Uses of Methotrexate Oral Solution:

• It is used to treat cancer.
• It is used to treat some types of arthritis.
• It may be given to you for other reasons. Talk with the doctor.

What do I need to tell my doctor BEFORE I take Methotrexate Oral Solution?

• If you are allergic to methotrexate oral solution; any part of methotrexate oral solution; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have any of these health problems: Bone marrow disease (like low white blood cell count, low platelet count, or anemia), drinking problem, liver disease, or a weak immune system.
• If you are breast-feeding. Do not breast-feed while you take methotrexate oral solution. You may also need to avoid breast-feeding for some time after your last dose. Talk with your doctor to see if you need to avoid breast-feeding after your last dose.

This is not a list of all drugs or health problems that interact with methotrexate oral solution.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take methotrexate oral solution with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Methotrexate Oral Solution?

For all uses of methotrexate oral solution:

• Tell all of your health care providers that you take methotrexate oral solution. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how methotrexate oral solution affects you.
• You may have more chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu.
• You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
• Talk with your doctor before getting any vaccines. Use of some vaccines with methotrexate oral solution may either raise the chance of an infection or make the vaccine not work as well.
• Avoid drinking alcohol while taking methotrexate oral solution.
• You may get sunburned more easily. Avoid sun, sunlamps, and tanning beds. Use sunscreen and wear clothing and eyewear that protects you from the sun. Keep protecting yourself from sunburn for as long as you were told by your doctor.
• Tell your doctor if you have too much sweat, fluid loss, throwing up, diarrhea, not hungry, or more thirst.
• A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
• If you are 65 or older, use methotrexate oral solution with care. You could have more side effects.
• This medicine may affect fertility. This may lead to not being able to get pregnant or father a child. If this happens, it is not known if fertility will go back to normal.
• If you are a woman and you miss a period, have unprotected sex, or think that your birth control has not worked, call your doctor right away.

Cancer treatment:

• Patients with cancer who take methotrexate oral solution may be at a greater risk of getting a severe health problem called tumor lysis syndrome (TLS).This may lead to death. Call your doctor right away if you have a fast or abnormal heartbeat; any passing out; trouble passing urine; muscle weakness or cramps; upset stomach, throwing up, diarrhea, or not able to eat; or feel sluggish.

How is this medicine (Methotrexate Oral Solution) best taken?

Use methotrexate oral solution as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Measure liquid doses carefully. Use the measuring device that comes with methotrexate oral solution. If there is none, ask the pharmacist for a device to measure methotrexate oral solution.
• Do not use a household teaspoon or tablespoon to measure methotrexate oral solution. Doing so could lead to the dose being too high.
• Take as you have been told by your doctor. This medicine is not to be used every day. Be sure you know how to use methotrexate oral solution.
• How methotrexate oral solution is taken may change based on blood work results, side effects, and how well the drug is working.
• You will need to take special care when handling methotrexate oral solution. Check with the doctor or pharmacist to see how to handle methotrexate oral solution.
• Drink lots of noncaffeine liquids unless told to drink less liquid by your doctor.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
• Signs of bleeding like throwing up or coughing up blood; vomit that looks like coffee grounds; blood in the urine; black, red, or tarry stools; bleeding from the gums; abnormal vaginal bleeding; bruises without a cause or that get bigger; or bleeding you cannot stop.
• Signs of a pancreas problem (pancreatitis) like very bad stomach pain, very bad back pain, or very bad upset stomach or throwing up.
• Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Signs of lung or breathing problems like shortness of breath or other trouble breathing, cough, or fever.
• Signs of nerve problems like a burning, numbness, or tingling feeling that is not normal; weakness; or not being able to move a part of the body (paralysis).
• Pinpoint red spots on the skin.
• Very bad dizziness or passing out.
• Seizures.
• Feeling confused.
• Feeling sleepy.
• Change in eyesight.
• Bone pain.
• Swelling, warmth, numbness, change of color, or pain in a leg or arm.
• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
• Headache.
• Neck stiffness.

What are some other side effects of Methotrexate Oral Solution?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Upset stomach or throwing up.
• Not hungry.
• Hair loss.
• Feeling dizzy, tired, or weak.
• Stomach pain.
• Signs of a common cold.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Methotrexate Oral Solution?

• Store liquid (solution) in a refrigerator or at room temperature. If stored at room temperature, throw away any part not used after 2 months.
• Keep lid tightly closed.
• Do not freeze.
• Protect from heat.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about methotrexate oral solution, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Frequently asked questions

• Why should I take folic acid with methotrexate?
• How do I know if methotrexate is working for rheumatoid arthritis?
• Does it cause weight gain?
• How long does it take to work?
• What causes Plaque Psoriasis?
• How long does methotrexate stay in your system?
• How does methotrexate work for ectopic pregnancy?
• What are the different brands of methotrexate?

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