be more severe or last longer
  • Medicines that may harm the kidney (eg, amphotericin B; tacrolimus; aminoglycoside antibiotics such as gentamicin) or the liver (eg, azathioprine; retinoids such as acitretin or isotretinoin; acetaminophen; ketoconazole; isoniazid; certain medicines for HIV infection) because the risk of kidney or liver side effects may be increased. Ask your doctor if you are unsure if any of your medicines might harm the kidney or liver
  • Chloramphenicol, ciprofloxacin, corticosteroids (eg, prednisone), cyclosporine, dantrolene, hydantoins (eg, phenytoin), hydroxychloroquine, leflunomide, NSAIDs (eg, ibuprofen, celecoxib, ketorolac), penicillamine, penicillin antibiotics (eg, amoxicillin), phenylbutazone, pristinamycin, probenecid, proton pump inhibitors (PPIs) (eg, omeprazole), salicylates (eg, aspirin), sulfonamide medicines (eg, sulfamethoxazole, sulfasalazine), tetracycline antibiotics (eg, doxycycline), trimethoprim, or vancomycin because they may increase the risk of methotrexate tablets's side effects
  • Folic acid because it may decrease methotrexate tablets's effectiveness
  • Digoxin because its effectiveness may be decreased by methotrexate tablets
  • Mercaptopurine, oral anticoagulants (eg, warfarin), or theophylline because the risk of their side effects may be increased by methotrexate tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if methotrexate tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use methotrexate tablets:

Use methotrexate tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Take methotrexate tablets by mouth with or without food. However, you should take it the same way each time in relation to food.
  • Drinking extra fluids while you are taking methotrexate tablets is recommended. Check with your doctor for instructions.
  • The dose of methotrexate tablets and how often you use it are based on your medical condition and response to treatment. It is very important that you follow your doctor's instructions carefully. Taking too much of methotrexate tablets may cause serious and sometimes fatal side effects. Be sure you understand exactly how much of methotrexate tablets to take and how often you should take it. Ask your doctor or pharmacist if you have any questions.
  • It may take several weeks for the full benefit of methotrexate tablets to be seen in the management of psoriasis or rheumatoid arthritis. Do not stop taking methotrexate tablets without checking with your doctor.
  • Methotrexate tablets works best if each dose is taken at the scheduled time.
  • Continue to take methotrexate tablets even if you feel well. Do not miss any doses.
  • If you miss a dose of methotrexate tablets, contact your doctor right away. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use methotrexate tablets.

Important safety information:

  • Methotrexate tablets may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use methotrexate tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Check with your doctor before you drink alcohol while you are taking methotrexate tablets.
  • Nausea, vomiting, and loss of appetite are common with methotrexate tablets. Ask your doctor or pharmacist for ways to decrease these effects if they occur.
  • If vomiting or diarrhea occurs, you will need to take care not to become dehydrated. Contact your doctor for instructions.
  • Methotrexate tablets may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to methotrexate tablets. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
  • Methotrexate tablets may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
  • Methotrexate tablets may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
  • Do not receive a live vaccine (eg, measles, mumps) while you are taking methotrexate tablets. Talk with your doctor before you receive any vaccine.
  • Methotrexate tablets may affect your ability to become pregnant or to father a child. Discuss any questions or concerns with your doctor.
  • Men who take methotrexate tablets should always use a condom when having sex with a woman who may become pregnant. Do this for as long as you take methotrexate tablets and for 3 months after you stop taking it.
  • Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
  • Lab tests, including complete blood cell counts, liver function, and kidney function, may be performed while you use methotrexate tablets. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use methotrexate tablets with caution in the ELDERLY; they may be more sensitive to its effects.
  • Methotrexate tablets should be used with extreme caution in CHILDREN younger than 2 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Methotrexate tablets may cause birth defects and fetal or newborn death if you take it while you are pregnant. Do not become pregnant while you are using it. Use an effective form of birth control while you take methotrexate tablets and for at least 1 ovulatory cycle after you stop taking it. If you think you may be pregnant, contact your doctor right away. Methotrexate tablets is found in breast milk. Do not breast-feed while taking methotrexate tablets.

Possible side effects of methotrexate tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; drowsiness; general body discomfort; headache; loss of appetite; mild hair loss; mild stomach pain; nausea; tiredness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; blood in the urine; bone pain; calf or leg pain, redness, swelling, or tenderness; change in the amount of urine produced; chest pain; confusion; coughing up blood; diarrhea or vomiting; difficult or painful urination; dry cough; enlargement of the breasts (in males); fainting; fever, chills, or persistent sore throat; menstrual changes; mental or mood changes; mouth or tongue sores or swelling; muscle weakness; night sweats; one-sided weakness; red, swollen, peeling, or blistered skin; seizures; severe or persistent dizziness or light-headedness; shortness of breath; speech changes; swollen glands; symptoms of liver problems (eg, dark urine, pale stools, persistent loss of appetite, severe stomach pain, yellowing of the skin or eyes); symptoms of pancreas inflammation (eg, severe stomach pain with or without nausea or vomiting); unexplained weight loss; unusual bleeding or bruising; unusual pain and discoloration of the skin; unusual tiredness or weakness; vaginal discharge; vision loss or other vision changes (eg, blurred vision); vomit that looks like coffee grounds.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include black or bloody stools; change in the amount of urine produced; seizures; severe headache, nausea, vomiting, or stomach pain; swelling or soreness of the mouth or tongue; unusual bruising or bleeding; unusual tiredness or weakness; vomit that looks like coffee grounds.

Proper storage of methotrexate tablets:

Store methotrexate tablets at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep methotrexate tablets out of the reach of children and away from pets.

General information:

  • If you have any questions about methotrexate tablets, please talk with your doctor, pharmacist, or other health care provider.
  • Methotrexate tablets 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.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take methotrexate tablets or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about methotrexate tablets. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to methotrexate tablets. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using methotrexate tablets.

Issue Date: July 2, 2014
Database Edition 14.3.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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