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Trexall is used to treat certain types of cancer of the breast, skin, head and neck, or lung. This medicine is also used to treat severe psoriasis and rheumatoid arthritis.
Trexall is usually given after other treatments have failed.
Trexall may also be used for purposes not listed in this medication guide.
YOU MAY NOT NEED TO TAKE Trexall EVERY DAY. Some people have died after incorrectly taking this medicine every day. You must use the correct dose for your condition.
Do not use Trexall to treat psoriasis or rheumatoid arthritis if you have low blood cell counts, a bone marrow disorder, liver disease (especially if caused by alcoholism), or if you are pregnant or breast-feeding.
Trexall can cause serious or life-threatening side effects. Call your doctor if you have diarrhea, mouth sores, cough, shortness of breath, upper stomach pain, dark urine, numbness or tingling, muscle weakness, confusion, seizure, or skin rash that spreads and causes blistering and peeling.
You should not use Trexall if you are allergic to it. You may not be able to take this medicine if you have:
alcoholism, cirrhosis, or chronic liver disease;
low blood cell counts;
a weak immune system or bone marrow disorder; or
if you are pregnant or breastfeeding.
Trexall is sometimes used even when patients do have one of the conditions listed above. Your doctor will decide if Trexall is right for you.
Tell your doctor if you have ever had:
liver problems, especially fluid in your stomach (ascites);
kidney disease;
lung problems, especially fluid in the lungs (pleural effusion);
radiation treatments; or
a stomach ulcer or ulcerative colitis.
Trexall can harm an unborn baby or cause birth defects if the mother or the father is using this medicine.
If you are a woman, do not use Trexall to treat psoriasis or rheumatoid arthritis if you are pregnant. You may need to have a negative pregnancy test before starting this treatment. Use an effective form of birth control while you are taking this medicine, and for 6 months after your last dose.
If you are a man, use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 3 months after your last dose.
Tell your doctor right away if a pregnancy occurs while either the mother or the father is using Trexall.
This medicine may affect fertility (ability to have children) in both men and women. However, it is important to use birth control to prevent pregnancy because Trexall can harm an unborn baby.
Do not breastfeed while using this medicine.
Do not give this medicine to a child without the advice of a doctor.
YOU MAY NOT NEED TO TAKE Trexall EVERY DAY. This medicine is sometimes taken only 1 or 2 times per week, or once every 12 hours for only 3 doses. Some conditions are treated daily for just a few days followed by a rest period of 1 week or longer before taking the medicine again.
You must use the correct dose. Some people have died after incorrectly taking Trexall every day.
Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed. Ask your doctor or pharmacist if you have questions about how often to take Trexall.
Measure liquid medicine carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).
Trexall can be toxic to your organs, and may lower your blood cell counts. You will need frequent medical tests, and your next dose may be delayed based on the results.
If you need to be sedated for dental work, tell your dentist you currently use Trexall.
Store tablets at room temperature away from moisture, heat, and light.
Store the liquid medicine in the refrigerator, do not freeze.
You may also store the liquid at room temperature for up to 60 days.
Call your doctor for instructions if you miss a dose of Trexall.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of methotrexate can be fatal.
Overdose symptoms may include bruising or unusual bleeding, mouth sores, vomiting, little or no urination, bloody or tarry stools, or coughing up blood or vomit that looks like coffee grounds.
Avoid drinking alcohol. It may increase your risk of liver damage.
Do not receive a "live" vaccine while using Trexall, or you could develop a serious infection. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.
Trexall could make you sunburn more easily. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.
Trexall can pass into body fluids (urine, feces, vomit). Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.
Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).
Call your doctor at once if you have:
severe ongoing vomiting or diarrhea;
dry cough, chest pain, shortness of breath or rapid breathing;
kidney problems--little or no urination, swelling in your feet or ankles;
liver problems--stomach pain (upper right side), dark urine, jaundice (yellowing of the skin or eyes);
low blood cell counts--fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath;
nerve problems--weakness, coordination problems, loss of movement in any part of your body;
signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds; or
signs of tumor cell breakdown--confusion, weakness, muscle cramps, fast or slow heart rate, decreased urination, tingling in your hands and feet or around your mouth.
Common side effects may include:
low blood cell counts, infections (fever, chills, tiredness, bruising, not feeling well);
dizziness;
mouth sores;
nausea, upset stomach, vomiting, diarrhea;
hair loss; or
abnormal liver function tests.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Trexall can harm your liver, especially if you also use certain medicines for infections, tuberculosis, depression, birth control, hormone replacement, high cholesterol, heart problems, high blood pressure, seizures, pain, or arthritis (including Tylenol, Advil, Motrin, or Aleve).
Many drugs can affect Trexall. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Trexall (www.drugs.com/mtm/trexall.html).
Note: This document contains side effect information about methotrexate. Some of the dosage forms listed on this page may not apply to the brand name Trexall.
Common side effects of Trexall include: increased liver enzymes. See below for a comprehensive list of adverse effects.
Applies to methotrexate: oral solution, oral tablet
Other dosage forms:
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 (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
Less common
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
Less common
Applies to methotrexate: compounding powder, injectable powder for injection, injectable solution, oral solution, oral tablet, subcutaneous solution
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
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
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
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
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.
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
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
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
Uncommon (0.1% to 1%): Allergic vasculitis, severe allergic reactions progressing to anaphylactic shock
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
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
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
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
Frequency not reported: Lymphomas and leukemias have been associated with this drug
Very rare (less than 0.01%): Fever, impaired wound healing
Frequency not reported: Fetal death, fetal damage, abortion, tinnitus, chills, malaise, fatigue
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
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
Rare (0.01% to 0.1%): Diabetes mellitus, hyperuricemia
Frequency not reported: Metabolic disorder, tumor lysis syndrome
Rare (0.01% to 0.1%): Mood alterations
Very rare (less than 0.01%): Insomnia, cognitive dysfunction
Frequency not reported: Psychosis, depression, confusion, irritability
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Trexall (www.drugs.com/mtm/trexall.html).
March 28, 2020
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