Rasuvo Side Effects
Generic name: methotrexate
Medically reviewed by Drugs.com. Last updated on Feb 23, 2024.
Note: This document provides detailed information about Rasuvo Side Effects associated with methotrexate. Some dosage forms listed on this page may not apply specifically to the brand name Rasuvo.
Applies to methotrexate: powder for solution, solution.
Other dosage forms:
Important warnings
This medicine can cause some serious health issues
Precautions
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects. Blood tests and chest x-rays may be needed to check for unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby. The medicine may also cause birth defects if it is used by the father when his sexual partner becomes pregnant. If you are a woman who can bear children, your doctor may give you a pregnancy test before you start using this medicine to make sure you are not pregnant. Female patients should use an effective form of birth control during treatment and for at least 6 months after the last dose. Male patients who have female partners should use an effective form of birth control during treatment and for at least 3 months after the last dose. Tell your doctor right away if pregnancy occurs while you are using this medicine.
Talk with your doctor before using this medicine if you plan to have children. Some men and women who use this medicine have become infertile (unable to have children).
Limit alcohol use with this medicine. Alcohol may increase the risk for liver problems.
This medicine may cause organ system toxicity. Call your doctor right away if you have the following symptoms: a fever, confusion, diarrhea, dry cough, irritability, neck stiffness, seizures, severe skin rash, sleepiness, trouble breathing, weakness, vomiting, or problems with coordination.
Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.
This medicine may cause serious nerve problems. Check with your doctor right away if you have seizures, confusion, tingling or numbness in your hands, feet, or lips, trouble seeing, or headache.
Methotrexate can lower the number of white blood cells in your blood, which increases the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:
- If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
- Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
- Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
- Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
- Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
- Avoid contact sports or other situations where bruising or injury could occur.
While you are being treated with methotrexate (the active ingredient contained in Rasuvo) and after you stop treatment with it, do not have any immunizations (vaccines) without your doctor's approval. Methotrexate may lower your body's resistance and the vaccine may not work as well or you might get the infection the vaccine is meant to prevent. In addition, you should not be around other persons living in your household who receive live virus vaccines because there is a chance they could pass the virus on to you. Some examples of live vaccines include measles, mumps, influenza (nasal flu vaccine), poliovirus (oral form), rotavirus, and rubella. Do not get close to them and do not stay in the same room with them for very long. If you have questions about this, talk to your doctor.
Check with your doctor right away if you have cough, fever, or trouble breathing. These could be symptoms of a serious lung or breathing problems (eg, acute or chronic interstitial pneumonitis).
Tell your doctor right away if you have a change in how much or how often you urinate, rapid weight gain, swelling in the legs, ankles, or feet, or trouble breathing. These could be symptoms of a serious kidney problem.
Serious skin reactions (eg, toxic epidermal necrolysis, Stevens-Johnson syndrome, exfoliative dermatitis, skin necrosis, or erythema multiforme) can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, blue-green to black skin discoloration, cough, cracks in the skin, diarrhea, itching, joint or muscle pain, loss of heat from the body, red irritated eyes, red skin lesions, often with a purple center, sore throat, sores, ulcers, or white spots in the mouth or on the lips, fever or chills, or unusual tiredness or weakness while you are using this medicine.
This medicine may make your skin more sensitive to sunlight. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds.
This medicine may make you dizzy or tired. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
This medicine may increase your risk of having a lymphoma (cancer of the lymph system). Discuss these possible effects with your doctor.
This medicine may cause a serious reaction called tumor lysis syndrome. Tell your doctor right away if you have a change in urine amount, joint pain, stiffness, or swelling, lower back, side, or stomach pain, rapid weight gain, swelling of the feet or lower legs, or unusual tiredness or weakness.
Using this medicine with radiation therapy may increase risk of tissue or bone problems, such as tissue or bone not receiving enough blood. Tell your doctor if you are receiving other treatments, including radiation therapy, while using this medicine.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Serious side effects of Rasuvo
Along with its needed effects, methotrexate 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 side effects
- 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 side effects
- 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 Rasuvo
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 side effects
- hair loss, temporary
- loss of appetite
- nausea or vomiting
Less common side effects
- 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, intravenous solution, oral liquid, oral solution, oral tablet, subcutaneous solution.
General adverse events
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]
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References
1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
2. Cerner Multum, Inc. "Australian Product Information."
3. (2017) "Product Information. Methotrexate Sodium (methotrexate)." Teva Pharmaceuticals (formerly IVAX)
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Further information
Rasuvo side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.