This information from Lexicomp® explains what you need to know about this medication, including what it’s used for, how to take it, its side effects, and when to call your healthcare provider.
- It is used to lower the chance of heart attack, stroke, and death in some people.
- If you are allergic to this drug; any part of this drug; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
- If you have an allergy to aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen.
- If you have gotten nasal polyps or had swelling of the mouth, face, lips, tongue, or throat; unusual hoarseness; or trouble breathing with aspirin or NSAID use.
- If you have bleeding problems.
- If you have any of these health problems: Kidney disease or liver disease.
- If you have had kidney problems caused by this drug or a drug like this one.
- If you are taking any of these drugs: Atazanavir, clopidogrel, nelfinavir, rifampin, rilpivirine, St. John’s wort, ticagrelor, or voriconazole.
- If you are taking another drug that has the same drug in it.
- If you are taking any other NSAID.
- If you are having trouble getting pregnant or you are having your fertility checked.
- If you are pregnant, plan to become pregnant, or get pregnant while taking this drug. This drug may cause harm to an unborn baby if taken at 20 weeks or later in pregnancy. If you are between 20 to 30 weeks of pregnancy, only take this drug if your doctor has told you to. Do not take this drug if you are more than 30 weeks pregnant.
- If you are breast-feeding. Do not breast-feed while you take this drug.
- If the patient is a child. This drug is not approved for use in children. The risk of a severe problem called Reye’s syndrome may be raised in children or teenagers who have or are getting better from flu-like symptoms, chickenpox, or other viral infections. Do not give this drug to a child or teenager who has or is getting better from a viral infection.
This is not a list of all drugs or health problems that interact with this drug.
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 this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
- Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
- You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
- This drug may raise the chance of severe and sometimes deadly stomach or bowel problems like ulcers or bleeding. The risk is greater in older people, and in people who have had stomach or bowel ulcers or bleeding before. These problems may occur without warning signs.
- This drug may affect certain lab tests. Tell all of your health care providers and lab workers that you take this drug.
- This drug may raise the chance of hip, spine, and wrist fractures in people with weak bones (osteoporosis). The chance may be higher if you take this drug in high doses or for longer than a year, or if you are older than 50 years old.
- Rarely, low magnesium levels have happened in people taking drugs like this one for at least 3 months. Most of the time, this happened after 1 year of treatment. You will need to have blood work if you take this drug for a long time or with certain other drugs.
- Rarely, long-term treatment (for instance longer than 3 years) with drugs like this one has caused low vitamin B-12 levels. Call your doctor right away if you have signs of low vitamin B-12 levels like shortness of breath, dizziness, abnormal heartbeat, muscle weakness, pale skin, tiredness, mood changes, or numbness or tingling in the arms or legs.
- Lupus has happened with this drug, as well as lupus that has gotten worse in people who already have it. Tell your doctor if you have lupus. Call your doctor right away if you have signs of lupus like a rash on the cheeks or other body parts, sunburn easy, muscle or joint pain, chest pain or shortness of breath, or swelling in the arms or legs.
- Very bad pancreas, liver, and white blood cell problems have happened in people who were taking this drug. Rarely, these have been fatal. Talk with the doctor if you have questions.
- This drug may raise the chance of a severe form of diarrhea called C diff-associated diarrhea (CDAD). Call your doctor right away if you have stomach pain or cramps, very loose or watery stools, or bloody stools. Do not try to treat diarrhea without first checking with your doctor.
- A severe and sometimes deadly reaction has happened with drugs like this one. Most of the time, this reaction has signs like fever, rash, or swollen glands with problems in body organs like the liver, kidney, blood, heart, muscles and joints, or lungs. If you have questions, talk with the doctor.
- If you are of Asian descent, use this drug with care. You could have more side effects.
- NSAIDs like this drug may affect egg release (ovulation). This may affect being able to get pregnant. This goes back to normal when this drug is stopped. Talk with the doctor.
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 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 low magnesium levels like mood changes, muscle pain or weakness, muscle cramps or spasms, seizures, shakiness, not hungry, very bad upset stomach or throwing up, or a heartbeat that does not feel normal.
- 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 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 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 a pancreas problem (pancreatitis) like very bad stomach pain, very bad back pain, or very bad upset stomach or throwing up.
- Bone pain.
- Very bad dizziness or passing out.
- Ringing in ears.
- Swollen gland.
- A severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause severe 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.
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:
- Stomach pain or heartburn.
- Upset stomach or throwing up.
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 your national health agency.
Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely.
- Take this drug at least 60 minutes before a meal.
- Swallow whole. Do not chew, break, crush, or dissolve.
- Take with a full glass of water.
- Keep taking this drug as you have been told by your doctor or other health care provider, even if you feel well.
- Do not take this drug for longer than you were told by your doctor.
- Do not stop taking this drug without calling the doctor who ordered it for you.
- Do not use this drug for sudden signs of a heart attack or stroke. Talk with your doctor about what to do if these signs happen to you.
- Talk with your doctor before you drink alcohol.
- Use care if you have risks for soft, brittle bones (osteoporosis). Some of these risks include drinking alcohol, smoking, taking steroids, taking drugs to treat seizures, or having family members with osteoporosis. Talk with your doctor about your risks of osteoporosis.
- Take a missed dose as soon as you think about it.
- If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
- Do not take 2 doses at the same time or extra doses unless told to do so by your doctor.
- Store tablets in the original container at room temperature. Keep the cap tightly closed.
- Store in a dry place. Do not store in a bathroom.
- 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.
- 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. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.
- This drug comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this drug is refilled. If you have any questions about this drug, please talk with the doctor, 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.
This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine. The use of this information is governed by the Lexicomp End User License Agreement, available at https://www.wolterskluwer.com/en/solutions/lexicomp/about/eula.
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