Methotrexate LPF Sodium Side Effects
Generic name: methotrexate
Medically reviewed by Drugs.com. Last updated on Oct 14, 2023.
Note: This document contains side effect information about methotrexate. Some dosage forms listed on this page may not apply to the brand name Methotrexate LPF Sodium.
Applies to methotrexate: powder for solution, solution. Other dosage forms:
Warning
Subcutaneous route (Solution)
Use only for severe rheumatoid arthritis and psoriasis unresponsive to other therapies. Monitor for bone marrow, liver, lung, skin, and kidney toxicities. Death, fetal death and/or congenital anomalies, and severe sometimes fatal lung disease, tumor lysis syndrome, skin reactions, and Pneumocystis jiroveci pneumonia have been reported. Use not recommended in women of childbearing potential and is contraindicated in pregnant women. Advise females and males of reproductive potential to use effective contraception during and after treatment. 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 NSAIDs. Hepatotoxicity, fibrosis, and cirrhosis may occur with prolonged use. Lung disease, including acute or chronic interstitial pneumonitis may occur, and has been reported at low doses. Diarrhea and ulcerative stomatitis require therapy interruption. Methotrexate elimination is reduced in patients with impaired renal function, ascites, or pleural effusions; dose reduction is required and discontinuation may be necessary with these conditions. Increased risk of soft tissue necrosis and osteonecrosis with concomitant radiotherapy. Malignant lymphoma may occur.
Injection route (Powder for Solution; Solution)
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. Use extreme caution with high-dose regimen for osteosarcoma. Do not use formulations/diluents with preservatives for intrathecal or high-dose therapy.
Serious side effects
Along with its needed effects, methotrexate (the active ingredient contained in Methotrexate LPF Sodium) 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 or nurse 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
- bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, or warmth at the injection site
- blurred vision
- confusion
- 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
- seizures
- trouble breathing
- unusual bleeding or bruising
- unusual tiredness or weakness
- yellow eyes or skin
Other side effects
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, intramuscular solution, oral liquid, oral solution, oral tablet, subcutaneous solution.
General
Frequently observed adverse reactions include ulcerative stomatitis, leukopenia, nausea, and abdominal distress. In addition, infections, malaise, fatigue, chills, fever, and dizziness are commonly reported adverse reactions.[Ref]
Cardiovascular
Rare (0.01% to 0.1%): Pericardial effusion, pericarditis, pericardial tamponade
Postmarketing reports: Thromboembolic events (including arterial thrombosis, cerebral thrombosis, deep vein thrombosis, retinal vein thrombosis, thrombophlebitis, and pulmonary embolus), pericarditis, pericardial effusion, hypotension, sudden death[Ref]
Dermatologic
Common (1% to 10%): Rash, pruritus, dermatitis, alopecia, photosensitivity, burning of skin lesions
Uncommon (0.1% to 1%): Allergic vasculitis, herpetiform eruptions of the skin, Stevens-Johnson´s syndrome, toxic epidermal necrolysis, increase in rheumatoid nodules, increased skin pigmentation, impaired wound healing
Rare (0.01% to 0.1%): Increased nail pigment changes, photo-hypersensitivity, acne petechiae, depigmentation, urticaria, erythema multiforme, painful damage to psoriatic lesion, skin ulceration, onycholysis
Very rare (less than 0.01%): Acute paronychia, telangiectasia, furunculosis, ecchymoses, hidradenitis
Frequency not reported: Skin exfoliation / dermatitis exfoliative
Postmarketing reports: Toxic epidermal necrolysis, Stevens-Johnson syndrome, exfoliative dermatitis, skin necrosis, and erythema multiforme, erythematous rashes, pruritus, alopecia, skin ulceration, accelerated nodulosis, urticaria, pigmentary changes, ecchymosis, telangiectasia, photosensitivity, acne, furunculosis[Ref]
Endocrine
Postmarketing reports: Diabetes[Ref]
Gastrointestinal
Very common (10% or more): Nausea/vomiting (10%), dyspepsia, abdominal pain
Common (1% to 10%): Diarrhea, stomatitis, oral ulcers
Uncommon (0.1% to 1%): Gastrointestinal ulcerations and bleeding
Rare (0.01% to 0.1%): Pancreatitis, gingivitis, enteritis, melena
Very rare (less than 0.01%): Toxic megacolon, hematemesis
Frequency not reported: Anorexia
Postmarketing reports: Hemorrhagic enteritis, intestinal perforation, gingivitis, pancreatitis, pharyngitis, hematemesis, melena, gastrointestinal ulceration[Ref]
Genitourinary
Uncommon (0.1% to 1%): Vaginal inflammation and ulceration
Rare (0.01% to 0.1%): Impotence, menstrual disorders
Very rare (less than 0.01%): Loss of libido, formation of defective oocytes or sperm cells, transient oligospermia, infertility, vaginal discharge, vaginal bleeding, gynecomastia
Frequency not reported: Vaginal discharge
Postmarketing reports: Defective oogenesis or spermatogenesis, loss of libido, impotence, gynecomastia, menstrual dysfunction[Ref]
Hematologic
Common (1% to 10%): Thrombocytopenia (platelet count less than 100,000/mm3), leukopenia (white blood cell count less than 3000/mm3), pancytopenia, anemia
Uncommon (0.1% to 1%): Bone marrow depression, agranulocytosis, hematopoietic disorders
Rare (0.01% to 0.1%): Megaloblastic anemia, hypotension
Very rare (less than 0.01%): Hypogammaglobulinemia, aplastic anemia, lympho-proliferative disorder, neutropenia, lymphadenopathy, vasculitis
Frequency not reported: Decreased hematocrit, eosinophilia
Postmarketing reports: Aplastic anemia, lymphadenopathy, hypogammaglobulinemia[Ref]
Hepatic
Very common (10% or more): Elevated liver function tests (15%)
Uncommon (0.1% to 1%): Cirrhosis, fibrosis and fatty degeneration of the liver, decrease in serum albumin
Rare (0.01% to 0.1%): Hepatotoxicity, acute hepatitis
Very rare (less than 0.01%): Reactivation of chronic hepatitis, hepatic failure
Postmarketing reports: Acute hepatitis, decreased serum albumin, fibrosis, cirrhosis, liver failure[Ref]
Immunologic
Uncommon (0.1% to 1%): Anaphylactic-type reaction, allergic reactions, anaphylactic shock
Very rare (less than 0.01%): Immuno-suppression
Postmarketing reports: Anaphylaxis, anaphylactoid reactions, vasculitis[Ref]
Metabolic
Uncommon (0.1% to 1%): Diabetes mellitus
Postmarketing reports: Hyperglycemia[Ref]
Musculoskeletal
Rare (0.01% to 0.1%): Osteoporosis, arthralgia, myalgia
Very rare (less than 0.01%): Stress fracture
Frequency not reported: Osteonecrosis of jaw (secondary to lymphoproliferative disorders)
Postmarketing reports: Stress fracture, soft tissue necrosis, arthralgia, myalgia, osteoporosis[Ref]
Nervous system
Common (1% to 10%): Dizziness, headache, fatigue, drowsiness
Uncommon (0.1% to 1%): Convulsions, vertigo
Rare (0.01% to 0.1%): Hemiparesis, paresis
Very rare (less than 0.01%): Cerebral edema, acute aseptic meningitis with meningism (paralysis, vomiting), irritation, dysarthria, aphasia, lethargy, transient subtle cognitive dysfunction, dysarthria, unusual cranial sensations, pain, muscular asthenia, paresthesia/ hypoesthesia, changes in sense of taste (metallic taste)
Frequency not reported: Encephalopathy/leukoencephalopathy
Postmarketing reports: Headaches, drowsiness, blurred vision, speech impairment (including dysarthria and aphasia), transient cognitive dysfunction, mood alteration, unusual cranial sensations, paresis, encephalopathy, leukoencephalopathy, convulsions, spinal radiculopathy (with intrathecal use)[Ref]
Ocular
Rare (0.01% to 0.1%): Severe visual disturbances
Very rare (less than 0.01%): Conjunctivitis, impaired vision, retinopathy
Frequency not reported: Eye discomfort
Postmarketing reports: Optic neuropathy, blurred vision, ocular irritation, conjunctivitis, xerophthalmia[Ref]
Oncologic
Uncommon (0.1% to 1%): Lymphoma[Ref]
Other
Uncommon (0.1% to 1%): Chills
Frequency not reported: Fever, infection, sweating, tinnitus[Ref]
Psychiatric
Uncommon (0.1% to 1%): Depression, confusion
Rare (0.01% to 0.1%): Mood swings
Very rare (less than 0.01%): Insomnia[Ref]
Renal
Uncommon (0.1% to 1%): Disturbed micturition, inflammation and ulceration of the urinary bladder (possibly with hematuria), renal insufficiency, nephropathy
Rare (0.01% to 0.1%): Oliguria, anuria, electrolyte disturbances
Very rare (less than 0.01%): Dysuria, azotemia, cystitis, hematuria, proteinuria
Postmarketing reports: Azotemia, hematuria, proteinuria, cystitis[Ref]
Respiratory
Common (1% to 10%): Interstitial pneumonitis
Uncommon (0.1% to 1%): Nosebleed, interstitial fibrosis
Rare (0.01% to 0.1%): Respiratory paralysis, dyspnea, pharyngitis, bronchial asthma
Very rare (less than 0.01%): Chronic interstitial obstructive lung disease, pleuritis, dry cough, pleural effusion
Frequency not reported: Upper respiratory infection, chest pain, coughing, epistaxis, alveolitis, pulmonary alveolar hemorrhage
Postmarketing reports: Pulmonary fibrosis, respiratory failure, chronic interstitial obstructive pulmonary disease, pleuritic pain and thickening, alveolitis[Ref]
Frequently asked questions
- Why should I take folic acid with methotrexate?
- Does it cause weight gain?
- How do I know if methotrexate is working for rheumatoid arthritis?
- How long does it take to work?
- What are the different brands of methotrexate?
- How long does methotrexate stay in your system?
- What causes Plaque Psoriasis?
- How does methotrexate work for ectopic pregnancy?
More about Methotrexate LPF Sodium (methotrexate)
- Check interactions
- Compare alternatives
- Reviews (1)
- Dosage information
- During pregnancy
- Drug class: antimetabolites
- Breastfeeding
Patient resources
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Related treatment guides
References
1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
2. Cerner Multum, Inc. "Australian Product Information."
3. (2017) "Product Information. Methotrexate Sodium (methotrexate)." Teva Pharmaceuticals (formerly IVAX)
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.