Rheumatrex Dose Pack 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 Rheumatrex Dose Pack.

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]