- This drug may raise the chance of heart and blood vessel side effects like heart attack and stroke. If these happen, they can be deadly. The risk of these side effects may be greater if your child has heart disease or risks for heart disease. However, the risk may also be raised in people who do not have heart disease or risks for heart disease. The risk of these health problems can happen as soon as the first weeks of using this drug and may be greater with higher doses or with long-term use. Do not give this drug to your child right before or after bypass heart surgery.
- This drug may raise the chance of very bad and sometimes deadly stomach or bowel side effects like ulcers or bleeding. The risk is greater in older people. The risk is also greater in people who have had stomach or bowel ulcers or bleeding before. These problems may occur without warning signs. Talk with the doctor.
- It is used to ease pain, swelling, and fever.
- It is used to treat arthritis.
- It may be given to your child for other reasons. Talk with the doctor.
- If your child has an allergy to this drug or any part of this drug.
- If your child has an allergy to aspirin or NSAIDs.
- If your child is allergic to any drugs like this one or any other drugs, foods, or other substances. Tell the doctor about the allergy and what signs your child had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
- If your child has kidney disease.
- If your child has GI (gastrointestinal) bleeding.
- If your child is having her fertility checked.
- If your child is taking phenylbutazone.
- If your child is taking any other NSAID.
- If your child is taking a salicylate drug like aspirin.
- If your child is taking pemetrexed.
If your child is pregnant or breast-feeding a baby:
- Do not give this drug to your child if she is in the third trimester of pregnancy. You may also need to avoid giving this drug to your child at other times during pregnancy. Talk with your child’s doctor to see when you need to avoid giving this drug to your child during pregnancy.
- Talk with the doctor if your child is breast-feeding a baby or plans to breast-feed a baby.
- Tell all of your child’s health care providers that your child is taking this drug. This includes your child’s doctors, nurses, pharmacists, and dentists.
- Have your child’s blood work checked if he/she is on this drug for a long time. Talk with your child’s doctor.
- This drug may affect certain lab tests. Tell all of your child’s health care providers and lab workers that your child takes this drug.
- High blood pressure has happened with drugs like this one. Have your child’s blood pressure checked as you have been told by the doctor.
- Alcohol may interact with this drug. Be sure your child does not drink alcohol.
- If your child smokes, talk with the doctor.
- Do not give your child more of this drug than what the doctor told you to give. Giving more of this drug than you are told may raise the chance of very bad side effects.
- Do not have your child use longer than you have been told by your child’s doctor.
- If your child has asthma, talk with the doctor. He/she may be more sensitive to this drug.
- Your child may bleed more easily. Make sure your child is careful and avoids injury. Be sure your child has a soft toothbrush.
- The chance of heart failure is raised with the use of drugs like this one. In people who already have heart failure, the chance of heart attack, having to go to the hospital for heart failure, and death is raised. Talk with the doctor.
- The chance of heart attack and heart-related death is raised in people taking drugs like this one after a recent heart attack. People taking drugs like this one after a first heart attack were also more likely to die in the year after the heart attack compared with people not taking drugs like this one. Talk with the doctor.
- If your child is taking aspirin to help prevent a heart attack, talk with the doctor.
- This drug may affect how much of some other drugs are in the body. If your child is taking other drugs, talk with the doctor. Your child may need to have blood work checked more closely while taking this drug with other drugs.
If your child is or may be sexually active:
- NSAIDs like this drug may affect egg release (ovulation) in females. This may affect being able to get pregnant. This goes back to normal when this drug is stopped. Talk with the doctor.
If your child is pregnant:
- This drug may cause harm to the unborn baby if your child takes it during pregnancy. If your child is pregnant or gets pregnant while taking this drug, call the doctor right away.
- 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 or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Signs of bleeding like throwing up blood or throw up that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; vaginal bleeding that is not normal; bruises without a reason or that get bigger; or any bleeding that is very bad or that you cannot stop.
- 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 high potassium levels like a heartbeat that does not feel normal; feeling confused; feeling weak, lightheaded, or dizzy; feeling like passing out; numbness or tingling; or shortness of breath.
- Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
- Shortness of breath, a big weight gain, swelling in the arms or legs.
- Chest pain or pressure or a fast heartbeat.
- Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
- Feeling very tired or weak.
- Ringing in ears.
- Mood changes.
- Low mood (depression).
- Very bad belly pain.
- Very bad back pain.
- Liver problems have happened with drugs like this one. Sometimes, this has been deadly. Call the doctor right away if your child has 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.
- 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 your child has signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in the mouth, throat, nose, or eyes.
- Belly pain or heartburn.
- Upset stomach or throwing up.
- Hard stools (constipation).
- Loose stools (diarrhea).
- Feeling tired or weak.
- Give this drug with or without food. Give with food if it causes an upset stomach.
- Give this drug with a full glass of water.
- Have your child swallow whole. Do not let your child chew, break, or crush.
- If your child takes this drug on a regular basis, give a missed dose as soon as you think about it.
- If it is close to the time for your child’s next dose, skip the missed dose and go back to your child’s normal time.
- Do not give 2 doses at the same time or extra doses.
- Many times this drug is given on an as needed basis. Do not give to your child more often than told by the doctor.
- Store at room temperature.
- 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.
- Check with your pharmacist about how to throw out unused drugs.
- If your child’s symptoms or health problems do not get better or if they become worse, call your child’s doctor.
- Do not share your child’s drug with others and do not give anyone else’s drug to your child.
- Keep a list of all your child’s drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your child’s doctor.
- Talk with your child’s doctor before giving your child any new drug, including prescription or OTC, natural products, or vitamins.
- Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your child’s 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.