Trexall Side Effects Center

Last updated on RxList: 6/25/2021
Trexall Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Trexall?

Trexall (methotrexate) is an antimetabolite drug that is used to treat some cancers, severe skin diseases such as severe psoriasis, and to treat forms of rheumatoid arthritis. Trexall is available in generic form as methotrexate.

What Are Side Effects of Trexall?

Side effects of Trexall include:

  • inflammation of the mouth and lips,
  • nausea,
  • vomiting,
  • upset stomach,
  • abdominal pain,
  • dizziness,
  • tired feeling,
  • headache,
  • bleeding gums,
  • blurred vision, and
  • leukopenia (low number of white cells in blood).

Tell your doctor if you have serious side effects of Trexall including:

  • dry cough,
  • shortness of breath,
  • diarrhea,
  • white patches or sores inside your mouth or on your lips,
  • blood in your urine or stools,
  • urinating less than usual or not at all,
  • fever,
  • chills,
  • body aches,
  • flu symptoms,
  • sore throat and headache with a severe blistering/peeling/red skin rash,
  • pale skin,
  • easy bruising or bleeding,
  • weakness,
  • stomach pain,
  • loss of appetite,
  • dark urine,
  • clay-colored stools, or
  • jaundice (yellowing of the skin or eyes).

Severe side effects occur more frequently in patients taking the high doses of Trexall.

Dosage for Trexall

Trexall is supplied in 5, 7.5, 10, and 15 mg tablets. The dose is designed for each patient's problem and can range from about 7.5 mg per week to 30 mg per day, depending on the disease process and the doctor's judgment. Trexall has been used in children with juvenile rheumatoid arthritis, but most doses were individualized.

What Drugs, Substances, or Supplements Interact with Trexall?

Trexall may interact with azathioprine, chloramphenicol, hydroxychloroquine, retinol, tretinoin, isotretinoin, steroids, sulfa drugs, phenytoin, probenecid, tetracycline, theophylline, gold treatments, oral diabetes medications, penicillin antibiotics, medicines that reduce stomach acid, nonsteroidal anti-inflammatory drugs (NSAIDs), or salicylates such as aspirin and others. Tell your doctor all medications and supplements you use.

Trexall During Pregnancy and Breastfeeding

This drug should not be used in pregnant or breastfeeding women due to likely harm to the fetus or infant.

Additional Information

Our Trexall Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

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Trexall Consumer Information

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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).

Methotrexate can cause serious or fatal side effects. Call your doctor at once if you have:

  • sudden chest pain, wheezing, dry cough, cough with mucus, chest pain, feeling short of breath;
  • fever, chills, swollen lymph glands, night sweats, weight loss;
  • blisters or ulcers in your mouth, red or swollen gums, trouble swallowing;
  • vomiting, diarrhea, blood in your urine or stools;
  • skin changes such as redness, warmth, swelling, or oozing;
  • 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;
  • kidney problems--little or no urination, swelling in your feet or ankles;
  • liver problems--swelling around your midsection, right-sided upper stomach pain, nausea, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes);
  • nerve problems--confusion, weakness, drowsiness, coordination problems, feeling irritable, headache, neck stiffness, vision problems, loss of movement in any part of your body, seizure; or
  • signs of tumor cell breakdown--tiredness, weakness, muscle cramps, nausea, vomiting, diarrhea, fast or slow heart rate, tingling in your hands and feet or around your mouth.

Common side effects may include:

  • fever, chills, tiredness, not feeling well;
  • low blood cell counts;
  • mouth sores;
  • nausea, stomach pain;
  • abnormal liver function tests;
  • hair loss;
  • burning skin lesions; or
  • being more sensitive to light.

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.

Read the entire detailed patient monograph for Trexall (Methotrexate)

Trexall Professional Information

SIDE EFFECTS

The following clinically significant adverse reactions are described elsewhere in the labeling:

  • Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]
  • Myelosuppression [see WARNINGS AND PRECAUTIONS]
  • Gastrointestinal Toxicity [see WARNINGS AND PRECAUTIONS]
  • Hepatotoxicity [see WARNINGS AND PRECAUTIONS]
  • Pulmonary Toxicity [see WARNINGS AND PRECAUTIONS]
  • Dermatologic Reactions [see WARNINGS AND PRECAUTIONS]
  • Renal Toxicity [see WARNINGS AND PRECAUTIONS]
  • Serious Infections [see WARNINGS AND PRECAUTIONS]
  • Neurotoxicity [see WARNINGS AND PRECAUTIONS]
  • Secondary Malignancies [see WARNINGS AND PRECAUTIONS]
  • Tumor Lysis Syndrome [see WARNINGS AND PRECAUTIONS]
  • Increased Risk of Adverse Reactions Due to Third-Space Accumulation [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials and other studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Common adverse reactions were: ulcerative stomatitis, leukopenia, nausea, and abdominal distress. Other clinically relevant adverse reactions were infection, malaise, fatigue, chills, fever, and dizziness.

Rheumatoid Arthritis

The most common adverse reactions of methotrexate that exceeded the rate of placebo in 12- to 18-week double-blind studies in patients (n=128) with rheumatoid arthritis are listed below.

Patients received methotrexate 7.5 mg to 15 mg orally once weekly. Most patients received concomitant nonsteroidal anti-inflammatory drugs (NSAIDs) and some also received corticosteroids. Hepatic histology was not examined in these short-term studies.

Incidence ≥10%: Elevated liver tests 15%, nausea/vomiting 10%
Incidence 3% to <10%: Stomatitis, thrombocytopenia (platelet count < 100,000/mm3)
Incidence 1% to <3%: Rash/pruritus/dermatitis, diarrhea, alopecia, leukopenia (white blood cell count < 3000/mm3), pancytopenia, dizziness

Two other controlled trials of patients (n=680) with rheumatoid arthritis who received methotrexate 7.5 mg to 15 mg orally once weekly showed the following serious adverse reaction:

Incidence 1%: Interstitial pneumonitis

Other less common adverse reactions were: anemia, headache, upper respiratory infection, anorexia, arthralgias, chest pain, coughing, dysuria, eye discomfort, epistaxis, fever, infection, sweating, tinnitus, vaginal discharge.

Polyarticular Juvenile Idiopathic Arthritis (pJIA)

The most common adverse reactions reported in patients 2 to 18 years of age with pJIA treated with methotrexate 5 mg/m2 to 20 mg/m2 orally once weekly or 0.1 to 0.65 mg/kg orally once weekly were as follows: elevated liver tests 14%; gastrointestinal reactions (e.g., nausea, vomiting, diarrhea) 11%; stomatitis 2%; leukopenia 2%; headache 1.2%; alopecia 0.5%; dizziness 0.2%; rash 0.2%. Most patients received concomitant NSAIDs and some also received corticosteroids.

Psoriasis

In two published series of adults with psoriasis (n=204, 248) who received methotrexate up to 25 mg per week for up to 4 years, adverse reaction rates were similar to those in patients with rheumatoid arthritis, except for alopecia, photosensitivity, and “burning of skin lesions” (3% to 10% each). Painful plaque erosions have been reported.

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of methotrexate. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure

Cardiovascular: Thromboembolic events (including arterial thrombosis, cerebral thrombosis, deep vein thrombosis, retinal vein thrombosis, thrombophlebitis, and pulmonary embolus), pericarditis, pericardial effusion, hypotension, sudden death

Endocrine: Diabetes

Eye: Optic neuropathy, blurred vision, ocular pain, conjunctivitis, xerophthalmia

Gastrointestinal: Hemorrhagic enteritis, intestinal perforation, gingivitis, pancreatitis, pharyngitis, hematemesis, melena, gastrointestinal ulceration

Hematology: Aplastic anemia, lymphadenopathy, hypogammaglobulinemia

Hepatobiliary: Acute hepatitis, decreased serum albumin, fibrosis, cirrhosis

Immune system: Anaphylaxis, anaphylactoid reactions, vasculitis

Metabolism: Hyperglycemia

Musculoskeletal: Stress fracture, soft tissue and bone necrosis, arthralgia, myalgia, osteoporosis

Nervous system: Headaches, drowsiness, blurred vision, speech impairment (including dysarthria and aphasia), transient cognitive dysfunction, mood alteration, unusual cranial sensations, paresis, encephalopathy, and convulsions.

Renal: Azotemia, hematuria, proteinuria, cystitis

Reproductive: Defective oogenesis or spermatogenesis, loss of libido, impotence, gynecomastia, menstrual dysfunction

Respiratory: Pulmonary fibrosis, respiratory failure, chronic interstitial obstructive pulmonary disease, pleuritic pain and thickening, alveolitis

Skin: 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

DRUG INTERACTIONS

Effects Of Other Drugs On Methotrexate

Drugs That Increase Methotrexate Exposure

Coadministration of methotrexate with the following products may increase methotrexate plasma concentrations, which may increase the risk of methotrexate severe adverse reactions. In some cases, the coadministration of methotrexate with these products may also subsequently reduce active metabolite formation, which may decrease the clinical effectiveness of methotrexate. Increased organ specific adverse reactions may also occur when methotrexate is coadministered with hepatotoxic or nephrotoxic products.

If coadministration cannot be avoided, monitor closely for methotrexate adverse reactions when coadministered with:

  • Oral antibiotics (including neomycin)
  • Antifolate drugs (e.g., dapsone, pemetrexed, pyrimethamine and sulfonamides)
  • Oral or intravenous penicillin or sulfonamide antibiotics
  • Aspirin and other nonsteroidal antiinflammatory drugs
  • Hepatotoxic products
  • Highly protein-bound drugs (e.g., oral anticoagulants, phenytoin, salicylates, sulfonamides, sulfonylureas, and tetracyclines)
  • Proton pump inhibitors
  • Weak acids (e.g., salicylates)
  • Nephrotoxic products
  • Probenecid
Nitrous Oxide

Coadministration of methotrexate with nitrous oxide anesthesia potentiates the effect of methotrexate on folate-dependent metabolic pathways, which may increase the risk of severe methotrexate adverse reactions. Avoid nitrous oxide anesthesia in patients receiving methotrexate. Consider alternative therapies in patients who have received prior nitrous oxide anesthesia.

Folic Acid

Coadministration of methotrexate with folic acid or its derivatives decreases the clinical effectiveness of methotrexate in patients with neoplastic diseases. Methotrexate competes with reduced folates for active transport across cell membranes. Instruct patients to take folic or folinic acid only as directed by their healthcare provider [see WARNINGS AND PRECAUTIONS].

Read the entire FDA prescribing information for Trexall (Methotrexate)

© Trexall Patient Information is supplied by Cerner Multum, Inc. and Trexall Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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