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Methotrexate Sodium

Methotrexate sodium Prescription
Generic Name: methotrexate (oral) (meth oh TREX ate)
Brand Names: Otrexup, Rasuvo, Rheumatrex Dose Pack, Trexall, Xatmep
Methotrexate is used to treat certain types of cancer of the breast, skin, head and neck, or lung. Learn about side effects, interactions and indications.

Average Savings for methotrexate sodium (generic): 28.54%
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Methotrexate Sodium Drug Information:

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. It is also used to treat severe psoriasis and and certain forms of rheumatoid arthritis. Methotrexate is usually given after other medications have been tried without successful treatment of symptoms. Methotrexate made also be used for purposes not listed in this medication guide. Learn more

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Methotrexate Sodium Side Effects

In Summary

Commonly reported side effects of methotrexate include: increased liver enzymes. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to methotrexate: oral solution, oral tablet

Other dosage forms:

  • powder for solution, solution

Warning

Oral route (Solution)

Severe Toxic Reactions, Including Embryo-Fetal ToxicityMethotrexate can cause severe or fatal toxicities. Monitor closely and modify dose or discontinue for the following toxicities: bone marrow suppression, infection, renal, gastrointestinal, hepatic, pulmonary, hypersensitivity and dermatologic.Methotrexate can cause embryo-fetal toxicity and fetal death. Use in polyarticular juvenile idiopathic arthritis is contraindicated in pregnancy. Consider the benefits and risks of methotrexate and risks to the fetus when prescribing methotrexate to a pregnant patient with a neoplastic disease. Advise patients to use effective contraception during and after treatment with methotrexate.

Oral route (Tablet)

Only use for life-threatening neoplastic disease or severe rheumatoid arthritis and psoriasis unresponsive to other therapies. Death, fetal death and/or congenital anomalies, lung disease, tumor lysis syndrome, fatal skin reactions, and Pneumocystis carinii pneumonia have been reported. Monitor for bone marrow, liver, lung, and kidney toxicities. Unexpectedly severe (sometimes fatal) bone marrow suppression, aplastic anemia, and gastrointestinal toxicity have been reported with concomitant administration of methotrexate (usually in high dosage) along with some nonsteroidal anti-inflammatory drugs (NSAIDs). Hepatotoxicity, fibrosis, and cirrhosis occur with prolonged use. Diarrhea and ulcerative stomatitis require interruption of therapy. Methotrexate elimination is reduced in patients with impaired renal function, ascites, or pleural effusions. Increased risk of soft tissue necrosis and osteonecrosis with concomitant radiotherapy. Malignant lymphoma may occur.

Along with its needed effects, methotrexate may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking methotrexate:

More common

  • Black, tarry stools
  • blood in the urine or stools
  • bloody vomit
  • diarrhea
  • joint pain
  • reddening of the skin
  • sores in the mouth or lips
  • stomach pain
  • swelling of the feet or lower legs

Less common

  • Back pain
  • blurred vision
  • confusion
  • convulsions (seizures)
  • cough or hoarseness
  • dark urine
  • dizziness
  • drowsiness
  • fever or chills
  • headache
  • lower back or side pain
  • painful or difficult urination
  • pinpoint red spots on the skin
  • shortness of breath
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • yellow eyes or skin

Some side effects of methotrexate may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  • Hair loss, temporary
  • loss of appetite
  • nausea or vomiting

Less common

  • Acne
  • boils on skin
  • pale skin
  • skin rash or itching

For Healthcare Professionals

Applies to methotrexate: compounding powder, injectable powder for injection, injectable solution, oral solution, oral tablet, subcutaneous solution

Cardiovascular

Uncommon (0.1% to 1%): Vasculitis

Rare (less than 0.1%): Pericarditis, pericardial effusion, pericardial tamponade, hypotension, thromboembolic events (e.g., arterial thrombosis, cerebral thrombosis, thrombophlebitis, deep vein thrombosis, retinal vein thrombosis, pulmonary embolism), myocardial ischemia

Frequency not reported: Cerebral edema

Dermatologic

Common (1% to 10%): Exanthema, erythema, itching

Uncommon (0.1% to 1%): Urticaria, photosensitivity, depigmentation or hyperpigmentation of the skin, alopecia, increase of rheumatic nodules, painful lesions of psoriatic plaque, herpetiform eruption of the skin, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome)

Rare (0.01% to 0.1%): Increased pigmentary changes of nails, acne, petechiae, ecchymoses, erythema multiforme, cutaneous erythematous eruptions

Very rare (less than 0.01%): Furunculosis, telangiectasia

Frequency not reported: Exfoliative dermatitis, skin necrosis, skin ulceration, folliculitis, hidradenitis, allergic vasculitis

Endocrine

Uncommon (0.1% to 1%): Inflammation and ulceration of the vagina

Very rare (less than 0.01%): Loss of libido (males and females), impotence, impaired menstruation, vaginal discharge, infertility, abortion, fetal death, fetal defects, gynecomastia, defective oogenesis or spermatogenesis, transient oligospermia, vaginal bleeding

Gastrointestinal

Very common (10% or more): Anorexia, nausea, vomiting, abdominal pain, inflammation, ulcerations of the mucous membrane of mouth and throat (especially during the first 24 to 48 hours after administration), stomatitis, dyspepsia, dehydration

Common (1% to 10%): Diarrhea (especially during the first 24 to 48 hours after administration)

Uncommon (0.1% to 1%): GI bleeding and ulcers, pancreatitis

Rare (0.01% to 0.1%): Gingivitis, enteritis, melena, malabsorption

Very rare (less than 0.01%): Hematemesis, toxic megacolon

Frequency not reported: Glossitis

General

Generally, the incidence and severity of acute side effects are related to dose and frequency of administration. The most frequently reported adverse reactions include ulcerative stomatitis, leukopenia, nausea, abdominal distress, malaise, undue fatigue, chills and fever, dizziness, and decreased resistance to infection.

Genitourinary

Uncommon (0.1% to 1%): Dysuria

Rare (0.01% to 0.1%): Oliguria, anuria, azotemia

Very rare (less than 0.01%): Proteinuria

Frequency not reported: Cystitis, hematuria

Hematologic

Common (1% to 10%): Leukocytopenia, thrombocytopenia, anemia

Uncommon (0.1% to 1%): Pancytopenia, agranulocytosis, hematopoietic disorders

Rare (0.01% to 0.1%): Megaloblastic anemia

Very rare (less than 0.01%): Severe bone marrow depression, aplastic anemia, lymphadenopathy, lymphoproliferative disorders (partly reversible), eosinophilia, neutropenia

Frequency not reported: Hemorrhage, hematoma, myelosuppression

Hepatic

Very common (10% or more): Increase in liver related enzymes (ALAT, ASAT, alkaline phosphatase, bilirubin, and LDH levels) is commonly reported but usually resolves within one month after cessation of therapy

Uncommon (0.1% to 1%): Development of liver fattening, fibrosis and cirrhosis (occurs frequently despite regularly monitored, normal values of liver enzymes), drop of serum albumin

Rare (0.01% to 0.1%): Acute hepatitis, hepatotoxicity

Very rare (less than 0.01%): Reactivation of chronic hepatitis, acute liver degeneration, liver insufficiency, liver failure, liver atrophy, necrosis

Hypersensitivity

Uncommon (0.1% to 1%): Allergic vasculitis, severe allergic reactions progressing to anaphylactic shock

Immunologic

Common (1% to 10%): Disseminated herpes zoster, pneumocystis carinii pneumonia

Very rare (less than 0.01%): Immunosuppression, hypogammaglobulinemia, sepsis, opportunistic infections (may be fatal in some cases), infections caused by the cytomegalic virus, acute paronychia

Frequency not reported: Nocardiosis, cryptococcus mycosis, disseminated herpes simplex, listeria meningitis, mycobacterium avium, intracellular pneumonia, systemic fungal infections (e.g., cryptococcosis, nocardiosis, aspergillosis, histoplasmosis), sepsis, decreased resistance to infection, pneumocystis jiroveci, pneumonia (most common infection), respiratory tract infection, cutaneous bacterial infections, pneumonia, reactivation of hepatitis B infection, worsening of hepatitis C infection

Musculoskeletal

Uncommon (0.1% to 1%): Osteoporosis, arthralgia, myalgia

Rare (0.01% to 0.1%): Stress fracture, nodulosis

Very rare (less than 0.01%): Pain, muscular asthenia or paresthesia of the extremities

Frequency not reported: Osteoporosis, osteonecrosis (aseptic necrosis of the femoral head), soft tissue necrosis, abnormal tissue cell changes, arthralgia/myalgia, back pain

Nervous system

Common (1% to 10%): Headache, fatigue, drowsiness

Uncommon (0.1% to 1%): Vertigo, confusion, seizures, convulsion, encephalopathy

Very rare (less than 0.01%): Paresis, effect on speech including dysarthria and aphasia, myelopathy, changes in sense of taste (metallic taste), meningism, acute aseptic meningitis

Ocular

Rare (0.01% to 0.1%): Severely impaired vision, visual disturbances, blurred vision

Very rare (less than 0.01%): Conjunctivitis, retinopathy, transient blindness/loss of vision, periorbital edema, blepharitis, epiphora, photophobia, eye discomfort

Oncologic

Frequency not reported: Lymphomas and leukemias have been associated with this drug

Other

Very rare (less than 0.01%): Fever, impaired wound healing

Frequency not reported: Fetal death, fetal damage, abortion, tinnitus, chills, malaise, fatigue

Renal

Uncommon (0.1% to 1%): Inflammation and ulceration of the urinary bladder (possibly with hematuria)

Rare (0.01% to 0.1%): Renal failure, elevated serum creatinine and urea level

Frequency not reported: Renal insufficiency (usually with high doses), severe nephropathy

Respiratory

Common (1% to 10%): Pulmonary complications due to interstitial alveolitis pneumonitis (e.g., general illness, dry/nonproductive cough, shortness of breath progressing to rest dyspnea, chest pain, fever)

Uncommon (0.1% to 1%): Pulmonary fibrosis

Rare (0.01% to 0.1%): Pharyngitis, apnea, bronchial asthma

Very rare (less than 0.01%): Pneumocystis carinii pneumonia, chronic obstructive pulmonary disease, pleural effusion

Frequency not reported: Acute pulmonary edema, pleurisy, hypoxia, respiratory failure

Metabolic

Rare (0.01% to 0.1%): Diabetes mellitus, hyperuricemia

Frequency not reported: Metabolic disorder, tumor lysis syndrome

Psychiatric

Rare (0.01% to 0.1%): Mood alterations

Very rare (less than 0.01%): Insomnia, cognitive dysfunction

Frequency not reported: Psychosis, depression, confusion, irritability

Editorial References and Review

Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.

Source: Drugs.com Methotrexate Sodium (www.drugs.com/methotrexate.html).