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Generic Name: methotrexate

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An antirheumatic - treats Trophoblastic Disease, Psoriasis, Lymphoma, Mycosis Fungoides, Acute Lymph... more

FDA Alerts

Experience of Supervising Clinician

Administer only under supervision of qualified clinicians experienced in use of antimetabolite therapy.

Serious Toxic Reactions (Sometimes Fatal) Possible

Deaths reported with use in treatment of malignancy, psoriasis, and rheumatoid arthritis.
Use only for treatment of life-threatening neoplastic diseases or severe, recalcitrant, disabling psoriasis or rheumatoid arthritis in patients who have not responded adequately to other forms of therapy.
Closely monitor patients for bone marrow, hepatic, pulmonary, or renal toxicities. (See Major Toxicities under Cautions.)
Inform patients of risks involved with therapy and importance of remaining under care of clinician throughout therapy.

High-Dose Regimens

Use of high-dose regimens recommended for treatment of osteosarcoma requires meticulous care. (See High-Dose Methotrexate Therapy with Leucovorin Rescue and also Osteosarcoma, under Dosage and Administration.)
Use of high-dose regimens for other neoplastic diseases is investigational; therapeutic advantage not established.

Formulations or Diluents Containing Preservatives

Do not use formulations or diluents containing preservatives for intrathecal administration or high-dose therapy.

Fetal/Neonatal Morbidity and Mortality

Fetal death and/or congenital anomalies reported. Not recommended for use in women of childbearing potential unless potential benefit clearly outweighs risks; do not use in pregnant women with psoriasis or rheumatoid arthritis. (See Contraindications and also Fetal/Neonatal Morbidity and Mortality, under Cautions.)

Reduced Elimination

Elimination reduced in patients with renal impairment, ascites, or pleural effusions. Carefully monitor for toxicity in such patients; dosage reduction or discontinuance may be required.

Concomitant Therapy with NSAIAs

Unexpectedly severe, sometimes fatal, myelosuppression, aplastic anemia, and GI toxicity reported with concomitant use of methotrexate (usually at high dosages) and some NSAIAs. (See Specific Drugs under Interactions.)

Hepatotoxicity

Possible hepatotoxicity, fibrosis, and cirrhosis, generally only after prolonged use. (See Hepatic Effects under Cautions.)
Acute liver enzyme elevations frequently observed; usually transient and asymptomatic and do not appear predictive of subsequent hepatic disease.
Liver biopsy after sustained use often shows histologic changes. Fibrosis and cirrhosis may not be preceded by symptoms or abnormal liver function tests in patients with psoriasis; periodic liver biopsies usually recommended in such patients undergoing long-term therapy.
Persistent abnormalities in liver function tests may precede appearance of fibrosis or cirrhosis in patients with rheumatoid arthritis.

Pulmonary Toxicity

Potentially dangerous pulmonary lesions, not always reversible, may occur acutely at any time during therapy and have been reported at dosages as low as 7.5 mg weekly. Pulmonary symptoms (especially dry, nonproductive cough) may require therapy interruption and careful evaluation.

GI Toxicity

Diarrhea and ulcerative stomatitis require interruption of therapy; otherwise, hemorrhagic enteritis and death from intestinal perforation may occur.

Malignant Lymphomas

Malignant lymphomas (e.g., non-Hodgkin’s lymphoma) may occur in patients receiving low-dose oral therapy; such lymphomas may regress following methotrexate discontinuance and may not require cytotoxic therapy. If the lymphoma does not regress following discontinuance, institute appropriate therapy.

Tumor Lysis Syndrome

May induce tumor lysis syndrome in patients with rapidly growing tumors; appropriate pharmacologic and supportive treatment may prevent or alleviate syndrome.

Dermatologic Reactions

Severe, occasionally fatal skin reactions reported following single or multiple doses; reactions occurred within days of oral, IM, IV, or intrathecal administration. Recovery reported with discontinuance of therapy. (See Dermatologic and Sensitivity Reactions under Cautions.)

Opportunistic Infections

Potentially fatal opportunistic infections, especially Pneumocystis jiroveci (formerly Pneumocystis carinii) pneumonia.

Concomitant Radiotherapy

Possible increased risk of soft tissue necrosis and osteonecrosis in patients receiving methotrexate concomitantly with radiotherapy.

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(meth oh TREX ate)

How should I take methotrexate?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

You must use the correct dose of methotrexate for your condition. The medication is sometimes taken only once per week. 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.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

It is important to use methotrexate regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

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, and you may need an occasional liver biopsy. Do not miss any scheduled appointments.

Store methotrexate at room temperature away from moisture and heat.

What happens if I miss a dose?

Call your doctor if you miss a dose of methotrexate.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of methotrexate can be fatal.

Overdose symptoms may include pale skin, easy bruising or bleeding, unusual weakness, mouth sores, nausea, vomiting, black or bloody stools, coughing up blood or vomit that looks like coffee grounds, and urinating less than usual or not at all.

What should I avoid while taking methotrexate?

Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds), especially if you are being treated for psoriasis. Methotrexate can make your skin more sensitive to sunlight and your psoriasis may worsen. Avoid drinking alcohol while taking methotrexate.

What are the possible side effects of methotrexate?

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).