Trexall Side Effects

Generic name: methotrexate

Medically reviewed by Drugs.com. Last updated on Nov 18, 2023.

Note: This document contains side effect information about methotrexate. Some dosage forms listed on this page may not apply to the brand name Trexall.

Applies to methotrexate: powder for solution, solution. Other dosage forms:

oral solution, oral tablet

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 of Trexall

Along with its needed effects, methotrexate (the active ingredient contained in Trexall) 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 of Trexall

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]