Trexall Side Effects

Generic name: methotrexate

Medically reviewed by Drugs.com. Last updated on Sep 16, 2022.

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

Summary

Common side effects of Trexall include: increased liver enzymes. Continue reading for a comprehensive list of adverse effects.

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 (Solution)

Jylamvo®Warning: Embryo-Fetal Toxicity, Hypersensitivity Reactions, and Severe Adverse ReactionsMethotrexate can cause embryo-fetal toxicity, including fetal death. For non-neoplastic diseases, methotrexate oral solution is contraindicated in pregnancy. For neoplastic diseases, advise females and males of reproductive potential to use effective contraception during and after treatment with methotrexate oral solution.Methotrexate oral solution is contraindicated in patients with a history of severe hypersensitivity reactions to methotrexate, including anaphylaxis.Serious adverse reactions, including death, have been reported with methotrexate. Closely monitor for infections and adverse reactions of the bone marrow, gastrointestinal tract, liver, lungs, skin, and kidneys. Withhold or discontinue methotrexate oral solution as appropriate.

Oral route (Tablet)

Embryo-Fetal Toxicity Hypersensitivity Reactions, and Severe Adverse ReactionsMethotrexate tablets can cause embryo-fetal toxicity, including fetal death. For non-neoplastic diseases, Methotrexate tablets are contraindicated in pregnancy. For neoplastic diseases, advise patients of reproductive potential of the potential risk to a fetus and to use effective contraception.Methotrexate tablets are contraindicated in patients with a history of severe hypersensitivity reactions to methotrexate, including anaphylaxis.Serious adverse reactions, including death, have been reported with methotrexate. Closely monitor for adverse reactions of the bone marrow, gastrointestinal tract, liver, lungs, skin, and kidneys. Withhold or discontinue methotrexate tablets as appropriate.

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 immediately if any of the following side effects occur while taking methotrexate:

More common

Black, tarry stools
bleeding gums
blood in the urine or stools
bloody vomit
diarrhea
increased heartbeat
itching, rash, reddening of the skin
joint pain
nausea
pinpoint red spots on the skin
sores in the mouth or lips
stomach pain
swelling of the eyelids, face, lips, hands, feet, or lower legs
swelling or inflammation of the mouth
trouble breathing
unusual bleeding or bruising
vomiting
yellow eyes or skin

Less common

Back pain
bloody nose
blurred vision
body and muscle pain
burning while urinating
confusion
continuing ringing, buzzing, or other unexplained noise in the ears
cough or hoarseness
cracked, dry, scaly skin
dark urine
dizziness
drowsiness
ear congestion
fever or chills
headache
loss of appetite
loss of hearing
loss of voice
lower back or side pain
painful or difficult urination
pale skin
runny nose
seizures
sneezing
sore throat
stuffy or runny nose
unusual tiredness or weakness
weight loss
white or brownish vaginal discharge

Incidence not known

Anxiety
blistering, peeling, or loosening of the skin
bloating
blurred or change in vision
changes in skin color
confusion
constipation
decreased interest in sexual intercourse
difficulty in moving
dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
dry mouth
dryness or soreness of the throat
eye pain
fruit-like breath odor
heartburn
inability to have or keep an erection
increased hunger or thirst
indigestion
irritation in the mouth
large, flat, blue, or purplish patches in the skin
loss in sexual ability, desire, drive, or performance
loss of consciousness
menstrual problem
night blindness
pain in the chest or groin
pain, redness, swelling, or tenderness in the arm or leg
red skin lesions, often with a purple center
red, wart-like spots on the skin
sudden loss of coordination
sudden onset of slurred speech
swelling or soreness of the breasts
swollen, painful, or tender lymph glands in the neck or armpit
tingling or numbness in the hands, feet, or lips

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 or thinning

Less common

Blemishes on the skin
hard, red, swollen skin irritation
pimples

For Healthcare Professionals

Applies to methotrexate: compounding powder, injectable powder for injection, injectable solution, intramuscular solution, oral liquid, 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^[Ref]

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^[Ref]

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^[Ref]

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^[Ref]

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.^[Ref]

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^[Ref]

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^[Ref]

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^[Ref]

Hypersensitivity

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

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^[Ref]

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^[Ref]

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^[Ref]

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^[Ref]

Oncologic

Frequency not reported: Lymphomas and leukemias have been associated with this drug^[Ref]

Other

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

Frequency not reported: Fetal death, fetal damage, abortion, tinnitus, chills, malaise, fatigue^[Ref]

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^[Ref]

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^[Ref]