Brand Names: Rheumatrex Dose Pack, Trexall

Generic Name: methotrexate (oral) (Pronunciation: meth oh TREX ate)

• What is methotrexate (Trexall)?
• What are the possible side effects of methotrexate (Trexall)?
• What is the most important information I should know about methotrexate (Trexall)?
• What should I discuss with my healthcare provider before taking methotrexate (Trexall)?
• How should I take methotrexate (Trexall)?
• What happens if I miss a dose (Trexall)?
• What happens if I overdose (Trexall)?
• What should I avoid while taking methotrexate (Trexall)?
• What other drugs will affect methotrexate (Trexall)?
• Where can I get more information?

What is methotrexate (Trexall)?

Methotrexate interferes with the growth of certain cells of the body, especially cells that reproduce quickly, such as cancer cells, bone marrow cells, and skin cells.

Methotrexate is used to treat certain types of cancer of the breast, skin, head and neck, or lung. Methotrexate is also used to treat severe psoriasis and rheumatoid arthritis.

Methotrexate is usually given after other medications have been tried without successful treatment of symptoms.

Methotrexate may also be used for other purposes not listed in this medication guide.

Methotrexate 2.5 mg-BAR

elliptical, yellow, imprinted with b 572

Methotrexate 2.5 mg-MYL

round, orange, imprinted with M 14

Methotrexate 2.5 mg-ROX

round, yellow, imprinted with 54 323

Trexall 10 mg

oval, pink, imprinted with b, 929 10

Trexall 15 mg

oval, lavender, imprinted with b, 945 15

Trexall 5 mg

oval, green, imprinted with b, 927 5

Trexall 7.5 mg

oval, blue, imprinted with b, 928 7 1/2

What are the possible side effects of methotrexate (Trexall)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using methotrexate and call your doctor at once if you have any of these serious side effects:

• dry cough, shortness of breath;
• diarrhea, vomiting, white patches or sores inside your mouth or on your lips;
• blood in your urine or stools;
• urinating less than usual or not at all;
• fever, chills, body aches, flu symptoms;
• sore throat and headache with a severe blistering, peeling, and red skin rash;
• pale skin, easy bruising or bleeding, weakness; or
• nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

• nausea, vomiting, upset stomach;
• dizziness, tired feeling;
• headache;
• bleeding of your gums; or
• blurred vision.

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.

What is the most important information I should know about methotrexate (Trexall)?

You must use the correct dose of methotrexate for your condition. Methotrexate is usually taken once or twice per week and not every day. Follow the directions on your prescription label. Some people have died after taking methotrexate every day by accident. Ask your doctor if you have any questions about your dose of methotrexate or how often to take it.

Methotrexate can cause serious or life-threatening side effects on your liver, lungs, kidneys, and bone marrow (immune system). Do not take this medication in larger amounts, or take it for longer than prescribed. Follow the directions on your prescription label.

Do not use methotrexate to treat psoriasis or rheumatoid arthritis if you have liver disease (especially if caused by alcoholism), a blood cell or bone marrow disorder, or if you are breast-feeding a baby.

This medication can cause birth defects in an unborn baby. Do not use methotrexate to treat psoriasis or rheumatoid arthritis if you are pregnant. Use an effective form of birth control, whether you are a man or a woman. Tell your doctor if you or your sexual partner become pregnant during treatment.

To be sure this medication is not causing harmful effects, your blood will need to be tested on a regular basis. Your kidney or liver function may also need to be tested. Do not miss any scheduled appointments.

There are many other medicines that can interact with methotrexate. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.